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Esaote MyLabSigma elite Getting Started

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Rev. 05
June 2021
MyLabSigma elite
GETTING STARTED
350061100

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Summary of Contents for Esaote MyLabSigma elite

  • Page 1 Rev. 05 June 2021 MyLabSigma elite GETTING STARTED 350061100...
  • Page 2 MyLab - G E T T I N G S T A R T E D...

  • Page 3: Manufacturer's Address

    MyLabSigma elite For US Customers: US Federal Law restricts this device to sale, distribution and use by or on the order of a physician. All information included in this manual is relative to the following Esaote ultrasound equipments: MyLabSigma elite...

  • Page 4: Guarantee

    Guarantee The information in this document is the exclusive property of Esaote S.p.A. and is reserved. Reproduction or distribution in any form is strictly prohibited. All rights reserved. All screenshots, pictures and graphics in this manual are used for descriptive purposes only and may be different from what you see on the screen or device.

  • Page 5: Red Declaration Of Conformity

    RED Declaration of Conformity MyLab - G E T T I N G S T A R T E D...
  • Page 6 MyLab - G E T T I N G S T A R T E D...

  • Page 7: Table Of Contents

    I N D E X Table of Contents Manufacturer’s Address ................i-iii Important Information ................i-iii Guarantee..................... i-iv Trade Marks....................i-iv RED Declaration of Conformity .............. i-v 1 Introduction.................. 1-1 Intended audience..................1-3 Disclaimer ....................1-3 MyLab use....................1-4 MyLab Manual Conventions..............1-5 Manufacturer’s Responsibility..............
  • Page 8 I N D E X Work related musculoskeletal disorders ..........2-9 Repetitive Strain Injury................2-9 Working with Video Display ..............2-9 Information about ultrasound residual risks .........2-10 Cardiac .....................2-10 Stress Echocardiography ..............2-10 Contrast Echocardiography ............2-10 Vascular and Neonatal Cephalic ............2-11 General Imaging..................2-12 Contrast Enhanced US ..............2-12 Shear Wave Elastography..............2-12 Transrectal access ................2-13 Intraoperative and Laparoscopic access........2-13...
  • Page 9 I N D E X Connections of mobile configuration ........... 3-13 Batteries...................... 3-14 Battery Status..................3-14 First Use....................3-15 Battery Lifetime ..................3-15 Error Messages..................3-16 Errors in Battery Management ............3-16 Power Supply Error Messages............. 3-17 4 Preparing for use ................4-1 Acclimation Time ..................
  • Page 10 I N D E X Image Area ....................5-12 Machine Parameters .................5-13 Thumbnails Area..................5-14 6 Customizing MyLab ..............6-1 Generic Configuration Procedure ............6-4 Clinical Configurations ................6-5 Real Time Preset ..................6-5 Creating a new preset from MENU ..........6-5 Creating a new preset from Real-Time..........6-6 eTouch Button..................6-6 Configuring eTouch button ..............6-6 System Settings ....................6-8...
  • Page 11 I N D E X Electronics manuals on Esaote website........6-23 7 Performing an Exam ..............7-1 Starting an Exam..................7-2 Entering Patient and Application data ..........7-4 Filling the Patient ID screen............. 7-4 Retrieving data from archive ............7-4 Selecting Probe ..................
  • Page 12 I N D E X Standards ......................9-6 MyLab - G E T T I N G S T A R T E D...

  • Page 13: Introduction

    Chapter 1. Introduction devices are supplied with a set of manuals to provide all MyLabSigma elite necessary and sufficient information to operate the device safely and effectively. Before operating the equipment, read carefully the complete set of manuals WARNING in order to understand the detailed operating procedures, functions, performance, and maintenance procedures.
  • Page 14 NOTE Specifications subject to change without notice. Information might refer to products or modalities not yet approved in all countries. Product images are for illustrative purposes only. For further details, please contact your Esaote sales representative. Before attempting to use...

  • Page 15: Intended Audience

    In case of device failure to operate correctly, the operator should contact the nearest Esaote Service Office. Special attention should be dedicated to intra-cavitary probes (e.g. vaginal, rectal or oesophageal probes). They should be cleaned according to established protocols (AIUM guidelines for cleaning probes) and should not be used if there is noticeable self-heating of the probe when operating in air.

  • Page 16: Mylab Use

    Use of the product for the purposes other than those intended and expressly stated by Esaote, as well as incorrect use or operation, may relieve Esaote or its agents from all or some responsibility for resultant noncompliance, damage, or injury.

