Esaote-Mylab-25-30

[Page 1] ESAOTE S.p.A. Rev. A May 2006 MyLab25 and MyLab30CV INTRODUCTION 8300416000

[Page 2] User's kit The box contains the licenses, the USB pen drive and the "Operator Manuals" disk. Licenses The licenses enable specific functions of the system, e.g. the Clip. Licenses are linked to the system’s serial number and are, therefore, unique. They should be carefully stored. The system is delivered by ESAOTE, with the licenses installed. MyLab Pen Drive The appliance is supplied with a customised USB pen drive. The pen drive can be used as a digital support for data. For further information on how to use it, please read the Getting Started manual. “Operator Manuals” Disk The disk contains, in digital format, all the manuals supplied with the system. The manuals are available in the languages that can be set on the system. 2/10

[Page 3] Operator Manuals These manuals refer to the MyLab25 and MyLab30CV products, indicated by the name MyLab inside the manuals. The Operator Manuals consist of three Sections: Getting Started The manual describes how to install the system and provides the main instructions for using it. This symbol is used to indicate this section of the manual. Whenever it is shown, it indicates that further information on GS G S the specific subject are available in this section. Transducers and Consumables The manual describes the cleaning, disinfecting and maintenance procedures for the probes and their accessories. Information is also supplied on the consumables that can be used. This symbol is used to indicate this section of the manual. Whenever it is shown, it indicates that further information on the specific subject are available in this section. Safety and Standards The manual contains information about the patient's and operator's safety. The system's conformity standards are also indicated. This symbol is used to indicate this section of the manual. Whenever it is shown, it indicates that further information on SS S S the specific subject are available in this section. This symbol is used to indicate the "Advanced Operations" A AO A O O Manual, available in the "Operator Manuals" CD. 3/10

[Page 4] Glossary MyLab ultrasound systems are available in two configurations: portable and mobile. Portable configuration means that the system is equipped with a handle, whose size and weight allow it to be used to carry the system. The term “portable” is always used with this meaning in these manuals. A mobile configuration is equipped with wheels allowing to carry the system from one room to another. The term “mobile” is always used with this meaning in these manuals. For detailed information on your model and its configurations, please refer to the “Getting Started” manual, which is specific for each product. 4/10

[Page 5] MANUFACTURER’S RESPONSIBILITY ESAOTE is responsible for the safety, reliability and functioning of this product only if: • the user follows all the instructions contained in this Manual for the use and the maintenance of this system; • this Manual is kept integral and readable in all its parts; • calibrations, modifications and repairing are performed only by ESAOTE qualified personnel; • the environment where the system is used complies with the current safety rules; • the electrical plant of the environment where the system is used complies with the current applicable rules and is perfectly efficient. 5/10

[Page 6] DICHIARAZIONE CE DI CONFORMITA’ - Direttiva 93/42/CEE - allegato II CE DECLARATION OF CONFORMITY - 93/42/EEC Directive - annex II DECLARATION DE CONFORMITÉ - 93/42/CEE - annexe II KONFORMITÄTSERKLÄRUNG - 93/42/EWG - Anhang II DECLARACIÓN DE CONFORMIDAD CE - Directiva 93/42/EEC Noi costruttori: We manufacturer: Nous les Constructeurs: Wir, die Hersteller: Nosotros, los fabricantes ESAOTE S.p.A. - Via di Caciolle, 15 - 50127 Firenze - Italy dichiariamo, sotto la nostra responsabilità, che il sistema: declare under our sole responsability that the system: déclarons sous notre responsabilité que le système: erklären, daß das System, unter unserer Verantwortung: declaramos, bajo nuestra responsabilidad, que el producto: MyLab25 MyLab30CV è stato costruito applicando il sistema di garanzia della qualità approvato per la progettazione, fabbricazione e controllo finale del prodotto e risponde alle disposizioni presenti dell'Allegato II della direttiva 93/42/CEE sui dispositivi medici. has been manufactured by applying the quality system approved for the design, manufacture and final inspection and meets the provisions of the 93/42/EEC-Annex II medical devices directive. a été construit en appliquant le système de qualité approuvé pour le projet, production et contrôle final du produit et répond aux dispositions de la directive 93/42/CEE-Annexe II pour les appareils médicaux. mit der Anwendung des geprüften Qualitätssystems für das Projekt, die Fertigung und die Schlußkontrolle des Produkts gefertigt wurde und daß es die Anordnungen der Richtlinie 93/42/EWG-Anhang II für medizinische Geräte erfüllt. ha sido fabricado aplicando el sistema de garantía de la calidad aprobado para el diseño, fabricación y control final del producto y responde a los requisitos presentes en el Anexo II de la directiva 93/42/EEC sobre los dispositivos médicos. Il rappresentante legale ESAOTE. ESAOTE legal representative. Le représentant légal de ESAOTE. ESAOTE autorisierter Bevollmächtiger. El representante legal de ESAOTE. 6/10

[Page 7] USAGE LICENSE AGREEMENT FOR THE SOFTWARE INCLUDED IN THE APPARATUS Attention Please read with care the terms and conditions indicated below before using the software on the unit. Use of the software implies acceptance of the terms and conditions listed below. PROPRIETARY RIGHTS You have acquired a device (“DEVICE”) which includes Esaote S.p.A. proprietary software and/or software licensed by Esaote S.p.A. from one or more software licensors (“Software Suppliers”). Such software products (“SOFTWARE”), as well as associated media, printed materials, and “online” or electronic documentation are protected by international intellectual property laws and treaties. The SOFTWARE is licensed, not sold. The SOFTWARE and, similarly, any copyrights and all industrial and intellectual ownership rights are and shall remain the exclusive propriety of Esaote S.p.A. or its Software Suppliers. The user will acquire no title or right on the SOFTWARE, except for the usage license granted herein. LICENSE RIGHTS AND LIMITATIONS With this license, Esaote S.p.A. grants the end user the right to use the SOFTWARE on the supplied DEVICE. The user may not, under any circumstances, make unauthorized copies and/or reproductions of the SOFTWARE or parts of it, including the enclosed documentation. On the basis of the above, and if the SOFTWARE is not protected against copying, only one copy of the SOFTWARE may be made for security purposes (back up copy). The user may not rent or lease the SOFTWARE, but he may transfer, on a permanent basis, the rights granted herein, on condition that he transfers all copies of the SOFTWARE and all written material, and that the transferee accepts all the conditions of this agreement. Any transfer must include the most up-to-date version and all the previous ones. The user may not convert, decode, reverse-engineer, disassemble or change in any way the SOFTWARE. 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. 7/10

[Page 8] PRODUCT TRACEABILITY To guarantee the product traceability according to what stated by the quality standard ISO13485 and by the European Directive on Medical Devices 93/42/EEC, ESAOTE kindly requests the original owner of the equipment to give communication to our central plants, or to one of our subsidiaries, or to one of our official distributors of any eventual conveyance of the product property. Please use a duly filled copy of the form reported below or send us a communication reporting the same data indicated in this form. All data relating to the system can be found on its identification label. Product Traceability Form To: ESAOTE S.p.A. Quality Assurance Department Via di Caciolle, 15 I-50127 Firenze ESAOTE system/device name: REF: SN: Name and address of the original owner: Name and address of the new owner: Date: Signature 8/10

[Page 9] VIGILANCE SYSTEM This equipment is subject to ESAOTE vigilance system (post-marketing vigilance) in case of potential or real hazards for the patient or for the operator which might occur during the normal system functioning, in order to be able to remove them with the best efficiency and timing. Therefore if the user records any malfunction or deterioration in the characteristics and/or performances of the device, as well as any inadequacy in the labelling or the instructions for use which might lead to potential or real hazards for a patient or for an operator, we kindly request to immediately inform ESAOTE central plants, or one of our subsidiaries, or one of our official distributors immediately through the following form, or through a communication reporting the same data contained in this form. All data relating to the system can be found on its identification label. In this way we will be able to take all adequate measures with the best efficiency and timing. Post-Marketing Vigilance Form To: ESAOTE S.p.A. Quality Assurance Department Via di Caciolle, 15 I-50127 Firenze ESAOTE system/device name: REF: SN: Description of the potential/real hazard: Notes and suggestions: Contact Person/Department: Address: Phone: Fax: Date: Signature 9/10

[Page 10] Important Information This mark complies with the Medical Device Directive 93/42/EEC. For US Customers: US Federal Law restricts this device to sale, distribution and use by or on the order of a physician. 10/10

[Page 11] ESAOTE S.p.A. Rev. A June 2006 MyLab25 and MyLab30CV OPERATOR MANUAL 8300415000

[Page 12]

[Page 13] Introduction This manual refers to the MyLab25 and MyLab30 ultrasound systems, named in the following chapters as MyLab . MyLab is available both in portable and in mobile configuration. The term “ MyLab ”, used in this manual, refers to both configurations. When the information refers to only one configuration, it will be specifically indicated. This manual explains how to install and use the MyLab ultrasound system. All system keys and their functions are described. Whether these keys are enabled or disabled depends on the installed software release. This manual is organized in the following chapters: • Chapter 1: Additional Information on Safety This chapter provides information about specific safety features of the MyLab system. • Chapter 2: Clinical Applications This chapter specifies in which clinical applications the MyLab can be used. • Chapter 3: System Components and Installation This chapter lists the available MyLab configurations. Moreover, it contains the installation instructions. • Chapter 4: Control Panel This chapter describes the MyLab control panel. • Chapter 5: Screen Lay-Out In this chapter one can learn how information is organized on the screen. • Chapter 6: Exam Performance This chapter explains how to perform an exam with the MyLab system. • Chapter 7: Measurements and Calculations This chapter explains how to perform measurements on ultrasound images. • Chapter 8: Exams Archive This chapter describes how to use MyLab archive. • Chapter 9: System Menu This chapter explains how to configure the MyLab . • Chapter 10: System Maintenance This chapter lists all necessary maintenance procedures. • Chapter 11: Technical Specifications This chapter lists all MyLab technical specifications. • Appendix A: Acoustic Output Tables This chapter lists all MyLab acoustic output tables. In this manual a WARNING pertains to possible injury to a patient and/or the operator. A CAUTION describes the precautions, which are necessary to protect the equipment. Be sure that you understand and observe each of the cautions and warnings.

[Page 14] In this manual control panel keys and software keys are indicated using the following graphical conventions: Control panel keys They are indicated by BLUE CAPITAL LETTERS or by the corresponding graphic symbol (e.g. ). Software keys They are indicated by B L A C K C A P I T A L L E T T E R S The confirmation key is always indicated throughout the manual as ENTER , while the menu context key as UNDO .

[Page 15] Table of Contents 1 - Additional Information on Safety 1-1 Environmental Safety 1-1 Transport Safety 1-1 Electromagnetic Compatibility 1-2 Probes Superficial Temperature 1-4 2 - Clinical Applications 2-1 Models 2-1 Clinical Applications 2-2 3 - System Components and Installation 3-1 Configurations 3-1 Installation 3-2 Acclimation Time 3-5 Adjusting the LCD Screen 3-6 Installing the Video Peripheral Units 3-6 Additional Connections 3-8 Moving and Transporting the System 3-9 4 - Control Panel 4-1 The Control Panel 4-1 Alphanumeric Section 4-1 Trackball 4-2 Software Keys 4-3 Controls Section 4-3 Advanced Operations 4-7 5 - Screen Lay-Out 5-1 Information about the Screen 5-1 Heading 5-1 Image Area 5-2 6 - Exam Performance 6-1 Exam Start and End 6-1 ECG 6-3 Performing the Exam 6-3 Freeze and Scrolling Memories 6-4 Exam Review 6-5 Annotations 6-6 System Shut Down 6-6 7 - Measurements and Calculations 7-1 General Information 7-1 Generic Measurements 7-2 Specific Calculation Packages 7-2 8 - Exams Archive 8-1 Archive Icons 8-1 Data Archival 8-1

[Page 16] Review of Archived Exams 8-2 End of Archive Review 8-3 Archival Media Management 8-4 9 - System Menu 9-1 Configuration Menu 9-1 Tools Preset 9-1 Application Measurements 9-1 Report Customization 9-1 Generic Measurements 9-2 General Preset 9-2 User Preset 9-3 Peripherals 9-4 Glossary 9-4 Dicom Configuration 9-4 Network Drives Configuration 9-4 Gray Map 9-5 Service 9-5 Save & Load Presets 9-5 Security 9-5 Licenses 9-5 System Configuration 9-5 Shut Down 9-5 10 - System Maintenance 10-1 Cleaning of System and Peripheral Units 10-1 11 - Technical Specifications 11-1 MyLab Models 11-1 Portable Configuration 11-3 Mobile Configuration 11-5 Safety Standards 11-5 Probes Operating Frequencies and Modes 11-5 Appendix A - Acoustic Output Tables A-1 Acoustic Output Data according to FDA A-1 Acoustic Output Data according to IEC61157 A-65 ii

[Page 17] Chapter 1 - Additional Information on Safety 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 These systems contain a lithium battery. The fluorescent lamp included in the LCD screen contains mercury. The battery and the LCD screen must be treated as special waste in conformity with applicable local regulations. Dispose of the equipment as special waste in conformity with applicable local regulations. Transport Safety The system front wheels are equipped with brakes, which can be activated individually. Do not park the system on a slope. Do not use the brakes to park the machine on a slope. If your system is equipped with peripherals, make sure that they are safely attached via Velcro strips; for transportation in a vehicle, it is strongly recommended to remove the peripheral(s) and follow the device manufacturer guidelines. 1-1

[Page 18] MyLab in its portable configuration has a fold-away trolley. The trolley must be closed in order to transport the system. Do not leave the trolley closed in the vertical position. Always leave the trolley in the open position to ensure maximum stability. Electromagnetic Compatibility This system was designed for use in the electromagnetic environments declared in the tables below, in compliance with standard IEC 60601-1-2:2001. The operator must make sure that s/he uses it in keeping with this standard. Electromagnetic Emissions Emission Test Conformity Electromagnetic Environment MyLab uses RF energy only for its internal RF emissions function. Therefore, its RF emissions are very Group 1 CISPR 11 low and are not likely to cause any interference in nearby electronic equipment. RF emissions Class B CISPR 11 Harmonic emissions MyLab is suitable for use in all establishments, on the electric power including domestic establishments and those supply mains Class A directly connected to the public low-voltage IEC 61000-3-2 power supply network that supplies buildings used for domestic purposes. Voltage fluctuations and flicker generation Conforms IEC 61000-3-3 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. Conformity Electromagnetic Environment and Measures Immunity Test Levels to Be Taken Electrostatic ± 6 kV on The floor should be in antistatic material (wood, discharge (ESD) contact ceramic,…). If covered with synthetic material, relative humidity should be maintained at least IEC 61000-4-2 ± 8 kV in air at 30%. 1-2

[Page 19] Conformity Electromagnetic Environment and Measures Immunity Test Levels to Be Taken Transients/trains of ± 2 kV on the The quality of the electrical power supply and rapid electric power supply the mains frequency magnetic fields should be pulses lines typical of domestic, commercial and hospital environments. IEC 61000-4-4 ± 1 kV on the input/output lines If the MyLab user has to work without a break Pulse ± 1 kV while power supply is interrupted, s/he is differential advised to have power supplied through a UPS IEC 61000-4-5 (Uninterruptible Power Supply) unit. mode ± 2 kV common mode Voltage gaps, brief <5 % of rated interruptions and voltage ( U T) voltage variations (voltage gap on power supply >95 %) input lines for half a cycle IEC 61000-4-11 40 % U T (voltage gap 60 %) for 5 cycles 70 % U T (voltage gap 30 %) for 25 cycles <5 % U T (voltage gap >95 %) for 5 sec Magnetic fields at 3 A/m mains frequency (50/60 Hz) IEC 61000-4-8 RF conducted 3 Vrms Mobile or portable radio frequency (RF) fields communication appliances should be used at from 150 kHz longer distances than those indicated on the IEC 61000-4-6 to 80 MHz following table. Interference may occur in the vicinity of equip- RF radiated fields 3 V/m ment marked with the following symbol: IEC 61000-4-3 from 80 MHz to 2.5 GHz R e c o m m e n d e d D i s t a n c e s b e t w e e n R a d i o f r e q u e n c y ( R F ) C o m m u n i c a t i o n S y s t e m s a n d MyLab 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 (cell telephones, mobile telephones…). The 1-3

