MyLabGamma GettingStarted E R13

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Rev.

13

May 2019

MyLabGamma

GETTING STARTED

359010000
MyLab - G E T T I N G S T A R T E D

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MyLab - G E T T I N G S T A R T E D

Introduction
This manual refers to all MyLabGamma ultrasound models, named in the following
chapters as MyLab. MyLab is available both in portable and mobile configuration. The
term “MyLab”, used in this manual, refers to both configurations and to all models.
When the information refers to only one configuration, it will be specifically indicated.

The manual contains information on MyLab indications for use and explains how to
install it. All system keys and their functions are described.

The manual is divided into the following chapters:

 Chapter 1: General Information

The chapter provides information on manuals organizations, manufacturer’s


responsibility, product life cycle and software licences. Moreover it contains
information on Esaote Traceability and Responsibility systems.

 Chapter 2: Additional Information on Safety

The chapter provides information about specific safety features of the MyLab system.

 Chapter 3: Clinical Applications

The chapter specifies in which clinical applications the MyLab can be used.

 Chapter 4: System Components and Installation

This chapter contains the installation instructions.

 Chapter 5: Control Panel

This chapter describes the MyLab control panel.

 Chapter 6: Screen Layout

In this chapter one can learn how information is organized on the screen.

 Chapter 7: Performing an Exam

This chapter describes the operations usually carried out to start and end an exam.

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MyLab - G E T T I N G S T A R T E D

 Chapter 8: eTouch Key

This chapter explains how to use the eTouch key of the control panel.

 Chapter 9: MyLab Settings

This chapter explains MyLab settings organization and how to use them.

 Chapter 10: MyLab Clinical Settings

This chapter explains how to create clinical settings and how to use them.

 Chapter 11: System Maintenance

This chapter lists all necessary maintenance procedures.

 Chapter 12: Technical Specifications

This chapter describes MyLab technical specifications.

In this manual system controls are indicated using the following graphical
conventions:

 Control panel keys are indicated by BLUE CAPITAL LETTERS.


Multifunction keys (for example LINE UPDATE) are indicated with
the mention of one of the functions only (for example LINE in
this example).

 Touchscreen controls are indicated by BLACK CAPITAL


L E T T E R S.

 Touchscreen exam management controls are indicated by GREY


CAPITAL LETTERS.

 Touchscreen navigation tabs are indicated by BRO W N CAPITAL


LETTERS.

The confirmation key is always indicated throughout the manual as ENTER, the menu
context key as UNDO.

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WARNING In this manual WARNING identifies a risk for the patient and/or the operator.

CAUTION The word CAUTION describes the precautions necessary for protecting the
equipment.

Be sure to understand and observe each of the cautions and warnings.

The MyLab systems have multiple configuration and feature sets. They are all
described in this user manual but not every option may be applied to your system.

System features are dependent on your system configuration, transducer, and exam
type. Not all the system features are approved in all countries.

Keep the manual with the system for future reference.

This manual revision refers to release F066XXX (8.XX.YY, 7.XX.YY and 5.5X.YY)
depending on the Country and the respective clearances. Features, probes and
applications described in this manual may change depending on your system
configuration.

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Table of Contents
1 General Information .......................................................................... 1-1
User's Kit .............................................................................................1-1
Licenses ............................................................................................1-1
“Product Documentation” Disk ........................................................1-1
MyLab Manuals...................................................................................1-1
Operator Manual...............................................................................1-2
Getting Started .............................................................................1-2
Probes and Consumables .............................................................1-2
Safety and Standards....................................................................1-2
Advanced Operations Manual ..........................................................1-2
System Data ......................................................................................1-2
Probes - Cleaning, Disinfection, Sterilization ..................................1-3
Manufacturer’s Address ......................................................................1-3
Manufacturer’s Responsibility ............................................................1-4
Product Life Cycle...............................................................................1-5
Life Time ..........................................................................................1-5
Maintainability Time ........................................................................1-5
End-of-Life Disposal ........................................................................1-5
Usage License Agreement for the Software Included in the
Apparatus ..........................................................................................1-10
Proprietary Rights...........................................................................1-10
License Rights and Limitations ......................................................1-10
Third Part Software.........................................................................1-11
Product Traceability ..........................................................................1-12
Vigilance System...............................................................................1-13
Important Information .......................................................................1-15

2 Additional Information on Safety .....................................................2-1


Environmental Safety ..........................................................................2-1
Transport Safety ..................................................................................2-1
Electromagnetic Compatibility............................................................2-2
Electromagnetic Emissions...............................................................2-2
Essential performance.......................................................................2-3
Electromagnetic Immunity ...............................................................2-4
Electromagnetic Immunity for All Medical Equipment .............2-5
Electromagnetic Immunity for Medical Equipment not Life
Supporting....................................................................................2-7
Recommended Distances between Radiofrequency (RF) Communication
Systems and MyLab ............................................................................2-7
Wireless Requirements ........................................................................2-8
Device Labels ....................................................................................2-10

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3 Clinical Applications .........................................................................3-1


Intended Use ........................................................................................3-1
Clinical Applications ...........................................................................3-1
Linear Array Probes..........................................................................3-4
Phased Array Probes.........................................................................3-5
Doppler Probes .................................................................................3-5
Specialty Probes................................................................................3-5
Bi-Scan Probes.............................................................................3-5
Endocavity Probes .......................................................................3-6
Abdominal and Related Applications...............................................3-7
Adult Cephalic ..................................................................................3-7
Gynecologic Application ..................................................................3-8
Intraoperative and Laparoscopic Applications .................................3-8
Musculo-Skeletal ..............................................................................3-8
Obstetrical and Fetal Applications....................................................3-8
Pediatric and Neonatal Head Applications .......................................3-9
Small Organ and Small Part Applications ........................................3-9
Peripheral Vascular Applications .....................................................3-9
Urologic Application ......................................................................3-10

4 System Components and Installation ...............................................4-1


System Overview.................................................................................4-1
Portable Configuration......................................................................4-1
Accessories for Outdoor Transport ..............................................4-2
Mobile Configuration .......................................................................4-2
Installation ...........................................................................................4-4
Portable Configuration......................................................................4-4
Identifying the Connectors...........................................................4-4
Installing the Portable Configuration...........................................4-6
Mobile Configuration .......................................................................4-6
Installing the Console ..................................................................4-6
Installation at Working Site .........................................................4-7
Turning the System On.....................................................................4-8
Probes Connections ..........................................................................4-8
Battery .................................................................................................4-8
Battery Status Led.............................................................................4-9
First Use..........................................................................................4-10
Battery Lifetime..............................................................................4-10
Acclimation Time ..............................................................................4-10
Peripheral and Network Connections ................................................4-11
How to safely connect peripherals.....................................................4-12
Safety Concept................................................................................4-12
Medical environments................................................................4-13
Auxiliary Monitor...........................................................................4-15

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Moving and Transporting the System ...............................................4-16

5 Control Panel .....................................................................................5-1


Touchscreen Section............................................................................5-1
Touchscreen......................................................................................5-1
Exam Panel Layout ......................................................................5-2
Multipurpose Panel Layout..........................................................5-4
Alphanumeric Keyboard Layout..................................................5-5
TGC Potentiometers .........................................................................5-5
ON/OFF Button ................................................................................5-5
Controls Section ..................................................................................5-6
Trackball ...........................................................................................5-6
Exam Controls ..................................................................................5-7
Exam Flow ...................................................................................5-7
The Mode Keys............................................................................5-7
Multiformat Controls ...................................................................5-9
Exam Revision .............................................................................5-9
Exam Report ................................................................................5-9
Printers .........................................................................................5-9
Settings.......................................................................................5-10
eTouch Key.....................................................................................5-10
Advanced Operations .....................................................................5-10

6 Screen Layout ....................................................................................6-1


Information about the Screen ..............................................................6-1
Heading Area ....................................................................................6-1
Footer Area .......................................................................................6-2
Trackball ......................................................................................6-2
Wi-Fi ............................................................................................6-2
Archival Media ............................................................................6-2
Advanced Features.......................................................................6-2
Battery..........................................................................................6-3
Peripheral Devices .......................................................................6-4
Image Area........................................................................................6-5
Machine Parameters.....................................................................6-6
Thumbnails Area .................................................................................6-7
Symbol on Screen................................................................................6-7

7 Performing an Exam .........................................................................7-1


Exam Start and End .............................................................................7-1
Exam Exported on CD/DVD Medium .............................................7-6
Performing the Exam...........................................................................7-7
2D and CFM Clips with High Frame Rate ..........................................7-8
Acquisition Procedure ......................................................................7-8

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Freeze and Scrolling Memories...........................................................7-8


How to Scroll through the Memories ...............................................7-9
Exam Review.......................................................................................7-9
System Shut Down ..............................................................................7-9
Error Messages ..................................................................................7-10
Power Supply Error Messages........................................................7-10

8 eTouch Key........................................................................................8-1
Keys Sequence.....................................................................................8-1
Configuration Menu ............................................................................8-1
How to Create a Customized Touchscreen..........................................8-2
Customized Touchscreen Organization...............................................8-3

9 MyLab Settings..................................................................................9-1
Settings Organization ..........................................................................9-1
How to Use MyLab Settings ...............................................................9-2

10 MyLab Clinical Settings .................................................................. 10-1


Definition of Clinical Settings...........................................................10-1
How to Create Clinical Settings ........................................................10-1
How to Rename or Delete Clinical Settings......................................10-3
Factory Clinical Settings ...................................................................10-3

11 System Maintenance........................................................................ 11-1


Inspecting the System........................................................................11-1
Cleaning of System and Peripheral Devices......................................11-1

12 Technical Specifications.................................................................. 12-1


MyLab Characteristics.......................................................................12-1
MyLab Technical Characteristics......................................................12-3
Display............................................................................................12-3
Probe connectors.............................................................................12-3
Video Output ..................................................................................12-3
Connectivity....................................................................................12-3
Image Files......................................................................................12-4
Software..........................................................................................12-4
Biometry .........................................................................................12-4
Keyboard.........................................................................................12-4
Power Cables ..................................................................................12-5
Dimensions .....................................................................................12-6
Weight.............................................................................................12-6
AC/DC Adapter ..............................................................................12-6
Batteries ..........................................................................................12-6
Operating Requirements .................................................................12-6

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MyLab - G E T T I N G S T A R T E D

Storage requirements ......................................................................12-7


Standards ...........................................................................................12-7
Probe..................................................................................................12-8
Storage Requirements .....................................................................12-8
Trolley Technical Characteristics......................................................12-8
Dimensions .....................................................................................12-8
Weight.............................................................................................12-9
Fold-Away Trolley Technical Characteristics...................................12-9
Dimensions .....................................................................................12-9
Weight.............................................................................................12-9

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Chapter

1 - General Information

GETTING STARTED
User's Kit
MyLab is equipped with licenses, and the “Product Documentation” disk.

