M27 - Technical Bulletin

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# 06 / Date: 2021-08-02

Product:
Date:
Bulletin number and title:
Issue has a relevance for the
device safety:
Field Safety Corrective Action:
Issue has a relevance for the
device performance:
Reason:
Technical Bulletin
EIDON FA (PN: AIFLAME001)
2021-08-02
006 – Release of SW 4.0.0
NO
Not required
YES (introduced support for Ultra-Wide Field Modality)
Introduction of software support for Ultra-Wide Field Lens, to
increase the native field of view to up to 200 degrees (center
of the eye notation).

S/N affected: Software 4.0.0 can be installed on all EIDON FA devices.

Scope of notice: All distributors and customers
Service time: Up to 45 minutes
eidon_4.0.0.zip installation file
Service parts:
(See next page for more details and options.)
Software downgrades are not possible once a device has been
Description: upgraded to software 4.0.0.
Further details are available in the following pages.
Required action: Upgrade to SW 4.0.0 is recommended.
Hardware compatibility: Software 4.0.0 is compatible with all EIDON FA.
service@centervue.com
For further info please contact:
quality@centervue.com
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# 06 / Date: 2021-08-02

How to install the software update

IMPORTANT:
Carefully review the following description.
There are significant differences compared to the installation process of previous software version.

Install SW 4.0.0 using a USB memory key with at least 2 GB of free space.
1. Download the new installation file from
https://service.icare-world.com/cdn/eidon/sw/eidon_4.0.0.zip
2. Extract (unzip) the content of the archive on the top folder of the USB memory key.
You will notice four (4) files: one .cif, two .cip and one file named “force_install”;
3. Power on EIDON FA, and wait for the device to complete the homing sequence (the
optical head will move from the side to the center);
4. Plug the USB memory key into any of the available USB ports on the back of the
device (you might need to disconnect the external fixation to free up one USB port);
5. EIDON FA will automatically detect the USB memory key, beep once and
IMMEDIATELY start the installation sequence;
6. The installation sequence is split in three parts:
a. First, the installer software is upgraded;
b. Then the main unit and tablet software are upgraded;
c. Finally the calibration software is upgraded;
7. During the upgrade of the installer, the tablet will reboot several times and will
show a custom “Android” logo for up to 5 minutes without any other feedback;
8. The installation sequence will then upgrade the software on the main unit and on
the tablet: the tablet might be restarted during this process and the optical head
might repeat the homing sequence;
9. While the installation is in progress, EIDON FA will emit dual tones beeps.
At the end of each installation step, EIDON FA will emit three long beeps.
10. This upgrade can take up to 45 minutes (depending on the software version
previously installed on the device).
11. At the end of the installation sequence, EIDON FA will emit a last sequence of “three
long beeps” and show a confirmation message “Eidon v.4.0.0 installed successfully”;
12. The calibration software must be installed manually.
Log in as “Admin” and tap the “Software Available” button.
The software installer will show the list of installation packages found in the USB
memory key.
Tap the “Install” button and wait until the installation procedure completes.
13. Unplug the USB media;
14. The update procedure is complete and EIDON FA can be used to perform examinations.

IMPORTANT
If one of the installation steps fails, EIDON FA will emit a single, long beep. When this occurs, unplug the
USB memory key, wait for a few seconds, and then re-plug it again to repeat the installation procedure.
The installation process will save on the USB memory key a few files containing diagnostic data, useful to
troubleshoot incomplete upgrades. When opening a support ticket with iCare Service team make sure to
attach those files.
The on-board software might get corrupted if the USB memory key is extracted or if the device is powered
off before the update is complete.
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# 06 / Date: 2021-08-02

Summary of changes since version 2.0.0

New features
• Introduced support for Ultra-Wide Field (UWF) Modality.
The new Modality requires an additional license and the new UWF Lens.

• Introduced support to LDAP protocol for operator authentication. The feature requires an
additional license.
• New software installer with graphical interface.
• Implemented patient merge feature to consolidate two patient records into one.

