Ambu aView 2 Advance Instructions For Use Manual
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Ambu aView 2 Advance Instructions For Use Manual

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

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Summary of Contents for Ambu aView 2 Advance

  • Page 1 INSTRUCTIONS FOR USE Ambu aView 2 Advance ® ™ For use by trained healthcare professionals only. For use with compatible Ambu visualisation devices. ®...
  • Page 2 Ø 18 - 35mm HDMI 3G-SDI Visualization Device Quick Guide Oct072019...
  • Page 3 Contents Page English (Instructions for use) ....................... 4-48...

  • Page 4: Table Of Contents

    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.

  • Page 5: Important Information - Read Before Use

    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®...
  • Page 6 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.

  • Page 7: Device Description

    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.

  • Page 8: Description Of Components

    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.

  • Page 9: Spare Parts

    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.

  • Page 10: System Overview

    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: •...

  • Page 11: Getting Started

    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.
  • Page 12 AmbuAdmin • Follow the instructions on the screen to change the password (required on first use). 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 .

  • Page 13: User Profiles

    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...

  • Page 14: General Settings

    • 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. •...

  • Page 15: Battery And Power

    • 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 •...
  • Page 16 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. •...
  • Page 17 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.

  • Page 18: Pacs And Worklist Setup

    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.
  • Page 19 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: •...

  • Page 20: Operating The Displaying Unit

    • 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.

  • Page 21: Setting Up Endoscope Button Configuration

    Note: For preparing and operating the Ambu visualization device, please refer to the Instructions for Use for the specific visualization device. 8. Verify that a live video image appears on the screen by pointing the distal end of the Ambu visualization device towards an object, e.g. the palm of your hand. Ensure that the live image has the correct orientation H .

  • Page 22: Starting And Stopping A Procedure

    • To deselect a patient, press the selected patient’s name and press Deselect. 6.5. Overview of Live View functions When an Ambu visualization device has been connected to the displaying unit, the Live View functions are available via the Live View tab.

  • Page 23: Using Image Adjustments

    Overview of Live View functions Icon Name Function Showing the live image when an Ambu visualization device Live View tab is connected. Video Starting and stopping video recording during a procedure recording icon (see section 6.3.). Taking photos during a procedure, also during video Photo icon recording (see section 6.3.).
  • Page 24 Zoom can be enabled/disabled in General settings by Administrator (see section 4.3). Adjust ARC (Advanced Red Contrast) setting: ARC is Ambu's proprietary red-colour contrast enhancement algorithm, which amplifies the red colour relative to other colour components at the same location. ARC is intended to improve the visibility of red colour tones in the image.

  • Page 25: Using The Stopwatch

    Use Dual View: • Connect two Ambu visualization devices to connector ports on the displaying unit. • The Live View screen shows two images, one larger and one smaller. The number shown in each image corresponds to the number on the connector port of the displaying unit.

  • Page 26: Current Procedure Folder

    Quick Guide on page 2. 1. Disconnect the Ambu visualization device from the displaying unit J . For disposal of the visualization device, please refer to the Instructions for Use for the specific visualization device.

  • Page 27: File Handling In The Archive

    7. File handling in the Archive 7.1. Accessing files in the Archive In the Archive, files can be viewed, exported, printed, and deleted. View photos and videos in the Archive: • Press the Archive tab, then press Procedures. • To search for a folder: Enter the date or note of the folder in the search field 1 and/or scroll the wheel to filter by time period 2 .
  • Page 28 Select file format: • Press the export icon 12 . • Select DICOM or BASIC file format 13 . • If you selected DICOM format, all patient information fields 14 must be filled out manually, unless the patient information has been retrieved from the Worklist before or during the procedure.

  • Page 29: Deleting Files From The Archive

    File formats Connector BASIC file format Image (Uncompressed) Blue 400 x 400 pixels – PNG format Grey 800 x 800 pixels – PNG format Green 400 x 400 pixels – PNG format Video (Compressed) MP4 format Explanations of functions in export menu Icon Name Function...

  • Page 30: Connect External Equipment

    Delete files permanently: • Press the Archive tab, then press Bin. • Press the required folder. • Select the required files by ticking the boxes below the thumbnails, or press Select all. • Press the permanently delete icon 21 , then press OK. 8.

  • Page 31: Printing Images Via External Medical Printer

    8.4. Printing images via external medical printer Before you print images via a medical printer, ensure that USB connection has been enabled for printing and a medical printer has been connected via USB (see section 4.3.). Select settings for printing: •...