  • Page 17: Mylab Manual Conventions

    I N T R O D U C T I O N MyLab Manual Conventions In this manual device controls are indicated using the following graphical conventions: Control panel buttons are indicated by GREY CAPI TAL LET- TERS BOLD BLUE CAPITAL Touchscreen keys are indicated by LETTERS Touchscreen software strings are indicated by...

  • Page 18: Manufacturer's Responsibility

    The reason for this is that the risk involved clearly outweighs the benefits of using the system in such conditions. 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 device manuals for the use and the maintenance of this device;...

  • Page 19: Maintainability Time

    You have acquired a device (“ ”) which includes Esaote S.p.A. DEVICE proprietary software and/or software licensed by Esaote S.p.A. from one or more software licensors (“Software Suppliers”). Such software products (“ ”), as well as associated media, printed materials, and “online”...

  • Page 20: License Rights And Limitations

    For any software updates and/or upgrades installed on the Equipment after installation, the terms herein shall apply in full. License Rights and Limitations With this license, Esaote S.p.A. grants the end user the right to use the on the supplied SOFTWARE...
  • Page 21 I N T R O D U C T I O N the event of equipment transfer to third parties, are requested to notify ESAOTE S.p.A., associate company or authorized distributor of the said transfer by means of the following form, duly compiled, or written notification with the same data as specified in the form.

  • Page 22: Vigilance System

    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.
  • Page 23 I N T R O D U C T I O N POST-MARKET SURVEILLANCE FORM ACCIDENT REPORT FORM To: ESAOTE S.p.A. Quality Assurance Department Via Enrico Melen, 77 16152, Genova, Italy [or associate company] [or authorized distributor] [and competent authorities] ESAOTE system/device name:................
  • Page 24 I N T R O D U C T I O N MyLab - G E T T I N G S T A R T E D 1 - 12...

  • Page 25: Additional Information On Safety

    Information about Reusing/Recycling This symbol identifies a recyclable component. Depending on the size of the recyclable component, Esaote prints on it this symbol and the indication of the material it is made of. In this system, packing materials are reusable and recyclable; the casings of the system and the monitor (plastics) and most of the cart components (plastics) are also recyclable.
  • Page 26 Do not replace the system fuses with different types from those specified by CAUTION “Getting Started” manual. MyLab Electrical shock hazard. Do not remove the system or the monitor cover. WARNING Refer servicing and internal adjustments to qualified Esaote personnel only. Turn off and unplug it before any cleaning operation. MyLab WARNING...

  • Page 27: Electromagnetic Compatibility

    Use of accessories, probes and cables other than those authorized by CAUTION Esaote may result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communication equipment (including peripherals such as...

  • Page 28: Electro-Surgical Devices (Esus)

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y powering the ultrasound system from an outlet different from the one of the interfering device, contacting Esaote Service personnel for help. Electro-Surgical Devices (ESUs) Electro-surgical devices or other devices that introduce radiofrequency electromagnetic fields or currents into the patient may interfere with the ultrasound image.

  • Page 29: Essential Performance

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y Use of this equipment adjacent to or stacked with other equipment should WARNING be avoided because it could result in improper operation.

  • Page 30: Electromagnetic Immunity For All Medical Equipment

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y Electromagnetic Immunity for All Medical Equipment MyLab is intended for use in the electromagnetic environment specified below. The customer or MyLab the user of should assure that it is used in such an environment.

  • Page 31: Electromagnetic Immunity For Medical Equipment Not Life Supporting

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y MyLab is intended for use in the electromagnetic environment specified below. The customer or MyLab the user of should assure that it is used in such an environment.

  • Page 32: Recommended Distances Between Radiofrequency (Rf) Communication Systems And Mylab

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y Recommended Distances between Radiofrequency (RF) Communication Systems and MyLab It is recommended not to use radiofrequency (RF) transmission systems near the ultrasound scanner.

  • Page 33: Work Related Musculoskeletal Disorders

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y Work related musculoskeletal disorders Execution of ultrasound examination can provoke work related musculoskeletal disorders (WRMDs) of ultrasound practitioners due to long- lasting arm abduction, body twisting, extensive wrist flexion and extensive transducer grip and pressure.

  • Page 34: Information About Ultrasound Residual Risks

    As such, to the best of its current knowledge on the state of the art in ultrasound diagnostic imaging, Esaote has identified the following additional potential residual risks that are hereafter grouped for main applications. Cardiac...

