Esaote MyLabOmega User manual

Rev. 04
July 2019
MyLabOmega
GETTING STARTED
350035100

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
MyLabOmega complies with the Medical Device Directive 93/42/EEC and
subsequent amendments and is CE marked.
MyLabOmega is a device in Class IIa according to the Medical Device
Directive.
MyLabOmega complies with the Radio Equipment Directive 2014/53/EU and
is CE marked.
MyLabOmega 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: MyLabOmega.
In this manual, all the above mentioned systems are referred to as MyLab.
Unless specifically noted, sections of this manual pertain to all the systems.

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
EC Declaration of Conformity

MyLab - GETTING STARTED vi
RED Declaration of Conformity

MyLab - GETTING STARTED vii
GETTING STARTED

MyLab - GETTING STARTED viii

INDEX
MyLab - GETTING STARTED ix
GETTING STARTED
Table of Contents
Manufacturer’s Address............................................................................. i-iii
Important Information .............................................................................. i-iii
Guarantee..................................................................................................... i-iv
Trade Marks................................................................................................. i-iv
EC Declaration of Conformity.................................................................. i-v
RED Declaration of Conformity ............................................................. i-vi
1 Introduction.................................................................................. 1-1
Safety and Standards.......................................................................... 1-1
Getting Started ................................................................................... 1-1
Probes and Consumables.................................................................. 1-1
System Data ........................................................................................ 1-1
Advanced Operations Manual ........................................................ 1-2
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
Electromagnetic Compatibility ................................................................. 2-2
Electromagnetic Emissions.................................................................... 2-2
Essential performance ............................................................................ 2-3
Electromagnetic Immunity .................................................................... 2-3
Electromagnetic Immunity for All Medical Equipment.............. 2-4
Electromagnetic Immunity for Medical Equipment not Life
Supporting........................................................................................... 2-5
Recommended Distances between Radiofrequency (RF)

INDEX
MyLab - GETTING STARTED x
Communication Systems and MyLab..............................................2-6
Wireless Requirements ...............................................................................2-7
3 System Overview ...........................................................................3-1
About the system.........................................................................................3-1
Intended Use.............................................................................................3-1
Clinical Applications and Supporting Probes ......................................3-1
Patient population....................................................................................3-4
Operator profile .......................................................................................3-4
Contraindications .....................................................................................3-4
System Overview.........................................................................................3-5
Portable Configuration............................................................................3-5
Identifying the Connectors ...............................................................3-6
Installing the Portable Configuration ..............................................3-8
Accessories for Outdoor Transport.................................................3-8
Mobile Configuration ..............................................................................3-9
Installing the Console ......................................................................3-11
Installation at Working Site.............................................................3-11
Probe Connections ................................................................................3-12
Batteries ......................................................................................................3-13
Battery Status ..........................................................................................3-13
First Use ..................................................................................................3-14
Battery Lifetime......................................................................................3-14
Error Messages ..........................................................................................3-15
Errors in Battery Management.............................................................3-15
Power Supply Error Messages .............................................................3-16
4 Preparing the System ....................................................................4-1
Acclimation Time........................................................................................4-1
Connecting the System to a Network ......................................................4-1
Connecting Peripherals...............................................................................4-2
Safety Concept..........................................................................................4-3
Medical environments........................................................................4-3
B/W Thermal Medical USB Printer housing ......................................4-6
USB Printer housing................................................................................4-6
Auxiliary Monitor.....................................................................................4-7
Moving and Transporting the System......................................................4-8
Portable Configuration............................................................................4-8
Mobile Configuration ..............................................................................4-8
MyLab Quick Displacement......................................................................4-9
5 Using the System ..........................................................................5-1
Connecting the system to the mains ........................................................5-1
Turning the System On and Off...............................................................5-1

INDEX
MyLab - GETTING STARTED xi
GETTING STARTED
System 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 ..................................................... 5-9
Heading Area.......................................................................................... 5-10
Footer Area ............................................................................................ 5-10
Trackball............................................................................................ 5-11
Wi-Fi .................................................................................................. 5-11
Archival Media.................................................................................. 5-11
Advanced Features........................................................................... 5-11
Battery................................................................................................ 5-11
Peripheral Devices ........................................................................... 5-12
Image Area.............................................................................................. 5-12
Machine Parameters......................................................................... 5-13
Thumbnails Area ................................................................................... 5-14
6 Customizing the System............................................................... 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

INDEX
MyLab - GETTING STARTED xii
Field AVAILABLE QWERTIES..................................................6-13
CINE MODE Folder ......................................................................6-14
APPLICATION PRESET Folder.................................................6-14
FOOTSWITCH Folder...................................................................6-15
PROBE BUTTONS Folder ...........................................................6-15
RAW DATA Folder.........................................................................6-15
KEYBOARD BUTTONS Folder .................................................6-15
Security.....................................................................................................6-16
Licenses Manager ...................................................................................6-16
License Activation ............................................................................6-16
Import/Export Menu............................................................................6-18
EXPORT Folder ..............................................................................6-18
IMPORT Folder ...............................................................................6-19
System Info .............................................................................................6-20
7 Performing an Exam.....................................................................7-1
Starting an Exam .........................................................................................7-1
Entering Patient and Application data..................................................7-3
Filling the Patient ID screen .............................................................7-3
Retrieving data from archive.............................................................7-3
Selecting Probe .........................................................................................7-4
Selecting Application ...............................................................................7-5
Selecting Preset.........................................................................................7-5
Performing the Exam .................................................................................7-6
Acquiring images .........................................................................................7-6
Freeze and Scrolling Memories..............................................................7-6
Reviewing Images ....................................................................................7-7
Ending the Exam ........................................................................................7-7
8 System Maintenance .....................................................................8-1
Cleaning Operations ...................................................................................8-3
Cleaning control panel and system........................................................8-4
Cleaning the trackball ..............................................................................8-4
Cleaning Probe and Gel Holders...........................................................8-5
Cleaning the Touchscreen ......................................................................8-5
Cleaning the LCD Screen .......................................................................8-5
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

