Esaote MyLabX75 Series User manual

Rev. 03
June 2021
MyLabX75 Family
GETTING STARTED
350079900

MyLab - GETTING STARTED iii
GETTING STARTED
Manufacturer’s Address
ESAOTE S.p.A.
Via Enrico Melen 77
16152 Genova
ITALY
Phone [phone]
[email protected]
www.esaote.com
Important Information
MyLabX75, MyLabX75 eHD, MyLabX75 eXP and MyLab XPro75 comply with the
Medical Device Directive 93/42/EEC and subsequent amendments and are
CE marked.
MyLabX75, MyLabX75 eHD, MyLabX75 eXP and MyLab XPro75 are devices in
Class IIa according to the Medical Device Directive.
MyLabX75, MyLabX75 eHD, MyLabX75 eXP and MyLab XPro75 comply with the
Radio Equipment Directive 2014/53/EU and are CE marked.
MyLabX75, MyLabX75 eHD, MyLabX75 eXP and MyLab XPro75 are devices in
Class 2 according to RED Directive.
For US Customers: US Federal Law restricts this device to sale, distribution
and use by or on the order of a physician.
All information included in this manual is relative to the following Esaote
ultrasound equipments: MyLabX75, MyLabX75 eHD, MyLabX75 eXP and MyLab
XPro75.
In this manual, all the above mentioned devices can be also referred as
MyLabX75 Family or MyLab.
Unless specifically noted, sections of this manual pertain to all the devices.

MyLab - GETTING STARTED iv
Guarantee
The information in this document is the exclusive property of Esaote S.p.A.
and is reserved. Reproduction or distribution in any form is strictly
prohibited. All rights reserved.
All screenshots, pictures and graphics in this manual are used for descriptive
purposes only and may be different from what you see on the screen or
device.
This manual has been written taking care to ensure the accuracy of all of the
information included, however, Esaote assumes no liability for errors or
omissions.
No translations of this documentation are allowed without the consent of
Esaote S.p.A.
The information contained in this documentation is subject to change
without prior notice.
Trade Marks
All the names are property of the respective owners and are used exclusively
for identification purposes.

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GETTING STARTED
RED Declaration of Conformity

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MyLab - GETTING STARTED vii
GETTING STARTED

MyLab - GETTING STARTED viii

MyLab - GETTING STARTED ix
GETTING STARTED

MyLab - GETTING STARTED x

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GETTING STARTED

MyLab - GETTING STARTED xii

INDEX
MyLab - GETTING STARTED xiii
GETTING STARTED
Table of Contents
Manufacturer’s Address............................................................................. i-iii
Important Information .............................................................................. i-iii
Guarantee..................................................................................................... i-iv
Trade Marks................................................................................................. i-iv
RED Declaration of Conformity .............................................................. i-v
1 Introduction.................................................................................. 1-1
Intended audience....................................................................................... 1-3
Disclaimer .................................................................................................... 1-3
MyLab use.................................................................................................... 1-4
MyLab Manual Conventions..................................................................... 1-5
Manufacturer’s Responsibility................................................................... 1-6
Product Life Cycle...................................................................................... 1-6
Life Time .................................................................................................. 1-6
Maintainability Time ............................................................................... 1-7
End-of-Life Disposal .............................................................................. 1-7
Usage License Agreement for the Software Included in the Apparatus1-
7
Proprietary Rights.................................................................................... 1-7
License Rights and Limitations ............................................................. 1-8
Third Part Software................................................................................. 1-8
Product Traceability ................................................................................... 1-8
Vigilance System ....................................................................................... 1-10
2 Additional Information on Safety ................................................ 2-1
Environmental Safety................................................................................. 2-1
Information about Reusing/Recycling................................................. 2-1
Special waste............................................................................................. 2-1
Exam Waste.............................................................................................. 2-1
Electrical Safety........................................................................................... 2-1
Electromagnetic Compatibility ................................................................. 2-3
Electro-Surgical Devices (ESUs) ..................................................... 2-4
Electromagnetic Emissions.................................................................... 2-4
Essential performance ............................................................................ 2-5
Electromagnetic Immunity .................................................................... 2-5
Electromagnetic Immunity for All Medical Equipment.............. 2-6
Electromagnetic Immunity for Medical Equipment not Life
Supporting........................................................................................... 2-7
Recommended Distances between Radiofrequency (RF)
Communication Systems and MyLab ............................................. 2-8