[Page 20] table shows the minimum distance in meters, according to the maximum power at the RF system output. Distance According to Transmission Frequency Maximum [m] Power at Transmitter From 150 kHz From 80 MHz to From 800 MHz Output to 80 MHz 800 MHz to 2,5 GHz [W] d = 1 . 2 P d = 1 . 2 P d = 2 . 3 P 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.3 100 12 12 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 As a precaution, always apply the greater distance supplied by the table. NOTE 2 Electromagnetic propagation is subjected to absorption and reflection in the presence of structures, objects and people. The values in the table are general guidelines. The operator must remember that the intensity of the electromagnetic fields generated by fixed transmitters (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 unit. If the intensity of the electromagnetic fields exceeds that specified in the immunity levels shown in the previous tables, and the echographic system performs incorrectly, additional measures may be necessary, i.e. positioning the system in a different way. Probes Superficial Temperature MyLab has been designed to keep the probes superficial temperature within the limits defined by the IEC 60601-2-37 standard. We recommend to freeze the system at the end of the exam by pressing the key to avoid any probe overheating. The system will automatically be frozen if left inactive for a few minutes. 1-4

[Page 21] Chapter 2 - Clinical Applications MyLab is designed for operators who are qualified in using ultrasound systems. Models In their complete configuration, MyLab systems offer several intended uses. "Safety and The operator must always follow the principle known as ALARA (As Standards" manual. Low As Reasonably Achievable) and, in particular with this application, must use minimum acoustic power for the minimum time compatible with obtaining diagnostic information. Do not use MyLab for ophthalmic or transorbital applications. MyLab25 The basic configuration of MyLab25 includes an imaging system with the following license: Application Notes General Imaging Includes ABDOMEN (ABD), PEDIATRIC (PED), BREAST, THYROID, other SMALL PARTS (testicles,…) and MUSCULO-SKELETAL (MS); includes endovaginal and transrectal exams if an endocavity probe is available MyLab30CV The basic configuration of MyLab30CV includes an color system with the following license: Application Notes Cardiac (adults and Includes transesophageal exams if a TEE022 is available pediatric) 2-1

[Page 22] Clinical Applications Please consult the The tables below list MyLab probes and their clinical intended use. corresponding chapter for specifications and licenses. CAR PED PV SP THY MS BRE NC AC UR ABD OB-GYN PA Probes PA230 9 9 9 PA121 9 9 PA122 9 9 9 9 PA023 9 9 9 9 LA Probes LA532 9 9 9 9 LA522 9 9 9 9 LA523 9 9 9 9 9 9 LA424 9 9 9 9 9 9 CA Probes CA621 9 9 9 9 9 CA421 9 9 9 9 9 CA430 9 9 9 9 CA123 9 9 9 9 9 9 9 9 Special Probes TE022 9 EC123 9 9 IO323 9 9 9 9 9 9 9 LP323* 9 Doppler Probes 2 CW 9 5 CW 9 CAR : Cardiac (adults and pediatric); PED : Pediatric PV : Peripheral vascular; SP : Small Parts and small organs; THY : Thyroid MS : musculo-skeletal; BRE : Breast; NC : Neonatal cephalic; AC : Adult cephalic ABD : Abdominal; UR : Urology; OB-GYN : Obstetric and Gynaecology * Not for the U.S. market Do not use MyLab for ophthalmic or transorbital applications. Do not use intraoperative and laparoscopic probes in direct contact with the heart, the central circulatory system and the central nervous system. Cardiac Applications The probe applies ultrasound energy through the thoracic cavity to obtain an image of the heart sufficient for evaluating any cardiac abnormalities. In Doppler modes, the probe applies energy through the thoracic cavity to determine the velocity and direction of blood in the heart and vessels. In adults, the heart can also be studied through the esophagus and/or transgastrically with the TEE022 probe ( Transesophageal exams). 2-2

[Page 23] Pediatric Applications The probe applies ultrasound energy through the skin in order to obtain images and evaluate flows in pediatric and neonatal exams. In the latter case, the probe applies ultrasound energy through the fontanel in order to visualize cerebral structures (Imaging) or flows (Doppler) to detect structural or functional abnormalities. "Safety and The operator must always follow the principle known as ALARA (As Standards" manual. Low As Reasonably Achievable) and, in particular with this application, must use minimum acoustic power for the minimum time compatible with obtaining diagnostic information. This application does not include transorbital or any other ophthalmic Vascular Applications The probe applies ultrasound energy through the neck or the limbs of a patient in order to obtain an image of the carotid artery or of other peripheral vessels. These images show the possible presence of abnormalities or obstructions of the vessels. In Doppler modes, the probe applies ultrasound energy through the neck or the hands/feet of a patient in order to evaluate blood velocity, flow or lack of flow, and the perviousness of the peripheral vessels. "Safety and The operator must always follow the principle known as ALARA (As Standards" manual. Low As Reasonably Achievable) and, in particular with this application, must use minimum acoustic power for the minimum time compatible with obtaining diagnostic information. This does not include transcranial, transorbital or any other ophtalmic Small Organs and Small Parts Application The probe applies ultrasound energy through the skin to obtain an image or a Doppler flow visualization of small organs such as thyroid (neck), testicles (scrotal sac) and breast (breast). Musculo-Skeletal The probe applies ultrasound energy through the skin to obtain an image of tendons, ligaments and muscles and to determine blood flow patterns and velocities. 2-3

[Page 24] Adult Cephalic The probe applies ultrasound energy through the skull in order to visualize cerbral vessels This application does not include transorbital or any other ophthalmic and flows, to detect funtional abnormalities. Abdominal and related Applications The probe applies ultrasound energy through the patient abdomen to obtain an image of the abdominal organs to detect abnormalities (Imaging) and assess the blood velocity, flow and patency of abdominal vessels through the Doppler modalities. Ultrasound energy is applied through the skin to respectively image the female genito-urinary organs or the kidney and males genito-urinary structures (prostate, bladder,…). An endocavity probe can also be used to image the same organs, either endovaginally (gynaecologic application) or transrectally (urologic application). OB Application The probe applies ultrasound energy through a pregnant woman’s abdomen to obtain an image of the fetus to detect structural abnormalities or to visualize and measure anatomic and physiologic parameters of the fetus for the purpose of assessing fetal growth. In Doppler modes, the probe applies energy through the patient abdomen to detect placental or fetal flow abnormalities. An endocavity probe can also be used for the same purposes ( endovaginal studies). "Safety and The user should always follow the ALARA (As Low As Reasonably Standards" manual. Achievable) principle, but especially in OB/fetal applications. Use the lowest amount of acoustic output power for the shortest duration of time to obtain the necessary clinical diagnostic information. 2-4

[Page 25] C hapter 3 - System Components and Installation The MyLab will be installed by ESAOTE personnel. This person will be responsible for opening the packaging and ensuring that the system is correctly programmed and operational. This chapter provides an overview of the system's components and the major operations that may be necessary. Configurations MyLab has a built-in LCD screen: in this way, the system can be used as portable M y L a b configuration. MyLab can be supplied with a trolley, in both portable and mobile ο Portable (with fold- configurations. away trolley) ο Mobile (hospital Portable Configuration type trolley) The console contains: the electronics, the control panel with speakers, a DVD burner (on the left), the probe connectors, the input/output connectors for the ECG, the peripheral units and a mains switch (rear panel). The console has a handle. The LCD opening and closing buttons are located at the side of the LCD. 3-1

[Page 26] Fold-away trolley This configuration's compact size and light weight make it possible to move the MyLab very easily. The fold-away trolley has a front compartment to hold accessories. Mobile Configuration MyLab can also be equipped with a hospital trolley, with compartments for peripheral units. Hospital trolley The hospital trolley can house a video recorder and a video printer. It has a compartment for additional accessories. The trolley has a master switch to power up both console and peripheral units. The posterior wheels are fixed; anterior wheels are rotational and have brakes. Installation Identifying Connectors and Switch With the exception of the probes, all connectors are located on the rear panel of the console. The connectors are all clearly identified according to the type of peripheral unit which they serve. 3-2

[Page 27] Rear panel The table below lists the connectors and their intended use. Ports indicated in Connectors Use italics are not C1 ECG cable currently in use C2 Video recorder C3 B/W or RGB printer C4 SVGA monitor C5 Not in use at present C6 LAN connection C7, C8 USB connection C10 Pedal input The rear panel also contains the power cable socket, the fuse box and the system's power switch. The probe connectors are located on the right. MyLab has two connectors for the electronic probes and one connector for the Doppler probe. Installing the Portable Configuration System Connection Lay MyLab on the work surface. Connect the power cable to the mains socket. Connect MyLab to a power socket. Press the LCD's safety push-buttons to open the screen. Probes Connection Electronic Probes The probes can be indiscriminately connected to EA1 or EA2 connectors. Probe connection procedure: make sure that the connector-securing device is in the "OPEN" position, align the pins of the two connectors and carefully fit the probe connector. To secure it, move the securing device to its "LOCK" position. Doppler Probe To connect a Doppler probe, fit its connector with its reference facing up. MyLab is now ready to be powered up. Press the switch to turn on the system. 3-3

[Page 28] Do not switch off the machine before initialization has finished. MyLab can be switched off only when the window allowing to start the exam is shown - this window is used for inputting the patient data and choosing the Never disconnect the probe while it is active. Press the Freeze key before disconnecting the probe. Installation on Hospital Trolley The hospital trolley is supplied by Esaote in a disassembled state, with the relevant assembly instructions. Esaote personnel will open the packaging and will ensure that the trolley is correctly assembled. Handle Lay the console on the top surface of the trolley, allowing it to slide to the Switch bottom, so that the profiles of the base match the housings. Secure the console to the trolley, screwing on Can't lose it knob. the 'can't lose it' knob located under the top surface. Make sure that the ‘can’t lose it’ knob is completely screwed. If it is not secured correctly, MyLab could come out of the housings and fall out. Socket panel Use one of the additional cables supplied with the trolley to power MyLab from any of the trolley sockets (indicated by symbols J1, J2, J3 and J4). Plug in the power cable and connect the trolley to the power mains. Press the LCD's safety push-buttons to open the screen. Connect the probes as described in the previous paragraph. To start the system, press the trolley’s power switch located on the upper left. The hospital trolley has brakes on the front wheels, which can be individually operated. 3-4

[Page 29] W A R N I N G Don’t park the system on a slope. Don’t use the brakes to park the system on a slope. Installation of Fold-Away Trolley Release the wheels, by exerting light upward pressure with the tip of your toe on the lever, and open the trolley. The console's support top is fitted to the trolley frame: slight upward force is sufficient to release it and position it horizontally. Lay the console on the horizontal surface, allowing it to slide to the bottom, so that the profiles of the base match the housings. Secure the console to the trolley, screwing on the 'can't lose it' knob located under the top surface. Make sure that the knob is completely screwed. If it is not secured correctly, MyLab could come out of the housings and fall. MyLab must always be fitted on and removed from the fold-away trolley in its open position. The trolley has neither a transformer nor additional sockets. To connect MyLab to the power mains and install the probes, follow the console installation instructions. Power up the system by pressing the system's master switch. Working Position The fold-away trolley has an extensible handle, with three different positions corresponding to three different MyLab heights. Push the interlocking buttons to release the handle and slide it into the desired position. Acclimation Time If the system has been left exposed to temperatures which are outside the range given for its correct working (15 ÷ 35°C), it must acclimate, before being switched on. The following table indicates the necessary waiting times:. T(°C) 60 55 50 45 40 35÷15 10 Hours 8 6 4 2 1 0 1 T(°C) 5 0 -5 -10 -15 -20 Hours 2 4 6 8 10 12 3-5

[Page 30] Adjusting the LCD Screen Brightness is adjusted by function keys F6 and F7 of the alphanumeric keyboard. The function keys are active if pressed simultaneously with the Fn key of the alphanumeric keyboard. Key F6 increases brightness, while key F7 reduces it. However, the most important adjustment is the relative orientation of the screen vis-à-vis the operator. Current LCD technology ensures that the orientation affects the chromatic perception of light. Consult the grey tones or color scale (on left of image) to correctly position the LCD screen. Installing the Video Peripheral Units The "Safety and Standards" manual provides the safety requirements and standards SS S S to be observed for using peripheral units with MyLab . The following cables are available for connecting the video peripheral units: Code Description 8830427000 Cable for S-VHS video recorder 8830428000 Cable for B/W printer 8830429000 Cable for Sony RGB printer 8830915000 Cable for Mitsubishi RGB printer 8830747000 Cable with 2 connectors for 2 printers 8830749000 USB A/B cable Before installing the peripheral units, make sure that the system is switched off and unplug the power cable from the mains. For video From the MyLab control panel it is possible to manage both video printers and requirements see VTRs. For more information on systems which are proven to conform to the chapter “Technical MyLab remote management characteristics, please contact the ESAOTE personnel. Specifications” Installation on Hospital Trolley • Lock the trolley by engaging the brakes. • Open the trolley's rear door. • Fit the peripheral unit on the desired shelf and secure it with the Velcro strips. Connection to B/W The cable has a multi-pin connector on one end and BNC and remote connectors Printer on the other end. Connect the cable as indicated in the table below. Cable connector Side Port Multi Pin MyLab C3 BNC Printer Video Remote Printer Remote control 3-6

[Page 31] Connection to RGB The "RGB Printer" cable has a multi-pin connector on one end and four colored Printer BNC and a remote connector on the other end. Cable connector Side Port Multi Pin MyLab C3 BNC Printer Input connectors Remote Printer Remote control If one wishes to simultaneously connect 2 different printers to MyLab , one must use the 2-connector cable which duplicates port C3. The cable has a multiple-pin connector at one end and 2 multi-pin sockets on the other. The multi-pin connector should be connected to connector C3 of the rear panel of MyLab . In this way, the cables of the printers can be connected to the 2 multi-pin sockets. Connection to the The cable for the video recorder (VTR) has a multi-pin connector on one end;. on Video Recorder the other end, there are two S-VHS connectors (IN, OUT), four audio connectors (two IN, two OUT) and one REMOTE. Cable connector Side Port Multi Pin MyLab C2 S-VHS IN VTR S-VHS In S-VHS OUT VTR S-VHS Out AUDIO IN VTR Audio In AUDIO OUT VTR Audio Out REMOTE VTR Remote control USB Printers MyLab can be connected to USB printers. The ports available for USB connections are C6 and C7 . The peripheral units must have an B-Type USB connector, to be able to use the available USB cable. Contact ESAOTE personnel for recommended models and their configuration. Power Feed to the • Use one of the additional cables supplied with the trolley connecting Peripheral Units the unit to any of the trolley sockets (indicated with symbols J1, J2, J3 and J4). Do not exceed the maximum absorption limits indicated for insulated sockets. There is a risk of blowing the trolley fuses. • Switch on the switches of the peripheral unit/s. • Close the trolley door At this point, the system can be connected to the mains, and the entire configuration can be powered, using the trolley main switch. If the peripherals aren’t powered through the trolley, do not place them within the patient’s area (1.5 m distance - 2.5 m height). 3-7