  • Page 35: Vascular And Neonatal Cephalic

    Multifunctional ultrasound scanners are indicated for the use in conjunction with such kind of medicinal products in order to assist them in achieving their own specific intended purpose. Esaote does not support or encourage the off-label use of contrast media Our Medical devices do not integrate or control the way how these medicinal products are administered to the patients.

  • Page 36: General Imaging

    Multifunctional ultrasound scanners are indicated for the use in conjunction with such kind of medicinal products in order to assist them in achieving their own specific intended purpose. Esaote does not support or encourage the off-label use of contrast media.

  • Page 37: Transrectal Access

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y Transrectal access Examinations should be performed with more cautions because heating of the transducer has the potential to produce additional heat to adjacent tissue.

  • Page 38: Women Health

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y Color Doppler should not be utilized except for clearly defined clinical reasons which provide additional diagnostic or prognostic information.

  • Page 39: Items In Contact With Patient

    Items in Contact with Patient Esaote probes and electrodes materials that are in contact with the patient have been proved to comply with EN ISO 10993 “Biocompatibility Tests Requirements”, according to their intended use. No negative reactions to these materials have been reported.

  • Page 40: Latex Sensitive Patient

    Containing Medical Devices”). For additional information in the U.S.A., refer to FDA Medical Alert MDA91-1. Device Modifications Esaote is not responsible for any unauthorized modification of equipment (including cables) and/or probes. Do not modify any Esaote equipment without authorization. Always refer CAUTION to Esaote personnel for authorized modifications of the device.

  • Page 41: Wireless Safety

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y Wireless safety is equipped with built-in wireless capability. MyLab If the equipment is not installed and used in accordance with the instructions, the equipment may cause harmful interference to radio communications.

  • Page 42: Users In The European Union

    A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y The use of wireless devices might be restricted in certain locations: always CAUTION verify local regulations before using them.

  • Page 43: Wireless Antenna Position

    The antennas are located on the where indicated by the red circle MyLab in the figure below. Fig. 2-1: Wireless antenna position on MyLabSigma elite, MyLab - G E T T I N G S T A R T E D 2 - 19...
  • Page 44 A D D I T I O N A L I N F O R M A T I O N O N S A F E T Y MyLab - G E T T I N G S T A R T E D 2 - 20...

  • Page 45: Mylab Overview

    Chapter 3. MyLab Overview is a professional, innovative and versatile, real-time high- MyLabSigma elite resolution ultrasound scanner. The wide range of probes makes it suitable for many clinical applications. About MyLab Intended Use is a compact portable system intended to perform diagnostic...

  • Page 46: Clinical Applications And Supporting Probes

    M Y L A B O V E R V I E W Clinical Applications and Supporting Probes A variety of ultrasound probes can be connected to MyLabSigma elite Table 3-1: Available probes and applications Probe Applications Biopsy AC2541 Abdominal, Musculo-skeletal, Urology, Vascular...
  • Page 47 NOTE MyLab exam type. Not all applications are approved in all Countries. Please refer to your Esaote local representative for further information. MyLab - G E T T I N G S T A R T E D 3 - 3...

  • Page 48: Patient Population

    Sex: male and female Weight: all weight categories (in terms of Body Mass Index) Height: no limitations Operator profile is designed for operators who are qualified and trained in MyLabSigma elite using ultrasound scanner: Sonographers Cardiologist Maternal-fetal Medicine Obstetrician / Perinatologist...

  • Page 49: Mylab Overview

    S Y S T E M O V E R V I E W MyLab Overview has a built-in LCD screen: in this way, the device can be used as MyLab portable configuration. can be supplied with a trolley in its mobile MyLab configuration.

  • Page 50: Identifying The Connectors

    S Y S T E M O V E R V I E W is equipped with an external AC/DC adapter and, as an option, with MyLab internal batteries. Identifying the Connectors Table 3-3: Connectors on right side Connector Symbol Description EA1÷EA2 Two probe connectors...
  • Page 51 The mains socket is located on the rear side of . Connect the AC/DC MyLab adapter to the mains socket. is equipped with an AC/DC adapter, Esaote P/N 151004301 (see label MyLab on the AC/DC adapter). Use only the AC/DC adapter provided by Esaote with the...

  • Page 52: Installing The Portable Configuration

    S Y S T E M O V E R V I E W Installing the Portable Configuration Refer further in this chapter Place the on the work surface using the handle as sloping support. MyLab for information on probe Position the equipment so that the power outlet is easily accessible.

