Rev.

02

May 2016

MyLabEight and MyLabEight eXP Families

GETTING STARTED

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S T A R T E D

Introduction
This manual refers to MyLabEight and MyLabEight eXP ultrasound system families.
The term “MyLab”, used in this manual, refers to both configurations. When the
information refers to only one configuration, it will be specifically indicated.

This manual explains how to install and use the MyLab ultrasound system. All
system keys and their functions are described. Whether these keys are enabled or
disabled depends on the installed software release.

This manual is organized in the following chapters:

• Chapter 1: General Information

This chapter provides information on manual 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
This chapter provides information about specific safety features of the
MyLab system.

• Chapter 3: Clinical Applications

This chapter specifies in which clinical applications the MyLab can be used.
• Chapter 4: System Components and Installation
This chapter lists the available MyLab configurations. Moreover, it contains
the installation instructions.
• Chapter 5: Control Panel and Touchscreen
This chapter describes the MyLab control panel and touchscreen.
• Chapter 6: Screen Layout
In this chapter one can learn how information is organized on the screen.
• Chapter 7: Exam Performance
This chapter explains how to perform an exam with the MyLab system.
• Chapter 8: Measurements and Calculations
This chapter explains how to perform measurements on ultrasound
images.
• Chapter 9: Exams Archive
This chapter describes how to use MyLab archive.
• Chapter 10: System Menu
This chapter explains how to configure the MyLab.

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• Chapter 11: System Maintenance

This chapter lists all necessary maintenance procedures.
• Chapter 12: Technical Specifications
This chapter lists all MyLab technical specifications.

In this manual WARNING pertains to possible injury to a patient and/or

W A R N I N G
the operator.

CAUTION describes the precautions, which are necessary to protect the

C A U T I O N
equipment.

Be sure that you understand and observe each of the cautions and warnings.

In this manual control panel keys and software keys are indicated using the
following graphical conventions:

Control panel keys They are indicated by BLUE CAPITAL LETTERS or by the
corresponding graphic symbol. Multifunction keys (for
instance LINE/UPDATE) are indicated with the mention of
one of the functions only (for instance LINE in this
example).

Function keys, They are indicated by B L A C K CAPITAL LETTERS.

button and software
keys relating to the
touchscreen

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

Keep this manual with the equipment for future reference.

This manual revision refers to release 13.01.00. Features, probes and applications
described in this manual may change depending on your system configuration and
the respective Country clearances.

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Table of Contents

Introduction ...................................................................................................................................... ii
1 - General Information ..................................................................................................................1-1
User’s Kit ......................................................................................................................................1-1
Licenses .....................................................................................................................................1-1
MyLab Pen Drive ......................................................................................................................1-1
“Operator Manuals” Disk..........................................................................................................1-1
MyLab Manuals ............................................................................................................................1-1
Operator Manual .......................................................................................................................1-2
Advanced Operations Manual ...................................................................................................1-2
System Data ..............................................................................................................................1-2
Manufacturer’s Responsibility ......................................................................................................1-3
Product Life Cycle ........................................................................................................................1-3
Life Time...................................................................................................................................1-3
Maintanibility Time ..................................................................................................................1-3
End-of-Life Disposal.................................................................................................................1-3
Usage License Agreement for the Software Included in the Apparatus .......................................1-7
PROPRIETARY RIGHTS ........................................................................................................1-7
License Rights and Limitations.................................................................................................1-7
Third Part Software ...................................................................................................................1-8
Product Traceability ......................................................................................................................1-9
PRODUCT TRACEABILITY FORM......................................................................................1-9
Vigilance System ........................................................................................................................1-10
POST-MARKETING VIGILANCE FORM ..........................................................................1-10
Important Information .................................................................................................................1-11
2 - Additional Information on Safety .............................................................................................2-1
Environmental Safety....................................................................................................................2-1
Transport Safety ............................................................................................................................2-1
Electromagnetic Compatibility .....................................................................................................2-2
Electromagnetic Emissions .......................................................................................................2-2
Electromagnetic Immunity........................................................................................................2-2
Probe Superficial Temperature .....................................................................................................2-6
3 - Clinical Applications.................................................................................................................3-1
Intended Use .................................................................................................................................3-1
Clinical Applications.....................................................................................................................3-2
MyLab Probes ...........................................................................................................................3-3
Cardiac Application ..................................................................................................................3-4
Abdominal and related applications ..........................................................................................3-4
Small Organs and Small Parts Application ...............................................................................3-4
OB/GYN Application ...............................................................................................................3-5
Musculo-Skeletal ......................................................................................................................3-5
Vascular Applications ...............................................................................................................3-5
Pediatric Application.................................................................................................................3-5
Adult Cephalic ..........................................................................................................................3-6
Intraoperative (Neuro) Application...........................................................................................3-6
4 - System Components and Installation ........................................................................................4-1
System Overview ..........................................................................................................................4-1
Control Panel Assembly................................................................................................................4-3

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 Console..........................................................................................................................................4-3
Connections ...................................................................................................................................4-4
Control Panel Assembly Orientation ............................................................................................4-4
Turning the System On and Off ....................................................................................................4-6
Acclimation Time .........................................................................................................................4-6
How to Safely Connect Peripherals ..............................................................................................4-7
Safety Concept ..........................................................................................................................4-7
Auxiliary Devices .......................................................................................................................4-10
Video Devices .........................................................................................................................4-10
Digital Printers ........................................................................................................................4-10
Transporting the System .............................................................................................................4-11
5 - Control Panel and Touchscreen ................................................................................................5-1
The Control Panel .........................................................................................................................5-1
Alphanumeric Section ...................................................................................................................5-2
Trackball .......................................................................................................................................5-3
Touchscreen ..................................................................................................................................5-3
Controls Section ............................................................................................................................5-6
Exam Flow ................................................................................................................................5-6
The Mode Keys .........................................................................................................................5-7
Format Controls ........................................................................................................................5-8
Basic Controls ...........................................................................................................................5-9
Exam Storage ............................................................................................................................5-9
Exam Report ...........................................................................................................................5-10
Peripherals Management .........................................................................................................5-10
Settings ....................................................................................................................................5-10
Advanced Operations ..................................................................................................................5-10
6 - Screen Layout ...........................................................................................................................6-1
Information about the Screen ........................................................................................................6-1
Heading .........................................................................................................................................6-1
Patient Data ...............................................................................................................................6-1
Footer ............................................................................................................................................6-2
Trackball ...................................................................................................................................6-2
Archival Systems ......................................................................................................................6-2
Peripheral Units.........................................................................................................................6-2
Image Area ....................................................................................................................................6-2
Applications ..............................................................................................................................6-3
7 - Performing an Exam .................................................................................................................7-1
Exam Start and End.......................................................................................................................7-1
ECG...............................................................................................................................................7-5
Error Messages ..............................................................................................................................7-6
Performing the Exam ....................................................................................................................7-6
Clips with High Frame Rate..........................................................................................................7-7
Setting Procedure ......................................................................................................................7-7
Acquisition Procedure ...............................................................................................................7-8
Freeze and Scrolling Memories ....................................................................................................7-8
How to Scroll through the Images in Memory .........................................................................7-8
Exam Review ................................................................................................................................7-8
Annotations ...................................................................................................................................7-9
System Shut Down ........................................................................................................................7-9
8 - Measurements and Calculations................................................................................................8-1
General Information ......................................................................................................................8-1

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 Generic Measurements ..................................................................................................................8-2
Specific Calculation Packages ......................................................................................................8-2
9 - Exams Archive ..........................................................................................................................9-1
Archive Icons ................................................................................................................................9-1
Data Archival ................................................................................................................................9-1
Review of Archived Exams ..........................................................................................................9-3
End of Archive Review .................................................................................................................9-4
Archival Media Management........................................................................................................9-4
Writable CDs.............................................................................................................................9-4
Rewritable CDs .........................................................................................................................9-4
Rewritable DVDs ......................................................................................................................9-5
Double Layers DVDs ................................................................................................................9-5
USB Pen Media .........................................................................................................................9-5
10 - System Menu........................................................................................................................10-1
Configuration Menu ....................................................................................................................10-1
General Preset .............................................................................................................................10-1
Date/Time................................................................................................................................10-1
Center ......................................................................................................................................10-1
Video .......................................................................................................................................10-2
Measure units ..........................................................................................................................10-2
Archive ....................................................................................................................................10-2
Keyboard .................................................................................................................................10-2
Trackball .................................................................................................................................10-2
Contrast ...................................................................................................................................10-2
Cine Mode ...............................................................................................................................10-2
Other........................................................................................................................................10-2
Application Preset .......................................................................................................................10-3
User Preset ..................................................................................................................................10-3
Tools Settings ..............................................................................................................................10-3
3D Presentation .......................................................................................................................10-3
QIMT Settings.........................................................................................................................10-3
QAS Settings ...........................................................................................................................10-3
Stress Echo Preset ...................................................................................................................10-3
Edit View Label ......................................................................................................................10-3
Peripherals ...................................................................................................................................10-4
Application Measurements .........................................................................................................10-4
Report Layout .............................................................................................................................10-4
Glossary ......................................................................................................................................10-4
DICOM Configuration ................................................................................................................10-5
Save/Load Presets & Settings .....................................................................................................10-5
Licenses .......................................................................................................................................10-5
System Info .................................................................................................................................10-5
Generic Measurements ................................................................................................................10-5
Network Directory ......................................................................................................................10-5
Security .......................................................................................................................................10-6
Footswitch and Trackball 4th Button ...........................................................................................10-6
Export Settings ............................................................................................................................10-6
11 - System Maintenance ............................................................................................................11-1
Inspecting the System .................................................................................................................11-1
Cleaning of System and Peripheral Units ...................................................................................11-2
Cleaning Agents ..........................................................................................................................11-3

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12 - Technical Specifications ......................................................................................................12-1
MyLab Configuration .................................................................................................................12-1
MyLab Technical Specifications ................................................................................................12-3
Control Panel Assembly..........................................................................................................12-3
Display ....................................................................................................................................12-3
Probe connectors .....................................................................................................................12-3
Video I/O.................................................................................................................................12-3
Connectivity ............................................................................................................................12-3
Image Files ..............................................................................................................................12-3
Printing Capability ..................................................................................................................12-4
Software ..................................................................................................................................12-4
Biometry..................................................................................................................................12-4
Power Cables...........................................................................................................................12-4
Dimensions..............................................................................................................................12-4
Weight .....................................................................................................................................12-4
Power supply ...........................................................................................................................12-4
Fuses........................................................................................................................................12-5
Operating requirements ...........................................................................................................12-5
Storage requirements...............................................................................................................12-5
Safety Standards ..........................................................................................................................12-5
System Accessories .....................................................................................................................12-5
Video Requirements ....................................................................................................................12-5

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Chapter

1 - General Information

User’s Kit
MyLab is equipped with licenses, the USB pen drive 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.

MyLab Pen Drive

The system is supplied with a customized USB pen drive. The pen drive can be used as a data
archive medium. To learn how to use it, please carefully read this manual.

“Operator Manuals” 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.

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

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

TC Transducers and Consumables

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

SS Safety and Standards

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

Advanced Operations Manual

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

• Software Keys,

• Calculations,

• Archiving,

• System Configuration.

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.

The MyLab systems have multiple configurations and feature sets. All are described in this user
manual but not every option may apply 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.

