Ambu aView 2 Advance User manual

For use by trained healthcare professionals only. For
use with compatible Ambu®visualisation devices.
Ambu®aView™2 Advance
INSTRUCTIONS
FOR USE

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Quick Guide Oct072019
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Contents Page
English (Instructions for use)....................................................................................................... 4-48
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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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1. Important information – Read before use
Read these Instructions for Use carefully before using the Ambu® aView™ 2 Advance.
The Instructions for Use may be updated without further notice. Copies of the current version
are available upon request. The latest version is available on ambu.com. Please be aware that
the instructions do not explain or discuss clinical procedures. They describe only the basic
operation and precautions related to the operation of the Ambu® aView™ 2 Advance.
In these Instructions for Use, the term displaying unit refers to Ambu® aView™ 2 Advance.
The terms visualization device and endoscope are used interchangeably throughout the
document and refer to compatible Ambu endoscopes and other visualization devices that
can be connected to and used with the displaying unit.
These Instructions for Use apply only to the displaying unit. For information on a specific
Ambu visualization device, refer to the relevant Instructions for Use.
According to the Spaulding’s/CDC classification, the displaying unit including the mounting
bracket is a non-critical device.
1.1. Intended use
The Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu
visualization devices.
1.2. Indications for use
As the aView™ 2 Advance is intended to display live imaging data from compatible Ambu
visualization devices, the intended medical indication will be defined by the connected
visualization devices.
1.3. Intended patient population
As the displaying unit is intended to display live imaging data from specific Ambu
visualization devices, the intended patient population will be defined by the connected
Ambu visualization device.
1.4. Intended user profile
Healthcare professionals trained on procedures with compatible visualization devices typically
assisted by other healthcare professionals and medical technicians with knowledge of setting
up medical devices.
1.5. Clinical benefits
In conjunction with a compatible single-use visualization device, the Ambu® aView™ 2
Advance provides visualization and inspection of hollow organs and cavities in the body.
1.6. Contraindications
None known for the displaying unit.
1.7. Potential adverse events
None known for the displaying unit.
1.8. General notes
If during the use of this device or as a result of its use, a serious incident has occurred,
please report it to the manufacturer and to your national authority.
1.9. Warnings and cautions
Failure to observe these warnings and cautions may result in patient injury or damage to the
equipment. Ambu is not responsible for any damage to the equipment or patient injury
resulting from incorrect use.
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WARNINGS
1. To avoid patient injury during procedure, be careful to check whether the image on the
screen is a live image or a recorded image and verify that the orientation of the image is
as expected.
2. To minimize risk of contamination, always wear gloves during handling of the displaying
unit and ensure that the displaying unit is cleaned and disinfected before and after each
use in accordance with the chapter 10.
3. Portable radio frequency (RF) communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the displaying unit and the attached visualization device,
including cables specified by the manufacturer. Otherwise, this could result in
degradation of the performance of this equipment.
4. To avoid risk of electric shock only connect mains or battery powered ancillary
equipment, if it is approved as medical electrical equipment.
5. To avoid risk of electric shock, this equipment shall only be connected to a supply mains
with protective earth.
6. Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
7. To avoid patient injury due to overheating of the displaying unit causing it to suddenly
shut down during procedure, do not cover the ventilation holes at the back of the
displaying unit.
8. Do not touch any metal parts of the displaying unit while using high frequency tools
(e.g. electrosurgical equipment), due to the risk of electric shock and burns.
9. To ensure that images and videos are correctly exported to external systems
and to avoid potential misdiagnosis due to mixing-up of patient data, carefully
check that the patient identifiers are correct before starting, saving and
exporting the procedure.
CAUTIONS
1. To prevent damaging the displaying unit, always place the displaying unit on a hard
flat surface or mounted on the bracket or a suitable VESA mount during use to avoid
covering the ventilation holes at the back of the displaying unit. Be aware that covering
the ventilation holes can also lead to a high surface temperature.