  • Page 53: Probe Connections

    S Y S T E M O V E R V I E W Fig. 3-2: MyLab Fold-away Trolley Before using carefully clean it and the fold-away trolley after they MyLab CAUTION have been transported outdoor. Probe Connections Both imaging and Doppler probes can be connected to the two (2) connectors, indicated by the EA1 and EA2 symbols.

  • Page 54: Mobile Configuration

    S Y S T E M O V E R V I E W Make sure that the securing device is placed in the lower position (open position) and carefully attach the probe connector by placing the cable feedthrough frontwards. To secure the probe, move the securing device up. Do not touch the probe connector pins or the probes receptacle.

  • Page 55: Basic Mobile Configuration

    S Y S T E M O V E R V I E W Basic mobile configuration In its basic configuration (picture above), the trolley is supplied with holders for probes, cables and gel. Insert the holders on the trolley lateral stirrups and place them in the desired position.

  • Page 56: Accesorized Mobile Configuration

    S Y S T E M O V E R V I E W Accesorized mobile configuration The trolley can be equipped with many accessories: Insulation transformer, Probe multi-connector, Auxiliary monitor. Insulation The insulation transformer is mounted under the base of the trolley. The transformer insulation transformer is always necessary when other optional accessories are mounted on the trolley.

  • Page 57: Connections Of Mobile Configuration

    S Y S T E M O V E R V I E W The auxiliary monitor must be powered through the power supply P/N 530000137 connected to the insulation transformer through the jumper P/N 8820074000, both P/Ns provided by Esaote. Connections of mobile configuration Fig. 3-5: Insulation transformer + probe multi-connector Fig.

  • Page 58: Batteries

    S Y S T E M O V E R V I E W Batteries can be equipped with an internal battery pack. MyLab The battery pack is installed by Esaote personnel. This person will be NOTE responsible for its installation and for ensuring that the device is working properly.

  • Page 59: First Use

    Esaote recommends to replace the battery pack every three years. The battery pack has to be replaced by Esaote personnel. This person will NOTE be responsible for ensuring that the device is working properly.

  • Page 60: Error Messages

    MyLab again to see whether the error message persists. Save anyway the log file (refer to the “Archive” section of the Advanced Operation manual for further information) and contact the Esaote Service department. Errors in Battery Management The battery icon is shown crossed out whenever an error in the battery management occurs.

  • Page 61: Power Supply Error Messages

    Switch on again and check whether the MyLab message is still present. If the problem persists, contact Esaote personnel. Error #4 This error indicates that at least one of the batteries has reached the maximum temperature allowed for its working conditions.
  • Page 62 S Y S T E M O V E R V I E W If this situation occurs, press and then shut down . Contact the MyLab Esaote Service department. Error #8 This error indicates that a fault of the impulse voltages occurs. displays MyLab the following message: Error #8: wrong impulse voltage.

  • Page 63: Preparing For Use

    To use connectivity features, the device must be connected to a network. The LAN plug is placed at the bottom of the rear side; it supports Gigabit, 10Base-T, and 100Base-T Ethernet LAN. An Esaote field engineer or your network administrator must configure for network connectivity.

  • Page 64: Connecting Peripherals

    , are usually MyLab already mounted and connected. The first mounting and connecting will usually be performed by an Esaote technician. Esaote suggests to contact its Service representative to install any auxiliary NOTE device. Before installing the peripheral devices, make sure that...

  • Page 65: Medical Environments

    P R E P A R I N G T H E S Y S T E M complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the above mentioned requirements.
  • Page 66 P R E P A R I N G T H E S Y S T E M Fig. 4-2: B) Medical Use Room Intended as area B, area A excluded. Fig. 4-3: C) Non-medical use room A room not designed for medical treatment, for example, an office or a storage room.
  • Page 67 B or area C connected by cable (USB, HDMI,...) - Auxiliary device must be powered through a safety insulation transformer complying to IEC 60601. Auxiliary Devices must be approved by Esaote. Auxiliary Devices must also NOTE comply with EN 60601-1-2 safety standard and subsequent amendments or the electromagnetic compatibility.
  • Page 68 The system must be powered so to satisfy the electrical safety requirements. WARNING 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.

