Rev.

02

March 2019

MyLab 9
MyLab 9 eXP

GETTING STARTED

350035900
Manufacturer’s Address
ESAOTE S.p.A.
Via Enrico Melen 77
16152 Genova
ITALY

GETTING STARTED
Phone +39 010 65471
info@esaote.com
www.esaote.com

Important Information
and MyLab 9 eXP comply with the Medical Device Directive 93/42/
MyLab 9
EEC and subsequent amendments and are CE marked.
MyLab 9 and MyLab 9 eXP are devices in Class IIa according to the Medical
Device Directive.
MyLab 9 and MyLab 9 eXP comply with the Radio Equipment Directive 2014/
53/EU and are CE marked.
MyLab 9 and MyLab 9 eXP 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: MyLab 9 and MyLab 9 eXP.
In this manual, all the above mentioned systems are referred to as MyLab 9
Family.

Unless specifically noted, sections of this manual pertain to all the systems.

MyLab - GETTING STARTED iii

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 iv

EC Declaration of Conformity

GETTING STARTED

MyLab - GETTING STARTED v

MyLab - GETTING STARTED vi
RED Declaration of Conformity

GETTING STARTED

MyLab - GETTING STARTED vii

MyLab - GETTING STARTED viii
 GETTING STARTED

MyLab - GETTING STARTED ix

MyLab - GETTING STARTED x
INDEX

Table of Contents

Manufacturer’s Address ............................................................................. i-iii

Important Information .............................................................................. i-iii

GETTING STARTED
Guarantee..................................................................................................... i-iv
Trade Marks................................................................................................. i-iv
EC Declaration of Conformity.................................................................. i-v
RED Declaration of Conformity ............................................................ i-vii

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)

MyLab - GETTING STARTED xi

INDEX

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 ......................................3-2
Patient population....................................................................................3-4
Operator profile .......................................................................................3-4
Contraindications .....................................................................................3-4
System Components ...................................................................................3-5
Monitor (1)................................................................................................3-7
On/Off Button (2) ..................................................................................3-7
Control Panel Assembly (3)....................................................................3-8
Control Panel Assembly Orientation...............................................3-9
Pull-out Qwerty Keyboard (14) .............................................................3-9
Data Storage..............................................................................................3-9
ECG and Physio Connectors...............................................................3-10
Probe Connectors and Cable Management .......................................3-10
Peripherals Housing...............................................................................3-10
Connections panels (8)..........................................................................3-11
Wheel Brakes ..........................................................................................3-11

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

5 Using the System ..........................................................................5-1

Connecting the system to the mains ........................................................5-1
Turning the System On and Off...............................................................5-1
System Controls...........................................................................................5-2
Control Panel Section..............................................................................5-2
TGC Sliding.........................................................................................5-4
Trackball...............................................................................................5-5
Joystick .................................................................................................5-5
Touchscreen Section................................................................................5-5
Menu Button .......................................................................................5-6

MyLab - GETTING STARTED xii

INDEX

Touchscreen........................................................................................ 5-6
Alphanumeric Keyboard Section .......................................................... 5-8
Information about the Screen Layout ..................................................... 5-8
Heading Area............................................................................................ 5-9
Footer Area ............................................................................................ 5-10

GETTING STARTED
Trackball ............................................................................................ 5-10
Wi-Fi .................................................................................................. 5-10
Archival Media.................................................................................. 5-10
Advanced Features........................................................................... 5-10
Peripheral Devices ........................................................................... 5-10
Image Area.............................................................................................. 5-11
Machine Parameters......................................................................... 5-12
Joystick Area........................................................................................... 5-13
Thumbnails Area ................................................................................... 5-13

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
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

MyLab - GETTING STARTED xiii

INDEX

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
Smart Preset.........................................................................................7-6
Performing the Exam .................................................................................7-6
Acquiring images .........................................................................................7-6
Freeze and Scrolling Memories..............................................................7-7
Reviewing Images ....................................................................................7-7
Ending the Exam ........................................................................................7-7
Monitor adjustments...................................................................................7-8

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............................................................................9-6
Display .......................................................................................................9-6
Probe connectors .....................................................................................9-6
Video Output............................................................................................9-6
Connectivity ..............................................................................................9-6
Image Files ................................................................................................9-7
Software.....................................................................................................9-7
Biometry ....................................................................................................9-7

MyLab - GETTING STARTED xiv

INDEX

Keyboard .................................................................................................. 9-7

Dimensions............................................................................................... 9-7
Weight ....................................................................................................... 9-7
IP Grade.................................................................................................... 9-8
Power supply............................................................................................ 9-8

GETTING STARTED
Power Cables............................................................................................ 9-8
Operating Requirements ........................................................................ 9-9
Storage requirements............................................................................. 9-10
Probe Storage Requirements ............................................................... 9-10
Standards.................................................................................................... 9-11
Opti-light.................................................................................................... 9-12

MyLab - GETTING STARTED xv

INDEX

MyLab - GETTING STARTED xvi

 1
Chapter

1. Introduction

GETTING STARTED
MyLab 9 Family 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:
• MyLab 9 Family 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.

MyLab - GETTING STARTED 1-1

 INTRODUCTION

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 MyLab 9 Family 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, 12.xx.yy and 11.xx.yy, and
subsequent maintenance releases, depending on the Country and the respective
clearances.
The instructions for use describe the most extensive configuration of your
MyLab 9 Family 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 MyLab 9 Family ultrasound systems, that can be named
in the following chapters as MyLab too.

MyLab - GETTING STARTED 1-2

 INTRODUCTION

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

GETTING STARTED
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

MyLab - GETTING STARTED 1-3

INTRODUCTION

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.

MyLab - GETTING STARTED 1-4

 INTRODUCTION

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

GETTING STARTED
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

B L A C K C A P I T A L L E T T E R S.

• 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 UN DO 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.

MyLab - GETTING STARTED 1-5

 INTRODUCTION

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.

MyLab - GETTING STARTED 1-6

 INTRODUCTION

Maintainability Time
Esaote ensures maintainability of MyLab ultrasound systems for seven (7)
years from the purchase date.

End-of-Life Disposal

GETTING STARTED
MyLab ultrasound systems 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 system label includes therefore the symbol shown below, indicating
- in an unequivocal way – that the system 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 system part, the user shall consider the following
points:
• any recyclable part of the system and/or of its packaging is
labelled with the corresponding symbol;
• all components used for the packaging are recyclable and/or
reusable, except the closed-coupled barriers.

CAUTION The system 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 system.

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

MyLab - GETTING STARTED 1-7

INTRODUCTION

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 13485:2000, and the European Directive on Medical
Devices 93/42/EEC (1993) and subsequent amendments, original owners, in

MyLab - GETTING STARTED 1-8

INTRODUCTION

the event of equipment transfer to third parties, are requested to notify

ESAOTE S.p.A., associate company or authorized distributor of the said
transfer by means of the following form, duly compiled, or written
notification with the same data as specified in the form. Equipment data are
found on the relative identification label.

GETTING STARTED
PRODUCT TRACEABILITY FORM
To: ESAOTE S.p.A.
Quality Assurance Department
Via Enrico Melen, 77
16152, Genova, Italy
[or associate company]
[or authorized distributor]

Esaote system/device name:....................................................................................

REF.............................................................................................................................
Serial Number (SN):.................................................................................................
Name and address of original owner:
.....................................................................................................................................
......................................................................................................................................
Name and address of new owner:
.....................................................................................................................................
.....................................................................................................................................

Date:......................................... Signature:..........................................................

MyLab - GETTING STARTED 1-9

INTRODUCTION

Vigilance System
This equipment is subject to Esaote vigilance system (post-market
surveillance) in case of potential or real hazards for the patient or for the
operator which might occur during the normal system functioning, in order
to be able to remove them with the best efficiency and timing.
The equipment is subject to a supervision system (post-sales supervision),
which ESAOTE S.p.A., all associates and authorized distributors apply to
products issued onto the market, in relation to real or potential hazards that
may arise for the patient or operator during normal use of the equipment, to
ensure optimal solutions in the most efficient and prompt manner possible.
Therefore if the user records any malfunction or deterioration in the
characteristics and/or performances of the device, as well as any inadequacy
in the labeling or the instructions for use which might lead to potential or real
hazards for a patient or for an operator, we kindly request to immediately
inform Esaote central plants, or one of our subsidiaries, or one of our official
distributors immediately through the following form, or through a
communication reporting the same data contained in this form. All data
relating to the system can be found on its identification label. In this way we
will be able to take all adequate measures with the best efficiency and timing.
Therefore, in the event of malfunctions, defective performance of the
equipment, or inadequate instructions, which may constitute a hazard to the
patient or operator, the user must notify ESAOTE S.p.A., associate company
or authorized distributor in writing, providing the information as specified in
the form below. Equipment data are found on the relative identification label.
On receipt of the notification ESAOTE S.p.A. will immediately activate the
process of examination and resolve the non-conformity that has been
reported.

MyLab - GETTING STARTED 1 - 10

INTRODUCTION

POST-MARKET SURVEILLANCE FORM

ACCIDENT REPORT FORM
To: ESAOTE S.p.A.
Quality Assurance Department

GETTING STARTED
Via Enrico Melen, 77
16152, Genova, Italy
[or associate company]
[or authorized distributor]

ESAOTE system/device name:..............................................................................

Code (REF):...............................................................................................................
Serial Number (SN):...................................................................................................
Description of the potential/real hazard: Description of accident or potential
accident:......................................................................................................................
......................................................................................................................................
Comments or suggestions:.......................................................................................
......................................................................................................................................
Contact Person/Department:
.....................................................................................................................................
Address:
.....................................................................................................................................
Phone:.................................................... Fax:.........................................................

Date:........................................ Signature:..........................................................

MyLab - GETTING STARTED 1 - 11

INTRODUCTION

MyLab - GETTING STARTED 1 - 12

 2
Chapter

2. Additional Information on

GETTING STARTED
Safety
SS This chapter provides additional information on safety specifically for MyLab
products. Please read the “Safety and Standards” manual carefully for a
complete overview of all safety aspects of MyLab products.

Environmental Safety
Special waste The system contains lithium-ion batteries. The fluorescent lamp included in
the LCD screen contains mercury. The batteries and the LCD screens must
be treated as special waste according to the applicable local regulations.
Dispose of the equipment as special waste according to the applicable local
regulations. For further information please refer to the local authority for
waste disposal.

MyLab - GETTING STARTED 2-1

 ADDITIONAL INFORMATION ON SAFETY

Electromagnetic Compatibility
This system was designed for use in the electromagnetic environments
declared in the tables below, in compliance with standard IEC 60601-1-
2:2007. The operator must make sure that s/he uses it in keeping with this
standard.

NOTE Cables and accessories other than the supplied ones could negatively affect
EMC performance of the system.

Electromagnetic Emissions

Guidance and manufacturer’s declaration – Electromagnetic emissions

MyLab is suitable for use in the specified electromagnetic environment.

The purchaser or user of MyLab should assure that it is used in an electromagnetic
environment as described below:

Emission Test Compliance Electromagnetic Environment

RF emissions Group 1 This MyLab uses RF energy only for its

CISPR 11 internal function. Therefore, the RF
emission is very low and not likely to cause
any interference in nearby electronic
equipment.

RF emissions Class A MyLab is suitable for use in all

CISPR 11 establishments, other than domestic and
those directly connected to the public low
Harmonic emissions Complies voltage power supply network that supplies
IEC 61000-3-2 Class A buildings used for domestic purposes.
Voltage fluctuations Complies
and flicker emissions
IEC 61000-3-3

NOTE The EMISSIONS characteristics of this equipment make it suitable for use
in industrial areas and hospitals (CISPR 11 class A). If it is used in a
residential environment (for which CISPR 11 class B is normally required)
this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures,
such as relocating or re-orienting the equipment.

WARNING Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is
necessary, this equipment and the other equipment should be observed to
verify that they are operating normally.

MyLab - GETTING STARTED 2-2

 ADDITIONAL INFORMATION ON SAFETY

WARNING Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.

GETTING STARTED
WARNING Portable RF communication equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of MyLab, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this
equipment could result.

Essential performance
• Free from noise on a waveform or artifacts or distortion in
an image or error of a displayed numerical value which
cannot be attributed to a physiological effect and which may
alter the diagnosis.
• Free from the display of incorrect numerical values
associated with the diagnosis to be performed.
• Free from the production of unintended or excessive
ultrasound output.
• Free from the production of unintended or excessive
TRANSDUCER ASSEMBLY surface temperature.

Electromagnetic Immunity
The electromagnetic tests are aimed at simulating the typical transients of an
electromagnetic environment. MyLab was tested for immunity to transients
and at their typical levels in a domestic, hospital or commercial environment.

MyLab - GETTING STARTED 2-3

ADDITIONAL INFORMATION ON SAFETY

Electromagnetic Immunity for All Medical Equipment

The MyLab system is intended for use in the electromagnetic environment specified below. The
customer or the user of the MyLab system should assure that it is used in such an environment.

IEC60601 Compliance Electromagnetic Environment

Immunity Test
Test Level Level and Guidance

Electrostatic ±8 kV on contact ±8 kV on contact The floor should be in wood,

discharge (ESD) concrete or ceramic tiles. If floors
IEC 61000-4-2 ±15 kV in air ±15 kV in air are covered with synthetic
material, the relative humidity
should be at least at 30%.

Electrical fast ±2 kV for power ±2 kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 hospital environment.
±1 kV for input/ ±1 kV for input/
output lines output lines

Surge ±1 kV differential ±1 kV differential Mains power quality should be

IEC 61000-4-5 mode mode that of a typical commercial or
hospital environment.
±2 kV common ±2 kV common
mode mode

Voltage dips 0% UT; 0,5 cycles 0% UT; 0,5 cycles Mains power quality should be
IEC 61000-4-11 at 0°, 45°, 90°, at 0°, 45°, 90°, that of a typical commercial or
135°, 180°, 225°, 135°, 180°, 225°, hospital environment. If the user
270° and 315° 270° and 315° of the MyLab system requires
continued operation during
0% UT; 1 cycle 0% UT; 1 cycle power mains interruptions, it is
recommended that the MyLab
and and system is powered from an
uninterruptible power supply or a
70% UT; 25/30 70% UT; 25/30 battery.
cycles cycles

Single phase: at Single phase: at

0° 0°

Power interruptions 0% UT; 250/300 0% UT; 250/300 Mains power quality should be
IEC 61000-4-11 cycles cycles that of a typical commercial or
hospital environment. If the user
of the MyLab system requires
continued operation during
power mains interruptions, it is
recommended that the MyLab
system is powered from an
uninterruptible power supply or a
battery.

