mylab-9

[Page 1] Rev. 05 February 2020 MyLab 9 MyLab 9 eXP 350035900

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[Page 3] Manufacturer’s Address ESAOTE S.p.A. Via Enrico Melen 77 16152 Genova ITALY GETTING STARTED Phone +39 010 65471 [email protected] www.esaote.com Important Information MyLab 9 and MyLab 9 eXP comply with the Medical Device Directive 93/42/ EEC and subsequent amendments and are CE marked. MyLab 9 and MyLab 9 eXP are devices in Class IIa according to the Medical Device Directive. MyLab 9 and MyLab 9 eXP comply with the Radio Equipment Directive 2014/ 53/EU and are CE marked. MyLab 9 and MyLab 9 eXP are devices in Class 2 according to RED Directive. For US Customers: US Federal Law restricts this device to sale, distribution and use by or on the order of a physician. All information included in this manual is relative to the following Esaote ultrasound equipments: MyLab 9 and MyLab 9 eXP . In this manual, all the above mentioned systems are referred to as MyLab 9 Family . Unless specifically noted, sections of this manual pertain to all the systems. MyLab - G E T T I N G S T A R T E D iii

[Page 4] 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. This manual has been written taking care to ensure the accuracy of all of the information included, however, Esaote assumes no liability for errors or omissions. No translations of this documentation are allowed without the consent of Esaote S.p.A. The information contained in this documentation is subject to change without prior notice. Trade Marks All names are property of the respective owners and are used exclusively for identification purposes. MyLab - G E T T I N G S T A R T E D iv

[Page 5] EC Declaration of Conformity MyLab - G E T T I N G S T A R T E D v

[Page 6] MyLab - G E T T I N G S T A R T E D vi

[Page 7] RED Declaration of Conformity MyLab - G E T T I N G S T A R T E D vii

[Page 8] MyLab - G E T T I N G S T A R T E D viii

[Page 9] MyLab - G E T T I N G S T A R T E D ix

[Page 10] MyLab - G E T T I N G S T A R T E D x

[Page 11] Table of Contents Manufacturer’s Address i-iii Important Information i-iii GETTING STARTED Guarantee i-iv Trade Marks i-iv EC Declaration of Conformity i-v RED Declaration of Conformity i-vii 1 Introduction 1-1 Safety and Standards 1-1 Getting Started 1-1 Probes and Consumables 1-1 System Data 1-1 Advanced Operations Manual 1-2 Intended audience 1-3 Disclaimer 1-3 MyLab use 1-4 MyLab Manual Conventions 1-5 Manufacturer’s Responsibility 1-6 Product Life Cycle 1-6 Life Time 1-6 Maintainability Time 1-7 End-of-Life Disposal 1-7 Usage License Agreement for the Software Included in the Apparatus 1-7 Proprietary Rights 1-7 License Rights and Limitations 1-8 Third Part Software 1-8 Product Traceability 1-8 Vigilance System 1-10 2 Additional Information on Safety 2-1 Environmental Safety 2-1 Electromagnetic Compatibility 2-2 Electromagnetic Emissions 2-2 Essential performance 2-3 Electromagnetic Immunity 2-3 Electromagnetic Immunity for All Medical Equipment 2-4 Electromagnetic Immunity for Medical Equipment not Life Supporting 2-5 Recommended Distances between Radiofrequency (RF) MyLab - G E T T I N G S T A R T E D xi

[Page 12] Communication Systems and MyLab 2-6 Wireless Requirements 2-7 3 System Overview 3-1 About the system 3-1 Intended Use 3-1 Clinical Applications and Supporting Probes 3-2 Patient population 3-5 Operator profile 3-5 Contraindications 3-5 System Components 3-6 Monitor (1) 3-8 On/Off Button (2) 3-8 Control Panel Assembly (3) 3-9 Control Panel Assembly Orientation 3-10 Pull-out Qwerty Keyboard (14) 3-10 Data Storage 3-10 ECG and Physio Connectors 3-11 Probe Connectors and Cable Management 3-11 Peripherals Housing 3-11 Connections panels (8) 3-12 Wheel Brakes 3-12 4 Preparing the System 4-1 Acclimation Time 4-1 Connecting the System to a Network 4-1 Connecting Peripherals 4-2 Safety Concept 4-2 Medical environments 4-3 B/W Thermal Medical USB Printer housing 4-6 USB Printer housing 4-6 Auxiliary Monitor 4-7 Gel warmer 4-7 External CD/DVD and HDD drives 4-8 Moving and Transporting the System 4-8 5 Using the System 5-1 Connecting the system to the mains 5-1 Turning the System On and Off 5-1 System Controls 5-2 Control Panel Section 5-2 TGC Sliding 5-4 Trackball 5-5 Joystick 5-5 MyLab - G E T T I N G S T A R T E D xii

[Page 13] Touchscreen Section 5-6 Menu Button 5-6 Touchscreen 5-6 Alphanumeric Keyboard Section 5-9 Information about the Screen Layout 5-9 GETTING STARTED Heading Area 5-10 Footer Area 5-10 Trackball 5-10 Wi-Fi 5-11 Archival Media 5-11 Advanced Features 5-11 Peripheral Devices 5-11 Image Area 5-12 Machine Parameters 5-13 Joystick Area 5-14 Thumbnails Area 5-14 6 Customizing the System 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 Profile Manager 6-8 Corrupted System Profile 6-9 Center ID 6-9 Center ID Field 6-9 Report Information Field 6-9 DICOM Field 6-9 General Settings 6-9 General Setup 6-10 DATE/TIME Folder 6-10 MEASURE UNITS Folder 6-11 BIOPSY Folder 6-11 CONTROL PANEL Folder 6-12 Field SHUTDOWN TYPE 6-13 Field AVAILABLE QWERTIES 6-14 CINE MODE Folder 6-14 APPLICATION PRESET Folder 6-14 FOOTSWITCH Folder 6-16 PROBE BUTTONS Folder 6-16 MyLab - G E T T I N G S T A R T E D xiii

[Page 14] RAW DATA Folder 6-16 KEYBOARD BUTTONS Folder 6-16 Security 6-16 Licenses Manager 6-16 License Activation 6-17 Import/Export Menu 6-18 EXPORT Folder 6-18 IMPORT Folder 6-19 System Info 6-20 Encryption Mode 6-20 7 Performing an Exam 7-1 Starting an Exam 7-1 Entering Patient and Application data 7-3 Filling the Patient ID screen 7-3 Retrieving data from archive 7-3 Selecting Probe 7-4 Selecting Application 7-5 Selecting Preset 7-5 Smart Preset 7-6 Performing the Exam 7-6 Acquiring images 7-6 Freeze and Scrolling Memories 7-7 Reviewing Images 7-7 Ending the Exam 7-7 Monitor adjustments 7-8 8 System Maintenance 8-1 Cleaning Operations 8-3 Cleaning control panel and system 8-4 Cleaning the trackball 8-4 Cleaning Probe and Gel Holders 8-5 Cleaning the Touchscreen 8-5 Cleaning the LCD Screen 8-5 Cleaning the LCD case 8-6 9 Technical Specifications 9-1 MyLab Characteristics 9-1 Licenses 9-1 Technical Characteristics 9-6 Display 9-6 Probe connectors 9-6 Video Output 9-6 Connectivity 9-6 MyLab - G E T T I N G S T A R T E D xiv

[Page 15] Image Files 9-7 Software 9-7 Biometry 9-7 Keyboard 9-7 Dimensions 9-7 GETTING STARTED Weight 9-7 IP Grade 9-8 Power supply 9-8 Power Cables 9-8 Operating Requirements 9-9 Storage requirements 9-9 Probe Storage Requirements 9-9 European and international standards 9-10 Opti-light 9-11 MyLab - G E T T I N G S T A R T E D xv

[Page 16] MyLab - G E T T I N G S T A R T E D xvi

[Page 17] Chapter 1. Introduction MyLab 9 Family systems are equipped with different manuals, and this Getting Started manual is only a part of the instruction for use required for safe and correct use of the device. The complete set of instruction for use giving all necessary and sufficient information to operate the system safely and effectively consists of the manuals and the additional sections listed below. The manuals and the additional sections can refer to:  MyLab 9 Family when the contents are relevant only to this family, or  MyLab when the contents are common to the other ultrasound systems belonging to the Esaote MyLab platform. Safety and Standards  SS The Safety and Standard manual contains information about the patient's and operator's safety. The system's conformity standards are also indicated. Getting Started  GS This present manual describes how to install the system and provides the main instructions for using it. Probes and Consumables  PC The Probes and Consumables manual gives detailed instruction for use for MyLab probes. Information is also supplied on the admitted consumables and on the recommended agents and cleaning, disinfecting and maintenance procedures for MyLab probes and related accessories. System Data The System Data manuals, supplied only on CD, contain data on probes temperatures and acoustic output for each probe and mode of operation. MyLab - G E T T I N G S T A R T E D 1 - 1

[Page 18] Advanced Operations Manual  AO The Advanced Operations manual in its standard configuration includes the following sections:  Advanced Features,  Image Optimization,  Measurements,  Archiving. Additional sections will be supplied in relation to the specific licenses ordered with your MyLab 9 Family system. NOTE All manuals are provided in hard-copy with exception of System Data that is provided in electronic format only. This manual revision applies to release 18.xx.yy and subsequent maintenance releases, depending on the Country and the respective clearances. For Singapore this manual revision applies to release 1.xx.yy for MyLab 9 eXP . The instructions for use describe the most extensive configuration of your MyLab 9 Family system, with the maximum number of options and accessories. Some functions, probes or applications described may be unavailable on your product’s configuration. NOTE Technology and features are system/configuration dependent. 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. This manual refers to MyLab 9 Family ultrasound systems, that can be named in the following chapters as MyLab too. MyLab - G E T T I N G S T A R T E D 1 - 2

[Page 19] Before attempting to use MyLab , read and understand all the instructions in this manual. Strictly observe all cautions and warnings. Always keep the manuals with the system for future reference. NOTE The manuals describe all operations to be performed for a proper and safe GETTING STARTED use of MyLab systems. Any system malfunction caused by incorrect operations is considered as falling under the user’s responsibility. Intended audience MyLab manuals are written for sonographers, physicians, and biomedical engineers who have been trained on basic ultrasound principles and techniques. Before reading these instructions for use, you need to be familiar with ultrasound techniques. Sonography training and clinical procedures are not included here. Disclaimer Ultrasound system should only be used by persons who are fully trained in its safe and proper operation. They should have detailed knowledge of ultrasound system, they should be aware of its specifications, accuracy and limitations, and should be able to manipulate the system correctly in order to ensure that patient diagnosis and management are not compromised. For this reason, anyone operating the system should read and understand the system operating manual. Ultrasound system, transducers, cables, monitor and image recorders should be regularly inspected and kept on acceptable levels of performance. In case of system 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. Particular care should be taken if trans-vaginal probes are to be used to investigate a pregnancy during the first 10 weeks after LMP. The images and calculations provided by ultrasound system should never be regarded as the only basis for clinical diagnosis. They are intended to be just MyLab - G E T T I N G S T A R T E D 1 - 3

[Page 20] a part of a more complex diagnostic process that includes medical history, symptoms and other instrumental examinations. A proper patient ID and exact examination date and time must be always included and must appear on all recorded data and prints. Identification error could result in mistaken diagnosis. It should be considered that ultrasound system is not meant for long-term data storage and that in case of serious system failure and consecutive repair, the stored data can be lost. Thus, a regular backup of data is recommended. For more detailed information please consult: Guidelines For Professional Ultrasound Practice. Society and College of Radiographers and British Medical Ultrasound Society. December 2015 https://www.sor.org/sites/default/ files/document-versions/ultrasound_guidance.pdf AIUM guidelines for cleaning probes. http://www.aium.org/officialStatements/57 Guidelines for the safe use of diagnostic ultrasound equipment. The British Medical Ultrasound Society. https://www.bmus.org/static/uploads/resources/BMUS-Safety-Guidelines-2009- revision-FINAL-Nov-2009.pdf Guidelines for Diagnostic Imaging During Pregnancy and Lactation. The American College of Obstetricians and Gynecologist. 2017. https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/ Committee-on-Obstetric-Practice/Guidelines-for-Diagnostic-Imaging-During-Pregnancy- and-Lactation MyLab use This product is intended to be installed, used, and operated only in accordance with the safety procedures and operating instructions supplied with the product, and only for the purposes for which it was designed. However, nothing stated in the user information reduces your responsibility for image clinical evaluation and best clinical procedure. MyLab - G E T T I N G S T A R T E D 1 - 4

[Page 21] Installation, use, and operation of this product are subject to the law in the jurisdictions in which the product is used. Install, use, and operate the product only in such ways that do not conflict with applicable laws or regulations, which have the force of law. 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. MyLab Manual Conventions In this manual system controls are indicated using the following graphical conventions:  Control panel buttons are indicated by GREY CAPI TAL LET- TERS .  Touchscreen keys are indicated by BOLD BLUE CAPITAL LETTERS .  Touchscreen software strings are indicated by NORMAL BLUE CAPITAL LETTERS .  Screen software buttons and options are indicated by B O L D B L A C K C A P I T A L L E T T E R S .  Screen software strings are indicated by NORMAL BLACK CAPITAL LETTERS . Select/Click means positioning the cursor with the trackball over the desired option and pressing EN TER to confirm. Right click means positioning the cursor with the trackball over the desired option and pressing UN DO to confirm. Double click means positioning the cursor with the trackball over the desired option and pressing EN TER twice. Tap means touching with your finger the desired command on the touchscreen. Swipe means placing your finger on the desired area of the touchscreen and moving it to the left or to the right. WARNING In this manual WARNING identifies a risk for the patient and/or the operator. MyLab - G E T T I N G S T A R T E D 1 - 5

