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Images and videos can be transferred to a PACS server. The following formats and protocols are used during the transfer
from the displaying unit to the PACS server:

Item

Format

Protocols

Comments

Images

DICOM object / PNG

DICOM without CMS

Can use either Wi-Fi or LAN communication.

Video

DICOM object / MP4
(h.264)

DICOM without CMS

Can use either Wi-Fi or LAN communication.

Appendix 3.3 Cybersecurity Bill Of Materials (CBOM)

The following main off-the-shelf software components are used in the displaying unit.
The main known vulnerabilities of each component are included with an explanation of, why they are acceptable for this
application. Vulnerabilities with a low CVSS score are omitted in this list as a consequence of the low security risk rating of
the displaying unit.

Title

Version

Used for

Known vulnerabilities from NVD (CVSS score)

Qt

5.12

Qt is used for the
graphical user interface
(GUI).

CVE-2019-18281 (7.5)
Can cause denial of service, by handcrafting text file containing
directional characters.

In the displaying unit there are no known interactions which allows
text files from a user to be loaded into Qt.

Boost

1.68.0

Boost is used for IO file
interaction and
asynchronous handling.

The only known exploits in IO file handling for boost are for XSS
exploits for web environment, which is not used in displaying unit.

Libyaml

0.6.2

Is used to parse YAML files
on the device.
YAML files are used for
configuration, including
keys and values.

CVE-2019-6292 (6.5)
CVE-2019-6285 (6.5)
CVE-2018-20574 (6.5)
CVE-2018-20573 (6.5)
3 of these are handcrafted malicious YAML files causing a
denial of service and one causing a stack exhaustion.

The displaying unit does not allow any external YAML file to be
added to the device.

SQLite

3.22

Main database.

None

Linux

Linux
Kernel
version
4.4

The embedded Linux
kernel is built custom
by Ambu.

Many known issues, but none of these are critical to the
Displaying Unit.
Some of the media and interactions kernel are
described below.

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Содержание 405011000

Страница 1: ...Reference Manual for Ambu aView 2 Advance For use by trained clinicians physicians qualified technicians and qualified professionals only For in hospital use For use with Ambu visualization devices ...

Страница 2: ...Ambu is a registered trademark and aScope and aView are trademarks of Ambu A S 2 ...

Страница 3: ... 3 Network setup 13 4 2 4 PACS setup 16 4 2 5 General settings 18 4 3 User profiles 19 4 3 1 User types 19 4 3 2 Create and edit user profiles 20 4 3 3 Password requirement 21 5 Operating the displaying unit 22 5 1 Live View main screen 22 5 1 1 Adjusting live image appearance 23 5 1 2 Rotation of live image 180 degrees 25 5 1 3 Recording images and videos 26 5 1 4 Access recorded images and video...

Страница 4: ...isted below No Part Function 1 Casing 2 LCD Touch Screen Displays the image from the Ambu visualization device and the graphical user interface 3 Stand Use the stand to place the displaying unit on a solid surface and to carry the displaying unit while turned OFF 4 Connector ports for Ambu visualization devices Match and align colours and arrows on device plug and the connector port 5 Power button...

Страница 5: ...button on the side of the displaying unit When the power button is released a pop up window will ask you to confirm that the displaying unit should be turned off If the battery level is low charge the displaying unit see section 3 6 3 2 Choosing connecter port orientation The displaying unit can be rotated 180 degrees to have the connector ports for the visualization devices oriented left or right...

Страница 6: ...ned sufficiently 2 Attach the power supply bracket on the bracket and place the power supply in the power supply bracket 3 The hook on the power supply bracket can be used for storing visualization devices in pouches The power adapter cable can be rolled up on the power supply bracket to improve cable management 4 When the bracket is secured on the pole the displaying unit is mounted on the bracke...

Страница 7: ...unit is charging the power button is orange When remaining battery level is below 20 of full capacity the power button will start blinking to indicate low battery level and charging is recommended This occurs both if the displaying unit is turned ON or OFF 3 6 Charging the displaying unit The displaying unit is charged by connecting the supplied power supply as follows Connect the power cord to a ...