  • Page 32: Software Updates/Upgrades

    If you are experiencing problems with the displaying unit, please follow the Troubleshooting guide in chapter 14 to find a solution. If this does not solve the problem, please contact your local Ambu representative. To solve the problem, Ambu may need a log file providing information about the displaying unit system.

  • Page 33: Cleaning And Disinfection Of The Displaying Unit

    Reset the data: • Press the Settings tab, then press About. • Press Data reset, then press Delete 6 . A dialog box appears informing of the consequences and asking to confirm. • Press Confirm, then enter Administrator password and press Continue. •...

  • Page 34: Maintenance

    If the battery is discharged, the procedure can take up to 3 hours. The battery should be charged at temperatures between 10 – 35 °C. CAUTION: To avoid malfunction of the equipment only use spare parts supplied by Ambu. Do not modify the spare parts.

  • Page 35: Disposal

    The power supply conforms with: • IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. 13.2. Specifications for aView 2 Advance Display Resolution: 1920 x 1080 pixels...

  • Page 36: Specifications For Aview 2 Advance Bracket

    Operation relative humidity: 30 – 85 % Operation atmospheric pressure: 80 – 106 kPa Operation altitude: ≤ 2000 m IP Protection Classification The aView 2 Advance is classified IP30: Protection System: against solid objects Dimensions Width (a): 331 mm (13.03") Height (b): 215 mm (8.46")

  • Page 37: Troubleshooting

    If replacement of spare parts is necessary, please refer to the Spare Part Replacement Manual included in the spare parts kit, or you can find it on ambu.com. Here you will also find information about the available Ambu authorized spare parts.
  • Page 38 Perform a Power OFF Cycle The displaying unit screen and the Ambu (follow the procedure above this table). visualization device have communication problems. No LED light in the distal end of the...

  • Page 39: Warranty And Replacement

    The warranty applies only to the original customer of Ambu and cannot be assigned or otherwise transferred. In order to avail itself of this limited warranty, if requested by Ambu, the customer must return the displaying unit to Ambu (at its own expense and risk of shipment). In compliance with...

  • Page 40: Appendix 1. Electromagnetic Compatibility

    Appendix 1. Electromagnetic compatibility Like other electrical medical equipment, the system requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC) the system must be installed and operated according to the EMC information provided in this Instructions for Use. The system has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices.
  • Page 41 Guidance and manufacturer’s declaration – Electromagnetic immunity The system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment. Immunity test IEC 60601-1-2 Compliance level Electromagnetic test level...

  • Page 42: Appendix 2. Radio Frequency Compliance

    Note 1: At 80 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast, cannot be predicted theoretically with accuracy.
  • Page 43 Sweden (SE) and United Kingdom (UK). The full text of the EU declaration of conformity is available at the following internet adress: www.ambu.com. Industry Canada statement (IC) EN: This device complies with ISED’s licence-exempt RSSs. Operation is subject to the...
  • Page 44 Federal Communication Commission Interference Statement (FCC) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.

  • Page 45: Appendix 3. Cybersecurity

    The displaying unit is of medium security risk (according to NIST) as: • The displaying unit does not allow any input from external devices (except from Ambu visualization devices and secured software updates).

  • Page 46: Appendix 3.2. Data At Rest And In Transit

    (h.264) Ambu Clear-text format The log files exported are mainly for Application log troubleshooting purposes by Ambu staff, in case you encounter problems with the displaying unit. The files are compressed in a format more secure than Windows standard compression function.

  • Page 47: Appendix 3.3. Software Bill Of Materials (Sbom)

    The following main off-the-shelf software components are used in the displaying unit. Main known vulnerabilities of each component including explanations of why they are acceptable for this application are continuously updated by Ambu. Contact your local Ambu representative for an up-to-date list with this information. Vulnerabilities with a low CVSS score are omitted as a consequence of the medium security risk rating of the displaying unit.
  • Page 48 Title Version Used for DICOMConnect 3.3.3 Used for the DICOM protocol communicating to the PACS server. Barebox 2021.03.0 Used for bootloading the Embedded system. RAUC 1.5.1 Used for updating new software on the embedded system. yocto dunfell Used to build the embedded Linux system.
  • Page 49 Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark T +45 72 25 20 00 ambu.com...

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