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Esaote MyLabX6 - User Manual

Esaote MyLabX6
124 pages
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Rev. 08
February 2020
MyLabX6
MyLabX7
GETTING STARTED
350031500

Table of Contents

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Summary

Manufacturers Address

ESAOTE S.p.A.

Manufacturer's official company name and address details.

Important Information

Key compliance and regulatory information for the MyLab system.

Guarantee

Trade Marks

Mentions intellectual property and identification purposes for names.

EC Declaration of Conformity

RED Declaration of Conformity

1 Introduction

Safety and Standards

Information on patient and operator safety and system conformity standards.

Getting Started

Manual details system installation and main usage instructions.

Probes and Consumables

Detailed instructions for MyLab probe usage and related consumables.

System Data

Information on probe temperatures and acoustic output, supplied on CD.

Advanced Operations Manual

Describes advanced features, image optimization, measurements, and archiving.

Intended audience

Specifies the target users for MyLab manuals and required prior knowledge.

Disclaimer

Outlines system usage limitations, operator responsibilities, and probe care.

Manufacturer’s Responsibility

Details conditions under which Esaote is responsible for product safety and reliability.

Product Life Cycle

Covers system safety and efficiency guarantees, maintainability, and disposal.

End-of-Life Disposal

Guidance on disposing of MyLab systems according to WEEE directive and local regulations.

Proprietary Rights

Explains software licensing, intellectual property laws, and user rights.

License Rights and Limitations

Details end-user license terms, copying, transfer, and modification restrictions.

Vigilance System

Describes post-market surveillance and reporting of potential hazards or malfunctions.

2 Additional Information on Safety

Environmental Safety

Discusses handling of lithium-ion batteries and mercury-containing fluorescent lamps.

Electromagnetic Compatibility

Explains system design for electromagnetic environments per IEC 60601-1-2.

Electromagnetic Emissions

Details MyLab's RF and harmonic emissions compliance for different environments.

Essential performance

Lists criteria for MyLab's core functional performance, free from artifacts.

Electromagnetic Immunity

Explains electromagnetic tests simulating transient environments for MyLab.

Electromagnetic Immunity for All Medical Equipment

Specifies immunity test levels and guidance for MyLab in various environments.

Electromagnetic Immunity for Medical Equipment not Life Supporting

Details immunity test levels for conducted RF, radiated RF, and power frequency magnetic fields.

Recommended Distances between Radiofrequency (RF) Communication Systems and MyLab

Advises on maintaining distances from RF systems to prevent interference with echographic image.

Wireless Requirements

Covers built-in wireless capability, distance recommendations, and potential interference.

3 System Overview

Intended Use

Defines MyLab's purpose for diagnostic general ultrasound studies and guidance.

Clinical Applications and Supporting Probes

Lists available probes and their corresponding clinical applications and biopsy capabilities.

Patient population

Specifies the age, location, sex, weight, and height criteria for MyLab's patient population.

Operator profile

Identifies qualified operators for MyLab systems, including sonographers and physicians.

Contraindications

Lists specific uses, such as ophthalmic, for which MyLab is not intended.

Control Panel Assembly

Describes components like handle, touchscreen, speakers, and probe holders.

Electrical Connection

Details location of fuse box, main switch, power cable socket, and earth terminal.

Probe Connections

Explains how to connect imaging and Doppler probes to the system's connectors.

Control Panel Assembly Orientation

How to adjust the control panel and screen position using levers for operator comfort.

Batteries

Information on internal battery pack, charging, status indicators, and lifetime.

Error Messages

Describes system error codes, causes, and recommended actions for battery and power supply issues.

4 Preparing the System

Acclimation Time

Waiting times required for system acclimation to ambient temperatures before initial use.

Connecting the System to a Network

Steps for connecting the MyLab system to a network for connectivity features.

Connecting Peripherals

Guidance on connecting external devices like printers and monitors to the system.

Safety Concept

Details MyLab's safety features, insulation transformer, and compliance with standards.

Medical environments

Defines patient environment conditions (A, B, C) based on IEC60601 for system installation.

5 Using the System

Connecting the system to the mains

Procedure for plugging the system into the power mains for operation.

Turning the System On and Off

Steps for powering the system on and off at the examination site.

System Controls

Overview of controls on the Control Panel Assembly including panel, touchscreen, and keyboard.

Control Panel Section

Details main imaging controls, exam buttons, knobs, and trackball functions.

Exam Panel Layout

Describes the touchscreen organization into navigation, main, knobs, and exam management areas.

Information about the Screen Layout

Explains the four main screen areas: Heading, Footer, Image, and Thumbnails.

Trackball

Describes trackball operation in standard and mouse modes for cursor positioning.

Wi-Fi

Information on Wi-Fi status icon and connectivity details, referring to advanced manual.

Archival Media

Icons and management of archival media, with reference to advanced manual for details.

Image Area

Details elements in the image area independent of active mode, application, or probe.

Machine Parameters

Lists parameters for Imaging, CFM, and Doppler modes with their descriptions.

