Esaote MyLabDelta User manual

Rev. 02
April 2016
MyLabDelta
GETTING STARTED
350009500

MyLab - GETTING S TARTED
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Introduction
This manual refers to all MyLabDelta ultrasound models, named in the following
chapters as MyLab. MyLab is available both in portable and mobile configuration. The
term “MyLab”, used in this manual, refers to both configurations and to all models.
When the information refers to only one configuration, it will be specifically indicated.
The manual contains information on Mylab indications for use and explains how to
install it. All system keys and their functions are described.
The manual is divided into the following chapters:
Chapter 1: General Information
The chapter provides information on manuals organizations, manufacturer’s
responsability, product life cycle and software licences. Moreover it contains
information on Esaote Traceability and Responsability systems.
Chapter 2: Additional Information on Safety
The chapter provides information about specific safety features of the MyLab system.
Chapter 3: Clinical Applications
The chapter specifies in which clinical applications the MyLab can be used.
Chapter 4: System Components and Installation
This chapter contains the installation instructions.
Chapter 5: Control Panel
This chapter describes the MyLab control panel.
Chapter 6: Screen Layout
In this chapter one can learn how information is organized on the screen.
Chapter 7: Performing an Exam

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This chapter describes the operations usually carried out to start and end an exam.
Chapter 8: eTouch Key
This chapter explains how to use the eTouch key of the control panel.
Chapter 9: MyLab Settings
This chapter explains MyLab settings organization and how to use them.
Chapter 10: MyLab Clinical Settings
This chapter explains how to create clinical settings and how to use them.
Chapter 11: System Maintenance
This chapter lists all necessary maintenance procedures.
Chapter 12: Technical Specifications
This chapter describes MyLab technical specifications.
WARNING In this manual WARNING identifies a risk for the patient and/or the operator.
CAUTION The word CAUTION describes the precautions necessary for protecting the
equipment.
Be sure to understand and observe each of the cautions and warnings.
The MyLab systems have multiple configuration and feature sets. They are all
described in this user manual but not every option may be applied to your system.
System features are dependent on your system configuration, transducer, and exam
type. Not all the system features are approved in all countries.
Keep the manual with the system for future reference.

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This manual revision refers to release 5.53.00 and 6.03.00 depending on the Country
and the respective clearances. Features, probes and applications described in this
manual may change depending on your system configuration

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1 General Information .......................................................................... 1-1
User's Kit .............................................................................................1-1
Licenses ............................................................................................1-1
MyLab Pen Drive .............................................................................1-1
“Product Documentation” Disk ........................................................1-1
MyLab Manuals...................................................................................1-2
Operator Manual...............................................................................1-2
Getting Started .............................................................................1-2
Probes and Consumables .............................................................1-2
Safety and Standards....................................................................1-2
Advanced Operations Manual ..........................................................1-2
System Data ......................................................................................1-3
Probes - Cleaning, Disinfection, Sterilization ..................................1-3
Veterinary Use ..................................................................................1-3
Manufacturer’s Responsibility ............................................................1-4
Product Life Cycle...............................................................................1-5
Life Time ..........................................................................................1-5
Maintainability Time ........................................................................1-5
End-of-Life Disposal ........................................................................1-5
Usage License Agreement for the Software Included in the Apparatus 1-
6
Proprietary Rights.............................................................................1-6
License Rights and Limitations ........................................................1-6
Usage License Agreement for the Software Included in the Apparatus 1-
10
Proprietary Rights...........................................................................1-10
License Rights and Limitations ......................................................1-10
Third Part Software.........................................................................1-11
Product Traceability ..........................................................................1-12
Vigilance System...............................................................................1-13
Important Information .......................................................................1-15
2 Additional Information on Safety .....................................................2-1
Environmental Safety ..........................................................................2-1
Transport Safety ..................................................................................2-1
Electromagnetic Compatibility............................................................2-1
Electromagnetic Emissions...............................................................2-2
..........................................................................................................2-2
Electromagnetic Immunity ...............................................................2-2
Electromagnetic Immunity for All Medical Equipment .............2-3
Electromagnetic Immunity for Medical Equipment not Life
Supporting....................................................................................2-4
Recommended Distances between Radiofrequency (RF) Communication
Systems and MyLab ............................................................................2-5