[Page 22] CAUTION The word CAUTION describes the precautions necessary for protecting the equipment. NOTE In this manual NOTE points out information of special interest but not related to risks for patient, operator or device. 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. 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. MyLab - G E T T I N G S T A R T E D 1 - 6

[Page 23] 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 label 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. 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 NOTE Please read with care the terms and conditions indicated below before using the software on the system. Use of the software implies acceptance of the terms and conditions listed below. Proprietary Rights You have acquired a device (“ DEVICE ”) which includes Esaote S.p.A. proprietary software and/or software licensed by Esaote S.p.A. from one or more software licensors (“Software Suppliers”). Such software products (“ SOFTWARE ”), as well as associated media, printed materials, and “online” or electronic documentation are protected by international intellectual property laws and treaties. The SOFTWARE is licensed, not sold. The SOFTWARE and, similarly, any copyrights and all industrial and intellectual MyLab - G E T T I N G S T A R T E D 1 - 7

[Page 24] 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. 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 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 . 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. Product Traceability To guarantee the product traceability according to requirements of the standard EN ISO 13485:2016, and the European Directive on Medical Devices 93/42/EEC (1993) and subsequent amendments, original owners, in MyLab - G E T T I N G S T A R T E D 1 - 8

[Page 25] 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. Equipment data are found on the relative identification label. GETTING STARTED PRODUCT TRACEABILITY FORM To: ESAOTE S.p.A. Quality Assurance Department Via Enrico Melen, 77 16152, Genova, Italy [or associate company] [or authorized distributor] Esaote system/device name: REF Serial Number (SN): Name and address of original owner: Name and address of new owner: Date: Signature: MyLab - G E T T I N G S T A R T E D 1 - 9

[Page 26] Vigilance System This equipment is subject to Esaote vigilance system (post-market surveillance) 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. The equipment is subject to a supervision system (post-sales supervision), which ESAOTE S.p.A., all associates and authorized distributors apply to products issued onto the market, in relation to real or potential hazards that may arise for the patient or operator during normal use of the equipment, to ensure optimal solutions in the most efficient and prompt manner possible. Therefore if the user records any malfunction or deterioration in the characteristics and/or performances of the device, as well as any inadequacy in the labeling or the instructions for use which might lead to potential or real hazards for a patient or for an operator, we kindly request to immediately inform Esaote central plants, or one of our subsidiaries, or one of our official distributors immediately through the following form, or through a communication reporting the same data contained in this form. All data relating to the system can be found on its identification label. In this way we will be able to take all adequate measures with the best efficiency and timing. Therefore, in the event of malfunctions, defective performance of the equipment, or inadequate instructions, which may constitute a hazard to the patient or operator, the user must notify ESAOTE S.p.A., associate company or authorized distributor in writing, providing the information as specified in the form below. Equipment data are found on the relative identification label. On receipt of the notification ESAOTE S.p.A. will immediately activate the process of examination and resolve the non-conformity that has been reported. MyLab - G E T T I N G S T A R T E D 1 - 10

[Page 27] 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] ESAOTE system/device name: Code (REF): Serial Number (SN): Description of the potential/real hazard: Description of accident or potential accident: Comments or suggestions: Contact Person/Department: Address: Phone: Fax: Date: Signature: MyLab - G E T T I N G S T A R T E D 1 - 11

[Page 28] MyLab - G E T T I N G S T A R T E D 1 - 12

[Page 29] Chapter 2. Additional Information on Safety  SS This chapter provides additional information on safety specifically for MyLab products. Please read the “Safety and Standards” manual carefully for a complete overview of all safety aspects of MyLab products. Environmental Safety Special waste The system contains lithium-ion batteries. The fluorescent lamp included in the LCD screen contains mercury. The batteries and the LCD screens must be treated as special waste according to the applicable local regulations. Dispose of the equipment as special waste according to the applicable local regulations. For further information please refer to the local authority for waste disposal. MyLab - G E T T I N G S T A R T E D 2 - 1

[Page 30] Electromagnetic Compatibility This system was designed for use in the electromagnetic environments declared in the tables below, in compliance with standard IEC 60601-1- th 2:2014 (4 edition). The operator must make sure that s/he uses it in keeping with this standard. NOTE Cables and accessories other than the supplied ones could negatively affect EMC performance of the system. Electromagnetic Emissions Guidance and manufacturer’s declaration – Electromagnetic emissions MyLab is suitable for use in the specified electromagnetic environment. The purchaser or user of MyLab should assure that it is used in an electromagnetic environment as described below: Emission Test Compliance Electromagnetic Environment RF emissions Group 1 This MyLab uses RF energy only for its CISPR 11 internal function. Therefore, the RF emission is very low and not likely to cause any interference in nearby electronic equipment. RF emissions Class A MyLab is suitable for use in all CISPR 11 establishments, other than domestic and those directly connected to the public low Harmonic emissions Complies voltage power supply network that supplies IEC 61000-3-2 Class A buildings used for domestic purposes. Voltage fluctuations Complies and flicker emissions IEC 61000-3-3 NOTE The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. MyLab - G E T T I N G S T A R T E D 2 - 2

[Page 31] WARNING Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. WARNING Portable RF communication equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of MyLab , including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Essential performance  Free from noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value which cannot be attributed to a physiological effect and which may alter the diagnosis.  Free from the display of inaccurate numerical values associated with the diagnosis to be performed.  Free from the display of inaccurate safety-related indications.  Free from the production of unintended or excessive ultrasound output.  Free from the production of unintended or excessive transducer assembly surface temperature.  Free from the production of unintended or uncontrolled motion of transducer assemblies intended for intra-corporeal use. 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. MyLab - G E T T I N G S T A R T E D 2 - 3

[Page 32] Electromagnetic Immunity for All Medical Equipment The MyLab system is intended for use in the electromagnetic environment specified below. The customer or the user of the MyLab system should assure that it is used in such an environment. IEC60601 Compliance Electromagnetic Environment Immunity Test Test Level Level and Guidance Electrostatic  kV on contact  kV on contact The floor should be in wood, discharge (ESD) concrete or ceramic tiles. If floors IEC 61000-4-2  kV in air  kV in air are covered with synthetic material, the relative humidity should be at least at 30%. Electrical fast  2 kV for power  2 kV for power Mains power quality should be transient/burst supply lines supply lines that of a typical commercial or IEC 61000-4-4 hospital environment.  1 kV for input/  1 kV for input/ output lines output lines Surge  1 kV differential  1 kV differential Mains power quality should be IEC 61000-4-5 mode mode that of a typical commercial or hospital environment.  2 kV common  2 kV common mode mode Voltage dips 0% U T ; 0,5 cycles 0% U T ; 0,5 cycles Mains power quality should be IEC 61000-4-11 at 0°, 45°, 90°, at 0°, 45°, 90°, that of a typical commercial or 135°, 180°, 225°, 135°, 180°, 225°, hospital environment. If the user 270° and 315° 270° and 315° of the MyLab system requires continued operation during 0% U T ; 1 cycle 0% U T ; 1 cycle power mains interruptions, it is recommended that the MyLab system is powered from an and and uninterruptible power supply or a battery. 70% U T ; 25/30 70% U T ; 25/30 cycles cycles Single phase: at Single phase: at 0° 0° Power interruptions 0% U T ; 250/300 0% U T ; 250/300 Mains power quality should be IEC 61000-4-11 cycles cycles that of a typical commercial or hospital environment. If the user of the MyLab system requires continued operation during power mains interruptions, it is recommended that the MyLab system is powered from an uninterruptible power supply or a battery. MyLab - G E T T I N G S T A R T E D 2 - 4

[Page 33] The MyLab system is intended for use in the electromagnetic environment specified below. The customer or the user of the MyLab system should assure that it is used in such an environment. IEC60601 Compliance Electromagnetic Environment Immunity Test Test Level Level and Guidance Power frequency 30 A/m 30 A/m Power frequency magnetic fields (50/60 Hz) should be at levels characteristic magnetic field of a typical location in a typical IEC 61000-4-8 commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level 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 and Test Test Level Level Measures to Be Taken Conducted RF 3 V 3 V Mobile or portable radio frequency (RF) IEC 61000-4-6 0.15-80 MHz 0.15-80 MHz communication equipment should be used no closer to any part of the MyLab system, 6 V in ISM 6 V in ISM including cables. band between band between 0.15 MHz and 0.15 MHz and Field strengths from fixed RF transmitters, 80 MHz 80 MHz as determined by an electromagnetic site survey , should be less than the compliance 80% AM at 80% AM at level in each frequency range . 1 kHz 1 kHz Radiated RF 3 V/m 3 V/m Interference may occur in the vicinity of IEC 61000-4-3 80 MHz - 80 MHz - equipment marked with the following 2.7 GHz 2.7 GHz symbol: 80% AM at 80% AM at 1 kHz 1 kHz NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MyLab system is used exceeds the applicable RF compliance level above, the MyLab system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re–orienting or relocating the MyLab system. b. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. MyLab - G E T T I N G S T A R T E D 2 - 5

[Page 34] Recommended Distances between Radiofrequency (RF) Communication Systems and MyLab  SS As stated in the “Safety and Standards” manual, it is recommended not to use radiofrequency (RF) transmission systems near the ultrasound system. RF systems can cause interference, which alters the echographic image and Doppler traces. The operator can prevent interference caused by electromagnetic fields by maintaining a minimum distance between the echographic system and the RF communication systems being used (for example cell telephones, mobile telephones). The following degradation shall not be allowed:  the disturbance shall not produce noise on a waveform, artefacts, distortion in an image or error of a displayed numerical value which cannot be attributed to a physiological effect and which may alter the diagnosis;  the disturbance shall not produce an error displaying inaccurate numerical values associated with the diagnosis to be performed;  the disturbance shall not produce an error displaying inaccurate safety-related indications;  the disturbance shall not produce unintended or excessive ultrasound output;  the disturbance shall not produce unintended or excessive transducer assembly surface temperature. MyLab , according to the definition of the IEC 60601-1-2 ed. 4 standard is suitable to be installed in professional healthcare facility environment. The operator must remember that the intensity of the electromagnetic fields generated by fixed transmitters (for example radio-base stations for cellular or cordless telephony, TV and radio transmissions, amateur radio transmissions) cannot be predicted on a theoretical basis. Consequently, a direct measure may be necessary in the use environment of a MyLab system. If the intensity of the electromagnetic fields exceeds that one specified in the immunity levels shown in the previous tables, and the echographic system performs incorrectly, additional measures may be necessary, for example by positioning the system in a different way. MyLab - G E T T I N G S T A R T E D 2 - 6

[Page 35] Wireless Requirements MyLab is equipped with built-in wireless capability. When wireless is active, the operator should make sure to stay at a minimum distance of 20 cm from the rear of the equipment. If it is necessary to work at a shorter distance, temporarily switch the wireless device off. NOTE The wireless capability has to be considered as an intentional RF (Radio Frequency) transmitter as indicated by the symbol: When the wireless is active, MyLab might interfere with other equipment.  SS Refer to the “Safety and Standards” manual for further information on restrictions for the use of wireless connections. WARNING The system is equipped with a standard Wireless LAN RF receiver and transmitter module that uses the following frequencies: Receiver/Transmitter Band Maximum Transmitter Power Modulation [MHz] [dBm] 2400 to 2483.5 DSSS and OFDM 20 (WLAN standard limit) 5150 to 5350 OFDM 30 (WLAN standard limit) 5470 to 5725 OFDM 30 (WLAN standard limit) The system may be interfered with by other equipment, even if that other equipment complies with CISPR emission requirements. MyLab - G E T T I N G S T A R T E D 2 - 7

[Page 36] MyLab - G E T T I N G S T A R T E D 2 - 8

[Page 37] Chapter 3. System Overview MyLab 9 and MyLab 9 eXP are professional, innovative and versatile real-time high-resolution ultrasound systems. The wide range of probes makes them suitable for many clinical applications. MyLab 9 and MyLab 9 eXP are based on a mainframe easily movable platform. MyLab 9 and MyLab 9 eXP have four swiveling wheels, they have a range of height adjustments for one-time installation, the main screen can be easily moved due to an optional articulated arm. Due to their small footprint they can fit in any real-world clinical environment. The possibility to adjust both the main screen, control panel and touchscreen brightness enables the use of MyLab in any environment even with really different lighting conditions: from the really bright scenario of the operative room, to the dark scenario of the examination room, passing through the medium-light environment of the bed-side examination setting. About the system Intended Use MyLab 9 and MyLab 9 eXP are intended to perform diagnostic general ultrasound studies including: Fetal, Abdominal, Intraoperative (Abdominal), Intraoperative (Neuro), Laparoscopic, Pediatric, Small organ, Neonatal, Neonatal Cephalic, Adult Cephalic, Transrectal, Transvaginal, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Urological, Cardiovascular Adult, Cardiovascular Pediatric, Transoesophageal (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 probes (convex array, linear array and phase array) and Doppler probes. MyLab - G E T T I N G S T A R T E D 3 - 1