  • Page 69: Peripheral Housing

    P R E P A R I N G T H E S Y S T E M Peripheral housing When is set in a mobile configuration (refer to chapter 3 for further MyLab details), the trolley can house a peripheral on the dedicated tray. When selecting the peripheral, consider its dimension so that it can be NOTE safely installed on the dedicated tray.
  • Page 70 P R E P A R I N G T H E S Y S T E M Before connecting any peripheral, verify that the total power consumption CAUTION does not exceed 350VA that is the maximum power available on insulated sockets.

  • Page 71: Moving And Transporting The System

    P R E P A R I N G T H E S Y S T E M Moving and Transporting the System Portable Configuration Disconnect all probes, peripherals and the AC/DC adapter. Close the LCD screen being sure that the safety push-buttons are closed. Always use the handle to move the system.

  • Page 72: Mylab Quick Displacement

    P R E P A R I N G T H E S Y S T E M To steadily lock the system, all the wheels must be locked. Do not park the system on a slope. Do not use the brakes to park the machine on a slope. Avoid any unnecessary mechanical shock to the system while moving it.

  • Page 73: Using Mylab

    Chapter 5. Using MyLab This chapter provides a brief description of the device controls. Refer to the “Advanced Operations Manual” for further detailed information. Connecting MyLab to the mains The power plug and the electrical main switch (when present) are located on the rear-bottom of the .

  • Page 74: Mylab Controls

    U S I N G M Y L A B When installing , check that the power cable is not tightly bent, that MyLab WARNING it can’t be squashed by a misplaced foot or by heavy objects. Place in a location allowing an easy unplug of from the mains MyLab MyLab...
  • Page 75 U S I N G M Y L A B Button Description key, available on both CFM and Doppler AUTO ADJUST LEFT AUTO ADJUST modes, automatically adjusts some controls of the active mode to AN D make the echo acquisition easier. DO PPLER GAI N The knob around this key amplifies CFM, CW and PW gains over...

  • Page 76: Eknob

    U S I N G M Y L A B Button Description Stops the current analysis or scan and puts MyLab in Freeze mode. FREEZE To re-activate real time, press it again or directly press the button of the required mode. This button re-activates a B-Mode image in real time when any other mode is active.

  • Page 77: Touchscreen Section

    U S I N G M Y L A B Table 5-2: Trackball cursors Mode Trackball M-Mode, Doppler LINE cursor Color Flow Mapping (CFM) CFM ROI cursor The cursor function is indicated below the image. When several cursors are present on the screen, switches between the active cursors.

  • Page 78: Menu Button

    U S I N G M Y L A B Pressing the button turns on or off, activating or closing the MyLab O N /O FF examination session. Optional Batteries When is equipped with optional batteries, the same button places the MyLab device in stand-by, partially shutting it down: in this case the initialization phase at start up is significantly reduced.
  • Page 79 U S I N G M Y L A B Fig. 5-1: CFM touchscreen 1. Navigation area, it contains the navigation tabs allowing to select the desired features for the relevant controls. For example B-Mode, CFM. 2. Main area, it contains main controls, varying according to the active mode, application and settings.
  • Page 80 U S I N G M Y L A B Table 5-4: Touchscreen key status Active Key with Disabled Key Active Key Selected Key Submenu Gray text on dark White text on light As Active Key with Blue text on dark gray background gray background three lines at...

  • Page 81: Tgc Sliding

    U S I N G M Y L A B Fig. 5-2: Annotations touchscreen Refer to the “Advanced Operations” manual for further details. Alphanumeric The alphanumeric keyboard is based on the QWERTY standard. The Keyboard Layout alphanumeric keys are used to enter text data in the enabled windows. The Caps Lock key sets the keyboard to upper case characters.

  • Page 82: Information About The Screen Layout

    U S I N G M Y L A B Information about the Screen Layout The screen is split into four main areas. Fig. 5-3: Screen Layout 1. Heading Area 2. Footer Area 3. Image Area 4. Thumbnails Area Controls on the Screen Layout are indicated in the operator manuals with , while strings and fields are indicated B O L D B L A C K C A P I T A L L E T T E R S with...

  • Page 83: Footer Area

    U S I N G M Y L A B Footer Area This area is used to display the following information: trackball functionality, Wi-Fi icon (when enabled), archival media icons, advanced features icons, battery icons, peripherals icons. Trackball When the trackball can perform multiple functions, the next function is indicated below the image as yellow text.

  • Page 84: Image Area

    U S I N G M Y L A B Image Area The visualization of the image depends on various factors such as the active mode, the selected application and the probe. The following figure shows the elements in the image area that are independent of these factors. Fig.

