Instructions for Use
348 Pages
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INSTRUCTIONS FOR USE
Ambu® aView™ 2 Advance For use by trained healthcare professionals only. For use with compatible Ambu ® visualization devices.
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HDMI 3G-SDI Visualization Device
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Quick Guide Oct072019 2
English (Instructions for use)...4-48 Deutsch (Bedienungsanleitung)... 49-99 Español (Manual de instrucciones)... 100-149 Français (Mode d´emploi)... 150-199 Italiano (Manuale d’uso)... 200-248 Nederlands (Gebruiksaanwijzing)... 249-298 Português (Manual de instruções)... 299-347
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ContentsPage
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 profile... 5 1.5. Clinical benefits... 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 profiles ...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 configuration...21 6.3. Starting and stopping a procedure...22 6.4. Procedure workflow 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 files in the Archive...27 7.2. Exporting files to PACS server or USB flash drive...27 7.3. Deleting files from the Archive...29 8. Connect external equipment... 30 8.1. Connecting to an external monitor...30 8.2. Connecting USB flash 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 specifications... 35 13.1. Standards applied...35 13.2. Specifications for aView 2 Advance...35 13.3. Specifications for aView 2 Advance bracket...36 13.4. Specifications 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
Ambu is a registered trademark and aScope and aView are trademarks of Ambu A/S. 4
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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)
• Medical USB printer
• USB 3.0 Type A flash drives
• USB powered audio devices that comply with IEC 60601-1, IEC 60950-1 or IEC 62368-1 7
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 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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2.3. Description of components 1
No. Part 1 Casing
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Touch screen
Stand Connector ports for Ambu® visualization devices Power button Hardware reset button Ventilation holes
Function Displays the image from the Ambu visualization device and the graphical user interface. Use the stand to place the displaying unit on a solid surface and to carry the displaying unit while turned OFF. Match and align colours, arrows and geometry on visualization device plug and the connector port. Push button for power ON and OFF. Reset the displaying unit hardware without impacting stored data. Cools hardware during use.
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No. Part 8
Power inlet
9-1 USB connection 10
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Function Power inlet for charging the displaying unit. Two inputs/outputs for USB 3.0 Type A.
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Input/output connection
HDMI, 3G-SDI, LAN (Ethernet)
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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
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 Ambu® aView™ 2 Advance - Battery Kit. This kit contains a battery and a replacement part kit.
Item numbers 405012100
Ambu® aView™ 2 Advance 405014100 Visualization device interface kit - Blue. Ambu® aView™ 2 Advance 405000503 Visualization device interface kit - Grey. 405000502 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. Ambu® aView™ 2 Advance - Fan Kit. 405016100 This kit contains a fan and a replacement part kit. 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 Ambu Imaging System
External Connection Option
Ambu Displaying Unit HDMI Image and Video Streams
3G-SDI Extermal Monitor
Visualization Device
USB 3.0 Type A Recording/ Log File
Software Update/Upgrade
USB 3.0 Type A Audio Device USB 3.0 Type A
USB Flash Drive
USB 3.0 Type A Medical Printer DICOM
Wi-fi
Wi-fi LAN LAN
Server
PACS Server/ Worklist Server
3. Explanation of symbols used Symbol
Description
Description
Warning
Caution
Follow the Instructions for Use
Country of Manufacturer
Consult Instructions for Use Waste Bin symbol, indicating that waste must be collected according to local regulation and collection schemes for disposal of electronic and electrical waste (WEEE)
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Symbol
IP30
E354633
Protection against solid objects Medical – general medical equipment as to electric shock, fire and mechanical hazards only in accordance with ANSI/AAMI ES606011:2005+ AMD 2012, CAN/ CSA-C22.2 No. 606011:14+IEC 60601-2-18:2009
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Symbol
Description
Symbol
Universal Serial Bus (USB)
HDMI
Description Waste Bin symbol, indicating that waste must be collected according to local regulation and collection schemes for disposal of batteries High-Definition Multimedia Interface
Serial Digital Interface
LAN
Local Area Network
Catalogue number
3G-SDI
%
Rx only
Batch Code
Medical Device
Humidity limitation
Atmospheric pressure limitation
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
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• Follow the instructions on the screen to change the password (required on first use).
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6 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.
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• 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.
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For daily operation it is 13 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 Default user
Advanced user
Administrator Service user
Access without login
Daily operation
Administrator Service with full access related tasks
Function access
+ARC
Login required
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Live View
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Video recording
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Photo
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Current procedure
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Worklist
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Image adjustments
x **
x **
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Archive
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x
x
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Settings
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x ****
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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. *
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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 upperand lower-case letters, numbers, and symbols to enhance password protection.
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• To delete a user profile, press the user name, then press the delete icon. 13
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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. refer Pole mounting brackets are supplied with the displaying unit. Letters in grey circles 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. 14
• 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
Red
< 20 %
Charge
Blinking orange *
*
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 .
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• 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 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.
• Press Configure 5 and 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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• 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.
5.1.2. Set up Wi-Fi network with WPA/WPA2 authentication: • Select the required Wi-Fi network from the list.
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• Enter the password and press Save 6 , then press Connect.
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• When the connection has been appears in the Toolbar. established, a Wi-Fi symbol • 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 8 and enter the username. • Press the input field next to Password 9 and enter the password.
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• If the certificate name is not 11 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.
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• 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.
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• 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.).
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• 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.
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• 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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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
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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 .
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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
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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 .
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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. 19
• 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.).
39 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.
43
• 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. 20