[Page 38] The transducers intended to perform intraoperative neurosurgical imaging, following craniotomy, are enclosed in a CE marked sterile cover for intraoperative neurosurgical application. Clinical Applications and Supporting Probes A variety of ultrasound probes can be connected to MyLab 9 and MyLab 9 eXP models: Table 3-1: Available probes and applications Probe Applications Biopsy BL433 Abdominal, Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid, NO Vascular C 1-8 Abdominal, Gynecology, Musculo-skeletal, Obstetric and Fetal, YES Pediatric, Urology, Vascular C 2-9 Abdominal, Gynecology, Musculo-skeletal, Obstetric and Fetal, NO Pediatric, Urology, Vascular E 3-12 Gynecology, Obstetric and Fetal, Urology YES EC123 Gynecology, Obstetric and Fetal, Urology YES IH 6-18 Abdominal, Musculo-skeletal, Neonatal, Pediatric, Small Organ, NO Vascular IL 4-13 Abdominal, Breast, Musculo-skeletal, Pediatric, Small Organ, Thyroid, YES Vascular IOT342 Abdominal, Musculo-skeletal, Pediatric, Small Organ, Vascular YES L 3-11 Abdominal, Breast, Musculo-skeletal, Neonatal, Obstetric and Fetal, YES Pediatric, Small Organ, Thyroid, Vascular L 4-15 Abdominal, Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organ, YES Thyroid, Vascular L 8-24 Breast, Musculo-skeletal, Neonatal, Pediatric, Small Organ, Thyroid, NO Vascular LP 4-13 Abdominal NO mC 3-11 Abdominal, Cardiac, Neonatal, Obstetric and Fetal, Pediatric, Pediatric YES Cardiac, Small Organ, Thyroid, Vascular P 1-5 Abdominal, Adult Cephalic, Cardiac, Pediatric Cardiac, Vascular NO P 2-9 Cardiac, Neonatal, Pediatric Cardiac NO P2 5-13 Cardiac, Neonatal, Pediatric, Pediatric Cardiac, Small Organ, Vascular NO S2MCW Cardiac, Pediatric Cardiac NO S5MCW Vascular NO MyLab - G E T T I N G S T A R T E D 3 - 2

[Page 39] Probe Applications Biopsy SB2C41 Abdominal, Gynecology, Musculo-skeletal, Obstetric and Fetal, NO Pediatric, Urology SB3123 Gynecology, Obstetric and Fetal, Urology NO GETTING STARTED SHFCW Vascular NO SI2C41 Abdominal, Gynecology, Musculo-skeletal, Obstetric and Fetal, YES Pediatric, Urology ST2612 Cardiac NO TLC 3-13 Gynecology, Urology YES Table 3-2: Available applications and related probes Application Probes Abdominal BL433, C 1-8, C 2-9, IL 4-13, L 3-11, L 4-15, mC 3-11, P 1-5, SB2C41, SI2C41 Intraoperative: IH 6-18, IOT342 Laparoscopic: LP 4-13 Adult Cephalic P 1-5 Breast BL433, IL 4-13, L 3-11, L 4-15, L 8-24 Cardiac mC 3-11, P 1-5, P 2-9, P2 5-13, S2MCW, Transoesophageal: ST2612 Gynecology C 1-8, C 2-9, SB2C41, SI2C41, Transrectal/Transvaginal: E 3-12, EC123, SB3123, TLC 3-13 Musculo-skeletal BL433, C 1-8, C 2-9, IH 6-18, IL 4-13, IOT342, L 3-11, L 4-15, L 8-24, SB2C41, SI2C41 Neonatal IH 6-18, L 3-11, L 4-15, L 8-24, mC 3-11, P 2-9, P2 5-13 Obstetric and Fetal C 1-8, C 2-9, L 3-11, mC 3-11, SB2C41, SI2C41 Transrectal/Transvaginal: E 3-12, EC123, SB3123 Pediatric BL433, C 1-8, C 2-9, IH 6-18, IL 4-13, IOT342, L 3-11, L 4-15, L 8-24, mC 3-11, P2 5-13, SB2C41, SI2C41 Pediatric Cardiac mC 3-11, P 1-5, P 2-9, P2 5-13, S2MCW, Small Organ BL433, IH 6-18, IL 4-13, IOT342, L 3-11, L 4-15, L 8-24, mC 3-11, P2 5-13 Thyroid BL433, IL 4-13, L 3-11, L 4-15, L 8-24, mC 3-11 Urology C 1-8, C 2-9, SB2C41, SI2C41, Transrectal/Transvaginal: E 3-12, EC123, SB3123, TLC 3-13 MyLab - G E T T I N G S T A R T E D 3 - 3

[Page 40] Application Probes Vascular BL433, C 1-8, C 2-9, IH 6-18, IL 4-13, IOT342, L 3-11, L 4-15, L 8-24, mC 3-11, P 1-5, P2 5-13, S5MCW, SHFCW a. Applications are listed here as they appear on user interface. Some clinical applications are managed by using proper probe and preset. b. Both conventional and superficial (including nerve blocks) c. Includes Neonatal and Neonatal Cephalic NOTE System applications are dependent on your system configuration, transducer and exam type. Not all applications are approved in all Countries. Please refer to your Esaote local representative for further information. MyLab - G E T T I N G S T A R T E D 3 - 4

[Page 41] Patient population  Age: all ages (including embryos and fetuses)  Location: worldwide  Sex: male and female  Weight: all weight categories (in terms of Body Mass Index)  Height: no limitations Operator profile MyLab 9 and MyLab 9 eXP are designed for operators who are qualified and trained in using ultrasound system:  Sonographers  Cardiologist  Maternal-fetal Medicine Obstetrician / Perinatologist  Radiologist and Internist  System Administrator and Customer Service Engineer The operator must have read and understood the user manuals. Contraindications The MyLab 9 and MyLab 9 eXP are not intended for:  ophthalmic use or any use causing the acoustic beam to pass through the eye. WARNING Do not use MyLab for ophthalmic or transorbital applications. The ultrasound beam must not be directed to the eyes. MyLab - G E T T I N G S T A R T E D 3 - 5

[Page 42] System Components The system consists of a control panel assembly with LCD monitor and a console with the system electronics and connectors, housed in an ergonomic cart designed to be both highly mobile and adjustable for a range of users and operating conditions. The cart top is equipped to house peripherals. It has a rear mains switch to power up the console, the screen and the peripheral devices. The system provides handles and independent brakes for front and rear wheels for movement and transportation. Removable components can be locked in place so the cart can be safely moved. Fig. 3-1: System components MyLab - G E T T I N G S T A R T E D 3 - 6

[Page 43] Table 3-3: System components description Number System Component 1 Monitor 2 On/Off button 3 Control Panel Assembly 4 Orientation and sliding lever 5 Cable hangers 6 Physio connector (black) 7 ECG connector (gray) 8 Connections panels 9 Probe holders 10 Front wheel brake pedal 11 Probe connectors 12 Probe connector locks 13 Printer Drawer 14 Pull-out QWERTY keyboard 15 Lifting lever 16 Gel holder 17 Probe holder 18 Touch screen 19 USB ports 20 DVD drive 21 Loudspeakers 22 Power cord hook 23 Virtual Navigation connection (optional) 24 Main switch 25 Rear wheel brake pedal 26 LAN 27 Peripheral plate MyLab - G E T T I N G S T A R T E D 3 - 7

[Page 44] Monitor (1) MyLab is equipped with an LCD LED flat-plan display on an articulated mounting arm. The monitor is adjustable to accommodate different operating positions and operator heights. The monitor can also be locked in position for moving the system. The monitor is suitable for reading medical images, in particular each production unit is calibrated according to the Greyscale Standard Display Function (GSDF) defined in Part 14 of the DICOM medical standard. In addition, the entire apparatus, of which the monitor is an integral part, complies with the mandatory standards of biomedical equipment (safety according to IEC 60601-1 Ed. 3.1 and EMC according to IEC 60601-1-2 Ed. 4). WARNING The LCD must be considered an Information Technology (IT) device: it can be safely used inside the patient area only when it is powered through the cart insulation transformer. On/Off Button (2) The O N /O FF button is located beside the touchscreen, on the left side of the control panel assembly, while the Main Switch (23) is located on the rear- bottom of the system. Beside the Main Switch is also located an earth terminal to be connected to an external protective earthing system as additional protection. When MyLab is connected to the mains and the Main Switch is on, the lighting of the O N /O FF button changes to indicate its status. The different indicators are described in the table below. Table 3-4: On/Off button light Led Colour Meaning GREEN MyLab is on AMBER MyLab can be turned on OFF MyLab can not be turned on. In this case check both the rear main switch and the mains connection. Pressing the O N /O FF button turns the system on or off, activating or closing the examination session. MyLab - G E T T I N G S T A R T E D 3 - 8

[Page 45] Control Panel Assembly (3) The Control Panel Assembly includes the main controls: physical buttons, knobs, and trackball, TGC, touchscreen and a pull-out QWERTY keyboard placed in the drawer below the panel. The control module also allows to select transducers, enter patient data, review and annotate images, perform measurements and calculations, and change setups. The Control Panel Assembly includes the system handle, the probe and ECG cables holders. Two loudspeakers (21) are placed on both side of the touchscreen. Fig. 3-2: Control Panel Assembly Table 3-5: Control Panel Assembly description Number Control Panel Assemble 18 Touch screen 27 Knob controls 28 TCG slide controls 29 Trackball MyLab - G E T T I N G S T A R T E D 3 - 9

[Page 46] Control Panel Assembly Orientation The Control Panel Assembly is adjustable to accommodate a wide range of operator heights and operating positions. . These adjustments can be controlled by two levers located below the Control Panel Assembly (as shown in the image beside). The orientation and sliding lever (4), located on the left, allow to swivel and slide back and forth the control panel. Push the lever to rotate and slide the control panel into the new position. Release the lever when the control panel is correctly positioned. This lever allows to rotate by up to 45° clockwise and by up to 180° counterclockwise (closed position for optimal handling). CAUTION When rotating the keyboard, pay attention not to damage the peripherals placed on the console. If the peripheral falls down, injury may be caused. The lifting lever (15), located on the right, allows to adjust the position of the control panel vertically, lifting or lowering it. Push the lever and act on the handle to adjust the height of the control panel. This lever allows a vertical displacement of  20 cm  Pull-out Qwerty Keyboard (14) Beneath the Control Panel there is a pull-out alphanumeric keyboard. The keyboard is mounted on a sliding drawer: just pull it to extract the keyboard. The keyboard is used to enter patient data, comments and text annotation on images. Data Storage You can store exam data onto removable media. Removable media include USB storage devices and the DVDs and CDs. The DVD drive (20) is located on the right side of the control panel behind the touchscreen. It allows both to read and to burn CDs and DVDs. Two USB ports (19) are located on the right side of the control panel next to the touchscreen protected by a rubber cover. These ports can be used to connect an USB device for digital storage, an USB foot-switch or a USB printer. MyLab - G E T T I N G S T A R T E D 3 - 10

[Page 47] ECG and Physio Connectors The ECG cable connector (7) and Physio cable connector (6) are placed on the left side of the console. Probe Connectors and Cable Management Four probe connectors (11) are located on the front of the console. All connectors can be occupied simultaneously, but only one probe at time can be active. Probe Connector Locks (12) are placed above the probe connectors. Make sure that the Probe Connector Lock is positioned on the right (open position) and carefully attach the probe connector by placing the cable feed- through downwards. To secure the probe, move the securing device towards left (locked position). Two additional Probe Connectors holders (9) are available to the left of Probe Connectors. WARNING Do not touch the probe connector pins or the system probes receptacle. Never disconnect the probe while it is active. Press FREEZE before disconnecting the probe. CAUTION Check to correctly align the probe connector before inserting it. Close the connector-securing device only after having completely inserted the connector. When a transducer is not in use, store it in one of the probe holders (17) on the sides of Control Panel Assembly. Always loop transducer cables over the cable hangers (5) to prevent cables from being stepped on or run aver by the cart wheels. Peripherals Housing The console top is equipped with a peripheral plate (26) to house peripheral devices. Those devices can be any combination of the following devices: a black-and-white printer, a color printer, and a DVD recorder. The peripheral can be easily connected and disconnected and secured to the system console with belts. An additional Printer Drawer (13) for B/W thermal USB printer storage is located on the front side of the console. MyLab - G E T T I N G S T A R T E D 3 - 11

[Page 48] Connections panels (8) On the rear left side of the console two doors protect additional connections panels. The one on the lateral side on the system allows to access the PC ports like auxiliary USB 3.0 ports and the headphone connector. The USB ports can be used to connect a USB printer, a USB footswitch or a USB digital archive medium. The microphone has not current use. The other door placed on the corner of the console allows to access peripherals power connections and the fuse box. The main switch, the power cable socket and an earth terminal are placed on the rear-bottom of the system. Wheel Brakes MyLab is equipped with four rotational wheels. Each couple of wheels has a brake pedal (10 and 24) between them. When the pedal is fully pressed down, the brake is engaged to avoid rotation of wheels keeping the system stationary during use. To release the brake, move the pedal to the middle position. When the pedal is fully up, the brake is engaged to avoid whirling of wheels to aid in steering while moving the system. To release the brake, move the pedal to the middle position. MyLab - G E T T I N G S T A R T E D 3 - 12

[Page 49] Chapter 4. Preparing the System 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. The information and procedure provided in this chapter will guide to prepare the system for use. Preparation includes connecting probes and external devices, locking articulated components for moving, and ensuring that system operating is met. 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. Table 4-1: Acclimation Time T(C°) 60 55 50 45 40 35÷15 10 5 0 -5 -10 -15 -20 Hours 8 6 4 2 1 0 1 2 4 6 8 10 12 Connecting the System to a Network To use connectivity features, the system 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 the system for network connectivity. 1. Turn off the system power. 2. Connect one end of the provided network connection cable to the wall plug for your network. 3. Connect the other end of the cable to the network plug on the system. 4. Turn on the system. MyLab - G E T T I N G S T A R T E D 4 - 1

[Page 50] Connecting 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. Before installing the peripheral devices, make sure that the system is switched off and unplug the power cable from the mains outlet. Brake the wheel to fix the system. Powering sockets for peripheral devices are placed at the rear on the left; peripheral connections are placed at the rear, on the right. The network connector is placed at the rear in the bottom central position. How to connect peripheral devices: 1. Ensure that the MyLab is switched off (complete shut down not stand-by or other conditions). 2. Connect the peripheral device to the MyLab . 3. Switch the peripheral device on, making sure that the device is not in stand-by condition. 4. Switch the MyLab on by pressing the Power ON button. NOTE Always observe the instructions given in the manual of the peripheral/ auxiliary device. NOTE Contact Esaote personnel for recommended USB printers and for safe and proper installation. 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. Two 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). MyLab - G E T T I N G S T A R T E D 4 - 2