INDEX
MyLab - GETTING STARTED xiv
Work related musculoskeletal disorders ..................................................2-9
Repetitive Strain Injury...............................................................................2-9
Working with Video Display .....................................................................2-9
Information about ultrasound residual risks.........................................2-10
Cardiac .....................................................................................................2-10
Stress Echocardiography .................................................................2-10
Contrast Echocardiography ............................................................2-10
Vascular and Neonatal Cephalic..........................................................2-11
General Imaging.....................................................................................2-12
Contrast Enhanced US ....................................................................2-12
Shear Wave Elastography................................................................2-12
Transrectal access .............................................................................2-13
Intraoperative and Laparoscopic access........................................2-13
Neonatal.............................................................................................2-13
Women Health .......................................................................................2-14
Gynecology - Transvaginal..............................................................2-14
Gynecology - Shear Wave Elastography.......................................2-14
Fetal ....................................................................................................2-14
Items in Contact with Patient ..............................................................2-15
Latex Sensitive Patient...........................................................................2-16
Device Modifications................................................................................2-16
Explosive Hazard ......................................................................................2-16
Wireless safety............................................................................................2-17
Users in the European Union.........................................................2-18
Users in the United States of America ..........................................2-18
Users in Australia..............................................................................2-18
Wireless antenna position .....................................................................2-20
3 MyLab Overview...........................................................................3-1
About MyLab...............................................................................................3-1
Intended Purpose.....................................................................................3-1
Clinical Applications and Supporting Probes ......................................3-2
Patient population....................................................................................3-4
Intended users ..........................................................................................3-4
Contraindications .....................................................................................3-4
MyLab Components ...................................................................................3-5
Monitor (1)................................................................................................3-6
On/Off Button (2) ..................................................................................3-7
Control Panel Assembly (4)....................................................................3-8
Control Panel Assembly Orientation...............................................3-9
Pull-out Qwerty Keyboard (12) .............................................................3-9
Probe Connectors and Cable Management .......................................3-10
Peripherals Housing...............................................................................3-10
Connections panels (8)..........................................................................3-11

INDEX
MyLab - GETTING STARTED xv
GETTING STARTED
Wheel Brakes.......................................................................................... 3-11
Batteries...................................................................................................... 3-12
Battery Status.......................................................................................... 3-12
First Use.................................................................................................. 3-13
Battery Lifetime ..................................................................................... 3-13
Error Messages.......................................................................................... 3-14
Errors in Battery Management ............................................................ 3-14
Power Supply Error Messages............................................................. 3-15
4 Preparing for use .......................................................................... 4-1
Acclimation Time ....................................................................................... 4-1
Connecting MyLab to a Network ............................................................ 4-1
Connecting Peripherals.............................................................................. 4-2
Safety Concept ......................................................................................... 4-2
Medical environments ....................................................................... 4-3
B/W Thermal Medical USB Printer housing...................................... 4-7
USB Printer housing ............................................................................... 4-7
Auxiliary Monitor .................................................................................... 4-8
Gel warmer............................................................................................... 4-9
Thermasonic gel warmer................................................................... 4-9
Lifeguard UGW-01 gel warmer ..................................................... 4-10
External CD/DVD and HDD drives................................................ 4-12
Moving and Transporting MyLab.......................................................... 4-12
5 Using MyLab................................................................................ 5-1
Connecting MyLab to the mains.............................................................. 5-1
Turning MyLab On and Off..................................................................... 5-1
MyLab Controls .......................................................................................... 5-2
Control Panel Section ............................................................................. 5-2
TGC Sliding ........................................................................................ 5-4
Trackball.............................................................................................. 5-5
Encoders.............................................................................................. 5-5
Touchscreen Section............................................................................... 5-6
Menu Button....................................................................................... 5-6
Touchscreen........................................................................................ 5-6
Alphanumeric Keyboard Section.......................................................... 5-9
Information about the Screen Layout ..................................................... 5-9
Heading Area.......................................................................................... 5-10
Footer Area ............................................................................................ 5-10
Wi-Fi .................................................................................................. 5-10
Archival Media.................................................................................. 5-11
Advanced Features........................................................................... 5-11
Peripheral Devices ........................................................................... 5-11
Image Area.............................................................................................. 5-12