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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 this Manual for the use and the maintenance
of this system;

• this Manual is kept integral and readable in all its parts;

• calibrations, modifications and repairing are performed only by ESAOTE qualified

personnel;

• the environment where the system is used complies with the current safety rules;

• the electrical plant of the environment where the system is used complies with the current
applicable rules and is perfectly efficient.

Product Life Cycle

Life Time
The safety and efficiency of MyLab ultrasound systems are guaranteed for at least seven (7) years from
the purchase date, provided that:

• the system is used in accordance with the instructions given in the Operator Manual (and its
eventual Addenda), which must be always accessible to the whole personnel in an integral
and readable status;

• any installation, maintenance, calibration, modification and repairing operation is performed

on the system only by Esaote qualified personnel, using original Esaote spare parts.

When approaching the seven (7) years limit from the purchase date, it is recommended to contact
Esaote Service or to visit Esaote web site (www.esaote.com), to get updated information on the
product’s end of life and/or to agree on the most suitable solution for its safe disposal.

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.

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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.

When disposing of any system part, the user shall consider the following points:

• any recyclable part of the system and/or of its packaging is labelled with the corresponding
symbol;

• all components used for the packaging are recyclable and/or reusable, except the closed-
coupled barriers.

C A U T I O N
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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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 unit.

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.

The user may not convert, decode, reverse-engineer, disassemble or change in any way the
SOFTWARE.

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The user may not remove, obscure or alter the copyright notice, trademarks or other proprietary
rights notices affixed to or contained within the SOFTWARE.

The user may not publish data or information comparing the performances of said SOFTWARE
with that of software written by others.

Third Part Software

Esaote software uses parts of the 7-Zip program. The 7-Zip is licensed under the GNU LGPL
license; the source code can be found in www.7-zip.org.

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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 di Caciolle, 15
50127 Firenze
Italy

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

REF: ................................................................................................................

SN: ..................................................................................................................

Name and address of the original owner: ..........................................................

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

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 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 labelling 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 di Caciolle, 15
50127 Firenze
Italy
e-mail: [email protected]
ESAOTE system/device name: .........................................................................

REF: ................................................................................................................

SN: ..................................................................................................................

Description of the hazard: ..............................................................................

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

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.

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

MyLab complies with the Radio equipment and Telecommunications Terminal Equipment
Directive 1999/5/EC and is CE marked.

MyLab is a device in Class 2 according to R&TTE Directive and the following symbol is applied
on the system.

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 the following table.

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Chapter

2 - Additional
Information on Safety
This chapter provides additional information on safety specifically for MyLab.
SS Please read the "Safety and Standards" manual carefully for a complete overview of
all safety aspects of MyLab.

Environmental Safety
Special waste These systems contain a lithium battery. The fluorescent lamps of the LCD screens
contain mercury. The battery and the LCD screens must be treated as special waste
in conformity with applicable local regulations.

The battery and the LCD screens are special waste: do not put them in
W A R N I N G
trash that is disposed in landfills. Dispose of them as required by local
regulations.

The equipment must be disposed of as special waste according to the local

regulations in a special waste disposal center. For further information refer to the
local authority for waste disposal.

Transport Safety
The system front wheels are equipped with brakes, which can be activated
individually.

Do not park the system on a slope.

W A R N I N G

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
through 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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Electromagnetic Compatibility
This system was designed for use in the electromagnetic environments declared in
the tables below, in compliance with standard IEC 60601-1-2:2001. The operator
must make sure that s/he uses it in keeping with this standard.

Electromagnetic Emissions
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.

Emission Test Compliance Electromagnetic Environment

The MyLab system uses RF energy only for its

RF emissions internal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions The MyLab system is suitable for use in all
Class A establishments other than domestic, and may be
CISPR 11
used in domestic establishments and those
Harmonic emissions directly connected to the public low-voltage power
Class A supply network that supplies buildings used for
IEC 61000-3-2 domestic purposes, provided that the following
warning is heeded:
WARNING: This equipment/system is intended
Voltage fluctuations for use by healthcare professionals only. This
and flicker emissions equipment/system may cause radio interference
Complies
or may disrupt the operation of nearby equipment.
IEC 61000-3-3 It may be necessary to take mitigation measures,
such as re-orienting or relocating the MyLab or
shielding the location.

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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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.

Immunity IEC60601 Compliance Electromagnetic Environment

Test Test Level Level Guidance

Electrostatic ±6 kV on ±6 kV on The floor should be wood, concrete or

discharge contact contact ceramic tile. If floors are covered with
(ESD) synthetic material, the relative humidity
±8 kV in air ±8 kV in air should be at least at 30%.
IEC 61000-4-2
Electrical fast ±2 kV for ±2 kV for Mains power quality should be that of a
transient/burst power supply power supply typical commercial or hospital
lines lines environment.
IEC 61000-4-4
±1 kV for ±1 kV for
input/output input/output
lines lines
Surge ±1 kV ±1 kV Mains power quality should be that of a
differential differential typical commercial or hospital
IEC 61000-4-5 mode mode environment.

±2 kV common ±2 kV common
mode mode
Voltage dips, <5 % of rated <5 % of rated Mains power quality should be that of a
short voltage (U T ) voltage (U T ) typical commercial or hospital
interruptions (voltage gap (voltage gap environment. If the user of the MyLab
and voltage >95 %) >95 %) system requires continued operation
variations on for 0,5 cycle for 0,5 cycle during power mains interruptions, it is
power supply recommended that the MyLab system be
input lines 40 % U T 40 % U T
powered from an uninterruptible power
(voltage dip 60 (voltage dip 60
supply or a battery.
IEC 61000-4- %) %)
11 for 5 cycles for 5 cycles
70 % U T 70 % U T
(voltage dip 30 (voltage dip 30
%) %)
for 25 cycles for 25 cycles
<5 % U T <5 % U T
(voltage dip (voltage dip
>95 %) >95 %)
for 5 sec for 5 sec
Power 3 A/m 3 A/m Power frequency magnetic fields should
frequency be at levels characteristic of a typical
(50/60 Hz) location in a typical commercial or
magnetic field hospital environment.
IEC 61000-4-8

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

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Electromagnetic Immunity for Medical Equipment not Life Supporting

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

Immunity IEC60601 Compliance Electromagnetic Environment

Test Test Level Level Guidance

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

communications equipment should be
IEC 61000-4-6 150 kHz to 80 150 kHz to 80 used no closer to any part of the MyLab
MHz MHz
system, including cables, than the
Radiated RF 3 V/m 3 V/m recommended separation distance
calculated from the equation applicable to
IEC 61000-4-3 80 MHz to 2.5 80 MHz to 2.5 the frequency of the transmitter.
GHz GHz
Recommended separation distance

 3,5 
=d =  P 1, 2 P
 3 
 3,5 
d =   P =1,2 P 80 MHz to 800 MHz
 3 
7
d =   P =2,4 P 800 MHz to 2,5 GHz
3

where P is the maximum output power

rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey a , should be
less than the compliance level in each
frequency range b .
Interference may occur in the vicinity of
equipment marked with the following
symbol:

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. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended Distances between Radiofrequency (RF) Communication Systems

a n d MyLab
As stated in the Safety and Standards manual, it is recommended not to use
SS radiofrequency (RF) transmission systems near the ultrasound system. RF systems
can cause interference, which alters the echographic image and Doppler traces.

The operator can prevent interference caused by electromagnetic fields by

maintaining a minimum distance between the echographic system and the RF
communication systems being used (cell telephones, mobile telephones…). The
following table shows the minimum distance in meters, according to the maximum
power at the RF system output.

Recommended separation distances between

portable and mobile RF communications equipment and the MyLab System

The MyLab system is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the MyLab system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the MyLab system as recommended below, according
to the maximum output power of the communications equipment.
Separation Distance According to Frequency of Transmitter
[m]
Rated Maximum
Power of the From 150 kHz to From 80 MHz to 800 From 800 MHz to
Transmitter 80 MHz MHz 2,5 GHz
[W]  3,5   3,5  7
=d = P 1, 2 P=d = P 1, 2 P =d = P 2, 4 P
 3   3   3 

0.01 0.12 0.12 0.23

0.1 0.37 0.38 0.74
1 1.17 1.17 2.33
10 3.69 3.69 7.38
100 11.67 11.67 23.33
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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.

The operator must remember that the intensity of the electromagnetic fields
generated by fixed transmitters (radio-base stations for cellular or cordless
telephones, TV and radio transmissions, amateur radio transmissions…) cannot be
predicted on a theoretical basis. A direct measurement of the area in which the
MyLab is to be used may be necessary. If the intensity of the electromagnetic fields
exceeds that specified in the immunity levels shown in the previous tables, and the
echographic system does not perform correctly, additional measures may be
necessary, i.e. positioning the system in a different way.

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Probe Superficial Temperature

MyLab has been designed to maintain the probes’ superficial temperature within the
limits defined by the IEC 60601-2-37 standard. Esaote recommends freezing the
system at the end of each exam by pressing the FREEZE key to avoid probe
overheating. The system will automatically be frozen if left inactive for a few
FREEZE key minutes.

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Chapter

3 - Clinical Applications
MyLab is designed for operators who are qualified in using ultrasound systems.

Intended Use
The ultrasonic medical diagnostic equipment is intended to perform diagnostic
general ultrasound studies including:
Fetal, Abdominal, Intraoperative (Abdominal), Intraoperative (Neuro),
Laparoscopic, Pediatric, Small organs, Neonatal Cephalic, Adult Cephalic,
Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal
(Superficial), Urological, Cardiac Adult, Cardiac Pediatric, Trans-esophageal
(cardiac), Peripheral Vessel.

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

The ultrasonic medical diagnostic equipment is intended to be connected to

mechanical and electronic ultrasound transducers.

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Clinical Applications
When fully configured, the system offers a variety of intended uses.

SS Note
Carefully read
Chapter 2 of the
"Safety and The operator must always follow the principle known as ALARA (As
Standards" manual. Low As Reasonably Achievable) and must use minimum acoustic
power for the minimum time required to obtain diagnostic
information.

Do not use MyLab for ophthalmic or transorbital applications.

W A R N I N G

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

Application Notes
General Imaging Includes ABDOMINAL, BREAST, MUSCULO-
SKELETAL, NEONATAL, PEDIATRIC, SMALL PARTS
(testicles…), THYROID and UROLOGIC; includes
endovaginal and transrectal exams if an endocavity probe is
available
Obstetrics (OB-GYN) Includes OBSTETRIC and GYNECOLOGIC application
Cardiac (Cardiac and Includes transesophageal exams if a TEE022 (for cardiology
Pediatric Cardiac) on adults) or TEE 132 (pediatric cardiac) is available
Vascular Includes ADULT CEPHALIC application
Intraoperative (Neuro) --

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.