2. Using high frequency tools (e.g. electrosurgical equipment) in proximity of a
connected visualization device may affect the live image. This is not a malfunction.
Wait a few seconds for the image to return to normal.
3. Use of accessories, transducers, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
4. To avoid malfunction during procedure, do not use the displaying unit if it is damaged
in any way or if any part of the functional check described in section 6.1 fails.
5. To avoid malfunction of the equipment only use spare parts supplied by Ambu. Do not
modify the spare parts.
6. Cleaning and disinfection wipes shall be moist, but not dripping to ensure no damage
to internal electronics of the displaying unit.
7. If using wipes containing hypochlorite or citric acid during cleaning, ensure that all
residue is completely removed. Wipes containing hypochlorite or citric acid may affect
the screen's antireflective coating over time. You should limit the use of wipes
containing hypochlorite or citric acid to required cases only.
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2. Device description
The displaying unit is a reusable device that can be connected to compatible Ambu
visualization devices to display live imaging data (see section 2.2). The following sections
describe the components of the displaying unit and list compatible devices.
2.1. Displaying unit parts
Ambu® aView™ 2 Advance Item number
405011000
2.2. Product compatibility
aView 2 Advance includes up to three connector ports on the side of the displaying unit that
are marked in colours. Ambu visualization devices are compatible with aView 2 Advance at the
colour-coded connection mechanism and connector geometry.
A full list of visualization devices supported in your country is displayed in the user interface of
the displaying unit.
To see supported Ambu visualization devices:
• Press the Settings tab 1, then press About 2.
• Press Device info 3, then scroll to Supported visualization devices 4.
Note: Connector port colour and geometry on the displaying unit must match the connector colour and
geometry on the visualization device.
Note: aView 2 Advance is NOT compatible with any products in the Ambu Gastroenterology aScope™
portfolio or scope generations prior to the aScope™ 4 family, e.g. Ambu aScope™ 3 family.
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Compatible external equipment
• External medical grade monitors
(HDMI, 3G-SDI video outputs)
• USB 3.0 Type A flash drives
• Medical USB printer
• USB powered audio devices that comply with
IEC 60601-1, IEC 60950-1 or IEC 62368-1
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Note: Verified compatibility with Sony UP-DR80MD digital colour printer for medical applications.
For specifications of connections to external equipment, refer to chapter 8.
Note: IEC 60950-1 and IEC 62368-1 are consumer electronic standards and do not cover patient safety.
Therefore do not touch the accessories while touching the patient and place the equipment out of reach of
the patient.
2.2.1. Endoscope activation
New endoscope types not found on the list of supported visualization devices (see section 2.2)
must be activated with an activation code before they can be used. The activation code is
entered only once per endoscope type. Hereafter, the endoscope type can be found on the list
of supported visualization devices. The activation codes are found on Ambu's website via the
URL, or QR code shown next to the input field where the activation code is to be entered.
Activate a new endoscope type:
• Press the Settings tab, then press About.
• Scroll to Activation codes 5and press the question mark 6to find the URL or QR code
for the activation codes.
• Enter the URL in the address field of the internet browser on your connected device, e.g.
computer, tablet or mobile phone or scan the QR code with your mobile phone.
• Find the activation code for the endoscope to be activated and enter the code into the input
field below Activation codes 7.
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2.3. Description of components
No. Part Function
1Casing -
2Touch screen
Displays the image from the Ambu
visualization device and the
graphical user interface.
3Stand
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,
arrows and geometry on
visualization device plug
and the connector port.
5Power button Push button for power ON and OFF.
6Hardware
reset button
Reset the displaying unit hardware
without impacting stored data.
7Ventilation holes Cools hardware during use.
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No. Part Function
8Power inlet Power inlet for charging
the displaying unit.
9-1 USB connection Two inputs/outputs for
USB 3.0 Type A.