Страница 8: ...fication will remain visible when the battery turns red until manually closed The battery status is also indicated by the light in the power button See section 3 5 3 8 Connecting an Ambu visualization device 1 The displaying unit has two identical connector ports for Ambu visualization devices marked with blue rings To connect a device Insert the connector plug 1 on the Ambu visualization device c...

Страница 9: ...ment which are approved as medical electrical equipment 3 10 Connecting to Wi Fi and local area network LAN The displaying unit contains a Wi Fi module and ethernet connection to connect the device to a local network This can be used for exporting recorded imaging data to a PACS picture archiving and communication system on the hospital network see section 5 2 3 If a network error occurs in your o...

Страница 10: ...default login is required to gain the full functionality of the displaying unit Without logging in the default user see section 4 3 1 is active and you only have access to the functions in Live View and the Current Procedure folder For a new displaying unit the temporary password for the Administrator is AmbuAdmin The password must be changed according to your organization s guideline once the dis...

Страница 11: ...ase note that your organization is responsible for the following areas which should be implemented according to your local policy and schedule Network setup Ensuring availability and confidentiality of network Ensuring confidentiality and integrity of physical devices Management of the displaying unit user profiles Maintenance of user passwords Monitoring and audit of the Ambu Imaging System Compl...

Страница 12: ...ference for the graphical user interface is selected By default the language setting of the displaying unit is English When setting up the displaying unit select your language preference Press the Settings tab in the tool bar on the right Press Setup and the Language 1 menu will be open Open the System language 2 drop down menu and select language from the list 1 2 NOTE The language will change im...

Страница 13: ...ed automatically Use the Set time 5 wheel to set the current time Select the current date in the Date 6 calendar The settings are activated as soon as they are chosen 3 4 5 6 4 2 3 Network setup In Network Setup under the Setup menu you can setup connection to Wi Fi and local area network LAN NOTE Always use a secure network when handling images and patient data See technical details about the con...

Страница 14: ... static fixed Hostname 8 of the device This is used if it is required to have a fixed name by which the device is recognized on the network similar to a static IP address The Hostname can be between 1 and 63 characters excl dot separator is the format of xxx xxx xxx with dots separating e g domain names The following characters are allowed a z lowercase letters A Z uppercase letters 0 9 numbers hy...

Страница 15: ...tion to a login webpage for entering user name and password are not supported on the displaying units You can choose automatic connection to this specific network by pressing the ON OFF by Connect automatically 13 The displaying unit will then automatically connect to this network when it is recognized 13 12 When Wi Fi is connected a Wi Fi symbol will be shown above the battery level indicator in ...

Страница 16: ...configuration of PACS in Appendix 3 To access the DICOM setup page login as Administrator Press the Settings tab in the tool bar on the left Press Setup and press DICOM setup An overview of already configured PACS servers is shown if any Choose Device AE Application Entity title to enter the name of the displaying unit The default name is AmbuMon This name will allow the PACS to recognize the disp...

Страница 17: ... connection to PACS server Press Add new and the Configure new PACS server menu will appear Press the first field PACS name 15 and type to add the details Use the arrow 16 to go to the next field 15 16 17 EN ...

Страница 18: ...rades In Live view controls the rotation of the graphical user interface can be locked so it does not rotate when the displaying unit is physically rotated to have connectors to the left or right see section 3 2 You can lock the orientation of the graphical user interface to your preferrece by disabling the automatic rotation when the interface is in your preferred position The Access archive with...

Страница 19: ...ave different degrees of system access and privileges as shown in the table below User Types and System Access User Type Function Access Default User Advanced User Admin User Service User Instant access without login Daily operation Administrator with full access Service related tasks Login Required x x x Live View x x x x Video Recording x x x x Snapshot x x x x 1 Current Procedure x x x x Image ...

Страница 20: ...ve privileges to change their own passwords 4 3 2 Create and edit user profiles To access the User profiles menu Press the Settings tab in the tool bar on the left Press User Profiles Create a new Advanced User profile Press Add user 1 Enter User name Password and Repeat password 2 Use the arrows to go to the next field Password must be at least 8 characters For information on password requirement...

Страница 21: ...Save button Press OK in the pop up window to confirm the change 4 4 3 3 Password requirement Passwords are required to be at least 8 characters Any character is allowed It is recommended to use a combination of capital and small letter numbers and symbols to enhance password protection 21 EN ...

