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Rev. 03September 2020ADDENDUM TO MYLAB USER MANUAL350077200

IN TR ODU CT I ONIntroductionThe aim of this addendum is to describe the new functionalities introduced with therelease 21.xx.yy (software version F090201) on the Esaote MyLab devices.For this reason, this addendum is to be considered an integration of the entire set ofmanuals supplied with your MyLab.Never refer exclusively to this addendum when operating with MyLab.Make sure you understand and follow these instructions.Keep this addendum with the equipment for future reference.Features, probes and applications described in this addendum may changerelating to your device configuration and depending on the Country and therespective clearances.MyLab Addendum ConventionsIn this addendum system controls are indicated using the following graphicalconventions: Control panel buttons are indicated by GREY CAPITAL LETTERS.Touchscreen keys are indicated by BOLD BLUE CAPITALLETTERS. Touchscreen software strings are indicated byCAPITAL LETTERS. Screen software buttons and options are indicated byB L A C K C A P I T A L L E T T E R S. NORMAL BLUEBOLDScreen software strings are indicated by NORMAL BLACK CAPITALLETTERS.Select/Click means positioning the cursor with the trackball over the desired optionand pressing EN TER to confirm.Right click means positioning the cursor with the trackball over the desired option andpressing UN DO to confirm.Double click means positioning the cursor with the trackball over the desired optionand pressing EN TER twice.MyLab- ADDENDUM TO MYLAB USER MANUALii

INTRODUCTIONTap means touching with your finger the desired command on the touchscreen.WARNINGIn this addendum WARNING identifies a risk for the patient and/or theoperator.CAUTIONThe word CAUTION describes the precautions necessary for protecting theequipment.NOTEIn this addendum NOTE points out information of special interest but notrelated to risks for patient, operator or device.MyLab- ADDENDUM TO MYLAB USER MANUALiii

INTRODUCTIONMyLab- ADDENDUM TO MYLAB USER MANUALiv

INDEXTable of ContentsIntroduction. 1-iiMyLab Addendum Conventions. 1-ii1 Addendum to Getting Started manual . 1-1Electronic Instruction for Use. 1-1How to access the manuals built-in on MyLab. 1-1How to access the manuals on Esaote website. 1-2Clinical Applications and Supporting Probes - MyLabSigma elite . 1-3Customizing the System - General Setup. 1-4System Maintenance - Cleaning Operations. 1-52 Addendum to Advanced Operations manual. 2-1IMAGE OPTIMIZATION . 2-1B-Mode Controls and Optimization . 2-1Controls in B-Mode. 2-13 Addendum to Probes and Consumables manual. 3-1Needle Guide Kits. 3-1Reusable Needle Guides by Esaote. 3-1MyLab- ADDENDUM TO MYLAB USER MANUALv

INDEXMyLab- ADDENDUM TO MYLAB USER MANUALvi

1Chapter1 - Addendum to GettingStarted manualThis chapter describes the modifications that affect the Getting Started manual.Electronic Instruction for UseFrom now on, MyLab operation manuals are provided in electronic form too: built-in on the MyLab and accessible through its userinterface, on a website.How to access the manuals built-in on MyLabTo access the manuals built-in on MyLab you have to:1. Connect your MyLab to a power source;2. Press O N /O FF to turn MyLab on;3. Wait for the device software fully to start;4. Press M EN U ;5. Click on M A N U A L S M A N A G E R : the window below is displayed showing on the left the list of the available manuals.MyLab- ADDENDUM TO MYLAB USER MANUAL1-1

ADDENDUM TO GETTING STARTED MANUALFig. 1-1: User manual display6. Click on one of the manual titles in the list to open therelated content.NOTEThe PDF reader is already integrated in MyLab.The manuals installation and update is always done by the Esaote servicepersonnel. The UPDATE MANUALS button on top-right is for the unlikely eventyou have to update manuals on your own. If this particular case happens, thepackage for the update is provided by the Esaote service. This remote case iscommunicated by MyLab through a warning message at starting-up.How to access the manuals on Esaote websiteTo access the manuals on Esaote website you have to:1. Access the website https://eifu.esaote.com;2. Click on the dropdown menu CHOOSE THE MEDICAL SYSTEM;3. Select the MyLab for which the manuals are needed;4. Once the page related to the selected MyLab is displayed,select the manuals corresponding to the software versioninstalled on your MyLab;5. Select the language you desire;6. Click on the manual to open it or click onMyLab- ADDENDUM TO MYLAB USER MANUALto download it.1-2

ADDENDUM TO GETTING STARTED MANUALNOTEYou can download the entire set of manuals by clicking on DOWNLOAD ALLFILES (.ZIP).Manuals are PDF files, you may need a PDF reader installed on your PC toconsult them. You can download for free the program Adobe Acrobat Reader from the Adobe web site.Clinical Applications and SupportingProbes - MyLabSigma eliteTable 1-1: Available probes and , Musculo-skeletal, Urology, VascularYESIH 6-18Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organ,Thyroid, Urology, VascularNOL 3-11Abdominal, Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid,VascularYESL 4-15Abdominal, Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid,VascularYESSL2325Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid, VascularYESSL3116Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid, VascularYESSL3235Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid, VascularNOSL3323Abdominal, Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid,VascularNOMyLab- ADDENDUM TO MYLAB USER MANUAL1-3