9-2 Input/output
connection HDMI, 3G-SDI, LAN (Ethernet)
10 Power supply Powers the displaying unit. Power
cord with country-specific plug.
11 Bracket Secures the displaying unit to e.g.
an IV pole.
12 Power supply
bracket
Secures the placement of the
power supply.
13 Release buttons Releases displaying unit from
the bracket.
14 Hook Holder for pouches containing
visualization devices.
2.4. Spare parts
Spare parts are intended as replacements for components exposed to wear and tear during
the device's lifetime. Consult the troubleshooting guide in chapter 14 for issues that might
require a change of spare parts. In addition to the list below, Ambu® aView™ 2 Advance -
Power Supply and Ambu® aView™ 2 Advance – Bracket described in section 2.3. are available
as spare parts.
Spare part Item numbers
Ambu® aView™ 2 Advance - Battery Kit.
This kit contains a battery and a
replacement part kit.
405012100
Ambu® aView™ 2 Advance -
Visualization device interface kit - Blue.
Ambu® aView™ 2 Advance -
Visualization device interface kit - Grey.
Ambu® aView™ 2 Advance -
Visualization device interface kit - Green.
This kit contains a visualization device
interface board, a colour ring, and a
replacement part kit.
405014100
405000503
405000502
Ambu® aView™ 2 Advance - Fan Kit.
This kit contains a fan and a replacement
part kit.
405016100
Ambu® aView™ 2 Advance - Bracket.
This kit contains a bracket and a
Bracket Guide.
405013100
Ambu® aView™ 2 Advance power supply
manufacturer: FSP Group Inc.
Ambu® aView™ 2 Advance power supply
manufacturer: FSP065M-DBA.
E / F (EU) + J (CH)
405015300
G (UK)
405015400
K (DK)
405015500
The spare parts are not available in all countries. Please contact your local Ambu representative.
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2.5. System overview
A complete Ambu Imaging System is configured as illustrated below. The various connection
options are described in chapter 5.
Please note that your organization is responsible for the following areas, which should be
implemented according to your local policy:
• Network setup
• Ensuring availability and confidentiality of the 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 erasure before disposal of the displaying unit
USB Flash Drive
Server
DICOM
LAN
Wi-
PACS Server/
Worklist Server
HDMI
3G-SDI
Extermal Monitor
Visualization
Device
Image and Video
Streams
USB 3.0 Type A
Ambu Displaying Unit
External Connection OptionAmbu Imaging System
Software
Update/Upgrade
LAN
Wi-
USB 3.0 Type A
Recording/
Log File
Medical Printer
USB 3.0 Type A
USB 3.0 Type A
Audio Device
3. Explanation of symbols used
Symbol Description Symbol Description
Warning Caution
Follow the
Instructions for Use Country of Manufacturer
Consult Instructions for Use IP30 Protection against
solid objects
Waste Bin symbol,
indicating that waste must
be collected according to
local regulation and
collection schemes for
disposal of electronic and
electrical waste (WEEE)
E354633
Medical – general medical
equipment as to electric
shock, fire and mechanical
hazards only in accordance
with ANSI/AAMI ES60601-
1:2005+ AMD 2012, CAN/
CSA-C22.2 No. 60601-
1:14+IEC 60601-2-18:2009
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Symbol Description Symbol Description
Catalogue number
Waste Bin symbol,
indicating that waste must
be collected according to
local regulation and
collection schemes for
disposal of batteries
Universal Serial Bus (USB) HDMI High-Definition
Multimedia Interface
3G-SDI Serial Digital Interface LAN Local Area Network
Batch Code Medical Device
%Humidity limitation Atmospheric
pressure limitation
Rx only US Federal Law restricts
this device to use by or on
the order of a physician
CE marking with
identification number
of the notified body
Japan Radio Law
TELEC RF certification
Australia and New
Zealand’s Regulatory
Compliance Mark
Taiwan Radio Requirement NCC certification
4. Getting started
4.1. First-time setup
Follow the steps below before using the displaying unit for the first time. Letters in grey circles
refer to the illustrations in the Quick Guide on page 2.