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MyLab Probes
Please refer to the The following tables list MyLab probes and their supported Clinical Applications.
corresponding chapter
for specifications and
licenses.
Probes Clinical Applications
CA Probes
C1-8* ABD, BRE, CAR, GYN, MSK, OB, PC, PED, SO, URO, VAS
CA123 ABD, BRE, CAR, GYN, MSK, NC, OB, PC, PED, SO, THY, VAS
CA430 ABD; BRE, CAR, GYN, MSK, OB, PC, PED, SO, URO, VAS
CA431 ABD, BRE, CAR, GYN, MSK, OB, PC, PED, SO, URO, VAS
CA541 ABD, BRE, CAR, GYN, MSK, OB, PC, PED, SO, URO, VAS
CA631 ABD, BRE, CAR, GYN, MSK, OB, PC, PED, SO, THY, URO, VAS
SC3121* ABD, BRE, CAR, GYN, MSK, OB, PC, PED, SO, URO, VAS
SC3123* ABD, BRE, CAR, GYN, INT, MSK, NC, OB, PC, PED, SO, THY, VAS
SI2C41* ABD, BRE, CAR, GYN, MSK, OB, PC, PED, SO, URO, VAS
LA Probes
L4-15* ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
LA332 ABD, BRE, CAR, GYN, INT, MSK, NC, OB, PED, SO, THY, URO,
VAS
LA435 ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
LA522 ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
LA523 ABD, BRE, CAR, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
LA533 ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
SL2325* ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
SL3116* INT, MSK, SO
PA Probes
PA023 CAR, NC, PC, PED, VAS
PA122 ABD, CAR, NC, PC, PED, VAS
PA230 ABD, AC, CAR, GYN, OB, PC, PED, SO, VAS
PA240 ABD, AC, CAR, GYN, INT, OB, PC, PED, SO, VAS
PA250 ABD, AC, CAR, GYN, INT, OB, PC, PED, SO, VAS
Special Probes
BC441** ABD, BRE, CAR, GYN, MSK, OB, PC, PED, SO, URO, VAS
BL433** ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
BE1123** GYN, OB, URO
EC123 ABD, GYN, OB, URO, VAS
EC1123 ABD, GYN, OB, URO, VAS
TEE022 CAR
TEE132 CAR, PC
IH 6-18* ABD, BRE, GYN, INT, MSK, NC, OB, PED, SO, THY, URO, VAS
IOE323 ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
IOT342* ABD, BRE, GYN, MSK, NC, OB, PED, SO, THY, URO, VAS
LP323 ABD, GYN, PED, SO, VAS
TRT33 GYN, URO
Doppler Probes
2CW CAR, PC, VAS
5CW VAS
HF CW VAS
S2MPW* AC, VAS

ABD: Abdominal; AC: Adult Cephalic; BRE: Breast; CAR: Cardiac; PC: Pediatric Cardiac; GYN: Gynecologic;
MSK: Musculo-skeletal conventional and superficial (including nerve blocks); NC: Neonatal Cephalic; OB: Obstetric;
PED: Pediatric; SO: Small Organs and Small Parts; THY: Thyroid; URO: Urologic; VAS: Vascular; INT:
Intraoperative (Neuro).

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* The probe requires a proper adapter to be connected to MyLab;

** The BC441, BL433 and BE1123 probes enable the volumetric acquisition;

Do not use MyLab for ophthalmic or transorbital applications.

W A R N I N G

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.

Cardiac Application
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.

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

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 the
blood velocity, flow and patency of abdominal vessels through the Doppler
modalities. In gynecology and urology, ultrasound energy is applied through the
skin to image the female genito-urinary organs or the kidney and males genito-
urinary structures (for example prostate, bladder). An endocavity probe can also be
used to image the same organs, either endovaginally (gynaecologic application) or
transrectally (urologic application).

Small Organs and Small Parts Application

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).

OB/GYN Application
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

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patient abdomen to detect placental or fetal flow abnormalities. An endocavity

probe can also be used for the same purposes (endovaginal studies).

SS Note
Carefully read
Chapter 2 of the
"Safety and The user should always follow the ALARA (As Low As Reasonably
Standards" manual. Achievable) principle, but especially in OB/fetal applications. Use the
lowest amount of acoustic output power for the shortest duration of
time to obtain the necessary clinical diagnostic information.

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

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

This does not include transcranial, transorbital or any other ophthalmic

W A R N I N G
application.

The ultrasound beam must not be directed to the eyes.

Pediatric Application
The probe applies ultrasound energy through the skin to acquire images and to
analyse flows in pediatric and neonatal exams. In neonatal exams, the probe applies
ultrasound energy through the neonatal head fontanels to visualize brain structures
(imaging) or flows (Doppler), to detect structural or functional abnormalities.

SS Note
Carefully read
Chapter 2 of the
"Safety and The user should always follow the ALARA (As Low As Reasonably
Standards" manual. Achievable) principle, but especially in OB/fetal applications. Use the
lowest amount of acoustic output power for the shortest duration of
time to obtain the necessary clinical diagnostic information.

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This does not include transorbital or any other ophthalmic application.

W A R N I N G

The ultrasound beam must not be directed to the eyes.

Adult Cephalic
The probe applies ultrasound energy through the adult patient skull to visualize
cerebral vessels and flows to detect functional abnormalities.

This does not include transorbital or any other ophtalmic application.

W A R N I N G

The ultrasound beam must not be directed to the eyes.

Intraoperative (Neuro) Application

TC The probe applies ultrasound energy, following craniotomy, to the patient brain to
Carefully read
Chapter 2 of the obtain an image to detect abnormalities (Imaging) and assess the blood velocity,
“Transducers and flow and patency of vessels through the Doppler modalities.
Consumables”
manual. Neurosurgery is a critical application thus probes used in neurosurgery should be
sterilized and the use of sterile non-pyrogenic sheath is required. Please note that the
use of sheaths does not change the type of processing that is recommended for the
probe. After use, the single-use sheath should be removed and properly discarded.

When in direct contact with the brain or with the central nervous system,
W A R N I N G
the probes has to be enclosed in a sterile non-pyrogenic sheath.

The sterile non-pyrogenic sheaths must be in Class III according to Council

Directive 93/42/EEC and its amendments.

The protective sheaths available on the market often contain latex. Make sure
that patients who are allergic to latex are identified before each examination.
Serious allergic reactions to latex have been reported; the Operator should be
prepared to handle such a reaction. Refer to the package indications to
identify whether the product contain Latex (for further information refer to
FDA Medical Alert, March 29, 1991, “Allergic Reaction to Latex-Containing
Medical Devices”).

Probes used for critical applications should be cleaned and sterilized before the first
use and after use even if a sterile sheath was used. Sheaths can fail during use and the
level of resulting contamination may not be easily visible.

W A R N I N G
Probes that contact brain tissue and cerebrospinal fluid should always be
used with a sterile, endotoxin-free sheath because the disinfectant/sterilant
residue left on the probe is neuro-toxic and endotoxin is pyrogenic (e.g., it
causes fevers).

If the probe is used on a patient with known or suspected Creutzfeldt-Jakob

Disease (CJD or vCJD) the probe shall be destroyed.

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Use only sterile saline or other non-pyrogenic coupling media.

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Chapter

4 - System Components
and 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's
components and the major operations that may be necessary.

The monitor must be considered an IT device: it can be safely used inside

W A R N I N G
the patient area only when it is powered through the cart insulation
transformer.

The plugs panel of the trolley includes an earth terminal to be connected to an

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

System Overview
MyLab models are equipped with a 21.5” Full HD LCD screen, which can be freely
oriented thanks to its articulated arm.

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MyLabEight

The orientable LCD holder can be easily adjusted to optimize the LCD position
for the exam.

The system is completed by the control panel assembly and a console with the
system electronics and connectors.

The console top is equipped to house video peripherals. It has a rear mains switch
to power up the console, the screen and the peripheral units. For transportation,
the system provides a handle (control panel front) and independent brakes on the
four wheels.

MyLab Sat MyLabSat, a portable ultrasound scanner, is a peculiarity of MyLabEight eXP:

MyLabEight eXP can be equipped with an optional lateral cover to host MyLabSat
for storing and recharging purposes.

The battery of MyLabSat can be always recharged, both whether MyLabEight eXP is
on or off. Refer to MyLabSat user manual for further information.

Note

The rear panel mains switch of MyLabEight eXP must be turned on

when recharging.

MyLabEight eXP can access MyLabSat database, configured as a remote folder.

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Note

Refer to the MyLabSat operator manuals for information on the

database configuration.

Refer to the “Advanced Operations” manual for all information related to access
AO and management of the remote folder located on MyLabSat.

Control Panel Assembly

The control panel assembly includes the unit handle, all system controls, including
an ON/OFF button, the loud speakers, probe and gel holders on the right, and
probe and ECG cables holders on the left. The panel also includes a touch screen
containing system controls, a DVD/CD burner and audio connectors.

USB Ports Two USB ports are located on the right of the touch screen; these ports can be
used to connect a USB printer or a USB device for digital data storage.

Burner A CD/DVD burner is available on left of the touch screen; it allows the operator
to burn data both on CDs and DVDs or to read data both from a CD and a DVD.

The assembly can be rotated to find its optimal orientation for operation and
transportation.

Console
Probe Connectors Probes connectors are located on the front of the system (right side); five
connectors are available, one of which is dedicated to Doppler probes.

Power Plug The power cord plug, the fuse box and the electrical power switch (mains switch)
are located on the bottom of the system, at the rear.

When installing MyLab, check that the power cable is not tightly bent, that it
W A R N I N G
can’t be squashed by a misplaced foot or by heavy objects.

Wheels All four wheels are rotational. Each wheel has two locking levers (the grey one to
brake and the green one to lock the rotational mechanism) and one lever on top to
release the wheel.

Peripherals The console top is equipped to house two video peripherals (e.g. one printer and
Housing one VTR). Secure them to the system console with the provided belts.

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Connections
Probes Imaging probes can be connected to the EA1, EA2, EA3 or EA4 connectors; the
Doppler probe has its own dedicated connector (D).

Do not touch the probe connector pins or the system probes receptacle.
W A R N I N G

Never disconnect the probe while it is active. Press the FREEZE key before
disconnecting the probe.
Probes with big Probe connection procedure: make sure that the connector-securing device is in
connector the "OPEN" position, align the pins of the two connectors and carefully attach the
probe connector. To secure it, move the securing device to its "LOCK" position.
To connect a Doppler probe, attach the connector with the reference facing up.

Probe Adapter MyLab can be equipped with a probe adapter to be placed in any connector. This
adapter changes the connector dimension from big to small size, allowing the use
of small connector probes.

Probe adapter connection procedure: make sure that the probe adapter is in the
“OPEN” position, align the pins of the two connectors and carefully attach it. To
secure the adaptor, move the securing device to its “LOCK” position.

Probes with small Probe connection procedure: make sure that the securing device is positioned
connector downward (open position) and carefully attach the probe connector. To secure the
probe, move the securing device upward (close position).

Control Panel Assembly Orientation

This assembly can be pushed up/down and also laterally oriented to maximize
operator comfort; also, it can be rotated by 180° to get an optimal system
maneuverability (closed position).

In MyLab these two rotations are controlled by two levers located below the
control panel (as shown in the drawings below).

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The levers can be used to optimally

adjust the control panel and the screen
into its working position.

The orientation lever, located on the left,

allows lateral rotation of the assembly.

The lifting lever, located on the right,

allows to lift or to lower the control
panel.

The LCD can be Push the orientation lever to rotate the control panel into the new position. Release
directly rotated or the lever when the control panel is correctly positioned. This lever allows to rotate
tilted independently
from the control
by up to 90° clockwise and by up to 180° counterclockwise.
panel.
Push the lifting lever and acting on the handle adjust the height of the control
panel. This lever allows a vertical displacement of ±20cm.

When rotating the keyboard, pay attention not to damage the peripherals
W A R N I N G
placed on the console.

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Turning the System On and Off

At the examination site, rotate the control panel assembly into its working position;
unlock the wheels (green levers) to adjust the system into its final position.

When in working position, all the wheels must be locked to steadily secure
W A R N I N G
the system before starting the examination.

Plug the cable into the reliable grounding power outlet to assure adequate grounding.
Turn the mains switch of the rear panel on.

Note

Whenever the system has to be insulated from the mains, disconnect

the cable from the power outlet.