MyLab - GETTING STARTED 2-4

ADDITIONAL INFORMATION ON SAFETY

The MyLab system is intended for use in the electromagnetic environment specified below. The
customer or the user of the MyLab system should assure that it is used in such an environment.

IEC60601 Compliance Electromagnetic Environment

Immunity Test
Test Level Level and Guidance

GETTING STARTED
Power frequency 30 A/m 30 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic
magnetic field of a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level

Electromagnetic Immunity for Medical Equipment not Life

Supporting

The MyLab system is intended for use in the electromagnetic environment specified below. The
customer or the user of the MyLab system should assure that it is used in such an environment.

Immunity IEC60601 Compliance Electromagnetic Environment and

Test Test Level Level Measures to Be Taken

Conducted RF 3V 3V Mobile or portable radio frequency (RF)

IEC 61000-4-6 0.15-80 MHz 0.15-80 MHz communication equipment should be used
no closer to any part of the MyLab system,
6 V in ISM 6 V in ISM including cables.
band between band between
0.15 MHz and 0.15 MHz and Field strengths from fixed RF transmitters,
80 MHz 80 MHz as determined by an electromagnetic site
surveya, should be less than the compliance
80% AM at 80% AM at
1 kHz 1 kHz level in each frequency rangeb.

Radiated RF 3 V/m 3 V/m Interference may occur in the vicinity of

IEC 61000-4-3 80 MHz - 80 MHz - equipment marked with the following
2.7 GHz 2.7 GHz symbol:

80% AM at 80% AM at
1 kHz 1 kHz

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation
is affected by absorption and reflection from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the MyLab system is used exceeds the applicable RF compliance level above, the
MyLab system should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re–orienting or relocating the MyLab system.
b. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

MyLab - GETTING STARTED 2-5

 ADDITIONAL INFORMATION ON SAFETY

Recommended Distances between Radiofrequency (RF)

Communication Systems and MyLab

SS As stated in the “Safety and Standards” manual, it is recommended not to use

radiofrequency (RF) transmission systems near the ultrasound system. RF
systems can cause interference, which alters the echographic image and
Doppler traces.
The operator can prevent interference caused by electromagnetic fields by
maintaining a minimum distance between the echographic system and the RF
communication systems being used (for example cell telephones, mobile
telephones).
The following degradation shall not be allowed:
• the disturbance shall not produce noise on a waveform,
artefacts, distortion in an image or error of a displayed
numerical value which cannot be attributed to a physiological
effect and which may alter the diagnosis;
• the disturbance shall not produce an error displaying
inaccurate numerical values associated with the diagnosis to
be performed;
• the disturbance shall not produce an error displaying
inaccurate safety-related indications;
• the disturbance shall not produce unintended or excessive
ultrasound output;
• the disturbance shall not produce unintended or excessive
transducer assembly surface temperature.
MyLab, according to the definition of the IEC 60601-1-2 ed. 4 standard is
suitable to be installed in professional healthcare facility environment.
The operator must remember that the intensity of the electromagnetic fields
generated by fixed transmitters (for example radio-base stations for cellular or
cordless telephony, TV and radio transmissions, amateur radio transmissions)
cannot be predicted on a theoretical basis. Consequently, a direct measure
may be necessary in the use environment of a MyLab system. If the intensity
of the electromagnetic fields exceeds that one specified in the immunity levels
shown in the previous tables, and the echographic system performs
incorrectly, additional measures may be necessary, for example by positioning
the system in a different way.

MyLab - GETTING STARTED 2-6

 ADDITIONAL INFORMATION ON SAFETY

Wireless Requirements
MyLab is equipped with built-in wireless capability.
When wireless is active, the operator should make sure to stay at a minimum
distance of 20 cm from the rear of the equipment. If it is necessary to work

GETTING STARTED
at a shorter distance, temporarily switch the wireless device off.

NOTE The wireless capability has to be considered as an intentional RF (Radio

Frequency) transmitter as indicated by the symbol:

When the wireless is active, MyLab might interfere with other equipment.

SS Refer to the “Safety and Standards” manual for further information on

restrictions for the use of wireless connections.

WARNING The system is equipped with a standard Wireless LAN RF receiver and
transmitter module that uses the following frequencies:

Receiver/Transmitter Band Maximum Transmitter Power

Modulation
[MHz] [dBm]

2400 to 2483.5 DSSS and OFDM 20 (WLAN standard limit)

5150 to 5350 OFDM 30 (WLAN standard limit)

5470 to 5725 OFDM 30 (WLAN standard limit)

The system may be interfered with by other equipment, even if that other
equipment complies with CISPR emission requirements.

MyLab - GETTING STARTED 2-7

ADDITIONAL INFORMATION ON SAFETY

MyLab - GETTING STARTED 2-8

 3
Chapter

3. System Overview

GETTING STARTED
MyLab 9 and MyLab 9 eXP are professional, innovative and versatile real-time
high-resolution ultrasound systems. The wide range of probes makes them
suitable for many clinical applications.
MyLab 9 and MyLab 9 eXP are based on a mainframe easily movable platform.
MyLab 9 and MyLab 9 eXP have four swiveling wheels, they have a range of
height adjustments for one-time installation, the main screen can be easily
moved due to an optional articulated arm. Due to their small footprint they
can fit in any real-world clinical environment.
The possibility to adjust both the main screen, control panel and touchscreen
brightness enables the use of MyLab in any environment even with really
different lighting conditions: from the really bright scenario of the operative
room, to the dark scenario of the examination room, passing through the
medium-light environment of the bed-side examination setting.

About the system

Intended Use
MyLab 9 and MyLab 9 eXP are intended to perform diagnostic general
ultrasound studies including:
Fetal, Abdominal, Intraoperative (Abdominal), Intraoperative (Neuro),
Laparoscopic, Pediatric, Small organ, Neonatal, Neonatal Cephalic, Adult
Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional),
Musculoskeletal (Superficial), Urological, Cardiovascular Adult,
Cardiovascular Pediatric, Transoesophageal (cardiac), Peripheral Vessel.
The equipment provides imaging for guidance of biopsy and imaging to assist
in the placement of needles and catheters in vascular or other anatomical
structures as well as peripheral nerve blocks in Musculoskeletal applications.
The ultrasonic medical diagnostic equipment is intended to be connected to
mechanical and electronic ultrasound probes (convex array, linear array and
phase array) and Doppler probes.

MyLab - GETTING STARTED 3-1

SYSTEM OVERVIEW

The transducers intended to perform intraoperative neurosurgical imaging,

following craniotomy, are enclosed in a sterile cover for intraoperative
neurosurgical application.

Clinical Applications and Supporting Probes

A variety of ultrasound probes can be connected to MyLab 9 and MyLab 9 eXP
models:
• BL433
• C 1-8 including biopsy capabilities
• C 2-9
• E 3-12 including biopsy capabilities
• EC123 including biopsy capabilities
• IH 6-18
• L 3-11 including biopsy capabilities
• L 4-15 including biopsy capabilities
• L 8-24
• mC 3-11 including biopsy capabilities
• P 1-5
• P 2-9
• S2MCW
• S5MCW
• SB2C41
• SB3123
• SHFCW
• SI2C41 including biopsy capabilities
• ST2612
• TLC 3-13 including biopsy capabilities

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 SYSTEM OVERVIEW

Table 3-1: Available probes and applications

Applicationa Probes

Abdominal C 1-8, C 2-9, L 3-11, L 4-15, mC 3-11, P 1-5, SB2C41, SI2C41

GETTING STARTED
Adult Cephalic P 1-5

Breast BL433, IH 6-18, L 3-11, L 4-15, L 8-24

Cardiac mC 3-11, P 1-5, P 2-9, S2MCW, ST2612

Gynecology C 1-8, C 2-9, E 3-12, EC123, SB2C41, SB3123, SI2C41, TLC 3-13

Musculo-skeletalb BL433, C 1-8, C 2-9, IH 6-18, L 3-11, L 4-15, L 8-24, SB2C41,

SI2C41

Neonatal IH 6-18, L 3-11, L 4-15, L 8-24, mC 3-11, SI2C41

Obstetric and Fetal C 1-8, C 2-9, E 3-12, EC123, L 3-11, mC 3-11, SB2C41, SB3123,
SI2C41

Pediatric C 1-8, C 2-9, IH 6-18, L 3-11, L 4-15, L 8-24, mC 3-11, SB2C41,

SI2C41

Pediatric Cardiac mC 3-11, P 1-5, P 2-9, S2MCW, ST2612

Small Organ BL433, IH 6-18, L 3-11, L 4-15, L 8-24, mC 3-11

Thyroid BL433, IH 6-18, L 3-11, L 4-15, L 8-24, mC 3-11

Urology C 1-8, C 2-9, E 3-12, EC123, SB2C41, SB3123, SI2C41, TLC 3-13

Vascular BL433, C 1-8, IH 6-18, L 3-11, L 4-15, L 8-24, mC 3-11, P 1-5,

S5MCW, SHFCW
a. Applications are listed here as they appear on user interface. Some clinical appli-
cations are managed by using proper probe and preset.
b. Both conventional and superficial (including nerve blocks)

NOTE System applications are dependent on your system configuration,

transducer and exam type. Not all applications are approved in all
Countries. Please refer to your Esaote local representative for further
information.

MyLab - GETTING STARTED 3-3

 SYSTEM OVERVIEW

Patient population
• Age: all ages (including embryos and fetuses)
• Location: worldwide
• Sex: male and female
• Weight: all weight categories (in terms of Body Mass Index)
• Height: no limitations

Operator profile
MyLab 9 and MyLab 9 eXP are designed for operators who are qualified and
trained in using ultrasound system:
• Sonographers
• Cardiologist
• Maternal-fetal Medicine Obstetrician / Perinatologist
• Radiologist and Internist
• System Administrator and Customer Service Engineer
The operator must have read and understood the user manuals.

Contraindications
The MyLab 9 and MyLab 9 eXP are not intended for:
• ophthalmic use or any use causing the acoustic beam to pass
through the eye.

WARNING Do not use MyLab for ophthalmic or transorbital applications.

The ultrasound beam must not be directed to the eyes.

MyLab - GETTING STARTED 3-4

SYSTEM OVERVIEW

System Components
The system consists of a control panel assembly with LCD monitor and a
console with the system electronics and connectors, housed in an ergonomic
cart designed to be both highly mobile and adjustable for a range of users and

GETTING STARTED
operating conditions.
The cart top is equipped to house peripherals. It has a rear mains switch to
power up the console, the screen and the peripheral devices. The system
provides handles and independent brakes for front and rear wheels for
movement and transportation.
Removable components can be locked in place so the cart can be safely
moved.

Fig. 3-1: System components

MyLab - GETTING STARTED 3-5

SYSTEM OVERVIEW

Table 3-2: System components description

Number System Component

1 Monitor

2 On/Off button

3 Control Panel Assembly

4 Orientation and sliding lever

5 Cable hangers

6 Physio connector (black)

7 ECG connector (gray)

8 Connections panels

9 Probe holders

10 Front wheel brake pedal

11 Probe connectors

12 Probe connector locks

13 Printer Drawer

14 Pull-out QWERTY keyboard

15 Lifting lever

16 Gel holder

17 Probe holder

18 Touch screen

19 USB ports

20 DVD drive

21 Loudspeakers

22 Power cord hook

23 Virtual Navigation
connection (optional)

24 Main switch

25 Rear wheel brake pedal

26 LAN

27 Peripheral plate

MyLab - GETTING STARTED 3-6

 SYSTEM OVERVIEW

Monitor (1)
MyLab is equipped with an LCD LED flat-plan display on an articulated
mounting arm. The monitor is adjustable to accommodate different operating
positions and operator heights. The monitor can also be locked in position
for moving the system.

GETTING STARTED
The monitor is suitable for reading medical images, in particular each
production unit is calibrated according to the Greyscale Standard Display
Function (GSDF) defined in Part 14 of the DICOM medical standard.
In addition, the entire apparatus, of which the monitor is an integral part,
complies with the mandatory standards of biomedical equipment (safety
according to IEC 60601-1 Ed. 3.1 and EMC according to IEC 60601-1-2 Ed.
4).

WARNING The LCD must be considered an Information Technology (IT) device: it

can be safely used inside the patient area only when it is powered through
the cart insulation transformer.

On/Off Button (2)

The O N /O FF button is located beside the touchscreen, on the left side of the
control panel assembly, while the Main Switch (23) is located on the rear-
bottom of the system.
Beside the Main Switch is also located an earth terminal to be connected to
an external protective earthing system as additional protection.
When MyLab is connected to the mains and the Main Switch is on, the lighting
of the O N /O FF button changes to indicate its status. The different indicators
are described in the table below.

Table 3-3: On/Off button light

Led Colour Meaning

GREEN MyLab is on

AMBER MyLab can be turned on

OFF MyLab can not be turned on. In this case check both
the rear main switch and the mains connection.

Pressing the O N /O FF button turns the system on or off, activating or closing

the examination session.

MyLab - GETTING STARTED 3-7

SYSTEM OVERVIEW

Control Panel Assembly (3)

The Control Panel Assembly includes the main controls: physical buttons,
knobs, and trackball, TGC, touchscreen and a pull-out QWERTY keyboard
placed in the drawer below the panel.
The control module also allows to select transducers, enter patient data,
review and annotate images, perform measurements and calculations, and
change setups.
The Control Panel Assembly includes the system handle, the probe and ECG
cables holders.
Two loudspeakers (21) are placed on both side of the touchscreen.
Fig. 3-2: Control Panel Assembly

Table 3-4: Control Panel Assembly description

Number Control Panel Assemble

18 Touch screen

27 Knob controls

28 TCG slide controls

29 Trackball

MyLab - GETTING STARTED 3-8

 SYSTEM OVERVIEW

Control Panel Assembly Orientation

The Control Panel Assembly is adjustable to accommodate a wide range of
operator heights and operating positions.
. These adjustments can be controlled by two levers located below the Control
Panel Assembly (as shown in the image beside).