1. Unpack the displaying unit and verify that no parts are missing. Refer to the parts
described in chapter 2.
2. Closely examine the displaying unit and other parts for any damage. Do not use the
displaying unit if it is damaged in any way A.
3. Connect the power supply to a power outlet and insert the power plug into the power
inlet on the back of the displaying unit E.
4. Turn ON the displaying unit by short pressing the power button. The indicator light in the
power button switches from orange (STANDBY mode) to green (ON) D. A live image is
available soon after the monitor is turned on if a visualization device is connected. If no
visualization device is connected, the interface will illustrate how to correctly connect a
visualization device to the displaying unit.
5. Go to Appendix 3. Cybersecurity and ensure that the use of the displaying unit's software
and connectivity is aligned with your organization's policies.
6. Select the preferred language, then press Continue 1.
7. Select your country, then press Continue 2. Press Confirm 3.
IMPORTANT: Selecting the correct country from the first time is a requirement for regulatory
compliance, and the selected country cannot subsequently be changed by any users of the displaying unit.
If selection of a new country is necessary, please contact your local Ambu representative. The displaying
unit’s language can be changed by the Administrator at any time.
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8. Log in as Administrator to get access
to system settings:
• Press the Login tab in the Toolbar.
• Press arrow right 4, then press
System Administrator 5.
• Enter the password and press Log in 6.
The factory default password is
AmbuAdmin
• Follow the instructions on the screen to change the password (required on first use).
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Note: If the Administrator password is lost, please contact your local Ambu representative.
9. Change system language:
• Press the Settings tab, then press Setup 7.
• Press Language 8.
• Press Device language 9, and select the required language. The system language
changes immediately when selected.
10. Set date and time:
• Press Date and time 10 .
• Press Time zone setting 11 ,
and select the required
time zone.
• Press Set date and time to
return to the previous menu.
• Select the required setting
below Time format 12 .
• Scroll the hours and minutes
below Set time 13 to set
the time.
• Select the required date in the calendar.
Note: It is important to set time and date correctly to ensure that patient procedures are saved and exported
in correct order.
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4.2. User profiles
User profiles are created as
different user types according to
their purpose (see table below).
Only the Administrator has full
access to the displaying unit's
settings and functions, including
the creation of
new users.
For daily operation it is
recommended to create
minimum one Advanced user
profile, either as a shared
department login or as individual profiles. It is not possible to create additional Administrator
or Service Technician user profiles.
User profile types and system access
User profile type
Function access
Default user Advanced
user
Administrator Service user
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
Photo x x x x
Current procedure x x x x
Worklist -*x x -*
+ARC
Image adjustments x** x** x x
Archive -*x x -*
Settings - x**** x x****
*The Administrator can enable or disable access without login.
** The Administrator and the Service Technician can enable or disable functions for other users.
*** Some settings are not accessible for the Service Technician.
**** Some settings are not accessible for the Advance user and the Service Technician.
Create an Advanced user:
• Press the Settings tab.
• Press User Profiles, then press
Add user 14 .
• Enter username, password,
and repeated password in
the respective input fields 15 ,
and press the Save icon 16 .
Note: Passwords must be minimum 8
characters. Any character is allowed, but it is
recommended to use a combination of upper-
and lower-case letters, numbers, and symbols
to enhance password protection.
• To delete a user profile, press the user name, then press the delete icon.
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• Press OK to confirm.
Log in as any user profile:
• Press the Login tab.
• Press arrow right, then press your user name.
• Enter your password and press Login.
Change username or password:
• Press the Settings tab, then press User Profiles.
• Press the username 17 , then press the edit icon 18 .
• Enter the new username, password, and repeated password in the respective input fields 20
and press the save icon 19 .
Note: The Administrator can change username and password for other user types.
4.3. General settings
The Administrator can enable and disable functionalities for all users.