  • Page 85: Machine Parameters

    U S I N G M Y L A B Machine Parameters Table 5-6: Imaging Parameters Displayed Parameter Description format Imaging or TEI (Tissue Enhancement Imaging) mode: General, Resolution or Penetration (L: Low, H: High) Imaging gain (Min,%, Max) Auto Adjust nn mm Depth C or +n/n...

  • Page 86: Thumbnails Area

    U S I N G M Y L A B Table 5-7: Color Flow Mapping (CFM) Parameters Displayed Parameter Description format VM (Tissue Velocity nnn MHz Color frequency or T Mapping) frequency when enabled Color gain (Min,%, Max) nnn kHz Pulse Repetition Frequency Wall filter Smooth (L: Low, M: Medium, H: High) /...

  • Page 87: Customizing Mylab

    Chapter 6. Customizing MyLab can be customized to increase efficiency and streamline your work- MyLab flow. You can do the following: Create preset designed specifically for the exams you perform. Change device settings to reflect your needs. Add options to enhance your imaging abilities. Create custom procedures for specific patients, transducers, and presets.
  • Page 88 C U S T O M I Z I N G M Y L A B The menu is organized in three areas: Clinical Configuration, the upper area shows all options relating to Clinical Settings or Presets, System Settings, the central area shows all options relating to System Settings, General Settings, the lower area shows all options relating to General Settings.
  • Page 89 C U S T O M I Z I N G M Y L A B System Settings System Settings define the ’s parameters related to a specific device MyLab profile: Profile Manager, DICOM configuration, Saving Options for end exam saving configuration, Center ID for hospital configuration to set the name of the hospital, Multimedia,...

  • Page 90: Generic Configuration Procedure

    C U S T O M I Z I N G M Y L A B Generic Configuration Procedure Once accessed the configuration screen for the parameter you want to set, a common set of commands is available and a common setting procedure can be used.

  • Page 91: Clinical Configurations

    C U S T O M I Z I N G M Y L A B Clinical Configurations This chapter explains how to set many options. For configurations not MyLab described here refer to relevant chapters in the “Advanced Operations” manual. Real Time Preset A Preset is a group of settings that optimizes for a specific type of...

  • Page 92: Creating A New Preset From Real-Time

    C U S T O M I Z I N G M Y L A B Creating a new preset from Real-Time Procedure To create a new preset or modify an existing one: Adjust the real time image as desired in all modes (2D, CFM and Doppler).
  • Page 93 C U S T O M I Z I N G M Y L A B on the right the menu to record the macro and to edit the customized buttons, on the bottom the fields where customized touchscreens are named and described.

  • Page 94: System Settings

    C U S T O M I Z I N G M Y L A B button adds a new tab that will be automatically displayed. Place N E W T A B the cursor on the tab and press to change its name, using the EN TER alphanumeric keyboard to edit it.

  • Page 95: Corrupted System Profile

    (no component has to be without any setting). Should this not solve the problem, contact Esaote personnel. Center ID Center ID allows to set the center name displayed in the Heading Area of the screen and the center information shown in the report.

  • Page 96: General Setup

    C U S T O M I Z I N G M Y L A B General Setup The menu is organized in internal folders, selectable using the tabs displayed on the top of the menu. Fig. 6-3: General Configuration Menu saves the settings, which will be activated as soon as they are saved.

  • Page 97: Measure Units Folder

    C U S T O M I Z I N G M Y L A B Format Displayed date MMM/DD/YYYY Apr/01/2011 Set Time Using the keyboard set the time manually. Time Format The time format is available on a 24 or 12 hour basis. In the 12 hour option, the time is shown as AM and PM.

  • Page 98: Control Panel Folder

    C U S T O M I Z I N G M Y L A B CONTROL PANEL Folder The table below lists and explains the available fields and the corresponding actions. Table 6-3: Control Panel Folder Fields Action TRACKBALL SPEED Sets the speed of the trackball.

  • Page 99: Field Shutdown Type

    When the OFF button is pressed, MyLab performs an VIRUS SCAN ONCE antivirus scan and then a complete shut-down. At the next OFF pressure the previous choice is restored. Esaote does not install a real-time antivirus program, because it could affect NOTE the regular operations of MyLab The antivirus scan could take a long time.