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.

“Product Documentation” Disk

This disk contains, in digital format, all manuals supplied with the system. The
manuals are available in the languages that can be set on the system.

Note
The “System Data” document, containing information on Acoustic
Output data and transducers surface temperatures, is included in
the “Product Documentation” disk.

MyLab Manuals
MyLab systems are equipped with two manuals, called “Operator Manual” and
“Advanced Operations”. These manuals refer to MyLab products, indicated as
MyLab within the manuals.

Note
The manuals describe all operations to be performed for a proper
and safe use of MyLab systems. Any system malfunction caused by
incorrect operations is considered as falling under the user’s
responsibility.

MyLab manuals are written for operators who have been trained on basic
ultrasound principles and techniques.

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Read and understand all instructions contained in MyLab manuals before using the
system. Always keep the manuals with the system.

Operator Manual

The “Operator Manual” consists of following sections:

Getting Started
 GS This section describes how to install the system and provides the main instructions
for using it.

Probes and Consumables


 PC This section describes cleaning, disinfecting and maintenance procedures for the
probes and related accessories. Information is also supplied on admitted
consumables.

Safety and Standards


 SS This section contains information about the patient's and operator's safety. The
system's conformity standards are also indicated.

Advanced Operations Manual

 AO This symbol is used to indicate the “Advanced Operations” manual. The standard
configuration of this manual includes the following sections:

 Image Optimization and Annotations,

 Calculations,

 Archive,

 Clinical and System Settings.

All other sections can be ordered using the specific part numbers.

System Data

Data on probes temperatures and acoustic output for each probe and mode of
operation are included in the “System Data” manual, included in the “Product
Documentation” disk.

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Probes - Cleaning, Disinfection, Sterilization

The manual lists the recommended cleaning, disinfection and sterilization agents
for MyLab probes and needle guides. Information is also supplied on
manufacturers of the recommended agents.

GETTING STARTED
Manufacturer’s Address
Esaote S.p.A.
Via Enrico Melen, 77
16152 Genova
Italy

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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.

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Product Life Cycle


Life Time

The safety and efficiency of MyLab ultrasound systems are guaranteed for at least

GETTING STARTED
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.

Maintainability Time

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

End-of-Life Disposal

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 plate 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.

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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


labeled 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.

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MyLab - G E T T I N G S T A R T E D

GETTING STARTED

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GETTING STARTED

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MyLab - G E T T I N G S T A R T E D

Usage License Agreement for the Software


Included in the Apparatus
Attention

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 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.

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.

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MyLab - G E T T I N G S T A R T E D

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.

GETTING STARTED
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.

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Product Traceability
To guarantee the product traceability according to what stated by the quality
standard ISO13485 and by the European Directive on Medical Devices 93/42/
EEC, Esaote kindly requests the original owner of the equipment to give
communication to our central plants, or to one of our subsidiaries, or to one of our
official distributors of any eventual conveyance of the product property. Please use
a duly filled copy of the form reported below or send us a communication
reporting the same data indicated in this form. All data relating to the system can
be found on its identification label.

PRODUCT TRACEABILITY FORM

To: ESAOTE S.p.A.


Quality Assurance Department
Via Enrico Melen, 77
16152 Genova

Esaote system/device name:

......................................................................................................................................................

REF:

......................................................................................................................................................

Serial Number (SN):

......................................................................................................................................................

Name and address of the new owner:

......................................................................................................................................................

......................................................................................................................................................

Date:

Signature

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Vigilance System
This equipment is subject to Esaote vigilance system (post-marketing vigilance) 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

GETTING STARTED
with the best efficiency and timing.

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.

POST-MARKETING VIGILANCE FORM

To: ESAOTE S.p.A.


Quality Assurance Department
Via Enrico Melen, 77
16152 Genova

E-mail: [email protected]

ESAOTE system/device name:

......................................................................................................................................................

REF:

......................................................................................................................................................

SN:

......................................................................................................................................................

Description of the hazard:

......................................................................................................................................................

......................................................................................................................................................

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MyLab - G E T T I N G S T A R T E D

Notes and suggestions:

......................................................................................................................................................

......................................................................................................................................................

Contact Person/Department:

......................................................................................................................................................

Address:

......................................................................................................................................................

Phone:.......................................................... Fax:................................................................

Date:

Signature

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Important Information
MyLab complies with the Medical Device Directive 93/42/EEC and subsequent
amendments and is CE marked.

GETTING STARTED
MyLab is a device in Class IIa according to the Medical Device Directive.

MyLab complies with the Radio Equipment Directive (RED) and is CE


marked.

MyLab s a device in Class 2 according to RED Directive.

For US Customers: US Federal Law restricts this device to sale, distribution and
use by or on the order of a physician.

The list of countries (code ISO 3166 has been used) in which the system is
intended to be sold is contained in the following table.

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MyLab - G E T T I N G S T A R T E D
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 a lithium battery. The auxiliary battery pack contains lithium-
ion batteries. The fluorescent lamp included in the LCD screen contains mercury.
The batteries, the LCD screens and the AC/DC adapter 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.

Transport Safety
In the mobile configuration all the system wheels are equipped with brakes, which
can be activated individually.

WARNING Do not park the system on a slope.

Do not use the brakes to park the machine on a


slope.

If your system is equipped with peripherals,


make sure that they are safely attached using
locking belts; for transportation in a vehicle, it is
strongly recommended to remove the
peripheral(s) and follow the device
manufacturer guidelines.

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MyLab - G E T T I N G S T A R T E D

Electromagnetic Compatibility
This system was designed for use in the electromagnetic environments declared in
the tables below, in compliance with standard IEC 60601-1-2:2014 (4th edition).
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

This MyLab uses RF energy only for its internal


RF emissions function. Therefore, the RF emission is very low
Group 1
CISPR 11 and not likely to cause any interference in nearby
electronic equipment.

RF emissions MyLab is suitable for use in all establishments,


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

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MyLab - G E T T I N G S T A R T E D

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

GETTING STARTED
verify that they are operating normally.

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.

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 can-
not be attributed to a physiological effect and which may alter
the diagnosis.

 Free from the display of incorrect numerical values associ-


ated with the diagnosis to be performed.

 Free from the production of unintended or excessive ultra-


sound output.

 Free from the production of unintended or excessive


TRANSDUCER ASSEMBLY surface temperature.

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MyLab - G E T T I N G S T A R T E D

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.

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MyLab - G E T T I N G S T A R T E D

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 and


Immunity Test

GETTING STARTED
Test Level Level Guidance

 kV on  kV on The floor should be in wood, concrete


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

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

1 kV 1 kV
differential differential
mode mode Mains power quality should be that of a
Surge
typical commercial or hospital
IEC 61000-4-5
2 kV 2 kV environment.
common common
mode mode

0% UT; 0,5 0% UT; 0,5


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

Single phase: Single phase:


at 0° at 0°

Mains power quality should be that of a


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

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MyLab - G E T T I N G S T A R T E D

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 and


Immunity Test
Test Level Level Guidance

Power frequency Power frequency magnetic fields should


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

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

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MyLab - G E T T I N G S T A R T E D

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.

IEC60601 Complianc Electromagnetic Environment


Immunity Test

GETTING STARTED
Test Level e Level and Measures to Be Taken

3V 3V
0.15-80 MHz 0.15-80 MHz
Mobile or portable radio frequency (RF)
6 V in ISM 6 V in ISM communication equipment should be used no
band band closer to any part of the MyLab system,
Conducted RF including cables.
between between
IEC 61000-4-6
0.15 MHz 0.15 MHz
and 80 MHz and 80 MHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
surveya, should be less than the compliance
80% AM at 80% AM at level in each frequency rangeb.
1 kHz 1 kHz Interference may occur in the vicinity of
equipment marked with the following
3 V/m 3 V/m symbol:
80 MHz - 80 MHz -
Radiated RF 2.7 GHz 2.7 GHz
IEC 61000-4-3
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.

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

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MyLab - G E T T I N G S T A R T E D

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, arte-


facts, 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 inaccu-


rate numerical values associated with the diagnosis to be per-
formed;

 the disturbance shall not produce an error displaying inaccu-


rate 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 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.

Wireless Requirements
MyLab is equipped with built-in wireless capability. The led placed on the right side
of the control panel indicates the wireless status: either blue when wireless
connection has been activated or completely off.

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MyLab - G E T T I N G S T A R T E D

GETTING STARTED
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 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.

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MyLab - G E T T I N G S T A R T E D

Device Labels
 SS The following table lists specific labels that are used on the equipment and its
options. Refer to the “Safety and Standards” manual for the list of all the other
labels.

Symbol Explanation

General prohibition

No pushing from the side

No sitting

Audio Input on Multiconnector

2 - 10
3
MyLab - G E T T I N G S T A R T E D
Chapter

3 - Clinical Applications

GETTING STARTED
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.

Intended Use
MyLabGamma is a compact ultrasound system used to perform diagnostic general
ultrasound studies including Cardiac, Transesophageal Cardiac, Peripheral
Vascular, Neonatal Cephalic, Adult Cephalic, Small Organ, Musculoskeletal
(Conventional and Superficial), Abdominal, Fetal, Transvaginal, Transrectal,
Pediatric, Intaoperative (Abdominal), Laparoscopic and Other: Urologic.

The equipment provides imaging for guidance of biopsy and imaging to assist in
the placement of needles in vascular or other anatomical structures as well as
peripheral nerve blocks in Musculoskeletal applications.

Clinical Applications
In the complete configuration, MyLab systems offer several intended uses.
 SS
Carefully read “Safety Note
and Standards”
manual. The operator must always follow the principle known as ALARA
(As Low As Reasonably Achievable) and must use minimum
acoustic power for the minimum time compatible with obtaining
diagnostic information.

WARNING Do not use MyLab for ophthalmic or transorbital applications.

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MyLab - G E T T I N G S T A R T E D

The ultrasound beam must not be directed to the eyes.

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 models can be configured with one or more of the following applications:

Licence Notes

Cardiac Adult and Pediatric Cardiac applications.

General Imaging Includes Abdominal, Musculo-skeletal,


Neonatal Cephalic, Pediatric, Small Organ and
Urology applications; includes transvaginal and
transrectal exams if an endocavity probe is available.

Ob-Gyn Includes Gynaecology and Obstetrics-Fetal;


includes transvaginal exams if an endocavity probe
is available.

Vascular Includes Peripheral Vascular and Adult Cephalic


applications.

