Reference Manual
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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.
Ambu is a registered trademark and aScope and aView are trademarks of Ambu A/S. 2
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Content 1. Important information ... 4 2. Device overview ... 4 3. Setting up the displaying unit ... 5 3.1. Turning power ON and OFF ... 5 3.2. Choosing connecter port orientation ... 5 3.3. Placing the displaying unit on a solid surface ... 6 3.4. Mounting the displaying unit on a pole ... 6 3.5. Power button light indications ... 7 3.6. Charging the displaying unit ... 7 3.7. Battery status on the graphical user interface ... 8 3.8. Connecting an Ambu visualization device ... 8 3.9. Connecting to external screens using HDMI or SDI ... 9 3.10. Connecting to Wi-Fi and local area network (LAN) ... 9 3.11. Connecting USB storage devices ... 9 4. Setting up the displaying unit software ...10 4.1. How to log in ...10 4.2. System setup ... 11 4.2.1. System language ... 12 4.2.2. Date and Time ... 13 4.2.3. 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 videos in Current Procedure folder ...26 5.1.5. Zoom ...27 5.1.6. Dual View ...28 5.2. Archive ...29 5.2.1. Viewing Procedure Folder in Archive ...31 5.2.2. Adding a procedure note ...31 5.2.3. Viewing recordings ...32 5.2.4. Deleting files ...33 5.2.5. Export to USB or PACS ...34 6. System information and upgrade ...35 6.1. Monitor information page ...35 6.2. System upgrade ...36 6.3. Reporting a Problem ...37 6.3.1. Export Log Files ...37 6.4. Backup ...37 Appendix 1. Electromagnetic Compatibility ...38 Appendix 2. Radio Frequency Compliance ...41 Appendix 3. Cybersecurity ...44
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1. Important information This is a reference manual for Ambu® aView™ 2 Advance, item number 405011000, software version 1.0.0. The reference manual may be updated without further notice. The latest version of the reference manual is available online at www. ambu.com. In this reference manual, the term displaying unit refers to aView 2 Advance. Please be aware that this manual does not explain or discuss clinical procedures. The reference manual describes only information and functions related to the operation of the aView 2 Advance. Before operating the displaying unit, please read the Instruction for Use (IFU) delivered with your aView 2 Advance or download at www.ambu.com. For specific information about specifications of aView 2 Advance and troubleshooting, please consult the IFU.
2. Device overview The displaying unit consists of the parts listed below
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No.
Part
Function
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Casing
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2
LCD Touch Screen
Displays the image from the Ambu visualization device and the graphical user interface.
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Stand
Use the stand to place the displaying unit on a solid surface and to carry the displaying unit while turned OFF.
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Connector ports for Ambu® visualization devices
Match and align colours and arrows on device plug and the connector port.
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Power button
Push button for power ON and OFF.
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Hardware reset button
Reset the displaying unit hardware without impacting stored data.
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Ventilation holes
Cools hardware during use
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Power inlet
Power inlet for charging the displaying unit.
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Input/output connections*
USB, HDMI, SDI, LAN *Wi-Fi available.
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Power supply
Powers the displaying unit. Power cord with country-specific plug.
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Bracket
Secures the displaying unit to e.g. an IV pole.
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Power supply bracket
Secures the placement of the power supply.
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Release buttons
Releases displaying unit from the bracket.
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Hook
Storage of visualization device pouches.
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3. Setting up the displaying unit This section explains the physical setup of the displaying unit in its place of operation.
3.1. Turning power ON and OFF Turn the displaying unit ON: on the side of the displaying unit. • Press the power button • A live image is available within seconds after power on, if a visualization device is connected. • The graphical user interface takes approximately 20 seconds to start up, but a live image is available as soon as the monitor is turned on. If no visualization device is connected, an animation will be shown how to correctly connect a visualization device to the displaying unit. Turn the displaying unit OFF • Press and release the power 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 in your preferred direction depending on the clinical situation. The displaying unit has a build in sensor which enables the graphical user interface to adapt automatically to its physical orientation. Automatic image rotation can be enabled or disabled under General settings (see section 4.2.5) The displaying unit can be placed on a plane surface with the build-in stand (see section 3.3) or on a pole with the supplied bracket (see section 3.4) in both orientations.
