DOCUMENT APPARATUS DATE

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To be applied to:  MyLab 9 Family

• SUBJECT
MyLab Release build F080401.

IMPORTANT
NOTICE ✓ MyLab Release build F080401 is NOT RELEASED for ML 9VET, therefore
such systems MUST NOT BE UPDATED on the field with F080401SW
release.

• DESCRIPTION
The following SW pack is available on OwnCloud: MyLab9_F080401_340074400.zip

Build F080401
Regulatory Name 13.04.00
Commercial Name Evo 3.1

The Software Release files are available through OwnCloud and the link is available in the E-portal
(Service Documentations\[MyLab]\Software Upgrade)

This software version includes the changes made in two previous versions (F080201 and F080400) for which
a small-scale launch was made.
A full scale launch is made for this version.

Please note that the Regulatory/Commercial Name can be different depending on the country (because
based on the registrations made in that country).

With this Build there are new versions of the User Manuals. They are available in the E-portal restricted
area. Please be sure to provide to the end user the new copy of the user manuals after the SW upgrade.

WARNING: Before proceeding with the SW upgrade is recommended to advice the customer to make a prior
archive of the images to avoid the possibility of losing data.

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This SW release is not compatible with operating system Windows 10 Enterprise

2016 that can be present on some device on the field.
Before to proceed with the upgrade is necessary to determine the operating system
of the unit and select the proper installation procedure.
IMPORTANT Procedure A – upgrade only: is suitable only for devices with Windows 10 Enterprise
NOTICE 2015
Procedure B – quick format: is necessary for devices with Windows 10 Enterprise
2016
Before going to the customer site download from the owncloud link both SW and
prepare two USB pendrives to be ready to proceed with the correct installation
procedure according the operating system you will detect.
Upgrade a system with incorrect procedure will bring to serious issues as no audio
in PW.

Link for upgrade disk download (procedure A):

https://cloudbox.esaote.com/public.php?service=files&t=9abec5588676647ec685af72fc875884
Link for quick format disk download (procedure B):
https://cloudbox.esaote.com/public.php?service=files&t=67bfb865903c40c864cad99d5e5c8e46

The file is splitted in small zip files to avoid network issues. “how to use.txt” that you will find at this
link will contain all the info needed to properly download and properly pack all the files.

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How to check the Win 10 edition in the system:

• Start the system with service key inserted

• Select the start icon in the lower left corner and select “settings”
• Select “system” and “about”
• The info about operating SW must indicate “Windows 10 Enterprise 2015…”.

In case the OS is “Windows 10 Enterprise 2015”, upgrade the system following:

Procedure A – Upgrade to F080401 (pag. 9)

In case the OS is “Windows 10 Enterprise 2016”, upgrade the system following:

Procedure B – Quick Format and upgrade to F080401 (pag. 13)

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Build F080401 includes stability improvements and bug fixing.

New functionality in build F080201:

• E 3-12 End-fire Endocavitary probe introduction

• iQ Improvements on already released probes
- C 1-8: AT dropping recovering starting from harmonic imaging and selecting CFM
- mC 3-11: AT dropping recovering starting from harmonic imaging and selecting CFM
- P 2-9: Consistency check between Lion and X7 and improved settings
- L 4-15, mC 3-11, P 1-5, P 2-9 veterinary presets
- P 2-9 – Introduced Neonatal application, preset Fontanel
• More Homogeneity in the Image Bmode
• Four-Quadrant Screen Layout
• Workflow Improvements
- OB Fetal Growth/Age Graphs on Touchscreen
- OB Biometry on Uterine Artery – Umbilical Artery – MCA
- EDD on Measure Panel
- MICRO V – PWRD separate use of Gain
- Dual Mark Workflow Improvements
- ADM Measure output configurability
- DICOM image Rotation (including FollowUp)
- Thyroid Report Nodules increased to 8
• Connectivity
- General Data Protection Regulation (GDPR) compatibility
- Antivirus
- Printing to a DICOM server
• 3D/4D Improvements
- Volume Filtering Improved
- Level curves artifacts removal
- XLIGHT Improved Rendering
• eSpeed (Manual set of speed of sound)
• Report Templates
• BI-RADS / TI-RADS risk calculators
• QElaXto 2D Extensions
- Dual-Simultaneous Acquisition
- Noise Reduction Control
- Real time ROI measurement calculation
- New ROI Ratio measurement calculation
• MylabRemote
• Breast Navigation
• E 3-12 Virtual Navigator and Biopsy kit availability
• Automatic Biometry OB Measure
• EasyMode