MyLab models are intended to be connected to mechanical and electronic


ultrasound transducers.

Convex Array Probes

Probe Application

Abdominal
Cardiac
Gynaecological
AC2541 Obstetrical and Fetal
Musculo-skeletal a
Peripheral Vascular
Urology

Abdominal
Gynaecological
Obstetrical and Fetal
SC3421
Musculo-skeletal a
Peripheral Vascular
Urology

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MyLab - G E T T I N G S T A R T E D

Probe Application

Abdominal
Cardiac (adult and pediatric)
SC3123 Pediatric
Peripheral Vascular

GETTING STARTED
Small Organb

Abdominal
Gynaecological
Musculo-skeletal a
Obstetrical and Fetal
SI2C41
Pediatric
Peripheral Vascular
Small Organb
Urology
a. Superficial and Conventional Musculo-
skeletal. It includes nerve block.
b. Includes Thyroid, Testicles and Breast

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MyLab - G E T T I N G S T A R T E D

Linear Array Probes

Probe Application

Abdominal
Cardiac (adult)
Gynecology
AL2442 Musculo-skeletala
Obstetrical and Fetal
Pediatric
Peripheral Vascular
Small Organb

Abdominal
Cardiac (adult and pediatric)
Gynecology
Musculo-skeletalc
SL3332
Obstetrical and Fetal
Pediatric
Peripheral Vascular
Small Organd

Abdominal
Cardiac (pediatric)
Gynecology
Musculo-skeletala
L3-11
Obstetrical and Fetal
Pediatric
Peripheral Vascular
Small Organb

Abdominal
Cardiac (adult and pediatric)
SL1543 Musculo-skeletala
SL3323 Pediatric
Peripheral Vascular
Small Organb

Musculo-skeletal a
SL3116
Pediatric
SL2325
SL3235 Small Organ b
Peripheral Vascular
a. Superficial and Conventional Musculo-
skeletal. It includes nerve block.
b. Includes Thyroid, Testicles and Breast
c. Superficial and Conventional Musculo-
skeletal. It includes nerve block.
d. Includes Thyroid, Testicles and Breast

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MyLab - G E T T I N G S T A R T E D

Phased Array Probes

Probe Application

Abdomen

GETTING STARTED
Adult Cephalic
Cardiac (adult and pediatric)
SP2730
Neonatal Cephalic
Obstetrical and Fetal
Peripheral Vascular

Doppler Probes

Probe Application

Cardiac (adult and pediatric)


S2MCW
Peripheral Vascular

S5MCW Peripheral Vascular

SHFCW Peripheral Vascular

Specialty Probes

Bi-Scan Probes
BiScan probes enable volumetric acquisition.

Probe Application

Abdominal
SB2C41 Gynaecological
Obstetrical and Fetal

Gynaecological
Obstetrical and Fetal
SB3123 Transrectal
Transvaginal
Urology

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MyLab - G E T T I N G S T A R T E D

Endocavity Probes

Probe Application

Gynaecological
Obstetrical and Fetal
SE3123 Transrectal
Transvaginal
Urology

Gynaecological
Obstetrical and Fetal
SE3133 Transrectal
Transvaginal
Urology

Gynaecological
TLC3-13 Transrectal
Urology

Intraoperative and Laparoscopic Probes

Probe Application

Abdominal
Gynaecological
Obstetrical and Fetal
Intraoperative (abdominal)
IH6-18 Musculo-skeletala
Pediatric
Small Organb
Peripheral Vascular
Urology

Abdominal
Intraoperative (abdominal)
Musculo-skeletala
IL4-13
Pediatric
Small Organb
Peripheral Vascular

Laparoscopic (Abdominal)
LP4-13
Laparoscopic
a. Superficial and Conventional Musculo-
skeletal
b. Includes Thyroid, Testicles and Breast

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MyLab - G E T T I N G S T A R T E D

Transesophageal Probe

Probe Application

Cardiac (adult)
ST2612

GETTING STARTED
Transesophageal

WARNING Do not use MyLab for ophthalmic or transorbital applications.

The ultrasound beam must not be directed to the eyes.

Note
Probe availability is dependent on your system configuration and
application. Not all probes and applications are approved in all
Countries, please refer to your Esaote local representative for
further information.

Abdominal and Related Applications

The probe applies ultrasound energy through the patient abdomen to obtain an
image of the abdominal organs to detect abnormalities (Imaging) and assess blood
velocity, flow and patency of abdominal vessels through the Doppler modalities.

Adult Cephalic

The probe applies ultrasound energy through the skull in order to visualize cerebral
vessels and flows, to detect functional abnormalities.

WARNING This application does not include transorbital or any other ophthalmic
application.

The ultrasound beam must not be directed to the eyes.

Cardiac Applications

The probe applies ultrasound energy through the thoracic cavity to obtain an image
of the heart sufficient for evaluating any cardiac abnormalities. In Doppler modes,
the probe applies energy through the thoracic cavity to determine the velocity and
direction of blood in the heart and vessels.

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MyLab - G E T T I N G S T A R T E D

The heart can also be studied through the esophagus and/or transgastrically with
a transesophageal probe.

Gynecologic Application

Ultrasound energy is applied through the skin to image the female genito-urinary
organs and evaluate (Doppler) blood velocity, flow and patency of vessels. An
endocavity probe can also be used to image the same organs in endovaginal exams
(transvaginal application).

Intraoperative and Laparoscopic Applications

The probe, in direct contact with the structures under exam during surgical
operations, allows to identify surgical lesions, blood vessels and eventual
anatomical abnormalities and technical imperfections.

WARNING Do not use intraoperative probes in direct contact with the heart, the
central circulatory system and the central nervous system.

Musculo-Skeletal

The probe applies ultrasound energy through the skin to obtain an image of
tendons, ligaments and muscles and to determine blood flow patterns and
velocities.

The probe can be used to provide ultrasound guidance in biopsy procedure to


assist placements of the needles in vascular and anatomical structures as well as
peripheral nerve blocks.

Obstetrical and Fetal Applications

The probe applies ultrasound energy through a pregnant woman’s abdomen to


obtain an image of the fetus to detect structural abnormalities or to visualize and
measure anatomic and physiologic parameters of the fetus for the purpose of
assessing fetal growth. In Doppler modes, the probe applies energy through the
patient abdomen to detect placental or fetal flow abnormalities. An endocavity
probe can also be used for the same purposes (endovaginal studies).

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MyLab - G E T T I N G S T A R T E D

 SS
Carefully read Chapter 2 of the "Safety and Standards" manual.

Carefully read “Safety Note


and Standards”
manual The operator must always follow the principle known as ALARA
(As Low As Reasonably Achievable) and, in particular with this

GETTING STARTED
application, must use minimum acoustic power for the minimum
time compatible with obtaining diagnostic information.

Pediatric and Neonatal Head Applications

The probe applies ultrasound energy through the skin in order to obtain images
and evaluate flows in pediatric and neonatal exams. In the latter case, the probe
applies ultrasound energy through the fontanel in order to visualize cerebral
structures (imaging) and flows (Doppler) to detect structural and functional
abnormalities.

 SS
Carefully read Chapter 2 of the "Safety and Standards" manual.

Carefully read “Safety Note


and Standards”
manual The operator must always follow the principle known as ALARA
(As Low As Reasonably Achievable) and, in particular with this
application, must use minimum acoustic power for the minimum
time compatible with obtaining diagnostic information.

WARNING This application does not include transorbital or any other ophthalmic
application.

The ultrasound beam must not be directed to the eyes.

Small Organ and Small Part Applications

The probe applies ultrasound energy through the skin to obtain an image or a
Doppler flow visualization of small organs such as thyroid (neck), testicles (scrotal
sac) and breast (breast).

Peripheral Vascular Applications

The probe applies ultrasound energy through the neck or the limbs of a patient in
order to obtain an image of the carotid artery or of other peripheral vessels. These
images show the possible presence of abnormalities or obstructions of the vessels.
In Doppler modes, the probe applies ultrasound energy through the neck or the

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MyLab - G E T T I N G S T A R T E D

hands/feet of a patient in order to evaluate blood velocity, flow or lack of flow, and
the perviousness of the peripheral vessels.

 SS
Carefully read Chapter 2 of the "Safety and Standards" manual.

Carefully read “Safety Note


and Standards”
manual The operator must always follow the principle known as ALARA
(As Low As Reasonably Achievable) and, in particular with this
application, must use minimum acoustic power for the minimum
time compatible with obtaining diagnostic information.

WARNING This does not include transcranial, transorbital or any other ophtalmic
application.

The ultrasound beam must not be directed to the eyes.

Urologic Application

Ultrasound energy is applied through the skin to image the male genito-urinary
organs (for example prostate, bladder) and to detect structural and functional
abnormalities. An endocavity probe can also be used to image the same organs in
transrectal exams (transrectal application).

3 - 10
4
MyLab - G E T T I N G S T A R T E D
Chapter

4 - System Components and

GETTING STARTED
Installation
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. This chapter provides an overview of the system
components and the major operations that may be necessary.

System Overview
MyLab has a built-in LCD screen: in this way, the system can be used as portable
configuration. MyLab can be supplied with a trolley in its mobile configuration.

Portable Configuration

The console contains: the electronics, the control


panel with speakers, the probe connectors (on the
right), the input/output connectors for the ECG,
the network and the peripherals and the security
lock connector.

The ON/OFF button is located on the upper left


part of the control panel; the batteries status led is
located on the lower right side of the control
panel.

The LCD safety push-buttons are laterally located. The LCD can be 90° rotated on
both sides.

CAUTION While rotating the LCD avoid any tilting movement on vertical axis.

The console is equipped with an handle located in the bottom side that can be used
both to move the system and as sloping support in working conditions.

The system is equipped with an external AC/DC adapter and, as an option, with
internal batteries.

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MyLab - G E T T I N G S T A R T E D

Accessories for Outdoor Transport


MyLab Shell Body and Fold-away Trolley
MyLab and its AC/DC adapter can be
housed on a shell body, that is equipped
with a rucksack and optional straps.

The instructions for the installation are


provided with the house shell.

Fold-away trolley When MyLab is housed in the shell body can


be installed on the fold-away trolley. The
configuration’s compact size and light weight
make it possible to move the MyLab very
easily.

The instructions for the installation are


provided with the fold away trolley.

CAUTION Before using the system carefully clean it and the fold-away trolley after they
have been transported outdoor.

Mobile Configuration

A height-adjustable trolley is available to set MyLab in a mobile configuration.

Note
The trolley is not equipped with insulation transformer.

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MyLab - G E T T I N G S T A R T E D

The trolley provides a handle and independent


brakes on four wheels to be easily moved.