INDEX
MyLab - GETTING STARTED xvi
Machine Parameters .........................................................................5-13
Encoder Area..........................................................................................5-14
Trackball.............................................................................................5-14
Thumbnails Area....................................................................................5-14
6 Customizing MyLab .....................................................................6-1
Generic Configuration Procedure ............................................................6-4
Clinical Configurations ...............................................................................6-5
Real Time Preset ......................................................................................6-5
Creating a new preset from MENU ................................................6-5
Creating a new preset from Real-Time............................................6-6
eTouch Button..........................................................................................6-6
Configuring eTouch button ..............................................................6-6
System Settings ............................................................................................6-8
Profile Manager ........................................................................................6-8
Corrupted System Profile ..................................................................6-9
Center ID ..................................................................................................6-9
Center ID Field...................................................................................6-9
Report Information Field..................................................................6-9
DICOM Field......................................................................................6-9
General Settings...........................................................................................6-9
General Setup .........................................................................................6-10
DATE/TIME Folder ......................................................................6-10
MEASURE UNITS Folder.............................................................6-11
BIOPSY Folder.................................................................................6-11
CONTROL PANEL Folder...........................................................6-12
Field SHUTDOWN TYPE ............................................................6-13
Field AVAILABLE QWERTIES..................................................6-14
CINE MODE Folder ......................................................................6-14
APPLICATION PRESET Folder.................................................6-14
Field ACTION ON FREEZE.......................................................6-16
FOOTSWITCH Folder...................................................................6-17
PROBE BUTTONS Folder ...........................................................6-17
RAW DATA Folder.........................................................................6-17
KEYBOARD BUTTONS Folder .................................................6-17
SECURITY Folder...........................................................................6-17
Security.....................................................................................................6-18
Licenses Manager ...................................................................................6-18
License Activation ............................................................................6-19
Import/Export Menu............................................................................6-19
EXPORT Folder ..............................................................................6-20
IMPORT Folder ...............................................................................6-21
System Info .............................................................................................6-22
Encryption Mode..............................................................................6-22