GETTING STARTED
The orientation and sliding lever (4), located on the left, allow to swivel and
slide back and forth the control panel.
Push the lever to rotate and slide the control panel into the new position.
Release the lever when the control panel is correctly positioned. This lever
allows to rotate by up to 45° clockwise and by up to 180° counterclockwise
(closed position for optimal handling).

CAUTION When rotating the keyboard, pay attention not to damage the peripherals
placed on the console. If the peripheral falls down, injury may be caused.

The lifting lever (15), located on the right, allows to adjust the position of the
control panel vertically, lifting or lowering it.
Push the lever and act on the handle to adjust the height of the control panel.
This lever allows a vertical displacement of ±20 cm.

Pull-out Qwerty Keyboard (14)

Beneath the Control Panel there is a pull-out alphanumeric keyboard. The
keyboard is mounted on a sliding drawer: just pull it to extract the keyboard.
The keyboard is used to enter patient data, comments and text annotation on
images.

Data Storage
You can store exam data onto removable media. Removable media include
USB storage devices and the DVDs and CDs.
The DVD drive (20) is located on the right side of the control panel behind
the touchscreen. It allows both to read and to burn CDs and DVDs.
Two USB ports (19) are located on the right side of the control panel next to
the touchscreen protected by a rubber cover. These ports can be used to
connect an USB device for digital storage, an USB foot-switch or a USB
printer.

MyLab - GETTING STARTED 3-9

 SYSTEM OVERVIEW

ECG and Physio Connectors

The ECG cable connector (7) and Physio cable connector (6) are placed on
the left side of the console.

Probe Connectors and Cable Management

Four probe connectors (11) are located on the front of the console. All
connectors can be occupied simultaneously, but only one probe at time can
be active.
Probe Connector Locks (12) are placed above the probe connectors.
Make sure that the Probe Connector Lock is positioned on the right (open
position) and carefully attach the probe connector by placing the cable feed-
through downwards. To secure the probe, move the securing device towards
left (locked position).
Two additional Probe Connectors holders (9) are available to the left of Probe
Connectors.

WARNING Do not touch the probe connector pins or the system probes receptacle.

Never disconnect the probe while it is active. Press FREEZE before

disconnecting the probe.

CAUTION Check to correctly align the probe connector before inserting it. Close the
connector-securing device only after having completely inserted the
connector.

When a transducer is not in use, store it in one of the probe holders (17) on
the sides of Control Panel Assembly. Always loop transducer cables over the
cable hangers (5) to prevent cables from being stepped on or run aver by the
cart wheels.

Peripherals Housing
The console top is equipped with a peripheral plate (26) to house peripheral
devices. Those devices can be any combination of the following devices: a
black-and-white printer, a color printer, and a DVD recorder. The peripheral
can be easily connected and disconnected and secured to the system console
with belts.
An additional Printer Drawer (13) for B/W thermal USB printer storage is
located on the front side of the console.

MyLab - GETTING STARTED 3 - 10

SYSTEM OVERVIEW

Connections panels (8)

On the rear left side of the console two doors protect additional connections
panels.
The one on the lateral side on the system allows to access the PC ports like

GETTING STARTED
auxiliary USB 3.0 ports and the headphone connector.
The USB ports can be used to connect a USB printer, a USB footswitch or a
USB digital archive medium.
The microphone has not current use.
The other door placed on the corner of the console allows to access
peripherals power connections and the fuse box.
The main switch, the power cable socket and an earth terminal are placed on
the rear-bottom of the system.

Wheel Brakes
MyLab is equipped with four rotational wheels.
Each couple of wheels has a brake pedal (10 and 24) between them.
When the pedal is fully pressed down, the brake is engaged to avoid rotation
of wheels keeping the system stationary during use. To release the brake,
move the pedal to the middle position.
When the pedal is fully up, the brake is engaged to avoid whirling of wheels
to aid in steering while moving the system. To release the brake, move the
pedal to the middle position.

MyLab - GETTING STARTED 3 - 11

SYSTEM OVERVIEW

MyLab - GETTING STARTED 3 - 12

 4
Chapter

4. Preparing the System

GETTING STARTED
The system will be installed by Esaote personnel. Esaote personnel will be
responsible for opening the packaging and ensuring that the system is
correctly programmed and operational.
The information and procedure provided in this chapter will guide to prepare
the system for use. Preparation includes connecting probes and external
devices, locking articulated components for moving, and ensuring that system
operating is met.

Acclimation Time
If the system has been exposed to temperatures which are outside the range
given for its correct working (15÷35°C), it must acclimate, before being
switched on. The following table indicates the necessary waiting times.

Table 4-1: Acclimation Time

T(C°) 60 55 50 45 40 35÷15 10 5 0 -5 -10 -15 -20

Hours 8 6 4 2 1 0 1 2 4 6 8 10 12

Connecting the System to a Network

To use connectivity features, the system must be connected to a network.
The LAN plug is placed at the bottom of the rear side; it supports Gigabit,
10Base-T, and 100Base-T Ethernet LAN. An Esaote field engineer or your
network administrator must configure the system for network connectivity.
1. Turn off the system power.
2. Connect one end of the provided network connection cable
to the wall plug for your network.
3. Connect the other end of the cable to the network plug on
the system.
4. Turn on the system.

MyLab - GETTING STARTED 4-1

 PREPARING THE SYSTEM

Connecting Peripherals
Peripherals, that have been ordered simultaneously with the MyLab, are
usually already mounted and connected. The first mounting and connecting
will usually be performed by an Esaote technician.

NOTE Esaote suggests to contact its Service representative to install any auxiliary
device.

Before installing the peripheral devices, make sure that the system is switched
off and unplug the power cable from the mains outlet. Brake the wheel to fix
the system.
Powering sockets for peripheral devices are placed at the rear on the left;
peripheral connections are placed at the rear, on the right. The network
connector is placed at the rear in the bottom central position.
How to connect peripheral devices:
1. Ensure that the MyLab is switched off (complete shut down
not stand-by or other conditions).
2. Connect the peripheral device to the MyLab.
3. Switch the peripheral device on, making sure that the device
is not in stand-by condition.
4. Switch the MyLab on by pressing the Power ON button.

NOTE Always observe the instructions given in the manual of the peripheral/
auxiliary device.

NOTE Contact Esaote personnel for recommended USB printers and for safe and
proper installation.

NOTE Not all the external monitors are compatible with MyLab. Please contact
your Service representative to select an external monitor that can be
managed by the system.

Safety Concept
MyLab is equipped with an insulation transformer to provide required
separation from AC mains for both the system and the auxiliary devices. Two
plugs for connecting auxiliary devices are located in the back of the system
and are accessible opening the rear door.
Additional equipment connected to MyLab must comply with respective IEC
or ISO standards (e.g. IEC 60950 for data processing equipment).

MyLab - GETTING STARTED 4-2

 PREPARING THE SYSTEM

Furthermore, all configurations shall comply with the requirements for

medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd Edition
of IEC 60601-1, respectively).
Anybody connecting additional equipment to medical electrical equipment
configures a medical system and is therefore responsible that the system

GETTING STARTED
complies with the requirements for medical electrical systems. Attention is
drawn to the fact that local laws take priority over the above mentioned
requirements. If in doubt, consult your local representative or the technical
service department.
SS The “Safety and Standards” manual provides the safety requirements and
standards to be observed for using peripherals devices with MyLab.
Medical environments
Based on IEC60601 three different conditions can be defined for patient
environment:
Fig. 4-1: A) Patient area

Fig. 4-2: B) Medical Use Room

Intended as area B, area A excluded.

MyLab - GETTING STARTED 4-3

 PREPARING THE SYSTEM

Fig. 4-3: C) Non-medical use room

A room not designed for medical treatment, for example, an office or a

storage room.
Possible configurations:
• MyLab + auxiliary device complying to IEC 60601 in area A
- No additional safety requirements.
• MyLab + auxiliary device not complying to IEC 60601
(complying to IEC XXX1) in area A
- Auxiliary device must be powered through a safety
insulation transformer complying to IEC 60601.
• MyLab + auxiliary device not complying to IEC 60601
(complying to IEC XXX1) in area B or area C connected by
WiFi or Ethernet cable
- No additional safety requirements.
• MyLab + auxiliary device not complying to IEC 60601 in area
B or area C connected by cable (USB, HDMI,...)
- Auxiliary device must be powered through a safety
insulation transformer complying to IEC 60601.

NOTE Auxiliary Devices must be approved by Esaote. Auxiliary Devices must also
comply with EN 60601-1-2 safety standard and subsequent amendments or
the electromagnetic compatibility.

1. IEC XXX stands for standards such as: IEC 60601 for medical devices, IEC 60950 for
information technology equipment etc.

MyLab - GETTING STARTED 4-4

 PREPARING THE SYSTEM

Additional safety measures are:

• Additional protective earth connection between the two
devices, or a safety insulation mains transformer for the
auxiliary device.
•

GETTING STARTED
Do not connect a multiple-socket outlet or extension cord to
MyLab.
• Avoid touching the patient and the auxiliary device
simultaneously.
Additionally the IEC60601 requires control measurement of leakage currents.
The system integrator (any person connecting the medical device to other
devices) is responsible that the connections are safe.

WARNING The system must be powered so to satisfy the electrical safety requirements,
as specified in the “Safety and Standards” manual. Esaote recommends
running a current leakage (patient and environment) test when installing in
order to check whether the applicable limits of standard EN60601-1 are not
being surpassed.

MyLab - GETTING STARTED 4-5

 PREPARING THE SYSTEM

B/W Thermal Medical USB Printer housing

Those kinds of printers can be hosted in the lateral storage area.
Procedure 1. Open the rear door.
2. Connect both the power and the USB cables to the printer.
3. Insert the printer into the storage area by first introducing the
cables.
4. Let the cables come out from the slot placed just above the
peripheral powering sockets.
5. Plug the printer power cable to any of the socket indicated by
symbols J1, J2 and J3.
6. Connect the USB printer cable to any of the USB ports
placed on the right.
7. Switch the printer on.
8. Close the rear door.

USB Printer housing

The system can be connected to USB printers via a USB Port. The printer can
be housed on the console top. MyLab is equipped with belts to secure the
peripheral device.

NOTE When selecting the peripheral, consider its dimension so that it can be
safely installed on the console. The console top measures 29 x 20 cm.

CAUTION The peripheral weight does not have to exceed ten (10) kg. The console
could be damaged if the peripheral weight exceeds this limit.

Procedure 1. Introduce the belt below the stirrup mounted on the console
top and stretch it along the console top.
2. Place the printer on the console top.
3. Introduce the belt into the hole placed at the top of the rear
side of the console.
4. Secure the peripheral by closing the belt.
5. Connect both the power and the USB cables to the printer.
6. Open the rear door and connect both cables to the console.
7. Close the rear door by letting the cable come out from the
upper door slot.

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 PREPARING THE SYSTEM

8. Switch the printer on.

WARNING Always power any USB device (such as USB printers or external USB
archiving devices) through the trolley.

GETTING STARTED
Now the system can be connected to the mains and the entire configuration
can be powered through the main switch.

CAUTION Before connecting the peripheral verify not to exceed the maximum power
consumption limits indicated for insulated sockets. There is a risk of
blowing the system fuses.

WARNING The maximum current supplied by the MyLab USB ports is 500mA (for USB
2.0) and 1A (for USB 3.0). Peripherals exceeding this limit can be connected
only if powered by their external power supply through a medical insulation
transformer.

Auxiliary Monitor
Any auxiliary monitor connected to the Display Port has not to be used for
diagnostic purposes.

NOTE The resolution of the auxiliary monitor cannot be lower then the main
display. The system automatically shuts down whenever a lower resolution
is detected.

Monitor Connection Connect the monitor cable to the suitable connector on MyLab.

External CD/DVD and HDD drives

Any external USB CD/DVD drive and/or USB hard disk drive have to be
connected to MyLab USB ports both for data transfer and power. For safety
reasons, the drive must be fixed to MyLab console. Mechanical damage may
occur if the drive falls down.
The External Slim DVD Writer kit supplied by Esaote includes a Velcro tape
to easily and securely fix it to MyLab console. Stick the tape both on the MyLab
console and on the DVD case, then attach them to fix the External Slim
DVD Writer to MyLab console. Power the External Slim DVD Writer
through two USB ports using the split cable present on the kit.

WARNING The maximum current supplied by the MyLab USB ports is 500mA (for USB
2.0) and 1A (for USB 3.0). Peripherals exceeding this limit can be connected

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 PREPARING THE SYSTEM

only if powered by their external power supply through a medical insulation

transformer.

Moving and Transporting the System

MyLab is provided with wheels and handle to allow the user to easily move the
device. The following precautions must be observed:
Moving the system 1. Switch the system off.
2. Engage the wheel brakes by pressing the pedals fully down.
3. Push in the QWERTY keyboard completely beneath the
Control Panel.
4. Use the handle lever to center the control panel and move it
to a comfortable height for moving.
5. Turn the mains switch off and unplug the power cord,
wrapping it on the rear hook to ensure it.
6. Disconnect all external cables, including network and
external devices.
7. Secure all cables, probes and accessories so that they do not
interfere with the wheels.
8. Peripheral can be placed on the MyLab peripheral platform,
provided that it is secured with the locking belt.
9. If peripherals are placed on an external additional platform,
be sure they are disconnected from MyLab before moving the
ultrasound system.
10. Lock the monitor arm by rotating the lever on the monitor
arm on lock position.
11. Release the wheel brakes and set the steering locks for
comfortable moving.
12. Move the system using the front or rear handle.
13. Avoid any unnecessary mechanical shock to the system while
moving it.
Observe the following warnings and cautions before moving the system:

WARNING Use the handles on the keyboard only to move the system and rotate the
keyboard.