The trolley is equipped with an internal


compartment to house and connect the AC/DC

GETTING STARTED
adapter and an optional mains filter.

It has a compartment for additional accessories.

The trolley can house an external peripheral to be


placed on the dedicated tray.

Peripheral

Note
When selecting the peripheral, consider its dimension so that it can
be safely installed on the console. The shelf measures 33x17 cm.

CAUTION The peripheral weight may not exceed 3 kg. The shelf could be damaged if
the peripheral weight exceeds this limit.

CAUTION The weight in the compartment for additional accessories may not exceed
3 kg. The compartment could be damaged if the weight exceeds this limit.

CAUTION The max. weight of the trolley is 63.5 kg. (including all options).

The base of the trolley offers the possibility to mount an optional UPS
(uninterruptible power supply) or an optional insulation transformer.
CAUTION Do not use the optional UPS in combination with the optional insulation
transformer or vice versa.

 SS The “Safety and Standards” manual provides the safety requirements and
standards to be observed for using peripherals devices with MyLab.

4-3
MyLab - G E T T I N G S T A R T E D

Installation
Portable Configuration

Identifying the Connectors


Probe Connectors Two probes connectors (EA1÷EA2) are located on the right side of the system.

ECG Connector The ECG cable connector is placed on the right side, beside the probe connectors.

Connector Symbol

ECG Connector

System left side

Connector Symbol

USB Port

Headphones

Microphone
(not currently used)

RJ45

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MyLab - G E T T I N G S T A R T E D

Connector Symbol

Security Lock

GETTING STARTED
USB Ports Four USB ports are located on the left side of the system. These ports can be used
to connect a USB device for digital storage, a USB footswitch or a USB printer.

LAN Connector The LAN connector is placed on the left side.

Security Lock This connector is placed on the left side and provides protection for the portable
Connector configuration.

System rear side

Connector Symbol

HDMI type

28 Pins Connector
(not currently used)

Mains Socket

Mains Socket The mains socket is located on the rear side of the system. Connect the AC/DC
adapter to the mains socket.

If the system is equipped with the AC/DC adapter, Esaote P/N 151004300 (see
label on the AC/DC adapter):

WARNING Use only the AC/DC adapter provided by Esaote with the MyLab.

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MyLab - G E T T I N G S T A R T E D

If the system is equipped with the AC/DC adapter, Esaote P/N 151004301 (see
label on the AC/DC adapter):

WARNING Use only the XP Power AC/DC adapter, type AHM180PS19-XE1057,


provided by Esaote with the MyLab.

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.

HDMI Type Output MyLab can be connected to an auxiliary monitor. Any auxiliary monitor
connected to this port has not to be used for diagnostic purposes.

Note
The resolution of the auxiliary monitor can not be lower of the
main display. The system automatically shuts down whenever a
lower resolution is detected.

Connect the monitor's cable to the connector of the rear panel.

Installing the Portable Configuration


Refer further in this chapter Place the MyLab on the work surface using the handle as sloping support. Position
for information on probe the equipment so that the power outlet is easily accessible. Connect the power
connection. cable to the system socket. Plug the cable to the reliable grounding power outlet to
assure adequate grounding.

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

Press the LCD's safety push-buttons to open the screen and rotate it into its
working position. Connect the probes and all accessories.

Mobile Configuration

Installing the Console


Refer further in this chapter Place the console on the top surface of the trolley, allowing it to slide to the bottom,
for information on probe so that the profiles of the base match the housings. Secure the console to the
connection. trolley, screwing on the captive screw located under the top surface.

WARNING Make sure that the captive screw is completely screwed. If it is not secured
correctly, MyLab could come out of the housings and drop down.

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MyLab - G E T T I N G S T A R T E D

Probes, Gel and Insert the holders on the trolley lateral stirrups and place them in the desired
Cable Holders position.

Follow the instruction provided with the trolley to install the AC/DC adapter.

GETTING STARTED
Connect the cable, located at the top of the trolley column, to MyLab mains socket.

WARNING Do not use the lateral stirrups to push the system.

Installation at Working Site


At the examination site, position the equipment so that the power outlet is easily
accessible.

Adjust the system into its final position and then lock them to fix the position.

This assembly can be pushed up/down to maximize operator comfort.

A pedal is placed in central position of the


trolley base.

Push the pedal and act on the handle to adjust


the height of the control panel. This lever
allows a vertical displacement of 23 cm.

Rotate the LCD into its working position. Connect the probes and all accessories.

Plug the power cable into the reliable grounding power outlet to assure adequate
grounding.

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

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.

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MyLab - G E T T I N G S T A R T E D

Turning the System On

Once the installation has been completed, MyLab is ready to be powered up. Press
the ON/OFF key to turn the system on.

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.

Probes Connections

Both imaging and Doppler probes can be connected to the two (2) connectors,
indicated by symbols EA1 and EA2.

Connector-securing devices are placed


beside the probe connectors.

Make sure that the securing device is


positioned in the lower position (open
position) and carefully attach the probe
connector by placing the cable feedthrough frontwards. To secure the probe,
move the securing device up.

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

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

CAUTION Make sure to correctly align the probe connector before inserting it. Close
the securing device only after the complete insertion of the connector.

Battery
Refer to the next chapters MyLab can be equipped with an internal battery pack, composed of two batteries,
for further information on that allows the system both to work when no mains power is available and to
battery using and partially shut down the system, leaving it in stand-by.
functioning.
Note
The battery pack is installed by Esaote personnel. This person will
be responsible for its installation and for ensuring that the system is
working properly.

4-8
MyLab - G E T T I N G S T A R T E D

A fully charges battery ensures more than one hour of scanning.

CAUTION When MyLab is equipped with its internal battery, do not leave the system
exposed to direct sunlight.

GETTING STARTED
If some smell is noticed coming from a MyLab equipped with its internal
battery, stop using it immediately and contact Esaote personnel.

When the system is connected to the power mains and the main switch is on ON,
the battery is continuously charged, even if MyLab is switched off. On the other
hand, the battery discharges whenever the system is disconnected from the power
mains.

When the charging level of the battery reaches the minimum threshold needed for
working, the icon is contoured by a blinking frame and the residual time is
displayed beside. Either connect the system to the mains power or switch the
system off. MyLab automatically switches itself off when the residual operating time
is expired.

 AO The battery mode of operation has to be set: refer to section “Clinical and System
Settings” of the “Advanced Operations” manual for further information.

Battery Status Led

The battery led is located on the right corner of the control panel.

Its color indicates the status of the battery: when the led is lighted, at least one
battery is being charged.

The best method for charging the battery is to connect the system to the power
mains while keeping it switched off. In these conditions the charging cycle lasts
around four and a quarter hours (4.15 h).

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MyLab - G E T T I N G S T A R T E D

During the charging procedure the battery led is orange: the procedure is
completed when the battery led switches off.

A system which has not been used for a month needs to be charged before using
it with the battery.

CAUTION Charge and discharge the battery only when the environment temperature
is between 15°C and 30°C.

The battery pack is not charged when overheating.

When the battery reaches the maximum temperature threshold for its working
condition, a red cross is displayed over the battery icon.

When this occurs, disconnect the power cable and wait for about two (2) hours
before connecting the power cable again, so that the battery cools down.

Blinking of the battery led When the battery can’t be charged, the led starts blinking.

First Use

A new battery pack might be partially discharged: before using it for the first time,
perform one full charging procedure.

Battery Lifetime

The battery lifetime is limited and varies according to circumstances. In normal


conditions battery pack lasts three years. Esaote recommends to replace the
battery pack every three years.

Note
The battery pack has to be replaced by Esaote personnel. This
person will be responsible for ensuring that the system is working
properly.

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:

T(C°) 60 55 50 45 40 35÷15 10

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MyLab - G E T T I N G S T A R T E D

Hours 8 6 4 2 1 0 1

T(C°) 5 0 -5 -10 -15 -20

Hours 2 4 6 8 10 12

GETTING STARTED
Peripheral and Network Connections
 SS The “Safety and Standards” manual provides the safety requirements and
standards to be observed for using peripherals devices with MyLab.

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

Special care has to be taken, if the device is connected to a computer network (e.g.,
Ethernet).

When connecting MyLab to a local area network (LAN) via the Ethernet
connection, the LAN components have to be IEC 60950 compliant.

Because other devices could be connected without any control, an isolated signal
link has to be used to operate the system safely, in compliance with IEC60601 incl.
national deviations.

For computer networks there are media converters available which convert the
electrical signals to optical signals. Please consider that this converter has to comply
with IEC XXX1 standards and is battery operated or connected to the isolated
mains output of the MyLab.

MyLab can be connected to USB printers via a USB Port. To correctly power the
peripherals, follow the manufacturer's instructions.

When the peripheral is installed on the trolley, always secure the peripheral by
closing the belt.

WARNING The maximum current supplied by the MyLab USB ports is 500 mA.
Peripherals exceeding this limit can be connected only if powered by their
external power supply.

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

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MyLab - G E T T I N G S T A R T E D

How to safely connect 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.

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
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

MyLabGamma is not equipped with an insulation transformer to provide required


separation from AC mains for both the system and the auxiliary devices.

Additional equipment connected to MyLab must comply with respective IEC or


ISO standards (e.g. IEC 60950 for data processing equipment). 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 complies

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MyLab - G E T T I N G S T A R T E D

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

Medical environments

GETTING STARTED
Based on IEC60601 three different conditions can be defined for patient
environment:

A) Patient area

B) Medical Use Room

Intended as area B, area A excluded.

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MyLab - G E T T I N G S T A R T E D

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 (com-


plying to IEC XXX1) in area A
- Auxiliary device must be powered through a safety insula-
tion transformer complying to IEC 60601.

 MyLab + auxiliary device not complying to IEC 60601 (com-


plying 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 insula-
tion transformer complying to IEC 60601.

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

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MyLab - G E T T I N G S T A R T E D

Note
Auxiliary Devices must be approved by Esaote. Auxiliary Devices
must also comply with EN 60601-1-2 safety standard and

GETTING STARTED
subsequent amendments or the electromagnetic compatibility.

Additional safety measures are:

 Additional protective earth connection between the two


devices, or a safety insulation mains transformer for the aux-
iliary device

 Do not connect a multiple-socket outlet or extension cord to


MyLab.

 Avoid touching the patient and the auxiliary device


simultaneously.

Additionally the IEC 60601 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.

Auxiliary Monitor

Any auxiliary monitor connected to HDMI type port has not to be used for
diagnostic purposes.

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

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MyLab - G E T T I N G S T A R T E D

Monitor Connection Connect the monitor cable to the connector of the rear panel.

Moving and Transporting the System


Portable Disconnect all probes, peripherals and the AC/DC adapter. Close the LCD screen
Configuration being sure that the safety push-buttons are closed.