  • Page 100: Field Available Qwerties

    If a virus is found, it is advisable to switch off the , disconnect it from MyLab the data network and call the Esaote service, which will check for the presence of a virus and restore MyLab Field AVAILABLE QWERTIES...
  • Page 101 C U S T O M I Z I N G M Y L A B Table 6-5: Application Preset Folder Fields Action ABSOLUTE ANGLE The angle correction factor of linear probes can be correlated either to the line cursor or to the line perpendicular to the transducer surface (absolute angle).

  • Page 102: Field Action On Freeze

    C U S T O M I Z I N G M Y L A B Fields Action When checked, pressing PW from B-Mode, MyLab 1-CLICK CHANGEOVER ENABLED FOR PW, switches to B-Mode frozen + Doppler live at once. CW, M-MODES When not checked, pressing PW from B-Mode, MyLab switches to B live + PW frozen.

  • Page 103: Footswitch Folder

    The update from the web requires a web access and it can take long time to finish, so a message warns you before starting. is not enabled and can be used from Esaote Service personnel only. If S C A N you want to perform an antivirus scan, you have to perform a shut-down with virus scan.

  • Page 104: Security

    The recovery key is necessary to decrypt the disk in the remote case the machine on which it is located is broken. Without recovery key Esaote Service personnel will not be able to recover any encrypted data from the disk.

  • Page 105: License Activation

    C U S T O M I Z I N G M Y L A B Fig. 6-5: License Configuration Menu License Activation Tabs allow to respectively activate the A P P L I C A T I O N S O P T I O N S application licenses and the optional licenses.

  • Page 106: Import/Export Menu

    C U S T O M I Z I N G M Y L A B Import/Export Menu The menu is organized with internal folders, selectable using the tabs displayed on the top of the menu. Fig. 6-6: Import/Export Menu EXPORT Folder This option allows the user to save customized clinical and system settings on the USB medium.

  • Page 107: Import Folder

    C U S T O M I Z I N G M Y L A B customized SAVING OPTIONS customized center configuration ( CENTER ID customized export settings; MULTIMEDIA customized configurations; NETWORK customized OBSERVATIONS customized printer profiles ( PRINTERS customized report styles ( REPORTS customized settings;...

  • Page 108: System Info

    ENCRYPTION MODE Encryption Mode Encryption allows to preserve health data storage confidentiality. Encryption can be performed by Esaote Service personnel only. Encryption can be applied to the internal hard disk and to one or more external USB memory devices. At the end of encryption a recovery key will be given to you. The recovery key is stored on USB pen drive, or on file, or by printing it.

  • Page 109: Manuals Manager

    UPDATE MANUALS you have to update manuals on your own. If this particular case happens, the package for the update is provided by the Esaote service. This remote case is communicated by through a warning message at starting-up.
  • Page 110 C U S T O M I Z I N G M Y L A B 5. Select the language you desire; 6. Click on the manual to open it or click on to download it. You can download the entire set of manuals by clicking on NOTE DOWNLOAD ALL FILES (.ZIP).

  • Page 111: Performing An Exam

    Chapter 7. Performing an Exam This chapter describes the procedures commonly used in performing patient exams with . These procedures include entering patient and application MyLab data, acquiring images, making measurements and calculations; annotating and reviewing images. is designed for operators who are qualified in using ultrasound MyLab scanners.

  • Page 112: Starting An Exam

    P E R F O R M I N G A N E X A M Among these conditions belong obesity, scoliosis, chronic obstructive lung disease, scars, decubitus. Starting an Exam At power-up, at end of the initialization phase, or when starting every new exam, displays the Patient ID screen and the touchscreen is configured MyLab...
  • Page 113 P E R F O R M I N G A N E X A M Fig. 7-2: Probe, Application, Preset touchscreen Starting exam The steps to be followed to start an exam are: procedure 1. Entering patient and application data; 2.

  • Page 114: Entering Patient And Application Data

    P E R F O R M I N G A N E X A M Entering Patient and Application data There are two ways to enter patient data: Filling the Patient ID screen, Retrieving existing data from archive. Filling the Patient ID screen The Patient ID screen is used to enter patient data and application data, when applicable.

  • Page 115: Selecting Probe

    P E R F O R M I N G A N E X A M At any time during the exam, Patient Data can be viewed and modified by PATIENT ID pressing PATIENT ID Do not use to start a new exam of a new patient as it will update WARNING existing patient’s data with new entries.