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 PREPARING THE SYSTEM

Make sure that the probes are locked and the probe cables are properly
hanged in the cable hooks while moving the system.

WARNING The handles on the keyboard cannot be used to lift the system.

GETTING STARTED
To steadily lock the system, all the wheels must be locked.

Do not park the system on a slope.

Do not use the brakes to park the machine on a slope.

Avoid any unnecessary mechanical shock to the system while moving it.

Transportation When transporting the system in a vehicle, remember to:

• Disconnect and remove all probes and peripheral devices.
• Rotate the control panel in its closing position.

CAUTION The keyboard could be damaged during transportation in a vehicle, if it is

locked.

• Bring the control panel to its lowest position.

• Protect the LCD screen (for example with bubble wrap) and
placed it horizontally, taking care to place something thick
(such as foam or bubble wrap) between the control panel and
the LCD itself, to avoid any contact between the parts and to
avoid screen swing during transportation.

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PREPARING THE SYSTEM

Fig. 4-4: Transporting Configuration

• Protect the screen orientable arm so that no lateral

movements are possible (for example with film).
• Use the brakes to lock the system.
• Fasten securely the system inside the vehicle.

MyLab - GETTING STARTED 4 - 10

 5
Chapter

5. Using the System

GETTING STARTED
This chapter provides a brief description of the system controls.
AO Refer to the “Advanced Operations” manual for further detailed information.

Connecting the system to the mains

The power plug and the electrical main switch are located on the rear-bottom
of the system. The power plug symbol is screen-printed on the console
plastic.
Procedure 1. Plug in the power cord.
2. Connect MyLab to the power mains.

WARNING When installing MyLab, check that the power cable is not tightly bent, that
it can’t be squashed by a misplaced foot or by heavy objects.

The earth terminal can be connected to an external protective earthing system

as additional protection. This connection is not necessary in most cases and
is only recommended for situations involving multiple equipment in a high-
risk patient environment to provide assurance that all equipment is at the
same potential and operates within acceptable leakage current limits.

Turning the System On and Off

At the examination site:
1. Position the system into its final position.
2. Rotate the control panel assembly into its working position.
3. Set the control panel height into a comfortable position.
4. Engage the wheel brakes by pressing the pedals fully down.
5. Position the monitor where you want it.

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 USING THE SYSTEM

6. Connect the network and other cables from the system to the
appropriate wall plugs.
7. Plug the cable to a reliable grounding power outlet to assure
adequate grounding.
8. Turn the main switch of the rear panel on.
9. Press O N /O FF to turn on the system.

WARNING When installing MyLab, check that the power cable is not tightly bent, that
it can’t be squashed by a misplaced foot or by heavy objects.

WARNING Position the system in a location allowing an easy unplug of MyLab from the
mains in case of need.

NOTE It is recommended to turn the rear panel switch off before unplugging the
power cable, whenever the system is expected not to be used for long
periods.

NOTE Whenever the system has to be insulated from the mains, disconnect the
cable from the power outlet.

CAUTION Do not turn the system off while working (for example saving data) or
during the initialization phase: the hard disk could be damaged by this
operation.

CAUTION This is a PC based system; data loss or driver damage may occur if the
system is turned off while working (for example saving data) or during the
initialization phase. Refer to the appropriate chapters of this manual for
detailed information on when and how to safely power the system off.

System Controls
System controls are located on the Control Panel Assembly that includes the
control panel, the touchscreen and the alphanumeric keyboard.

Control Panel Section

The control panel includes the main imaging controls: the TGC slide
controls, a trackball, the joystick and the exam control buttons and knobs.
The control module also allows to select imaging modes, review and annotate
images, perform measurements and calculations.

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USING THE SYSTEM

Table 5-1: Exam Control Buttons

Button Description

ETO UCH Toggles between factory and customized touchscreen that can be
created by the user. Refer to the chapter “Customizing the system”

GETTING STARTED
further in this manual.
ARCHIVE Gives access, at any time, to the archived data.
EN D EXAM Closes the current exam archiving the patient’s data and producing
a report on the exam. The system clears the stored data and shows
the Exam Start menu again.
CW Activates the Continuous Wave Doppler (CW). At its pressure the
positioning cursor is activated as well.
PW Activates the Pulsed Wave Doppler (PW). At its pressure the
positioning cursor is activated as well. The knob around this button
amplifies both CW and PW gains. To increase gain, turn the knob
clockwise, to reduce it, turn the knob counter-clockwise.
PD/TVM Activates the Power Color Doppler or Tissue Velocity Mapping.
C Activates/deactivates Color Doppler (CFM). The knob around this
button amplifies both CFM and Power Color gains. To increase
gain, turn the knob clockwise, to reduce it, turn the knob counter-
clockwise. In B-Mode, a cursor delimits the Region of Interest
(ROI) where color analysis is performed and displayed.
M Activates the M-Mode and, if necessary, its selection cursor (B-
Line).
B This button re-activates a B-Mode image in real time when any
other mode is active. If pressed in M-Mode, Doppler or Freeze, it
restores a full screen bi-dimensional image. The knob around this
button amplifies both B-Mode add M-Mode gains over the entire
depth of the image. To increase gain, turn the knob clockwise, to
reduce it, turn the knob counter-clockwise.
M ARK Activates bodymarks; further details on how to use them are
described in the “Advanced Operations” manual.
CLEAR Deletes all measurements or annotations from the screen.
ALL

ABC Activates annotations; further details on how to use them are

described in the “Advanced Operations” manual.
M EASURE Activates Advanced Measurements showing the list of available
measurements on the right of the image.

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USING THE SYSTEM

Button Description

+...+ Activates Generic Measurements showing the list of available

measurements on the right of the image.
ACTIO N Changes the function linked to the trackball. Refer to the
“Trackball” paragraph further in this chapter.
AUTO Automatically adjusts both the overall gain and TGC distribution
improving the contrast resolution of the image. The activation is
indicated on the screen by the corresponding icon and it is labeled
as “AG”. Refer to “Advanced Operations” Manual, “Imaging
Optimization” Section for further information.
PO IN TER Toggles the trackball operation from standard to mouse mode.
Refer to the “Trackball” paragraph further in this chapter.
LIN E In B-Mode or CFM, this button allows to interactively activate the
UPDATE cursor or disable it to select the M-Mode or Doppler line.
During the exam, when a trace is active, the same button freezes
the trace acquisition and temporarily reactivates the reference B-
Mode image.
ACQ UIRE Activates advanced features; further details on how to use them are
described in the “Advanced Operations” manual
FREEZE Stops the current analysis or scan and puts the system in Freeze
mode. To re-activate real time, press it again or directly press the
button of the required mode.
3D/4D Activates three dimension features; further details on how to use
them are described in the “Advanced Operations” manual
DUAL Activates dual and quad view both in real time and freeze.
Press LEFT or RIGHT to activate dual presentations: the active image
is displayed on the left/right. Press CEN TER to restore a single
format.
Press CEN TER to activate quad presentations: the active image is
displayed on the top-left. Press LEFT or RIGHT to add other images.
Press CEN TER to restore a single format.
1, 2, 3, 4 These buttons can be customized to save clips, save and print
images. Refer to chapter 6 “Customizing the system” for further
information.

TGC Sliding
The TGC sliding control signal amplification in individual areas of the image.
Potentiometers are used to adjust the signal zone by zone.

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 USING THE SYSTEM

Trackball
The trackball operates in two different modes.
Standard Mode In its standard mode, the trackball makes it possible to quickly position the
cursors on the screen.

GETTING STARTED
Each mode automatically activates the trackball on its cursor.

Table 5-2: Trackball cursors

Mode Trackball

M-Mode, Doppler LINE cursor

Color Flow Mapping (CFM) CFM ROI cursor

The cursor function is indicated on the left bottom side of the screen. When
several cursors are present on the screen, ACTIO N switches between the active
cursors. Blue indicates active cursor function while white next cursor
function.
Mouse Mode In its mouse mode, the trackball can be used to move a pointer on the screen,
to access to the thumbnails of the images, displayed on the right side of the
screen or to access to the archiving media and peripheral menus. The buttons
placed on the left and right side of the trackball can be set as mouse keys (as
confirmation and context menu buttons).
Regardless of the trackball configuration, the confirmation and context menu
buttons are respectively indicated as EN TER and UN DO in this manual.
Press PO IN TER to change the trackball operation from standard to mouse
mode.
Joystick
The JO YSTICK is a special control providing multiple functions to make easy
your workflow. The functions linked to both the joysticks depend on the
current system status (they are contextual the operative mode).
A proper layout on the screen indicates the current function.
Refer to “Advanced Operations” Manual, “Imaging Optimization” Section
for further information.

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 USING THE SYSTEM

Touchscreen Section
This section includes the M EN U and the O N /O FF buttons, a touchscreen and
two USB ports.
Menu Button
M EN Udisplays the system menu for all configurations/settings (both clinical
and system settings).
Touchscreen
The touchscreen displays controls used to select probes, enter patient data,
select applications and change setups; it also displays exam controls related to
the active modality.
Touchscreen controls are indicated in the operator manuals by BOLD BLUE
CAPITAL LETTERS for keys that can be tapped while by NORMAL BLUE CAPITAL
LETTERS for software text strings.
Tap the displayed key to activate/deactivate the corresponding control.
Many modes provide two or more pages of controls.
Swipe left/right to move to the next/previous page.
A page indicator shows you the page in which you are.

The touchscreen layout changes depending on the different working

modality:
• as Exam panel, providing control keys to perform the exam,
• as Multipurpose panel, providing software buttons to use
advanced exam controls,
• as Alphanumeric keyboard to enter data,
• for image review.
Multipurpose Panel This layout is used for standard exam functions necessary to perform the
Layout exam.

Keys The keys have a color coding depending on their status.

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 USING THE SYSTEM

Table 5-3: Touchscreen key status

Active Key with

Disabled Key Active Key Selected Key
Sub-menu

GETTING STARTED
Gray text on dark White text on light As Active Key with Blue text on dark
gray background gray background three lines at gray background
bottom right

If the key is active, the displayed function will be enabled when tapping the
corresponding key on the touchscreen.
Knobs Six rotating knobs are located along the bottom side of the touchscreen.
Each knob acts on the control key just above it. Rotate the knob to change
the control value.
Sometimes, two controls are available for a knob. Only one of the controls
can be active at a time. Pressing the corresponding knob or tapping the label
toggles the active control.

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 USING THE SYSTEM

Multipurpose Panel This layout is used for advanced exam functions, for example bodymarks or
Layout annotations.
The touchscreen is organized in six main areas.
Fig. 5-1: CFM touchscreen

1. Work flow Area, it contains keys related to the exam flow.

2. Smart Preset, it displays the available smart presets.
3. Tools, it lists the available tools.
4. Navigation tab bar, each tab contains additional keys.
5. Main Area, it contains main controls for the active modality.
6. Knobs Area, it contains functions whose value can be
changed by rotating the knob beneath.
On top-right, a dedicated key activates the emulation of the Qwerty
alphanumeric keyboard. Tap the keyboard icon to display the keyboard. Tap
again to hide the keyboard.
Tap the cogwheel icon to access a menu for easy configuration of display
settings to adapt the contrast and brightness of your display to the lighting
conditions of your room.
Image Review This layout is used to review on the touchscreen saved images. Swipe down
Layout on the blue arrow on top center of the touchscreen to access this layout.
Swipe left/right to scroll the images. Swipe up to close.

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 USING THE SYSTEM

Alphanumeric Keyboard Section

The alphanumeric keyboard is based on the QWERTY standard. The
alphanumeric keys are used to enter text data in the enabled windows. The
Caps Lock key sets the keyboard to upper case characters.

GETTING STARTED
The ÏShift key is used to type in lower case or upper case characters
(according to how the keyboard is set); the Fn key is used to type numeric
functions (for example +, *).
AO Refer to the “Advanced Operations” manual for the use of the keyboard in
annotation modality.

Information about the Screen Layout

The screen is split into five main areas.
Fig. 5-2: Screen Layout

1. Heading Area
2. Footer Area
3. Image Area
4. Joystick Area
5. Thumbnails Area

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 USING THE SYSTEM

Controls on the Screen Layout are indicated in the operator manuals with
B O L D B L A C K C A P I T A L L E T T E R S , while strings and fields are indicated
with NORMAL BLACK CAPITAL LETTERS.
Symbol on Screen When this symbol is displayed on the screen, it indicates to carefully read the
manual. Refer to the appropriate section of the manual for a detailed
explanation.

Heading Area
This area is used to display the following information: center and patient data,
accession number and date.
Patient data are displayed only if entered at the beginning of the exam.
Data can be entered or modified at any time during the exam by pressing
PATIENT ID.

Footer Area
This area is used to display the following information:
• joystick functionality,
• trackball functionality,
• Wi-Fi icon (when enabled),
• archival media icons,
• advanced features icons,
• peripherals icons.
Trackball
The trackball function is indicated on the bottom left side of the footer area
as text and in the middle as graphic.
When there are several cursors on the screen, two functions are displayed
simultaneously. The function shown on the upper line indicates the active
cursor; the one on the lower line indicates the next cursor that can be
activated. ACTIO N switches among cursors.
Wi-Fi
When Wi-Fi is enabled, its icon is shown beside the archival media icons. The
icon is shown crossed out whenever Wi-Fi is not connected.
AO For more details on Wi-Fi connectivity, consult the relevant section on the
“Advanced Operations” manual.

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 USING THE SYSTEM

Archival Media
Archival media are shown on the left, beside the trackball function. The icon
is shown crossed out whenever there are management problems involving the
specific archival system.
AO For more details on data archival, consult the relevant section on the

GETTING STARTED
“Advanced Operations” manual.
Advanced Features
When advanced features such as XView or MView are activated, the
corresponding icons are displayed on the center of the footer area.
Peripheral Devices
The system is able to simultaneously manage two peripheral devices (b/w or
RGB printers). The icons of the peripheral devices are shown at right of the
footer area. The icon is shown crossed out whenever there are management
problems involving the specific peripheral device.