Always use the handle to move the system.

Mobile MyLab is provided with wheels and handle to allow the user to easily move the
Configuration system. The following precautions must be observed:

Moving the system  Switch the system off and unplug the power supply, wrapping
its cable on the handle to ensure it.

 Close the LCD display being sure that the safety push-
buttons are closed.

 If probes are connected, be sure that they are properly


secured and that their cables do not reach the floor, securing
them on the hooks.

 Peripheral can be placed on the MyLab peripheral platform,


provided that it is secured with the locking strips.

 If peripherals are placed on an external additional platform,


be sure they are disconnected from MyLab before moving the
ultrasound system.

 Be sure that the brakes are unlocked before moving the


system.

 Avoid any unnecessary mechanical shock to the system while


moving it.

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

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

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

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

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MyLab - G E T T I N G S T A R T E D

Do not park the system on a slope.

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

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

 Disconnect and remove all probes and peripheral devices.

 Close the LCD display being sure that the safety push-
buttons are closed.

 Use the brakes to lock the system.

 Fasten securely the system inside the vehicle.

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MyLab - G E T T I N G S T A R T E D

4 - 18
5
MyLab - G E T T I N G S T A R T E D
Chapter

5 - Control Panel

GETTING STARTED
This chapter provides a brief description of the system controls.

The Control Panel

The Control panel consists of touchscreen, general controls (for example TGC,
ON/OFF switch), and controls section.

Loudspeakers are placed on the left and right upper corners of the panel.

Touchscreen Section
This section includes the TGC controls, the ON/OFF switch and the MENU key.

Touchscreen

The touchscreen displays exam controls related to the active modality. Press the
displayed key to activate/deactivate the corresponding control.

The touchscreen works in different modalities:

 as Exam panel, providing control keys to perform the exam,

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MyLab - G E T T I N G S T A R T E D

 As Multipurpose panel, providing software buttons to use


advanced exam controls,

 As Alphanumeric keyboard to enter data.

The touchscreen lay-out depends on the working modality.

Exam Panel Layout


The touchscreen is organized in three main areas, as shown in the figure below:

Navigation Area The upper bar of the touchscreen contains the Navigation tabs. These allow to
select the desired features for the relevant controls, e.g. which controls will be
available for each active mode (B-Mode, CFM.). To select the desired mode, press
the corresponding tab on the touchscreen.

The Navigation tabs are indicated in the operator manuals with this FO N T SIZE.

Exam Management This area of the touchscreen displays the buttons for the exam management, that
Area is the buttons allowing to start the exam, to change the probe or the preset etc. To
activate the desired function, press the corresponding button on the touchscreen.

Exam Management buttons are indicated in the operator manuals with this FO N T.

If the displayed menu has several levels, press the button ADV>>/BASIC<< to scroll
through all functions.

Image Parameters This area contains the exam functions and controls, varying according to the active
Area mode, applications and settings.

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MyLab - G E T T I N G S T A R T E D

Buttons The buttons have different colors depending on the active status:

Selected/Pressed
Disabled Button Active Button
Button

GETTING STARTED
Dark gray Dark blue Light blue

If the button is active, the displayed function will be enabled when pressing the
corresponding key on the touchscreen.

Button with sub-menus Touchscreen buttons showing a frame have a dedicated sub-
menu: press the button to display the sub-menu allowing to
optimize the function.

Toggles On the bottom of the touchscreen there are six levers (or toggles) which act on the
functions displayed just above.

Each lever can control two functions, displayed on the area above. The functions
depend on the active modality.

The lever acts on the active control, displayed in the upper position. Press up or
down the lever to change the control value.

To switch to the other displayed function, press the corresponding button on the
touchscreen: the lever will act now on the other control.
Furthermore each toggle can be associated to the EKNOB key of the control panel:
in this case the knob around this key acts as the associated toggle on the active
function.

The EKNOB key can be associated to more touchscreen buttons: to change the
associated toggle press the EKNOB key.

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MyLab - G E T T I N G S T A R T E D

This symbol is displayed to each touchscreen button that is correlated to the


EKNOB key. The symbol is displayed in bright orange when the knob around the
EKNOB key acts on the active function; it is displayed in grey on the other case.

Both image parameter buttons and toggles are indicated in the operator manuals
with this F O N T .

If the displayed menu has several levels, press key A D V > > / B A S I C < < to scroll
through all functions.

Multipurpose Panel Layout


This layout is used for advanced exam functions, for example body marks or
annotations.

The touchscreen is organized in three main areas.

Annotation touchscreen

The upper bar of the touchscreen contains the Navigation tabs of the selected
functions (for example the glossary library tabs in the Annotation modality). Like
the Exam layout, Navigation tabs are indicated in the operator manuals with this
FO N T SIZE.

The right column contains general controls of the active modality (for example
“DELETE ALL” in the Annotation modality) These buttons are indicated in the
operator manuals with this FO N T SIZE.

The remaining area contains more specific controls (like the list of available words/
sentences in the active application glossary in the Annotation modality). These
buttons and knobs are indicated in the operator manuals by this F O N T S I Z E .

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Alphanumeric Keyboard Layout


A dedicated button displayed on the upper right side activates the emulation of the
Qwerty alphanumeric keyboard.

GETTING STARTED
Press the Qwerty icon to display the keyboard. Press the Qwerty icon again to close
the keyboard.

TGC Potentiometers

See also the The TGC potentiometers control signal amplification in individual areas of the
AUTOADJUST key image. Potentiometers are used to adjust the signal zone by zone.
function in the next pages.
ON/OFF Button

When MyLab is connected to the main, the led located on the right corner of the
control panel is lighted and the ON/OFF key switches the system on or off,
activating the closing session.

Optional Batteries When MyLab is equipped with optional batteries, the same button places the
system in stand-by partially shutting it down: in this case the initialization phase at
start up is significantly reduced.

Note
A complete shut down procedure is periodically and automatically
run to prevent misfunctioning: when this occurs MyLab displays an
information message. The following start up will require running
the whole initialization phase.

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MyLab - G E T T I N G S T A R T E D

 AO Refer to the “Clinical and System Settings” section for information on how to set
the mode of operation.

The table below explains the status of the ON/OFF button:

Led Colour Meaning

GREEN MyLab is on.

AMBER MyLab can be switched on.

OFF MyLab can not be switched on. In this case check


both the rear main switch and the main connection.

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.

Controls Section
Trackball

The trackball operates in two different modes.

Standard Mode In its standard function, the trackball makes it possible to quickly position the
cursors on the screen.

Each mode automatically activates the trackball on its cursor:

Mode Trackball

M-Mode, Doppler LINE cursor

Color Flow Mapping CFM Region of Interest (ROI)


(CFM) cursor

The cursor function is indicated on the left bottom side of the screen. When
several cursors are present on the screen, the ACTION key switches between the
active cursors.

Mouse Mode The trackball can then 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 keys placed on the left and right

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MyLab - G E T T I N G S T A R T E D

side of the trackball can be set as mouse keys (as confirmation and context menu
keys).

Regardless of the trackball configuration, the confirmation and context menu keys
are respectively indicated as ENTER and UNDO keys in this manual.

GETTING STARTED
The POINTER key makes it possible to change the trackball operation from
standard to mouse mode.

Exam Controls

Exam Flow
The START EXAM button can be pressed only once the desired probe, application
and preset have been selected. This button opens every exam activating real time.
During the exam, the PRO BE button allows to select a different probe, application
and preset.

Closing session
When the exam is finished, press the END EXAM key. It is then possible to archive
the patient's data and produce a report on the exam. The system clears the stored
data and shows the Exam Start menu again.

During the exam, the PATIEN T ID button allows to enter or to modify patient data.

The Mode Keys


The B key 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.

To activate/deactivate Color Doppler (CFM), press the CFM key in B- or M-Mode.

In B-Mode, a cursor delimits the Region of Interest (ROI) where color analysis is
performed and displayed. The ROI dimensions and position can be varied with the
trackball, after activating the ROI cursor with the ACTION key.

The touchscreen menu allows the operator to vary the displayed mode and to
switch to Power Color.

TVM Mode The touchscreen menu allows the operator to switch to Tissue Velocity Mapping
(TVM). This mode uses Doppler to display heart walls motions, rather than flows.
TVM is available with specific probes.
This key activates the M-Mode, and if necessary, its selection cursor (B-Line).
There are five possible viewing formats: the format with full screen M-Mode; the
dual format, with the screen split vertically with 2D on the left and trace on the

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MyLab - G E T T I N G S T A R T E D

right; the split formats, with the screen split horizontally, with the reference 2D
above (out of three possible dimensions) and the M-Mode trace below. The
viewing format can be preset and varied in real time through the displayed menu.
The PW key is used for activating the Pulsed Wave Doppler (PW), CW for
activating the Continuous Wave Doppler (CW); both keys activate the positioning
cursor if necessary. As in M-Mode, there are five viewing formats: the three split
formats, the dual format and the full screen format.

TV Mode In PW, the buttons on the touchscreen allows the operator to switch to Tissue
Velocity (TV) mode. TV sets Doppler filters to display the strong signals with low
motion such as the heart walls motion, rather than flow. TV mode is available with
specific probes.

During the exam, the format can be preset or varied interactively through the
menu.

In 2D or CFM, the cursor can be interactively activated or disabled to select the M-


Mode or Doppler line (taste LINE UPDATE). When a trace is active, the same key
freezes the trace acquisition and reactivates the 2D reference.
The AUTOADJUST keys, available both in B-Mode and Doppler, automatically
adjusts some controls of the active mode to make the echo acquisition easier.

The knobs around the Auto Adjust keys respectively acts on imaging and Doppler
Imaging and Color
signals.
Gain Knobs
The knob on the right side of the panel acts on B- and M-Mode signals, adjusting
amplification over the entire depth of the image.

The knob on the left side amplifies CFM, Power Doppler and Doppler gains.

To increase gain, turn the knob clockwise, to reduce it, turn the knob counter-
clockwise.

In Doppler modes, gain acts on the video component of the signal. The level of
the audio signal can be independently adjusted with the A U D I O rotating knob.
This key stops the current analysis or scan and puts the system in Freeze mode. To
re-activate real time, press FREEZE a second time or directly press the key of the
required mode.

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MyLab - G E T T I N G S T A R T E D

Multiformat Controls
Depending on system presets or on the active selections on the displayed menu,
these keys activate multiple views of two (dual) images both in real time and in
freeze.

GETTING STARTED
Press any key to activate multiple presentations. The active 2D/2D-CFM is
displayed on the left. If the key or the key is pressed, the system
freezes the acquisition of the 2D/2D-CFM and activates the following 2D/2D-
CFM.