ADDENDUM TO GETTING STARTED MANUALTable 1-2: Available applications and related probesApplicationaProbesAbdominalAC2541, IH 6-18, L 3-11, L 4-15, SL3323BreastIH 6-18, L 3-11, L 4-15, SL2325, SL3116, SL3235, SL3323Musculo-skeletalbAC2541, IH 6-18, L 3-11, L 4-15, SL2325, SL3116, SL3235, SL3323NeonatalcIH 6-18PediatricIH 6-18, L 3-11, L 4-15, SL2325, SL3116, SL3235, SL3323Small OrganIH 6-18, L 3-11, L 4-15, SL2325, SL3116, SL3235, SL3323ThyroidIH 6-18, L 3-11, L 4-15, SL2325, SL3116, SL3235, SL3323UrologyAC2541, IH 6-18VascularAC2541, IH 6-18, L 3-11, L 4-15, SL2325, SL3116, SL3235, SL3323a. Applications are listed here as they appear on user interface. Some clinical applications aremanaged by using proper probe and preset.b. Both conventional and superficial (including nerve blocks)c. Includes Neonatal and Neonatal CephalicNOTESystem applications are dependent on your system configuration,transducer and exam type. Not all applications are approved in allCountries. Please refer to your Esaote local representative for furtherinformation.Customizing the System - General SetupBelow you can find the new available option in thefolder under M EN U - G E N E R A L S E T U P .APPLICATION PRESETTable 1-3: New option in Application Preset FolderFieldsActionAVF ENABLEDWhen checked, this option enables AVF that makes thefocus positioning automatic, improving the focusmanagement. When enabled, all controls related to focusmanagement are disabled.MyLab- ADDENDUM TO MYLAB USER MANUAL1-4

ADDENDUM TO GETTING STARTED MANUALSystem Maintenance - CleaningOperationsCleaning the QWERTY keyboardTo clean the QWERTY keyboard switch your MyLab off, unplug it and usecommercial wet wipes only (refer to the Getting Started section for the list ofthe compatible cleaning agents).CAUTIONDo not use any kind of spray, foam, gel cleaner on the QWERTY keyboard,either directly or on moistened soft cloths, which could lead to a dropinside. This can cause damage to the QWERTY keyboard, which couldlead to system malfunctioning.MyLab- ADDENDUM TO MYLAB USER MANUAL1-5

ADDENDUM TO GETTING STARTED MANUALMyLab- ADDENDUM TO MYLAB USER MANUAL1-6

2Chapter2 - Addendum to AdvancedOperations manualThis chapter describes the modifications that affect the Advanced Operationsmanual.IMAGE OPTIMIZATIONB-Mode Controls and OptimizationControls in B-ModeBelow are the new touchscreen controls being now available in B-Mode.The new controls may not be present on your MyLab depending on yourdevice configuration and enabled licenses.FOCUSWhen this key is pressed, the system activates the visualization of theextension of the focal regions. The yellow arrows displayed on the side of theimage indicate the extension of each focal region.Available only with AC2541 probe in all applications.FOCUSES # REGIONFOCUSES # and REGION share the same knob.FOCUSES # is active when FOCUS (see above)is not pressed. It changes thenumber of active focuses in transmission, increasing resolution for a specificarea. Rotate the knob clockwise/counterclockwise to increase/decrease thenumber of focal zones. A graphic caret corresponding to the focal zoneposition(s) is displayed on the side of the image. The frame rate decreases ifmore than one focal point is active.NOTESeveral transmitting focuses can be activated; in this case, the relativedistance between focuses is pre-established.REGIONis active when FOCUS (see above) is pressed. It changes the numberof active focal regions. Rotate the knob clockwise/counterclockwise toincrease/decrease the number of focal regions. The number of the yellowarrows displayed on the side of the image changes accordingly.MyLab- ADDENDUM TO MYLAB USER MANUAL2-1

ADDENDUM TO ADVANCED OPERATIONS MANUALMyLab- ADDENDUM TO MYLAB USER MANUAL2-2

3Chapter3 - Addendum to Probes andConsumables manualThis chapter describes the modifications that affect the Probes and Consumablesmanual.Needle Guide KitsReusable Needle Guides by EsaoteThe following table updates the list of the available kits present on the Probesand Consumables manual. Refer to the Probes and Consumables manual forany further information.Table 3-1: Reusable Needle Guides by EsaoteProbeBiopsy adaptorAngleGaugeCA430ECA431ABS42120 /30 14, 18, 20, 21, 22CA631ABS62125 /35 14, 18, 20, 21, 22LA523ABS52345 14, 18, 20, 21, 22LA435SL2325ABS42445 14, 18, 20, 21, 22LA332ESL3332WBSL33X35 14, 18, 20, 21, 22TLC 3-13TRT33ABS33A90 14, 16, 18, 20EC123ABS1233.8 16IL 4-13IOE323ABS1545 14, 18, 20, 21, 22AC2541C 1-8WBAC54X20 /30 14, 18, 20, 21, 22SI2C41ABSIC4X0 /5 /15 14-15, 16-17, 18-19, 20-21MyLab- ADDENDUM TO MYLAB USER MANUAL3-1

ADDENDUM TO PROBES AND CONSUMABLES MANUALMyLab- ADDENDUM TO MYLAB USER MANUAL3-2

IN TR ODU CT I ON Introduction The aim of this addendum is to describe the new functionalities introduced with the release 21.xx.yy (software version F090201) on the Esaote MyLab devices. For this reason, this addendum is to be considered an integration of the entire set of manuals supplied with your MyLab.