When installing MyLab, check that the power cable is not tightly bent, that it
W A R N I N G
can’t be squashed by a misplaced foot or by heavy objects.

The ON/OFF control panel button may then be used to power the system on and
off.

Note

It is recommended to turn the rear panel off prior to unplugging the

power cable or whenever the system is expected not to be used for
long periods.

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
Hours 8 6 4 2 1 0 1
T(°C) 5 0 -5 -10 -15 -20
Hours 2 4 6 8 10 12

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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 with the power cable unplugged from the
main and wheels braked.
2. Connect the peripheral device to the MyLab.
3. Switch the peripheral device on, assuring 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
MyLab is equipped with an insulation transformer to provide required separation
from AC mains for both the system and the auxiliary devices. Three plugs for
connecting auxiliary devices are located in the back of the system and are accessible
opening the rear door.

Additional equipment connected to MyLab must comply with respective IEC or

ISO standards (e.g. IEC 60950 for data processing equipment). 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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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
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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C) Non-medical used room

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

Note

Auxiliary Devices must be approved by Esaote. Auxiliary Devices

must also comply with EN 60601-1-2 safety standard and subsequent
amendments or the electromagnetic compatibility.

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

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Additional safety measures are:

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

The system must be powered so to satisfy the electrical safety requirements,

W A R N I N G
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 Devices
The "Safety and Standards" manual provides the safety requirements and standards
SS to be observed for using peripheral units with your system.

Before installing the peripheral units, make sure that the system is switched off and
unplug the power cable from the mains. Lock the trolley by engaging the brakes.

Video Devices
Before connecting the peripheral video verify not to exceed the maximum
C A U T I O N
power consumption limits indicated for insulated sockets. There is a risk of
blowing the system fuses.
Contact Esaote Installation of peripherals units can be easily performed, as each cable is labeled, at
personnel for the connector end, with a description of its destination port (ex.: C-VIDEO IN).
recommended video
peripherals
Once the connection has been completed, secure the peripherals with the provided
compatible with the belts.
system.
Note

Disconnect and remove probes and peripherals when transporting

the system in a vehicle.

Digital Printers
The system can be connected to digital printers via a USB port or a network
interface.

The maximum current supplied by the USB ports is 500mA. USB

W A R N I N G
peripherals exceeding this limit can be connected only if powered by their
external power supply.

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Transporting the System

MyLab is provided with wheels and handle to allow the user to easily move the unit.
The following precautions must be observed:
Moving the system • Switch the system off and unplug the power cord.

• The wheels of MyLab are provided with brakes; be sure that the brakes are
unlocked (green levers) before moving the ultrasound system.

• Tilt the touch screen in its transportation position.

• The LCD must be in its transportation position (magnetic coupling).

• Avoid any unnecessary mechanical shocks to the system while moving it.

• If the probes are connected, be sure that they are properly placed in the
suitable MyLab probe-carriers and that the cables do not reach the floor.

• The peripherals can be placed on the MyLab peripheral platform on the

rear part of the system.

• If the peripherals are also placed on an external additional platform, be

sure they are disconnected from MyLab before moving the ultrasound unit.

Only the handles on the keyboard must be used to move the system and
W A R N I N G
rotate the keyboard.

Make sure that the probes are locked in the appropriate holders and the
probe cables are properly hanged in the cable hooks during the movement.

The handles on the keyboard cannot be used for lifting the system.

To steadily lock the system, it is necessary to lock the wheels.

The orientable LCD screen must be centrally positioned using the magnetic
C A U T I O N
coupling.
Transportation When transporting the system in a vehicle, remember to:

• Protect both the holder and the screen so that no movement is

possible (ex. with a film).
• Disconnect and remove all probes and peripherals.
• Unlock the posterior locking device. To unlock it pull it and rotate
it till it clicks.
The keyboard could be damaged during transportation in a vehicle if it is
C A U T I O N
locked.

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Chapter

5 - Control Panel and

Touchscreen
This chapter provides a brief description of the system controls.

The Control Panel

The control panel is composed of:

• an alphanumeric section (keyboard),

• the trackball,
• a touchscreen with dedicated software keys,
• a controls section, including TGC and ON/OFF switch.

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Alphanumeric Section
The alphanumeric keyboard is based on the QWERTY standard. The
alphanumeric keys are used for inputting text data in the enabled windows. The
Caps Lock key presets the keyboard to upper case characters.

The Shift key is used for typing in lower case or upper case characters (according
to how the keyboard is set) or the characters indicated in the top left section of
some keys.

Special Characters With MyLab, the operator can type in the special characters through the
Windows® XP standard modalities. To type in special characters, two keys have to
be simultaneously pressed. The table below: shows the operating modalities.

First key Second key Special characters

‘ (Apostrophe) e, y, u, i, o, a é, ý, ú, í, ó, á

` (Grave accent) e, u, i, o, a è, ù, ì, ò, à

^ (Circumflex) e, u, i, o, a ê, û, î, ô, â

~ (Tilde) o, a, n õ, ã, ñ

“ (Diaeresis) e, y, u, i, o, a, ë, ÿ, ü, ï, ö, ä

The following characters are also available, if the operator presses the Alt key
(located on the right side of the spacebar) and the letters listed in the table below:

Right Alt + key Special character

, (comma) ç
w å
z æ
l ø
s ß

Text Entry If any of the alphanumeric keys are pressed during the exam, this automatically
activates the input of text. All writing operations are managed by the alphanumeric
AO keyboard and trackball; the trackball is used to position the cursor.

The ANNOT key allows to access a glossary, which can be configured by the user.
Refer to the “Advanced Operation” manual for more information on text entry.
Annot key

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Trackball
The trackball operates in two different modes.

Standard Mode In its standard function, the trackball allows quickly positioning of the cursors on
the screen. The following chapters provide details of the specific functions
performed by the trackball.

Each mode automatically activates the trackball cursor:

Mode Trackball
B-Mode Transmission focal point
M-Mode, Doppler LINE cursor
Color Flow Mapping CFM ROI cursor
(CFM)
When several cursors are on the screen, the ACTION key activates the active cursor.

Mouse Mode In this mode the trackball is used to move a pointer on the screen. In this case, the
keys placed on the left and right side of the trackball can be set as mouse keys (as
AO enter and context menu keys).
Refer to “System
Configuration” section for
trackball configuration. Regardless of the trackball configuration, the enter and context menu keys are
respectively indicated as ENTER and UNDO keys in this manual.

The POINTER key enables the user to change the trackball operation from standard
to mouse mode.

Touchscreen
The touchscreen includes three main sections:

• Section of software options (tools),

• Section of function keys,
• Section of buttons and software keys.

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Tool Section The upper part of the touchscreen shows the icons of the tools (software options
like 4D). If necessary, two arrows are displayed, to scroll the options. To activate
the desired option, press the corresponding icon on the touchscreen. For further
information on the use of these tools, refer to the manual Advanced Operations.

Tool keys have different colors, depending on the active status:

Active key Selected key Inactive key

Light gray background – White Gray background – Blue text and Light gray background – Gray
icon and text borders icon and text
To activate the desired tool, press the corresponding icon on the touchscreen.

Function Keys The middle area of the touchscreen shows ten keys, having the following
Section functions:

• ARCHIVE REVIEW allows to access the data contained in archive at any

time.
• PHYSIO allows the operator to modify the amplitude of the ECG trace
(if this function is available in the active application) and its position on
the screen.
• PLEX enables combined modes, depending on the active settings.

• VTR activates and disables the VTR menu.

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Note

To ensure the correct functioning of operations with the video

recorder, MyLab must be configured with the correct VTRs and with
the relevant settings.

• ORIENTATION changes right/left or left/right orientation, indicated by a

symbol that represents the probe led (see next chapter for further
Orientation key
details).
• EXAM REVIEW is used for accessing, at any time, the data stored during
the current exam.
• BIOPSY is displayed only when the active probe can work with a biopsy
needle guide. Pressing this key enables/disables the display of the
biopsy line.
• GAIN ADJUST opens a software key menu allowing to control the auto
gain, the PBI (Pure Brilliant Imaging) function and the TGC options
(absolute and relative modes).
• CLEAR ALL erases all graphical annotations entered in the screen
(annotations, measurements etc.).

• REVERSE changes up/down orientation.

Reverse key
Function keys have different colours, depending on the active status:
Active key Selected key Inactive key

Black background – White text Black background – Blue text and Gray background – Black text
borders
To activate the desired key, press the corresponding icon on the touchscreen.

Section of Buttons This section includes six buttons and six scrolling keys (software keys). Functions
and Software Keys and definitions of these keys vary depending on modes, applications and settings.
Buttons The four central buttons have different colors, depending on the status: the
available colors and corresponding meanings are the ones already described.

The two lateral buttons respectively open the burner drawer and turn the system
light on.
Software keys The lower part of the screen shows six software keys. These keys are controlled by
six encoders, distributed below the software keys. Press the touchscreen to
activate/deactivate the function related to the key; rotate the encoders to select the

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desired value. If the displayed menu is organised in several levels, the sixth key
(NEXT/PREV) is to be used to scroll the menus of the first five keys.

Software keys have different colors, depending on their active status:

Key that can be only rotated Key that can be rotated and pressed

Black background – White text Gray background – White text

To activate the desired key, press the corresponding icon on the touchscreen.

Controls Section
This section includes the ON/OFF switch, TGC controls and a functional
keyboard.

The ON/OFF button turns the system on and off; this button is active only if the
rear panel mains switch is on ON.

This is a PC based system; data loss or driver damage may occur if the
C A U T I O N
system is turned off while working. Refer to the appropriate sections of this
manual for detailed information on when and how to safely power the
system off.

TGC potentiometers control the signal amplification in individual areas of the

image. Potentiometers are used to adjust the signal zone by zone.

Exam Flow
START/END is the key that opens and closes every exam. The menu is used for
entering patient data and for the choice of application, probe and required presets.
Start/End
During the exam, the user may select a different probe (PROBE key), select and
create a different preset (PRESET key).
Probe
When the exam is finished, press the START/END key again. It is then possible to
archive the patient's data and produce an exam report. The system clears the stored
data and shows the exam start window again.
Preset
The PATIENT ID key is used to input or modify the patient's data during the exam.

Patient ID

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The Mode Keys

This key activates a full screen B-Mode image in real time.

This key activates the M-Mode, and if necessary, the selection cursor (B-Line).
There are five possible viewing formats: full screen format in M-Mode; dual
format, with the screen split vertically with 2D on the left and the trace on the
right; the split screen formats, with the screen split horizontally, with the reference
2D above (with three possible sizes) and the M-Mode trace below. The viewing
format can be preset and modified in real time through the displayed menu.
B- and M-Mode The knob around the B/M key affects the B- and M-Mode gain signals, adjusting
Gain amplification over the entire depth of the image: to increase the gain, rotate the
knob clockwise, to reduce it, rotate the knob counterclockwise.

The Color Doppler Mode (CFM) is activated by pressing the CFM key.

This key activates Power Doppler (PWR D).

In B-Mode, a cursor delimits the Region of Interest (ROI) where color analysis is
executed and displayed. The ROI dimensioning and positioning can be modified
with the trackball, activating the ROI cursor with the ACTION key.
Action key
The real time Soft Keys menu allows the operator to change the display mode and
to switch to Power Color or TVM (Tissue Velocity Mapping). TVM1 uses Doppler
to display the heart walls motion, rather than flows. The displayed menu enables to
change the B-Mode and make it coincident with the ROI ("Coincident" view).

