Ambu aBox™ 2 Istruzioni per l'uso

For use by trained healthcare professionals only.

For use with compatible Ambu® visualization devices.

Ambu® aBox™ 2

INSTRUCTIONS

FOR USE

A B

C D

E F

G H

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QUICK GUIDE

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Contents Page

English (Instructions for use) ........................................................................................................ 4-51

Deutsch (Bedienungsanleitung) ............................................................................................ 52-106

Español (Manual de instrucciones) ..................................................................................... 107-159

Français (Mode d´emploi) .......................................................................................................160-211

Italiano (Manuale d’uso) ..........................................................................................................212-263

Nederlands (Gebruiksaanwijzing) .......................................................................................264-315

Português (Manual de instruções) ......................................................................................316-367

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Content Page

1. Important Information – Read Before Use ........................................................................................ 6

1.1. Intended use .............................................................................................................................................................................6

1.2. Indications for use .................................................................................................................................................................6

1.3. Intended patient population ............................................................................................................................................6

1.4. Intended user profile ............................................................................................................................................................6

1.5. Clinical benefits ......................................................................................................................................................................6

1.6. Potential adverse events .....................................................................................................................................................6

1.7. General notes ...........................................................................................................................................................................6

1.8. Contraindications...................................................................................................................................................................6

1.9. Warnings and cautions ........................................................................................................................................................6

2. Device Description ............................................................................................................................... 8

2.1. Displaying unit parts ............................................................................................................................................................. 8

2.2. Product compatibility ..........................................................................................................................................................8

2.3. Endoscope activation ..........................................................................................................................................................9

2.4. Description of components ............................................................................................................................................ 10

2.5. Spare parts ..............................................................................................................................................................................11

2.6. System overview ..................................................................................................................................................................11

3. Explanation of Symbols Used ........................................................................................................... 12

4. Getting Started ................................................................................................................................... 13

4.1. First-time setup ....................................................................................................................................................................13

4.2. User profiles ..........................................................................................................................................................................14

5. General Settings ................................................................................................................................. 16

6. Network Setup .................................................................................................................................... 16

6.1. Wi-Fi setup ............................................................................................................................................................................. 16

6.1.1. Wi-Fi network with WPA/WPA2 authentication ............................................................................................17

6.1.2. Hidden Wi-Fi network (Wi-Fi not showing on the list of available Wi-Fi connections) ................17

6.1.3. Wi-Fi network with WPA2 Enterprise authentication (username and password required) ........17

6.1.4. Import network certificate for WPA2 (TLS -transport security layer) ...................................................17

6.2. LAN connection via Ethernet cable ............................................................................................................................ 18

6.3. Set up static IP address and/or DNS server for a Wi-Fi or LAN network ..................................................... 18

6.4. Disconnect from Wi-Fi network .................................................................................................................................... 18

6.5. Clear all network data from the displaying unit .....................................................................................................19

7. Setup Connection to PACS and Worklist ......................................................................................... 19

7.1. Set up the displaying unit for server connection ....................................................................................................19

7.2. Set up connection to PACS server .................................................................................................................................19

7.3. Set up connection to Worklist server ......................................................................................................................... 20

8. Output Setup ...................................................................................................................................... 21

9. Endoscope Buttons Configuration...................................................................................................22

9.1. Configure the endoscope buttons ............................................................................................................................... 22

10. Operating the Displaying Unit .......................................................................................................22

10.1. Preparation and inspection of the displaying unit before use ...................................................................... 22

10.2. Starting and stopping a procedure .......................................................................................................................... 23

10.2.1. Starting a procedure ............................................................................................................................................. 23

10.2.2. Stopping a procedure .........................................................................................................................................23

10.3. Procedure workflow using the worklist .................................................................................................................. 23

10.4. Overview of Live View functions ................................................................................................................................ 24

10.5. Using image adjustments ............................................................................................................................................. 24

10.5.1. Adjust colour, contrast, sharpness and brightness ................................................................................... 25

10.5.2. Rotate the live image ............................................................................................................................................ 25

10.5.3. Use the zoom function ........................................................................................................................................25

10.5.4. Light on/off .............................................................................................................................................................. 26