[Page 32] In this latter case, peripheral units must be powered ensuring compliance with the medical security standards: please contact Esaote Service department to correctly install them. When peripherals units aren’t powered thorugh the trolley, it is good practice not to touch simultaneously the patient and the peripheral unit. Trolley-Free Installation To correctly power the system, follow the manufacturer's instructions. The system must be powered 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 SS S S order to check whether the applicable limits of standard EN60601-1 are not being surpassed. As a further precaution, the operator is recommended to position these peripheral units, whenever possible, outside the patient's area (1.5 m for distance - 2.5 m for height). In this case, peripheral units must be powered ensuring compliance with the medical security standards: please contact Esaote Service department to correctly install them. Additional Connections SVGA Monitor MyLab can be connected to an external SVGA monitor. Connect the monitor's signal cable to the C4 connector of the rear panel. ECG Cable The ECG cable should be connected to the connector C1 of MyLab 's rear panel. The ECG cable is wired to generate a I lead. By suitably positioning the electrodes, one can however obtain a II or III lead. The ECG cable is available as an accessory, both with an IEC lead (code 9630028000) and with an AHA lead (code 9630028010). Footswitch With MyLab , a footswitch for managing the Freeze or other real-time modes can be connected. The footswitch should be connected to connector C10 on the rear panel. The footswitch (code 9102756000) is also available as an optional accessory. Connection to a If it has a DICOM license, MyLab can be connected to a DICOM server, by using DICOM Server the LAN C6 port. 3-8

[Page 33] Moving and Transporting the System Transport of Hospital Configuration MyLab in his hospital configuration is provided with wheels and handle to allow the user to easily move the unit. The following precautions must be observed: • Switch the system off and unplug the power cord. • If the probes are connected, be sure that they are properly placed in the suitable MyLab probe-carriers and that the cables do not reach the floor. • If the peripherals are also placed on an external additional platform, be sure they are disconnected from MyLab before moving the ultrasound unit. • The wheels of MyLab are provided with brakes; be sure the brakes are disabled before moving the ultrasound apparatus. • Avoid any unnecessary mechanical shocks to the system while moving it. Be sure that the probes are locked in the appropriate holders and the probe cables are properly hanged in the cable hooks during the movement of the system . For locking the system in a stable way is necessary to lock at least two wheels. Transport on Fold-Away Trolley The system must be moved with the trolley in closed position. Remove any connected probes, shut the LCD screen and unplug the mains plug. If necessary, take the handle to its lowest position. When the handle is lowered, a light pressure on it is enough to release the horizontal top and close the trolley. To close the trolley, push the handle only. Any pressure exerted on the hood could damage the LCD screen. Empty the accessories compartment before closing the trolley. 3-9

[Page 34] Close the wheels: the locking lever hooks automatically. To facilitate transport, the fold-away trolley has an extendable handle. The handle has three different positions. Press the jointing push-buttons to release the handle, allowing it to slide to the desired position. Do not leave the trolley closed in vertical position. Always leave the trolley in open position to ensure maximum stability. Transportation • When transporting the system on a vehicle, remind to: • Disconnect and remove all probes and peripherals. • Use the brakes to lock the system in his hospital configuration. Fasten securely the system inside the vehicle. • Place the system on a flat surface if in his fold-away configuration. Protect the system with some padding during transportation. 3-10

[Page 35] C hapter 4 - Control Panel This chapter provides a brief description of the system controls. The Control Panel Control panel components: an alphanumeric section (keyboard, general controls), the trackball, a software keys section (at the bottom of the LCD), and a controls section. Loudspeakers (Doppler) are in the controls section. Alphanumeric Section This section includes the TGC controls and an alphanumeric keyboard. The TGC potentiometers control signal amplification in individual zones of the image. The potentiometers are used to adjust the signal zone by zone. The alphanumeric keyboard is based on the QWERTY standard. The alphanumeric keys are used for inputting text data in the enabled windows. The Caps Lock key presets the keyboard to upper case characters. The y Shift key is used for typing in lower case or upper case characters (according to how the keyboard is set) or the characters indicated in the top left section of some keys. 4-1

[Page 36] Special Characters With MyLab , the operator can type in the special characters through the Windows® XP standard modalities. To type in special characters, two keys have to be simultaneously pressed. The table below: shows the operating modalities. First key Second key Special characters ‘ (Apostrophe) e, y, u, i, o, a é, ý, ú, í, ó, á ` (Grave accent) e, u, i, o, a è, ù, ì, ò, à ^ (Circumflex) e, u, i, o, a ê, û, î, ô, â ~ (Tilde) o, a, n õ, ã, ñ “ (Diaeresis) e, y, u, i, o, a, ë, ÿ, ü, ï, ö, ä The following characters are also available, if the operator presses the Alt key and the numbers sequence listed in the table below: Alt + sequence Special character 0231 ç 0229 å 0230 æ 0248 ø 0233 ß T ext Entry If any of the alphanumeric keys are pressed during the exam, this automatically activates the input of text. All writing operations are managed by the alphanumeric keyboard and trackball, the latter being used to position the cursor. The key allows to access a glossary, which can be configured by the user. Refer to the “Advanced Operation” manual for more information on text entry. Trackball The trackball operates in two different modes. Standard Mode In its standard function, the trackball makes it possible to quickly position the cursors on the screen. The following chapters provide details of the specific functions performed by the trackball in operations requiring it to be used. Each mode automatically activates the trackball on its cursor: 4-2

[Page 37] Mode Trackball B-Mode Transmission focal point M-Mode, Doppler LINE cursor CFM CFM ROI cursor When several cursors are present on the screen, the ACTION key switches the active cursor. Mouse Mode The trackball can then be used to move a pointer on the screen. In Real-Time the pointer can be used to activate software keys functions and to toggle through their menus. In Freeze, Exam review and Archive review the pointer can be used to Refer to “System access archive menus. In this case, the keys placed on the left and right side of the Configuration” section for trackball configuration trackball can be set as mouse keys (as enter and context menu keys). Regardless of the trackball configuration, the enter and context menu keys are respectively indicated as ENTER and UNDO keys in this manual. The POINTER key makes it possible to change the trackball operation from standard to mouse mode. Software Keys Four buttons and six menu toggles are located at the bottom of the LCD screen. The functions of these keys vary according to mode, application, and settings. The menu shown above the keys indicates the functions assigned to them. To correctly use the software keys, keep in mind the following: • The buttons are shown according to their status. To be Pressed Diasbled pressed Blue Sky-Blue Dark Grey If the button is active, the displayed function is enabled by pressing the key. • If the displayed menu has more than six scrolling toggles, the sixth toggle ( NEXT/PREVIOUS ) is used to scroll through the menus of the first five keys. Press the push-buttons to select the required setting. Controls Section Exam Flow START END is the key that opens and closes every exam. The menu is used for entering the patient data and the choice of application, probe and required presets. During the exam, one can select a different probe (key ) or preset (key ). 4-3

[Page 38] When the exam is finished, press the START END key again. It is then possible to archive the patient's data and produce a report on the exam. The system clears the stored data and shows the exam start window again. The STARTEND key, kept pressed for more than three seconds, activates the closing session procedure. Closing session This is a PC based system; data loss or driver damage may occur if the system is turned off while working. Refer to appropriate sections of this manual for detailed information on when and how to safely power the system off . This key is used to input or modify the patient's data during the exam. The Mode Keys This key re-activates a B-Mode image in real-time when it is used in any other mode. If pressed in M-Mode, Doppler or Freeze, it restores a full screen bi- dimensional image. Color Doppler (CFM) is activated or disabled by pressing this key in B- or M- Mode. In B-Mode, a cursor delimits the Region of Interest (ROI) where color analysis is executed and displayed. The ROI's dimensions and position can be varied with the trackball, activating the ROI cursor with key . The Real-Time Soft Keys menu allows the operator to vary the display modality and to switch to Power Color or TVM (Tissue Velocity Mapping). TVM1 utilizes Doppler to display the heart walls motion, rather than flow. The displayed menu makes it possible to vary the B-Mode and make it coincide with the ROI ("Coincident" view). Color M-Mode is shown full screen or with a reference 2D, according to the choices on the displayed menu. This key activates the M-Mode, and if necessary, its selection cursor (B-Line). There are five possible viewing formats: the format with full screen M-Mode; the dual format, with the screen split vertically with 2D on the left and trace on the right; the split formats, with the screen split horizontally, with the reference 2D above (out of three possible dimensions) and the M-Mode trace below. The viewing format can be preset and varied in real-time through the displayed menu. 1 TVM and TV modes are enabled only with PA230, PA122 and TE022 probes in a cardiac application. 4-4

[Page 39] The PW key is used for activating the Pulsed Wave Doppler (PW), CW for activating the Continuous Wave Doppler (CW); both keys activate the positioning cursor if necessary. As in M-Mode, there are five viewing formats: the three split formats, the dual format and the full screen format. In PW, the Real-Time Soft Keys menu allows the operator to switch to the display modality TV1 (Tissue Velocity). TV sets Doppler filters to display strong signals with low motion such as the heart walls motion, rather than flow. During the exam, the format can be preset or varied interactively through the menu. In 2D or CFM, the LINE cursor can be interactively activated or disabled to select the M-Mode or Doppler line. Both in M-Mode and in Doppler, the key starts trace acquisition. If this key is pressed during acquisition, the trace is frozen and the reference 2D is temporarily re-activated. Gain Knobs These two keyboard knobs are used for adjusting the amplification of the echo signal. Gain is increased by turning clockwise and is reduced by turning counter- clockwise. The knob on the right acts on the B- and M-Mode signals, adjusting amplification over the entire depth of the image. The left knob amplifies the CFM and Doppler gain, according to which mode is active. In Doppler mode, gain acts on both components of the signal (video and audio). The level of the audio signal may be independently adjusted with the AUDIO knob, which is disabled in the imaging modes. If some preset parameters are varied during the exam, the key can be used to restore the presets set for the active application. This key stops the current analysis or scan and puts the system in Freeze mode. To re-activate in real-time, press a second time or directly press the key for the required mode. According to how the system is preset or to the selections on the displayed menu, these keys activate multiple views of two (dual) or four 2D (quad) images. In Dual mode, one can display two different images or the same 2D image simultaneously. Press any key to activate multiple presentations. The active 2D is displayed on the left (in the upper box for quad presentation). If one of the keys is then pressed, this freezes the 2D in acquisition and activates the next 2D; if the key is pressed, or the previous if the key is pressed. Press the key to restore a normal format 4-5

[Page 40] The Zoom function, active both in Real-Time and in Freeze, is used to selectively enlarge a zone of the image in B-Mode or in CFM. Initial pressing of the ZOOM key activates a sectorial cursor that can be positioned (and possibly varied in terms of dimensions) by the trackball on the zone of interest. The second pressure activates the enlarged presentation of the selected zone. Press ZOOM to return to a normal format. Use the key to cancel the enlargement factor cursor from the as yet non- enlarged image. The DEPTH key increases or reduces scanning depth in all imaging modes. When the cursor is active, the DEPTH key varies the dimension of the area to be enlarged. This key is active in real-time only and is used for varying emitted power during the exam. It operates independently for each mode: e.g. in PW mode, it controls the power of the Pulsed Wave Doppler; in 2D-CFM mode, it controls the power of the CFM. Power control must be adjusted to the minimum possible level compatible SS S S with an acceptable image. Carefully read the "Safety and Standards" manual with reference to the guidelines on the safety of ultrasound. In all applications where the ECG is shown, the key enables the operator to vary the amplitude of the ECG trace and its position selection on the screen. Exam Storage During the exam, the operator can save both individual images and sequences (for systems having the clip license). The keys to use are IMAGE for the frames and CLIP for the sequences (2D or CFM). The stored images and sequences are displayed as thumbnails on the right of the screen. The key is used for accessing, at any time, the data stored during the current exam. To access the data archive, press the key. Exam Report The following may always be executed: general measurements (key ) and access to the calculations package, specifically for the application in progress ( MEASURE key). When the required key is pressed, the list of available measurements is shown to the right of the image. MyLab can control two different peripheral units with keys 1 and 2 , according to the system's presets. For example, the operator can connect both a B/W printer and an RGB printer and control them separately with these keys. 4-6

[Page 41] This key activates and disables the VTR Menu. The software keys menu enables video recorder play-back and other VTR operations (fast forward, eject, ). To ensure correct video recorder operation, MyLab must be configured with the correct VTRs and with the relevant settings. Settings This displays the system menu for all configurations / settings (center name, preset…). The menu is explained in detail in another chapter. Advanced Operations Keys MARK , REPORT , ANNOT , ACQUIRE and CONTRAST activate advanced operations: further details on how to use them are described in the "Advanced Operations" manual l. 4-7

[Page 42] 4-8

[Page 43] C hapter 5 - Screen Lay-Out This chapter provides a brief description of the information on the MyLab screen. Information about the Screen The screen is subdivided into three main areas: Heading The video area (i.e., the screen area which can be managed by video peripherals) is a screen sub-set; it Image includes most of the A rea Heading and the entire Image Area. Software Keys Menu Heading This area is used for displaying the icons of the following: trackball, archival systems, configured peripheral units; it also shows the following information: center and patient data, and the date. For setting centre Patient data are displayed only if entered at the beginning of the exam. The system data, see the displays the following patient data: last name and first name, age and patient code. appropriate chapter of this manual. 5-1

[Page 44] Trackball The trackball function is indicated by the icon shown at the top left of the screen. When there are several cursors on the screen, two icons are displayed simultaneously. The yellow icon shown on the left indicates the active cursor; the one in green on the right indicates the next cursor that can be activated. The key switches between cursors. Archival Systems The archival system icons are shown at top left, after the trackball icons. The icon is shown crossed out whenever there are management problems involving the specific archival system. For more details on data archival, consult the relevant chapter and the Advanced Operations manual. Peripheral Units The system is able to simultaneously manage two peripheral units (b/w or RGB printer and the VTR). The icons of the peripheral units are shown at top right of the screen. If no peripheral unit is enabled, the right side of the header bar shows two gray icons. The icon is shown crossed out whenever there are management problems involving the specific peripheral unit. Real-Time and Freeze A specific icon is used for the real-time and frozen image - it is shown on the right of the heading area. Whenever an image is frozen, a memory bar is displayed (at bottom right) concerning the scrolling memories. The images acquired immediately before the system are frozen and archived in these memories. The trackball can be used to examine the 2D, M-Mode, Doppler and CFM information image by image. Image Area The display of the image depends on various factors such as active mode, selected application, and transducer. The following figure shows the elements in the image area that are independent of these factors. 5-2

[Page 45] Legenda: Number Icon 1 Active application 2 Machine parameters 3 Sector orientation 4 Acoustic output data 5 Thumbnails of stored images 6 Focal zone 7 If colored, it indicates images to be scrolled 8 Frame Rate 9 Heart rate 10 CFM scale 11 Imaging scale 12 Active probe 13 Selected preset Applications The system displays different icons according to the selected application. 5-3

[Page 46] Machine Parameters Imaging Parameter Quantity Description F nnn MHz Imaging frequency or TEI mode (Resolution or Penetration), when enabled G nn % Imaging gain (Min, %, Max) D nn cm Depth PRC n-n-l Dynamic range, Sharpness , Density (L: Low, H: High) PRS n Persistence PST n Post -processing curve SV nn-nnn mm Sample volume Size and Depth (PW) Θ nn ° Doppler correction-angle SV and Θ are displayed only if the relevant cursor is active. CFM Parameter Quantity Description F nnn MHz CFM frequency or TVM frequency when enabled G nn % CFM gain (Min, %, Max) PRF nnn kHz Pulse Repetition Frequency PRC n-l Sensitivity, Density (L: Low, H: High) PRS n Persistence WF n CFM filter (L: Low, M: Medium, H: High) Doppler Parameter Quantity Description F nnn MHz Doppler frequency or TV frequency when enabled G nn % Doppler gain (Min, %, Max) PRF nnn kHz Pulse Repetition Frequency (kHz) PRC n-n Pre-processing curves (Dynamic range, Rejection) PST n Post-processing curve WF nnnn Hz Wall filters 5-4