INDEX
MyLab - GETTING STARTED xvii
GETTING STARTED
Manuals Manager................................................................................... 6-23
Electronics manuals on Esaote website........................................ 6-23
7 Performing an Exam .................................................................... 7-1
Starting an Exam......................................................................................... 7-2
Entering Patient and Application data................................................. 7-4
Filling the Patient ID screen............................................................. 7-4
Retrieving data from archive ............................................................ 7-4
Selecting Probe ........................................................................................ 7-5
Selecting Application .............................................................................. 7-6
Selecting Preset ........................................................................................ 7-6
Smart Preset ........................................................................................ 7-7
Performing the Exam................................................................................. 7-7
Acquiring images......................................................................................... 7-7
Freeze and Scrolling Memories ............................................................. 7-8
Reviewing Images.................................................................................... 7-8
Ending the Exam........................................................................................ 7-8
Monitor adjustments .................................................................................. 7-9
8 Maintenance ................................................................................. 8-1
Cleaning Operations................................................................................... 8-3
Cleaning control panel and device ........................................................ 8-4
Cleaning the QWERTY keyboard ........................................................ 8-4
Cleaning the trackball.............................................................................. 8-4
Cleaning Probe and Gel Holders .......................................................... 8-5
Cleaning the Touchscreen...................................................................... 8-5
Cleaning the LCD Screen....................................................................... 8-6
Cleaning the LCD case ........................................................................... 8-6
9 Technical Specifications............................................................... 9-1
MyLab Characteristics................................................................................ 9-1
Licenses..................................................................................................... 9-1
Technical Characteristics ........................................................................... 9-4
Display....................................................................................................... 9-4
Probe connectors..................................................................................... 9-4
Connectivity ............................................................................................. 9-4
Image Files................................................................................................ 9-5
Software .................................................................................................... 9-5
Biometry.................................................................................................... 9-5
Keyboard .................................................................................................. 9-6
Dimensions............................................................................................... 9-6
Weight ....................................................................................................... 9-6
IP Grade.................................................................................................... 9-6
Power supply............................................................................................ 9-6

INDEX
MyLab - GETTING STARTED xviii
Fuses...........................................................................................................9-7
Batteries .....................................................................................................9-8
Power Cables................................................................................................9-8
Opti-light...................................................................................................9-9
Operating Requirements.........................................................................9-9
Storage requirements ...............................................................................9-9
Heat output...............................................................................................9-9
Probe Storage Requirements..................................................................9-9
European and international standards ...................................................9-10

MyLab - GETTING STARTED 1 - 1
Chapter
1
GETTING STARTED
1. Introduction
MyLabX75 Family devices are supplied with a set of manuals to provide all
necessary and sufficient information to operate the device safely and
effectively.
WARNING Before operating the equipment, read carefully the complete set of manuals
in order to understand the detailed operating procedures, functions,
performance, and maintenance procedures.
The complete set of manuals is composed by:
Essential Instructions for Use - describes the basic
information you need to operate with MyLab and information
on foreseeable medical emergency situations.
Safety and Standards - provides information about the
patient's and operator's safety.
Getting Started (this manual) - describes how to install
MyLab and provides the main instructions for using it.
Probes and Consumables - provides detailed instructions
for using and reprocessing MyLab probes and their
accessories.
System Data - provides data on probe temperatures and
acoustic output for each probe and mode of operation.
Advanced Operations - provides advanced instructions to
use MyLab and includes the following sections:
•Advanced Features,
•Image Optimization,
•Measurements,
•Archiving.
Optional Sections - additional sections to describe specific
features (i.e. 3D/4D, Virtual Navigator, QElaXto,...)

INTRODUCTION
MyLab - GETTING STARTED 1 - 2
NOTE All manuals are provided in electronic format with exception of Essential
Instructions for Use that is provided in hard-copy.
The manuals can refer to:
MyLabX75 Family when the contents are relevant only to this
family, or
MyLab when the contents are common to the other
ultrasound devices belonging to the Esaote MyLab platform.
This manual revision applies to release 24.xx.yy and subsequent maintenance
releases, depending on the Country and the respective clearances.
The instructions for use describes the most extensive configuration of your
MyLabX75 Family device, with the maximum number of options and
accessories. Some functions, probes or applications described may be
unavailable on your product’s configuration.
NOTE Technology and features are device/configuration dependent.
Specifications subject to change without notice. Information might refer to
products or modalities not yet approved in all countries. Product images are
for illustrative purposes only. For further details, please contact your Esaote
sales representative.
Before attempting to use MyLab, read and understand all the instructions in
the set of manuals. Strictly observe all cautions and warnings. Always keep the
manuals with the equipment in an easily accessible place for future reference.
NOTE The manuals describe all operations to be performed for a proper and safe
use of MyLab . Any device malfunction caused by incorrect operations is
considered as falling under the user’s responsibility.