Color M-Mode is shown in full screen or with a reference 2D, according to the
choices on the displayed menu.
CFM Gain The knob around the CFM key affects the CFM and PWR-D gain signals, adjusting
amplification over the entire signal. To increase the gain, rotate the knob clockwise,
to reduce it, rotate the knob counterclockwise.

This key activates Pulsed Doppler (PW).

This key activates Continuous Doppler (CW).

1 TVM and TV modes are enabled only with the PA230, PA240, PA122, PA023, TEE022 and TEE132

probes in a cardiac application.

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Both keys activate the positioning cursor. As in M-Mode, five viewing formats are
available: the three split formats, the dual format and the full screen format. During
the exam, the format can be preset or modified interactively through the use of the
menu.

In PW, the available software keys in real time allow to activate the TV (Tissue
Velocity) modality. TV sets the Doppler filters to enable the visualization of strong
signals with low velocity (ex. heart walls motion).
Doppler Gain The knob around the PW key affects the PW and CW gain signals, adjusting
amplification over the entire depth of signal. To increase the gain, rotate the knob
clockwise, to reduce it, rotate the knob counterclockwise.

The level of the audio signal may be independently adjusted with this key, which is
disabled in the imaging modes.

In 2D or CFM, the line cursor (LINE key) can be interactively activated or disabled
to select the M-Mode or Doppler Mode.
Line/Update In both M-Mode and Doppler, the UPDATE key starts the trace acquisition. If this
key is pressed during acquisition, the trace is frozen, while the reference 2D keeps
being active.

This key stops the current analysis or scan and puts the system in Freeze mode. To
re-activate in real time, press it a second time or directly press the applicable key for
the required mode.

Format Controls
Depending on how the system is preset or on the selections on the displayed
menu, these keys activate multiple views of two (dual) or four 2D (quad) images. In
Dual mode, the user can display two different images or the same 2D image
simultaneously.

Press any key to activate multiple presentations. The active 2D is displayed on the
left (in the upper box for quad presentation). If the key is pressed, or the key
is pressed the 2D freezes in acquisition and activates the next 2D.

Press B/M to return to the normal format.

The DEPTH/ZOOM multifunction encoder allows to change the scanning depth or to

enlarge the 2D image.
Depth/Zoom Key By default rotating DEPTH/ZOOM increases or reduces scanning depth in all imaging
modes.

Pressing DEPTH/ZOOM actives, both in real time and in Freeze, the Zoom function,
used to selectively enlarge a zone of the image in B-Mode or in CFM.

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Once the Zoom function is active, rotating DEPTH/ZOOM increases or reduces the
enlargement factor. The zone of interest can be positioned by the trackball. Press
DEPTH/ZOOM again to return to a normal format.

When the High Definition Zoom is set, the zoom offers a superior definition of
the enlarged image in real time (see later in this manual for further details).

Basic Controls
TGCs can be used in two ways: absolute or relative.

In absolute mode, the sliders action is always distributed on the maximum depth of
the probe. Non active TGCs, depending on current depth, are not lighted.
Auto Adj In relative mode all sliders are distributed on the current depth. Every time depth is
changed, TGC are redistributed. All TGC are always lighted.

The AUTO ADJ key automatically adjusts both gain and TGC.

The STEER toggle key allows to orient the Doppler line or to align the angle vector
with the flow direction. Steering allows to get an insonation angle as closed as
possible to 90 degrees, improving the visualization of anisotropic structures (for
example tendons). Steering is available on linear probes and can be applied by
acting on STEER when in live B-mode.

The POWER knob is active in real time only and it is used to modify the emitted
power during the exam. It operates independently for each mode: e.g. in PW
Power mode, it controls the power of the Pulsed Wave Doppler; in 2D-CFM mode, it
controls the power of the CFM.

Power control must be adjusted to the minimum possible level compatible

SS with an acceptable image. Carefully read the "Safety and Standards"
manual regarding the guidelines on the safety of ultrasound.

The FREQ-TEI multifunction encoder allows the imaging frequency to be quickly

changed (higher frequency to optimize resolution, lower frequency to increase
penetration). The TEI mode can be activated on lower frequency probes by
Freq-TEI pressing the encoder. This mode generally improves the brightness of the image by
decreasing acoustic noise. Because of the non-linear response of tissues to
ultrasound energy, TEI may require higher acoustic emissions compared
with conventional imaging; the use of this mode is therefore recommended
especially on patients with difficult acoustic windows.

Exam Storage
During the exam, the operator can save both individual images and sequences (for
systems having the clip license) by using the IMAGE key, for the frames, and CLIP
Image key, for the sequences (2D or CFM). The stored images and sequences are
displayed as thumbnails on the bottom of the screen.

Clip

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Exam Report
General measurements (+∙∙∙∙+ key) and access to the calculations package may
always be executed, specifically for the current application (MEASURE key). When
the required key is pressed, the list of available measurements is shown on the right
of the image.

Measure Peripherals Management

The keyboard can control different peripheral units with keys 1 and 2, depending
on the system's presets. For example, the operator can connect both a B/W printer
and an RGB printer and control them separately with these keys.

REC/Print
Settings
This key displays the system menu for all configurations / settings (center name,
preset…). The menu is explained in detail in a following chapter.
Menu

Advanced Operations
Keys MARK, REPORT and ACQUIRE activate advanced operations: further details on
AO how to use them are described in the "Advanced Operations" manual.

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Chapter

6 - Screen Layout
This chapter provides a brief description of the information on the MyLab screen.

Information about the Screen

The screen is subdivided into three main areas:

Heading
Thumbnails

The video area (i.e.,

the screen area which
can be managed by Image
video peripherals) is a Area
screen sub-set; it
includes most of the
Heading and the
entire Image Area.

Footer

Heading
This area is used for displaying the following information: center and patient data,
and the current date and time.
For setting center Patient Data
data, see Chapter 9 Patient data is displayed only if entered at the beginning of the exam. The system
of this manual.
displays the following patient data: last name and first name, age and patient code.

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Footer
This area is used for displaying the icons for the following: trackball, archival
systems and configured peripheral units.

Trackball
The trackball function is indicated by the icon shown at the left of the screen.

When there are several cursors on the screen, two icons are displayed
simultaneously. The yellow icon shown on the left indicates the active cursor; the
green cursor on the right indicates the next cursor that can be activated. The
ACTION key switches between the cursors.

Archival Systems
The archival system icons are shown on the left of the screen, after the trackball
icons. The icon is blinking and bordered in yellow while working; it is shown
crossed out whenever there are management problems involving the specific
archival system.

For more details on data archival, consult Chapter 8 and the Advanced Operations
AO manual.

Peripheral Units
The system is able to simultaneously manage two peripheral units (b/w or RGB
printer and the VTR). The icons of the peripheral units are shown at the right of
the screen.

The peripheral units’ icon is shown crossed out whenever there are management
problems involving the specific peripheral unit.

Image Area
The display of the image depends on various factors such as active mode, selected
application, and transducer. The following screen shot shows the elements in the
image area which are independent of the factors listed above.

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Legenda:

Number Icon

1 Active application
2 Sector orientation
3 Machine parameters
4 Acoustic output data
5 Focal zone
6 Frame Rate
7 Thumbnails of stored images
8 If colored, it indicates images to be scrolled
9 CFM scale
10 Imaging scale
11 Active probe
12 Selected preset
13 Frequency bar

Applications
The system displays different icons according to the selected application.

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System Parameters

Imaging Parameter Quantity Description

TEI - TEI mode when enabled
XV n X-View
G nn % Imaging gain (Min, %, Max)
AG nn % Automatic gain when enabled
D nn mm Depth
PRC n/n/n Dynamic range, Enhancement,
Density
PST n Gray map
PRS n Persistence
C n Dynamic Compression
SV nn-nnn mm Sample volume Size and Depth (PW)
Θ nn° Doppler correction-angle

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

Color Flow Parameter Quantity Description

Mapping (CFM) F nnn MHz CFM frequency or TVM frequency
when enabled
G nn % CFM gain (Min, %, Max)
PRF nnn kHz Pulse Repetition Frequency
PRC l/n Smooth, Density
PRS n Persistence
WF n CFM filter

Doppler Parameter Quantity Description

F nnn MHz Doppler frequency or TV frequency
when enabled
G nn % Doppler gain (Min, %, Max)
PRF nnn kHz Pulse Repetition Frequency (kHz)
PRC n Dynamic range
WF nnnn Hz Wall filters

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Chapter

7 - Performing an Exam
This chapter describes the operations typically performed while an exam is being
performed and how to turn the system off at the end of the session.

Read the Safety and Standards Manual carefully: all the safety
SS characteristics, cautions and warnings listed 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 relevant diagnostic information.

Exam Start and End

At power-up, at the end of the initial autotest and at the start of every new exam
(START/END key) the system shows the screenshot shown in the following figure.

Do not turn the system off during the initialization phase: the hard disk
C A U T I O N
could be damaged by this operation.

Note

Connect the probe before switching the unit on: if no probe is

connected, the system doesn’t allow to enter real time.

The Exam Start window is used for inputting patient data, for selecting the
application, as well as the required presets and probe.

Note
AO To guarantee data integrity and confidentiality, the system allows to
configure a list of users allowed to work on the system. In this case to
access the system the user needs to log in and type a password. See
the “Advanced Operations” manual for further information.

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Age is automatically
calculated from the
date of birth.

Note

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

At any time during the exam, the operator can view and modify the patient's data
with PATIENT ID and can also select a different probe and setting by using PROBE
and PRESET. Moreover the PRESET key allows to create, to edit and to save the
presets in real time in any application.

Do not use PATIENT ID to begin a new exam as this will update the existing
W A R N I N G patient’s information with new entries. To activate a new procedure, always
use the START/END key.

To select fields and options, use the trackball and the ENTER key: The trackball
moves the cursor; the ENTER key fixes the cursor’s position, opens the drop-down
menu and selects the option.

How to Input • Move the cursor with the trackball.

Patient Data and
Select an • Input the patient's data using the alphanumeric keyboard. The  Back
Application Space key is used to remove input characters.

• To move rapidly through the different items, use the Tab  key.
• Select the required application, preset and probe. The selected
application and presets are displayed over a black background, and
the selected probe is displayed over a blue field.

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Note

For each application, the presets are sorted out according to their
frequency of use.

• Move the cursor over OK and press ENTER to begin the exam.
Alternatively it is possible to press START/END again or FREEZE.
For the “Referring Physician”, “Performing Physician” and “Operators” fields, a
pop-up menu offers the possibility to select a previously inserted name. Press
ENTER on the triangle on the right side of the box to open the list, then ENTER
again to confirm the selection of the name. To reset the list, press UNDO on the box
you desire, then press “Reset”.

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

Note

When starting a new exam, the previously selected application and

preset are already highlighted in the window allowing to start the
exam.

Note

When starting an Intraoperative (Neuro) application, before

proceeding with the exam, you have to confirm in order to have
understood the following message, displayed in a modal dialogue
window: “Neurosurgery Application - The probe has to be enclosed
in a sterile non-pyrogenic sheath. If the probe is used on a patient
with known or suspected Creutzfeldt-Jakob Disease (CJD) the probe
shall be destroyed”.

If a patient is already present in the archive, it is possible to retrieve his/her data

from an archived exam without the need to enter them again. In the window
allowing to start the exam press the E X A M L I S T key, select the patient from the
list of archived exams, then press R E T R I E V E to load data: the windows fields will
be filled with the selected patient. Start the exam as described above. If a DICOM
archive is available, it is also possible to load data from it using the W O R K L I S T
key.