In the Setup menu under the tab General Settings the following functionalities can be enabled
or disabled using the ON/OFF sliders:
USB Management – possibility to enable file export, software upgrade, import of TLS
certificate and ability to print using the USB port. Refer to sections 5.2.3, 7.2, 8.4, 9.2.
Communication Settings – enabling allows the possibility to upgrade software on-line if
connected to the Internet. Refer to section 9.2.
Archive Settings – decide when a procedure is moved to the bin and when it is deleted
from the bin. Refer to section 7.3.
180° Rotation, Zoom, Stopwatch, ARC – functions available during a procedure can be
disabled for all types of scopes and users. Refer to sections 6.6, 6.7.
Login Settings – determine if a user that is not logged in can still access the archive and
see the Worklist. Refer to sections 6.4, 7.1.
User inactivity settings – choose if the displaying unit will logout the user due to inactivity.
Note: Be aware that if a function is disabled (not green), the symbol is not visible in the menu where it is
normally located.
4.4. Mounting the displaying unit on a pole
The displaying unit can be mounted on a pole with wheels for easy portability, e.g. an IV pole.
Pole mounting brackets are supplied with the displaying unit. Letters in grey circles refer
to the illustrations in the Quick Guide on page 2.
Attach the bracket to a pole: Cb
• Fold out the bracket and tighten the nut in the centre.
• Attach the bracket to the pole, and ensure the knob is tightened sufficiently.
• Attach the power supply bracket to the main bracket and place the power supply in the
power supply bracket.
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• The hook on the power supply bracket can be used for storing visualization devices in
pouches. In addition, the power adapter cable can be rolled up on the power supply bracket
to improve cable management.
Place the displaying unit in the bracket: Cc
• Fold the stand upwards against the upper edge of the displaying unit.
• Place the lower edge of the displaying unit in the bracket. The stand must be
oriented upwards.
• Push the displaying unit backward 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.
• Ensure that the displaying unit is securely placed in the bracket before letting go with
your hands.
Remove the displaying unit from the bracket: K
• Use both hands to hold the displaying unit while pressing the two grey release buttons on
the bracket behind the displaying unit.
• Pull the displaying unit towards yourself.
4.5. Battery and power
The displaying unit's remaining battery power is shown by the colour of the power button and
the battery icon in the Toolbar. For information about power supply, see section 2.3.
Power button light
indicator
Battery icon in
Toolbar
Remaining battery
power
Action required
before use
Green Green > 40 % -
Orange Orange < 40 % Charge
Blinking orange*Red < 20 % Charge
*Also when powered OFF.
5. Network setup
Always use a secure network when handling images and patient data. See technical details
about the configuration of LAN and Wi-Fi in Appendix 3. Cybersecurity.
5.1. Wi-Fi and LAN/Ethernet setup
Importing a Worklist or transferring imagery requires that the displaying unit is connected to the
network via Wi-Fi or LAN/Ethernet cable. The displaying unit supports WPA, WPA2 and WPA2
Enterprise authentication. Wi-Fi networks that redirect to a login webpage are not supported.
5.1.1. Set up the displaying unit for Wi-Fi connection:
• Press the Settings tab, then press Setup 1.
• Press Network setup 2.
• Press the ON/OFF slider to turn on Wi-Fi 3(switch to green).
• If required by your organization’s Wi-Fi network, press the input field
next to Hostname 4and enter the hostname.
Note: The hostname is provided by your organization's IT administrator and is
used for identifying the displaying unit on the Wi-Fi network. The hostname can
be 1-63 characters long excl. dots and can consist of numbers and upper- or
lowercase letters (A-Z/a-z). Hyphens cannot be used as first or last character.
• Press Configure 5and wait while
the displaying unit searches for
available networks.
Note: If a Wi-Fi network has been
set up previously, press Configure
a new network.
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5.1.2. Set up Wi-Fi network
with WPA/WPA2 authentication:
• Select the required Wi-Fi network
from the list.