Press the same key again to restore a normal format.

Exam Revision
During the exam, the operator can save both individual images (IMAGE key) and
2D or CFM sequences (CLIP key). The stored images and sequences are displayed
as thumbnails on the right of the screen. The EXAM REVIEW tab is used to access
the data stored during current exam. Alternatively, images and clips can be accessed
by placing the cursor (trackball working as pointer) on the thumbnail and by
pressing ENTER.
The ARCHIVE key is used to access, at any time, the archived data.

Exam Report
These functions can always be performed: general measurements (+...+ key) and
access to the calculations package (MEASURE key). When the required key is
pressed, the list of available measurements is shown on the right of the image.

Printers
MyLab can control one peripheral device with printer key, according to the system
presets.

Printer Key

WARNING For correct use of the thermal printer, it is strictly recommended to employ
only original paper.

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MyLab - G E T T I N G S T A R T E D

Settings
This key displays the system menu for all configurations/settings (both clinical and
system settings). This key is indicated as MENU key within MyLab manuals.

eTouch Key

The ETOUCH key allows to configure macro-operations to launch sequences of


commands both through touchscreen buttons and control panel keys.

Refer to the dedicated chapter on this manual for further information on its use.

Advanced Operations

 AO 3D/4D and ACQUIRE keys activate advanced operations: further details on how to
use them are described in this manual and in the “Advanced Operations” manual.

5 - 10
6
MyLab - G E T T I N G S T A R T E D
Chapter

6 - Screen Layout

GETTING STARTED
This chapter provides a brief description of the information provided on the
MyLab screen.

Information about the Screen


The screen is split into four main areas:

Heading Area

This area is used to display the following information: center and patient data,
accession number and date.

 AO To set data of your center, please refer to the “Advanced Operations” manual.

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 the PATIEN T ID button.

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MyLab - G E T T I N G S T A R T E D

Footer Area

This area is used to display the following information:

 trackball functionality,

 Wi-Fi icon (when enabled),

 archival media icons,

 advanced features icons,

 peripherals icons,

 battery icon (when installed).

Trackball
The trackball function is indicated on the bottom left side of the footer area.

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. The
ACTION key switches between 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.

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, please refer to the relevant section on the
“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.

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MyLab - G E T T I N G S T A R T E D

Battery
When the battery pack is not installed, MyLab displays the following icon:

Battery not Main power


installed cable

GETTING STARTED
When the battery is installed, the battery icon changes depending on its charging
status:

Partially
Fully charged Discharged
charged
battery battery
battery

The residual charge (indicated in percentage) is displayed above the battery icon
and it is continuously updated.

Once the minimum threshold of the working condition is reached, the residual
operating time, indicated in minutes, replaces the main power icon, surrounded by
a flashing yellow frame.
When the battery is charging, its icon replaces the Main power cable icon. Once
the battery is fully charged, the Main power cable icon is displayed again.

Errors in Battery Management


The battery icon is shown crossed out whenever an error in the battery
management occurs.

The number in the warning message indicates the type of error.

Error #1 This error indicates a fault on the Power Supply: in this case, information on
batteries may not be correct. The system displays the following message:

Error #1: wrong communication with


power supply. The automatic shut down is
disabled.

6-3
MyLab - G E T T I N G S T A R T E D

If this situation occurs, shut down MyLab, by keeping the ON/OFF key pressed,
and contact Esaote Service.

Error #2 This error indicates a failed access to the battery pack: in this case, information on
batteries may not be correct. The system displays the following message:

Error #2: wrong communication with


battery logics. The automatic shut down is
disabled.

If this situation occurs, shut down MyLab, by keeping the ON/OFF key pressed,
and contact Esaote Service.

Error #3 This error indicates that one battery couldn’t be charged. The system displays the
following message:

Error #3: problem with battery charging.

If this situation occurs, close the exam as soon as possible by pressing the END
EXAM key and switch the system off by pressing the ON/OFF key and then the
main switch placed on the rear panel. Switch MyLab on again and check whether
the message is still present. If the problem persists, contact Esaote personnel.

Error #4 This error indicates that at least one of the batteries has reached the maximum
temperature allowed for its working conditions. The system displays the following
message and shuts down automatically:

Error #4: problem with battery status. The


automatic shut down will start in a few
seconds.

Should this situation occurs, contact Esaote Service.

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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MyLab - G E T T I N G S T A R T E D

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.

GETTING STARTED
Legenda:

Number

1 Frequency Bar

2 System Parameter

3 Sector orientation

4 Acoustic output data

5 Focal zone

6 Image and color scales

7 Active application, probe and


preset

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

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MyLab - G E T T I N G S T A R T E D

frozen and archived in these memories. The trackball can be used to examine the
2D, M-Mode, Doppler and color information image by image.

Machine Parameters
Imaging

Displayed
Parameter Description
format

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% AutoAdjust

D nn cm 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 Sample volume size and depth


mm

 nn° Doppler correction-angle

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

Color Flow Mapping (CFM)

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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MyLab - G E T T I N G S T A R T E D

Doppler

Displayed
Parameter Description
format

F nnn MHz Doppler frequency or TV (Tissue Velocity)

GETTING STARTED
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

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.

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.

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6-8
7
MyLab - G E T T I N G S T A R T E D
Chapter

7 - Performing an Exam

GETTING STARTED
This chapter describes the operations usually carried out to start and end an exam.

 SS Read the “Safety and Standards” manual carefully: all the safety characteristics,
cautions and warnings listed there apply to all exams.

Remember that it is necessary to be familiar with the mechanical and thermal


indices display and the ALARA principle (As Low As Reasonably Achievable)
before using any probe. The patient must be exposed to ultrasound for as short a
time as possible and only for as long as it takes to achieve the diagnostic
information.

Exam Start and End


At power-up, at end of the initial auto-test and at the start of every new exam the
system displays both the Patient ID screen and the touchscreen that allows the
operator to enter patient data and application and to select the probe, the
application and the preset (PRO BE button).

 AO
Note
At start up MyLab displays the window allowing to select the
configuration, when more system configurations are set. See further
in this manual and in the “Advanced Operations” manual for
detailed information.

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

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MyLab - G E T T I N G S T A R T E D

Patient ID screen

Probe, Application, Preset


touchscreen

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


procedure
1. Probe selection,

2. Application selection,

3. Preset selection,

4. Patient data and application data entry.

Probe selection The touchscreen displays all connected probes: the pressed button indicates the
active probe. Press the button of the desired probe to activate it.

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Application Depending on the selected probe, the touchscreen displays the available
selection applications: the pressed button indicates the active one. Press the button of the
desired application to set it.

Preset application The preset (or Clinical Settings) can be selected only when both the probe and the
application have been set. Press the desired preset button to select it.

GETTING STARTED
Note
The user may program and add presets to better suit individual
clinical needs or preferences, while applications depend on the
installed optional licenses.

 GS and AO See further in this manual and in the “Advanced Operations” manual for detailed
information on clinical settings.

Patient data and The Patient ID screen is used to enter patient data and application data, when
application data applicable. Age is automatically calculated from the date of birth. Patient data will
entry
be saved together with images, measures and reports during archiving operations.

To navigate the Patient ID screen, use either the trackball and the ENTER key or
the  tab key of the alphanumeric keyboard. To enter patient data, use the
alphanumeric keyboard.

The CURREN T button retrieves the patient data of the last exam.

The RETR PAT IN FO button retrieves from the archive the patient data of a
previously performed examination.

If the “PAUSE EXAM” option is checked in Saving Option Menu, pressing the
PAUSED EXAMS button, 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
WORKLIST 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!

At any time during the exam, the operator can view and modify the patient's data
by pressing the button PATIEN T ID . The operator can also select a different probe,

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MyLab - G E T T I N G S T A R T E D

application, preset, set a new preset or modify the actual preset by using the PRO BE
button.

WARNING Do not use the PATIEN T ID key 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 the END EXAM key and then proceed
with the Starting Exam procedure.

Pressing IMAGE 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 this data
but always check the current patient data.

Once all patient and application data have been entered, press the START EXAM
button to start the exam.

The system activates real time in 2D. The selected application and presets
automatically define the type of format, CFM maps and power values...

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

End Exam To end the exam, press the END EXAM key. 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.

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MyLab - G E T T I N G S T A R T E D

GETTING STARTED
Before archival, patient data can be made anonymous by checking the
corresponding box.

Note
The native format of the exam cannot be made anonymous.

The exam can be simultaneously exported to the local archive and to external
media (in native, DICOM and multimedia formats). Press OK to confirm and
close the exam.

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 the
END EXAM key you will be asked to end or pause the exam.

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MyLab - G E T T I N G S T A R T E D

Note
At switch off, the system will inform if there is any paused exam.

System reboot At the end of each exam MyLab executes an auto-test that, in same cases, might
requests the system reboot. The following message is displayed:

Please restart the unit to improve system


performance.

Switch the unit off as soon as possible.

Exam Exported on CD/DVD Medium

CD/DVD are not managed in multi-session: only one burning operation at a time
can be activated.

When the exam is exported to a CD/DVD medium, the system will be inoperative
during the burning procedure. The system displays the following message:

Warning:
one of the selected destinations is CD/DVD;
during CD/DVD operations, the user interaction
will be stopped.
Do you want to continue?

The duration of the burning procedure corresponds to the estimated time for the
selected CD/DVD operation.

Press NO to end the procedure.

The burning procedure starts as soon as the YES button is pressed. The system
displays a waiting icon and the following message:

A burning procedure is in progress.


Pressing CANCEL the operation stops.
Warning: the CD/DVD may be unusable.

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MyLab - G E T T I N G S T A R T E D

The procedure can be stopped at any time by pressing the CANCEL button. In
this case the CD/DVD is unusable.

Note
When burning data, do not use any Double Layer DVD disk nor

GETTING STARTED
disks with applied stickers.

Performing the Exam


By pressing the different mode keys, the specific mode is activated in real time. If
the same key is pressed again, the system automatically returns to the previous
presentation.

Line Cursor Press LINE UPDATE to display the scanning line. During the scan this key freezes
the trace and re-activates the 2D reference; the P L E X button activates or freezes
the 2D reference, maintaining the trace in real time.

The control panel keys and the commands displayed on the touchscreen make it
possible to optimize presentation quality. Different menus correspond to each
format.

When more modes are active, the navigation tabs (B-M O DE, M -M O DE...) allow the
operator to scroll among the specific mode menu. If the displayed menu has
several levels, press the button A D V >>/ B A S I C < < to scroll through all functions.