If the “Enable paused exam” option is enabled, pressing P A U S E D E X A M S a list

with paused exams is displayed, allowing to RETRIEVE, CLOSE or DELETE them.

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Before beginning the exam, ensure that the active probe displayed on the
W A R N I N G
screen matches the one selected on the Exam Start page.

Probe, application and preset can be selected from the touchscreen.

Start an exam • Touch the probe you want to select.

from the
touchscreen • Touch the required application.
• Touch the required preset to start the exam. Every time a preset is
touched the exam starts.

Note

For each application, the presets are sorted out according to their
frequency of use.

When the probe/applications/preset are more than ten, the icon beside is
displayed: press it to scroll the list.

Exam End To end the exam, press the START/END key. The window displayed at the end of
the exam is used to archive the exam. This window shows the patient's first name,
the type of activated application and the size of stored images.

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If the “Auto save” option is enabled the above window is not displayed and the
exam is automatically saved as set in the General Preset menu.

When the “Enable paused exam” option is enabled a third button is displayed
allowing the user to pause the exam (PAUSE EXAM) or to definitively close it (END
EXAM).

Note

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

Further details are Before archival, the patient’s data may be made anonymous. The exam can be
provided in the data simultaneously archived and exported and the corresponding report can be saved
archival chapter.
on an external medium.

The system automatically presents the window at the start of 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.

ECG
When the electrodes have been applied and connected, the position of the ECG
trace on the screen can be selected, and the gain can be adjusted.

• Press PHYSIO to display the software keys menu.

• Press E C G to display the ECG trace on the screen.
• Modify the signal's amplitude by pressing the G A I N key.
• If necessary, rotate P O S I T I O N to move the ECG trace on the screen.
• The H E I G H T key changes the area size to display the ECG trace.
Press P H Y S I O to return to the real time menu.

Do not use the physiological trace displayed on the screen for diagnosis or
W A R N I N G
monitoring.

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Error Messages
Whenever an internal fault occurs, the system automatically freezes and an error
message is displayed. 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 “Advanced Operations” manual, “Archive”
section for further information) and contact Esaote Service department.

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 mode.

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

The keyboard and commands displayed on the software keys menu make it
possible to optimize presentation quality. Different menus correspond to each
format. If the displayed menu has several levels, press the N E X T /P R E V I O U S key
to scroll through all functions.

High Definition If the High Definition Zoom function in real time has been set, the DEPTH/ZOOM
Zoom key activates the ROI cursor.

• Place the ROI cursor on the area to be enlarged.

• Press the ACTION key to change the area size using the trackball. Press the
ACTION key again to confirm.

• Press the DEPTH/ZOOM key to enlarge the selected area. Rotate

DEPTH/ZOOM to enlarge/reduce the zoom factor. Use the trackball to
move the area within the ROI.

• Press the DEPTH/ZOOM key again to quit the zoom function.

To save images and image sequences (2D or CFM), press IMAGE and CLIP. Clips
are acquired in Prospective Mode: the CLIP IMAGE key starts the loops acquisition.
For further
The number of captured loops depends on the set value (CLIPS DUR key).
information about
clip formats, consult Single images are saved with full definition; sequences are compressed. Sequences,
the “Advanced or clips, are compressed in Jpeg format, with a minimum loss of information.
Operations” manual.

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Note

Digital data storage is typically slower than the ultrasound frame rate;
the clip frame rate may be lower than the original rate. A Warning
message is displayed if the archival frame rate drops below 20 fps,
which may occur if multiple tasks (example: burning a CD and saving
new clips) are operating simultaneously.

The thumbnails of the saved data are shown in chronological order, from the left
towards the right. A maximum of eight thumbnails are shown: the colored arrow
in the thumbnails row indicates that further images are available for scrolling.

The “Advanced Operations” manual provides a detailed description of all the

AO software keys active in the different modes.

Whenever there is a fault in the front end boards, the system automatically freezes
showing the following message:

Calibration in progress

The calibration procedure requires a few seconds. If the procedure ends

successfully, the system is reactivated and the following message appears on the
lower part of the screen:

Warning: reduced ultrasound power! Please contact the Service department.

This message will then be displayed at every start up.

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

Clips with High Frame Rate

In cardiac applications MyLab allows the acquisition of clips with a 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 (whose number is set by CLIPS DUR key) are
shown on the screen.
Clips with high frame rate can only be acquired after setting the automatic play.

Setting Procedure
• Press MENU.
• Select the “General Preset” option and then “Cine mode” option.
• Set the “Automatic Play” option to ON.

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• Press OK to confirm.
Acquisition Procedure
• Press START END to view the Start Exam page.
• Enter the patient’s data.
• Select the Cardiac application and press OK to confirm.
• Make sure that the patient’s ECG is correctly displayed.
• Start scanning and press the ACQUIRE key to select the desired cycles:
the system automatically shows in cine mode the last acquired loops.
• Using the trackball, scroll the memories to select the desired sequence.
• Press CLIP to save the sequence.
Clips acquired with the ECG signal (P H Y S I O key) synchronization and through
this modality are identified by a specific symbol, shown on the left. These clips are
indicated as Clip ART clips within the manual.
High frame rate clip
symbol (Clip ART)

Freeze and Scrolling Memories

The FREEZE key freezes the image. The system displays the scroll bar of the
memories, where the images acquired prior to the system being put on freeze are
temporarily saved.

How to Scroll through the Images in Memory

Move the trackball horizontally to scroll through the images one by one. The
scrolling bar shows the trackball position. The arrow keys ( and ) of the
Trackball icon alphanumeric keyboard can be alternatively used to scroll the memories.

For multiple formats, several scrolling bars are displayed; the ACTION key switches
over from one bar to the other; the trackball scrolls through the images of the
Trackball icon selected bar.

In freeze the sequence of stored images can be seen in cine mode if the P L A Y key
is active or if the A U T O M A T I C P L A Y option (MENU key) is set. The sequence can
be seen again at different speeds (use the S P E E D key) and the duration can be
changed (C L I P D U R key). When the clip is displayed in cine mode, move
horizontally the trackball to scroll the bar and display another interval.

The “Advanced Operations” manual provides a detailed description of all the

AO software menu keys active in freeze state.

Exam Review
During the exam, the E X A M R E V I E W key allows the operator to review the saved
images and sequences. When the E X A M R E V I E W key has been pressed, the

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trackball automatically changes over to pointer mode, allowing the operator to

scroll through the thumbnails and select the data item to be reviewed. The
software S C R O L L key enables the operator to scroll through the thumbnails when
more than eight images or sequences have been saved. If there are more than eight
saved images and clips, the P A G E software key allows the operator to quickly scroll
the thumbnails: the next eight thumbnails are displayed when the key is pressed.

The selected image or sequence is presented on the screen. Clips are presented in
cine mode: the P L A Y key disables the kinetic presentation and enables the
operator to scroll through the sequence image-by-image with the trackball.

Note

Images are usually compressed, with minimal loss of information.

Please see the “Technical Specifications” section in Chapter 11 for
more information.

The key A T T A C H attaches the selected image to the report: in this case the letter
“A” is displayed on the bottom left part of the screen, whenever the user reviews
an image attached to the report.

Image Clearing To clear a saved image or sequence, select it with the trackball and press the
D E L E T E key.

The E X P O R T key is used to export the image or sequence to an outside medium,

which can be selected from the appropriate window.

Annotations
If any of the alphanumeric keys are pressed during the exam, this automatically
activates the input of text. All writing operations are managed by the alphanumeric
keyboard and trackball, the latter being used to position the cursor.

The ANNOT key provides access to a user-settable glossary. The “Advanced

AO Operations” manual describes how to create and use the glossary.

System Shut Down

This is a PC based system; data loss or driver damage may occur if the
C A U T I O N
system is turned off while working.

Press the keyboard ON/OFF button to turn the system off; if there is at least one
operation still in progress, a dialog box will appear asking whether to wait till the
operation is completed. If the user confirms, the system automatically shuts down

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at the end of the operation, otherwise it interrupts any pending operation an turns
off immediately.

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Chapter

8 - Measurements and
Calculations
This chapter describes how to access the generic measurements and the specific
calculation packages of the applications.

General Information
Measurements can be made on frozen, stored and archived images. The available
measurements are shown to the right of the image. The messages displayed on the
screen guide the operator through the stages, facilitating measurement execution.
The results are shown on the left of the image.

Clips are compressed for digital storage. Compressed files involve a minimal loss of
information (see Technical Specifications Chapter 11). The Compression algorithm
used by MyLab ensures the preservation of the image features for the reporting
functions.

This symbol is displayed on the screen when the image features, compared to the
W A R N I N G
original one, may not be optimal for the reporting functions.

To select the views and the positioning of the cursors, Esaote urges the
operator to act according to current medical practice and the instructions of
specialists on this subject.

Note

Always enlarge the format to maximize the structure/signal to be

measured.

If possible, use the full screen formats for M-Mode and Doppler
measurements.

The system cannot be used to measure images with ambiguous

calibrations. An error message is shown on such images when the
measurement is made. Measurements on QUAD formats cannot be
made.

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Generic Measurements
The generic measurements feature allows the user to make rapid measurements,
for example: distance, area, time and speed.

This key activates the generic measurements menu. The system displays the list of
available measurements, which are automatically identified according to the active
mode and application. The software M E A S U R E key is used for rapid selection of
the required measurement. The measurement shown in yellow is immediately
operational.

Following the instructions displayed on the monitor, position the cursors with the
trackball and confirm the position by pressing ENTER. The UNDO key can be used
to restart a measurement before it has been confirmed. The Back Space deletes
point by point the traced line. The value being measured is displayed in real time
on the left side of the image.

Selective Deletion • Activate the trackball as a pointer by pressing POINTER.

of a Measurement
• Position the pointer on the measurement to be deleted (the
measurement is shown in yellow).
• Press the C L E A R key to delete the measurement.
• Press POINTER again to return to the measurements menu.
The C L E A R A L L key deletes all measurement cursors and the values shown in the
measurements field from the screen.

The “Advanced Operations” manual provides a detailed description of the generic

AO measurements available in every application.

Specific Calculation Packages

The specific calculation packages are based on the measurements to be performed
on identified anatomical structures.

To access the specific calculations, press the MEASURE key. The system
automatically identifies the calculations package according to the selected mode
and application.

The list of executable measurements is shown on the right side of the screen. The
measurements are arranged in groups (identified by the symbol ), which
correspond to specific anatomical structures. Each group includes the
measurements executable in that structure. To display the measurements included
in a group, position the trackball on the group and press the E X P A N D key.

Executed measurements are marked by the symbol  by the instructions.

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How to Select a • Freeze the image and press MEASURE.

Measurement
• Using the trackball, select the required group (the selected group is
displayed in yellow).
• To proceed with the entire measurement sequence specified by the
group, press ENTER over the selected group.
• To make a specific measurement press E X P A N D , select the required
measurement with the trackball, and press ENTER.
The system displays - at the bottom of the screen - the image with the operating
instructions for making the selected measurement. The trackball is used to position
the measurements cursors, while ENTER is used to confirm positioning when
prompted by the instructions.

To delete a specific unconfirmed measurement follow the instructions provided

for the generic measurements.

The “Advanced Operations” manual provides a detailed description of the specific

AO measurements available in each application.

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Chapter

9 - Exams Archive
This chapter describes how to archive images and to access the relevant archive.