Страница 22: ...rea Tool bar Live View is active The toolbar is always located in the left side of the screen It contains the Live View Archive Login and Settings tabs The active tab in the tool bar is always highlighted in green colour The toolbar is always visible when sub menus are opened It is always possible to go back to Live View with one click on the Live View tab The icons in the Live View are described ...

Страница 23: ... image area If no action is taken within 5 seconds the first level menu will close again If user selects any of the sub menus a new menu will open that covers the live image 5 1 1 Adjusting live image appearance In the Image Adjustment menu you can change the Colour Contrast and Sharpness in the live image as well as the Brightness backlight of the LCD screen An Image Rotation function is also ava...

Страница 24: ...s for each image parameter is in the middle indicated by the small arrow below the slider bar marked with a red circle Explanation of icons in Image Adjustments Icon Name Function Colour Adjusts the image colour temperature from cold to warm Contrast Adjust the image contrast the higher value the larger difference between dark and bright areas Sharpness Enhances the image details the higher value ...

Страница 25: ...ve image This symbol R indicates that the image is rotated 180 degrees compared to default orientation To return image orientation back to normal press the Image Rotation again R The displaying unit will remember the setting of the image rotation also when the system is restarted NOTES The images and video are recorded in rotated orientation but the inverted R icon is not saved in the recording Th...

Страница 26: ...lization device Maximum video recording length The maximum duration of a recorded video sequence is 30 minutes A notification will be shown in the user interface area when the time limit is about to be reached The recording will stop automatically when the limit is reached and the thumbnail will show and animate into the procedure folder See also sections 5 2 for information on access to stored im...

Страница 27: ... is opened through the Current Procedure Folder When a procedure is ended by disconnecting the visualization device the Current Procedure 1 folder will open automatically to show the recorded files If no files are recorded the procedure folder is created internally in the displaying unit to recognize the visualization device if connected again Administrators have privileges to see these empty proc...

Страница 28: ...wo live images simultaneously when two Ambu visualizations devices are connected in at the same time see section 3 8 The displaying unit will show two live images a bigger image on the left and a smaller image on the right The images are not overlapping In the upper left corner of each live image a roman numeral I II III is indicating which visualization device is displayed in each image The roman...

Страница 29: ...Administrator see section 4 1 How to log in 5 2 Archive In the Archive recordings from all previous procedures can be found The recordings are saved in procedure folders which are unique for each visualization device connected to the displaying unit see section 5 2 1 To access the Archive log in as Advanced User or Administrator see section 4 1 Press the Archive tab in the tool bar and press Recen...

Страница 30: ...ocedure archive by deleting multiple procedure folders Administrators can also see all empty procedure folders which are created for connected visualization devices where no recordings are made These empty procedure folders are not visible to other users To delete procedure folders select the individual folders to be deleted by pressing the Selection box or used Select all to select all folders in...

Страница 31: ... the name of the specific displaying unit set up in Settings as Device Name All the recorded images and videos in the procedure are shown in descending order with the newest recording at the top left Below each recording is the file name and a selection box The Select all icon is found above the recordings overview The file name is XXXX indicating the image count starting from 0001 The count does ...

Страница 32: ...ording These data are stored on the displaying unit with the files and not exported to USB and PACS On the left side you will find the procedure name and any notes written for the procedure To playback a video Press the play 10 in the centre of full size video to view it A playback bar is shown below the playing video To stop pause the video press pause 10 To step forward and backwards frame by fr...

Страница 33: ...iew Use Selection box or Select all to select the recording s to be deleted Press the Trach Can to delete selected files A pop up confirmation window will appear prior to deleting to show how many files are about to be deleted and for you to confirm To proceed with delete press OK or press Cancel to stop You may also delete a file directly in the file viewer Press the Trach Can to delete the viewe...

Страница 34: ...edure name and the note if any Example below the procedure name is 2020 02 04 001 and the note written is For teaching The exported files in the folder will be called YYYY MM DD XXX XXXX Where XXX is the procedure count and XXXX is the image count within the procedure To export files go to the Procedure folder to view all recordings in the procedure Use the Selection boxes to select individual or ...