[Page 51] 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 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.  SS The “Safety and Standards” manual provides the safety requirements and standards to be observed for using peripherals devices with MyLab . Medical environments Based on IEC60601 three different conditions can be defined for patient environment: Fig. 4-1: A) Patient area Fig. 4-2: B) Medical Use Room Intended as area B, area A excluded. MyLab - G E T T I N G S T A R T E D 4 - 3

[Page 52] Fig. 4-3: C) Non-medical use room A room not designed for medical treatment, for example, an office or a storage room. Possible configurations:  MyLab + auxiliary device complying to IEC 60601 in area A - No additional safety requirements.  MyLab + auxiliary device not complying to IEC 60601 (complying to IEC XXX ) 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. MyLab - G E T T I N G S T A R T E D 4 - 4

[Page 53] 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 IEC60601 requires control measurement of leakage currents. The system integrator (any person connecting the medical device to other devices) is responsible that the connections are safe. WARNING The system must be powered so to satisfy the electrical safety requirements, as specified in the “Safety and Standards” manual. Esaote recommends running a current leakage (patient and environment) test when installing in order to check whether the applicable limits of standard EN60601-1 are not being surpassed. MyLab - G E T T I N G S T A R T E D 4 - 5

[Page 54] B/W Thermal Medical USB Printer housing Those kinds of printers can be hosted in the lateral storage area. Procedure 1. Open the rear door. 2. Connect both the power and the USB cables to the printer. 3. Insert the printer into the storage area by first introducing the cables. 4. Let the cables come out from the slot placed just above the peripheral powering sockets. 5. Plug the printer power cable to any of the socket indicated by symbols J1, J2 and J3. 6. Connect the USB printer cable to any of the USB ports placed on the right. 7. Switch the printer on. 8. Close the rear door. USB Printer housing The system can be connected to USB printers via a USB Port. The printer can be housed on the console top. MyLab is equipped with belts to secure the peripheral device. NOTE When selecting the peripheral, consider its dimension so that it can be safely installed on the console. The console top measures 29 x 20 cm. CAUTION The peripheral weight does not have to exceed ten (10) kg. The console could be damaged if the peripheral weight exceeds this limit. Procedure 1. Introduce the belt below the stirrup mounted on the console top and stretch it along the console top. 2. Place the printer on the console top. 3. Introduce the belt into the hole placed at the top of the rear side of the console. 4. Secure the peripheral by closing the belt. 5. Connect both the power and the USB cables to the printer. 6. Open the rear door and connect both cables to the console. 7. Close the rear door by letting the cable come out from the upper door slot. MyLab - G E T T I N G S T A R T E D 4 - 6

[Page 55] 8. Switch the printer on. WARNING Always power any USB device (such as USB printers or external USB archiving devices) through the trolley. Now the system can be connected to the mains and the entire configuration can be powered through the main switch. CAUTION Before connecting the peripheral verify not to exceed the maximum power consumption limits indicated for insulated sockets. There is a risk of blowing the system fuses. WARNING The maximum current supplied by the MyLab USB ports is 500mA (for USB 2.0) and 1A (for USB 3.0). Peripherals exceeding this limit can be connected only if powered by their external power supply through a medical insulation transformer. Auxiliary Monitor Any auxiliary monitor connected to the Display Port has not to be used for diagnostic purposes. NOTE The resolution of the auxiliary monitor cannot be lower than the main display. The system automatically shuts down whenever a lower resolution is detected. Monitor Connection Connect the monitor cable to the suitable connector on MyLab . Gel warmer Gel Warmers can be mounted on MyLab . WARNING To provide required separation from AC mains for both the system and the auxiliary devices, any gel warmer must be powered through the MyLab insulation transformer. MyLab - G E T T I N G S T A R T E D 4 - 7

[Page 56] External CD/DVD and HDD drives Any external USB CD/DVD drive and/or USB hard disk drive have to be connected to MyLab USB ports both for data transfer and power. For safety reasons, the drive must be fixed to MyLab console. Mechanical damage may occur if the drive falls down. The External Slim DVD Writer kit supplied by Esaote includes a Velcro tape to easily and securely fix it to MyLab console. Stick the tape both on the MyLab console and on the DVD case, then attach them to fix the External Slim DVD Writer to MyLab console. Power the External Slim DVD Writer through two USB ports using the split cable present on the kit. WARNING The maximum current supplied by the MyLab USB ports is 500mA (for USB 2.0) and 1A (for USB 3.0). Peripherals exceeding this limit can be connected only if powered by their external power supply through a medical insulation transformer. Moving and Transporting the System MyLab is provided with wheels and handle to allow the user to easily move the device. The following precautions must be observed: Moving the system 1. Switch the system off. 2. Engage the wheel brakes by pressing the pedals fully down. 3. Push in the QWERTY keyboard completely beneath the Control Panel. 4. Use the handle lever to center the control panel and move it to a comfortable height for moving. 5. Turn the mains switch off and unplug the power cord, wrapping it on the rear hook to ensure it. 6. Disconnect all external cables, including network and external devices. 7. Secure all cables, probes and accessories so that they do not interfere with the wheels. 8. Peripheral can be placed on the MyLab peripheral platform, provided that it is secured with the locking belt. 9. If peripherals are placed on an external additional platform, be sure they are disconnected from MyLab before moving the ultrasound system. MyLab - G E T T I N G S T A R T E D 4 - 8

[Page 57] 10. Lock the monitor arm by rotating the lever on the monitor arm on lock position. 11. Release the wheel brakes and set the steering locks for comfortable moving. 12. Move the system using the front or rear handle. 13. Avoid any unnecessary mechanical shock to the system while moving it. Observe the following warnings and cautions before moving the system: WARNING Use the handles on the keyboard only to move the system and rotate the keyboard. Make sure that the probes are locked and the probe cables are properly hanged in the cable hooks while moving the system. WARNING The handles on the keyboard cannot be used to lift the system. 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. Transportation When transporting the system in a vehicle, remember to:  Disconnect and remove all probes and peripheral devices.  Rotate the control panel in its closing position. CAUTION The keyboard could be damaged during transportation in a vehicle, if it is locked.  Bring the control panel to its lowest position.  Protect the LCD screen (for example with bubble wrap) and placed it horizontally, taking care to place something thick (such as foam or bubble wrap) between the control panel and the LCD itself, to avoid any contact between the parts and to avoid screen swing during transportation. MyLab - G E T T I N G S T A R T E D 4 - 9

[Page 58] Fig. 4-4: Transporting Configuration  Protect the screen orientable arm so that no lateral movements are possible (for example with film).  Use the brakes to lock the system.  Fasten securely the system inside the vehicle. MyLab - G E T T I N G S T A R T E D 4 - 10

[Page 59] Chapter 5. Using the System This chapter provides a brief description of the system controls.  AO Refer to the “Advanced Operations” manual for further detailed information. Connecting the system to the mains The power plug and the electrical main switch are located on the rear-bottom of the system. The power plug symbol is screen-printed on the console plastic. Procedure 1. Plug in the power cord. 2. Connect MyLab to the power mains. WARNING When installing MyLab , check that the power cable is not tightly bent, that it can’t be squashed by a misplaced foot or by heavy objects. The earth terminal can be connected to an external protective earthing system as additional protection. This connection is not necessary in most cases and is only recommended for 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. Turning the System On and Off At the examination site: 1. Position the system into its final position. 2. Rotate the control panel assembly into its working position. 3. Set the control panel height into a comfortable position. 4. Engage the wheel brakes by pressing the pedals fully down. 5. Position the monitor where you want it. MyLab - G E T T I N G S T A R T E D 5 - 1

[Page 60] 6. Connect the network and other cables from the system to the appropriate wall plugs. 7. Plug the cable to a reliable grounding power outlet to assure adequate grounding. 8. Turn the main switch of the rear panel on. 9. Press O N /O FF to turn on the system. WARNING When installing MyLab , check that the power cable is not tightly bent, that it can’t be squashed by a misplaced foot or by heavy objects. WARNING Position the system in a location allowing an easy unplug of MyLab from the mains in case of need. NOTE It is recommended to turn the rear panel switch off before unplugging the power cable, whenever the system is expected not to be used for long periods. NOTE Whenever the system has to be insulated from the mains, disconnect the cable from the power outlet. CAUTION Do not turn the system off while working (for example saving data) or during the initialization phase: the hard disk could be damaged by this operation. CAUTION This is a PC based system; data loss or driver damage may occur if the system is turned off while working (for example saving data) or during the initialization phase. Refer to the appropriate chapters of this manual for detailed information on when and how to safely power the system off. System Controls System controls are located on the Control Panel Assembly that includes the control panel, the touchscreen and the alphanumeric keyboard. Control Panel Section The control panel includes the main imaging controls: the TGC slide controls, a trackball, the joystick and the exam control buttons and knobs. The control module also allows to select imaging modes, review and annotate images, perform measurements and calculations. MyLab - G E T T I N G S T A R T E D 5 - 2

[Page 61] Table 5-1: Exam Control Buttons Button Description ETO UCH Toggles between factory and customized touchscreen that can be created by the user. Refer to the chapter “Customizing the system” further in this manual. ARCHI VE Gives access, at any time, to the archived data. EN D EXAM Closes the current exam archiving the patient’s data and producing a report on the exam. The system clears the stored data and shows the Exam Start menu again. CW Activates the Continuous Wave Doppler (CW). At its pressure the positioning cursor is activated as well. PW Activates the Pulsed Wave Doppler (PW). At its pressure the positioning cursor is activated as well. The knob around this button amplifies both CW and PW gains. To increase gain, turn the knob clockwise, to reduce it, turn the knob counter-clockwise. PD/TVM Activates the Power Color Doppler or Tissue Velocity Mapping. C Activates/deactivates Color Doppler (CFM). The knob around this button amplifies both CFM and Power Color gains. To increase gain, turn the knob clockwise, to reduce it, turn the knob counter- clockwise. In B-Mode, a cursor delimits the Region of Interest (ROI) where color analysis is performed and displayed. M Activates the M-Mode and, if necessary, its selection cursor (B- Line). B This button re-activates a B-Mode image in real time when any other mode is active. If pressed in M-Mode, Doppler or Freeze, it restores a full screen bi-dimensional image. The knob around this button amplifies both B-Mode add M-Mode gains over the entire depth of the image. To increase gain, turn the knob clockwise, to reduce it, turn the knob counter-clockwise. M ARK Activates bodymarks; further details on how to use them are described in the “Advanced Operations” manual. CLEAR Deletes all measurements or annotations from the screen. ALL ABC Activates annotations; further details on how to use them are described in the “Advanced Operations” manual. M EASURE Activates Advanced Measurements showing the list of available measurements on the right of the image. MyLab - G E T T I N G S T A R T E D 5 - 3

[Page 62] Button Description +. . . + Activates Generic Measurements showing the list of available measurements on the right of the image. ACTI O N Changes the function linked to the trackball. Refer to the “Trackball” paragraph further in this chapter. AUTO Automatically adjusts both the overall gain and TGC distribution improving the contrast resolution of the image. The activation is indicated on the screen by the corresponding icon and it is labeled as “AG”. Refer to “Advanced Operations” Manual, “Imaging Optimization” Section for further information. PO I N TER Toggles the trackball operation from standard to mouse mode. Refer to the “Trackball” paragraph further in this chapter. LI N E In B-Mode or CFM, this button allows to interactively activate the UPDATE cursor or disable it to select the M-Mode or Doppler line. During the exam, when a trace is active, the same button freezes the trace acquisition and temporarily reactivates the reference B- Mode image. ACQ UI RE Activates advanced features; further details on how to use them are described in the “Advanced Operations” manual FREEZE Stops the current analysis or scan and puts the system in Freeze mode. To re-activate real time, press it again or directly press the button of the required mode. 3D/4D Activates three dimension features; further details on how to use them are described in the “Advanced Operations” manual DUAL Activates dual and quad view both in real time and freeze. Press LEFT or RI GHT to activate dual presentations: the active image is displayed on the left/right. Press CEN TER to restore a single format. Press CEN TER to activate quad presentations: the active image is displayed on the top-left. Press LEFT or RI GHT to add other images. Press CEN TER to restore a single format. 1 , 2 , 3 , 4 These buttons can be customized to save clips, save and print images. Refer to chapter 6 “Customizing the system” for further information. TGC Sliding The TGC sliding control signal amplification in individual areas of the image. Potentiometers are used to adjust the signal zone by zone. MyLab - G E T T I N G S T A R T E D 5 - 4

[Page 63] Trackball The trackball operates in two different modes. Standard Mode In its standard mode, the trackball makes it possible to quickly position the cursors on the screen. Each mode automatically activates the trackball on its cursor. Table 5-2: Trackball cursors Mode Trackball M-Mode, Doppler LINE cursor Color Flow Mapping (CFM) CFM ROI cursor The cursor function is indicated on the left bottom side of the screen. When several cursors are present on the screen, ACTI O N switches between the active cursors. Blue indicates active cursor function while white next cursor function. Mouse Mode In its mouse mode, the trackball can be used to move a pointer on the screen, to access to the thumbnails of the images, displayed on the right side of the screen or to access to the archiving media and peripheral menus. The buttons placed on the left and right side of the trackball can be set as mouse keys (as confirmation and context menu buttons). Regardless of the trackball configuration, the confirmation and context menu buttons are respectively indicated as EN TER and UN DO in this manual. Press PO I N TER to change the trackball operation from standard to mouse mode. Joystick The JO YSTI CK is a special control providing multiple functions to make easy your workflow. The functions linked to both the joysticks depend on the current system status (they are contextual the operative mode). A proper layout on the screen indicates the current function. Refer to “Advanced Operations” Manual, “Imaging Optimization” Section for further information. MyLab - G E T T I N G S T A R T E D 5 - 5