• Biopsy kits:
o For E 3-12 to biopsy kits are released (already used on EC1123 probe, as E 3-12 uses the same
plastic body):

o BSE12X- BIOPSY KIT 0deg REUSABLE (141002900)

o CBSE12X Disposable Kit Civco 639-012 (142012200)

• Breast Nav kit (P/N 140042900) due to the introduction of Breast Nav Tool. It is composed of parts
already used on other VN application + New Breast Biopsy Licence (300060300)

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• MyLab Remote licence (340048900)

New functionality in build F080400:

• Keyboard firmware upgrade
• Introduce the possibility to display/use a focus which is different from the one set in the focalization
file
• Preset the speed of Sound Value per Probe/Application/preset
• Improve the automatic management of gain after Vat changes
• Improvement on QElaxto function
• IH 6-18:
o IQ fine tuning
o IQ Improvement and porting of XVIEW Filter from L 8-24
• L 8-24 - IQ improvement
• L 4-15:
o Different tuning of focus compared to the one set in the focalization file
o BREAST - Improve IQ in B FUND
o IQ Compliance activities
o Improved Contrast in All Appl/Preset
• L 3-11 - IQ Compliance activities
• L 3-11/Vascular:
o Improve B/TEI quality
o CFM/PW Low sensitivity on deep vessels
• C 1-8 - IQ Compliance activities in QElaxto

New functionality in build F080401:

• C 2-9 probe introduction

• Installation must be denied on not compatible Windows version: in case the OS is not compatible,
the following message is shown:

Solved bugs in build F080201:

• C1-8 - Escan/Autogain don't work properly
• 3D/4D: In TSI and Xligth active the volume disappears changing the position of the cut planes -
• System error reviewing OB graph on the touch screen
• MyLab 9 eXP unit hangs randomly after going in exam review and pressing StartEnd
• After a Multimedia export with anonimize checkbox on the Dicom storage becomes anonimized as

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well
• Print Preview: 3x2 format when opening the print preview an image not printed is included (the
thumbnail selected) - user tries each time to delete is but it appears again each time he re-opens the
preview
• System error while using CnTI with easytuning
• System does not show color in the box the first time is enabled; closing and opening again the CFM
box, the color appears
• Incorrect saving of images in B+CFM+PW mode
• Image Anomaly >> lines freq setting (GEN-M)
• Left Ventricle Measure MMode: Crossline indicators are not displayed (when set to active). It looks to
be the only measure where they do not work
• Complaint about image quality with convex probe and strange error message shown once
• LV measure in M-mode, caliper does not stay on last fixed point
• ML 9 V2 showed an error message when in freeze status after having used the QElaxto2D
• In bodymap, image doesn't appear on monitor uploading 2D Dicom
• Border of Circle in QElaxto is not visible
• VN: Breast nav jammed changing layout after a stripe has been deleted
• Elaxto strain E 3-12 EC123 change the Offset and dynamic range in prostate and Gyn application
according to MyLab Twice settings
• ElaXto Histograms are not fully displayed
• Cannot connect to a hiddend WPA2-Enterprise Wi-Fi network.
• For having balanced images, you need to move the first 2 TGC on the right
• Measure of AUTOEF can be misleading if the user manually modifies the contour and approve without
confirming
• Enable the elaxto offset under WIP user
• Random error message ERROR n.8 HIGH VOLTAGE in Probe Section connecting a new
PROBE in VET model (L4-15 probe used at 90V of VAT)
• System error with Qelaxto function
• System error connecting system to projector
• At every start up system does not show the US image, enlarging with F9 the image appears
• Problem with Auto EF: a same detected contour is saved on overlay on all frames while the user
clones the editable clip
• Continuos "click" coming from the speakers
• In Elaxto, problems with a big ROI; the size of ROI has to be decreased for having acquisition.
• TLC 3-13 cannot be selected
• Random error message during the studies “the system detected a defective condition…” and
the system reboots itself
• Equipment blocked with system error while scanning with microconvex probe