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 USING THE SYSTEM

Image Area
The visualization of the image depends on various factors such as the active
mode, the selected application and the probe. The following figure shows the
elements in the image area that are independent of these factors.
Fig. 5-3: Image Area

Table 5-4: Image Area description

Number Description

1 Frequency Bar, active

application, probe and preset

2 System Parameter

3 Sector orientation

4 Acoustic output data

5 Focal Zone(s)

6 Image and color scales

7 Memory bar

Freeze Status Whenever an image is frozen, a memory bar is displayed (at bottom right)
concerning the scrolling memories. The images acquired immediately before
are frozen and archived in these memories. The trackball can be used to
examine the 2D, M-Mode, Doppler and color information image by image.

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USING THE SYSTEM

Machine Parameters

Table 5-5: Imaging Parameters

Displayed
Parameter Description
format

GETTING STARTED
F l Imaging or TEI (Tissue Enhancement
Imaging) mode: General, Resolution or
Penetration (L: Low, H: High)

G nn% Imaging gain (Min,%, Max)

AG nn% Auto Adjust

D nn mm Depth

X/M C or +n/n XView Algorithm or CrystaLine Imaging /

MView algorithm

PRC n/n/n/n Dynamic range / Dynamic compression /

Density / Gray map

PRS n Persistence

SV nn/nnn mm Sample volume size and depth

Θ nn° Doppler angle correction

SV and Θ are displayed only if the relevant cursor is active.

Table 5-6: Color Flow Mapping (CFM) Parameters

Displayed
Parameter Description
format

F nnn MHz Color frequency or TVM (Tissue Velocity

Mapping) frequency when enabled
G nn% Color gain (Min,%, Max)

PRF nnn kHz Pulse Repetition Frequency

WF n Wall filter

PRC l/n Smooth (L: Low, M: Medium, H: High) /

Density

PRS n Persistence

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USING THE SYSTEM

Table 5-7: Doppler Parameters

Displayed
Parameter Description
format

F nnn MHz Doppler frequency or TV (Tissue Velocity)

frequency when enabled
G nn% Doppler gain (Min,%, Max)

PRF nnn kHz Pulse Repetition Frequency

PRC n/n Dynamic range / Rejection

WF nnn Hz Wall filter

PRC n/n Dynamic range / Gray map

Joystick Area
Control Panel Commands are displayed in this area providing information
about the function related to joysticks and 1, 2, 3, 4 buttons.

Thumbnails Area
Clips and images both saved during the exam and previously archived are
displayed on the right side of the screen as thumbnails. The thumbnails are
displayed in chronological order, from left to right.
The tabs displayed at the top of the thumbnails columns allow to scroll
among the images saved during current exam and images retrieved from other
exams.

MyLab - GETTING STARTED 5 - 14

 6
Chapter

6. Customizing the System

GETTING STARTED
MyLab can be customized to increase efficiency and streamline your work-
flow. You can do the following:
• Create preset designed specifically for the exams you
perform.
• Change system settings to reflect your needs.
• Add options to enhance your imaging abilities.
• Create custom procedures for specific patients, transducers,
and presets.
The M EN U button is used to access the system menu. The system displays all
the available options.
Fig. 6-1: System Menu

MyLab - GETTING STARTED 6-1

 CUSTOMIZING THE SYSTEM

The menu is organized in three areas:

• Clinical Configuration, the upper area shows all options
relating to Clinical Settings or Presets,
• System Settings, the central area shows all options relating to
System Settings,
• General Settings, the lower area shows all options relating to
General Settings.
Clinical A clinical setting is a group of configurations optimizing MyLab for a specific
Configuration type of exam (for example for a cardiac exam or an obstetrical exam). This
clinical setting is associated to the specific probe in the selected application.
You can save several clinical settings for each probe in each application. This
means that the preset, selected at the beginning of the exam or during the
exam pressing PRO BE, establishes the initial settings of the exam controls (like
gray map, depth...) together with the initial available measures (measurement
configuration), the initial available library both for annotations and for
bodymarks (Annotation and Bodymark configurations) and the customized
touchscreen.
Clinical Configuration allows to set different parameters listed below:
• Real Time Preset for Presets configuration,
• Measure for measurement configuration,
• Annotations for annotation configuration,
• Bodymarks for bodymark configuration,
• eTouch for eTouch configuration,
• When licensed, advanced tool configurations (such as 3D/
4D, Stress Echo) are part of the clinical settings.

NOTE Refer to the dedicated sections of this manual for further information on the
above Clinical Configurations.

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 CUSTOMIZING THE SYSTEM

System Settings System Settings define the MyLab’s parameters related to a specific system
profile:
• Profile Manager,
• DICOM configuration,

GETTING STARTED
• Saving Options for end exam saving configuration,
• Center ID for hospital configuration to set the name of the
hospital,
• Multimedia,
• Network for network configuration,
• Observations for observation configuration,
• Printers for printer configuration,
• Report for report style configuration,
• XStrain2D,
• Acquisition Protocols.
You can save several system profiles. If, for example, MyLab is used in two
structures differing in Network and DICOM connectivity, two specific
System Configuration profiles can be created: each time the user will load the
configuration required by the structure.
MyLab allows the user to save several system configurations. If, for example,
MyLab is used in two structures differing in Network and DICOM
connectivity, two specific System Configuration profiles can be created: each
time the user will load the configuration required by the structure.

General Settings General Settings define the MyLab’s general parameters:

• General Setup for general configuration, like measure units,
control panel setting,
• Security for general configuration,
• Licenses for license settings,
• Import/Export for exam export configuration,
• System Info,
• Remote Service,
• ePortal.

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 CUSTOMIZING THE SYSTEM

Generic Configuration Procedure

Once accessed the configuration screen for the parameter you want to set, a
common set of commands is available and a common setting procedure can
be used.
In a few limited cases the procedure may differ to the one described below,
in these cases it will be described in the specific paragraph.
Procedure • Press M EN U, and select the parameter you want configure.
The configuration screen for the selected parameter is
displayed.
• On the left of the screen is displayed the list of possible
items.
• Select the desired item, then choose one of the following
options.
Table 6-1: Configuration Menu Options

Option Description

EDIT To modify the settings of the item selected

on the top-left list.
Alternatively double click on the item you
want to modify
CLONE To create a new customized item starting
from a copy of the existing selected one.
NEW It replaces C L O N E when no customized
items are present.
REMOVE To delete the selected customized item. A
confirmation dialog will be displayed. Only
customized items can be deleted.
FACTORY To retrieve all factory values and to delete
all customized items.

• Once in editing mode you can change the name of the

selected item (NAME field), enter a description (NOTES field),
confirm and save the settings (S A V E ), or exit the menu
without saving the settings (C A N C E L ).
At any time you can go back to the main menu (B A C K TO MENU) or exit
from the menu and go back to Real Time (C L O S E ).

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 CUSTOMIZING THE SYSTEM

Clinical Configurations
AO This chapter explains how to set many MyLab options. For configurations not
described here refer to relevant chapters in the “Advanced Operations” manual.

GETTING STARTED
Real Time Preset
A Preset is a group of settings that optimizes the system for a specific type of
exam. Presets establish many initial settings, such as gain value, color map,
filter and items on the touchscreen.
You can choose from several default presets, modify them and create many
others. Default presets can not be deleted, however, they provide a starting
point from which you can create your own presets.
The available presets are determined by the selected transducer.
The creation/modification of a preset is achievable in two steps:
• from M EN U, where you can add the desired measurement
configuration, annotation and bodymark libraries,
• from Real Time, where you can set the parameters that
optimize the real time image in all modes and create the
customized preset.
Creating a new preset from MENU
To create a new preset or modify an existing one press M EN U , then select
R E A L T I M E P R E S E T and then follow the generic configuration procedure,
taking in account that on the left of the screen is displayed the list of all clinical
settings, grouped by probes. Within each probe clinical settings are grouped
by applications.
During editing you can select from the curtain menu each parameter
(Measure, Annotation, Body Marks...) to be associated of the preset in the
desired configuration.
Here you can also assign the default application for each probe
independently. Each time the probe is selected its default application is
selected as well.
When selecting each probe you can also establish which application to show
on the touchscreen. Uncheck the application in order not to show it. The
option ALL PROBES allows to select/unselect the application for all probes.
The configured preset is associated to the active probe and application: this
preset will be available each time the same probe and application are selected
either from the Start Exam page or by tapping PROBE.

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 CUSTOMIZING THE SYSTEM

Creating a new preset from Real-Time

Procedure To create a new preset or modify an existing one:
• Adjust the real time image as desired in all modes (2D, CFM
and Doppler).
• Tap PROBE and then PRESET MANAGER.
• Press O V E R W R I T E to overwrite the current preset (also
factory presets can be overwritten) or using the alphanumeric
keyboard type a new preset NAME and NOTE and press N E W
to confirm.
OVERWRITE saves all settings done in real time in the active preset.
NEW creates a new preset whose configuration is the one defined in every
modality in real time.
CLOSE exits without saving any modification.

eTouch Button
MyLab allows the user to record sequences of keys both of the touchscreen
and of the control panel. Each recorded sequence (Macro) can be named and
saved to be available as customized button in customized touchscreens.
ETO UCH switches between factory and customized touchscreen. Whenever the
customized button is pressed, MyLab will automatically launch the keys
sequence.
Each system configuration is linked only to one customized touchscreen.

NOTE Keys sequences that require interaction with the user (like measurements
or pointer positioning) can not be recorded as macro.

Configuring eTouch button

To access to the ETO UCH configuration menu:
• Press M EN U. The configuration menu is organized in two
main areas: the list of all saved customized touchscreens on
the left side and the eTouch configuration menu on the right
side.
• Select one of the saved customized touchscreens, then follow
the generic configuration procedure.
During editing the screen displays:
• in the center the touchscreen layout,

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 CUSTOMIZING THE SYSTEM

• on the right the menu to record the macro and to edit the
customized buttons,
• on the bottom the fields where customized touchscreens are
named and described.

GETTING STARTED
From here you can:
• Record the Macro sequence,
• Customize the touchscreen,
• Create additional tabs on the touchscreen.
To create a customized touchscreen, follow one of the following procedures.

NOTE Wait for any background operations to be finished before starting the
procedure.

Recording • Place the cursor on the R E C O R D I N G field and press S T A R T

Procedure to begin the recording: MyLab switches to the frozen status.
• The system displays on the upper left side of the screen the
following flashing message:

Press eTouch to start recording.

Prepare MyLab to be ready for the recording so that only the keys
to be used can be pressed and then press ETO UCH to start.
• Press the desired keys in sequence and press again ETO UCH to
end the recording. During the sequence recording, the
message turns color.
The eTouch configuration menu displays the customized button. Place the
cursor on the button and press EN TER to change its name, using the
alphanumeric keyboard to edit it.
Repeat the procedure to add other customized buttons.

Customized Button The customized button can be freely positioned within the touchscreen.
Organizations
MOVE BUTTON changes the button position: select the button with the
trackball, place the cursor on the desired position and click EN TER to confirm.
DELETE BUTTON cancels the button selected with the trackball.
Tab Organization Customized touchscreen can be organized in more tabs. Each tab has one
level of buttons.

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 CUSTOMIZING THE SYSTEM

NEW TAB button adds a new tab that will be automatically displayed. Place
the cursor on the tab and press EN TER to change its name, using the
alphanumeric keyboard to edit it.
M O V E L E F T and M O V E R I G H T buttons respectively shift to left or to right
the selected tab: select the tab with the trackball and press the desired button.
DELETE SELECTED TAB button cancels the tab selected with the trackball.

NOTE Empty tabs (that is tab not containing customized button) are not
displayed in the customized touchscreen.

System Settings
AO This chapter explains how to set many MyLab options. For configurations not
described here refer to relevant chapters in the “Advanced Operations” manual.

Profile Manager
Profile Manager allows to create a system profile for each user with a personalized
system configuration.
To configure the Profile press M EN U , then select P R O F I L E MANAGER and
then follow the generic configuration procedure.
During editing you can configure each displayed component selecting the
desired option among the ones available in the relevant SETTINGS combo.
Fig. 6-2: Profile Manager Menu

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 CUSTOMIZING THE SYSTEM

Corrupted System Profile

Whenever a profile is corrupted, a red exclamation mark is displayed on the Profile
Manager option. In this case, enter the profile manager menu and, for each system
profile, check that every component has a specific setting (no component has to
be without any setting).

GETTING STARTED
Should this not solve the problem, contact Esaote personnel.

Center ID
Center ID allows to set the center name displayed in the Heading Area of the
screen and the center information shown in the report.
To configure the Center ID press M EN U, then select CENTER ID and then
follow the generic configuration procedure.
During editing you can configure many fields described below.
Center ID Field
The name entered in this field will be displayed in the heading area of the screen.

Report Information Field

This option allows to add to the report header the following information:

• the hospital name;

• the department name;
• the contact details;
• two fields for other additional information;
• the hospital logo.
DICOM Field
This option allows to enter the station name used in DICOM.

General Settings
AO This chapter explains how to set many MyLab options. For configurations not
described here refer to relevant chapters in the “Advanced Operations” manual.

NOTE Some settings described below may be unavailable on your product’s

configuration.

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 CUSTOMIZING THE SYSTEM

General Setup
The menu is organized in internal folders, selectable using the tabs displayed on the
top of the menu.

Fig. 6-3: General Configuration Menu

SAVE saves the settings, which will be activated as soon as they are saved.

CANCEL exits the menu without saving the new settings.

FACTORY retrieves all factory values and deletes all customized items.

DATE/TIME Folder
This option is used to set date and time, displayed on the screen.

Set Date Using the trackball scroll the month and select the day on the calendar.

Date Format Various formats can be set: the available options are listed in the following table.

Table 6-2: Date Formats

Format Displayed date

DD/MM/YYYY 01/04/2011
DD/MMM/YYYY 01/Apr/2011
MM/DD/YYYY 04/01/2011
MMM/DD/YYYY Apr/01/2011

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 CUSTOMIZING THE SYSTEM

Set Time Using the keyboard set the time.