[Page 47] C hapter 6 - Exam Performance This chapter describes the operations usually carried out while an exam is being performed and how to turn the system off at the end of the session. Read the Safety and Standards Manual carefully: all the safety characteristics, cautions and warnings listed apply to all exams. Remember that it is necessary to be familiar with the mechanical and thermal indices display and the ALARA principle (A s L ow A s R easonably A chievable) before using any probe. The patient must be exposed to ultrasound for as short a time as possible and only for as long as it takes to achieve the diagnostic information Exam Start and End At power-up, at end of the initial autotest and at the start of every new exam (key ) the system shows the screen in the figure below. If necessary, the key allows activation of real time before ending the initialization phase). Do not turn the system off during the initialization phase: the hard disk coud be damaged by this operation. To guarantee data integrity and confidentiality, the system allows to configure a list of users allowed to work on the system. In this case to access the system the user needs to log in and type a password. See the “Advanced Operations” manual for further information. The Exam Start window is used for inputting patient data, for selecting the application, as well as the required presets and probe. 6-1

[Page 48] Age is automatically calculated from the date of birth. In cardiac applications one can enter height, weight and BSA values. The user may program and add presets to better suit individual clinical needs or preferences, while applications depend on the installed optional licenses. At any time during the exam, the operator can view and modify the patient's data with and can also select a different probe and setting by using and . Do not use to start a new exam as it will update existing patient’s data with new entries. To activate a new procedure, always use the key. To select fields and options, use the trackball and the key: The trackball moves the cursor; the key fixes its position, opens the drop-down menu and selects the option. How to Input • Move the cursor with the trackball. Patient Data and • Input the patient's data with the alphanumeric keyboard. Key  Back Select an Space is used to clear input characters. Application • To move rapidly through the different items, use the Tab ' key. • Select the required application, preset and probe. The selected application and presets are displayed over a black background, and the selected probe is displayed over a blue field. • Locate the cursor over OK and press to begin the exam. The system activates real-time in 2D. The selected application and presets automatically determine the type of format, CFM maps and power values … Before beginning the exam, ensure that the active probe displayed on the screen matches the one selected on the Exam Start page. 6-2

[Page 49] Exam End To end the exam, press the key again. The window displayed at the end of the exam is used to archive the exam. This window shows the patient's first name, the type of activated application and the dimensions of the stored images. Further details are Before archival, the patient data can be made anonymous. The exam can be provided in the data simultaneously archived and exported. archival chapter. The system automatically presents the window allowing the start of the exam. At power-up, the system prompts the operator to archive the last exam performed if the system was switched off without first closing the exam in progress. ECG When the electrodes have been applied and connected, the position of the ECG trace on the screen can be selected, and its gain can be adjusted. • Press to display the software keys menu. • Modify the signal's amplitude by pressing key G A I N . • If necessary, press P O S I T I O N to move the ECG trace on the screen. • The E C G key enables or disables the display of the trace on the screen. Press to return to the real-time menu. Performing the Exam By pressing the different mode keys, the specific mode is activated in real -time. If the same key is pressed again, the system automatically returns to the previous presentation. 6-3

[Page 50] In the formats with a trace (M-Mode and Doppler), before activating the mode, press to display the scanning line. Line cursor During scanning, freezes the trace and re-activates the 2D reference; the P L E X key activates or freezes the 2D reference, maintaining the trace in real-time. The keyboard and the commands displayed on the software keys make it possible to optimize presentation quality. Different menus correspond to each format. If the displayed menu has several levels, press key N E X T / P R E V I O U S to scroll through all functions. To save images and image sequences (2D or CFM), press and in real- time. Single images are saved with full definition, whereas sequences are For further compressed. Sequences, or clips, are compressed in BMP format, with minimum information about loss of information. clip formats, consult the next chapters. Digital data storage is typically slower than the ultrasound frame rate; the clip frame rate may therefore be lower than the original one. A Warning message is displayed if the archival frame rate drops below 20 fps, as it may occur if multiple tasks (example: burning a CD and saving new clips) are concurrently working. The thumbnails of the saved data are shown downward in chronological order. A maximum of eight thumbnails are shown: the colored arrow in the thumbnails column indicates that further images are present for scrolling. The Advanced Operations manual provides a detailed description of all the software keys active in the different modes. Freeze and Scrolling Memories The key freezes the image. The system displays the scroll bar of the memories, where the images acquired just before the system was put on freeze are temporarily saved. How to Scroll through the Memories Move the trackball horizontally to scroll through the images one by one. The scrolling bar shows the trackball position. Use the S T A R T / E N D key to Trackball icon automatically move to the start or end of the sequence. In the case of multiple formats, several scrolling bars are displayed; the key changes over from one bar to the other, whereas the trackball scrolls through the Trackball icon images of the selected bar. 6-4

[Page 51] In Freeze the sequence of stored images can be seen in cine mode if the P L A Y key is active. The sequence can be seen again at different speeds (use the S P E E D key). The M O D E key displays the entire contents of the memory (when enabled on F U L L ) or single cardiac cycles , when the ECG is shown, or seconds intervals when there is no ECG. Use the trackball to scroll along the bar and display another cycle/interval. The single cardiac cycles and the intervals selected through the C I N E M O D E key can be saved by pressing the CLIP key. The Advanced Operations manual provides a detailed description of all the software keys active in freeze state. Exam Review During the exam, the EXAM REV key enables the operator to review the saved images and sequences. When the key has been pressed, the trackball automatically changes over to pointer mode, allowing the operator to scroll through the thumbnails and select the data item to be reviewed. Software key S C R O L L enables the operator to scroll through the thumbnails when more than eight images or sequences have been saved. If there are more than eight saved images and clips, the P A G E sofware key allows the operator to quickly scroll the thumbnails: the next eight thumbnails are displayed when the key is pressed. The selected image or sequence is presented on the screen. Clips are presented in cine mode: the P L A Y key disables the kinetic presentation and enables the operator to scroll through the sequence image by image with the trackball. Images are usually compressed, with some loss of information. Please see the technical specifications for more information. 6-5

[Page 52] Image Clearing To clear a saved image or sequence, select it with the trackball and press the D E L E T E key. The E X P O R T key is used to export the image or sequence to an outside medium, which can be selected from the appropriate window. In Exam revision single cardiac cycles and intervals selected thorugh the C I N E M O D E key can be saved as clip by pressing the corresponding key. Annotations If any of the alphanumeric keys are pressed during the exam, this automatically activates the input of text. All writing operations are managed by the alphanumeric keyboard and trackball, the latter being used to position the cursor. The key provides access to a user-settable glossary. The Advanced Operations manual describes how to create and use the glossary. System Shut Down This is a PC based system; data loss or driver damage may occur if the system is turned off while working. This shut down procedure is always recommended; it is MANDATORY that the operator interrupts any pending PC operation prior to turning the system off. Make sure that no heading archival system icon has a flashing yellow frame; if so, there is a pending PC operation, which requires the system shut down operation be performed. When closing the session, follow this procedure: • Keep the key pressed for at least (3) seconds. • Place the pointer on O K and press . Once the operation has been completed, the system displays the shut-down message: press the ON/OFF key on the rear panel to turn the system off. If the system isn’t correctly shut down, a message will be shown at next switching on. 6-6

[Page 53] C hapter 7 - Measurements and Calculations This chapter describes how to access the generic measurements and the specific calculation packages of the applications. General Information Measurements can be made on frozen, stored and archived images. The available measurements are shown on the right of the image. The messages displayed on the screen guide the operator through the stages, facilitating measurement execution. The results are shown on the left of the image. Clips are compressed for digital storage. Compressed files involve a minimal loss of information (see Technical Specifications Chapter 11). The Compression algorithm used by MyLab ensures the preservation of the image features for the reporting functions. This symbol is displayed on the screen when the image features, compared to the original one, may not be optimal for the reporting functions. To select the views and the positioning of the cursors, we urge the operator to act according to current medical practice and the instructions of specialists in this subject. Always enlarge the format to maximize the structure/signal to be measured. If possible, use the full screen formats for M-Mode and Doppler measurements. The system cannot be used to measure images with ambiguous calibrations. An error message is shown on such images when the measurement is made. Measurements on QUAD formats cannot be made. 7-1

[Page 54] Generic Measurements The generic measurements feature makes it possible to rapidly measure, for example: distance, area, time and speed. This key activates the generic measurements menu. The system shows the list of available measurements, which are automatically identified according to active mode and application. Software key M E A S U R E is used for rapidly selecting the required measurement. The measurement shown in yellow is immediately operational. Following the instructions on the monitor, position the cursors with the trackball and confirm the position by pressing . The key can be used to restart a measurement before it has been confirmed. The Back Space deletes point by point the traced line. The value being measured is displayed in real-time on the left of the image. Selective Deletion • Activate the trackball as a pointer by pressing . of a Measurement • Position the pointer on the measurement to be deleted (the measurement is shown in yellow). • Press the C L E A R key to delete the measurement. • Press again to return to the measurements menu. The C L E A R A L L key deletes all measurement cursors and the values shown in the measurements field from the screen. The Advanced Operations manual provides a detailed description of the generic measurements available in every application. Specific Calculation Packages The specific calculation packages are based on the measurements to be executed on identified anatomical structures. To access the specific calculations, press the MEASURE . key. The system automatically identifies the calculations package according to the selected mode and application. The list of executable measurements is shown on the right of the screen. The measurements are arranged in groups (identified by the symbol ), which correspond to specific anatomical structures. Each group includes the measurements executable in that structure. To display the measurements included in a group, position the trackball on the group and press the E X P A N D key. Executed measurements are marked by the symbol 9 . 7-2

[Page 55] How to Select a • Freeze the image and press . Measurement • Using the trackball, select the required group (the selected group is displayed in yellow). • To follow the entire measurement sequence specified by the group, press over the selected group. • To make a specific measurement press E X P A N D , select the required measurement with the trackball, and press . The system displays - at the bottom of the screen - the image with the operating instructions for making the selected measurement. The trackball is used to position the measuring cursors, while is used to confirm positioning when requested by the instructions. To delete an unconfirmed measurement or to delete a measurement selectively, the instructions provided for the generic measurements apply. The ACTION key allows to interrupt the active measure and select a different group.. The Advanced Operations manual provides a detailed description of the specific measurements available in each application. 7-3

[Page 56] 7-4

[Page 57] C hapter 8 - Exams Archive This chapter describes how to archive images and to access the relevant archive. Archive Icons When the system accesses the archive, the relevant archive icons are shown on the right of the heading bar. The active icon is displayed on a dark background, while the icons that can be activated are shown over a blue background. Icons shown in grey are inactive. To activate the function, locate the trackball over the required icon and press . Data Archival The system has an internal hard disk in which the exams can be archived (local archive). The data can be saved on external supports and on DICOM ® format (for systems having a DICOM license), and exported in BMP format or AVI format This system uses (see specification for codec information). Exported data cannot be reviewed by the under license the system. MergeCOM-3 ™ Advanced DICOM1 The and keys save single images (with full resolution) and image library of Merge sequences (in compressed format). When the CLIP key is pressed, the system stores Technologies Inc. sequences of a preset duration, which can be set from the System Menu (see “Advanced Operations” manual). Data is compressed with a minimum loss of information, with a maximum frame rate of about 25 images. Digital data storage is typically slower than the ultrasound frame rate; the clip frame rate may therefore be lower than the original one. A Warning message is displayed if the archival frame rate drops below 20 fps, as it may occur if multiple tasks (example: burning a CD and saving new clips) are concurrently working. 1 DICOM is a registered mark of NEMA (National Electrical Manufacturers Association) 8-1

[Page 58] Archiving the During an exam, the images are temporarily stored on the system's hard disk. The Exam exam ends as soon as the START END key is pressed. The system shows the window of the exam end, which enables the operator to select the required format (DICOM with the ARCHIVE option; BMP or AVI with the EXPORT option) and the final archival support. When the exam is archived on CD or DVD in DICOM format, the Biopacs Lite2 viewer is automatically enclosed in the CD or DVD. In this way the exam can be reviewed in any PC. Before archival, the patient's data can be made anonymous. Archival Procedure • If necessary, use the trackball to enable archival and export of the exam • Select the required supports. • Locate the cursor on OK and press to confirm. While data are being saved, the icon for the relevant destination support is outlined by a yellow flashing frame. The frame disappears when the operation ends. Do not switch off the system nor remove the archiving medium while data is being saved (yellow flashing frame on the destination support). The data and the hard disk could be damaged. If necessary, you may run the Shut Down procedure to interrupt and safely power off the system. If no option is selected, all stored data will be deleted. Review of Archived Exams The operator can reload and review the patient's exams. The images can be reloaded and a specific exam can be reviewed for each patient. 2 Biopacs Lite is an Esaote DICOM viewer . 8-2

[Page 59] This key displays the following page. The image shows the archive consultation window. The relevant icons are shown at top right. The system displays the list of archived exams and enables the operator to selectively choose the exams to be reviewed, setting query criteria such as the patient’s first name, the application and the exam date. The R E S E T key • Use the trackball and alphanumeric keyboard to input the search criteria. deletes the set search criteria. • Locate the pointer on QUERY and press to activate the search. At the end of the search, a list of the exams within the set criteria is presented on the screen. The S C R O L L key enables the operator to scroll inside the list and select the specific exam. To select several exams, use the trackball to position the cursor and press the Ctrl and keys simultaneously. After selecting, activate the archive display icon to access the data. The list of selected exams is displayed on the right of the screen next to the thumbnails. Use Archive display icon the trackball to locate the cursor on the required exam and press to confirm. The system is in exam review status, and, therefore, the same instructions apply. The Advanced Operations manual provides a detailed description of the possible operations and of the active software keys. End of Archive Review The or key closes the archive review session and reactivates real-time. The review session can also be closed by pressing . In this case, all the open exams will be closed before starting on a new patient. 8-3

[Page 60] Archival Media Management When the trackball is operating as a pointer, it is possible to determine the space available in the archive. If the pointer is positioned on the specific icon, the system displays the remaining available memory space. The operator can also control the data transfer operations. Locate the cursor on the icon of the specific support and press . The displayed interactive window enables the operator to follow the operation. The crossed out icon indicates management problems of the specific archival support. The interactive window allows the operator to understand which operation has failed, and, if necessary, to repeat ( RETRY ) or cancel the failed operation. Do not switch off the system nor remove the archiving medium while data are being saved ( yellow flashing frame on the destination support). The data and the hard disk could be damaged. If necessary, you may run the Shut Down procedure to interrupt and safely power off the system. Writable CDs Empty disks must be used. If the CD contains data, the system will not allow writing and shows the following message: 8-4

[Page 61] Rewritable CDs Rewritable CDs may be used for archiving data providing such CDs are empty. The system allows the deletion of data stored on rewritable CDs. Locate the cursor on the CD icon and press . The system displays the CD management menu: CD icon select "ERASE DEVICE" and press . Rewritable DVDs Empty single-layer DVDs must be used; if the DVD already contains some data, the system won’t allow to burn them . USB Pen Keys The USB pen keys are managed in multi-sessions. Data can be added to data already on the device. 8-5

[Page 62] 8-6

[Page 63] C hapter 9 - System Menu This chapter describes how to set and configure the system. Configuration Menu The MENU key provides access to the system menu. The key can be pressed in any environment. The system displays the possible options. Some menu options are arranged in groups (identified by the symbol ). To display the options included in a group, position the cursor on the group and press the ENTER key. • Select the option with the trackball. • Press to continue. Tools Preset This option allows to modify the labels used in Stress Echo to identify the single views. Application Measurements This option allows the user to configure the available measurement packages by using the key. MyLab allows to program different packages for each application. For each measurement group, one can give a description and enable the desired measures. The "Advanced Operations" manual provides a detailed description on how to optimally configure the measurements package. Report Customization MyLab offers different menus allowing to configure the desired report. The following table lists the available setting options (key ): 9-1