Archive Icons
When the system accesses the archive, the relevant archive icons are shown on the
right of the heading bar. The active icon is displayed on a dark background, while
the icons that can be activated are shown over a blue background. Icons shown in
grey are inactive.

To activate the function, locate the trackball over the required icon and press
ENTER.

Data Archival
Refer to the “System The system has an internal hard disk in which the exams can be archived (local
Configuration”
section of the archive). The data can be saved on external supports and on DICOM format (for
Advanced Operations systems having a DICOM license), and exported in BMP, JPEG, PNG, TIFF
manual for further format or AVI format (see chapter 11 for further details).
details.
The IMAGE and CLIP keys save single images (with full or compressed resolution)
and image sequences (in compressed format). Pressing IMAGE when the Exam Start
window is displayed to save a screenshot of this window.

The screenshot of the Exam Start window contains the patient data at the
W A R N I N G
date and time of when the image has been taken. Do not refer to this data
but always check the current patient data.

When the CLIP key is pressed, the system stores sequences of a preset duration,
which can be set from the System Menu (see “Advanced Operations” manual).
Data is compressed with a minimum loss of information, with a maximum frame
rate of about 25 images.

Note

Digital data storage is typically slower than the ultrasound frame rate;
the clip frame rate may therefore be lower than the original one. A

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Warning message is displayed if the archival frame rate drops below

20 fps, as it may occur if multiple tasks (example: burning a CD and
saving new clips) are concurrently working.

Archiving the During an exam, the images are temporarily stored on the system's hard disk. The
Exam exam ends as soon as the START/END key is pressed. The system shows the window
of the exam end, which enables the operator to select the required format (DICOM
with the DICOM option; BMP, PNG, TIFF or JPEG for single frames and AVI for
clips with the EXPORT option; native format with the ARCHIVE option) and the
final archival medium. The same window allows to enable the storing of the report
(in XML format) on a selectable external medium.

When the exam is archived on CD or DVD in DICOM format, the Biopacs Lite1
viewer is automatically enclosed in the CD or DVD. In this way the exam can be
reviewed in any PC.

Before archival, the patient's data can be made anonymous.

Archival Procedure • If necessary, use the trackball to enable archival and export of the exam.
• Select the required supports.
• Locate the cursor on OK and press ENTER to confirm.
While data are being saved, the icon for the relevant destination support is outlined
by a yellow flashing frame. The frame disappears when the operation ends.

1 Biopacs Lite is an Esaote DICOM viewer. Biopacs Lite has to be installed on a PC with Windows XP

Professional operative system by Microsoft.

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Do not switch off the system nor remove the archiving medium while data is
C A U T I O N
being saved (yellow flashing frame on the destination support). The data and
the hard disk could be damaged. If necessary, you may run the Shut Down
procedure to interrupt and safely power off the system.

If no option is selected, all stored data will be deleted.

Review of Archived Exams

The operator can reload and review the patient's exams. The images can be reloaded
and a specific exam can be reviewed for each patient.

The A R C H I V E REVIEW key displays the following page.

The image shows the
archive consultation
window. The relevant
icons are shown at
top right.

The system displays the list of archived exams and enables the operator to
selectively choose the exams to be reviewed, setting query criteria such as the
patient’s first name, the application and the exam date.

The R E S E T key • Use the trackball and alphanumeric keyboard to input the search criteria.
deletes the set search
criteria. • Locate the pointer on QUERY and press ENTER to activate the search.
At the end of the search, a list of the exams within the set criteria is presented on
the screen. The S C R O L L key enables the operator to scroll inside the list and select
the specific exam. To select several exams, use the trackball to position the cursor
and press the Ctrl and ENTER keys simultaneously.

After selecting, activate the archive display icon to access the data. The list of
selected exams is displayed on the right of the screen. Use the trackball to locate the
Archive display icon cursor on the required exam and press ENTER to confirm.

The system is in exam review status, and, therefore, the same instructions apply.

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The Advanced Operations manual provides a detailed description of the possible

AO operations and of the active software keys.

End of Archive Review

The A R C H I V E R E V I E W or FREEZE keys close the archive review session and
reactivate real time.

Archival Media Management

When the trackball is operating as a pointer, it is possible to determine the space
available in the archive. If the pointer is positioned on the specific icon, the system
displays the remaining available memory space.

The operator can also control the data transfer operations. Locate the cursor on the
icon of the specific support and press ENTER.

The displayed interactive window enables the operator to follow the operation.

The crossed out icon indicates management problems of the specific archival
support. The interactive window allows the operator to understand which operation
has failed, and, if necessary, to repeat (RETRY) or cancel the failed operation.

Do not switch off the system nor remove the archiving medium while data
C A U T I O N
are being saved (yellow flashing frame on the destination support). The data
and the hard disk could be damaged. If necessary, you may run the Shut
Down procedure to interrupt and safely power off the system.

Writable CDs
Empty disks must be used. If the CD contains data, the system will not allow
writing and shows the message: “The device is not ready: cannot continue.”.

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Rewritable CDs
Rewritable CDs may be used for archiving data providing such CDs are empty.

The system allows the deletion of data stored on rewritable CDs. Locate the cursor
on the CD icon and press UNDO. The system displays the CD management menu:
Disk icon select "ERASE DEVICE" and press ENTER.

Rewritable DVDs
Empty single-layer DVDs must be used; if the DVD already contains some data,
the system won’t allow to burn them.

Double Layers DVDs

Double Layers DVDs are not supported by MyLab systems.

USB Pen Media

The USB pen media are managed in multi-sessions. Data can be added to data
already on the device.

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10 - System Menu
This chapter describes how to set and configure the system.

Configuration Menu
The MENU key provides access to the system menu. The key can be pressed in
Freeze. Some menu options are arranged in groups (identified by the symbol ).
To display the options included in a group, position the cursor on the group and
press the ENTER key.

• Select the option with the trackball.

• Press ENTER to continue.

General Preset
The available options are internally organized in folders. To access the individual
folders, position the trackball on the required folder and press ENTER.

Parameter Setting • Position the trackball on the field to be altered and press ENTER to
confirm.
• Use the alphanumeric keyboard to type in characters.
• In the window menus, select the option and press ENTER to confirm.
• Press OK to confirm.
The Tab  key is used to move quickly from field to field; the Pgup  and Pgdn 
keys open the window menus and scroll among the relevant options. After the
modifications have been confirmed, the system may ask to be re-started to activate
the settings.

Date/Time
Date/Time allows the operator to change the date and time, and to select the
required data and time formats (12 or 24 hour).

Center
Center is used to enter the name of the center, to be then shown on the screen.

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In addition the field “DICOM Configuration” allows to enter the department and
the station names that will be shown in the DICOM header.

Video
Video is used for selecting the required video standard (PAL or NTSC) and the
video input signal (VHS or SVHS).

Measure units
Measure units option is used to set the desired units for the height/weight ratio
(cm/Kg or ft/lb).

Archive
Allows to choose to pause an exam (ENABLE PAUSED EXAM option) instead of
ending it at START/END pressure.

Allows to set the automatic storing (option AUTO SAVE) of the exam on one or
more defined media, with the possibility of anonymising data (option
ANONYMIZE). If this option is enabled, the system won’t require archival at the end
of the exam.

The same window allows to automatically save data for multiple application exams
(option AUTO START WHEN CHANGING APPLICATION) and to set the exam type
in the OB application (whether fetal age or fetal growth).

Keyboard
Keyboard allows the operator to change the control panel light, the touchscreen
LCD backlight, the keys beep duration and the upper lighting through different
sliders. In addition a checkbox allows the user to set the action of the left key of
the trackball: the left key can be set as ENTER or as UNDO.

Trackball
Trackball is used to set the trackball speed.

Contrast
Contrast is used to set additional options for the CnTI.

Cine Mode
The option allows to automatically review the saved clips in cine mode (AUTOMATIC
PLAY) once the FREEZE key is pressed.

Other
This option allows to define whether the frame rate shall be displayed and to set
the exam type for OB exams (Fetal Age or Fetal Growth).

When the option AUTOMATIC UNFREEZE ON 3D is set, the system automatically

shows the 2D real time image at the end of the 3D CnTI acquisition.

When the option INCLUDE OPERATOR IN HEADERS is selected, the initials of the
operator entered in the Exam Start page are inserted in the header of the image and
the field Hospital Name is reduced.

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4D Settings In the same menu option the user can set the presentation to be used for 4D
acquisition: refer to the specific section for further information.

Application Preset
This option allows to configure the available parameters. MyLab allows to program
different presets for each application.

User Preset
This procedure allows to delete a defined preset (DELETE PRESET) or all presets,
and to reset the default parameters (FACTORY SETTINGS). In addition the RESET
HISTORY option allows to reset the frequency of use of the presets: they are listed
in the Exam Start page according to the factory default.
AO
The defined presets can be selected in the page allowing to start the exam or
through the PRESET key.

The “Advanced Operations” manual details the settable parameters for each mode.

Tools Settings
This option allows the user to configure the advanced available tools. The options
are organized in groups.

3D Presentation
This option allows the user to configure the 3D display profiles.

QIMT Settings
This option allows to set the QIMT REFERENCE LINE DISTANCE and the display of
the average value only (SHOW AVERAGE ONLY).

QAS Settings
This option allows to define whether pressure data are required (ALWAYS REQUEST
PRESSURE VALUES) and to set the display of the average value only (SHOW
AVERAGE ONLY).

Stress Echo Preset

This option allows the user to ADD, EDIT and DELETE Stress echo presets.

Edit View Label

This option allows the user to edit the view labels used for Stress echo.

The “Advanced Operations” manual details the settable parameters for each mode.
AO

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Peripherals
The system can remotely control (with keys 1 or 2) recording by VTR (for specific
models) and printing (in black and white and color).

The menu also enables the operator to select the required print format. The set
printing format icon is displayed next to the relevant printer symbol, in the heading
bar.

The "Advanced Operations" manual provides a detailed description on how to

AO optimally configure the peripherals.

Do not switch the system off until the printing stage has been completed.
C A U T I O N

Application Measurements
This option allows configuration of the available measurement packages by using
the MEASURE key. MyLab allows programming of different packages for each
application. For each measurement group, a description may be entered and the
derived measurement enable.

The "Advanced Operations" manual provides a detailed description on how to

AO optimally configure the measurements package.

Report Layout
MyLab offers different menus allowing configuration of the desired report. The
following table lists the available setting options (MENU key):

Option Setting
Header Headers setting
Print Layout Selection of data to be printed.
Edit Observations Observations setting.
Print Layout Style Selection of the template.

This option allows the user to choose which data must be inserted into the report,
to create a glossary to use when writing the report, or to customize the print layout.

The “System Menu” section of the "Advanced Operations" manual details how to
AO configure the report.

Glossary
When in annotation mode, the system allows the user to enter pre-existing
sentences or words. Through this option, applications libraries of words can be
created.

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The "Advanced Operations" manual provides a detailed description on how to

AO optimally configure the application glossary.

DICOM Configuration
This option allows to configure the DICOM Server to which the MyLab is
connected.

The "Advanced Operations" manual provides a detailed description on how to

AO optimally configure the DICOM.

Save/Load Presets & Settings

This option allows to save/load presets in/from an external USB pen drive. To
save the presets, insert an USB pen drive into one of the two connectors, select
SAVE PRESETS & SETTINGS and press ENTER. To load the presets, insert the USB
pen drive containing the presets into one of the two connectors, select LOAD
PRESETS & SETTINGS and press ENTER. To activate the loaded presets, the system
needs to be restarted.