Time Format The time format is available on a 24 or 12 hour basis. In the 12 hour option, the
time is shown as AM and PM.

MEASURE UNITS Folder

GETTING STARTED
This option is used to set the desired units for height and weight. You can choose
between cm/kg and ft/lb.

The Celsius or Fahrenheit scale can be selected for probes equipped with
temperature sensor.

BIOPSY Folder
This option is used to set the type of needle guide line to be superimposed on the
image during biopsy procedures. For further information about biopsy and needle
guides, refer to the related chapter in the Advanced Features section of the
Advanced Operations manual.

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CUSTOMIZING THE SYSTEM

CONTROL PANEL Folder

The table below lists and explains the available fields and the corresponding
actions.

Table 6-3: Control Panel Folder

Fields Action

TRACKBALL SPEED Sets the speed of the trackball.

LEFT CLICK Sets the action of the left key of the trackball.
The left key can be set as confirming key (EN TER)
or as context menu key (UN DO )
CHARACTER SET Sets the characters used for all the system
information (for example screen information,
touchscreen button).
SHUTDOWN TYPE Sets the preferred shutdown type.
AVAILABLE QWERTIES Sets which alphanumeric keyboards are available in
the touchscreen and which is the default one.
When more alphanumeric keyboards have been set,
the touchscreen displays an alphanumeric keyboard
with dedicated tabs allowing to select the desired
keyboard.
BEEP VOLUME Sets the volume of the beep.
FOCUS CONTROLLED Sets the default action of the trackball when starting
BY TRACKBALL the exam.
ETOUCH BUTTON When Acquisition Protocol is licensed, the eTouch
button can be configured to work with protocols.
DEPTH INCREASE Allows to set the depth changing the value
clockwise/counterclockwise.
AUTOMATIC START When checked, it allows a direct access to B-Mode
EXAM after booting without passing through Patient ID.
SHOW CONTROL When checked, functions related to joysticks and 1,
PANEL COMMANDS ON 2, 3, 4 buttons are displayed on monitor.
MONITOR

TOUCHSCREEN Sets the brightness of the touchscreen.

CONTROL PANEL Sets the brightness of the control panel.
MAIN DISPLAY Sets the brightness of the main display.

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 CUSTOMIZING THE SYSTEM

Field SHUTDOWN TYPE

Various shutdown types can be set; the available options are listed in the table
below.

Table 6-4: Shutdown types

GETTING STARTED
Fields Action

STANDBY When the OFF button is pressed, MyLab goes in

hibernation state saving all configurations allowing a
following quick boot-up. In these conditions MyLab
can be unplugged from the main.
When OPTIMIZE MEMORY USAGE is checked, all
memory is erased to make repeated use of standby
more reliable over time. This results in a slowdown of
boot-up time.
SHUT DOWN When the OFF button is pressed, MyLab performs a
complete shut-down.
SHUT DOWN WITH When the OFF button is pressed, MyLab performs an
VIRUS SCAN antivirus scan and then a complete shut-down. If
viruses are found, the shut-down is not executed and an
information pop-up is displayed.
SHUT DOWN WITH When the OFF button is pressed, MyLab performs an
VIRUS SCAN ONCE antivirus scan and then a complete shut-down. At the
next OFF pressure the previous choice is restored.

NOTE Esaote does not install a real-time antivirus program, because it could affect
the regular operations of MyLab.

The antivirus scan could take a long time. Before starting the scan, a
confirmation is requested.

If a virus is found, it is advisable to switch off the MyLab, disconnect it from

the data network and call the Esaote service, which will check for the
presence of a virus and restore the system.

Field AVAILABLE QWERTIES

When more alphanumeric keyboards have been set, the touchscreen displays an
alphanumeric keyboard with dedicated tabs allowing to select the desired
keyboard.

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CUSTOMIZING THE SYSTEM

Fig. 6-4: Qwerty keyboard

CINE MODE Folder

When set, the AUTOMATIC PLAY and TRACE AUTOMATIC PLAY options
respectively allow to review the stored images and the trace in cine mode when
FREEZE is pressed.

APPLICATION PRESET Folder

This option is used to set specific features for each application.
The menu is organized in two areas: the left side shows the list of the available
applications, the right side the list of the features.
Select the application and then check the boxes of the desired features.
The table below lists and explains the available fields and the corresponding
actions.

Table 6-5: Application Preset Folder

Fields Action

ABSOLUTE ANGLE The angle correction factor of linear probes can be

correlated either to the line cursor or to the line
perpendicular to the transducer surface (absolute angle).
In the first case the angle correction is kept constant when
the line is moved; in the latter case an angle correction is
calculated whenever the line is moved.
SHOW SWEEP When checked, this option allows to display the Sweep
VELOCITY Velocity (cm/s) below the PW/CW/M scroll area.
SAMPLE VOLUME When checked, the Doppler line can be oriented by using
SWIVELING STEERING the center of the sample gate as rotation axis.
IMAGE SIZE Sets the default dimension for reference image in split
format for the selected application.
ACTION ON FREEZE Sets the action after FREEZE pressure.

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 CUSTOMIZING THE SYSTEM

Fields Action

AUTO BUTTON SETUP Sets the action after AUTO pressure: AUTOADJUST (to
automatically adjust the B-Mode image), ECFM (to
automatically optimize CFM image) or BOTH of them.

GETTING STARTED
EASYTRACE ENABLED When checked, this option allows to enable easyTrace.
IMAGE AUTOFITTING When checked, for linear probes and superficial depths, it
adapts the size to the width of the screen.
ENABLE SMARTOUCH When checked, it enables the smarTouch for the selected
application.
INVERT CFM SCALE When checked, this option allows to automatically invert
WITH STEERING the Doppler scale when inverting the steering with reference
to the vertical line.

WARNING The displayed Sweep Velocity is correct as long as you do not use a
secondary monitor and/or an incorrectly calibrated monitor.

FOOTSWITCH Folder
This option is used to set which function is associated to each pedal (left, middle
and right) of the footswitch.

Select from the curtain menu the function then press S A V E .

PROBE BUTTONS Folder

This option is used to set which function is associated to each probe button.

Select from the curtain menu the function then press S A V E .

RAW DATA Folder

When the associated license is enabled and the option selected, data are saved in
raw format for Post Processing elaboration.
Refer to the “Archive” section of this manual for further information on this
feature.
KEYBOARD BUTTONS Folder
This option is used to set which function is associated to ACQ UIRE button and to
each of the four configurable buttons (1, 2, 3, and 4).

From the curtain menu select the function you desire then press S A V E .

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 CUSTOMIZING THE SYSTEM

NOTE When the buttons 1, 2, 3, 4 are associated to save image or save clip, they
will be named further in this manual as IM AGE or CLIP respectively.

Security
For further information about security options provided by MyLab, refer to the
related chapter in the Advanced Features section of the Advanced Operations
manual.

Licenses Manager
Licenses Manager allows to install optional licenses and to check the status of a
demo license.

NOTE To activate a new license, the operator needs the appropriate form listing
the licenses associated to the system. License codes are generated
according to the system Hardware ID, shown on the left upper corner of the
license configuration menu.

Press M EN U then L I C E N S E S to enter the License Manager Menu. It is

organized in internal folders, selectable using the tabs displayed on the top of the
menu.

Fig. 6-5: License Configuration Menu

License Activation
Tabs A P P L I C A T I O N S and O P T I O N S allow to respectively activate the
application licenses and the optional licenses.

The INCLUDING field, shown in the A P P L I C A T I O N S menu, indicates which

applications will be available once the license is activated.

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 CUSTOMIZING THE SYSTEM

License Activation To activate a new license, type the license number in the KEYS field and press
V E R I F Y to confirm. If the number is correct, the status changes to PERMANENT.

NOTE All license fields are not case sensitive with the exception of the CrystaLine
license that is case sensitive.

GETTING STARTED
Demo License If a demo license has been activated (DEMO box checked), EXPIRATION DATE
shows the expiration date of each demo licence.

SAVE saves the configuration, activating the licenses.

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 CUSTOMIZING THE SYSTEM

Import/Export Menu
The menu is organized with internal folders, selectable using the tabs displayed on
the top of the menu.

Fig. 6-6: Import/Export Menu

EXPORT Folder
This option allows the user to save customized clinical and system settings on the
USB medium.

The option is organized in internal folders, one folder for the clinical settings and
one folder for the system configuration settings.

Clinical Configuration The clinical settings that can be exported are:

Folder
• customized real-time settings (REALTIME PRESETS);
• customized calculation packages (MEASURE);
• customized glossary libraries (ANNOTATIONS);
• customized body-mark libraries (BODYMARKS);
• customized ETOUCH;
• when available, other customized profiles.
System Settings Folder The system configuration settings that can be exported are:

• customized DICOM configuration;

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 CUSTOMIZING THE SYSTEM

• customized SAVING OPTIONS;

• customized center configuration (CENTER ID);
• customized MULTIMEDIA export settings;
• customized NETWORK configurations;

GETTING STARTED
• customized OBSERVATIONS;
• customized printer profiles (PRINTERS);
• customized report styles (REPORTS);
• customized XSTRAIN 2D settings;
• customized acquisition protocols (ACQUISITION PROTOCOLS);
• customized general configuration (GENERAL SETUP);
• customized SECURITY profiles;
• customized streaming settings (EPORTAL).
In both folders the menu allows the user to select both individual settings and all
settings.

Select the desired options, connect the USB medium to the system and press
E X P O R T to confirm.

NOTE Only custom configurations will be exported.

IMPORT Folder
This option allows the user to load customized clinical and system configuration
settings. MyLab allows the user to load specific clinical and system configurations.

Procedure • Connect the USB medium containing the customized

configurations to MyLab,
• Select the configuration you want to import,
• Press I M P O R T to start the loading procedure.
MyLab shows the list of all saved configurations, grouped by components. The
menu allows either to select all profiles included in a component (by checking the
box beside the component), or to separately load a specific configuration (by
checking the box displayed beside the configuration).

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 CUSTOMIZING THE SYSTEM

NOTE In case of homonymy, MyLab asks for confirmation to completely overwrite

the existing profiles, saved on the system. If confirmed, the previous
configurations are then lost.

System Info
Press M EN U then S Y S T E M INFO, the following information is displayed:

• the model name and serial number;

• the system hardware ID, necessary for license generation;
• the current installed software version and its build;
• the BIOS revision;
• the hardware level of the installed boards.
From this menu you can export the log file on a USB medium and you can also
check if the encryption is enabled or not (ENCRYPTION MODE).
Encryption Mode
Encryption allows to preserve health data storage confidentiality.
Encryption can be performed by Esaote Service personnel only. Encryption
can be applied to the internal hard disk and to one or more external USB
memory devices.
At the end of encryption a recovery key will be given to you. The recovery key
is stored on USB pen drive, or on file, or by printing it.
You have the responsibility to store the key in a safe place for future use.

NOTE To make effective use of encryption it is strongly advised to use it with

security access enabled (see further).

When data are encrypted, they can only be read on the system where the
encryption was performed.
When an encrypted USB memory device is connected to the MyLab where it
has been encrypted, data will be automatically unlocked and accessible.
When an encrypted USB memory device is connected to a different system,
data will remain locked and then not accessible.

MyLab - GETTING STARTED 6 - 20

 7
Chapter

7. Performing an Exam

GETTING STARTED
This chapter describes the procedures commonly used in performing patient
exams with MyLab. These procedures include entering patient and application
data, acquiring images, making measurements and calculations; annotating
and reviewing images.
SS Read the “Safety and Standards” manual carefully: all the safety
characteristics, cautions and warnings listed there apply to all exams.
MyLab is designed for operators who are qualified in using ultrasound systems.

Only physicians or sonographers who are qualified in using ultrasound

systems should perform ultrasound scanning on human subjects for medical
diagnostic purposes.

NOTE The operator must be familiar with the mechanical and thermal indexes
display as well as know the ALARA (As Low As Reasonably Achievable)
principle. The patient must be exposed to ultrasound for as short time as
possible and only for as long as it takes to achieve the diagnostic
information.

Starting an Exam
At power-up, at end of the initialization phase, or when starting every new
exam, the system displays the Patient ID screen and the touchscreen is
configured to allow the operator to enter patient and application data, and to
select the probe, the application and the preset.

CAUTION Do not turn the system off during the initialization phase: the hard disk
could be damaged by this operation.

MyLab - GETTING STARTED 7-1

 PERFORMING AN EXAM

Fig. 7-1: Patient ID screen

Fig. 7-2: Probe, Application, Preset touchscreen

Starting exam The steps to be followed to start an exam are:

procedure
1. Entering patient and application data;
2. Selecting probe;
3. Selecting Application;
4. Selecting Preset.

MyLab - GETTING STARTED 7-2

 PERFORMING AN EXAM

Entering Patient and Application data

There are two ways to enter patient data:
• Filling the Patient ID screen,
• Retrieving existing data from archive.

GETTING STARTED
Filling the Patient ID screen
The Patient ID screen is used to enter patient data and application data, when
applicable. Age is automatically calculated from the date of birth. Patient data
will be saved together with images, measures and reports during archiving
operations.
To navigate the Patient ID screen, you can use either the trackball and the
EN TER key or the ' tab key of the alphanumeric keyboard. To enter the
patient data use the alphanumeric keyboard.
The Application data are additional information required for specific
application (Cardiac, Urologic, Vascular, Gynecology, Obstetric and Pediatric
Cardio) for calculation purposes.
Retrieving data from archive
CURRENT retrieves the patient data of the last exam.
REOPEN EXAM allows to open an exam already closed to add images and/or
measurements.

NOTE The key is enabled only for exam closed in the same day of reopening. It is
not allowed to reopen exams taken the days before the current one.

