Esaote MyLabSigma elite User manual

Rev. 05
June 2021
MyLabSigma elite
GETTING STARTED
350061100

MyLab - GETTING STARTED ii

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
MyLabSigma elite complies with the Medical Device Directive 93/42/EEC
and subsequent amendments and is CE marked.
MyLabSigma elite is a device in Class IIa according to the Medical Device
Directive.
MyLabSigma elite complies with the Radio Equipment Directive 2014/53/EU
and is CE marked.
MyLabSigma elite is a device 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: MyLabSigma elite.
In this manual, all the above mentioned devices are referred to as 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 names are property of the respective owners and are used exclusively for
identification purposes.

MyLab - GETTING STARTED v
GETTING STARTED
RED Declaration of Conformity

MyLab - GETTING STARTED vi

INDEX
MyLab - GETTING STARTED vii
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
Apparatus..................................................................................................... 1-7
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 viii
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 Use.............................................................................................3-1
Clinical Applications and Supporting Probes ......................................3-2
Patient population....................................................................................3-4
Operator profile .......................................................................................3-4
Contraindications .....................................................................................3-4
MyLab Overview.........................................................................................3-5
Portable Configuration............................................................................3-5
Identifying the Connectors ...............................................................3-6
Installing the Portable Configuration ..............................................3-8
Accessories for Outdoor Transport.................................................3-8
Probe Connections ..................................................................................3-9
Mobile Configuration ............................................................................3-10
Basic mobile configuration..............................................................3-11
Accesorized mobile configuration .................................................3-12

INDEX
MyLab - GETTING STARTED ix
GETTING STARTED
Connections of mobile configuration........................................... 3-13
Batteries...................................................................................................... 3-14
Battery Status.......................................................................................... 3-14
First Use.................................................................................................. 3-15
Battery Lifetime ..................................................................................... 3-15
Error Messages.......................................................................................... 3-16
Errors in Battery Management............................................................ 3-16
Power Supply Error Messages............................................................. 3-17
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
Peripheral housing................................................................................... 4-7
B/W Thermal Medical USB Printer................................................ 4-7
Non-medical USB Printer................................................................. 4-7
Moving and Transporting the System ..................................................... 4-9
Portable Configuration ........................................................................... 4-9
Mobile Configuration.............................................................................. 4-9
MyLab Quick Displacement ................................................................... 4-10
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
EKnob ................................................................................................. 5-4
Trackball .............................................................................................. 5-4
Touchscreen Section............................................................................... 5-5
On/Off Button .................................................................................. 5-5
Menu Button....................................................................................... 5-6
Touchscreen........................................................................................ 5-6
TGC Sliding ........................................................................................ 5-9
Information about the Screen Layout ................................................... 5-10
Heading Area.......................................................................................... 5-10
Footer Area ............................................................................................ 5-11
Trackball ............................................................................................ 5-11
Wi-Fi .................................................................................................. 5-11
Archival Media.................................................................................. 5-11
Advanced Features........................................................................... 5-11
Battery................................................................................................ 5-11
Peripheral Devices ........................................................................... 5-11

INDEX
MyLab - GETTING STARTED x
Image Area ..............................................................................................5-12
Machine Parameters .........................................................................5-13
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............................................................................6-20
EXPORT Folder ..............................................................................6-20
IMPORT Folder ...............................................................................6-21
System Info .............................................................................................6-22
Encryption Mode..............................................................................6-22
Manuals Manager ...................................................................................6-23

INDEX
MyLab - GETTING STARTED xi
GETTING STARTED
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
Performing the Exam................................................................................. 7-7
Acquiring images......................................................................................... 7-7
Freeze and Scrolling Memories ............................................................. 7-7
Reviewing Images.................................................................................... 7-8
Ending the Exam........................................................................................ 7-8
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 ........................................................................... 9-3
Display....................................................................................................... 9-3
Probe connectors..................................................................................... 9-3
Connectivity ............................................................................................. 9-3
Image Files................................................................................................ 9-4
Software .................................................................................................... 9-4
Biometry.................................................................................................... 9-4
Keyboard .................................................................................................. 9-4
Dimensions............................................................................................... 9-4
Weight ....................................................................................................... 9-5
IP Grade.................................................................................................... 9-5
Power supply............................................................................................ 9-5
Operating Requirements ........................................................................ 9-5
Storage requirements............................................................................... 9-5
Probe Storage Requirements ................................................................. 9-6

INDEX
MyLab - GETTING STARTED xii
Standards ......................................................................................................9-6

MyLab - GETTING STARTED 1 - 1
Chapter
1
GETTING STARTED
1. Introduction
MyLabSigma elite 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:
xEssential Instructions for Use - describes the basic
information you need to operate with MyLab and information
on foreseeable medical emergency situations.
xSafety and Standards - provides information about the
patient's and operator's safety.
xGetting Started (this manual) - describes how to install
MyLab and provides the main instructions for using it.
xProbes and Consumables - provides detailed instructions
for using and reprocessing MyLab probes and their
accessories.
xSystem Data - provides data on probe temperatures and
acoustic output for each probe and mode of operation.
xAdvanced Operations - provides advanced instructions to
use MyLab and includes the following sections:
•Advanced Features,
•Image Optimization,
•Measurements,
•Archiving.
xOptional 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:
xMyLabSigma elite when the contents are relevant only to this
family, or
xMyLab 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
MyLabSigma elite 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.