10.5.5. Adjust ARC (Advanced Red Contrast) setting ............................................................................................. 26

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10.6. Using the stopwatch ....................................................................................................................................................... 26

10.7. Using dual view .................................................................................................................................................................. 27

10.8. Taking photos and recording videos ....................................................................................................................... 27

10.9. Current procedure folder ............................................................................................................................................. 27

10.10. After use of the displaying unit ................................................................................................................................ 28

11. File Handling in The Archive ...........................................................................................................28

11.1. Accessing files in the Archive ....................................................................................................................................... 28

11.2. Exporting files to PACS server or USB flash drive ................................................................................................ 29

11.3. Deleting files from the Archive ................................................................................................................................... 31

12. Connect External Equipment .........................................................................................................32

12.1. Connecting to an External Monitor .......................................................................................................................... 32

12.2. Connecting USB Flash Drives....................................................................................................................................... 33

12.3. Connecting to an External Medical Imaging Recorder ................................................................................... 33

12.4. Printing images via external medical printer ....................................................................................................... 33

12.5. Connect external audio devices .................................................................................................................................34

12.5.1. Record sound during the procedure ..............................................................................................................34

12.5.2. Play sound recorded during a procedure .................................................................................................... 34

13. System Information and Software Updates/Upgrades ...............................................................34

13.1. Device information page ............................................................................................................................................... 34

13.2. Software updates/upgrades ........................................................................................................................................34

13.3. Reporting a problem .......................................................................................................................................................35

13.4. Data reset ............................................................................................................................................................................. 35

14. Cleaning and Disinfection of the Displaying Unit ....................................................................... 35

15. Maintenance .....................................................................................................................................37

16. Disposal .............................................................................................................................................37

17. Technical Product Specifications ...................................................................................................37

17.1. Standards applied ............................................................................................................................................................. 37

17.2. Specifications for the displaying unit ....................................................................................................................... 38

18. Troubleshooting ............................................................................................................................... 39

19. Warranty and Replacement ............................................................................................................42

Appendix 1. Electromagnetic Compatibility ..................................................................................... 43

Appendix 2. Radio Frequency Compliance .........................................................................................46

Appendix 3. Cybersecurity ....................................................................................................................49

Appendix 3.1. Network Setup ................................................................................................................................................ 49

Appendix 3.2. Data at Rest and In Transit ......................................................................................................................... 50

Appendix 3.3. Software Bill Of Materials (SBOM) ........................................................................................................... 51

1. Important Information – Read Before Use

Read these Instructions for Use carefully before using the Ambu® aBox™ 2. These 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® aBox™ 2.

In these Instructions for Use, the term displaying unit refers to Ambu® aBox™ 2. 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

1.1. Intended use

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

1.2. Indications for use

As the aBox™ 2 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 devices.

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® aBox™ 2 provides

visualization and inspection of hollow organs and cavities in the body.

1.6. Potential adverse events

None known for the displaying unit.

1.7. 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.

1.8. Contraindications

None known for the displaying unit.

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 14.

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 loss of the live image during procedure, ensure to

correctly connect the power cord to an appropriate power source that will ensure

continuous power supply.

8. 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 bottom of the

displaying unit.

9. 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.

10. 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 during use to avoid covering the ventilation holes at the bottom 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. Do not place any heavy objects on the top of the displaying unit when it is folded

flat, as this could damage the equipment and lead to malfunction or exposure of

electrical parts.

4. 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.

5. 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 10.1 fails.

6. To avoid malfunction of the equipment only use spare parts supplied by Ambu.

Do not modify the spare parts.

7. Cleaning and disinfection wipes shall be moist, but not dripping to ensure no damage

to internal electronics of the displaying unit.

8. 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.

2. Device Description

The displaying unit can be connected to compatible Ambu visualization devices to display

video images. The following sections describe the components of the displaying unit and list

compatible devices.

2.1. Displaying unit parts

Ambu® aBox™ 2 Item number

505001000

2.2. Product compatibility

aBox 2 includes two connector ports on the front marked in colours. Ambu visualization

devices are compatible with aBox 2 at the colour-coded connection mechanism and

connector geometry.

A full list of compatible visualization devices is displayed in the user interface of the displaying unit.