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3.3. Placing the displaying unit on a solid surface Place the displaying unit on a solid flat surface by folding out the stand on the back of the displaying unit. The stand has multiple settings and can be adjusted to a suitable angle.
3.4. Mounting the displaying unit on a pole The displaying unit can be mounted on a pole solution, e.g. an IV pole with wheels for easy portability, using the supplied bracket. NOTE: The bracket is compatible with poles having diameter range of 18-35mm. 1
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Ø 18 - 35mm
Ø 18 - 35mm
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18 - 35mm
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The bracket is mounted on a pole as follows: • Fold out the bracket and tighten the nut in the middle. 1 • Mount the bracket on the pole, and ensure the knob is tightened 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 bracket as follows: • Fold the Stand upwards against the upper edge of the displaying unit. 5 • Place the lower edge of the displaying unit in the bracket. The stand must be oriented upwards. 6 • Push the displaying unit backwards until the lock engages and a click is heard. The hooks on the bracket must engage with the holes on the back of the displaying unit. 7 • Make sure that the displaying unit is securely placed in the bracket before letting go with your hands. 8
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Unmounting the displaying unit from the bracket: • Use two hands to hold the displaying unit, while pressing the two grey release buttons on the bracket behind the displaying unit. 9 • Pull the displaying unit towards yourself. 10
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3.5. Power button light indications Green Light
Orange Light
Flashing orange
Displaying unit is turned ON and battery level is above 40% of full capacity the power button is green.
When the displaying unit is turned ON and the remaining battery level is below 40% of full capacity, the power button turns 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.
When the power supply is connected and displaying unit is charging, the power button is orange.
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 power outlet. • Insert the power plug into the power inlet on the back of the displaying unit. • The power button turns orange and a icon is shown in the battery lightning indicator on the graphical user interface when the displaying unit is charging. Make sure the power supply is present and working at any time. It is recommended to locate the nearest mains socket before starting a procedure.
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3.7. Battery status on the graphical user interface To check the battery level when the displaying unit is turned ON, check the battery indicator 1:45 in the lower left corner of the graphical user interface.
3:00 Green = Battery level > 40% = Charging
0:45 Orange =
A full charge lasts more than 3 hours when the battery is new. The colour of the battery icon indicates the power level. It is recommended to charge the displaying unit if the battery icon is orange or red. When battery level changes to orange (< 40%) and red (< 20%) a notification with an enlarged battery icon will appear in the lower left corner of the graphical user. The notification will remain visible when the battery turns red until manually closed.
Battery level < 40%
0:25 Red =
The battery status is also indicated by the light in the power button. See section 3.5.
Battery level < 20%
3.8. Connecting an Ambu visualization device The displaying unit has two identical connector ports for Ambu visualization devices marked with blue rings.
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To connect a device: • Insert the connector plug 1 on the Ambu visualization device cable into one of the connector ports on the displaying unit. • Ensure that the colours on the connector plug arrow and displaying unit connector ring are matching, and that the arrows are aligned when inserting the plug. Two visualization devices can be connected at the same time. In this case the displaying unit will show the images side by side (see section 5.1.6 Dual View). Refer to the IFU for the displaying unit for the list of compatible Ambu visualization devices.
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3.9. Connecting to external screens using HDMI or SDI
HDMI SDI
The graphical user interface and live image can be displayed on external screens in high-quality. An external screen can be connected using the HDMI or 3G-SDI video output ports located in the back of the displaying unit. The 3G-SDI resolution is 1920 x 1080 (1080p) and 60 fps.
To connect an external screen: • Connect an HDMI or SDI cable to the video-in port on the external screen. • Insert the other end of the HDMI or SDI cable to the corresponding video-out port on the back of the displaying unit. The graphical user interface of the displaying unit will be shown on the external screen automatically and on both the displaying unit and external screen simultaneously. Both HDMI and SDI can be used simultaneously. If using SDI, use a 3G-SDI cable for best video quality on you external screen, (ex. RG6/U graded cables) To avoid risk of electrical shock only connect ancillary equipment, 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 organization, the displaying unit has full functionality while being off-line, except for exporting to PACS. Imaging data is stored in the displaying unit local storage until MANUALLY exported to USB or PACS. Setting up Wi-Fi and LAN are explained in section 4.2.3
3.11. Connecting USB storage devices The displaying unit has two USB 3.0 Type A slots which are located on the side of the displaying unit below the power button. The USB ports are accessed by opening the cover plate marked with a USB symbol. The displaying unit is compatible with commercially available USB storage devices designed for USB 3.0 Type A or earlier. Connect a USB storage device to export recorded imaging data (see section 5.2.5) or log files (see section 6.3.1).