Licenses
The license number can be input from this option. The license comes into
operation at the next power up. If a demo license is installed, the user can check its
expiration date in the corresponding folder.

System Info
This option displays the system’s software version.

Generic Measurements
Allows to configure the available generic measurements for each application.

Network Directory
Allows to configure one network drive to be used as archive.

The "Advanced Operations" manual provides a detailed description on how to

AO optimally configure the Network Directory.

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Security
This option allows to define the list of users allowed to work on the system: in this
case the access to the system can occur only through a log in procedure, by
entering user name and password.

The "Advanced Operations" manual provides a detailed description on how to

AO configure the Security.

Footswitch and Trackball 4th Button

Each key of the double footswitch can replicate any button or software key.

To configure the footswitch, move the cursor over the left (or right) foot icon,
press ENTER to confirm and the press the keys you wish to duplicate on the
selected key.

The function duplicated on the left footswitch is also associated to the key below
the trackball.

Press CLOSE to save and close the menu.

Export Settings
The option sets the export quality of images and clips.

Clips can be exported in different video formats.

Images can be exported in HIGH level format (BMP, not compressed), MEDIUM
(compressed PNG without loss of information) or LOW (compressed JPG with
minimum loss of information).

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

11 - System
Maintenance
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.

Refer to “Transducers and Consumables” manual for periodic inspections for

TC probes.

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Cleaning of System and Peripheral Units

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

To clean the peripheral units, follow the instructions supplied by the manufacturer.

Turn off the system before any cleaning operation.

W A R N I N G

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

Make sure that the detergent has completely evaporated before turning on
W A R N I N G
the equipment.

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

C A U T I O N

Trackball The trackball can be accessed, for cleaning purpose only, by rotating the upper
locking disk clockwise.

Clean the ball rotating it in its socket. Do not remove the ball from the socket.

The X-series trackballs contain two 855 nm semiconductor lasers. The device is
designed such that it fulfills laser safety class 1M regulations according to IEC
60825-1 edition 1.2, 2001-08’.

The laser radiation emitted is invisible to the human eye.

Although not considered harmful, staring into the beams is not advised. Staring
into the beams by means of optical aids such as eye loupes, magnifiers,
microscopes, lenses or other optical means within a distance of 100 mm might
cause permanent damage to the human eye.

Invisible laser radiation. Do not view directly with optical instruments. Class
W A R N I N G
1M laser product.

Do not remove the ball from the socket.

Cleaning the Probe Probe and gel holders are easily removed from their location for cleaning and can
and Gel Holders be washed in a mild soap solution. Make sure they are completely dry prior to
replacing them.

To clean the transducers, refer to the manual entitled "Transducers and

TC Consumables".

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LCD To clean the LCD use a soft dry cloth, lightly rubbing the display surface. Never
spray or pour any liquid directly onto the screen or case.

Overspray or liquid may cause electrical shock.

W A R N I N G

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.

Do not spray or apply the cleaning agents directly on the touch screen
W A R N I N G
surface as the liquid of the cleaning agents may permeate into the front
bezel of the display and cause damage.

 Gently wipe the screen with a slightly dump (not wet) soft cloth to remove
dust and other particulate matter.
To clean the LCD
monitor
 If necessary, apply a small amount of ammonia-free glass cleaner onto a
clean, soft cloth and then wipe the surface.
To clean the case  Use a soft, dry cloth to wipe the surface of the case.

 If necessary, apply a small amount of ammonia-free, not abrasive detergent

onto a clean, soft cloth and then wipe the surface.

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

C A U T I O N
monitor’s screen and case.

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Cleaning Agents
The following table indicates cleaning agents that have been tested with MyLab
systems.

Product Supplier

Cavicide Metrex Research Corporation,

CaviWipes USA (www.metrex.com)
Metrizyme

Asepti-Wipes II Ecolab Co.

Canada (www.ecolab.com)

CidezymeXTRA ASP
Enzol USA (www.aspjj.com)

Cleanisept-wipes Dr. Schumacher GmbH

Germany (www.schumacher-
online.com)

Sani-Cloth HB PDI
Sani-Cloth Plus USA (www.pdipdi.com)
Sani-Cloth Super

SaniZide plus Safetec

USA (www.safetec.com)

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

Mikrozid AF wipes Schülke & Mayr, Germany

Mikrozid PAA wipes (www.schuelke-mayr.com)
Mikrozid sensitive wipes

Mid Soap

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Chapter

12 - Technical
Specifications
This chapter describes the technical specifications1 of the MyLab product.
0
AO Note

Special packages are listed and described in the specific sections of

the Advanced Operations manual.

MyLab Configuration
MyLab systems can be licensed for one or more of the following applications:

Applications License Application Features

Cardiac Cardiac, Cardiac Pediatric Presets, Calculations, ECG
General Imaging Abdominal, Breast, Musculo- Presets, Calculations
Skeletal, Neonatal, Pediatric,
Small Parts, Thyroid, Urology
OB/GYN Obstetric, Gynecology Presets, Calculations
Vascular Vascular, Adult Cephalic Presets, Calculations

MyLab configurations can be licensed for the following modes:

Modes Mode Feature Note

Doppler PW and CW Doppler CW Probe dependent
Color Flow Mapping (CFM) Color and Power Doppler -
TEI Tissue Enhancement Imaging Probe dependent
TVM Tissue Velocity Mapping Probe dependent
CMM Compass M-Mode Probe dependent
MVIEW MView Mode Probe dependent
microV Tool for micro- -
vascularization

1 The specifications can be modified without prior notice.

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Optional Features
The following features are optional:

License Feature
DICOM DICOM classes2
XView Extended View
XStrain Strain and Strain Rate
STRESS Stress Echo
FWI Fetal weight Index
TPView Trapezoidal View (Probe dependent)
Automatic Gain Automatic Gain
QIMT Quality Intima Media Thickness (Probe dependent)
QAS Quality Arterial Stiffness (probe dependent)
IMT Intima Media Thickness (Probe dependent)
Virtual Navigator Virtual Navigator (basic, advanced, extended)
Intelligent Positioning Intelligent Positioning and Virtual biopsy
3D Pan Panoramic 3D
RFLab RF Data Management
CnTI Contrast
ElaXto Elastography
ElaXto Measures Elastography Measures
ElaXto Advanced Additional Elastographic functions
PPSF Post-processing of archived images and clips
3D/4D 3D and 4D
XLight Advanced Lighting algorithm in 3D/4D
XSTIC 3D Acquisition for fetal heart
MyLabRemote Possibility to remote control MyLab by iPad 3
PPW Enable S2MPW probe
VPan Panoramic View
Neurosurgery Availability of Intraoperative (Neuro) application
QElaXto Quantitative pSWE Quantitative Elastosonographic analysis4
TRT Stepper Civco Stepper Grid for multiple biopsies for TRT33
PLA Licence Laser
Auto NT Automatic Nuchal Translucency measure
VueBox Bracco VueBox Quantification Toolbox
BodyMap BodyMap including DICOM Query/Retrieve
management
Needle tracking Needle tracking

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.

2 For further details refer to the DICOM Conformance Statement available at www.esaote.com

3 Not available in the U.S.A.

4 Intended only for the Countries where the CE mark is mandatory and sufficient

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MyLab Technical Specifications

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

Control Panel Assembly

 Lateral orientation clockwise: 15°, 22°, 29°, 36°, 43°, 50°, 90°
 Lateral orientation counterclockwise: 15°, 22°, 29°, 36°, 43°, 50°, 180°
 Vertical displacement: ±20 cm

Display

 Full HD LED 21.5” monitor

Probe connectors
 4 electronic probes
 1 Doppler probe

Video I/O
 Full HD
 XVGA output (monitor)
 XVGA output (auxiliary monitor)
 C-Video I/O
 S-Video I/O
 Video standard
 PAL / NTSC (software controlled)

Connectivity
 I/Os connectors
 Serial RS-232
 LAN RJ45
 4 USB
 Dedicated connectors
 Audio I/O (stereo)
 ECG input
 Double footswitch

Image Files
 Formats
 Standard output file formats (BMP, PNG, JPEG, TIFF; AVI)
 Native and DICOM formats
 Clip formats: AVI Codec: Microsoft MPEG4-V1, MPEG4-V2, MS-Video1 and MS-WMV9
 Still frames: compressed (lossy, not lossy) and not compressed
 Graphic overlays
 Reports

Printing Capability
 Ink jet color or Laser B/W & Color USB Printer (1,2,4 and 6 images printed out on A4 format
 Thermal B/W and Color Video Printers
 Thermal Digital B/W and Color Video Printers
 WIFI & Bluetooth compatible

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Software
 Operating system: Windows Embedded Standard
 Multilanguage (English, Italian, French, German, Spanish, Portuguese)

Biometry
 Basic and advanced calculation, application dependent
 Annotations, Body Marks

Power Cables
 Power cable with CEE socket
 Socket type and amperage: EN60320/C19; 16A-250V
 Plug: VII (7) VII type; 16A-250V
 Conductors: 3
 Section: 1,5 mm2
 Length: 4 m
 Power cable with CEI socket
 Socket type and amperage: EN60320/C19; 16A-250V
 Plug: I/3/16 type; 16A-250V
 Conductors: 3
 Section: 1,5 mm2
 Length: 4 m
 Power cable with NEMA socket
 Socket type and amperage: EN60320/C19; 15A-250V
 Plug: NEMA-15; 15°-125V
 Conductors: 3
 Section: AWG 14
 Length: 4 m

Dimensions
 MyLab with tiltable holder
 On site: 630(w) x 1480-1550(h) x 1020(d) mm
 For transportation 630(w) x 1480(h) x 900(d) mm

Weight
 approximately 100 kg without monitor
 approximately 110 kg with orientable holder and monitor

Power supply
 Voltage operative range
 100  120V
 200  240 V
 Voltage limit range
 90  132V
 180  264 V
 Working frequency range: 45  65 Hz
 Max power consumption
 1400 VA (MyLabEight eXP)
 1200 VA (MyLabEight)
 Available power on peripherals
 up to 400 VA

Fuses
 Operative Range 100  120V:
 T 10A H, 250V 5x20mm
 Operative Range 200  240 V:
 T 5A H, 250V 5x20mm

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Operating requirements
 Temperature: 1535C
 Humidity: 1595 % (not condensing)
 Pressure: 7001060 hPa

Storage requirements
 Temperature: -20  +60C
 Humidity: 595 % (not condensing)
 Pressure: 7001060 hPa

Safety Standards
 EN 60601-1
 EN 60601-1-1
 EN 60601-1-2
 EN 60601-1-4
 EN 60601-1-6
 EN ISO 10993-1
 EN 60601-2-37
 EN 61157
 EN 62304
 AIUM / NEMA UD-2 / UD-3Maximum acoustic output according to FDA pre-amendment
upper limits (refer to “Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers”, issued on September 2008).

System Accessories
ECG Cables and consumables are listed in the “Transducers and Consumables”
Manual. The MyLab can be equipped with a double foot-switch (Reference:
9102756100).

Video Requirements
B/W and Color  Input: C-Video (1 Vp-p, 75 ohm)
 Connectors: standard BNC
Printer  Safety standard: IEC 950 o EN60601-1

VTR and Color  I/O: S-Video YC

 Y: 1 Vp-p, 75 ohm
Printer  C: 0.3 Vp-p Color burst, 75 ohm
 Tape format: VHS, S-VHS
 Audio traces: 2
 Connectors:
 Video: 4 pin connector
 Audio: jack
 Safety standard: IEC 650 o EN60601-1

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