[Page 64] Touchscreen Section This section includes the M EN U and the O N /O FF buttons, a touchscreen and two USB ports. Menu Button M EN U displays the system menu for all configurations/settings (both clinical and system settings). Touchscreen The touchscreen displays controls used to select probes, enter patient data, select applications and change setups; it also displays exam controls related to the active modality. Touchscreen controls are indicated in the operator manuals by BOLD BLUE CAPITAL LETTERS for keys that can be tapped while by NORMAL BLUE CAPITAL LETTERS for software text strings. Tap the displayed key to activate/deactivate the corresponding control. Many modes provide two or more pages of controls. Swipe left/right to move to the next/previous page. A page indicator shows you the page in which you are. The touchscreen layout changes depending on the different working modality:  as Exam panel, providing control keys to perform the exam,  as Multipurpose panel, providing software buttons to use advanced exam controls,  as Alphanumeric keyboard to enter data,  as an image viewer. Multipurpose Panel This layout is used for standard exam functions necessary to perform the Layout exam. Keys The keys have a color coding depending on their status. MyLab - G E T T I N G S T A R T E D 5 - 6

[Page 65] Table 5-3: Touchscreen key status Active Key with Disabled Key Active Key Selected Key Sub-menu Gray text on dark White text on light As Active Key with Blue text on dark gray background gray background three lines at gray background bottom right If the key is active, the displayed function will be enabled when tapping the corresponding key on the touchscreen. Knobs Six rotating knobs are located along the bottom side of the touchscreen. Each knob acts on the control key just above it. Rotate the knob to change the control value. Sometimes, two controls are available for a knob. Only one of the controls can be active at a time. Pressing the corresponding knob or tapping the label toggles the active control. MyLab - G E T T I N G S T A R T E D 5 - 7

[Page 66] Multipurpose Panel This layout is used for advanced exam functions, for example bodymarks or Layout annotations. The touchscreen is organized in six main areas. Fig. 5-1: CFM touchscreen 1. Work flow Area, it contains keys related to the exam flow. 2. Smart Preset, it displays the available smart presets. 3. Tools, it lists the available tools. 4. Navigation tab bar, each tab contains additional keys. 5. Main Area, it contains main controls for the active modality. 6. Knobs Area, it contains functions whose value can be changed by rotating the knob beneath. On top-right, a dedicated key activates the emulation of the Qwerty alphanumeric keyboard. Tap the keyboard icon to display the keyboard. Tap again to hide the keyboard. Tap the cogwheel icon to access a menu for easy configuration of display settings to adapt the contrast and brightness of your display to the lighting conditions of your room. Image Review This layout is used to display both real-time and saved images on the Layout touchscreen. Swipe down on the blue arrow on top center of the touchscreen to access this layout, two keys allow you to choose to view the image in real time or review the saved ones. Swipe left/right to scroll the images. Tap the MyLab - G E T T I N G S T A R T E D 5 - 8

[Page 67] bottom right button to switch between real-time and review. Swipe up to close. WARNING The touchscreen cannot be used for diagnosis. Alphanumeric Keyboard Section The alphanumeric keyboard is based on the QWERTY standard. The alphanumeric keys are used to enter text data in the enabled windows. The Caps Lock key sets the keyboard to upper case characters. The  Shift key is used to type in lower case or upper case characters (according to how the keyboard is set); the Fn key is used to type numeric functions (for example +, *).  AO Refer to the “Advanced Operations” manual for the use of the keyboard in annotation modality. Information about the Screen Layout The screen is split into five main areas. Fig. 5-2: Screen Layout 1. Heading Area 2. Footer Area 3. Image Area 4. Joystick Area MyLab - G E T T I N G S T A R T E D 5 - 9

[Page 68] 5. Thumbnails Area Controls on the Screen Layout are indicated in the operator manuals with B O L D B L A C K C A P I T A L L E T T E R S , while strings and fields are indicated with NORMAL BLACK CAPITAL LETTERS . Symbol on Screen When this symbol is displayed on the screen, it indicates to carefully read the manual. Refer to the appropriate section of the manual for a detailed explanation. Heading Area This area is used to display the following information: center and patient data, accession number and date. Patient data are displayed only if entered at the beginning of the exam. Data can be entered or modified at any time during the exam by pressing PATIENT ID . Footer Area This area is used to display the following information:  joystick functionality,  trackball functionality,  Wi-Fi icon (when enabled),  archival media icons,  advanced features icons,  peripherals icons. Trackball The trackball function is indicated on the bottom left side of the footer area as text and in the middle as graphic. When there are several cursors on the screen, two functions are displayed simultaneously. The function shown on the upper line indicates the active cursor; the one on the lower line indicates the next cursor that can be activated. ACTI O N switches among cursors. MyLab - G E T T I N G S T A R T E D 5 - 10

[Page 69] Wi-Fi When Wi-Fi is enabled, its icon is shown beside the archival media icons. The icon is shown crossed out whenever Wi-Fi is not connected.  AO For more details on Wi-Fi connectivity, consult the relevant section on the “Advanced Operations” manual. Archival Media Archival media are shown on the left, beside the trackball function. The icon is shown crossed out whenever there are management problems involving the specific archival system.  AO For more details on data archival, consult the relevant section on the “Advanced Operations” manual. Advanced Features When advanced features such as XView or MView are activated, the corresponding icons are displayed on the center of the footer area. Peripheral Devices The system is able to simultaneously manage two peripheral devices (b/w or RGB printers). The icons of the peripheral devices are shown at right of the footer area. The icon is shown crossed out whenever there are management problems involving the specific peripheral device. MyLab - G E T T I N G S T A R T E D 5 - 11

[Page 70] 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. 5-3: Image Area Table 5-4: Image Area description Number Description 1 Frequency Bar, active application, probe and preset 2 System Parameter 3 Sector orientation 4 Acoustic output data 5 Focal Zone(s) 6 Image and color scales 7 Memory bar Freeze Status Whenever an image is frozen, a memory bar is displayed (at bottom right) concerning the scrolling memories. The images acquired immediately before are frozen and archived in these memories. The trackball can be used to examine the 2D, M-Mode, Doppler and color information image by image. MyLab - G E T T I N G S T A R T E D 5 - 12

[Page 71] Machine Parameters Table 5-5: Imaging Parameters Displayed Parameter Description GETTING STARTED format F l Imaging or TEI (Tissue Enhancement Imaging) mode: General, Resolution or Penetration (L: Low, H: High) G nn% Imaging gain (Min,%, Max) AG nn% Auto Adjust D nn mm Depth X/M C or +n/n XView Algorithm or CrystaLine Imaging / MView algorithm PRC n/n/n/n Dynamic range / Dynamic compression / Density / Gray map PRS n Persistence SV nn/nnn mm Sample volume size and depth  nn° Doppler angle correction SV and  are displayed only if the relevant cursor is active. Table 5-6: Color Flow Mapping (CFM) Parameters Displayed Parameter Description format F nnn MHz Color frequency or TVM (Tissue Velocity Mapping) frequency when enabled G nn% Color gain (Min,%, Max) PRF nnn kHz Pulse Repetition Frequency WF n Wall filter PRC l/n Smooth (L: Low, M: Medium, H: High) / Density PRS n Persistence MyLab - G E T T I N G S T A R T E D 5 - 13

[Page 72] Table 5-7: Doppler Parameters Displayed Parameter Description format F nnn MHz Doppler frequency or TV (Tissue Velocity) frequency when enabled G nn% Doppler gain (Min,%, Max) PRF nnn kHz Pulse Repetition Frequency PRC n/n Dynamic range / Rejection WF nnn Hz Wall filter PRC n/n Dynamic range / Gray map Joystick Area Control Panel Commands are displayed in this area providing information about the function related to joysticks and 1 , 2 , 3 , 4 buttons. Thumbnails Area Clips and images both saved during the exam and previously archived are displayed on the right side of the screen as thumbnails. The thumbnails are displayed in chronological order, from left to right. The tabs displayed at the top of the thumbnails columns allow to scroll among the images saved during current exam and images retrieved from other exams. MyLab - G E T T I N G S T A R T E D 5 - 14

[Page 73] Chapter 6. Customizing the System MyLab can be customized to increase efficiency and streamline your work- flow. You can do the following:  Create preset designed specifically for the exams you perform.  Change system settings to reflect your needs.  Add options to enhance your imaging abilities.  Create custom procedures for specific patients, transducers, and presets. The M EN U button is used to access the system menu. The system displays all the available options. Fig. 6-1: System Menu MyLab - G E T T I N G S T A R T E D 6 - 1

[Page 74] 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. Clinical A clinical setting is a group of configurations optimizing MyLab for a specific Configuration type of exam (for example for a cardiac exam or an obstetrical exam). This clinical setting is associated to the specific probe in the selected application. You can save several clinical settings for each probe in each application. This means that the preset, selected at the beginning of the exam or during the exam pressing PRO BE , establishes the initial settings of the exam controls (like gray map, depth...) together with the initial available measures (measurement configuration), the initial available library both for annotations and for bodymarks (Annotation and Bodymark configurations) and the customized touchscreen. Clinical Configuration allows to set different parameters listed below:  Real Time Preset for Presets configuration,  Measure for measurement configuration,  Annotations for annotation configuration,  Bodymarks for bodymark configuration,  eTouch for eTouch configuration,  When licensed, advanced tool configurations (such as 3D/ 4D, Stress Echo) are part of the clinical settings. NOTE Refer to the dedicated sections of this manual for further information on the above Clinical Configurations. MyLab - G E T T I N G S T A R T E D 6 - 2

[Page 75] System Settings System Settings define the MyLab ’s parameters related to a specific system profile:  Profile Manager,  DICOM configuration, GETTING STARTED  Saving Options for end exam saving configuration,  Center ID for hospital configuration to set the name of the hospital,  Multimedia,  Network for network configuration,  Observations for observation configuration,  Printers for printer configuration,  Report for report style configuration,  XStrain2D,  Acquisition Protocols. You can save several system profiles. If, for example, MyLab is used in two structures differing in Network and DICOM connectivity, two specific System Configuration profiles can be created: each time the user will load the configuration required by the structure. MyLab allows the user to save several system configurations. If, for example, MyLab is used in two structures differing in Network and DICOM connectivity, two specific System Configuration profiles can be created: each time the user will load the configuration required by the structure. General Settings General Settings define the MyLab ’s general parameters:  General Setup for general configuration, like measure units, control panel setting,  Security for general configuration,  Licenses for license settings,  Import/Export for exam export configuration,  System Info,  Remote Service,  ePortal. MyLab - G E T T I N G S T A R T E D 6 - 3

[Page 76] 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. In a few limited cases the procedure may differ to the one described below, in these cases it will be described in the specific paragraph. Procedure  Press M EN U , and select the parameter you want configure. The configuration screen for the selected parameter is displayed.  On the left of the screen is displayed the list of possible items.  Select the desired item, then choose one of the following options. Table 6-1: Configuration Menu Options Option Description E D I T To modify the settings of the item selected on the top-left list. Alternatively double click on the item you want to modify C L O N E To create a new customized item starting from a copy of the existing selected one. N E W It replaces C L O N E when no customized items are present. R E M O V E To delete the selected customized item. A confirmation dialog will be displayed. Only customized items can be deleted. F A C T O R Y To retrieve all factory values and to delete all customized items.  Once in editing mode you can change the name of the selected item ( NAME field), enter a description ( NOTES field), confirm and save the settings ( S A V E ), or exit the menu without saving the settings ( C A N C E L ). At any time you can go back to the main menu ( B A C K T O M E N U ) or exit from the menu and go back to Real Time ( C L O S E ). MyLab - G E T T I N G S T A R T E D 6 - 4

[Page 77] Clinical Configurations Real Time Preset A Preset is a group of settings that optimizes the system for a specific type of exam. Presets establish many initial settings, such as gain value, color map, filter and items on the touchscreen. You can choose from several default presets, modify them and create many others. Default presets can not be deleted, however, they provide a starting point from which you can create your own presets. The available presets are determined by the selected transducer. The creation/modification of a preset is achievable in two steps:  from M EN U , where you can add the desired measurement configuration, annotation and bodymark libraries,  from Real Time, where you can set the parameters that optimize the real time image in all modes and create the customized preset. Creating a new preset from MENU To create a new preset or modify an existing one press M EN U , then select R E A L T I M E P R E S E T and then follow the generic configuration procedure, taking in account that on the left of the screen is displayed the list of all clinical settings, grouped by probes. Within each probe clinical settings are grouped by applications. During editing you can select from the curtain menu each parameter (Measure, Annotation, Body Marks...) to be associated of the preset in the desired configuration. Here you can also assign the default application for each probe independently. Each time the probe is selected its default application is selected as well. When selecting each probe you can also establish which application to show on the touchscreen. Uncheck the application in order not to show it. The option ALL PROBES allows to select/unselect the application for all probes. The configured preset is associated to the active probe and application: this preset will be available each time the same probe and application are selected either from the Start Exam page or by tapping PROBE . MyLab - G E T T I N G S T A R T E D 6 - 5

[Page 78] 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).  Tap PROBE and then PRESET MANAGER .  Press O V E R W R I T E to overwrite the current preset (also factory presets can be overwritten) or using the alphanumeric keyboard type a new preset NAME and NOTE and press N E W to confirm. O V E R W R I T E saves all settings done in real time in the active preset. N E W creates a new preset whose configuration is the one defined in every modality in real time. C L O S E exits without saving any modification. eTouch Button MyLab allows the user to record sequences of keys both of the touchscreen and of the control panel. Each recorded sequence (Macro) can be named and saved to be available as customized button in customized touchscreens. ETO UCH switches between factory and customized touchscreen. Whenever the customized button is pressed, MyLab will automatically launch the keys sequence. Each system configuration is linked only to one customized touchscreen. NOTE Keys sequences that require interaction with the user (like measurements or pointer positioning) can not be recorded as macro. Configuring eTouch button To access to the ETO UCH configuration menu:  Press M EN U . The configuration menu is organized in two main areas: the list of all saved customized touchscreens on the left side and the eTouch configuration menu on the right side.  Select one of the saved customized touchscreens, then follow the generic configuration procedure. During editing the screen displays:  in the center the touchscreen layout, MyLab - G E T T I N G S T A R T E D 6 - 6