[Page 64] Option Setting Report Header Headers setting Report Print Layout Selection of data to be printed. Edit Report Observations Observations setting. Report Print Layout Selection of the template. This option allows to choose which data have to be inserted into the report, to create a glossary to be used when writing the report, customize the print layout. Section “System Menu” of the "Advanced Operations" manual details how to configure the report. Generic Measurements This option allows to program the generic measurements available for each General Preset The available options are internally organized in folders. To access the different folders, position the trackball on the required folder and press . Parameter Setting • Position the trackball on the field to be varied and press to confirm. • Use the alphanumeric keyboard to type in the characters. • In the window menus, select the required option and press to confirm. • Press OK to confirm. The Tab ' key is used to change over quickly from field to field; the keys Pgup c and Pgdn d open the window menus and scroll among the relevant options. After the modifications have been confirmed, the system displays following message: Date/Time This enables the operator to change the date and time, and to select the required data and time formats (12 or 24 hour). 9-2

[Page 65] Center This field is used for inputting the name of the hospital/clinic, which will then be shown on the screen. Video This field is for selecting the required video standard (PAL or NTSC) and the video signal (S-VHS or VHS). Measure Units The temperature scale can be set to Celsius or Fahrenheit. This option also allows to select the measure units for height and weight. Cine The option allows the user to define the default size of the memory to be used for sequences and to set the default speed. Archival When set to auto, the unit automatically saves the exam, per user preset, at the end of the exam without displaying the end exam window. Trackball The menu allows the user to set the functioning mode of the trackball left key. The key can be configured as the enter key ( ENTER ) or as the context menu key ( UNDO ). User Preset This procedure allows to create a new preset ( ADD option), and to modify ( EDIT option) or cancel and existing one ( CLEAR option) for both standard applications and for specific applications such as Stress Echo. The set presets can be selected in the page allowing the start of the exam or with the PRESET button. Parameter Setting The menu is organized into one general folder, four mode folders and till four probe folders. General Folder With this menu, the operator can assign a name to the new preset and associate a new application with it from among the available applications. From this folder the operator can set general parameters such as the display of the ECG trace, clips duration, and the final archival support for the exam. In the OB application, this folder allows to preselect the exam type (fetal growth or fetal age). Mode Folders Every mode (B-Mode, CFM, M-Mode and Doppler) has a specific folder, inside which different parameters can be set. To save the settings, press SAVE : the set presets will become operable when the system is next powered up. The CLOSE key closes the menu without saving any modifications that may have been made. 9-3

[Page 66] The factory presets for the required application ( FACTORY SETTINGS key) can be set from the same window. Probe Folders For the active preset the system allows to configure four probes. Each probe can be individually configured. As soon as a probe has been selected, the system shows its parameters. Parameters are gourped in three settigns types: power values, other parameters (number of transmission focuses, 2D sector size etc) and gains. To save the settings, press SAVE : the set presets will become operable when the system is next powered up. The CLOSE key closes the menu without saving any modifications that may have been made. The "Advanced Operations" manual provides a detailed description of which parameters can be set in the individual modes. Peripherals The system can remotely control (with keys 1 and 2 ) recording by VTR (for specific models) and printing (in B&W and color). The menu also enables the operator to select the required print format. The icon of the set printing format is displayed next to the printer symbol of the relevant printer, in the heading bar. Do not switch the system off until the printing stage has been completed. Glossary When in annotation mode, the system allows the user to enter pre-existing sentences or words. Through this option, applications libraries of words can be created. The "Advanced Operations" manual provides a detailed description on how to optimally configure the application glossary. Dicom Configuration This option allows configuration of the Dicom servers and printers to which the MyLab is connected. Network Drives Configuration Allows to configure one network drive to be used as archive. 9-4

[Page 67] Gray Map This option allows to edit and save the gray map used in the active application. Service This option is strictly for service use and, therefore, its details are given in the system Service Manual. Save & Load Presets This option allows the user to save and reload all user presets. Security This option allows to define the list of users allowed to work on the system: in this case the access to the system can occur only through a log in procedure, by entering a password. Licenses The license number can be input from this option. The license becomes functional at the next power up. System Configuration This option displays the system's hardware and software configuration. If a demo license is installed, it is possible to control its expiration date in the corresponding folder. Shut Down This option allows to shut down the system. This procedure can be used as an alternative to pressing the STARTEND key . See the "Advanced Operations" manual for futher information. 9-5

[Page 68] 9-6

[Page 69] Chapter 10 - System Maintenance This chapter describes the system's main maintenance operations. Cleaning of System and Peripheral Units Periodic cleaning of the system and any connected peripheral units is important. Peripherals may contain dust sensitive parts, the reliability of which could be compromised in the event of poor maintenance. Turn off the system before any cleaning operation. Make sure that the detergent has completely evaporated before turning on the equipment. To clean the peripheral units, follow the instructions supplied by the manufacturer. Cleaning the To clean the system, use a soft cloth slightly dampened with water. If necessary, system apply a small amount of ammonia- and alcohol-free, not abrasive detergent onto a clean, soft cloth and then wipe the surface. Switch the system off and rub the outside with the cloth. Do not use any type of ammonia-, alcohol- or benzene-based cleaners on the case. LCD screen To clean the LCD screen, use a soft dry cloth, lightly rubbing the display surface. Do not use detergents or other liquids directly on the screen. Immediately dry any drops of water that may fall on the screen as they could stain the screen. Cleaning the The trackball is easy to remove. With the machine switched off, rotate counter- Trackball clockwise the crown surrounding the trackball, exerting light downward pressure. Remove the crown and then remove the trackball. Clean the trackball with a soft cloth lightly dampened with water or alcohol. Refit the trackball in its housing and lock it by rotating the crown clockwise. 10-1

[Page 70] Cleaning the Probe These items (available in the mobile configuration) are easily removed from their and Gel Holders location for cleaning and can be washed in a mild soap solution. Make sure they are completely dry prior to replacing them. To clean the transducers, refer to the manual entitled "Transducers and Consumables". 10-2

[Page 71] Chapter 11 - Technical Specifications This chapter describes the technical specifications1 of the MyLab product. AO A O Note Special packages (such as Stress Echo) are listed and described in the specific sections of the Advanced Operations manual. MyLab Models MyLab25 Basic MyLab25 basic configuration consists in the imaging system licensed for General Configuration Imaging applications, i.e.: • Abdominal • Breast, Thyroid, Small parts • Muscolo-skeletal • Pediatric The basic configuration may archive and export individual images only (in BMP format). Optional The system can be equipped with the following licenses to enhance its applications Applications range: License Application Features Cardiac Cardiac, Pediatric cardiac Presets, Calculations; ECG Vascular Peripheral Vascular, Adult Presets, Calculations cephalic Urology Urology Presets, Calculations Obstetric Obstetric, Fetal, Gynaecogical Presets, Calculations 1 The specifications can be modified without prior notice. 11-1

[Page 72] Optional Modes The system can be licensed for the following additional modes: License Feature Note Doppler Doppler - CFM CFM - TEI TEI Probe dependent TVM TVM Probe dependent CMM Compass M-Mode Probe dependent The CFM license requires prior installation of the Doppler license. The TVM license works only if a CFM license is already available. The CMM license requires a cardiac license first. Optional Features The following features are optional: License Feature Clip Clip digital storage DICOM DICOM classes V-Pan Panoramic View Xstrain Strain, Strain rate MyLab30CV MyLab30CV basic configuration consists in the color imaging system licensed for Basic Configuration cardiac (adult and pediatric) applications. The basic configuration may archive and export individual images only (in BMP format). Optional The system can be equipped with the following licenses to enhance its applications Applications range: License Application Features Vascular Peripheral Vascular, Adult Presets, Calculations cephalic General Imaging Abdominal, Muscolo-skeletal, Presets, Calculations Breast, Small parts, Thyroid, Pediatric Urology Urology Presets, Calculations Obstetric Obstetric, Fetal, Gynaecogical Presets, Calculations Optional Modes The system can be licensed for the following additional modes: License Feature Note TEI TEI Probe dependent TVM TVM Probe dependent CMM Compass M-Mode Probe dependent 11-2

[Page 73] Optional Features The following features are optional: License Feature Clip Clip digital storage DICOM DICOM classes2 V-Pan Panoramic View Xstrain Strain, Strain rate Portable Configuration This section describes the product when fully loaded with all options; refer to the previous paragraph for basic configurations. General Display • Built-in LCD, TFT technology, color XVGA Probe connectors • 2 electronic probes • 1 Doppler probe Video I/O • XVGA (monitor) • S-VHS I/O • VHS I/O • RGB (TV standard) • Video standard • PAL / NTSC Connectivity • I/Os connectors • LAN RJ45 • 2 USB • Dedicated connectors • ECG input • Foot switch • Other • Laser/Ink jet printers • Complies with IHE integration profiles Image Files • Formats • Standard output file formats (BMP, AVI) • Native and Dicom formats • Clips characteristics • AVI Codec: Microsoft ® MPEG-4 V2 • Compression: JPEG lossy compression (about 70% of quality) • Still frames / BMPs are stored at full resolution 2 Refer to DICOM Conformance Statement on www.esaote.com for further details. 3 Refer to www.esaote.com for further details 11-3

[Page 74] Software • Operating system: WIN XP Embedded • Multi-lingual Biometry • Basic and advanced calculation, application dependent • Annotations, bodymarks Keyboard • Echografic • Potentiometers for TGC • Encoders for general gains • Keys for modes, peripherals management and controls Power Cables • Power cable with CEE socket • Socket: 510 IEC 320/C13 type; 10A-250V • Plug: VII (7) VII type; 10A-250V • Conductors: 3 • Section: 1 mm2 • Length:2,5 m • Power cable with CEI socket • Socket:: 510 IEC 320/C13 type; 10A-250V • Plug: I/3 CEI 23-16 type; 10A-250V • Conductors: 3 • Section: 1 mm2 • Length: 2,5 m • Power cable with NEMA socket • Socket type and amperage: 510 IEC 320/C13 type; 13A-125V • Plug type: NEMA 5-15; 13A-125V • Conductors: 3 • Section: AWG 16 • Length: 3 m Dimensions • Closed: 35.6 (L) x 15.7 (H) x 49 (D) cm • In working position: 35.6 (L) x 41 (H) x 49 (D) cm Weight • about 9 kg Power supply • Voltage operative range • 100 ÷ 240 V • Mains frequency: 50 ÷ 60 Hz • Power consumption: ≤ 200 VA Operating requirements • Temperature: 15 ÷ 35 ° C • Humidity: 15 ÷ 95 % (not condensing) • Pressure: 700 ÷ 1060 hPa Storage requirements • Temperature: -20 ÷ +60 ° C • Humidity: 5 ÷ 95 % (not condensing) • Pressure: 700 ÷ 1060 hPa 11-4

[Page 75] Mobile Configuration Trolley • Housings: • Upper space about 33 (L) x 14.5 (H) x 38.5 (D) cm • Lower space about: 33 (L) x 17 (H) x 41 (D) cm • Dimensions: about 50 (L) x 90 (H) x 51 (D) cm • Weight: about 31 kg • Auxiliary power plugs: 4 insulated Configuration Dimensions • About 50 (L) x 99,5 (H) x 51 (D) cm Configuration Weight • About 45 kg Power Supply • Voltage operative range: • 100 ÷ 115V • 200 ÷ 240 V • Mains frequency: 50 ÷ 60 Hz • Power consumption: ≤ 600 VA • Available power for peripheral units: up to 600 VA Safety Standards • EN 60601-1 • EN 60601-1-1 • EN 60601-1-2 • EN 60601-1-4 • EN ISO 10993-1 • EN 60601-2-37 • EN 61157 • AIUM / NEMA UD-2 / UD-3 – FDA 510(k) Track 3 Probes Operating Frequencies and Modes Phased Array Probes Probe ID PA230 PA121 PA122 PA023 Linear Probes Probe ID LA522 LA523 LA532 LA424 11-5

[Page 76] Convex Probes Probe ID CA430 CA421 CA621 CA123 Special Probes Probe ID TE022 EC123 IOE323 LP323* *Not for the U.S. market Doppler Probes Probe ID 2CW 5CW Video requirements • Input: RGB SYNC RGB Printer • RGB (analog): 0.7 Vp-p, 75 ohm • SYNC : 5 Vp-p • Connectors: standard BNC • Safety standard: IEC 950 o EN60601-1 • Input: Video composite (1 Vp-p, 75 ohm) b/w Printer • Connectors: standard BNC • Safety standard: IEC 950 o EN60601-1 • I/O video: YC VTR • Y: 1 Vp-p, 75 ohm • C: 0.3 Vp-p Color burst, 75 ohm • Tape format: VHS, S-VHS • Audio traces: 2 • Connectors: • Video: 4 pin connector • Audio: jack • Safety standard: IEC 650 o EN60601-1 11-6

[Page 77] Appendix Appendix A - Acoustic Output Tables Acoustic Output Data according to FDA This section includes the acoustic output tables for each probe and mode of operation (tables s t r u c t u r e a n d m e a s u r e m e n t s p r e c i s i o n a c c o r d i n g t o t h e d o c u m e n t “ I n f o r m a t i o n f o r M a n u f a c t urers S e e k i n g Ma r k e t i n g C l e a r a n c e o f D i a g n o s t i c U l t r a s o u n d S y s t e m s a n d T r a n s d u c e r s ” i s s u e d b y t h e FDA on september 30, 1997). Summary Table For transducer/mode combinations marked "yes", MI or TI index is equal or greater than 1.0. Mode PA230E PA121E PA122E PA023E LA522E LA523 IOE323/L 2CW 5CW P323 B/M Yes Yes Yes No Yes Yes Yes - - TEI (B/M) Yes Yes N/A N/A No Yes N/A - - CFM (B/M) Yes Yes Yes Yes Yes Yes Yes - - PW Yes Yes Yes Yes Yes Yes Yes - - CW Yes Yes Yes Yes - - - Yes Yes Mode LA424 LA532E CA421 CA621 CA430E CA123 EC123 TE022 LV513 B/M Yes No Yes Yes Yes Yes Yes Yes Yes TEI (B/M) N/A Yes Yes No Yes Yes No Yes N/A CFM (B/M) Yes Yes Yes Yes Yes Yes Yes Yes Yes PW Yes Yes Yes Yes Yes Yes Yes Yes Yes CW - - - - - - - Yes - A-1