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Wireless Requirements........................................................................2-6
Device Labels ......................................................................................2-7
3 Clinical Applications .........................................................................3-1
Intended Use........................................................................................3-1
Convex Array Probes........................................................................3-2
Phased Array Probes.........................................................................3-3
Specialty Probes................................................................................3-3
Endorectal Probes ........................................................................3-3
Transesophageal Probes...............................................................3-3
Abdominal and Related Applications...............................................3-4
Cardiac Applications ........................................................................3-4
Musculo-Skeletal ..............................................................................3-4
Obstetrical Application (for Reproductive studies)..........................3-4
4 System Components and Installation ...............................................4-1
System Overview.................................................................................4-1
Portable Configuration......................................................................4-1
Mobile Configuration .......................................................................4-2
Installation ...........................................................................................4-3
Portable Configuration......................................................................4-3
Identifying the Connectors...........................................................4-3
Installing the Portable Configuration...........................................4-5
Mobile Configuration .......................................................................4-5
Installing the Console ..................................................................4-5
Installation at Working Site .........................................................4-6
Turning the System On.....................................................................4-7
Probes Connections ..........................................................................4-7
Battery .................................................................................................4-8
Battery Status Led.............................................................................4-8
First Use............................................................................................4-9
Battery Lifetime..............................................................................4-10
Acclimation Time..............................................................................4-10
Peripheral and Network Connections................................................4-10
How to safely connect peripherals.....................................................4-11
Safety Concept................................................................................4-12
Medical environments................................................................4-12
Auxiliary Monitor...........................................................................4-15
Moving and Transporting the System ...............................................4-15
5 Control Panel .....................................................................................5-1
Touchscreen Section............................................................................5-1
Touchscreen......................................................................................5-1
Exam Panel Layout ......................................................................5-2

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Multipurpose Panel Layout..........................................................5-4
Alphanumeric Keyboard Layout..................................................5-4
Touch Screen TGC Sliders ...............................................................5-5
ON/OFF Button ................................................................................5-5
Controls Section ..................................................................................5-6
Trackball ...........................................................................................5-6
Exam Controls ..................................................................................5-7
Exam Flow ...................................................................................5-7
The Mode Keys............................................................................5-7
Multiformat Controls ...................................................................5-8
Exam Revision .............................................................................5-9
Exam Report ................................................................................5-9
Printers .........................................................................................5-9
Settings.........................................................................................5-9
eTouch Key.......................................................................................5-9
Acquire Key....................................................................................5-10
Assigning the acquire function to a keyboard button ...............5-10
6 Screen Layout ....................................................................................6-1
Information about the Screen ..............................................................6-1
Heading Area ....................................................................................6-1
Footer Area .......................................................................................6-2
Trackball ......................................................................................6-2
Wi-Fi ............................................................................................6-2
Archival Media ............................................................................6-2
Advanced Features.......................................................................6-2
Battery..........................................................................................6-3
Peripheral Devices .......................................................................6-4
Image Area........................................................................................6-5
Machine Parameters.....................................................................6-6
Thumbnails Area .................................................................................6-7
Symbol on Screen................................................................................6-7
7 Performing an Exam .........................................................................7-1
Exam Start and End .............................................................................7-1
Exam Exported on CD/DVD Medium .............................................7-6
Performing the Exam...........................................................................7-7
2D and CFM Clips with High Frame Rate ..........................................7-8
Acquisition Procedure ......................................................................7-8
Freeze and Scrolling Memories...........................................................7-8
How to Scroll through the Memories ...............................................7-9
Exam Review.......................................................................................7-9
System Shut Down ..............................................................................7-9
Error Messages ..................................................................................7-10