• Enter the password and press
Save 6, then press Connect.
• When the connection has been
established, a Wi-Fi symbol appears in the Toolbar.
• To enable automatic connection to a previously used Wi-Fi network, press the ON/OFF slider
next to Connect automatically 7(switch to green).
5.1.2.1.
Set up Wi-Fi network with WPA2 Enterprise authentication:
Note: When setting up Wi-Fi network with WPA2 Enterprise authentication the first time, a displaying unit
will require to trust your network-provider service. Follow the instructions in section 5.1.4, instead contact
either your IT administrator or the network-provider.
• Select the required Wi-Fi
network from the list.
• Press the input field next
to Identity 8and enter
the username.
• Press the input field next
to Password 9and enter
the password.
• If the certificate name is not
present, then press the arrow
next to Certificate 10 and manually import it to the system (see section 5.1.4.).
• Press Connect 11 .
• When the connection has been established, a Wi-Fi symbol appears in the Toolbar.
• To enable automatic connection to a previously used Wi-Fi network, press the ON/OFF slider
next to Connect automatically 12 (switch to green).
5.1.2.2. Set up hidden Wi-Fi network:
• Below the list of available networks,
press Add network 13 .
• Press the input field next to SSID and enter
the name of the hidden Wi-Fi network,
then press OK.
• Enter the remaining information in the input
fields depending on the type of Wi-Fi
network (see sections 5.1.2./5.1.2.1.).
5.1.3. Set up wired LAN connection via Ethernet cable:
• Connect a LAN cable to the Ethernet connection port on the back of the displaying unit
(see section 2.3.) and to a router or LAN wall connector.
• In the Network menu, check the LAN connection status shown below Ethernet.
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5.1.4. Import network certificate for WPA2
Enterprise authentication:
• In the Network menu, scroll to Imported
Network certificates 14 .
To import TLS certificates from a server:
• Ensure that the displaying unit is connected
to a temporary Wi-Fi or LAN network
(see section 5.1.2. or 5.1.3.).
• Press Server import.
• Press the input field next to Certificate file
name 15 and enter the file name.
• Press the input field next to Host name 16 and enter the hostname.
• Press the input field next to Port number 17 and enter the port number.
15
16
17
18
• Press Import 18 .
To import network certificates from a USB flash drive:
• Ensure that USB connection has been enabled for certificate import (see section 4.3.)
and a USB flash drive connected to the displaying unit (see section 2.3.).
19
• Press USB import and wait while the displaying unit searches for network certificates on the
USB flash drive.
• Select the required network certificate and press Import 19 .
Note: When the network certificate has been imported, the name of the certificate file is shown below
Imported Network certificates in the Network menu.
5.1.5. Set up static IP address and/or DNS server
for a Wi-Fi or LAN network:
• In the Network menu, press the currently selected
Wi-Fi network.
• Below the name of the Wi-Fi network, press the
arrow next to IP address.
Press the ON/OFF slider next to Enable static IP 20
or Configure manual DNS servers 21 (switch to
green) and enter the required information.
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21
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5.1.6. Disconnect from Wi-Fi network:
• In the Network menu, press the currently selected Wi-Fi network, then press Disconnect.
5.1.7. Clear all network data from the displaying unit:
• In the Network menu, press Clear all data.
• Press OK.
5.2. PACS and Worklist setup
You can transfer patient data between the displaying unit and external servers. Before procedure
you can retrieve patient data from the Worklist server, including information about an upcoming
procedure. After procedure, the images and videos created during procedure can be exported in
DICOM format from the Archive to a PACS server. Before setting up server connections, ensure
that the displaying unit is connected to a Wi-Fi or LAN network (see section 5.1.).
5.2.1. Set up the displaying unit for server connection:
• Press the Settings tab, then press Setup.
• Press DICOM setup 22 .
• Press the input field next to Station name 23 and enter the device name.