[Page 79]  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. From here you can:  Record the Macro sequence,  Customize the touchscreen,  Create additional tabs on the touchscreen. To create a customized touchscreen, follow one of the following procedures. NOTE Wait for any background operations to be finished before starting the procedure. Recording  Place the cursor on the R E C O R D I N G field and press S T A R T Procedure to begin the recording: MyLab switches to the frozen status.  The system displays on the upper left side of the screen the following flashing message: Press eTouch to start recording. Prepare MyLab to be ready for the recording so that only the keys to be used can be pressed and then press ETO UCH to start.  Press the desired keys in sequence and press again ETO UCH to end the recording. During the sequence recording, the message turns color. The eTouch configuration menu displays the customized button. Place the cursor on the button and press EN TER to change its name, using the alphanumeric keyboard to edit it. Repeat the procedure to add other customized buttons. Customized Button The customized button can be freely positioned within the touchscreen. Organizations M O V E B U T T O N changes the button position: select the button with the trackball, place the cursor on the desired position and click EN TER to confirm. D E L E T E B U T T O N cancels the button selected with the trackball. Tab Organization Customized touchscreen can be organized in more tabs. Each tab has one level of buttons. MyLab - G E T T I N G S T A R T E D 6 - 7

[Page 80] N E W T A B button adds a new tab that will be automatically displayed. Place the cursor on the tab and press EN TER to change its name, using the alphanumeric keyboard to edit it. M O V E L E F T and M O V E R I G H T buttons respectively shift to left or to right the selected tab: select the tab with the trackball and press the desired button. D E L E T E S E L E C T E D T A B button cancels the tab selected with the trackball. NOTE Empty tabs (that is tab not containing customized button) are not displayed in the customized touchscreen. System Settings Profile Manager Profile Manager allows to create a system profile for each user with a personalized system configuration. To configure the Profile press M EN U , then select P R O F I L E M A N A G E R and then follow the generic configuration procedure. During editing you can configure each displayed component selecting the desired option among the ones available in the relevant SETTINGS combo. Fig. 6-2: Profile Manager Menu MyLab - G E T T I N G S T A R T E D 6 - 8

[Page 81] Corrupted System Profile Whenever a profile is corrupted, a red exclamation mark is displayed on the Profile Manager option. In this case, enter the profile manager menu and, for each system profile, check that every component has a specific setting (no component has to be without any setting). GETTING STARTED 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. To configure the Center ID press M EN U , then select C E N T E R I D and then follow the generic configuration procedure. During editing you can configure many fields described below. Center ID Field The name entered in this field will be displayed in the heading area of the screen. Report Information Field This option allows to add to the report header the following information:  the hospital name;  the department name;  the contact details;  two fields for other additional information;  the hospital logo. DICOM Field This option allows to enter the station name used in DICOM. General Settings NOTE Some settings described below may be unavailable on your product’s configuration. MyLab - G E T T I N G S T A R T E D 6 - 9

[Page 82] 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 S A V E saves the settings, which will be activated as soon as they are saved. C A N C E L exits the menu without saving the new settings. F A C T O R Y retrieves all factory values and deletes all customized items. DATE/TIME Folder This option is used to set date and time, displayed on the screen. Set Date Using the trackball scroll the month and select the day on the calendar. Date Format Various formats can be set: the available options are listed in the following table. Table 6-2: Date Formats Format Displayed date DD/MM/YYYY 01/04/2011 DD/MMM/YYYY 01/Apr/2011 MM/DD/YYYY 04/01/2011 MMM/DD/YYYY Apr/01/2011 MyLab - G E T T I N G S T A R T E D 6 - 10

[Page 83] Set Time Using the keyboard set the time. 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. MEASURE UNITS Folder This option is used to set the desired units for height and weight. You can choose between cm/kg and ft/lb. The Celsius or Fahrenheit scale can be selected for probes equipped with temperature sensor. BIOPSY Folder This option is used to set the type of needle guide line to be superimposed on the image during biopsy procedures. For further information about biopsy and needle guides, refer to the related chapter in the Advanced Features section of the Advanced Operations manual. MyLab - G E T T I N G S T A R T E D 6 - 11

[Page 84] CONTROL PANEL Folder The table below lists and explains the available fields and the corresponding actions. Table 6-3: Control Panel Folder TRACKBALL SPEED Sets the speed of the trackball. TRACKBALL When checked, it adjusts cursor pointer acceleration ACCELERATION in order to react exactly on how quickly you move your trackball. LEFT CLICK Sets the action of the left key of the trackball. The left key can be set as confirming key ( EN TER ) or as context menu key ( UN DO ) CHARACTER SET Sets the characters used for all the system information (for example screen information, touchscreen button). SHUTDOWN TYPE Sets the preferred shutdown type. SCREEN RESOLUTION Sets the screen resolution when secondary monitor is connected. AVAILABLE QWERTIES Sets which alphanumeric keyboards are available in the touchscreen and which is the default one. When more alphanumeric keyboards have been set, the touchscreen displays an alphanumeric keyboard with dedicated tabs allowing to select the desired keyboard. BEEP VOLUME Sets the volume of the beep. FOCUS CONTROLLED Sets the default action of the trackball when starting BY TRACKBALL the exam. ETOUCH BUTTON When Acquisition Protocol is licensed, the eTouch button can be configured to work with protocols. DEPTH INCREASE Allows to set the depth changing the value clockwise/counterclockwise. AUTOMATIC START When checked, it allows a direct access to B-Mode EXAM after booting without passing through Patient ID. MyLab - G E T T I N G S T A R T E D 6 - 12

[Page 85] DIRECT PROBE When checked, it allows to show on the SELECTION touchscreen work flow area icons of connected probes for quick change. If the current application is available on the new probe, the application is maintained, otherwise it will be changed to the default one at probe switching. SHOW CONTROL When checked, functions related to joysticks and 1, PANEL COMMANDS ON 2, 3, 4 buttons are displayed on monitor. MONITOR TOUCHSCREEN Sets the brightness of the touchscreen. CONTROL PANEL Sets the brightness of the control panel. Field SHUTDOWN TYPE Various shutdown types can be set; the available options are listed in the table below. Table 6-4: Shutdown types STANDBY When the OFF button is pressed, MyLab goes in hibernation state saving all configurations allowing a following quick boot-up. In these conditions MyLab can be unplugged from the main. When OPTIMIZE MEMORY USAGE is checked, all memory is erased to make repeated use of standby more reliable over time. This results in a slowdown of boot-up time. SHUT DOWN When the OFF button is pressed, MyLab performs a complete shut-down. SHUT DOWN WITH When the OFF button is pressed, MyLab performs an VIRUS SCAN antivirus scan and then a complete shut-down. If viruses are found, the shut-down is not executed and an information pop-up is displayed. SHUT DOWN WITH 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. When the system is equipped with batteries, the STANDBY AT POWER FAIL field is displayed. When checked, if you disconnect MyLab from the power supply MyLab - G E T T I N G S T A R T E D 6 - 13

[Page 86] without pressing the OFF key, MyLab enters autonomously in hibernation mode by saving all the configurations that allow a subsequent rapid restart. NOTE Esaote does not install a real-time antivirus program, because it could affect the regular operations of MyLab . The antivirus scan could take a long time. Before starting the scan, a confirmation is requested. If a virus is found, it is advisable to switch off the MyLab , disconnect it from the data network and call the Esaote service, which will check for the presence of a virus and restore the system. Field AVAILABLE QWERTIES When more alphanumeric keyboards have been set, the touchscreen displays an alphanumeric keyboard with dedicated tabs allowing to select the desired keyboard. Fig. 6-4: Qwerty keyboard CINE MODE Folder When set, the AUTOMATIC PLAY and TRACE AUTOMATIC PLAY options respectively allow to review the stored images and the trace in cine mode when FREEZE is pressed. APPLICATION PRESET Folder This option is used to set specific features for each application. The menu is organized in two areas: the left side shows the list of the available applications, the right side the list of the features. Select the application and then check the boxes of the desired features. The table below lists and explains the available fields and the corresponding actions. MyLab - G E T T I N G S T A R T E D 6 - 14

[Page 87] Table 6-5: Application Preset Folder 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). In the first case the angle correction is kept constant when the line is moved; in the latter case an angle correction is calculated whenever the line is moved. SHOW SWEEP When checked, this option allows to display the Sweep VELOCITY Velocity (cm/s) below the PW/CW/M scroll area. SAMPLE VOLUME When checked, the Doppler line can be oriented by using SWIVELING STEERING the center of the sample gate as rotation axis. SHOW ZOOM When checked, the zoom navigation window is displayed REFERENCE WINDOW on the screen just as the zoom has been activated. USE REFERENCE BOX When checked, in dual visualization, the ROI box is ON DUAL COLOR overlaid to the B-Mode image as a reference. DOPPLER IMAGE SIZE Sets the default dimension for reference image in split format for the selected application. ACTION ON FREEZE Sets the action after FREEZE pressure. AUTO BUTTON SETUP Sets the action after AUTO pressure: AUTOADJUST (to automatically adjust the B-Mode image), ECFM (to automatically optimize CFM image) or BOTH of them. EASYTRACE ENABLED When checked, this option allows to enable easyTrace. IMAGE AUTOFITTING When checked, for linear probes and superficial depths, it adapts the size to the width of the screen. ENABLE SMARTOUCH When checked, it enables the smarTouch for the selected application. INVERT CFM SCALE When checked, this option allows to automatically invert WITH STEERING the Doppler scale when inverting the steering with reference to the vertical line. USE REFERENCE BOX When checked, in dual visualization, the ROI box is ON DUAL ELAXTO overlaid to the B-Mode image as a reference. WARNING The displayed Sweep Velocity is correct as long as you do not use a secondary monitor and/or an incorrectly calibrated monitor. MyLab - G E T T I N G S T A R T E D 6 - 15

[Page 88] FOOTSWITCH Folder This option is used to set which function is associated to each pedal (left, middle and right) of the footswitch. Select from the curtain menu the function then press S A V E . PROBE BUTTONS Folder This option is used to set which function is associated to each probe button. Select from the curtain menu the function then press S A V E . RAW DATA Folder When the associated license is enabled and the option selected, data are saved in raw format for Post Processing elaboration. Refer to the “Archive” section of this manual for further information on this feature. KEYBOARD BUTTONS Folder This option is used to set which function is associated to ACQ UI RE button and to each of the four configurable buttons ( 1 , 2 , 3 , and 4 ). From the curtain menu select the function you desire then press S A V E . NOTE When the buttons 1 , 2 , 3 , 4 are associated to save image or save clip, they will be named further in this manual as I M AGE or CLI P respectively. Security For further information about security options provided by MyLab , refer to the related chapter in the Advanced Features section of the Advanced Operations manual. Licenses Manager Licenses Manager allows to install optional licenses and to check the status of a demo license. NOTE To activate a new license, the operator needs the appropriate form listing the licenses associated to the system. License codes are generated according to the system Hardware ID, shown on the left upper corner of the license configuration menu. MyLab - G E T T I N G S T A R T E D 6 - 16

[Page 89] Press M EN U then L I C E N S E S to enter the License Manager Menu. It is organized in internal folders, selectable using the tabs displayed on the top of the menu. Fig. 6-5: License Configuration Menu GETTING STARTED License Activation Tabs A P P L I C A T I O N S and O P T I O N S allow to respectively activate the application licenses and the optional licenses. The INCLUDING field, shown in the A P P L I C A T I O N S menu, indicates which applications will be available once the license is activated. License Activation To activate a new license, type the license number in the KEYS field and press V E R I F Y to confirm. If the number is correct, the status changes to PERMANENT . NOTE All license fields are not case sensitive with the exception of the CrystaLine license that is case sensitive. Demo License If a demo license has been activated ( DEMO box checked), EXPIRATION DATE shows the expiration date of each demo licence. S A V E saves the configuration, activating the licenses. MyLab - G E T T I N G S T A R T E D 6 - 17

[Page 90] 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. The option is organized in internal folders, one folder for the clinical settings and one folder for the system configuration settings. Clinical Configuration The clinical settings that can be exported are: Folder  customized real-time settings ( REALTIME PRESETS );  customized calculation packages ( MEASURE );  customized glossary libraries ( ANNOTATIONS );  customized body-mark libraries ( BODYMARKS );  customized ETOUCH ;  when available, other customized profiles. System Settings Folder The system configuration settings that can be exported are:  customized DICOM configuration; MyLab - G E T T I N G S T A R T E D 6 - 18

[Page 91]  customized SAVING OPTIONS ;  customized center configuration ( CENTER ID );  customized MULTIMEDIA export settings;  customized NETWORK configurations;  customized OBSERVATIONS ;  customized printer profiles ( PRINTERS );  customized report styles ( REPORTS );  customized XSTRAIN 2D settings;  customized acquisition protocols ( ACQUISITION PROTOCOLS );  customized general configuration ( GENERAL SETUP );  customized SECURITY profiles;  customized streaming settings ( EPORTAL ). In both folders the menu allows the user to select both individual settings and all settings. Select the desired options, connect the USB medium to the system and press E X P O R T to confirm. NOTE Only custom configurations will be exported. IMPORT Folder This option allows the user to load customized clinical and system configuration settings. MyLab allows the user to load specific clinical and system configurations. Procedure  Connect the USB medium containing the customized configurations to MyLab ,  Select the configuration you want to import,  Press I M P O R T to start the loading procedure. MyLab shows the list of all saved configurations, grouped by components. The menu allows either to select all profiles included in a component (by checking the box beside the component), or to separately load a specific configuration (by checking the box displayed beside the configuration). MyLab - G E T T I N G S T A R T E D 6 - 19