2D and CFM To save images and sequences, press IMAGE and CLIP. These keys respectively
save still frames and clips in real time. Images are also saved in Freeze. Clips are
acquired in Prospective Mode: the CLIP key starts the acquisition. The number of
captured loops depends on the set value (C L I P S D U R toggle).

Single images are saved with full definition or compressed, whereas sequences are
compressed with a minimum loss of information.

Traces In the case of traces (M-Mode, Q-Mode, Compass M-Mode and Doppler) the key
IMAGE saves the image displayed on the screen. When the trace is displayed in cine
mode (P L A Y key), the ACQUIRE key allows to save the corresponding clip.

 AO Compression of both images and clips to be saved on external media can be set:
refer to the “Clinical and System Settings” section for further information.

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MyLab - G E T T I N G S T A R T E D

The thumbnails of the saved data are shown downwards in chronological order on
the right side of the screen.

 AO The “Advanced Operations” manual provides a detailed description of all active


controls in the different modes.

2D and CFM Clips with High Frame Rate


MyLab allows the acquisition of 2D and CFM Clips with high frame rate.

Clips with high frame rate are acquired in Retrospective Mode. In this modality the
system continuously captures consecutive loops, the ACQUIRE key stops the
acquisition and the last captured loops are shown on the screen.

Acquisition Procedure

Follow the procedure below to acquire clips with high frame rate:

Procedure  Enter the patient’s data,

 Select the probe, the desired application and preset and press
OK to confirm,

 Start scanning and press the ACQUIRE key: the system freezes
and displays the last acquired cycles in cine mode.

 Press ACQUIRE to save the sequence.

The number of acquired loops depends on the set value (C L I P S DUR toggle).
High frame rate clip symbol (Clip ART) 2D and CFM Clips acquired with the ECG signal (P H Y S I O button)
synchronization and using this modality are identified by a specific symbol, shown
here on the left. These clips are indicated as Clip ART clips within the manual.

WARNING Do not use the physiological trace displayed on the screen for diagnosis or
monitoring.

Freeze and Scrolling Memories


The FREEZE key freezes the image. The system displays the scroll bar of the
memories, where the images acquired just before the system was frozen are
temporarily saved.

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MyLab - G E T T I N G S T A R T E D

On frozen images the AN N O T and BO DYM ARKS buttons allows the user to add text
and icons on images.

How to Scroll through the Memories

GETTING STARTED
Move the trackball horizontally to scroll through the images one by one. The
scrolling bar shows the trackball position.

For multiple formats, several scrolling bars are displayed; the multiformat controls
( and keys) change over from one bar to the other, whereas the
trackball scrolls through the images of the selected bar.

PLAY shows the sequence of stored images in cine mode: MyLab displays single
cardiac cycles (when the ECG is active) or second intervals (when the ECG is off).
Use the trackball to scroll along the bar and display another cycle/interval whose
duration can be changed using the C L I P S D U R toggle.

SPEED shows the sequence at different speeds.

ACQUIRE key saves the displayed clip in Retrospective Mode.

 AO The “Advanced Operations” manual provides a detailed description of all available


controls in Freeze.

Exam Review
During the exam, the EXAM REVIEW tab enables reviewing of the saved images
and sequences. When the tab has been pressed, the trackball automatically changes
to pointer mode, allowing the operator to scroll through the thumbnails and select
the item to be reviewed. Alternatively press the POINTER key, select the thumbnail
and press ENTER to confirm: 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.

System Shut Down


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).

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The shut down procedure is always recommended; it is MANDATORY that the


operator interrupts any pending PC operation prior to turning the system off.
Make sure that no background operations are in progress (archiving media icons
are filled with color); this would indicate that there is a pending PC operation,
which must be completed, before shutting down the system.

Press the ON/OFF panel key to start the shut down procedure. The system
displays a message with a count-down timer: when the time is expired, the system
automatically shuts down.

SHUT DOWN button confirms the procedure.

CANCEL button interrupts the shut down procedure and reactivate the session.

Press the ON/OFF panel key to start the shut down procedure. Press the mains
switch placed on the rear panel to turn the system off.

Note
If the system isn’t correctly shut down, a message will be shown at
next switching on.

Error Messages
Whenever an internal fault occurs, the system automatically freezes and an error
message is displayed on the screen. Switch the system off and then turn it on again
to see whether the error message persists.

 AO Save anyway the log file (refer to the “Archive” section of the Advanced Operation
manual for further information) and contact the Esaote Service department.

Power Supply Error Messages

Whenever an error in the management of the power supply occurs, the system
displays a numbered error message: the number in the warning message indicates
the type of error.

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Error #5 This error indicates an overheating problem of the power supply. The system
displays the following message:

Error #5: overheating!


Please, contact the Service department.

GETTING STARTED
If this situation occurs, shut down the system and leave it off for a while. Verify
that there is adequate ventilation to prevent the overheating of the device.

Should the problem persist, contact the Esaote Service department.

Error #6 This error indicates that a fan is not working. The system displays the following
message:

Error #6: problem with fan.


Please, contact the Service department.

If this situation occurs, press OK and then shut down the system. Verify that
nothing is blocking the fan functioning, especially on the rear panel.

Should the problem persist, contact the Esaote Service department.

Error #7 This error indicates that a fault of the internal voltages occurs. The system displays
the following message:

Error #7: problem with internal voltage.


Please, contact the Service department.

If this situation occurs, press OK and then shut down the system. Contact the
Esaote Service department.

Error #8 This error indicates that a fault of the impulse voltages occurs. The system displays
the following message:

Error #8: wrong impulse voltage.


Please, contact the Service department.

If this situation occurs, press OK and then shut down the system. Contact the
Esaote Service department.

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MyLab - G E T T I N G S T A R T E D
Chapter

8 - eTouch Key

GETTING STARTED
This chapter explains how to use the ETOUCH key of the control panel.

Keys Sequence
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.

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

The user can not access to system controls and menu whenever a
macro is running.

The ETOUCH key switches between factory and customized touchscreen.


Whenever the customized button will be pressed, MyLab will automatically launch
the keys sequence.

Each system configuration is linked only to one customized touchscreen.

Configuration Menu
The eTouch configuration menu is an option of the MENU key. 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.

To access to the configuration menu press:

 EDIT to modify the customized touchscreen selected with


the trackball. Alternatively position the cursor on the desired
option and press ENTER to select it.

 CLONE to duplicate and modify a saved customized


touchscreen, always selected with the trackball.

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REMOVE deletes the selected customized touchscreen.

How to Create a Customized Touchscreen


The configuration menu shows:

 in the center the touchscreen layout,

 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.

SAVE saves and activates the settings.

CANCEL exits the menu without saving the settings.

To create a customized touchscreen follow this procedure:

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

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Procedure  Select the touchscreen to be copied and press the CLONE


button to add a new customized touchscreen, starting from
the selected one.

 Place the cursor on the NAME field and using the

GETTING STARTED
alphanumeric keyboard enter the desired name and
description (NOTES field).

 Place the cursor on the RECORDING field and press


START 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 the ETOUCH key to start.

 Press the desired keys in sequence and press again the


ETOUCH key 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 ENTER to change its name, using the alphanumeric
keyboard to edit it.

Repeat the procedure to add other customized buttons.

Customized Touchscreen Organization


Customized Buttons 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 ENTER to confirm.

Delete button cancels the button selected with the trackball.

Tabs Organization Customized touchscreen can be organized in more tabs. Each tab has one level of
buttons.

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New Tab button adds a new tab that will be automatically displayed. Place the
cursor on the tab and press ENTER to change its name, using the alphanumeric
keyboard to edit it.

Move left and Move right 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.

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MyLab - G E T T I N G S T A R T E D
Chapter

9 - MyLab Settings

GETTING STARTED
This chapter describes the organization of MyLab settings and explains how to use
them.

Settings Organization
MyLab has two groups of settings:

 System Settings,

 Clinical Settings (or Presets).

System Settings MyLab system configuration defines the equipment general parameters. One
system configuration (or system profile) is identified by the settings of the
following items:

 General configuration, like measure units, control panel


setting,

 Hospital configuration to set the name of the hospital,

 Licence settings,

 Report style configuration,

 Observations configuration,

 Printers configuration,

 Network configuration,

 DICOM configuration,

 End exam saving configuration,

 Exam export configuration,

 Security configuration.

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MyLab - G E T T I N G S T A R T E D

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.

 AO Refer to the “Advanced Operations” manual for detailed information on which


user profile can access to preset modification and how to create and set system
configurations.

Clinical Settings A clinical setting is a group of configurations optimizing MyLab for a specific 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. MyLab allows
the user to save several clinical settings for each probe in each application.

 GS See next chapter for further information on clinical settings.

How to Use MyLab Settings


Use of System When more system configurations are set, MyLab displays at every start up the
Settings window allowing to select a configuration.

Note
To activate the set system configuration, the user needs to restart
MyLab.

The system profile in use is displayed in the main menu (MENU


key).

Once the desired configuration has been loaded, the system automatically uses the
settings defined for hospital, printers, network and so on.

Use of Clinical All saved clinical settings are displayed in the Probe/Application/Preset
Settings touchscreen, under the “PRESET” area. The active probe defines which presets
are available. Clinical settings can be changed within the same exam at any time by
using the PRO BE button.

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MyLab - G E T T I N G S T A R T E D

Preset area .

GETTING STARTED
Once the desired configuration has been loaded, the system automatically uses the
selected settings.

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9-4
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10 - MyLab Clinical Settings

GETTING STARTED
This chapter describes how to create clinical settings, usually named “Preset”.

Definition of Clinical Settings


One clinical setting is identified by the settings of the following parameters:

 real time exam controls,

 smartouch configuration (if available),

 measurement configuration,

 bodymark configuration,

 annotation configuration,

 eTouch configuration.

This means that the preset, selected at the beginning of the exam or during the
exam by using the PRO BE button, 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.

Note
When licenced, advanced tool configurations (such as 3D/4D
settings, Stress Echo protocols) are part of the clinical settings.
Refer to the dedicated sections of this manual for further
information on these tools.

How to Create Clinical Settings


To create a new preset or modify an existing preset, follow the procedure below
that is organized in two phases, an on-line phase followed by an off-line phase.

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In the on-line phase the operator sets the parameters that optimize the real time
image in all modes and creates the customized preset; in the off-line phase the
operator adds the desired measurement configuration, annotation and bodymark
libraries and eTouch configuration to the customized preset.

On-Line Phase  Adjust the real time image as desired in all modes (2D, CFM
Procedure and Doppler).

 Press the PRO BE button and then select PRESET M AN AGER .

 Press OVERWRITE 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 NEW
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.

Note
The parameter set for the P O W E R control in B-Mode is not saved
in the user preset, which keeps for this control the factory value.

Off-Line Phase  Press the MENU key.