RETR PAT INFO or R E T R P A T I N F O retrieves from the archive the patient

data of a previously performed examination. Once pressed the list with
archived exams is opened, double click on the exam to retrieve patient data,
the Patient ID fields will be automatically filled with the data of the selected
exam. Press CANCEL to exit without retrieving any exam.
If the PAUSE EXAM option is checked in Saving Option Menu, pressing
PAUSED EXAMS a list with paused exams will be displayed, allowing to
resume, close or delete them.
If a DICOM archive is available, it is also possible to load data from it using
the W O R K L I S T button displayed on the screen. In this case MyLab displays
the following warning message whenever the characters used to enter patient
data are not supported:

Unsupported character setting!

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 PERFORMING AN EXAM

At any time during the exam, Patient Data can be viewed and modified by
pressing PATIENT ID.

WARNING Do not use PATIENT ID to start a new exam of a new patient as it will update
existing patient’s data with new entries. To activate a new exam, close first
the current exam by pressing EN D EXAM and then proceed with the Starting
Exam procedure.

Pressing IM AGE when the Patient ID Screen is displayed, a screenshot of this

window is saved.

WARNING The screenshot of the Patient ID Screen contains the patient data at the
date and time of when the image has been taken. Do not refer to these data
but always check the current patient data.

Selecting Probe
On the left side of the touchscreen all connected probes are displayed.
Tap the probe image to select it.
The blue rounded image indicates the active probe.
Fig. 7-3: Probe, Application, Preset touchscreen

At any time during the exam, a different probe can be selected pressing
PROBE.

MyLab - GETTING STARTED 7-4

 PERFORMING AN EXAM

Selecting Application
When a probe has been selected, on the middle of the touchscreen all the
application available with the selected probe are displayed. Tap the name of
the desired application to set it.

GETTING STARTED
The blue rounded application indicates the active one.
At any time during the exam, a different application can be selected tapping
PROBE.

Selecting Preset
The Preset (or Clinical Setting) can be selected only when both the probe and
the application have been set. Tap the name of the desired preset to select it.
The blue rounded preset indicates the active one.
At any time during the exam, a different preset can be selected tapping PROBE.
At Preset selection the exam starts; the system enables the selected probe to
operate in the application and preset you selected.

WARNING Before beginning the exam, ensure that the active probe displayed on the
screen matches the one selected.

Alternatively, the exam can be started also pressing EN D EXAM , END EXAM or
START EXAM.

NOTE You can program and add presets to better suit your individual clinical
needs or preferences, while applications depend on the installed optional
licenses.

MyLab - GETTING STARTED 7-5

 PERFORMING AN EXAM

Smart Preset
After exam starts, at the right side of the touchscreen, presets for the active
probe and application are shown.
When the preset is changed during the exam tapping one of them on the
touchscreen, all acquisition parameters are reset while the geometrical
characteristics (such as depth, size) are maintained.

Performing the Exam

MyLab offers a set of imaging modes to cover a variety of imaging needs. By
pressing the different mode buttons (B , M , C , PD/TVM , PW , CW ) the specific
mode is activated in real time. If the same button is pressed again, the system
automatically returns to the previous presentation.
Special modes are also available for 3D imaging and advanced imaging.
Touchscreen buttons change according to the activated mode.
When more modes are active, the navigation tabs (B-MODE, M-MODE) allow
the operator to scroll among the specific mode menu. If the displayed menu
has several levels, swipe left/right to scroll through all functions.
AO The control panel buttons and the commands displayed on the touchscreen
make it possible to optimize presentation quality. Different menus
correspond to each format., the “Advanced Operations” manual provides a
detailed description of all active controls in the different modes.

Acquiring images
MyLab allows to capture and save a single image or a cineloop sequence
pressing IM AGE or CLIP respectively.
These buttons respectively save still frames and clips in real time. Images are
also saved in Freeze.
Images and clips are saved in patient study and thumbnails of the saved data
are shown downwards in chronological order on the right side of the screen.
Single images are saved with full definition or compressed, whereas sequences
are compressed with a minimum loss of information.
AO Compression of both images and clips to be saved on external media can be
set: refer to the “Archiving” section for further information.

MyLab - GETTING STARTED 7-6

 PERFORMING AN EXAM

Freeze and Scrolling Memories

Use FREEZE to stop and start real-time image acquisition and update.
At FREEZE pressure the system displays the scroll bar of the memories,
assigning the trackball to manual cineloop review (frame-by-frame). Move the

GETTING STARTED
trackball horizontally to scroll through the images one by one. The scrolling
bar shows the trackball position.
AO The “Advanced Operations” manual provides a detailed description of all the
available controls in Freeze.

Reviewing Images
During the exam, tapping REVIEW enables reviewing of the saved images and
sequences, and the trackball automatically changes to pointer mode, allowing
you to scroll through the thumbnails and select the item to be reviewed.
Alternatively press PO IN TER , select the thumbnail: the system automatically
switches to Exam Review.
The selected image or sequence is shown on the screen.
AO The functionalities available in Exam Review are the same of the Archive
Review: refer to this specific session of the “Advanced Operations” manual
for further details.

Ending the Exam

To end the exam, press EN D EXAM or tap START EXAM. The window displayed
at the end of the exam is used to archive the exam. This window shows the
patient's name, the applications, the size of the stored images and the
estimated time to complete each selected operation.
Fig. 7-4: End Exam Window

MyLab - GETTING STARTED 7-7

 PERFORMING AN EXAM

Before archival, Patient Data can be made anonymous by checking the

ANONYMIZE box.

NOTE The native format of the exam can not be made anonymous.

The exam can be simultaneously exported to the local archive and to external
media (in native, DICOM and multimedia formats). Check all the
destinations you want, then press O K to confirm and close the exam archiving
it in the selected destination(s). The system automatically shows the window
allowing to start the exam.

NOTE At power-up, the system prompts the operator to archive the last exam
performed if the system was switched off without first closing the exam in
progress.

The exams that have been performed and not archived into the local
database can be locally saved at a later time from Archive Review. Refer to
the specific section of the “Advanced Operations” manual for further
information.

If the PAUSE EXAM option is checked in Saving Option Menu, pressing EN D

EXAM also P A U S E will be prompted.

NOTE At switch off, the system will inform if there are any paused exams.

Monitor adjustments
Tapping the gear icon on top-right of the touchscreen, you can access a menu
where quickly and intuitively adjust the brightness and contrast of the
monitor depending on your work environment. Three preset levels are
available: DARK ROOM, MEDIUM DARK ROOM, and BRIGHT ROOM.

MyLab - GETTING STARTED 7-8

 8
Chapter

8. System Maintenance

GETTING STARTED
To ensure that MyLab operates over time at its maximum efficiency, Esaote
recommends to perform maintenance procedures regularly.
Maintenance procedures should be performed both by the user itself and by
Esaote authorized service personnel. The maintenance operations and
schedule are provided in the table below.

Table 8-1: Maintenance Operations

Maintenance Minimum frequency Performed by

cleaning the probes after use user

checking the probes every week user

cleaning control panel and system every week user

cleaning touch screen every week user

cleaning probe and gel holders every week user

cleaning LCD case and screen every week user

checking system housings for any every month user

damage

checking control panel and keyboard for every month user

defects

checking equipment for loose or missing every month user

hardware

checking movements of all parts every month user

composing the system

checking LCD and touchscreen status every month user

checking trackball movement every month user

cleaning trackball every month user

checking connectors on cables for any every month user

mechanical defects

MyLab - GETTING STARTED 8-1

 SYSTEM MAINTENANCE

Maintenance Minimum frequency Performed by

checking entire length of electrical and every month user

power cables for cuts or damages

checking the system integrity, every year Esaote personnel

functionality and cleaning (including
internal components)

Electrical Safety Tests every two years Esaote personnel

or authorized
personnel

NOTE Frequency of cleaning can change depending on environment cleanliness.

NOTE Periodic maintenance operations that require the access to the system can
be performed only by trained personnel: contact your local Esaote
representative for further information on required periodic inspections.

Only trained persons are allowed to perform the safety inspection mentioned
above.

Disconnect the system from the power outlet before checking it.
Contact Esaote personnel for any problem found during inspection.
PC Refer to “Probes and Consumables” manual for periodic inspections for
probes and cleaning instructions.

MyLab - GETTING STARTED 8-2

 SYSTEM MAINTENANCE

Cleaning Operations
Periodic cleaning of the system and any connected devices is important.
In the event of poor maintenance, dust and dirt can compromise the
reliability and performance of MyLab and connected devices.

GETTING STARTED
The following table indicates the cleaning agents that have tested the
compatibility with the MyLab system.

Table 8-2: System compatible cleaning agents

Product Supplier

Asepti-Wipes II Ecolab Co
(www.ecolab.com)

Cavicide Metrex Research Corporation

Caviwipes (www.metrex.com/company/contact/
Metrizyme index.cfm)

CidezymeXTRA Advanced Sterilization Products

Enzol (www.aspjj.com)

Cleanisept-wipes Dr.Schumacher
(www.schumacher-online.com)

Mid Soap -

Mikrozid AF wipes Schülke&Mayr GmbH,

Mikrozid PAA wipes (www.schuelkemayr.com/int/en/
Mikrozid sensitive wipes contact/smi044_adresses.htm)

Sani-Cloth HB Professional Disposable International

Sani-Cloth Plus (www.pdipdi.com)
Sani-Cloth Super

SaniZide plus Safetec of America

(www.safetec.com)

Trionic D Ebiox
(www.ebiox.co.uk)

To clean the peripheral devices, follow the instructions supplied by the

manufacturer.

WARNING Turn the system off and unplug it before any cleaning operation.

NOTE The cleaning operation should be performed accordingly to the equipment

environment requirements in terms of temperature, pressure and humidity.

MyLab - GETTING STARTED 8-3

 SYSTEM MAINTENANCE

Check the instructions supplied by the manufacturer of the cleaning agents

for possible stricter limitation. Do not use hot cleaning agents for cleaning
the equipment.

CAUTION Apply the cleaning agents only for the time necessary to remove the dirt
without exceeding over.

A visual inspection of the parts subjected to the cleaning process in order to

evaluate possible damages or deteriorations.

Cleaning control panel and system

To clean the control panel and system, switch the MyLab off, unplug it and use
a soft cloth slightly dampened with water.
If necessary use the suggested wipes, or a soft cloth slightly dampened with
one of the suggested cleaning agents.
Otherwise, apply a small amount of ammonia-free and not abrasive detergent
on a clean, soft cloth and then wipe the surface.

WARNING Make sure that the detergent has completely evaporated before turning the
equipment on.

CAUTION Do not use any type of ammonia- or benzene-based cleaners on the case.

Cleaning the trackball

The trackball can be accessed, for cleaning purpose only, by rotating
counterclockwise the upper locking disk.
Once the disk has been removed, clean the trackball using a soft dry cloth.
Clean the trackball housing using a cotton swab.

CAUTION When cleaning the trackball housing, make sure not to spray any liquid into
the trackball housing.

Clean the ball rotating it in its socket. Do not remove the ball from the socket.
The X-series trackballs contain two 855 nm semiconductor lasers. The device
is designed such that it fulfills laser safety class 1M regulations, according to
IEC 60825-1 edition 3, 2014-05.
The laser radiation emitted is invisible to the human eye.

MyLab - GETTING STARTED 8-4

 SYSTEM MAINTENANCE

WARNING Invisible laser radiation. Do not view directly with optical instruments.
Class 1M laser products.

Do not remove the ball from the socket.

GETTING STARTED
WARNING Do not try to disassemble the trackball during the cleaning of the
removable sealing ring.

Cleaning Probe and Gel Holders

Probe and gel holders are easily removable from their location for cleaning
and can be washed in a mild soap solution. Make sure they are completely dry
before replacing them.
PC To clean the probes, refer to the manual “Probes and Consumables”.

Cleaning the Touchscreen

To clean the touchscreen, switch MyLab off, unplug it and use a soft dry cloth,
lightly rubbing the display surface. To remove stains, lightly dampen the cloth
with ethanol and water mixed in a 1:1 ratio and gently wipe the touch panel
surface; afterwards, dry the touch panel with a new dry cloth.
If strictly necessary, to clean the touchscreen during an examination, you can
temporarily lock the keyboard and the touchscreen pressing FREEZE while
keeping ETO UCH pressed. When the system is on and connected to the mains,
for safety reason, you must use only a soft dry cloth to clean the touchscreen.

WARNING Do not spray or apply the cleaning agents directly on the touchscreen
surface as the liquid of the cleaning agents may permeate into the front
bezel of the display and cause damage.

Do not press the touchscreen with any sharp objects as this may damage
the screen.

When the system has not been unplugged, clean the touchscreen
exclusively using a dry cloth. Never use wet cloth.

Cleaning the LCD Screen

To clean the LCD use a soft dry cloth, lightly rubbing the display surface to
remove dust and other particulate matter. If necessary, apply a small amount
of ammonia- free glass cleaner onto a clean, soft cloth and then wipe the
surface.

MyLab - GETTING STARTED 8-5

 SYSTEM MAINTENANCE

Never spray or pour any liquid directly onto the screen or case.

WARNING Overspray or liquid may cause electrical shock.

Cleaning the LCD case

Use a soft, dry cloth to wipe the surface of the case. If necessary, apply a small
amount of ammonia-free and not abrasive detergent onto a clean, soft cloth
and then wipe the surface.

CAUTION Do not use any type of ammonia- or benzene-based cleaners on the

monitor’s screen and case.

MyLab - GETTING STARTED 8-6

 9
Chapter

9. Technical Specifications

GETTING STARTED
This chapter describes the technical specifications1 of the MyLab systems.

NOTE Special packages (such as Strain) are listed and described in the specific
sections of the “Advanced Operations” manual.

MyLab Characteristics
MyLab models differ in licences that are installed per default and licences that
can be installed. The tables below list all the available licences regardless the
model on which they could be installed. Refer to the corresponding Sales
Area manager for further information.

Licenses
Licenses enable specific functions of the system, they are linked to the system
serial number and are, therefore, unique. They should be carefully stored. The
system is delivered by Esaote, with the licenses already installed.
Additional features can be added buying the related license.

1. Specifications subject to change without notice. Information might refer to products

or modalities not yet approved in all countries.

MyLab - GETTING STARTED 9-1

 TECHNICAL SPECIFICATIONS

Applications MyLab systems can be equipped with the following application licenses.