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4. Setting up the displaying unit software Under the Settings tab, you will find all the menu related to setup of the displaying unit and connectivity. Here you will find the menus: Setup, User Profiles and About.
In the Setup, menu all system settings, such as system language, date & time and network setup can be selected. In the User Profiles menu, you can create or edit user profiles (see section 4.3) . In the About menu you will find an overview of device relevant specifications, a menu where you can export log files for troubleshooting, and a menu where you can perform system upgrades (see section 6). Logging in as Administrator is required to get access to the menus under the Settings tab. If you are not logged in, you will only be able to access the About menu. See section 4.3 for login guide and information on user account privileges.
4.1. How to log in As 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 displaying unit is in use. To log in, press the Login tab in the tool bar. The first level menu will appear and show the last user who logged in to the displaying unit. To log in as this user, press the Enter password field and type the password. To log in as different user, press the arrow to open the User Profile menu with a list 5 of all available user accounts on the device. Select the desired user account and press the Enter password 6 field and type the password. Press the Log in button to login. A confirmation pop-up window will appear in the lower left corner if login was successful and the Login icon will change to showing the device is unlogged.
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NOTE: Login may be disabled for Advanced users. This is set up in the General Settings explained in section 4.2.5. As default, users are logged out of the device after inactivity for 10 min. These settings can also be changed – see section 4.2.5.
4.2. System setup In the Setup menu under the Settings tab you can access the system setup menus; Language, Date and time, Network setup, DICOM setup and General settings. Please 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 • Complete data erase at disposal of the displaying unit A complete Ambu Imaging System is configured as illustrated in the figure below. The various connections are described in more detail in the following sections.
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Ambu Imaging System
Hospital
Ambu Displaying Unit HDMI Visualization Device
SDI External screen Image and Video Streams
USB 3.0
Recordings /Log FIles
USB 3.0
Software Upgrade
DICOM
PACS Server
Wi-Fi LAN
4.2.1. System language In Language under the Setup menu the language preference 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. • • •
tab in the tool bar on the right Press the Settings Press Setup and the Language 1 menu will be open Open the System language 2 drop-down menu and select language from the list.
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NOTE: The language will change immediately when a new language is chosen. The default language is English. 12
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4.2.2. Date and Time In Date & Time under the Setup menu the local date and time, where the displaying unit is used, can be selected. • • •
• •
tab in the tool bar on the right Press the Settings Press Setup and press Date & Time 3 Open the Time zone 4 drop-down menu and select time zone from the list. The time zone setting is used to correct daylight savings automatically. It is important to choose the correct time zone so that correct daylight savings can be updated 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.
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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 configuration of the LAN in Appendix 3.
LAN
Setup LAN (Ethernet): • Connect one end of a LAN cable to the ethernet connection port on the back of the displaying unit. • Ensure that the other end of the LAN cable is connected to a router or LAN wall connector.
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Setup Wi-Fi: tab in the tool bar on the right • Press the Settings • Press Setup and press Network setup See technical details about the configuration of Wi-Fi in Appendix 3.
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• • •
•
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Open the Wi-Fi Regulatory Domain 7 drop-down menu and select your region from the list. After selecting your region an ON/OFF slider will appear. Make sure that the ON/OFF slider enabled (green) so the slider once to change between ON and OFF. Wi-Fi is turned on. Press the ON/OFF In the General menu you can set up the 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), "-" (hypens; not allowed as the first and last character in the hostname). Press Configure another network 9 and a list of available networks is shown. If a network is already connected it will be listed under Currently Selected Network, and otherwise the same field will say No network selected 10 .
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Connecting to a new network : • Choose a new network from the list Available networks 11 • Type the password 12 for the selected network, press OK and press Connect. IP-address will be assigned automatically. NOTE: Wi-Fi networks which require redirection 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.
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When Wi-Fi is connected a Wi-Fi symbol left on the screen.
will be shown above the battery level indicator in the tool bar menu to the 15
Disconnecting from network: Press the connected network and then press the Disconnect 14 button.