INTRODUCTION
MyLab - GETTING STARTED 1 - 3
GETTING STARTED
Intended audience
MyLab manuals are written for sonographers, physicians, and biomedical
engineers who have been trained on basic ultrasound principles and
techniques.
Before reading these instructions for use, you need to be familiar with
ultrasound techniques. Sonography training and clinical procedures are not
included here.
Disclaimer
Ultrasound scanner should only be used by persons who are fully trained in
its safe and proper operation. They should have detailed knowledge of
ultrasound scanner, they should be aware of its specifications, accuracy and
limitations, and should be able to manipulate the ultrasound scanner correctly
in order to ensure that patient diagnosis and management are not
compromised. For this reason, anyone operating the ultrasound scanner
should read and understand the ultrasound scanner operating manual.
Ultrasound scanner, transducers, cables, monitor and image recorders should
be regularly inspected and kept on acceptable levels of performance. In case
of device failure to operate correctly, the operator should contact the nearest
Esaote Service Office.
Special attention should be dedicated to intra-cavitary probes (e.g. vaginal,
rectal or oesophageal probes). They should be cleaned according to
established protocols (AIUM guidelines for cleaning probes) and should not
be used if there is noticeable self-heating of the probe when operating in air.
Particular care should be taken if trans-vaginal probes are to be used to
investigate a pregnancy during the first 10 weeks after LMP.
The images and calculations provided by ultrasound scanner should never be
regarded as the only basis for clinical diagnosis. They are intended to be just
a part of a more complex diagnostic process that includes medical history,
symptoms and other instrumental examinations.
A proper patient ID and exact examination date and time must be always
included and must appear on all recorded data and prints. Identification error
could result in mistaken diagnosis.
WARNING It should be considered that ultrasound scanner is not meant for long-term
data storage and that in case of serious device failure and consecutive
repair, the stored data can be lost. Thus, a regular backup of data is
recommended.

INTRODUCTION
MyLab - GETTING STARTED 1 - 4
For more detailed information please consult:
Guidelines For Professional Ultrasound Practice. Society and College of Radiographers and
British Medical Ultrasound Society. December 2015 https://www.sor.org/sites/default/
files/document-versions/ultrasound_guidance.pdf
AIUM guidelines for cleaning probes.
http://www.aium.org/officialStatements/57
Guidelines for the safe use of diagnostic ultrasound equipment. The British
Medical Ultrasound Society.
https://www.bmus.org/static/uploads/resources/BMUS-Safety-Guidelines-2009-
revision-FINAL-Nov-2009.pdf
Guidelines for Diagnostic Imaging During Pregnancy and Lactation. The
American College of Obstetricians and Gynecologist. 2017.
https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/
Committee-on-Obstetric-Practice/Guidelines-for-Diagnostic-Imaging-During-Pregnancy-
and-Lactation
MyLab use
This product is intended to be installed, used, and operated only in
accordance with the safety procedures and operating instructions supplied
with the product, and only for the purposes for which it was designed.
However, nothing stated in the user information reduces your responsibility
for image clinical evaluation and best clinical procedure.
Installation, use, and operation of this product are subject to the law in the
jurisdictions in which the product is used. Install, use, and operate the product
only in such ways that do not conflict with applicable laws or regulations,
which have the force of law.
Use of the product for the purposes other than those intended and expressly
stated by Esaote, as well as incorrect use or operation, may relieve Esaote or
its agents from all or some responsibility for resultant noncompliance,
damage, or injury.

INTRODUCTION
MyLab - GETTING STARTED 1 - 5
GETTING STARTED
MyLab Manual Conventions
In this manual device controls are indicated using the following graphical
conventions:
xControl panel buttons are indicated by GREY CAPITAL LET-
TERS.
xTouchscreen keys are indicated by BOLD BLUE CAPITAL
LETTERS.
xTouchscreen software strings are indicated by NORMAL BLUE
CAPITAL LETTERS.
xScreen software buttons and options are indicated by BOLD
BLACK CAPITAL LETTERS.
xScreen software strings are indicated by NORMAL BLACK
CAPITAL LETTERS.
Select/Click means positioning the cursor with the trackball over the desired
option and pressing EN TER to confirm.
Right click means positioning the cursor with the trackball over the desired option
and pressing UNDO to confirm.
Double click means positioning the cursor with the trackball over the desired
option and pressing EN TER twice.
Tap means touching with your finger the desired command on the touchscreen.
Swipe means placing your finger on the desired area of the touchscreen and
moving it to the left or to the right.
WARNING In this manual WARNING identifies a risk for the patient and/or the
operator.
CAUTION The word CAUTION describes the precautions necessary for protecting
the equipment.
NOTE In this manual NOTE points out information of special interest but not
related to risks for patient, operator or device.