Table 9-1: Applications licenses

Licence Application Features

Cardiology Cardiac (adult and pediatric) Presets, Calculations,

ECG, Auto EF

Radiology Gen. Abdominal, Neonatal, Musculo-skeletal, Presets, Calculations

Imaging Pediatric, Breast, Small Organ, Thyroid,
Urology

Women’s Health Obstetrics, Fetal, Gynaecology Presets, Calculations,

Ob/Gyn AutoNT

Vascular Vascular, Adult cephalic Presets, Calculations

SHARED Abdominal, Neonatal, Pediatric, Vascular, Presets, Calculations,

SERVICE GI Adult Cephalic, Obstetrics, Fetal, AutoNT
Gynaecology, Breast, Musculo-skeletal,
Small Organ, Thyroid, Urology

SHARED Abdominal, Neonatal, Pediatric, Vascular, Presets, Calculations,

SERVICE CV Adult Cephalic, Cardiac (adult and ECG, AutoEF
pediatric), Breast, Musculo-skeletal, Small
Organ, Thyroid, Urology

System Features Depending on the model, MyLab can be configured with one or more of the
following licenses.

Table 9-2: System Features

Licence Feature description

3D/4D 3D and 4D Volumetric acquisition

3D/4D Advanced TPI, TMI and TSI modalities

VRA analysis
XLight (Advanced illumination rendering technique)

AutoAdjust It enables the automatic adjustment of imaging parameters.

Auto EF Automatically detects and tracks the left ventricle (LV)

endocardial borders to calculate LV Volumes (Diastolic
Volume, Systolic Volume) and EF (Ejection Fraction).

AutoNT Automatic Nuchal Translucency allows to automatically

capture Nuchal Translucency measurement.

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TECHNICAL SPECIFICATIONS

Licence Feature description

CMM Compass M-Mode allows to correct M-Mode line position to

optimize tracing acquisition, even when the position of the
heart is not perpendicular to the ultrasound beam.

GETTING STARTED
CnTI Contrast Tuned Imaging, used in combination with ultrasound
contrast agents, enhances the B-Mode imaging.

Dicom DICOM Classesa

(including US Q/R) Ultrasound DICOM Query/Retrieve

Multi-modality & Multi-modality management

Dicom Q/R Multi-modality DICOM Query/Retrieve

eDoppler Automatic correction of the Doppler angle, box position and

steering, for a fast and optimized calculation

ElaXto ElaXto allows you to perform elastosonographic analysis of

the tissues

ElaXto Measures It enables measurements in elastosonography

eStreaming Possibility to visualize the MyLab images on different devices

on the same network

Fusion Imaging 2D - Real-time synchronization of ultrasound and second diagnostic

BodyMap 2D modality (e.g. Mammography or RX) and Body Map

Fusion Imaging 3D Real-time synchronization of ultrasound and volumetric

modality (e.g. CT, MR, PET) images

LVO Left Ventricular Opacification uses low mechanical index

ultrasound to interact with 2nd generation contrast agents to
enhance left ventricle (LV) visualization in difficult-to-scan
patients.

microV It automatically recognizes the lowest speeds with ultra

sensitivity for small vessels and slow flow detection

MView It is an ultrasound technique which applies beam-line steering

and acquires several coplanar scans of an organ from different
view angles.

MyLab Tablet Mobile application which allows to remotely review MyLab

images on tablet or mobile

MyLibrary Dedicated libraries for Rheumatology, MSK, Regional

anesthesia, Physiotherapy and Advanced vascular.
Live Preview features allow to scan in real-time while using
anatomical references and scanning guidance.

Needle Enhancement It increases the needle visibility.

Imaging

MyLab - GETTING STARTED 9-3

TECHNICAL SPECIFICATIONS

Licence Feature description

Protocols Clinical protocolsb

QElaXto - (pSWE) It allows to perform a Quantitative Elastosonographic analysis

of tissues

QElaXto 2D It enables 2D Quantitative Elastosonografic analysis

QElaXto 2D Advanced It enables QElaXto 2D on Linear Probes

(Linear Probes)

QIMT Quality Intima Media Thickness calculation automatically

measures the Carotid Intima-media thickness in real-time

QPack - Quantification Time/Intensity analysis

Raw Data Processing It enables raw data management in post-processing allowing to

act on the raw data of captured images and clips by modifying
some of the parameters represented.

Stress-Echo Stress-Echo allows to acquire multiple views of the left

ventricle (LV) under stress, using customizable protocols.

TEI Tissue Enhanced Imaging improves the signal-to-noise ratio

and enhances contrast resolution.

TPView It enlarges the field-of-view.

TVM Tissue Velocity Mapping provides a complete Wall Motion

Analysis for both systolic and diastolic myocardial function
evaluation.

VPan Panoramic Imaging merges multiple B-Mode images in one

complete panoramic image.

Virtual Biopsy Virtual Biopsy combined with Intelligent Positioning increases

confidence during ultrasound real-time biopsy procedures,
thanks to virtual tracking of the needle.

XSTIC It is a three-dimensional technique which allows the

acquisition of a volume of data from fetal heart, displayed as a
cineloop of a single cardiac cycle.

XStrain XStrain allows to quantify endocardial velocities of contraction

and relaxation and local deformation of the heart (Strain/
Strain Rate analysis).

XStrain 4D XStrain 4D creates a volumetric model of the left ventricle

(LV) based on the acquisition of standard apical views
(Strain/Strain Rate volumetric analysis)

XView XView and XView+ enhance the pattern of every frame at the
XView+ pixel level, eliminating speckle and noise artefacts.
a. Refer to www.esaote.com for further details on supported DICOM classes.

MyLab - GETTING STARTED 9-4

 TECHNICAL SPECIFICATIONS

b. Refer to the corresponding Sales Area manager for further information.

NOTE Features, probes and applications availability is dependent on your system

configuration. Not all features, probes and applications are approved in all
Countries. Please refer to your Esaote local representative for further

GETTING STARTED
information.

MyLab - GETTING STARTED 9-5

TECHNICAL SPECIFICATIONS

Technical Characteristics
This section describes the product when fully loaded with all options; refer to
the previous paragraph for basic configurations.

Display
• Built-in color LCD, WVGA resolution
• Full HD LED 21.5” (24” as optional) monitor (16:9 aspect
ratio)
• 12.1” LCD (touchscreen)

Probe connectors
• 4 electronic probes
• 2 parking supports

Video Output
• DVI (main monitor)

• DVI (auxiliary monitor)1

• Mini Display Port type1

Connectivity
• I/O connectors
• LAN RJ45
• 2 USB 2.0 on keyboard control panel
• 4 USB 2.0 on rear panel
• 4 USB 3.0 on rear panel
• Wi-Fi (802.11.A,B,G,N)
• Dedicated connectors
• ECG input
• Other
• Laser/Ink jet printers

• Complies with IHE integration profiles2

1. Auxiliary monitors connected to this input have not to be used for diagnostic
purposes.
2. Refer to www.esaote.com for further details.

MyLab - GETTING STARTED 9-6

TECHNICAL SPECIFICATIONS

Image Files
• Formats
• BMP (uncompressed)
• PNG (lossless)

GETTING STARTED
• JPEG (lossy)
• AVI: Codec Microsoft MPEG-4 V2 and MS-Video 1
• Native formats

Software
• Operating system: Windows 10
• Multi-lingual

Biometry
• Basic and advanced calculation, application dependent
• Annotations, bodymarks

Keyboard
• Height adjustable control panel
• Control panel:
• Potentiometers for TGC
• Encoders for general gains
• Keys for modes, peripherals management and controls
• Reconfigurable touchscreen LCD
• Pull out alphanumeric QWERTY keyboard

Dimensions
• Closed (approximately): 570 (L) x 1100 (H) x 857 (D) mm
• In working position: 570 (L) x 728÷1260 (H) x 857 (D) mm
(height of trackball)
• In working position: 570 (L) x 940÷1472 (H) x 600 (D) mm
(at top of Control Panel)
• In working position: 570 (L) x 1260÷1792 (H) x 600 (D) mm
(at top of the Monitor)

Weight
• < 120 kg (basic configuration without peripheral units)

MyLab - GETTING STARTED 9-7

TECHNICAL SPECIFICATIONS

IP Grade
• IP (X)0, this means MyLab models are not watertight.

Power supply
• Voltage operative range:
• 100 ÷ 120 V
• 200 ÷ 240 V
• Voltage limit range:
• 90 ÷ 132 V
• 180 ÷ 264 V
• Working frequency range: 50 ÷ 60 Hz ±10%
• Power consumption: ≤ 400 VA (MyLab only)
• Power consumption: ≤ 1000 VA (MyLab + peripherals)
• Fuses: T 5A H, 250 V (220V)/ T 10A H, 250 V (110V), 5x
20mm

Power Cables

Table 9-3: Power Cables

Connector Plug Type Cord Type Length

Italy EN60320/C13 I/3G CEI 23-50 H05VVF3G 4,5 m

Chile Section 1 mm2
3 conductors
10A-250V

EU EN60320/C13 Type VII G H05VVF3G 4,5 m

Germany CEE (7) VII Section 1 mm2
3 conductors
10A-250V

USA C13M HG (Hospital grade) SJT3x14AWG 4,5 m

North America EN60320/C13 NEMA 5-15 Section AWG 14
3 conductors
15A-125V

China EN60320/C13 PCR/3 H05VVF3G 4,5 m

GB2099 / GB1002 Section 1 mm2
3 conductors
10A-250V

MyLab - GETTING STARTED 9-8

TECHNICAL SPECIFICATIONS

Connector Plug Type Cord Type Length

Brazil EN60320/C13 BR/3 H05VVF3G 4,5 m

according to Section 1 mm2
NBR14136 3 conductors

GETTING STARTED
10A-250V

UK EN60320/C13 BS13/13 H05VVF3G 4,5 m

Singapore BS 1363/A Section 1 mm2
3 conductors
10A-250V

Swiss EN60320/C13 12G H05VVF3G 4,5 m

SEV 1011-2009 Section 1 mm2
SEV 6534/2 3 conductors
10A-250V

Israel EN60320/C13 IL/3G H05VVF3G 4,5 m

Middle East SI32 Section 1 mm2
3 conductors
10A-250V

Australia EN60320/C13 SAA/3 H05VVF3G 4,5 m

New Zealand AS/NZS 3112-2000 Section 1 mm2
3 conductors
10A-250V

Denmark EN60320/C13 DK3/HGA H05VVF3G 4,5 m

SB 107-2D1 DK2- Section 1 mm2
8a 3 conductors
10A-250V

South Africa EN60320/C13 ZA/3 H05VVF3G 4,5 m

India SANS 164/1 Section 1 mm2
Namibia IS 1292 3 conductors
10A-250V

Operating Requirements
• Temperature: 15 ÷ 35°C
• Humidity: 15 ÷ 85% (not condensing)
• Pressure: 700 ÷ 1060 hPa

MyLab - GETTING STARTED 9-9

TECHNICAL SPECIFICATIONS

Storage requirements
• Temperature: -20 ÷ +60°C
• Humidity: 5 ÷ 95% (not condensing)
• Pressure: 700 ÷ 1060 hPa

Probe Storage Requirements

• Probe storage requirements are indicated in the probe case.

MyLab - GETTING STARTED 9 - 10

TECHNICAL SPECIFICATIONS

Standards

Table 9-4: Standards

GETTING STARTED
Standard Title

IEC 60601-1:2012 (Ed.3.1) Medical electrical equipment - Part 1: General

EN 60601-1:2006 + CORR. 1 requirements for basic safety and essential
(2006) + CORR. 2 (2007) + performance
AMD. 1 (2015)

CAN/CSA C22.2 No. 60601-1:08 Medical Electrical Equipment - Part 1: General

CAN/CSA C22.2 No. 60601-1.14 Requirements for Safety

ANSI/AAMI ES60601-1: 2005 + Medical Electrical Equipment - Part 1: General

A2:2010 Requirements for Safety

IEC 60601-1-2:2014 (Ed.4) Medical electrical equipment - Part 1-2: General

EN 60601-1-2:2015 (Ed.4) requirements for safety - Collateral Standard:
Electromagnetic compatibility - Requirements and
tests

IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part 1-6: General

(Ed. 3.1) requirements for basic safety and essential
EN 60601-1-6:2010 + A1:2015 performance – Collateral standard: Usability

IEC 60601-2-37:2007 (Ed. 2.1) + Medical electrical equipment - Part 2-37: Particular
A1:2015 requirements for the basic safety and essential
EN 60601-2-37:2008 performance of ultrasonic medical diagnostic and
monitoring equipment

IEC 61157:2007 (Ed. 2.1) Standard means for the reporting of the acoustic
+A1:2013 output of medical diagnostic ultrasonic equipment

IEC 62304 Medical device software - Software life cycle

EN 62304 processes

IEC 62366:2007 + A1:2014 (Ed. Application of Usability Engineering to Medical

1.1) Devices
EN 62366:2008

EN ISO 10993-1:2009 Biological evaluation of medical devices -

Evaluation and testing

EN ISO 14971:2012 Medical equipment - Application of risk

management to medical devices.

ISO 15223-1 Medical devices - Symbols to be used with medical

device labels, labelling and information to be
supplied - Part 1: General Requirements

AIUM/NEMA UD-2:2004 Acoustic Output Measurement Standard for

(R2009) Diagnostic Ultrasound Equipment.

MyLab - GETTING STARTED 9 - 11

TECHNICAL SPECIFICATIONS

Standard Title

AIUM/NEMA UD-3:2004 Standard for Real Time Display of Thermal and

(R2009) Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment.

CAN/CSA C22.2 NO. 60601-2-37 Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment

Opti-light
On the monitor top edge is hosted the Opti-light function that provides
subtle room lighting for optimal scanning conditions.
The position of lighting source eliminates any kind of reflection on the
monitor resulting in improved image contrast resolution.
Opti-light can be activated by a finger-touch on the bottom-right corner of
the monitor frame. The illumination level can be adjusted by sliding the finger
on the corner to increase/decrease the level.

MyLab - GETTING STARTED 9 - 12