Solved bugs in build F080400:

• Boot from standby is 25 sec, target is 15sec as in first system

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Known restrictions in build F080401:

Known issues: Workaround:

Supported probes:

Code Description

CONVEX and ENDOCAVITARY PROBES

120000013 C1-8 - Convex Probe, Single Crystal, iQ-appleprobe, Multifrequency, Wide Band
120000025 TLC 3-13 - Endocavity Biplane Lin/Cvx, High Density, Multifrequency, Wide Band
120000046 mC 3-11 - MicroConvex Probe, iQ-appleprobe, Multifrequency, Wide Band
121201800 SI2C41 - Biopsy Convex Probe, iQ-appleprobe, Multifrequency, Wide band
9600157010 EC123 End-Fire 10R Endocavity Probe 9-4
120000038 E 3-12 Endocavitary Probe
120000040 C 2-9 Convex Probe

LINEAR PROBES
120000014 L 3-11 - Linear Probe, iQ-appleprobe, Multifrequency, Wide Band
120000023 IH 6-18 - Hockeystick Probe, iQ, Multifrequency, Wide Band
120000036 L 4-15 - Linear Probe, iQ-appleprobe, Multifrequency, Wide Band
120000037 L 8-24 - Linear Probe, High Frequency, iQ, Multifrequency, Wide Band
120000041 L 8-24 – elevation 3mm Linear Probe, High Frequency, iQ, Multifrequency, Wide Band
9600195010 BL433 BI-SCAN SC LINEAR PROBE

PHASED ARRAY PROBE

120000015 P 1-5 - Phased Array Probe, Single Crystal, iQ, Multifrequency, Wide Band - Adult
120000039 P 2-9 - Phased Array Probe, Single Crystal, iQ, Multifrequency, Wide Band - Pediatric

DOPPLER PROBES
121201000 S2MCW Doppler Probe
121201100 S5MCW Doppler Probe
121201200 SHFCW - High Frequency Doppler Probe

TEE PROBES
121200801 ST2612 - TEE Probe, Omniplane, iQ, Multifrequency, Wide Band - Adult

VOLUMETRIC PROBE
121201500 SB2C41 - Volumetric Convex Probe, iQ, Multifrequency, Wide band
122001900 SB3123 - Volumetric Endocavity Probe, iQ, Multifrequency, Wide Band

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• NOTES

Note

Please make sure that the PC for downloading the Software Release from ownCloud site and burning
copying to USB, has the following characteristics:
- Updated security patches of the operative system and installed programs
- Installed and updated antivirus
- Installed and running firewall

Esaote systems where this DVD-R/USB memory drive is produced are protected with:
1) Operative Systems and programs updated with the last Security Patches available
2) Updated Antivirus
3) Firewall
To copy the software upgrade on a removable device (USB key), always and only use removable devices with
a safe content (devices scanned and used on systems protected by an anti-virus and anti-malware program).
Before proceeding with the procedure:
• disconnect any digital USB peripherals connected to the unit;
• save both the clinical and system configurations
• Make a backup of the archive.