Procedure
 Select the “REAL TIME PRESETS” option.

 The system shows the menu displaying on the left the list of
all clinical settings, grouped by probes. Within each probe
clinical settings are grouped by applications.

 Using the trackball select the desired clinical setting and press
EDIT.

 Associate to each parameter (measurement, bodymark...) of


the preset the desired configuration.

 Press SAVE to confirm.

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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 using the PRO BE key.

Note

GETTING STARTED
The above procedure allows also to assign the default application
for each probe independently. Each time the probe is selected its
default application is selected as well.

 AO Refer the “Advanced Operations” manual for detailed information on how to


create and set measurement, bodymark and annotation configurations.

How to Rename or Delete Clinical Settings


Clinical settings can be renamed and deleted from the dedicated option of the
system menu (MENU key).

Procedure  Press the MENU key and select the option “REAL TIME
PRESETS”.

 The system shows the menu displaying on the left the list of
all clinical settings, grouped by probes. Within each probe
clinical settings are grouped by applications.

 Using the trackball select the desired preset.

 Press REMOVE to delete it.

 To change its name, place the cursor on the “NAME” field


and using the alphanumeric keyboard enter the desired name
and description (“NOTES” field). Press SAVE to confirm.

Factory Clinical Settings


Factory clinical settings can be retrieved at any time.

Procedure  Press the MENU key and select the option “REAL TIME
PRESETS”.

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 The system shows the menu displaying on the left the list of
all clinical settings, grouped by probes. Within each probe
clinical settings are grouped by applications.

 Using the trackball select the desired probe and application.

 Press FACTORY to restore the default preset.

Note
This operation retrieves all factory clinical settings and deletes all
user clinical settings saved for that probe/application.

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Chapter

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11 - System Maintenance

GETTING STARTED
This chapter describes the main maintenance operations that can be directly done
by the system user.

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

Inspecting the System


On periodic schedule (or whenever there is a reason to do it) disconnect the system
from the power outlet and check:

 all system cables for any cut or damage,

 system housings for any damage,

 connector status,

 LCD and touchscreen status,

 movements of all parts composing the system,

 trackball movement.

Contact Esaote personnel for any problem found during inspection.

 PC Refer to “Probes and Consumables” manual for periodic inspections for probes.

Cleaning of System and Peripheral Devices


Periodic cleaning of the system and any connected peripheral devices is important.
Peripherals may contain dust on sensitive parts, the reliability of which could be
compromised in the event of poor maintenance.

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

Product Supplier

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

Cavicide Metrex Research Corporation


Caviwipes (www.metrex.com/company/
Metrizyme contact/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


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

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.

Cleaning the system To clean the system, use a soft cloth slightly dampened with water. If necessary,
apply a small amount of ammonia-free and not abrasive detergent on a clean, soft
cloth and then wipe the surface. Switch the system off and rub the outside with the
cloth.

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.

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Trackball The trackball can be accessed 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

GETTING STARTED
the trackball housing.

Cleaning Probe and Probe and gel holders are easily removed from their location for cleaning and can
Gel Holders 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”.

Touchscreen To clean the touchscreen, 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.

To temporarily lock the keyboard and the touchscreen to allow to clean them,
press the FREEZE key while keeping ETOUCH pressed. When the system is locked,
to unlock it, press the FREEZE key while keeping ETOUCH pressed.

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.

LCD 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.

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

WARNING Overspray or liquid may cause electrical shock.

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

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


monitor’s screen and case.

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

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MyLab - G E T T I N G S T A R T E D

12 - Technical Specifications

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

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

MyLab Characteristics
MyLab models differ for default installed licences 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.

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

License Application Features

Cardiac Cardiac (adult and Presets, Calculations,


pediatric) ECG

General Imaging Abdominal, Neonatal Presets, Calculations


cephalic, Muscolo-
skeletal, Pediatric, Small
Organ, Urology

Ob-Gyn Obstetrics, Fetal, Presets, Calculations


Gynaecology

Vascular Peripheral Vascular, Adult Presets, Calculations


cephalic

1. The specifications can be modified without prior notice.

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Modes MyLab models is licensed for the following modes:

License Description Features

Doppler Doppler Includes Duplex

CFM Color (Color Flow With Doppler includes


Mapping) Triplex

TVM-TV Tissue Velocity Mapping Cardiac licence required;


and Tissue Velocity Probe dependent

CMM Compass M-Mode -

MView MView Probe dependent

The CFM license requires prior installation of the Doppler license.

Advanced Features Depending on the model, MyLab can be configured with one or more of the
following licences:

Licence Feature Note

Stress Echo Stress Echo analysis Cardiac licence required

QIMT Quality Intima Media Thickness Vascular licence required


(probe dependent)

VPan Panoramic View Probe dependent

Breathing Retrieve information about Cardiac licence required - probe


Curve patient breathing from ECG dependent

Needle Increases the needle brightness Probe dependent


Enhanced
Imaging

Library viewer Tool providing information and Dedicated libraries can be


suggestions required as option

Live preview Real-time image inside library Library viewer licence required
environment

3D/4D 3D and 4D Volumetric, TPI -


Modality

VueBox Bracco VueBox Quantification


Toolbox

DICOM DICOM Classesa -

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MyLab - G E T T I N G S T A R T E D

Licence Feature Note

Wireless Wi-Fi connection -


a. Refer to www.esaote.com for further details on supported DICOM classes.

GETTING STARTED
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 information.

MyLab 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, WXGA resolution


 8.9” LCD (touchscreen)
Probe connectors

 2 electronic probes
Video Output

 HDMI type 1
Connectivity

 I/Os connectors
• LAN RJ45
• 4 USB
• Wi-Fi
 Dedicated connectors
• ECG input
 Other

1. Auxiliary monitors connected to this input have not to be used for diagnostic
purposes. Refer to previous chapters for further information.

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MyLab - G E T T I N G S T A R T E D

• Laser/Ink jet printers


 Complies with IHE integration profiles1
Image Files

 Formats
• BMP (uncompressed)
• PNG (lossless)
• JPEG (lossy)
• AVI: Codec Microsoft MPEG-4 V2 and MS-Video 1
• Native formats

Software

 Operating system: Windows Embedded Standard


 Multi-lingual
Biometry

 Basic and advanced calculation, application dependent


 Annotations, bodymarks
Keyboard

 Control panel:
• Potentiometers for TGC
• Encoders for general gains
• Keys for modes, peripherals management and controls
 Reconfigurable touchscreen LCD

1. Refer to www.esaote.com for further details.

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MyLab - G E T T I N G S T A R T E D

Power Cables

Connector Plug Type Cord Type Length

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

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

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


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

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


according to Section 1 mm2
NBR14136 3 conductors
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

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MyLab - G E T T I N G S T A R T E D

Connector Plug Type Cord Type Length

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


SB 107-2D1 DK2-8a Section 1 mm2
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

Dimensions

 Closed: 34 (L) x 10.0 (H) x 38 (D) cm


 In working position: 34 (L) x 34 (H) x 40 (D) cm
Weight

 From 5.65 kg (basic configuration without driver and batter-


ies)
AC/DC Adapter

 Input:
• Voltage: 100  240 Vac
• Current: 2.2 A
• Frequency: 50/60 Hz
 Output:
• Voltage: 19 Vdc
• Current: 9.47 A
• Power: 180 W

Batteries

 Batteries for standard working condition and stand by


 Battery charger inside
 Battery life: 3 years
Operating Requirements

 Temperature: 15  35°C
 Humidity: 20  90% (not condensing)
 Pressure: 700  1060 hPa

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MyLab - G E T T I N G S T A R T E D

Storage requirements

 Temperature: -20  60°C


 Humidity: 5  90% (not condensing, -20  40°C); in the
range 40  60°C the max allowed humidity decreases from

GETTING STARTED
90% at 40°C to 27% at 60°C
 Pressure: 700  1060 hPa

Standards

Standard Title

IEC 60601-1:1988 and its Electromedical equipment - Part 1: General safety


amendments standards
EN 60601-1:1990

IEC 60601-1:2005 Medical electrical equipment - Part 1: General


EN 60601-1:2006 requirements for basic safety and essential performance

IEC 60601-1-1:2000 Electromedical equipment - Part 1: General safety


EN 60601-1-1:2001 standards – Collateral standard: Safety requirements for
electromedical systems

IEC 60601-1-2:2001 and Electromedical equipment - Part 1: General safety


its amendments standards – Collateral standard: Electromagnetic
EN 60601-1-2:2001 and compatibility - Requirements and tests
its amendments

IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General


EN 60601-1-2:2007 requirements for safety - Collateral Standard:
Electromagnetic compatibility - Requirements and tests

IEC 60601-1-4:1996 Electromedical equipment - Part 1: General safety


EN 60601-1-4:1996 standards – 4. Collateral standard: Programmable
electromedical systems

IEC 60601-1-6 Medical electrical equipment - Part 1-6: General


EN 60601-1-6 requirements for basic safety and essential performance
– Collateral standard: Usability

IEC 60601-2-37 Medical electrical equipment - Part 2-37: Particular


EN 60601-2-37 requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment

IEC 61157 Standard means for the reporting of the acoustic output
EN 61157 of medical diagnostic ultrasonic equipment

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MyLab - G E T T I N G S T A R T E D

Standard Title

IEC 62366 Application of Usability Engineering to Medical


EN 62366 Devices

IEC 62304 Medical device software - Software life cycle processes


EN 62304

ISO 14971 Medical equipment - Application of risk management


to medical devices.

EN 980 Graphical symbol for use in the labeling of medical


devices

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


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

ISO 10993-1 Biological evaluation of medical devices - Evaluation


and testing

AIUM/NEMA UD2 Acoustic Output Measurement Standard for Diagnostic


Ultrasound Equipment.

AIUM/NEMA UD3 Standard for Real-Time Display of Thermal and


Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment.

CAN/CSA C22.2 NO. Medical Electrical Equipment - Part 1: General


601.1-M90 Requirements for Safety

CAN/CSA C22.2 NO. Medical electrical equipment - Part 2-37: Particular


60601-2-37 requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and
monitoring equipment

UL 60601-1 Medical Electrical Equipment - Part 1: General


Requirements for Safety

Probe
Storage Requirements

 Probe storage requirements are indicated in the probe case.

Trolley Technical Characteristics


Dimensions

 46.3 (L) x 85 108 (H) x 67.5 (D) cm

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MyLab - G E T T I N G S T A R T E D

Weight

 < 22 kg

GETTING STARTED
Fold-Away Trolley Technical Characteristics
Dimensions

 49.2 (L) x 82 91.3 (H) x 65.3 (D) cm


Weight

 < 5.9 kg

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