[Page 78] Operating conditions for maximum acoustic output Ispta .3 data are in mW/cm 2 . Probe Parameter Max. System Setting TE022 Ispta .3 360 M-CFM 5.0MHz Foc=1 PRF=5.6 kHz P=Max MI 1.2 M 5.0MHz Foc=1 PRF=5.6 kHz P=Max PA230E Ispta .3 561 PW 2.0MHz SS=2mm SD=118 P=Max MI 1.3 PW 2.0MHz SS=2mm SD=77mm P=Max PA122E Ispta .3 543 PW 5.0MHz SS=2mm SD=20mm P=Max MI 1.5 B-CFM 5.0MHz Foc=2 PRF=5.6 kHz P=Max PA121E Ispta .3 524 CW 3.3MHz Foc=1 P=Max MI 1.5 PW 3.3MHz SS=2mm SD=19mm P=Max PA023E Ispta .3 546 CW 5.0MHz Foc=3 P=Max MI 1.1 B-CFM(Sens1) 5.0MHz Foc=5 PRF=5.6 kHz P=Max LA532E Ispta .3 533 M-TEI PEN Foc=7 PRF=6.7 kHz P=Max MI 1.5 PW-B-CFM 3.3MHz SS=2mm SD=61mm P=Max LV513 Ispta .3 600 M-CFM 5.0MHz Foc=3 PRF=5.6 kHz P=Max MI 1.7 PW 6.6MHz SS=2mm SD=57mm P=Max LA523 Ispta .3 539 B-CFM(Sens1) 6.6MHz Foc=7 PRF=5.6 kHz P=Max MI 1.5 B-CFM(Sens1) 5.0MHz Foc=4 PRF=0.7 kHz P=Max LA522E Ispta .3 544 M-CFM 5.0MHz Foc=3 PRF=5.6 kHz P=Max MI 1.5 B-CFM 5.0MHz Foc=3 PRF=5.6 kHz P=Max LA424 Ispta .3 474 M-CFM 8.0MHz Foc=3 PRF=5.6 kHz P=Max MI 1.5 M 10.0MHz Foc=3 PRF=1.0kHz P=Max EC123 Ispta .3 522 M 5.0MHz Foc=3 PRF=5.6 kHz P=Max MI 1.5 B 5.0MHz Foc=4 PRF=5.6kHz P=Max CA621 Ispta .3 516 PW 2.5MHz SS=2mm SD=88mm P=Max MI 1.2 PW 2.5MHz SS=2mm SD=56mm P=Max CA430E Ispta .3 534 PW 2.5MHz SS=2mm SD=90mm P=Max MI 1.5 B-TEI PEN Foc=5 PRF=5.6 kHz P=Max CA421 Ispta .3 529 PW 3.3MHz SS=2mm SD=86mm P=Max MI 1.3 PW 3.3MHz SS=2mm SD=26mm P=Max CA123 Ispta .3 509 M-CFM 5.0MHz Foc=3 PRF=5.6 kHz P=Max MI 1.4 B 5.0MHz Foc=3 PRF=5.6 kHz P=Max IOE323 Ispta .3 534 M-CFM 6.6MHz Foc=3 PRF=5.6 kHz P=Max LP323 MI 1.5 M 7.5MHz Foc=3 PRF=1.0kHz P=Max 2.0 CW Ispta .3 630 CW 2.0MHz P=Max MI <1.0 5.0 CW Ispta .3 601 CW 5.0MHz P=Max MI <1.0 A-2

[Page 79] Transducer Model: 2CW Operating Mode: CW Global Maximum Index Value <1 a 1.1 <1 4.4 b W o (mW) 116 116 Acoustic Z sp (cm) # 2.9 f c (MHz) # 2 # 2 Dim of A aprt X (cm) 0 # 0 Y (cm) 0 # 0 Focal Length (cm) 3.3 # Mode CW CW Operating Frequency (MHz) 2 2 Control Focus 1 1 Conditions PRF (kHz) A-3

[Page 80] Transducer Model: 5CW Operating Mode: CW Global Maximum Index Value <1 a <1 - 2.7 b W o (mW) # 33 Acoustic Z sp (cm) # 0.3 f c (MHz) # # - 5 Dim of A aprt X (cm) # - 0 Y (cm) # - 0 Focal Length (cm) # - Mode CW Operating Frequency (MHz) 5 Control Focus 1 Conditions PRF (kHz) Power Max A-4

[Page 81] Transducer Model: CA123 Operating Mode: B\M Global Maximum Index Value 1.4 <1 <1 - 1.3 b Pr .3 (MPa) 2.9 W o (mW) # # 24 Acoustic Z sp (cm) 1.4 1.8 f c (MHz) 4.8 # # - 4.8 Dim of A aprt X (cm) # # - 0.6 PD (mSec) 0.67 Other P r @PII max (MPa) 3.2 I PA.3 @MI max (W/cm 2 ) 170 Mode B M Control Focus 3 5 Conditions PRF (kHz) 5.6 5.6 A-5

[Page 82] Transducer Model: CA123 Operating Mode: B\M-CFM Global Maximum Index Value 1.3 <1 <1 - 1.2 b Pr .3 (MPa) 3 W o (mW) # # 10 Acoustic Z sp (cm) 1.2 1.2 Parameter d eq (Z sp ) (cm) 0.1 f c (MHz) 4.9 # # - 4.8 Dim of A aprt X (cm) # # - 0.5 PD (mSec) 0.79 Other P r @PII max (MPa) 3.4 Information d eq @PII max (cm) 0.1 I PA.3 @MI max (W/cm 2 ) 301 Mode(Sens.) B(Sens1) M Control Focus 3 3 Conditions PRF (kHz) 0.7 5.6 A-6

[Page 83] Transducer Model: CA123 Operating Mode: B\M-TEI Global Maximum Index Value 1 <1 <1 - <1 b Pr .3 (MPa) 2.1 W o (mW) # # # Acoustic Z sp (cm) 1.1 # Parameter d eq (Z sp ) (cm) # f c (MHz) 4.4 # # - # Dim of A aprt X (cm) # # - # Y (cm) # # - # PD (mSec) 0.62 Other P r @PII max (MPa) 2.4 Information d eq @PII max (cm) # I PA.3 @MI max (W/cm 2 ) 115 Mode B-TEI Operating Frequency (MHz) PEN Control Focus 2 Conditions PRF (kHz) 5.6 Power Max A-7

[Page 84] Transducer Model: CA123 Operating Mode: PW Global Maximum Index Value 1.3 a <1 - 1.9 b Pr .3 (MPa) 3.1 W o (mW) # 33 Acoustic Z sp (cm) 1.4 1.1 f c (MHz) 5.9 # - 4.9 Dim of A aprt X (cm) # - 0.7 Y (cm) # - 0.4 PD (mSec) 0.44 Other P r @PII max (MPa) 4 Focal Length (cm) # - I PA.3 @MI max (W/cm 2 ) 333 Mode PW-B-CFM PW Operating Frequency (MHz) 6.6 5 Control Sample Depth (mm) 0 45 Conditions Sample Size (mm) 0 2 A-8

[Page 85] Transducer Model: CA421 Operating Mode: B\M Global Maximum Index Value 1.2 2.8 1.8 2.4 3.6 b Pr .3 (MPa) 2.2 W o (mW) 200 114 200 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 75 Z 1 (cm) 2.5 Assoc. Z bp (cm) 1.9 Acoustic Z sp (cm) 4.8 4.5 f c (MHz) 2.9 2.9 3 3 3 Dim of A aprt X (cm) 1.1 0.8 1.1 1.1 PD (mSec) 0.64 Other P r @PII max (MPa) 3.4 Focal Length (cm) 4.8 3.9 4.8 I PA.3 @MI max (W/cm 2 ) 152 Mode B B M M M Operating Frequency (MHz) 3.5 3.5 3.5 3.5 3.5 Control Focus 6 6 4 6 6 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 5.6 A-9

[Page 86] Transducer Model: CA421 Operating Mode: B\M-CFM Global Maximum Index Value 1.1 3.4 1.7 1.7 3.5 b Pr .3 (MPa) 2.1 W o (mW) 224 118 140 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 120 Z 1 (cm) 1.8 Assoc. Z bp (cm) 1.8 Acoustic Z sp (cm) 4.3 4.2 f c (MHz) 3 3.2 3 3 3 Dim of A aprt X (cm) 1.3 0.8 1 1 PD (mSec) 0.54 Other P r @PII max (MPa) 3.1 Focal Length (cm) 5.5 4 4.3 I PA.3 @MI max (W/cm 2 ) 156 Mode(Sens.) M B(Sens2) M M M Operating Frequency (MHz) 3.3 3.3 3.3 3.3 3.3 Control Focus 5 8 4 5 5 Conditions PRF (kHz) 5.6 4.2 5.6 5.6 5.6 A-10

[Page 87] Transducer Model: CA421 Operating Mode: B\M-TEI Global Maximum Index Value <1 <1 <1 <1 1.5 b W o (mW) # # 68 Acoustic Z sp (cm) # 3.5 f c (MHz) # # # # 2.1 Dim of A aprt X (cm) # # # 1.1 Y (cm) # # # 1.2 Focal Length (cm) # # # Mode M-TEI Operating Frequency (MHz) RES Control Focus 6 Conditions PRF (kHz) 5.6 Power Max A-11

[Page 88] Transducer Model: CA421 Operating Mode: PW Global Maximum Index Value 1.3 a 2.3 2.2 4.3 b W o (mW) 138 138 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 147 Z 1 (cm) 2.2 Acoustic Z sp (cm) 1.4 2.2 f c (MHz) 3.2 3.2 3.2 3.2 Dim of A aprt X (cm) 0.7 1.3 0.7 Y (cm) 1.2 1.2 1.2 PD (mSec) 1.14 PRF (kHz) 2.1 Other P r @PII max (MPa) 2.6 Focal Length (cm) 4.5 5.8 I PA.3 @MI max (W/cm 2 ) 167 Mode PW PW PW PW Operating Frequency (MHz) 3.3 3.3 3.3 3.3 Control Sample Depth (mm) 26 44 135 44 Conditions Sample Size (mm) 2 2 2 2 A-12

[Page 89] Transducer Model: CA431 Operating Mode: B\M Global Maximum Index Value 1.5 3.8 2.4 3.2 3.8 b Pr .3 (MPa) 2.5 W o (mW) 215 136 214 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 85 Z 1 (cm) 2 Assoc. Z bp (cm) 2 Acoustic Z sp (cm) 3.9 1.1 Parameter d eq (Z sp ) (cm) 0.9 f c (MHz) 2.5 3.7 3.5 3.5 3.5 Dim of A aprt X (cm) 1.2 0.7 1.2 1.2 PD (mSec) 0.66 Other P r @PII max (MPa) 3.3 Focal Length (cm) 5.3 2.9 5.2 I PA.3 @MI max (W/cm 2 ) 214 Mode B B M M M Operating Frequency (MHz) 2.5 6.6 5 5 5 Control Focus 6 7 3 7 7 Conditions PRF (kHz) 5.6 4.8 5.6 4.8 4.8 A-13

[Page 90] Transducer Model: CA431 Operating Mode: B\M-CFM Global Maximum Index Value 1.3 2.9 1.5 2 3.9 b W o (mW) 216 118 192 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 154 Z 1 (cm) 2.1 Acoustic Z sp (cm) 4.6 4 f c (MHz) 2.7 2.8 2.8 2.7 2.5 Dim of A aprt X (cm) 1.3 0.8 1.3 1.2 PD (mSec) 0.57 PRF (kHz) 4.2 Other P r @PII max (MPa) 3.2 Focal Length (cm) 5 3.1 5 I PA.3 @MI max (W/cm 2 ) 145 Mode(Sens.) M B(Sens2) M M M Operating Frequency (MHz) 2.9 2.9 2.9 2.9 2.5 Control Focus 7 8 4 8 7 Conditions PRF (kHz) 4.2 3.7 5.6 3.7 4.2 A-14

[Page 91] Transducer Model: CA431 Operating Mode: B\M-TEI Global Maximum Index Value 1.5 3.5 2.4 3.3 3.2 b Pr .3 (MPa) 2.3 W o (mW) 155 107 165 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 63 Z 1 (cm) 1.9 Assoc. Z bp (cm) 1.9 Acoustic Z sp (cm) 2.6 1 Parameter d eq (Z sp ) (cm) 1 f c (MHz) 2.2 4.8 4.8 4.8 4.8 Dim of A aprt X (cm) 0.8 0.8 1.1 1.1 PD (mSec) 0.82 Other P r @PII max (MPa) 2.2 Focal Length (cm) 4.1 4.1 5 I PA.3 @MI max (W/cm 2 ) 59 Mode B-TEI B-TEI M-TEI M-TEI M-TEI Operating Frequency (MHz) GEN PEN PEN PEN PEN Control Focus 3 4 4 6 6 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 5.6 A-15

[Page 92] Transducer Model: CA431 Operating Mode: PW Global Maximum Index Value 1.4 a 2.3 2.7 4.8 b W o (mW) 171 230 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 75 Z 1 (cm) 2.1 Acoustic Z sp (cm) 1 1.1 Parameter d eq (Z sp ) (cm) 0.9 f c (MHz) 2.8 2.8 2.8 2.8 Dim of A aprt X (cm) 0.8 1.3 1.2 Y (cm) 1.2 1.2 1.2 PD (mSec) 0.61 Other P r @PII max (MPa) 2.6 Focal Length (cm) 3.1 5 I PA.3 @MI max (W/cm 2 ) 159 Mode PW-B-CFM PW-B-CFM PW PW Operating Frequency (MHz) 2.9 2.9 2.9 2.9 Control Sample Depth (mm) 0 0 140 107 Conditions Sample Size (mm) 0 0 2 2 A-16

[Page 93] Transducer Model: CA621 Operating Mode: B\M Global Maximum Index Value 1.2 1.9 1.2 1.6 2.7 b Pr .3 (MPa) 2 W o (mW) 162 100 161 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 59 Z 1 (cm) 3 Assoc. Z bp (cm) 2.2 Acoustic Z sp (cm) 4.2 5.2 f c (MHz) 2.5 2.5 2.5 2.5 2.5 Dim of A aprt X (cm) 1.1 0.8 1.4 1.4 PD (mSec) 1.05 Other P r @PII max (MPa) 2.8 Focal Length (cm) 4.8 4.2 6.1 I PA.3 @MI max (W/cm 2 ) 123 Mode B B M M M Operating Frequency (MHz) 2.5 2.5 2.5 2.5 2.5 Control Focus 5 6 4 7 7 Conditions PRF (kHz) 5.6 5.6 5.6 4.8 4.8 A-17

[Page 94] Transducer Model: CA621 Operating Mode: B\M-CFM Global Maximum Index Value 1 2.8 1.7 1.8 3.5 b Pr .3 (MPa) 1.6 W o (mW) 181 114 232 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 171 Z 1 (cm) 2.8 Assoc. Z bp (cm) 2.4 Acoustic Z sp (cm) 4.3 3.5 Parameter d eq (Z sp ) (cm) 0.7 f c (MHz) 2.5 3.3 3.1 2.4 2.4 Dim of A aprt X (cm) 1.4 0.7 1.6 1.6 PD (mSec) 1.23 Other P r @PII max (MPa) 2.2 Focal Length (cm) 6 4.6 7.3 I PA.3 @MI max (W/cm 2 ) 123 Mode(Sens.) B(Sens1) B(Sens2) M M M Operating Frequency (MHz) 2.5 3.3 3.3 2.5 2.5 Control Focus 5 7 3 8 8 Conditions PRF (kHz) 5.6 4.2 5.6 3.7 3.7 A-18

[Page 95] Transducer Model: CA621 Operating Mode: PW Global Maximum Index Value 1.2 a 1.9 2.1 3.5 b Pr .3 (MPa) 2 W o (mW) 132 160 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 57 Z 1 (cm) 3.4 Assoc. Z bp (cm) 2.4 Acoustic Z sp (cm) 3.9 5 f c (MHz) 2.5 3.1 3 2.5 Dim of A aprt X (cm) 0.8 1.6 1.4 Y (cm) 1.2 1.2 1.2 PD (mSec) 1.63 PRF (kHz) 2.1 Other P r @PII max (MPa) 2.7 Focal Length (cm) 4.8 7.6 I PA.3 @MI max (W/cm 2 ) 142 Mode PW PW-B-CFM PW-B-CFM PW Operating Frequency (MHz) 2.5 3.3 3.3 2.5 Control Sample Depth (mm) 56 0 0 105 Conditions Sample Size (mm) 2 0 0 2 A-19

[Page 96] Transducer Model: EC123 Operating Mode: B\M Global Maximum Index Value 1.5 <1 <1 - 1.1 b Pr .3 (MPa) 3.5 W o (mW) # # 20 Acoustic Z sp (cm) 1 1.2 f c (MHz) 5 # # - 5 Dim of A aprt X (cm) # # - 0.5 PD (mSec) 0.44 Other P r @PII max (MPa) 3.9 I PA.3 @MI max (W/cm 2 ) 371 Mode B M Control Focus 4 7 Conditions PRF (kHz) 5.6 5.6 A-20

[Page 97] Transducer Model: EC123 Operating Mode: B\M-CFM Global Maximum Index Value 1.4 <1 <1 - 1.3 b Pr .3 (MPa) 3.1 W o (mW) # # 13 Acoustic Z sp (cm) 1.2 1.2 f c (MHz) 5.1 # # - 5 Dim of A aprt X (cm) # # - 0.4 PD (mSec) 0.51 Other P r @PII max (MPa) 3.6 Information d eq @PII max (cm) 0.1 I PA.3 @MI max (W/cm 2 ) 364 Mode(Sens.) B(Sens1) M Control Focus 3 6 Conditions PRF (kHz) 0.7 5.6 A-21