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4.2.4. PACS setup In DICOM Setup under the Setup menu, you can configure connection to a PACS (picture archiving and communication system) to be able to transfer recorded images and video in DICOM (Digital Imaging and Communications in Medicine) format over the Wi-Fi or LAN network. To set up a PACS, you may need to involve your IT department or PACS manager in the department or hospital. See technical details about the 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. •
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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 displaying unit. Press the name field and type to change the name. The name can maximum be 16 characters. Choose if the Station name should be assigned as the device "serial number" or a "custom name" which is entered manually. The Station name is an optional attribute in DICOM used by PACS to identify the displaying unit.
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Set up 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
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The table below shows the information that must be filled out. Please contact your hospital IT and/or department PACS manager if you do not have this information available. Information needed
Explanation
PACS name
This is the name of the PACS. Used in the export menu to select the PACS when transferring images and videos.
PACS AE Title
PACS Application Entity Title The AE Title is maximum 16 characters
Host name
IP-address, MAC address or full web address for the PACS
Port number
Network port no. for the PACS
When all the fields have been filled out press Create to save the PACS configuration. In the following window you can test the PACS connectivity by pressing the "Test connection" button. If the the test fails, check the entered information is correct and try again. For further assistance please contact your hospital PACS manager.
4.2.5. General settings In General Settings under the Setup menu, you can enable and disable the USB connector ports, the Live View 180-degrees rotation function, access to archive without login as well as set user inactivity logout time. • • •
tab in the tool bar on the left of the Live View screen Press the Settings Press Setup and press the General Settings 17 sliders once to enable or disable functions Press the ON/OFF
USB input is used to enable and disable the USB ports. When USB input is disabled (slider set to OFF), the USB ports are blocked and cannot be used to export recorded image files or perform software upgrades. 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 without login function is used to enable and disable access to the archive without having to login. When activated, please note that the Archive is no longer password protected. The Default User is provided Advanced User privileges to access previous procedures and view, delete and export files. Please see section 4.3.1 for further information on user types. In factory default this feature is disabled. In the User inactive logout section, you set the time when the logged in user is automatically logged out if the displaying unit has been inactive for the selected time. The displaying unit is defined as inactive when no visualization device is connected and no functions on the graphical user interface are activated. You may choose the user should never be logged out while the displaying unit is turned on. Users are always logged out when the displaying unit is powered off, unless Access archive without login is enabled. In Enable 180 image rotation in Live View, the 180 degrees rotation feature of the live image can be disabled. The 180 degrees rotation function is available in the Image Adjustment menu in the Live View screen (see section 5.1.2). When the selector is activated the function is disabled and made invisible in the Image Adjustment menu.
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4.3. User profiles In the User Profiles menu, you can create new or edit existing user profiles. To access this menu, you must be logged in as Administrator. See sections below for login and information on user account privileges.
4.3.1. User types There are four types of users in the displaying unit: Default user, Advanced user (blue), the Administrator (orange) and the Service user (green). These profiles have different degrees of system access and privileges as shown in the table below. User Types and System Access User Type Default User Instant access without login
Advanced User
Admin User
Service User
Daily operation
Administrator with Service related full access tasks
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x
x
Function Access Login Required
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Live View
x
x
x
x
Video Recording
x
x
x
x
Snapshot
x
x
x
x
Current Procedure
x
x
x
x
Image Adjustments
x
x
x
x
Archive
x*
x
x
Settings
x
x**
* Access to Archive without log in can be enabled by Administrator in Settings. **Service User does not have permission to add and change user profiles.
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Advanced User profile gives daily users the privileges to access the Archive and to export recorded files to PACS via DICOM. It is recommended to create at least one Advanced user profile (e.g. department login), or individual Advanced user profiles for each user of the displaying unit. It is not possible to create additional Administrator and Service User profiles. The Administrator has privileges to change settings for all users. All users have privileges to change their own passwords.
4.3.2. Create and edit user profiles To access the User profiles menu: tab in the tool bar on the left • Press the Settings • 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 requirements, please see section 4.3.3. button • Press the Save
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Edit an existing Advanced User profile: • Press a user profile from the User list 3 to select it. Now, the User name, User type, Created time is shown in the left side of the screen • Press edit
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