To see compatible Ambu visualization devices:

•Press the Settings tab 1, then press About 2.

•Press Device info 3, then scroll to Supported visualization devices 4.

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Compatible external equipment

•External medical grade monitors (video output)

•External medical imaging recorders (video output and trigger output)

•USB flash drives

•Medical USB printer

•USB powered audio devices that comply with IEC 60601-1, IEC 60950-1 or IEC 62368-1

Note: Verified compatibility with Sony UP-DR80MD digital colour printer for medical

applications. For specifications of connections to external equipment, refer to chapter 12.

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.

2.3. Endoscope activation

New endoscope types that are not found on the displaying unit's list of supported endoscopes

(see section 2.2) must be activated with an activation code before they can be used with the

displaying unit. The activation code is entered only once for each endoscope type, and once

an endoscope type has been activated, it can be found on the list of supported visualization

devices. The activation codes are found on Ambu's website via the URL shown on the

displaying unit's screen 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 5 and press the question mark 6 to 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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2.4. Description of components

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Wi-Fi

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No. Component Function

1Touch screen Displays the graphical user interface and shows

the live image from the Ambu visualization device.

2

VDI port (connector port

for specific Ambu

visualization devices)

Connector port geometry and colour

ensures correct connection with compatible

visualization devices.

3USB 3.0 port (front) Enables connection of external USB flash drives.

4USB port cover (front) Protects the front USB port.

5Power button Turns the power ON or switches to STANDBY mode.

6Base Contains the main unit.

7Positioning arm

Enables manual positioning of the touch screen.

The screen can be adjusted horizontally and

vertically as well as rotated.

8Power cable Connects the displaying unit to a power outlet.

9Wi-Fi antenna Connect Wi-Fi antenna to the displaying unit for

improved Wi-Fi signal.

10 Video output ports

(2x DVI-D) Enable connection to external monitor or external

medical imaging recorder. See section 7.1. for details

on the difference between using DVI-D and 3G-SDI

on the displaying unit.

11 Video output ports

(2x 3G-SDI)

12 Wi-Fi antenna connector Enables connection of Wi-Fi antenna.

13 USB 3.0 ports Enables connection of external USB flash drives.

14 LAN port Enables connection to ethernet.

15 USB 2.0 ports Enables connection of external USB flash drives.

16 Trigger output ports

(2 x 3.5 mm jack) Enable connection to an external medical imaging

recorder to transfer trigger signals.

17 Trigger output ports

(2 x D-SUB9)

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No. Component Function

18 Power inlet Enables connection to power cable.

19 Connector for potential

equalization cable

Enables bonding of electrical products to eliminate

potential differences between conductive parts.

2.5. Spare parts

Spare parts are intended as replacements for components that are exposed to wear and tear

during the lifetime of the device. Consult the troubleshooting guide in chapter 13 for issues

that might require replacement of spare parts.

Spare parts Name Item number

Thickness: 4 pt

Ambu® aBox™ 2 -Visualization device

interface kit - Grey-Empty-Green

Contains:

One grey and one green visualization device

interface board (VDI), a front cover with a color

ring (grey and green), a plectrum tool, and two

screws for the VDI.

505000530

Power cable – B (US, JP) 505000521

Power cables – J (CH), K (DK), I (AUS) 505000520

Power cable – G (UK), E/F (EU, not DK, CH) 505000522

2.6. System overview

A complete Ambu Imaging System is configured as illustrated in the figure below. The various

connections are described in more detail in chapter 12.

DVI-D

3G-SDI

DVI-D

USB 2.0/3.0

USB 3.0 Type A

DICOM

USB Flash Drive

Server

Wi-Fi

LAN

PACS Server/

Worklist Server

Medical Printer

Audio Device

External Monitor

External Medical

Imaging Recorder

Visualization

Device

Image and

Video Streams

USB 3.0

Ambu Displaying Unit

External Connection OptionsAmbu Imaging System

Software

Update/Upgrade

Wi-Fi

LAN

Recordings/

Log Files

3G-SDI

3.5 mm Jack

D-SUB9

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

3. Explanation of Symbols Used

Symbols for the

displaying unit Description Symbols for the

displaying unit Description

Warning Caution

Medical Device Made in Taiwan

Type BF applied part Follow

Instructions for Use

Batch Code Consult

Instructions for Use

CE marking Japan Radio Law

TELEC RF certification

Australia and New

Zealand’s Regulatory

Compliance Mark

Taiwan Radio

Requirement

NCC certification

E354633

Medical – general

medical equipment as

to electrical 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

Waste Bin symbol,

indicating that waste

must be collected

according to local

regulation and

collection schemes for

disposal of electronic

and electrical waste

(WEEE)