Changes
• New Remote Viewer user interface.
• The Remote Viewer feature is now by default limited to 1 connection, on all new devices
manufactured with SW 4.0.0 (Q3 2021).
With an additional license it is possible to extend the number of concurrent connections (clients).
Devices manufactured prior to Q3 2021 with SW older than 4.0.0 will continue to support up to 11
concurrent connections even after they are upgraded to SW 4.0.0 (grandfather clause).
• When taking Stereo photos, the horizontal shift occurs toward the temporal field (previously:
toward the nasal field).
• Button previously labelled "Widefield acquisition" is now labelled "SmartMosaic", to avoid
confusion with new UWF modality.

Improvements
• Improved automatic session recovery after a tablet disconnection.
• DICOM: allow configuring character encoding.
• Operator is notified when a Remote Assistance (RA) session is in progress.
• Extended search functionality to also match the "notes" field.
• When the space available in the internal SSD gets below 30GB a "disk full" alert is shown to the
operator.

Bugs fixed
• DICOM: devices manufactured with SW 2.0.0 could not save the DICOM configuration.
• DICOM: The main application could crash when viewing an MWL entry if it does not contain all
mandatory fields.
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• DICOM: sending a study while another export is pending might result in the study not being
correctly exported.
• DICOM: unscheduled study does not accept empty descriptions.
• DICOM: when installing a DICOM license, exam loading fails if a PACS destination is not configured.
• DICOM: exported images always report "external gaze".
• DICOM: patient code on an MWL-originated patient record overwrites DICOM patientID when
sending to PACS.
• DICOM: PixelSpacing tag (0028,0030) should be 0.0049\0.0049 mm on 60° images.
• DICOM: full-manual images are not exported to shared folder in DICOM format.
• DICOM: MWL-initiated widefield exam shows MWL screen instead of Study Review screen after
mosaic creation.
• In some rare occasions, the main application can stop working right after an image is acquired.
• Enabling the HypoAF Boost filter on an AF Mosaic returns error.
• Switching eye while in the "eye not found" condition results in frames being dropped when video
recording is active.
• Pressing the "reset alignment" button several times as soon as it becomes enable can block the
optical head.
• Stopping second stereo image during acquisition in manual mode can lead to bad stereo couples.
• Device might enter the "locked" state if an exam is stopped when an image is being acquired.
• Stereo imaging does not work on full-manual exams.
• When the "Advanced settings" panel is open and a screen off/on transition occurs, user is not
prompted to enter the password again.
• While a backup is in progress, the operator is allowed to delete a patient but the delete operation
is not actually carried out.
• After switching to full manual from an automatic exam, snapshot preview is not available.
• On a device with many mosaics, tablet and RV can become unresponsive.
• When using "Verify" button in Configurator to test Shared Folder settings and the test result is
"timeout", Configurator app crashes.
• WiFi-direct printing fails to re-connect after a reboot.
• In the Remote Viewer, the "time since injection" value is not accurate in the milliseconds part.
• In some rare cases, the "reset lock" button would not actually reset the lock condition.
• An empty error message is shown when creating or editing a patient with name and surname
longer than 127 characters.
• Retaking an image used to create a mosaic and saving it yields to a error.
• When the operator resets the alignment during an automatic acquisition the device acquires a
central image instead of the selected field.
• When optical head is recentered due to motor stall, user interface does not report "At the end of
the procedure, exam has to be executed again".
• Device can be used to acquire images even if a previous installation left the SW in an inconsistent
state.
• Licenses are not always correctly installed if the installation process is started while the device is
still completing the initial boot sequence.
• The Configurator does not correctly handle network configurations with subnet smaller than /8 or
larger than /24.
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• When configuring a Remote Share export, a misleading error message is shown when the
credentials provided are wrong.
• When exporting files to USB or Shared Folder, some Asian characters are not correctly written in
the filename.
• Testing available disk space on remote file servers can time out if the remote share contains too
many files. This can result in errors with the NDS and Shared Folder features.
• Wrong rendering of Asian characters in printouts.
• In some rare conditions, thumbnails are not correctly shown in the patients list and studies list
pages.
• Sometimes thumbnails are not updated after a filter has been applied.
• A badly worded error message is displayed when trying to delete a mosaic during a long-running
backup operation.