Thumbnails Area

Displays saved clips and images as thumbnails, organized chronologically.

6 Customizing the System

Clinical Configuration

Optimizing MyLab for specific exams by setting parameters like presets, measures, and annotations.

System Settings

Defines MyLab parameters related to specific system profiles like DICOM and network configuration.

General Settings

Sets general MyLab parameters including setup, security, licenses, and system info.

Generic Configuration Procedure

Common procedure for setting parameters via the configuration screen using commands like EDIT, CLONE, NEW.

Clinical Configurations

Explains setting up options like presets, measurements, annotations, and bodymarks.

Creating a new preset from MENU

Steps to create or modify presets via the MENU, grouping by probes and applications.

Creating a new preset from Real-Time

Adjusting real-time image parameters to create or overwrite presets.

eTouch Button

Allows recording and saving key sequences for customized touchscreen buttons or macros.

Configuring eTouch button

Accessing eTouch menu to configure customized touchscreens and record macros.

Profile Manager

Enables creation of personalized system configurations for each user.

Center ID

Setting the center name for display in the Heading Area and report header.

General Setup

Configuring general system settings like date, time, measure units, and shutdown types.

DATE;TIME Folder

Option to set system date and time, with various display format options.

CONTROL PANEL Folder

Configures trackball speed, left click action, character set, shutdown type, etc.

Field SHUTDOWN TYPE

Options for different system shutdown behaviors like standby, full shutdown, or virus scan.

Licenses Manager

Manages installation and status of optional and demo licenses for system features.

License Activation

Process for activating new licenses by entering license numbers and verifying them.

Import;Export Menu

Allows saving and loading customized clinical and system settings to/from USB media.

System Info

Displays model, serial number, hardware ID, software version, and BIOS revision.

Encryption Mode

Preserves health data confidentiality through encryption performed by Esaote Service.

7 Performing an Exam

Starting an Exam

Initial steps after power-up or new exam start: Patient ID, probe, application, preset selection.

Entering patient and application data

Methods for entering patient details and application-specific data for an exam.

Selecting Probe

How to select the appropriate probe from connected options displayed on the touchscreen.

Selecting Application

Choosing the correct application from the list available for the selected probe.

Selecting Preset

Selecting the desired preset (Clinical Setting) to optimize system parameters for the exam.

Performing the Exam

General overview of actions during an examination session.

Acquiring images

Procedures for capturing and saving single images or cineloop sequences.

Freeze and Scrolling Memories

Using FREEZE to stop acquisition and review saved images via the scroll bar.

Reviewing Images

Enabling exam review, switching to pointer mode, and scrolling through saved items.

Ending the Exam

Steps to conclude an exam, archive data, and optionally anonymize patient information.

8 System Maintenance

Cleaning Operations

Importance of periodic cleaning for MyLab reliability and performance, listing compatible agents.

Cleaning control panel and system

Procedure for cleaning the control panel and system using a soft cloth and water or approved agents.

Cleaning the trackball

Steps for accessing and cleaning the trackball and its housing with a dry cloth and cotton swab.

Cleaning Probe and Gel Holders

How to remove and clean probe and gel holders using mild soap solution.

Cleaning the Touchscreen

Instructions for cleaning the touchscreen surface with dry or slightly dampened cloths.

Cleaning the LCD Screen

Method for cleaning the LCD screen to remove dust and particulate matter.

Cleaning the LCD case

Guidance on cleaning the LCD case using a soft, dry cloth and mild detergent.

9 Technical Specifications

MyLab Characteristics

Details MyLab model differences based on installed licenses and availability.

Licenses

Explains how licenses enable system functions and are linked to the serial number.

Applications

Lists available application licenses for MyLab systems like Cardiology, Radiology, etc.

System Features

Describes various system features such as 3D/4D, AutoAdjust, DICOM, Elastography, etc.

Technical Characteristics

Lists overall product specifications including display, probe connectors, video output, and connectivity.

Display

Information on the built-in color LCD, Full HD monitor, and touchscreen LCD sizes and resolutions.

Probe connectors

Details the number and types of electronic probe connectors available on the system.

Connectivity

Lists I/O connectors including LAN, USB ports, and Wi-Fi specifications.

Power Cables

Provides specifications for power cables used in different regions and their connectors.

Operating Requirements

Specifies temperature, humidity, and pressure conditions for optimal system operation.

Standards

Lists relevant standards and their titles for medical electrical equipment and usability.

Esaote MyLabX6 Specifications

General IconGeneral
CategoryMedical Equipment
TypeUltrasound System
Transducer PortsUp to 3
StorageInternal and external storage options
Power SupplyAC 100-240V, 50/60Hz
Imaging ModesColor Doppler
Advanced Imaging TechnologiesSpeckle Reduction Imaging
ConnectivityDICOM, USB, Ethernet
ApplicationsCardiology, Obstetrics, Musculoskeletal
PortabilityCart-based system
Display15-inch LCD monitor

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