Please note that if, for any reason, the unit main power turns off during the upgrade, the Installation
procedure could be compromised and a factory repair of the unit or the rack could be necessary.

If the equipment is equipped with the batteries, be sure that the system is connected to the mains before
starting the upgrading procedure. The system must remain connected to the mains during the upgrade,
including the first reboot to complete the firmware upgrade.

NOTICE
Do not connect any auxiliary monitor during the first installation (see TN000148)

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Procedure A - Upgrade to SW Rel. Build F080401

For system equipped with Windows 10 edition 2015 only

• REQUISITES

- USB memory drive (USB 3.0 recommended). Min 8GB.

- Service Key P/N 140009500

• PREPARATION
1. Download the F080401 SW Upgrading release file from ownCloud.
2. Format the USB key to avoid virus infection
3. If required, the download can be checked for correctness with the program: Total Commander.
Extract the .ZIP file in a folder created on the USB key called SWPACK.
Open the file SWPACK.MD5 with Total Commander and check for errors.
Continue when there are 0 errors.

Note: The .ZIP file mustn’t be extracted in the USB key ROOT

NOTICE Before installing this software build, check the installed version of the involved
unit.
Press MENU then select SYSTEM INFO.

For software build F080101 or higher, the below PRESET and X-View
modifications are already performed.

Apply the modifications when software build F080100 or lower is installed

• PRESET

User pre-sets must be reset to obtain maximum image quality.

The procedure is described after the Software installation description.

• X-view
Before applying this update, check if the X-View license is active.
Press Menu, the select Licenses.

Units equipped with the X-View license require a new license code after
installing this SW.
New codes are listed, per unit serial number, in the file “MyLab 9 eXP XVIEW
2.0.zip” published on the E-portal. (Service Documentations\MyLab 9 \Software
Upgrade)

The new license codes are generated based on the original System ID. In case,
for whatever reason the System ID has been changed, the new code will not
work.
Please contact Global Technical Service in this case.

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NOTICE Due to an upgrade of the Esaote trust certificate for Microsoft, a pop up dialog
rises up during the setup of the release F080201 or later:

It is necessary to click on “Install” to proceed with the sw installation.

This popup is shown just once (meaning that if you later on proceed with an
additional update of another sw release, the message is not displayed anymore)

• INSTALLATION PROCEDURE
1. With the service key inserted, turn on the system.
2. The system will start up in Windows mode.
3. Connect the USB pen drive that contains the Software pack to one of the USB slots. To speed up the
update, it is recommended to use the USB 3.0 slots on the side of the unit.
4. With Windows File Explorer navigate to the USB pen drive and open it.
5. Open the SWPACK folder
6. Double click the SETUP.exe to start the update process.
In case the following Windows Security pop-up screen appears, remove the Checkmark at the
“Always ask before opening this file” field (if present).
Then Click RUN to continue

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7. A message will pop up to make sure the unit is connected to the mains. Click OK. There are no
batteries in MyLab 9 eXP

NOTE: It could happen that the following window is not shown, because it is hidden in
background.
Please press ALT+TAB on alphanumeric keyboard and select this window.

Note

Please check periodically the background like pressing ALT+TAB, as other messages could
be shown in background.

8. Follow on-screen instructions.

9. The following message is shown.
At this point the USB pen drive has to be disconnected.

10. Click “OK, continue” to continue.

NOTE: In case the screen remains completely black for some minutes, DO NOT FORCE
SHUTDOWN

NOTE: In case black screen with following error appears, press OK

11. After several automatic reboots, the unit will end in Windows 10 desktop mode.

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12. Double click the WORKFLOW icon to start the MyLab software and finish the Firmware installation.

NOTE:
Do not open the MONITOR icon. This may cause malfunction of the unit and is used for
production purpose only.

Note

At the first reboot it may happen that the unit will crash with a “System error message” (in
the logs there is a reference about “ALGOL Device Not Found”). The unit needs to be
switched off and restarted. The problem has to appear one time only.