The default name is AmbuMon
22 25
24
23
Note: The maximum length of the station name is 16 characters.
• Press Use serial number or Use custom name next to Station AE title 24 . If you selected
Use custom name, press the input field and enter the name.
5.2.2. Set up connection to PACS server:
• Press Add new 25 below PACS servers.
• Press the input field next to PACS name 26 and enter the name you want to use for the
PACS connection.
• Press the input fields next to PACS AE title, Host name and Port number 27 and enter the
required information in each field.
• Press the required setting next to TLS 28 .
26
27
28
29
30
Note: If you enable TLS, you need to import the required TLS certificate from a server or USB flash drive
(see instructions in section 5.2.3.).
• Press Test connection 29 to verify that the information has been entered correctly and the
server connection can be established.
• Press Create 30 to save the server connection setup.
18

en
Some PACS systems may require the MAC address and the IP address of the displaying unit.
The MAC address is unique for each displaying unit, while the IP address is assigned by the
hospital network.
Retrieve the MAC address and IP address of the displaying unit:
• Login as Administrator, then go to Settings - About - Device Info.
• Depending on whether Wi-Fi or Ethernet is used, find the information tab Network.
The MAC address is a 48-BIT address grouped into 6 octets. In the example below, the MAC
address is highlighted in red boxes depending on the network setup.
The IP address assigned by your network can also be found. In the example below, the IP address
is highlighted in a blue box.
5.2.3. Set up connection to Worklist server:
• Press the ON/OFF slider next to Enable Worklist 31 (switch to green).
• Press the input fields next to Worklist server AE title, Worklist server hostname and
Worklist server port number 32 and enter the required information in each field.
• Press the required setting next to TLS 33 .
Note: If you enable TLS, you need to import the required TLS certificate from a server or USB flash drive
(see instructions further below).
• Press the required modality or enter one in the input field 34 .
31
37
35
32
33
36
34
38
• Press the input field next to Display upcoming procedures (hours) 35 and enter the
required number of hours.
• Press arrow right to select Hide past procedures older than (hours) 36 and enter the
required number of hours.
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• Press Test worklist connection 37 to verify that the information has been entered correctly
and the server connection can be established.
Import TLS certificate from server or USB flash drive:
You can use TLS for enhanced security when setting up PACS and Worklist server connections.
Enabling TLS requires a TLS certificate to be imported to the displaying unit from a server or
from a USB flash drive. If multiple TLS certificates are imported to the displaying unit, the
PACS/Worklist server will select the required TLS certificate automatically. For import from
server, ensure that the displaying unit is connected to a Wi-Fi or LAN network (see section 5.1.).
For import from USB flash drive, ensure that USB connection has been enabled for certificate
import and a USB flash drive connected to the displaying unit (see section 4.3.).
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40
41
42
To import TLS certificates from a server:
• Press Server import 38 .
• Press the input field next to Certificate file
name 39 and enter the file name.
• Press the input field next to Host name 40,
and enter the hostname.
• Press the input field next to Port number
41 and enter the port number.
• Press Import 42 .
To import TLS certificates from a USB flash drive:
• Press USB import and wait while the displaying unit searches for TLS certificates on the USB
flash drive.
• Select the required TLS certificate and press Import 43 .
Note: When the TLS certificate has been imported, the name of the certificate file is shown below Imported
TLS certificates.
Server information Explanation
PACS name The name entered here is the one shown on the list of
available servers in the Export menu.
PACS AE Title/
Worklist server AE title
The title entered here is used by the server to identify the
displaying unit's individual software application.
Host name/
Worklist server hostname
IP-address, MAC address or full web address for the server.
Port number/
Worklist server port number
Network port number for the server.
6. Operating the displaying unit
6.1. Preparation and inspection of the displaying unit before use
Before using the displaying unit for a patient procedure, follow the relevant steps below and
any other necessary steps according to your organization's procedures and requirements for
preparation and inspection of this type of device.
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