[Page 92] NOTE In case of homonymy, MyLab asks for confirmation to completely overwrite the existing profiles, saved on the system. If confirmed, the previous configurations are then lost. System Info Press M EN U then S Y S T E M I N F O , the following information is displayed:  the model name and serial number;  the system hardware ID, necessary for license generation;  the current installed software version and its build;  the BIOS revision;  the hardware level of the installed boards. From this menu you can export the log file on a USB medium and you can also check if the encryption is enabled or not ( 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. You have the responsibility to store the key in a safe place for future use. NOTE To make effective use of encryption it is strongly advised to use it with security access enabled (see further). When data are encrypted, they can only be read on the system where the encryption was performed. When an encrypted USB memory device is connected to the MyLab where it has been encrypted, data will be automatically unlocked and accessible. When an encrypted USB memory device is connected to a different system, data will remain locked and then not accessible. MyLab - G E T T I N G S T A R T E D 6 - 20

[Page 93] Chapter 7. Performing an Exam This chapter describes the procedures commonly used in performing patient exams with MyLab . These procedures include entering patient and application data, acquiring images, making measurements and calculations; annotating and reviewing images.  SS Read the “Safety and Standards” manual carefully: all the safety characteristics, cautions and warnings listed there apply to all exams. MyLab is designed for operators who are qualified in using ultrasound systems. Only physicians or sonographers who are qualified in using ultrasound systems should perform ultrasound scanning on human subjects for medical diagnostic purposes. NOTE The operator must be familiar with the mechanical and thermal indexes display as well as know the ALARA (As Low As Reasonably Achievable) principle. The patient must be exposed to ultrasound for as short time as possible and only for as long as it takes to achieve the diagnostic information. Starting an Exam At power-up, at end of the initialization phase, or when starting every new exam, the system displays the Patient ID screen and the touchscreen is configured to allow the operator to enter patient and application data, and to select the probe, the application and the preset. CAUTION Do not turn the system off during the initialization phase: the hard disk could be damaged by this operation. MyLab - G E T T I N G S T A R T E D 7 - 1

[Page 94] Fig. 7-1: Patient ID screen 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. Selecting probe; 3. Selecting Application; 4. Selecting Preset. MyLab - G E T T I N G S T A R T E D 7 - 2

[Page 95] 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. Age is automatically calculated from the date of birth. Patient data will be saved together with images, measures and reports during archiving operations. To navigate the Patient ID screen, you can use either the trackball and the EN TER key or the  tab key of the alphanumeric keyboard. To enter the patient data use the alphanumeric keyboard. The Application data are additional information required for specific application (Cardiac, Urologic, Vascular, Gynecology, Obstetric and Pediatric Cardio) for calculation purposes. Retrieving data from archive CURRENT retrieves the patient data of the last exam. REOPEN EXAM allows to open an exam already closed to add images and/or measurements. NOTE The key is enabled only for exam closed in the same day of reopening. It is not allowed to reopen exams taken the days before the current one. RETR PAT INFO or R E T R P A T I N F O retrieves from the archive the patient data of a previously performed examination. Once pressed the list with archived exams is opened, double click on the exam to retrieve patient data, the Patient ID fields will be automatically filled with the data of the selected exam. Press CANCEL to exit without retrieving any exam. If the PAUSE EXAM option is checked in Saving Option Menu, pressing P A U S E D E X A M S a list with paused exams will be displayed, allowing to resume, close or delete them. If a DICOM archive is available, it is also possible to load data from it using the W O R K L I S T button displayed on the screen. In this case MyLab displays the following warning message whenever the characters used to enter patient data are not supported: Unsupported character setting! MyLab - G E T T I N G S T A R T E D 7 - 3

[Page 96] At any time during the exam, Patient Data can be viewed and modified by pressing PATIENT ID . WARNING Do not use PATIENT ID to start a new exam of a new patient as it will update existing patient’s data with new entries. To activate a new exam, close first the current exam by pressing EN D EXAM and then proceed with the Starting Exam procedure. Pressing I M AGE when the Patient ID Screen is displayed, a screenshot of this window is saved. WARNING The screenshot of the Patient ID Screen contains the patient data at the date and time of when the image has been taken. Do not refer to these data but always check the current patient data. Selecting Probe On the left side of the touchscreen all connected probes are displayed. Tap the probe image to select it. The blue rounded image indicates the active probe. Fig. 7-3: Probe, Application, Preset touchscreen MyLab - G E T T I N G S T A R T E D 7 - 4

[Page 97] At any time during the exam, a different probe can be selected tapping PROBE or the new probe key on the touchscreen work flow area (available when DIRECT PROBE SELECTION is enabled). Selecting Application GETTING STARTED When a probe has been selected, on the middle of the touchscreen all the application available with the selected probe are displayed. Tap the name of the desired application to set it. The blue rounded application indicates the active one. At any time during the exam, a different application can be selected tapping PROBE . Selecting Preset The Preset (or Clinical Setting) can be selected only when both the probe and the application have been set. Tap the name of the desired preset to select it. The blue rounded preset indicates the active one. At any time during the exam, a different preset can be selected tapping PROBE . At Preset selection the exam starts; the system enables the selected probe to operate in the application and preset you selected. WARNING Before beginning the exam, ensure that the active probe displayed on the screen matches the one selected. Alternatively, the exam can be started also pressing EN D EXAM , END EXAM or S T A R T E X A M . NOTE You can program and add presets to better suit your individual clinical needs or preferences, while applications depend on the installed optional licenses. MyLab - G E T T I N G S T A R T E D 7 - 5

[Page 98] Smart Preset After exam starts, at the right side of the touchscreen, presets for the active probe and application are shown. When the preset is changed during the exam tapping one of them on the touchscreen, all acquisition parameters are reset while the geometrical characteristics (such as depth, size) are maintained. Performing the Exam MyLab offers a set of imaging modes to cover a variety of imaging needs. By pressing the different mode buttons ( B , M , C , PD/TVM , PW , CW ) the specific mode is activated in real time. If the same button is pressed again, the system automatically returns to the previous presentation. Special modes are also available for 3D imaging and advanced imaging. Touchscreen buttons change according to the activated mode. When more modes are active, the navigation tabs ( B-MODE , M-MODE ) allow the operator to scroll among the specific mode menu. If the displayed menu has several levels, swipe left/right to scroll through all functions.  AO The control panel buttons and the commands displayed on the touchscreen make it possible to optimize presentation quality. Different menus correspond to each format., the “Advanced Operations” manual provides a detailed description of all active controls in the different modes. Acquiring images MyLab allows to capture and save a single image or a cineloop sequence pressing I M AGE or CLI P respectively. These buttons respectively save still frames and clips in real time. Images are also saved in Freeze. Images and clips are saved in patient study and thumbnails of the saved data are shown downwards in chronological order on the right side of the screen. Single images are saved with full definition or compressed, whereas sequences are compressed with a minimum loss of information.  AO Compression of both images and clips to be saved on external media can be set: refer to the “Archiving” section for further information. MyLab - G E T T I N G S T A R T E D 7 - 6

[Page 99] Freeze and Scrolling Memories Use FREEZE to stop and start real-time image acquisition and update. At FREEZE pressure the system displays the scroll bar of the memories, assigning the trackball to manual cineloop review (frame-by-frame). Move the GETTING STARTED trackball horizontally to scroll through the images one by one. The scrolling bar shows the trackball position.  AO The “Advanced Operations” manual provides a detailed description of all the available controls in Freeze. Reviewing Images During the exam, tapping REVIEW 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. Alternatively press PO I N TER , select the thumbnail: the system automatically switches to Exam Review. The selected image or sequence is shown on the screen.  AO The functionalities available in Exam Review are the same of the Archive Review: refer to this specific session of the “Advanced Operations” manual for further details. Ending the Exam To end the exam, press EN D EXAM or tap START EXAM . The window displayed at the end of the exam is used to archive the exam. This window shows the patient's name, the applications, the size of the stored images and the estimated time to complete each selected operation. Fig. 7-4: End Exam Window MyLab - G E T T I N G S T A R T E D 7 - 7

[Page 100] Before archival, Patient Data can be made anonymous by checking the ANONYMIZE box. NOTE The native format of the exam can not be made anonymous. The exam can be simultaneously exported to the local archive and to external media (in native, DICOM and multimedia formats). Check all the destinations you want, then press O K to confirm and close the exam archiving it in the selected destination(s). The system automatically shows the window allowing to start the exam. NOTE At power-up, the system prompts the operator to archive the last exam performed if the system was switched off without first closing the exam in progress. The exams that have been performed and not archived into the local database can be locally saved at a later time from Archive Review. Refer to the specific section of the “Advanced Operations” manual for further information. If the PAUSE EXAM option is checked in Saving Option Menu, pressing EN D EXAM also P A U S E will be prompted. NOTE At switch off, the system will inform if there are any paused exams. Monitor adjustments Tapping the gear icon in the advanced level of the touchscreen, you can access a menu where quickly and intuitively adjust the brightness and contrast of the monitor depending on your work environment. Three preset levels are available: DARK ROOM , MEDIUM DARK ROOM , and BRIGHT ROOM . You can also customize the CONTRAST , BRIGHTNESS and GAMMA values by tapping USER-DEFINED and rotating the related knobs. Tap FACTORY DEFAULT to go back to the default values. PHYSICAL CLONE and SMART CLONE act on the resolution when a second monitor is present; refer to Advanced Operations manual for further information. Tap the gear icon again to exit the monitor adjustments menu. MyLab - G E T T I N G S T A R T E D 7 - 8

[Page 101] Chapter 8. System Maintenance To ensure that MyLab operates over time at its maximum efficiency, Esaote 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. Table 8-1: Maintenance Operations Maintenance Minimum frequency Performed by cleaning the probes after use user checking the probes every week user cleaning control panel and system every week user cleaning touch screen every week user cleaning probe and gel holders every week user cleaning LCD case and screen every week user checking system housings for any every month user damage checking control panel and keyboard for every month user defects checking equipment for loose or missing every month user hardware checking movements of all parts every month user composing the system checking LCD and touchscreen status every month user checking trackball movement every month user cleaning trackball every month user checking connectors on cables for any every month user mechanical defects MyLab - G E T T I N G S T A R T E D 8 - 1

[Page 102] Maintenance Minimum frequency Performed by checking entire length of electrical and every month user power cables for cuts or damages checking the system integrity, every year Esaote personnel functionality and cleaning (including internal components) Electrical Safety Tests every two years Esaote personnel or authorized personnel NOTE Frequency of cleaning can change depending on environment cleanliness. NOTE Periodic maintenance operations that require the access to the system can 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. Disconnect the system from the power outlet before checking it. Contact Esaote personnel for any problem found during inspection.  PC Refer to “Probes and Consumables” manual for periodic inspections for probes and cleaning instructions. MyLab - G E T T I N G S T A R T E D 8 - 2

[Page 103] Cleaning Operations Periodic cleaning of the system and any connected devices is important. In the event of poor maintenance, dust and dirt can compromise the reliability and performance of MyLab and connected devices. The following table indicates the cleaning agents that have tested the compatibility with the MyLab system. Table 8-2: System compatible cleaning agents Product Supplier Asepti-Wipes II Ecolab Co (www.ecolab.com) Cavicide Metrex Research Corporation Caviwipes (www.metrex.com/company/contact/ Metrizyme index.cfm) CidezymeXTRA Advanced Sterilization Products Enzol (www.aspjj.com) Cleanisept-wipes Dr.Schumacher (www.schumacher-online.com) Mid Soap - Mikrozid AF wipes Schülke&Mayr GmbH , Mikrozid PAA wipes (www.schuelkemayr.com/int/en/ Mikrozid sensitive wipes contact/smi044_adresses.htm) Sani-Cloth HB Professional Disposable International Sani-Cloth Plus (www.pdipdi.com) Sani-Cloth Super SaniZide plus Safetec of America (www.safetec.com) Trionic D Ebiox (www.ebiox.co.uk) To clean the peripheral devices, follow the instructions supplied by the manufacturer. WARNING Turn the system off and unplug it before any cleaning operation. NOTE The cleaning operation should be performed accordingly to the equipment environment requirements in terms of temperature, pressure and humidity. MyLab - G E T T I N G S T A R T E D 8 - 3

[Page 104] 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. CAUTION Apply the cleaning agents only for the time necessary to remove the dirt without exceeding over. A visual inspection of the parts subjected to the cleaning process in order to evaluate possible damages or deteriorations. Cleaning control panel and system To clean the control panel and system, switch the MyLab off, unplug it and use a soft cloth slightly dampened with water. If necessary use the suggested wipes, or a soft cloth slightly dampened with one of the suggested cleaning agents. Otherwise, apply a small amount of ammonia-free and not abrasive detergent on a clean, soft cloth and then wipe the surface. WARNING Make sure that the detergent has completely evaporated before turning the equipment on. CAUTION Do not use any type of ammonia- or benzene-based cleaners on the case. Cleaning the trackball The trackball can be accessed, for cleaning purpose only, by rotating counterclockwise the upper locking disk. Once the disk has been removed, clean the trackball using a soft dry cloth. Clean the trackball housing using a cotton swab. CAUTION When cleaning the trackball housing, make sure not to spray any liquid into the trackball housing. 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 2007 2nd edition. The laser radiation emitted is invisible to the human eye. MyLab - G E T T I N G S T A R T E D 8 - 4