13. Remove the Service key.

14. Shut down the system and start up again.

During the start up it may be operated a reboot, to adapt the recognizing of the network card and
wifi module.

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Procedure B – Quick format and upgrade to SW Rel. Build F080401

For system equipped with Windows 10 edition 2016

The F080401 QUICK FORMAT disk is applied only to the OS partition (NOT TO DATA PARTITION), this
allows to change the operating system from Windows 10 Enterprise LTSB 2016 to the correct
Windows 10 Enterprise LTSB 2015, without affect the patient database.

Requirements:

1. Service key P/N 140009500.

2. F080401 Quick Format. Zip file downloaded from the e-Portal
3. USB memory drive, Min 32GB.
4. ML 9 Family Service Manual
5. Licenses Codes Paper
NOTICE XView license will be lost after the upgrade. You will need to insert the license code.
Be sure to have all the license codes before proceed with the upgrade. If you do not
have the original paper enter in menu MODEL, visualize the codes and write them
down to have ready after the upgrade.

Preparation:

1. Download the file QUICK Format file (.iso) and program Rufus 2.9 from ownCloud.
2. Create bootable USB memory drive.
a) Connect USB memory drive to PC
b) Run the program rufus.exe. NOTE: DO NOT update when asked.
c) Set the Rufus fields as indicated below:

Click START to continue.

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3. A warning will be displayed:

Click OK to continue.

4. When DONE, click CLOSE

5. A bootable USB memory drive, with SSD image is created

6. Be sure to store all Customer licences in the License Codes Paper; store also the Context Vision
licence needed to be restored at the next startup.
7. Store Network and Dicom settings, system password and printers drivers
8. Save the customized order of application by probes (RT Preset Menu) if needed by customer.

Unit installation:

1. Insert the Quick Format USB key prepared with rufus (it is suggested to insert in one of the lower USB
3 sockets) and the Service Key. Start up the system
2. BIOS Setting:

a. press <DEL> on the keyboard, while starting up

b. Password: Fireball (key sensitive)
c. Select “BOOT” menu, with arrows
d. Select HARD DRIVE BBS PRIORITY and press ENTER to enter the options
e. Select the first boot device, indicated with n. 1 and press ENTER
f. Three option will be shown (HDD, DVD e USB): select usb as first using the arrows.

3. Save and start with the format (the system asks “press any key to boot from USB”)
4. The procedure is automatic: at first the OS is installed; some pop-up are shown, but automatically
closed; after the SW upgrade starts; no action has to be performed. The system will finally show
Windows desktop.
5. Follow the instructions on the screen till it is required to remove the USB memory drive and restart
with Service key inserted
6. After a few minutes the loading ends; double click the WORKFLOW icon to start the MyLab software
7. Enter system license and optional licenses:
a. Press the MENU key and select the License key.
b. Select the MODEL tab and enter the System license in the appropriate field.
c. Type the unit serial number in the serial number field.
d. Press VERIFY and then SAFE.
e. Restart and enter all optional licenses.
f. Press Verify and then SAFE.

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8. If necessary, install the printer. (Refer to the Getting Started manual)

9. If necessary, set the printer configuration (“PRINTERS” option).
10. Install the settings. Depending on how the settings had been saved, follow the corresponding
procedure:

NOTE
When the settings are not saved nor exported, the settings must be set manually.

Settings Saved through the Export Procedure

• Press the MENU key.
• Select the “Import/Export” option.
• Import the desired settings.

Settings Saved by Copying the “ConfSet” Folder

• Start up with the service key connected, to start up in Windows mode
• Press the UNDO key and create a new folder.
• Copy ConFSet folder from USB medium
• Open folder and select drive E:\Work and paste the ConFSet folder
• Delete New Folder

NOTE:
When ready, set the startup priority back to HDD/SSD when applicable.

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