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Power Supply Error Messages........................................................7-10
8 eTouch Key........................................................................................8-1
Keys Sequence.....................................................................................8-1
Configuration Menu ............................................................................8-1
How to Create a Customized Touchscreen..........................................8-2
Customized Touchscreen Organization...............................................8-3
9 MyLab Settings..................................................................................9-1
Settings Organization ..........................................................................9-1
How to Use MyLab Settings ...............................................................9-2
10 MyLab Clinical Settings .................................................................. 10-1
Definition of Clinical Settings...........................................................10-1
How to Create Clinical Settings ........................................................10-1
How to Rename or Delete Clinical Settings......................................10-3
Factory Clinical Settings ...................................................................10-3
11 System Maintenance........................................................................ 11-1
Inspecting the System........................................................................11-1
Cleaning of System and Peripheral Devices......................................11-1
Veterinary Applications..................................................................11-2
12 Technical Specifications.................................................................. 12-1
MyLab Characteristics.......................................................................12-1
MyLab Technical Characteristics......................................................12-3
Display............................................................................................12-3
Probe connectors.............................................................................12-3
Video Output ..................................................................................12-3
Connectivity....................................................................................12-3
Image Files......................................................................................12-4
Software..........................................................................................12-4
Biometry .........................................................................................12-4
Keyboard.........................................................................................12-4
Power Cables ..................................................................................12-5
Dimensions .....................................................................................12-5
Weight.............................................................................................12-5
AC/DC Adapter(151004300)..........................................................12-6
Batteries(140019400) .....................................................................12-6
Operating Requirements .................................................................12-6
Storage requirements ......................................................................12-6
Standards ...........................................................................................12-7
Directive ............................................................................................12-8
Probe..................................................................................................12-8

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Storage Requirements.....................................................................12-8
Trolley (150000024) Technical Characteristics ................................12-8
Dimensions .....................................................................................12-8
Weight.............................................................................................12-8

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Chapter
1
GETTING STARTED
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 customised 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.
“Product Documentation” Disk
This disk contains, in digital format, all manuals supplied with the system. The
manuals are available in the languages that can be set on the system.
Note
The “System Data” document, containing information on Acoustic
Output data and transducers surface temperatures, is included in
the “Product Documentation” disk.

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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.
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
 GS This section describes how to install the system and provides the main instructions
for using it.
Probes and Consumables
 PC This section describes cleaning, disinfecting and maintenance procedures for the
probes and related accessories. Information is also supplied on admitted
consumables.
Safety and Standards
 SS This section contains information about the patient's and operator's safety. The
system's conformity standards are also indicated.
Advanced Operations Manual
 AO This symbol is used to indicate the “Advanced Operations” manual. The standard
configuration of this manual includes the following sections:
Image Optimization and Annotations,
Calculations,
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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GETTING STARTED
Archive,
Clinical and System Settings.
All other sections can be ordered using the specific part numbers.
System Data
Data on probes temperatures and acoustic output for each probe and mode of
operation are included in the “System Data” manual, included in the “Product
Documentation” disk.
Probes - Cleaning, Disinfection, Sterilization
The manual lists the recommended cleaning, disinfection and sterilization agents
for MyLab probes and needle guides. Information is also supplied on
manufacturers of the recommended agents.
Veterinary Use
Esaote offers dedicated software intended for Veterinary use, providing specific
transducers and calculation packages: please refer to the Esaote web site for
complete information. However Esaote ultrasound systems dedicated to human
applications can be safely used also in veterinary applications by qualified
veterinarians. All information concerning the use of the systems, referenced in
these manuals, is considered to be applicable also to a veterinary use.
However, the user should be aware of the limitations in calculations and results.
Please contact Esaote personnel for information on the correct maintenance
procedures to be followed in case of use in veterinary environment.

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Manufacturer’s Responsibility
Esaote is responsible for the safety, reliability and functioning of this product only
if:
the user follows all the instructions contained in the system
manuals for the use and the maintenance of this system;
the manuals are kept integral and readable in all parts;
calibrations, modifications and repairing are performed only
by Esaote qualified personnel;
the environment where the system is used complies with the
current safety rules;
the electrical plant of the environment where the system is
used complies with the current applicable rules and is
perfectly efficient.

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GETTING STARTED
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.
The main system plate includes therefore the symbol shown below, indicating - in
an unequivocal way – that the system must be disposed of in a separate collection
from urban waste and that it was introduced in the market after August 13th, 2005.

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When disposing of any system part, the user shall consider the following points:
any recyclable part of the system and/or of its packaging is
labelled with the corresponding symbol;
all components used for the packaging are recyclable and/or
reusable, except the closed-coupled barriers.
CAUTION The system and its consumable parts must be disposed of, at end of life,
according to the applicable state and/or federal and/or local regulations.
Usage License Agreement for the Software
Included in the Apparatus
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.
Attention
Please read with care the terms and conditions indicated below before
using the software on the system
Use of the software implies acceptance of the terms and conditions
listed below

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GETTING STARTED

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GETTING STARTED

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Usage License Agreement for the Software
Included in the Apparatus
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.
Attention
Please read with care the terms and conditions indicated below before
using the software on the system
Use of the software implies acceptance of the terms and conditions
listed below