[Page 98] Transducer Model: EC123 Operating Mode: PW Global Maximum Index Value 1.4 a <1 - 1.6 b Pr .3 (MPa) 3 W o (mW) # 21 Acoustic Z sp (cm) 1.2 1.4 f c (MHz) 5.1 # - 5.1 Dim of A aprt X (cm) # - 0.5 Y (cm) # - 0.4 PD (mSec) 0.65 PRF (kHz) 2.1 Other P r @PII max (MPa) 3.7 Focal Length (cm) # - I PA.3 @MI max (W/cm 2 ) 319 Mode PW PW Control Sample Depth (mm) 18 96 Conditions Sample Size (mm) 2 2 A-22

[Page 99] Transducer Model: IOE323/LP323 Operating Mode: B\M Global Maximum Index Value 1.5 <1 <1 - 1.2 b Pr .3 (MPa) 3.9 W o (mW) # # 26 Acoustic Z sp (cm) 1.2 1 f c (MHz) 5.8 # # - 5.9 Dim of A aprt X (cm) # # - 0.7 PD (mSec) 0.22 Other P r @PII max (MPa) 4.7 I PA.3 @MI max (W/cm 2 ) 444 Mode M M Operating Frequency (MHz) 7.5 7.5 Control Focus 3 8 Conditions PRF (kHz) 1 6.7 A-23

[Page 100] Transducer Model: IOE323/LP323 Operating Mode: B\M-CFM Global Maximum Index Value 1.5 2.1 <1 - 1.4 b Pr .3 (MPa) 3.8 W o (mW) 67 # 23 Acoustic Z sp (cm) 1.1 1 f c (MHz) 6.4 6.6 # - 5.1 Dim of A aprt X (cm) 0.7 # - 0.7 Y (cm) 0.4 # - 0.4 PD (mSec) 0.47 Other P r @PII max (MPa) 4.9 Focal Length (cm) 1.3 # - I PA.3 @MI max (W/cm 2 ) 440 Mode(Sens.) B(Sens1) B(Sens2) M Operating Frequency (MHz) 6.6 6.6 5 Control Focus 3 8 8 Conditions PRF (kHz) 0.7 5.6 5.6 Power Max Max Max A-24

[Page 101] Transducer Model: IOE323/LP323 Operating Mode: PW Global Maximum Index Value 1.5 a 1.1 - 2 b Pr .3 (MPa) 3.8 W o (mW) 34 34 Acoustic Z sp (cm) 1.2 1.1 f c (MHz) 6.2 6.6 - 6.6 Dim of A aprt X (cm) 0.7 - 0.7 Y (cm) 0.4 - 0.4 PD (mSec) 0.33 Other P r @PII max (MPa) 4.9 Focal Length (cm) 1.3 - I PA.3 @MI max (W/cm 2 ) 488 Mode PW-B-CFM PW PW Operating Frequency (MHz) 6.6 6.6 6.6 Control Sample Depth (mm) 0 60 60 Conditions Sample Size (mm) 0 2 2 Power Max Max Max A-25

[Page 102] Transducer Model: LA424 Operating Mode: B\M Global Maximum Index Value 1.5 <1 <1 - 1 b Pr .3 (MPa) 4.4 W o (mW) # # 15 Acoustic Z sp (cm) 0.7 0.6 f c (MHz) 9.1 # # - 9.2 Dim of A aprt X (cm) # # - 0.5 Y (cm) # # - 0.3 PD (mSec) 0.19 Other P r @PII max (MPa) 5 I PA.3 @MI max (W/cm 2 ) 585 Mode M M Operating Frequency (MHz) 10 10 Control Focus 3 8 Conditions PRF (kHz) 1 6.7 A-26

[Page 103] Transducer Model: LA424 Operating Mode: B\M-CFM Global Maximum Index Value 1.3 1.4 <1 - <1 b Pr .3 (MPa) 3.6 W o (mW) 38 # # Acoustic Z sp (cm) 0.8 # Parameter d eq (Z sp ) (cm) # f c (MHz) 7.9 8 # - # Dim of A aprt X (cm) 0.5 # - # Y (cm) 0.3 # - # PD (mSec) 0.48 Other P r @PII max (MPa) 4.4 Information d eq @PII max (cm) # Focal Length (cm) 0.7 # - I PA.3 @MI max (W/cm 2 ) 401 Mode(Sens.) B(Sens1) B(Sens2) Operating Frequency (MHz) 8 8 Control Focus 4 8 Conditions PRF (kHz) 0.7 5.6 A-27

[Page 104] Transducer Model: LA424 Operating Mode: PW Global Maximum Index Value 1.3 a <1 - 1.3 b Pr .3 (MPa) 3.9 W o (mW) # 10 Acoustic Z sp (cm) 0.8 0.7 f c (MHz) 8.1 # - 7.9 Dim of A aprt X (cm) # - 0.5 Y (cm) # - 0.3 PD (mSec) 0.44 PRF (kHz) 2.1 Other P r @PII max (MPa) 4.7 Information d eq @PII max (cm) 0.1 Focal Length (cm) # - I PA.3 @MI max (W/cm 2 ) 446 Mode PW PW Operating Frequency (MHz) 8 8 Control Sample Depth (mm) 11 88 Conditions Sample Size (mm) 2 2 A-28

[Page 105] Transducer Model: LA522E Operating Mode: B\M Global Maximum Index Value 1 <1 <1 - 1.1 b Pr .3 (MPa) 2.3 W o (mW) # # 34 Acoustic Z sp (cm) 1.9 1.6 f c (MHz) 4.8 # # - 4.9 Dim of A aprt X (cm) # # - 1.1 Y (cm) # # - 0.6 PD (mSec) 0.25 Other P r @PII max (MPa) 3 I PA.3 @MI max (W/cm 2 ) 328 Mode M M Operating Frequency (MHz) 7.5 7.5 Control Focus 3 8 Conditions PRF (kHz) 1 6.7 A-29

[Page 106] Transducer Model: LA522E Operating Mode: B\M-CFM Global Maximum Index Value 1.5 2.4 1 - 1.8 b Pr .3 (MPa) 3.4 W o (mW) 102 47 24 Acoustic Z sp (cm) 1.7 1.7 f c (MHz) 4.8 4.9 4.6 - 3.5 Dim of A aprt X (cm) 1.1 1.1 - 0.6 Y (cm) 0.6 0.6 - 0.6 PD (mSec) 0.53 Other P r @PII max (MPa) 4.3 Focal Length (cm) 2.2 2 - I PA.3 @MI max (W/cm 2 ) 408 Mode(Sens.) B(Sens1) B(Sens2) M M Operating Frequency (MHz) 5 5 5 3.3 Control Focus 3 8 8 3 Conditions PRF (kHz) 0.7 5.6 5.6 5.6 A-30

[Page 107] Transducer Model: LA522E Operating Mode: PW Global Maximum Index Value 1.5 a 1.8 - 3.5 b W o (mW) 79 79 Acoustic Z sp (cm) 0.5 1.5 f c (MHz) 4.8 4.8 - 3.3 Dim of A aprt X (cm) 1.1 - 1 Y (cm) 0.6 - 0.6 PD (mSec) 0.73 PRF (kHz) 2.1 Other P r @PII max (MPa) 3.5 Focal Length (cm) 2.2 - I PA.3 @MI max (W/cm 2 ) 313 Mode PW PW PW Operating Frequency (MHz) 5 5 3.3 Control Sample Depth (mm) 1 77 67 Conditions Sample Size (mm) 2 2 2 Power Max Max Max A-31

[Page 108] Transducer Model: LA523 Operating Mode: B\M Global Maximum Index Value 1.4 <1 <1 - <1 b Pr .3 (MPa) 3.6 W o (mW) # # # Acoustic Z sp (cm) 1.4 # Parameter d eq (Z sp ) (cm) # f c (MHz) 6.3 # # - # Dim of A aprt X (cm) # # - # Y (cm) # # - # PD (mSec) 0.2 Other P r @PII max (MPa) 4.7 Information d eq @PII max (cm) # I PA.3 @MI max (W/cm 2 ) 451 Mode M Operating Frequency (MHz) 7.5 Control Focus 3 Conditions PRF (kHz) 1 Power Max A-32

[Page 109] Transducer Model: LA523 Operating Mode: B\M-CFM Global Maximum Index Value 1.5 1.4 <1 - 1.6 b Pr .3 (MPa) 3.4 W o (mW) 45 # 22 Acoustic Z sp (cm) 1.3 1 f c (MHz) 5 6.5 # - 5.2 Dim of A aprt X (cm) 0.7 # - 0.7 Y (cm) 0.5 # - 0.5 PD (mSec) 0.54 Other P r @PII max (MPa) 4.2 Focal Length (cm) 1.2 # - I PA.3 @MI max (W/cm 2 ) 475 Mode(Sens.) B(Sens1) B(Sens1) M Operating Frequency (MHz) 5 6.6 5 Control Focus 4 8 7 Conditions PRF (kHz) 0.7 5.6 5.6 Power Max Max Max A-33

[Page 110] Transducer Model: LA523 Operating Mode: B\M-TEI Global Maximum Index Value 1.4 <1 <1 - <1 b W o (mW) # # # Acoustic Z sp (cm) 1.2 # Parameter d eq (Z sp ) (cm) # f c (MHz) 5.4 # # - # Dim of A aprt X (cm) # # - # Y (cm) # # - # PD (mSec) 0.26 Other P r @PII max (MPa) 3.7 Information d eq @PII max (cm) # I PA.3 @MI max (W/cm 2 ) 394 Mode B-TEI Operating Frequency (MHz) RES Control Focus 3 Conditions PRF (kHz) 1 Power Max A-34

[Page 111] Transducer Model: LA523 Operating Mode: PW Global Maximum Index Value 1.4 a <1 - 2.1 b W o (mW) # 28 Acoustic Z sp (cm) 1.3 1 f c (MHz) 5.1 # - 5 Dim of A aprt X (cm) # - 0.7 Y (cm) # - 0.5 PD (mSec) 0.72 PRF (kHz) 2.1 Other P r @PII max (MPa) 4 Focal Length (cm) # - I PA.3 @MI max (W/cm 2 ) 326 Mode PW PW Control Sample Depth (mm) 23 51 Conditions Sample Size (mm) 2 2 A-35

[Page 112] Transducer Model: LA532E Operating Mode: B\M-CFM Global Maximum Index Value 1.5 1.9 1 - 3.2 b Pr .3 (MPa) 2.6 W o (mW) 122 54 67 Acoustic Z sp (cm) 1.5 1.4 f c (MHz) 3 3.2 4 - 3 Dim of A aprt X (cm) 1.1 1.1 - 1 Y (cm) 0.6 0.6 - 0.6 PD (mSec) 0.87 Other P r @PII max (MPa) 2.8 Focal Length (cm) 3.7 4.5 - I PA.3 @MI max (W/cm 2 ) 120 Mode(Sens.) B(Sens1) B(Sens2) M M Operating Frequency (MHz) 3.3 3.3 5 3.3 Control Focus 8 8 8 7 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 A-36

[Page 113] Transducer Model: LA532E Operating Mode: B\M-TEI Global Maximum Index Value 1.5 2.2 1.8 - 4.3 b Pr .3 (MPa) 2.5 W o (mW) 182 151 144 Acoustic Z sp (cm) 1.5 1.3 f c (MHz) 2.6 2.5 2.5 - 2.5 Dim of A aprt X (cm) 1.1 1.1 - 1 Y (cm) 0.6 0.6 - 0.6 PD (mSec) 0.79 Other P r @PII max (MPa) 2.7 Focal Length (cm) 3.4 3.4 - I PA.3 @MI max (W/cm 2 ) 180 Mode M-TEI B-TEI M-TEI M-TEI Operating Frequency (MHz) RES PEN PEN PEN Control Focus 3 8 8 7 Conditions PRF (kHz) 1 6.7 6.7 6.7 A-37

[Page 114] Transducer Model: LA532E Operating Mode: PW Global Maximum Index Value 1.5 a 1 - 3.1 b Pr .3 (MPa) 2.7 W o (mW) 65 65 Acoustic Z sp (cm) 2.4 1.5 f c (MHz) 3 3.2 - 3.2 Dim of A aprt X (cm) 1 - 1 Y (cm) 0.6 - 0.6 PD (mSec) 0.69 Other P r @PII max (MPa) 3.3 Focal Length (cm) 3.7 - I PA.3 @MI max (W/cm 2 ) 135 Mode PW-B-CFM PW PW Operating Frequency (MHz) 3.3 3.3 3.3 Control Sample Depth (mm) 0 67 67 Conditions Sample Size (mm) 0 2 2 Power Max Max Max A-38

[Page 115] Transducer Model: LV513 Operating Mode: B\M Global Maximum Index Value 1.5 2 1.7 - 2.3 b Pr .3 (MPa) 3.5 W o (mW) 83 63 68 Acoustic Z sp (cm) 1.8 0.7 f c (MHz) 4.9 4.9 5.6 - 4.9 Dim of A aprt X (cm) 0.9 1 - 0.9 Y (cm) 0.5 0.5 - 0.5 PD (mSec) 0.38 PRF (kHz) 6.7 Other P r @PII max (MPa) 4.3 Focal Length (cm) 1.6 1.8 - I PA.3 @MI max (W/cm 2 ) 487 Mode B B M M Operating Frequency (MHz) 5 5 7.5 5 Control Focus 3 7 8 7 Conditions PRF (kHz) 6.7 6.7 6.7 6.7 A-39

[Page 116] Transducer Model: LV513 Operating Mode: B\M-CFM Global Maximum Index Value 1.5 3.4 1 - 1.7 b Pr .3 (MPa) 3.5 W o (mW) 111 36 21 Acoustic Z sp (cm) 1.6 1.6 f c (MHz) 4.9 6.4 5.7 - 4.9 Dim of A aprt X (cm) 1 1 - 0.6 Y (cm) 0.5 0.5 - 0.5 PD (mSec) 0.59 Other P r @PII max (MPa) 4.2 Focal Length (cm) 1.8 1.8 - I PA.3 @MI max (W/cm 2 ) 407 Mode(Sens.) B(Sens1) B(Sens2) M M Operating Frequency (MHz) 5 6.6 6.6 5 Control Focus 3 8 8 3 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 A-40

[Page 117] Transducer Model: LV513 Operating Mode: PW Global Maximum Index Value 1.7 a 2.3 - 3.2 b Pr .3 (MPa) 4.2 W o (mW) 69 64 Acoustic Z sp (cm) 0.8 0.6 f c (MHz) 6.3 6.3 - 5 Dim of A aprt X (cm) 1 - 1 Y (cm) 0.5 - 0.5 PD (mSec) 0.62 PRF (kHz) 2.1 Other P r @PII max (MPa) 5.1 Focal Length (cm) 1.9 - I PA.3 @MI max (W/cm 2 ) 425 Mode PW PW PW Operating Frequency (MHz) 6.6 6.6 5 Control Sample Depth (mm) 57 88 88 Conditions Sample Size (mm) 2 2 2 Power Max Max Max A-41

[Page 118] Transducer Model: PA023E Operating Mode: B\M-CFM Global Maximum Index Value 1.1 1.2 <1 - 1.3 1.7 Pr .3 (MPa) 2.8 W o (mW) 48 # 21 49 Acoustic Z sp (cm) 2 2.1 f c (MHz) 5.2 5.1 # - 5.4 5.1 Dim of A aprt X (cm) 0.7 # - 0.6 0.7 Y (cm) 0.6 # - 0.6 0.6 PD (mSec) 0.53 Other P r @PII max (MPa) 3.7 Focal Length (cm) 2.4 # - 2.4 I PA.3 @MI max (W/cm 2 ) 271 Mode(Sens.) B(Sens1) B(Sens1) M B(Sens1) Operating Frequency (MHz) 5 5 5 5 Control Focus 5 7 6 7 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 A-42