Universal Serial Bus

(USB 2.0, USB 3.0) DVI-D Digital Visual Interface

3G-SDI Serial Digital Interface LAN Local Area Network

Rx Only

US Federal Law

restricts this device to

sale by or on the order

of a physician

IP31 Protection against

solid particles and

liquid ingress

Humidity Limitation Atmospheric

Pressure Limitation

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Symbols for the

displaying unit Description Symbols for the

displaying unit Description

Catalogue Number UK Conformity

Assessed

UK Responsible Person

Importer

(For products imported

into Great Britain only)

A full list of symbol explanations can be found on ambu.com/symbol-explanation.

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 section 2.4.

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. Place the displaying unit on a hard and leveled surface. Be aware to place the displaying

unit in a position where the power cord is accessible. The displaying unit can be placed on

a medical cart to make it moveable. Make sure to proper position of the displaying unit to

avoid falling down during transportation.

4. If necessary, connect the supplied Wi-Fi antenna to the back of the displaying unit.

5. Connect the power cable to a power outlet and insert the power plug into the power inlet

on the back of the displaying unit B.

6. If needed, connect an external monitor C and/or medical imaging recorder to the back of

the displaying unit.

7. If necessary, manually adjust the orientation of the touch screen of the displaying unit D

8. 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) E, but 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.

9. Select the preferred language, then press 1.

10. Select and confirm your country, then press Continue 2. Press confirm 3.

11. 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.

12. 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

– Navigate to User profiles to change the Password. For security reasons you should

change the factory default password as soon as possible.

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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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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.

Note: If the Administrator

password is lost, please contact

your local Ambu representative.

13. 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 10 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 14 in the calendar.

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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.

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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

Technician

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.

*** User profiles access to the Bin is described in section 11.3.

**** 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 5.

•Enter username, password, and

repeated password in the respective

input fields 6, and press the

Save icon 7.

To delete a user profile, press the user

name, then press the delete icon.

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.

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.

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Change username or password:

•Press the Settings tab, then press User Profiles.

•Press the username 8, then press the edit icon 9.

•Enter the new username, password, and repeated password in the respective input fields

10 and press the save icon 11 .

Note: The Administrator can change username and password for other user types.

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5. 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.

•Communication Settings – Enabling allows the possibility to upgrade software online if

connected to the internet.

•Archive Settings – Decide when a procedure is moved to the bin and when it is deleted

from the bin.

•Zoom, Stopwatch, ARC – functions available during a procedure can be disabled for all

types of scopes and users.

•Login Settings – determine if a user that is not logged in can still access the archive and

see the worklist.

•User inactivity settings – choose if the displaying unit will logout the user due to inactivity.

Be aware that if a function is disabled (not green), the symbol is not visible in the menu where

it is normally located.

6. Network Setup

Importing a worklist or transferring imagery requires that the displaying unit is connected to

the network via Wi-Fi or LAN/Ethernet cable.

6.1. Wi-Fi setup

The displaying unit supports WPA, WPA2 and WPA2 Enterprise authentication. Wi-Fi networks

that redirect to a login webpage are not supported.

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Enable Wi-Fi:

1) Press the Settings tab, then press Setup 1.

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2) Press Network setup 2.

3) Press the ON/OFF slider to turn on Wi-Fi 3 (switch to green).

4) If required by your organization’s Wi-Fi network, press the input

field next to Hostname 4 and 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.

5) Press Configure 5 and wait while the displaying unit searches

for available networks.

6.1.1. Wi-Fi network with

WPA/WPA2 authentication

1) Select the Wi-Fi network

from the list.