  • Page 116: Selecting Application

    P E R F O R M I N G A N E X A M PROBE At any time during the exam, a different probe can be selected tapping or the new probe key on the touchscreen work flow area (available when is enabled).

  • Page 117: Performing The Exam

    P E R F O R M I N G A N E X A M Performing the Exam offers a set of imaging modes to cover a variety of imaging needs. By MyLab pressing the different mode buttons the specific mode is activated in real time.

  • Page 118: Reviewing Images

    P E R F O R M I N G A N E X A M Reviewing Images EXAM REVIEW During the exam, taping enables reviewing of the saved images and sequences, and the trackball automatically changes to pointer mode, allowing you to scroll through the thumbnails and select the item to be reviewed.
  • Page 119 P E R F O R M I N G A N E X A M At power-up, prompts the operator to archive the last exam NOTE MyLab performed if the device was switched off without first closing the exam in progress.
  • Page 120 P E R F O R M I N G A N E X A M MyLab - G E T T I N G S T A R T E D 7 - 10...

  • Page 121: Maintenance

    Chapter 8. Maintenance To ensure that operates over time at its maximum efficiency, Esaote MyLab recommends to perform maintenance procedures regularly. Maintenance procedures should be performed both by the user itself and by Esaote authorized service personnel. The maintenance operations and schedule are provided in the table below.
  • Page 122 Periodic maintenance operations that require the access to the device can NOTE be performed only by trained personnel: contact your local Esaote representative for further information on required periodic inspections. Only trained persons are allowed to perform the safety inspection mentioned above.

  • Page 123: Cleaning Operations

    M A I N T E N A N C E Cleaning Operations Periodic cleaning of and any connected devices is important. MyLab In the event of poor maintenance, dust and dirt can compromise the reliability and performance of and connected devices. MyLab The following table indicates the cleaning agents that have tested the compatibility with the...

  • Page 124: Cleaning Control Panel And Device

    M A I N T E N A N C E Check the instructions supplied by the manufacturer of the cleaning agents for possible stricter limitation. Do not use hot cleaning agents for cleaning the equipment. Apply the cleaning agents only for the time necessary to remove the dirt CAUTION without exceeding over.

  • Page 125: Cleaning Probe And Gel Holders

    M A I N T E N A N C E When cleaning the trackball housing, make sure not to spray any liquid into CAUTION the trackball housing. Clean the ball rotating it in its socket. Do not remove the ball from the socket. Do not remove the ball from the socket.

  • Page 126: Cleaning The Lcd Screen

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

  • Page 127: Technical Specifications

    MyLab MyLab number and are, therefore, unique. They should be carefully stored. The device is delivered by Esaote, with the licenses already installed. Additional features can be added buying the related license. Applications can be equipped with the following application licenses.
  • Page 128 T E C H N I C A L S P E C I F I C A T I O N S Table 9-2: Features Feature Description 3D/4D 3D and 4D Volumetric acquisition 3D/4D Advanced TPI, TMI and TSI modalities VRA analysis AutoAdjust It enables the automatic adjustment of imaging parameters.

  • Page 129: Technical Characteristics

    It enhances the pattern of every frame at the pixel level, eliminating speckle and noise artefacts. a. Refer to www.esaote.com for further details on supported DICOM classes. b. www.elesta-echolaser.com c. Refer to the corresponding Sales Area manager for further information.

  • Page 130: Image Files

    Closed (approximately): 380 (w) x 98 (h) x 380 (d) mm In working position: 380 (w) x 360 (h) x 400 (d) mm 1. Refer to www.esaote.com for further details. MyLab - G E T T I N G S T A R T E D...

  • Page 131: Weight

    T E C H N I C A L S P E C I F I C A T I O N S Weight 6.4 kg approximately, without batteries 7.5 kg approximately, with batteries IP Grade IP (X)0, this means models are not watertight.

  • Page 132: Probe Storage Requirements

    T E C H N I C A L S P E C I F I C A T I O N S Probe Storage Requirements Probe storage requirements are indicated in the probe case. Standards Table 9-3: Standards Standard Title IEC 60601-1:2012 (Ed.3.1) Medical electrical equipment - Part 1: General...
  • Page 133 T E C H N I C A L S P E C I F I C A T I O N S Standard Title ISO 15223-1 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General Requirements AIUM/NEMA UD-2:2004 Acoustic Output Measurement Standard for...
  • Page 134 T E C H N I C A L S P E C I F I C A T I O N S MyLab - G E T T I N G S T A R T E D 9 - 8...

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