[Page 105] WARNING Invisible laser radiation. Do not view directly with optical instruments. Class 1M laser products. Do not remove the ball from the socket. WARNING Do not try to disassemble the trackball during the cleaning of the removable sealing ring. Cleaning Probe and Gel Holders Probe and gel holders are easily removable from their location for cleaning and can be washed in a mild soap solution. Make sure they are completely dry before replacing them.  PC To clean the probes, refer to the manual “Probes and Consumables”. Cleaning the Touchscreen To clean the touchscreen, switch MyLab off, unplug it and 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. If strictly necessary, to clean the touchscreen during an examination, you can temporarily lock the keyboard and the touchscreen pressing FREEZE while keeping ETO UCH pressed. When the system is on and connected to the mains, for safety reason, you must use only a soft dry cloth to clean the touchscreen. WARNING Do not spray or apply the cleaning agents directly on the touchscreen surface as the liquid of the cleaning agents may permeate into the front bezel of the display and cause damage. Do not press the touchscreen with any sharp objects as this may damage the screen. When the system has not been unplugged, clean the touchscreen exclusively using a dry cloth. Never use wet cloth. 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. MyLab - G E T T I N G S T A R T E D 8 - 5

[Page 106] Never spray or pour any liquid directly onto the screen or case. WARNING Overspray or liquid may cause electrical shock. Cleaning the LCD case Use a soft, dry cloth to wipe the surface of the case. If necessary, apply a small amount of ammonia-free and not abrasive detergent onto a clean, soft cloth and then wipe the surface. CAUTION Do not use any type of ammonia- or benzene-based cleaners on the monitor’s screen and case. MyLab - G E T T I N G S T A R T E D 8 - 6

[Page 107] Chapter 9. Technical Specifications This chapter describes the technical specifications of the MyLab systems. NOTE Special packages (such as Strain) are listed and described in the specific sections of the “Advanced Operations” manual. MyLab Characteristics MyLab models differ in licences that are installed per default and licences that can be installed. The tables below list all the available licences regardless the model on which they could be installed. Refer to the corresponding Sales Area manager for further information. 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. Additional features can be added buying the related license. 1. Specifications subject to change without notice. Information might refer to products or modalities not yet approved in all countries. MyLab - G E T T I N G S T A R T E D 9 - 1

[Page 108] Applications MyLab systems can be equipped with the following application licenses. Table 9-1: Applications licenses Licence Application Features Cardiology Cardiac (adult and pediatric) Presets, Calculations, ECG, Auto EF Radiology Gen. Abdominal, Neonatal, Musculo-skeletal, Presets, Calculations Imaging Pediatric, Breast, Small Organ, Thyroid, Urology Women’s Health Obstetrics, Fetal, Gynaecology Presets, Calculations, Ob/Gyn AutoNT Vascular Vascular, Adult cephalic Presets, Calculations SHARED Abdominal, Neonatal, Pediatric, Vascular, Presets, Calculations, SERVICE GI Adult Cephalic, Obstetrics, Fetal, AutoNT Gynaecology, Breast, Musculo-skeletal, Small Organ, Thyroid, Urology SHARED Abdominal, Neonatal, Pediatric, Vascular, Presets, Calculations, SERVICE CV Adult Cephalic, Cardiac (adult and ECG, Auto EF pediatric), Breast, Musculo-skeletal, Small Organ, Thyroid, Urology System Features Depending on the model, MyLab can be configured with one or more of the following features. Table 9-2: System Features 3D/4D 3D and 4D Volumetric acquisition 3D/4D Advanced TPI, TMI and TSI modalities VRA analysis XLight (Advanced illumination rendering technique) AutoAdjust It enables the automatic adjustment of imaging parameters. Auto EF Automatically detects and tracks the left ventricle (LV) endocardial borders to calculate LV Volumes (Diastolic Volume, Systolic Volume) and EF (Ejection Fraction). AutoNT Automatic Nuchal Translucency allows to automatically capture Nuchal Translucency measurement. MyLab - G E T T I N G S T A R T E D 9 - 2

[Page 109] Breast Suite It enables features for breast navigation, breast MRI navigation and breast biopsy. CMM Compass M-Mode allows to correct M-Mode line position to optimize tracing acquisition, even when the position of the heart is not perpendicular to the ultrasound beam. CnTI Contrast Tuned Imaging, used in combination with ultrasound contrast agents, enhances the B-Mode imaging. Dicom DICOM Classes a (including US Q/R) Ultrasound DICOM Query/Retrieve Multi-modality & Multi-modality management Dicom Q/R Multi-modality DICOM Query/Retrieve eDoppler Automatic correction of the Doppler angle, box position and steering, for a fast and optimized calculation ElaXto ElaXto allows you to perform elastosonographic analysis of the tissues ElaXto Measures It enables measurements in elastosonography eStreaming Possibility to visualize the MyLab images on different devices on the same network Fusion Imaging 2D - Real-time synchronization of ultrasound and second diagnostic BodyMap 2D modality (e.g. Mammography or RX) and Body Map Fusion Imaging 3D Real-time synchronization of ultrasound and volumetric modality (e.g. CT, MR, PET) images HyperDoppler Tool for the investigation of the intra-cardiac flows. LVO Left Ventricular Opacification uses low mechanical index ultrasound to interact with 2nd generation contrast agents to enhance left ventricle (LV) visualization in difficult-to-scan patients. microE It emphasizes small hyperechogenic structures in the image. microV It automatically recognizes the lowest speeds with ultra sensitivity for small vessels and slow flow detection MView It is an ultrasound technique which applies beam-line steering and acquires several coplanar scans of an organ from different view angles. MyLab Tablet Mobile application which allows to remotely review MyLab images on tablet or mobile MyLab - G E T T I N G S T A R T E D 9 - 3

[Page 110] MyLibrary Dedicated libraries for Rheumatology, MSK, Regional anesthesia, Physiotherapy and Advanced vascular. Live Preview features allow to scan in real-time while using anatomical references and scanning guidance. Needle Enhancement It increases the needle visibility. Imaging Percutaneous Laser It enables on MyLab a dedicated guidance to be used with Ablation Echolaser X4 laser units produced by El.En. Protocols Clinical protocols b QAS Quality Arterial Stiffness QElaXto - (pSWE) It allows to perform a Quantitative Elastosonographic analysis of tissues QElaXto 2D It enables 2D Quantitative Elastosonografic analysis QElaXto 2D Advanced It enables QElaXto 2D on Linear Probes (Linear Probes) QIMT Quality Intima Media Thickness calculation automatically measures the Carotid Intima-media thickness in real-time QPack - Quantification Time/Intensity analysis Raw Data Processing It enables raw data management in post-processing allowing to act on the raw data of captured images and clips by modifying some of the parameters represented. Stress-Echo Stress-Echo allows to acquire multiple views of the left ventricle (LV) under stress, using customizable protocols. TEI Tissue Enhanced Imaging improves the signal-to-noise ratio and enhances contrast resolution. TPView It enlarges the field-of-view. TVM Tissue Velocity Mapping provides a complete Wall Motion Analysis for both systolic and diastolic myocardial function evaluation. VPan Panoramic Imaging merges multiple B-Mode images in one complete panoramic image. Virtual Biopsy Virtual Biopsy combined with Intelligent Positioning increases confidence during ultrasound real-time biopsy procedures, thanks to virtual tracking of the needle. XSTIC It is a three-dimensional technique which allows the acquisition of a volume of data from fetal heart, displayed as a cineloop of a single cardiac cycle. MyLab - G E T T I N G S T A R T E D 9 - 4

[Page 111] XStrain XStrain allows to quantify endocardial velocities of contraction and relaxation and local deformation of the heart (Strain/ Strain Rate analysis). XStrain 4D XStrain 4D creates a volumetric model of the left ventricle (LV) based on the acquisition of standard apical views (Strain/Strain Rate volumetric analysis) XView XView and XView+ enhance the pattern of every frame at the XView+ pixel level, eliminating speckle and noise artefacts. a. Refer to www.esaote.com for further details on supported DICOM classes. b. Refer to the corresponding Sales Area manager for further information. NOTE Features, probes and applications availability is dependent on your system configuration. Not all features, probes and applications are approved in all Countries. Please refer to your Esaote local representative for further information. MyLab - G E T T I N G S T A R T E D 9 - 5

[Page 112] Technical Characteristics This section describes the product when fully loaded with all options; refer to the previous paragraph for basic configurations. Display  Built-in color LCD, WVGA resolution  Full HD LED 21.5” (24” as optional) monitor (16:9 aspect ratio)  12.1” LCD (touchscreen) Probe connectors  4 electronic probes  2 parking supports Video Output  DVI (main monitor)  DVI (auxiliary monitor)  Mini Display Port type Connectivity  I/O connectors • LAN RJ45 • 2 USB 2.0 on keyboard control panel • 4 USB 2.0 on rear panel • 4 USB 3.0 on rear panel • Wi-Fi (802.11.A,B,G,N)  Dedicated connectors • ECG input  Other • Laser/Ink jet printers  Complies with IHE integration profiles 1. Auxiliary monitors connected to this input have not to be used for diagnostic purposes. 2. Refer to www.esaote.com for further details. MyLab - G E T T I N G S T A R T E D 9 - 6

[Page 113] Image Files  Formats • BMP (uncompressed) • PNG (lossless) GETTING STARTED • JPEG (lossy) • AVI: Codec Microsoft MPEG-4 V2 and MS-Video 1 • Native formats Software  Operating system: Windows 10  Multi-lingual Biometry  Basic and advanced calculation, application dependent  Annotations, bodymarks Keyboard  Height adjustable control panel  Control panel: • Potentiometers for TGC • Encoders for general gains • Keys for modes, peripherals management and controls  Reconfigurable touchscreen LCD  Pull out alphanumeric QWERTY keyboard Dimensions  Closed (approximately): 570 (L) x 1100 (H) x 857 (D) mm  In working position: 570 (L) x 728  1260 (H) x 857 (D) mm (height of trackball)  In working position: 570 (L) x 940  1472 (H) x 600 (D) mm (at top of Control Panel)  In working position: 570 (L) x 1260  1792 (H) x 600 (D) mm (at top of the Monitor) Weight  < 120 kg (basic configuration without peripheral units) MyLab - G E T T I N G S T A R T E D 9 - 7

[Page 114] IP Grade  IP (X)0, this means MyLab models are not watertight. Power supply  Voltage operative range: • 100  120 V • 200  240 V  Voltage limit range: • 90  132 V • 180  264 V  Working frequency range: 50  60 Hz ±10%  Available power on peripherals: up to 400 VA NOTE The total power available on the three power outlets for peripheral devices is 400 VA maximum.  Power consumption:  400 VA ( MyLab only)  Power consumption:  1000 VA ( MyLab + peripherals)  Fuses: T 3.15 A H 250V (220V)/T 6.3 A H 250V (110V), 5x20 mm Power Cables Table 9-3: Power Cables Connector Plug Type Cord Type Length (MyLab side) (Mains side) Italy EN60320/C19 I/3/16 CEI 23-50 H05VVF3G 4 m Section 1,50 mm 3 conductors 16A-250V Europe EN60320/C19 Type VII H05VVF3G 4 m France CEE (7) VII Section 1,50 mm 2 Germany 3 conductors Spain 16A-250V MyLab - G E T T I N G S T A R T E D 9 - 8

[Page 115] Connector Plug Type Cord Type Length (MyLab side) (Mains side) USA EN60320/C19 HG (Hospital grade) SJT3X14AWG 4 m North America NEMA 5-15 Section 14AWG Latam 3 conductors 15A-125V UK EN60320/C19 BS13/13 H05VVF3G 4,5 m BS 1363/A Section 1,50 mm 2 3 conductors 13A-250V Operating Requirements  Temperature: 15  35°C  Humidity: 15  85% (not condensing)  Pressure: 700  1060 hPa Storage requirements  Temperature: -20  +60°C  Humidity: 5  95% (not condensing)  Pressure: 700  1060 hPa Probe Storage Requirements  Probe storage requirements are indicated in the probe case. MyLab - G E T T I N G S T A R T E D 9 - 9

[Page 116] European and international standards Table 9-4: Standards Reference and title of the standard (and reference document) EN 60601-1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance EN 60601-1:2006/AC:2010 EN 60601-1:2006/A1:2013 IEC 60601-1:2005 IEC 60601-1:2005/A1:2012 EN 60601-1-2:2015 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests IEC 60601-1-2:2014 EN 60601-1-6:2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability EN 60601-1-6:2010/A1:2015 IEC 60601-1-6:2010 IEC 60601-1-6:2010/A1:2013 EN 60601-2-37:2008 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment EN 60601-2-37:2008/A1:2015 IEC 60601-2-37:2007 IEC 60601-2-37:2007/A1:2015 IEC 61157:2007 Standard means for the reporting of the acoustic output of medical diagnostic ultrasonic equipment IEC 61157:2007/A1:2013 EN 62304:2006 Medical device software - Software life cycle processes EN 62304:2006/A1:2015 IEC 62304:2006 IEC 62304:2006/A1:2015 MyLab - G E T T I N G S T A R T E D 9 - 10

[Page 117] Reference and title of the standard (and reference document) EN 62366:2008 Medical devices - Application of usability engineering to Medical Devices IEC 62366:2015 EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process EN ISO 10993-1:2009/AC:2010 ISO 10993-1:2009 EN ISO 14971:2012 Medical devices - Application of risk management to medical devices ISO 14971:2019 EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General Requirements ISO 15223-1:2016, Corrected version 2017-03 AIUM/NEMA UD-2:2004 (R2009) Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. AIUM/NEMA UD-3:2004 (R2009) Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment ANSI/AAMI ES60601-1: 2005/(R)2012 Medical Electrical Equipment - Part 1: General Requirements for Safety CAN/CSA C22.2 No. 60601-1.14 Medical Electrical Equipment - Part 1: General Requirements for Safety Opti-light The monitor top edge hosts the Opti-light function that provides a subtle room lighting for optimal scanning conditions. The position of the lighting source eliminates any kind of reflection on the monitor resulting in improved image contrast resolution. Opti-light can be activated by a finger-touch on the bottom-right corner of the monitor frame. The illumination level can be adjusted by sliding the finger on the corner to increase/decrease the level. MyLab - G E T T I N G S T A R T E D 9 - 11

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