INDEX
MyLab - GETTING STARTED xiii
GETTING STARTED
Connectivity ............................................................................................. 9-4
Image Files................................................................................................ 9-5
Software .................................................................................................... 9-5
Biometry.................................................................................................... 9-5
Keyboard .................................................................................................. 9-5
Dimensions............................................................................................... 9-5
Weight ....................................................................................................... 9-5
IP Grade.................................................................................................... 9-5
Power supply............................................................................................ 9-5
Operating Requirements ........................................................................ 9-6
Storage requirements............................................................................... 9-6
Probe Storage Requirements ................................................................. 9-6
Standards...................................................................................................... 9-7

INDEX
MyLab - GETTING STARTED xiv

MyLab - GETTING STARTED 1 - 1
Chapter
1
GETTING STARTED
1. Introduction
MyLabOmega systems are equipped with different manuals, and this Getting
Started manual is only a part of the instruction for use required for safe and
correct use of the device.
The complete set of instruction for use giving all necessary and sufficient
information to operate the system safely and effectively consists of the
manuals and the additional sections listed below.
The manuals and the additional sections can refer to:
MyLabOmega when the contents are relevant only to this
family, or
MyLab when the contents are common to the other
ultrasound systems belonging to the Esaote MyLab platform.
Safety and Standards
 SS The Safety and Standard manual contains information about the patient's and
operator's safety. The system's conformity standards are also indicated.
Getting Started
 GS This present manual describes how to install the system and provides the
main instructions for using it.
Probes and Consumables
 PC The Probes and Consumables manual gives detailed instruction for use for
MyLab probes.
Information is also supplied on the admitted consumables and on the
recommended agents and cleaning, disinfecting and maintenance procedures
for MyLab probes and related accessories.
System Data
The System Data manuals, supplied only on CD, contain data on probes
temperatures and acoustic output for each probe and mode of operation.

INTRODUCTION
MyLab - GETTING STARTED 1 - 2
Advanced Operations Manual
 AO The Advanced Operations manual in its standard configuration includes the
following sections:
Advanced Features,
Image Optimization,
Measurements,
Archiving.
Additional sections will be supplied in relation to the specific licenses ordered
with your MyLabOmega system.
NOTE All manuals are provided in hard-copy with exception of System Data that
is provided in electronic format only.
This manual revision applies to release 13.xx.yy and 11.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
MyLabOmega system, 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 system/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.
This manual refers to MyLabOmega ultrasound systems, that can be named in
the following chapters as MyLab too.

INTRODUCTION
MyLab - GETTING STARTED 1 - 3
GETTING STARTED
Before attempting to use MyLab, read and understand all the instructions in
this manual. Strictly observe all cautions and warnings. Always keep the
manuals with the system for future reference.
NOTE The manuals describe all operations to be performed for a proper and safe
use of MyLab systems. Any system malfunction caused by incorrect
operations is considered as falling under the user’s responsibility.
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 system should only be used by persons who are fully trained in its
safe and proper operation. They should have detailed knowledge of
ultrasound system, they should be aware of its specifications, accuracy and
limitations, and should be able to manipulate the system correctly in order to
ensure that patient diagnosis and management are not compromised. For this
reason, anyone operating the system should read and understand the system
operating manual.
Ultrasound system, transducers, cables, monitor and image recorders should
be regularly inspected and kept on acceptable levels of performance. In case
of system 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 system should never be
regarded as the only basis for clinical diagnosis. They are intended to be just

INTRODUCTION
MyLab - GETTING STARTED 1 - 4
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. It should be considered that ultrasound
system is not meant for long-term data storage and that in case of serious
system failure and consecutive repair, the stored data can be lost. Thus, a
regular backup of data is recommended.
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.

INTRODUCTION
MyLab - GETTING STARTED 1 - 5
GETTING STARTED
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.
MyLab Manual Conventions
In this manual system controls are indicated using the following graphical
conventions:
Control panel buttons are indicated by GREY CAPITAL LET-
TERS.
Touchscreen keys are indicated by BOLD BLUE CAPITAL
LETTERS.
Touchscreen software strings are indicated by NORMAL BLUE
CAPITAL LETTERS.
Screen software buttons and options are indicated by BOLD
BLACK CAPITAL LETTERS.
Screen 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.

INTRODUCTION
MyLab - GETTING STARTED 1 - 6
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.
Manufacturer’s Responsibility
Esaote is responsible for the safety, reliability and functioning of this product
only if:
the user follows all the instructions contained in the system
manuals for the use and the maintenance of this system;
the manuals are kept integral and readable in all parts;
calibrations, modifications and repairing are performed only
by Esaote qualified personnel;
the environment where the system is used complies with the
current safety rules;
the electrical plant of the environment where the system is
used complies with the current applicable rules and is
perfectly efficient.
Product Life Cycle
Life Time
The safety and efficiency of MyLab ultrasound systems are guaranteed for at
least seven (7) years from the purchase date, provided that:
the system 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;
any installation, maintenance, calibration, modification and
repairing operation is performed on the system 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.