Страница 35: ...porting has completed Press OK to finalize exporting NOTES Always check that the entered patient data is correct when exporting to PACS Protected Health Information PHI for the patien is not stored on the displaying unit They are only used to send with the DICOM files to the PACS for correct identification and storage Always use a secure network when exporting files from the displaying unit You wi...

Страница 36: ...r software SW version build time and disk size This menu also gives you an overview of the current system conditions such as disk space and device temperature 1 6 2 System upgrade In System Upgrade under the About the system upgrade function is placed The software can only be upgraded by Ambu For more information contact your local Ambu representative 36 ...

Страница 37: ...se follow these steps to export a log file to a USB device Connect a portable USB device see section 3 11 Go to Settings and open the About menu Press Export log files 1 and press the Export icon A pop up window will inform you if the export was successful 1 6 4 Backup It is recommended to make a backup of your files on a regular basis by exporting videos and images to an external storage location...

Страница 38: ...F energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emission CISPR 11 Class A The system is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings...

Страница 39: ...onment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth Mains power quality shall be that of a typical commercial or hospital environment Voltage Dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 Ut 95 dip in Ut for 0 5 cycle 40 Ut 60 dip in Ut for 5 cycles 70 Ut 30 dip in Ut for 25 cycles 5 Ut 95 dip in Ut for 5 sec 100 reduction 0 5 period...

Страница 40: ...d by an electromagnetic site survey a Should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated Radio Frequency IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 80 AM at 1 kHz 3 V m 80 2700 MHz 80 AM at 1 kHz NOTE 1 At 80 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all si...

Страница 41: ...y of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Appendix 2 R...

Страница 42: ...adiation Exposure Statement Déclaration d exposition aux radiations EN This equipment complies with ISED radiation exposure limits set forth for an uncontrolled environment This equipment should be installed and operated with greater than 20cm between the radiator your body FR Cet équipement est conforme aux limites d exposition aux rayonnements ISED établies pour un environnement non contrôlé Cet...

Страница 43: ...h for an uncontrolled environment This equipment should be installed and operated with minimum distance 20cm between the radiator your body Wi Fi Standard IEEE802 11ac IEEE802 11a IEEE802 11b IEEE 802 11g IEEE 802 11n ISM frequency Band 2 4 5 GHz Data Rate 802 11a 54 48 36 24 18 12 9 6 Mbps 802 11b 11 5 5 2 1 Mbps 802 11g 54 48 36 24 18 12 9 6 Mbps 802 11n MCS 0 to 15 for HT20MHz MCS 0 to 15 for H...

Страница 44: ...T network responsible at the organization where the displaying unit is used It contains technical information regarding the setup of the IT network and the devices connected to the displaying unit It also contains information regarding the types of data contained in and transmitted from the displaying unit The displaying unit is of low security risk as No PHI is stored in the displaying unit The d...

Страница 45: ...as a NAT Network Address Translation gateway PACS servers DICOM To support a broad range of network infrastructures and PACS servers the device supports DICOM without CMS Cryptographic Message Syntax encryption for transporting images and video to the PACS server Ports There are no open ports the device firewall only accepts TCP responses for DICOM and replies to ICMP ping requests Appendix 3 2 Da...

Страница 46: ...terface GUI CVE 2019 18281 7 5 Can cause denial of service by handcrafting text file containing directional characters In the displaying unit there are no known interactions which allows text files from a user to be loaded into Qt Boost 1 68 0 Boost is used for IO file interaction and asynchronous handling The only known exploits in IO file handling for boost are for XSS exploits for web environme...

Страница 47: ...ing The displaying unit validates a signed public key certificate for the upgrade software and isn t applicable for this kind of vulnerability CVE 2019 12572 7 8 A vulnerability in the London Trust Media Private Internet Access PIA VPN Client 1 0 2 for Windows Not applicable for displaying unit running Linux without VPN CVE 2018 0734 5 9 The OpenSSL DSA signature algorithm has been shown to be vul...

Страница 48: ...Ambu A S Baltorpbakken 13 DK 2750 Ballerup Denmark T 45 72 25 20 00 F 45 72 25 20 50 ambu com 495 4060 01 V01 2020 04 TCC 10817 ...

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