INTRODUCTION
MyLab - GETTING STARTED 1 - 6
CONTRAINDICATION
This information notifies the user of a condition in which the system must
not be used. The reason for this is that the risk involved clearly outweighs the
benefits of using the system in such conditions.
Manufacturer’s Responsibility
Esaote is responsible for the safety, reliability and functioning of this product
only if:
xthe user follows all the instructions contained in the device
manuals for the use and the maintenance of this device;
xthe manuals are kept integral and readable in all parts;
xcalibrations, modifications and repairing are performed only
by Esaote qualified personnel;
xthe environment where the device is used complies with the
current safety rules;
xthe electrical plant of the environment where the device is
used complies with the current applicable rules and is
perfectly efficient.
Product Life Cycle
Life Time
The safety and efficiency of MyLab ultrasound scanners are guaranteed for at
least seven (7) years from the purchase date, provided that:
xthe device is used in accordance with the instructions given in
the Operator Manual (and its eventual Addenda), which must
be always accessible to the whole personnel in an integral and
readable status;
xany installation, maintenance, calibration, modification and
repairing operation is performed on the device only by
Esaote qualified personnel, using original Esaote spare parts.
When approaching the seven (7) years limit from the purchase date, it is
recommended to contact Esaote Service or to visit Esaote web site
(www.esaote.com), to get updated information on the product’s end of life
and/or to agree on the most suitable solution for its safe disposal.

INTRODUCTION
MyLab - GETTING STARTED 1 - 7
GETTING STARTED
Maintainability Time
Esaote ensures maintainability of MyLab ultrasound scanners for seven (7)
years from the purchase date.
End-of-Life Disposal
MyLab ultrasound scanners fall within the application field of the 2002/96/
EC Directive on waste electrical and electronic equipment (WEEE),
amended by directive 2003/108/EC.
The main device label includes therefore the symbol shown below, indicating
- in an unequivocal way – that the device must be disposed of in a separate
collection from urban waste and that it was introduced in the market after
August 13th, 2005.
When disposing of any device part, the user shall consider the following
points:
xany recyclable part of the device and/or of its packaging is
labelled with the corresponding symbol;
xall components used for the packaging are recyclable and/or
reusable, except the closed-coupled barriers.
CAUTION The device and its consumable parts must be disposed of, at end of life,
according to the applicable state and/or federal and/or local regulations.
Usage License Agreement for the
Software Included in the Apparatus
NOTE Please read with care the terms and conditions indicated below before
using the software on the device.
Use of the software implies acceptance of the terms and conditions listed
below.
Proprietary Rights
You have acquired a device (“DEVICE”) which includes Esaote S.p.A.
proprietary software and/or software licensed by Esaote S.p.A. from one or
more software licensors (“Software Suppliers”). Such software products
(“SOFTWARE”), as well as associated media, printed materials, and “online”
or electronic documentation are protected by international intellectual
property laws and treaties. The SOFTWARE is licensed, not sold. The
SOFTWARE and, similarly, any copyrights and all industrial and intellectual

INTRODUCTION
MyLab - GETTING STARTED 1 - 8
ownership rights are and shall remain the exclusive propriety of Esaote S.p.A.
or its Software Suppliers.
The user will acquire no title or right on the SOFTWARE, except for the usage
license granted herein.
For any software updates and/or upgrades installed on the Equipment after
installation, the terms herein shall apply in full.
License Rights and Limitations
With this license, Esaote S.p.A. grants the end user the right to use the
SOFTWARE on the supplied DEVICE.
The user may not, under any circumstances, make unauthorized copies and/
or reproductions of the SOFTWARE or parts of it, including the enclosed
documentation.
On the basis of the above, and if the SOFTWARE is not protected against
copying, only one copy of the SOFTWARE may be made for security purposes
(back up copy).
The user may not rent or lease the SOFTWARE, but he may transfer, on a
permanent basis, the rights granted herein, on condition that he transfers all
copies of the SOFTWARE and all written material, and that the transferee
accepts all the conditions of this agreement. Any transfer must include the
most up-to-date version and all the previous ones.
The user may not convert, decode, reverse-engineer, disassemble or change
in any way the SOFTWARE.
The user may not remove, obscure or alter the copyright notice, trademarks
or other proprietary rights notices affixed to or contained within the
SOFTWARE.
The user may not publish data or information comparing the performances
of said SOFTWARE with that of software written by others.
Third Part Software
Esaote software uses parts of the 7-Zip program. The 7-Zip is licensed under
the GNU LGPL license; the source code can be found in www.7-zip.org.
Product Traceability
To guarantee the product traceability according to requirements of the
standard EN ISO 13485:2016, and the European Directive on Medical
Devices 93/42/EEC (1993) and subsequent amendments, original owners, in