2) Enter the password and press

Save 6, then press Connect.

3) When the connection has been

established, a Wi-Fi symbol

appears in the Toolbar.

4) To enable automatic connection

to this Wi-Fi press the Connect

automatically 7 ON/OFF slider

(switch to green).

6.1.2. Hidden Wi-Fi network

(Wi-Fi not showing on the list

of available Wi-Fi connections)

1) Press Add network 8.

2) Press the input field next to SSID and enter

the name of the hidden Wi-Fi network,

then press OK.

3) Enter the remaining information in the

input fields depending on the type of

Wi-Fi network.

6.1.3. Wi-Fi network with WPA2

Enterprise authentication

(username and password

required)

1) Enter username in the Identity

9 field.

2) Enter password in the Password

10 field.

3) Select the required certificate 11 .

4) Press Connect 12 .

5) When the connection has been established,

a Wi-Fi symbol appears in the Toolbar.

6) To enable automatic connection to this

Wi-Fi, press the Connect automatically

13 ON/OFF slider (switch to green).

6.1.4. Import network certificate for

WPA2 (TLS -transport security layer)

In the Network menu, scroll to Imported

Network certificates 14 .

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6.1.4.1. Import TLS certiﬁcates from a server

1) Ensure that the displaying unit is connected to a temporary Wi-Fi or LAN network

(see section 5.1.1 or 5.2.).

2) Press Server import.

3) Enter Certificate file name 15 , Host name 16 , and Port number 17 .

4) Press Import 18 .

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6.1.4.2. Import network certiﬁcates from a USB ﬂash drive

1) Ensure that USB connection has been enabled for certificate import (see section 2.5.).

Insert USB containing network certificate. (see section 6.1.4).

2) Press USB import and wait while the displaying unit searches for network certificates on

the USB flash drive.

3) Select the required network certificate and press Import 19 .

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Note: When the network certificate has been imported, the name of the certificate file is

shown below Imported Network certificates in the Network menu.

6.2. LAN connection via Ethernet cable

1) Connect a LAN cable to the Ethernet connection port on the back of the displaying unit

and to a router or LAN wall socket.

2) In the Network menu, check the LAN connection status shown below Ethernet.

6.3. Set up static IP address and/or

DNS server for a Wi-Fi or LAN network

1) In the Network menu, press the currently

selected Wi-Fi network.

2) 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.

6.4. Disconnect from Wi-Fi network

In the Network menu, press the currently selected. Wi-Fi network, then press Disconnect.

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6.5. Clear all network data from the displaying unit

In the Network menu, press Clear all data. Press OK.

7. Setup Connection to PACS and Worklist

Importing a worklist and exporting of imagery requires that the worklist server/PACS (Picture

Archiving and Communication System) server can send and receive data in DICOM (Digital

Imaging and Communications in Medicine) format. Setting up server connections require that

the displaying unit is connected to a Wi-Fi or LAN network (see section 6.1 and 6.2).

7.1. Set up the displaying unit for server connection

•Press the Settings tab, then press Setup.

•Press DICOM setup 22 .

•It is optional to change the Station name 23 . The Station name is used to recognize the

unit if a special worklist needs to be pushed to a specific unit or if it is important to track

from which unit data has been sent from. The default name is AmbuMon and 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.

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7.2. Set up connection to PACS server

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•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 .

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 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.

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.

7.3. Set up connection to Worklist server

•Enable Worklist 31 with the ON/OFF switched to green.

•Enter the required information in Worklist server AE title, Worklist server hostname and

Worklist server port number 32 .

•Press the required TLS 33 settings .

Note: If you enable TLS, you need to import the required TLS certificate from a server or

USB flash drive.

•Choose the modality (ES=endoscopy, US=ultrasound) or enter a specific modality in the

Other 34 field deciding which worklist you choose to retrieve.

•Enter the timeframe, that the retrieved worklist will show, in the Display upcoming

procedures (hours) 35 field.

•Hide past procedures older than (hours) 36 allows you to limit the amount of

procedures in the worklist.

•Press Test worklist connection 37 to verify that the information has been entered

correctly and the server connection is established.

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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.

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.

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Ambu aBox™ 2 Istruzioni per l'uso

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