[Page 119] Transducer Model: PA023E Operating Mode: CW Global Maximum Index Value <1 a <1 - 1.8 1.1 W o (mW) # 22 28 Acoustic Z sp (cm) # 0.7 f c (MHz) # # - 5 5 Dim of A aprt X (cm) # - 0.6 0.6 Y (cm) # - 0.6 0.6 Focal Length (cm) # - 2.3 Mode CW CW Control Focus 2 7 Conditions PRF (kHz) A-43

[Page 120] Transducer Model: PA023E Operating Mode: PW Global Maximum Index Value 1.1 a <1 - 1.4 <1 Pr .3 (MPa) 2.8 W o (mW) # 24 # Acoustic Z sp (cm) 2.3 2.3 f c (MHz) 5.2 # - 5.1 # Dim of A aprt X (cm) # - 0.6 # Y (cm) # - 0.6 # PD (mSec) 0.73 PRF (kHz) 2.1 Other P r @PII max (MPa) 3.8 Focal Length (cm) # - # I PA.3 @MI max (W/cm 2 ) 269 Mode PW PW Control Sample Depth (mm) 29 42 Conditions Sample Size (mm) 2 2 A-44

[Page 121] Transducer Model: PA121E Operating Mode: B\M Global Maximum Index Value <1 1.3 1.1 1.1 1.5 1.5 W o (mW) 78 65 65 80 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 29 Z 1 (cm) 2.2 Acoustic Z sp (cm) # 1.9 f c (MHz) # 3.5 3.7 3.5 3.7 3.2 Dim of A aprt X (cm) 1.4 0.7 1.4 0.7 1.1 Y (cm) 1.3 1.3 1.3 1.3 1.3 Focal Length (cm) 6.5 2 6.5 4.5 Mode B M M M B Operating Frequency (MHz) 5 5 5 5 3.5 Control Focus 6 2 6 2 4 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 5.6 A-45

[Page 122] Transducer Model: PA121E Operating Mode: B\M-CFM Global Maximum Index Value 1.5 4 1.9 1.9 4.1 5.1 Pr .3 (MPa) 2.7 W o (mW) 256 120 120 256 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 124 Z 1 (cm) 1.9 Assoc. Z bp (cm) 1.9 Acoustic Z sp (cm) 1.9 1.8 f c (MHz) 3.2 3.3 3.3 3.3 3.3 3.3 Dim of A aprt X (cm) 0.9 0.7 0.9 0.7 0.9 Y (cm) 1.3 1.3 1.3 1.3 1.3 PD (mSec) 0.45 Other P r @PII max (MPa) 3.2 Focal Length (cm) 2.8 2.1 2.8 2.8 I PA.3 @MI max (W/cm 2 ) 299 Mode(Sens.) B(Sens1) B(Sens2) M M M B(Sens1) Operating Frequency (MHz) 3.3 3.3 3.3 3.3 3.3 3.3 Control Focus 2 3 2 3 2 3 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 5.6 5.6 Power Max Max Max Max Max Max A-46

[Page 123] Transducer Model: PA121E Operating Mode: B\M-TEI Global Maximum Index Value <1 1.2 <1 1 1.8 1.8 W o (mW) 109 # 109 109 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 41 Z 1 (cm) 2.9 Acoustic Z sp (cm) # 4.9 f c (MHz) # 2.2 # 2.2 2.2 2.2 Dim of A aprt X (cm) 1.4 # 1.4 1.4 1.4 Y (cm) 1.3 # 1.3 1.3 1.3 Focal Length (cm) 6 # 6 6 Mode B-TEI M-TEI M-TEI B-TEI Operating Frequency (MHz) PEN PEN PEN PEN Control Focus 6 6 6 6 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 A-47

[Page 124] Transducer Model: PA121E Operating Mode: CW Global Maximum Index Value <1 a <1 2.5 3.9 4 W o (mW) # 186 186 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 155 Z 1 (cm) 1.8 Acoustic Z sp (cm) # 1.1 Parameter d eq (Z sp ) (cm) 0.8 f c (MHz) # # 3.3 3.3 3.3 Dim of A aprt X (cm) # 0.8 0.8 0.8 Y (cm) # 1.3 1.3 1.3 Focal Length (cm) # 6.9 6.9 Mode CW CW CW Operating Frequency (MHz) 3.3 3.3 3.3 Control Focus 7 8 7 Conditions PRF (kHz) Power Max Max Max A-48

[Page 125] Transducer Model: PA121E Operating Mode: PW Global Maximum Index Value 1.5 a 1.8 2.3 4.2 3.4 Pr .3 (MPa) 2.6 W o (mW) 104 121 172 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 146 Z 1 (cm) 2.2 Acoustic Z sp (cm) 1.9 1.6 f c (MHz) 3.3 3.3 3.3 2.5 2.6 Dim of A aprt X (cm) 0.7 1.4 0.7 1.1 Y (cm) 1.3 1.3 1.3 1.3 PD (mSec) 0.97 PRF (kHz) 2.1 Other P r @PII max (MPa) 3.3 Focal Length (cm) 2.6 6.1 5.6 I PA.3 @MI max (W/cm 2 ) 217 Mode PW PW PW PW PW Operating Frequency (MHz) 3.3 3.3 3.3 2.5 2.5 Control Sample Depth (mm) 19 19 97 0 63 Conditions Sample Size (mm) 2 2 2 2 2 A-49

[Page 126] Transducer Model: PA122E Operating Mode: B\M Global Maximum Index Value <1 <1 <1 <1 1.1 1 W o (mW) # # 36 36 Acoustic Z sp (cm) # 1.7 f c (MHz) # # # # 4.5 4.5 Dim of A aprt X (cm) # # # 0.6 0.6 Y (cm) # # # 1 1 Focal Length (cm) # # # 1.9 Mode M B Control Focus 3 3 Conditions PRF (kHz) 5.6 5.6 A-50

[Page 127] Transducer Model: PA122E Operating Mode: B\M-CFM Global Maximum Index Value 1.5 3.4 1.7 1.2 3.1 4.2 Pr .3 (MPa) 3.4 W o (mW) 149 76 76 149 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 56 Z 1 (cm) 1.7 Acoustic Z sp (cm) 1.1 1.7 f c (MHz) 4.6 4.8 4.6 4.3 4.6 4.8 Dim of A aprt X (cm) 0.6 0.6 1.1 0.6 0.6 Y (cm) 1 1 1 1 1 PD (mSec) 0.33 Other P r @PII max (MPa) 3.8 Focal Length (cm) 1.9 1.9 4.4 1.9 I PA.3 @MI max (W/cm 2 ) 367 Mode(Sens.) B(Sens1) B(Sens2) M M M B(Sens1) Operating Frequency (MHz) 5 5 5 5 5 5 Control Focus 2 3 3 8 3 3 Conditions PRF (kHz) 0.7 0.7 5.6 5.6 5.6 0.7 Power Max Max Max Max Max Max A-51

[Page 128] Transducer Model: PA122E Operating Mode: CW Global Maximum Index Value <1 a 2.4 <1 2.9 2.8 W o (mW) 103 99 103 Acoustic Z sp (cm) # 2.1 f c (MHz) # 5 # 5 5 Dim of A aprt X (cm) 0.7 # 0.7 0.7 Y (cm) 1 # 1 1 Focal Length (cm) 4.9 # 4.9 Mode CW CW CW Operating Frequency (MHz) 5 5 5 Control Focus 6 5 6 Conditions PRF (kHz) Power Max Max Max A-52

[Page 129] Transducer Model: PA122E Operating Mode: PW Global Maximum Index Value 1.5 a 2.4 1.5 3.3 2.6 Pr .3 (MPa) 3.1 W o (mW) 107 72 80 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 61 Z 1 (cm) 1.7 Acoustic Z sp (cm) 1.3 1.5 f c (MHz) 4.8 4.8 4.7 3.4 4.5 Dim of A aprt X (cm) 1 1.1 0.6 0.5 Y (cm) 1 1 1 1 PD (mSec) 0.73 PRF (kHz) 2.1 Other P r @PII max (MPa) 3.9 Focal Length (cm) 4.1 4.5 1.3 I PA.3 @MI max (W/cm 2 ) 337 Mode PW PW PW PW PW-B-CFM Operating Frequency (MHz) 5 5 5 3.3 5 Control Sample Depth (mm) 11 70 99 22 0 Conditions Sample Size (mm) 2 2 2 2 0 A-53

[Page 130] Transducer Model: PA230E Operating Mode: B\M Global Maximum Index Value <1 1 <1 <1 1.4 1.3 W o (mW) 95 # 87 93 Acoustic Z sp (cm) # 5.5 f c (MHz) # 2.2 # # 2.2 2.2 Dim of A aprt X (cm) 2 # # 1.6 1.8 Y (cm) 1.4 # # 1.4 1.4 Focal Length (cm) 8.3 # # 6.9 Mode B M B Operating Frequency (MHz) 2.5 2.5 2.5 Control Focus 6 4 5 Conditions PRF (kHz) 4.4 5.6 5.1 Power Max Max Max A-54

[Page 131] Transducer Model: PA230E Operating Mode: B\M-CFM Global Maximum Index Value 1.2 4 <1 1.2 3.7 5.5 Pr .3 (MPa) 1.9 W o (mW) 345 # 166 370 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 109 Z 1 (cm) 3.7 Assoc. Z bp (cm) 2.5 Acoustic Z sp (cm) 4.8 5.5 f c (MHz) 2 2.4 # 2.3 2.3 2 Dim of A aprt X (cm) 1.6 # 1.6 1.6 1.6 Y (cm) 1.4 # 1.4 1.4 1.4 PD (mSec) 1.35 Other P r @PII max (MPa) 2.3 Focal Length (cm) 5.9 # 5.9 5.8 I PA.3 @MI max (W/cm 2 ) 131 Mode(Sens.) B(Sens1) B(Sens2) M M B(Sens1) Operating Frequency (MHz) 2 2.5 2.5 2.5 2 Control Focus 3 4 4 4 4 Conditions PRF (kHz) 5.6 5.6 5.6 5.6 5.6 A-55

[Page 132] Transducer Model: PA230E Operating Mode: B\M-TEI Global Maximum Index Value 1.2 2.5 1 2.1 4.3 3.7 Pr .3 (MPa) 1.9 W o (mW) 249 100 248 248 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 89 Z 1 (cm) 3.4 Assoc. Z bp (cm) 2.5 Acoustic Z sp (cm) 4.8 5.3 f c (MHz) 2.1 2.1 2 2.1 2.1 2.1 Dim of A aprt X (cm) 1.8 0.6 1.6 1.6 1.6 Y (cm) 1.4 1.4 1.4 1.4 1.4 PD (mSec) 1.19 Other P r @PII max (MPa) 2.3 Focal Length (cm) 6.9 1.4 5.8 5.8 I PA.3 @MI max (W/cm 2 ) 114 Mode B-TEI B-TEI M-TEI M-TEI M-TEI B-TEI Operating Frequency (MHz) RES RES RES RES RES RES Control Focus 3 5 1 4 4 4 Conditions PRF (kHz) 5.6 5.1 5.6 5.6 5.6 5.6 Power Max Max Max Max Max Max A-56

[Page 133] Transducer Model: PA230E Operating Mode: CnTI Global Maximum Index Value <1 <1 <1 <1 <1 1.5 W o (mW) # # # 103 Acoustic Z sp (cm) # # Parameter d eq (Z sp ) (cm) # f c (MHz) # # # # # 1.8 Dim of A aprt X (cm) # # # # 1.6 Y (cm) # # # # 1.4 Information d eq @PII max (cm) # Focal Length (cm) # # # 5.6 Mode CnTI(Lo) Operating Frequency (MHz) 1.6 Control Focus 4 Conditions PRF (kHz) 5.6 Power Max A-57

[Page 134] Transducer Model: PA230E Operating Mode: CW Global Maximum Index Value <1 a <1 1.9 5.1 3.7 W o (mW) # 178 192 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 162 Z 1 (cm) 2 Assoc. Z bp (cm) 1.9 Acoustic Z sp (cm) # 2.1 f c (MHz) # # 2.5 2.5 2.5 Dim of A aprt X (cm) # 1 1 1 Y (cm) # 1.4 1.4 1.4 Focal Length (cm) # 5.8 5.8 Mode CW CW CW Operating Frequency (MHz) 2.5 2.5 2.5 Control Focus 6 2 6 Conditions PRF (kHz) Power Max Max Max A-58

[Page 135] Transducer Model: PA230E Operating Mode: PW Global Maximum Index Value 1.3 a <1 2 4.8 3.9 Pr .3 (MPa) 2 W o (mW) # 295 299 min of [W .3 (z 1 ),I TA.3 (z 1 )] (cm) 207 Z 1 (cm) 3.6 Assoc. Z bp (cm) 2.9 Acoustic Z sp (cm) 4.6 4.1 Parameter d eq (Z sp ) (cm) 0.8 f c (MHz) 2 # 2 2 2 Dim of A aprt X (cm) # 2.2 2.2 2.2 Y (cm) # 1.4 1.4 1.4 PD (mSec) 1.82 PRF (kHz) 2.1 Other P r @PII max (MPa) 2.6 Information d eq @PII max (cm) 0.6 Focal Length (cm) # 9.1 9.4 I PA.3 @MI max (W/cm 2 ) 122 Mode PW PW PW PW Operating Frequency (MHz) 2 2 2 2 Control Sample Depth (mm) 77 175 175 188 Conditions Sample Size (mm) 2 2 2 2 A-59

[Page 136] Transducer Model: TE022 Operating Mode: B\M Global Maximum Index Value 1.2 <1 <1 - 1 b Pr .3 (MPa) 2.5 W o (mW) # # 26 Acoustic Z sp (cm) 1.6 1.6 f c (MHz) 4.2 # # - 4.2 Dim of A aprt X (cm) # # - 1 Y (cm) # # - 0.9 PD (mSec) 0.21 Other P r @PII max (MPa) 3.1 I PA.3 @MI max (W/cm 2 ) 240 Mode M M Control Focus 1 1 Conditions PRF (kHz) 5.6 5.6 A-60

[Page 137] Transducer Model: TE022 Operating Mode: B\M-CFM Global Maximum Index Value 1.1 <1 <1 - 1.2 b Pr .3 (MPa) 1.4 W o (mW) # # 22 Acoustic Z sp (cm) 3.4 1.6 f c (MHz) 4.8 # # - 3.4 Dim of A aprt X (cm) # # - 1 Y (cm) # # - 0.9 PD (mSec) 0.41 Other P r @PII max (MPa) 2.5 I PA.3 @MI max (W/cm 2 ) 60 Mode(Sens.) B(Sens1) M Operating Frequency (MHz) 5 3.3 Control Focus 1 1 Conditions PRF (kHz) 0.7 5.6 A-61

[Page 138] Transducer Model: TE022 Operating Mode: B\M-TEI Global Maximum Index Value 1 <1 <1 - <1 b Pr .3 (MPa) 1.9 W o (mW) # # # Acoustic Z sp (cm) 1.6 # Parameter d eq (Z sp ) (cm) # f c (MHz) 4 # # - # Dim of A aprt X (cm) # # - # Y (cm) # # - # PD (mSec) 0.25 Other P r @PII max (MPa) 2.3 Information d eq @PII max (cm) # I PA.3 @MI max (W/cm 2 ) 132 Mode B-TEI Operating Frequency (MHz) GEN Control Focus 1 Conditions PRF (kHz) 5.6 Power Max A-62

[Page 139] Transducer Model: TE022 Operating Mode: CW Global Maximum Index Value <1 a <1 - 1 b W o (mW) # 14 Acoustic Z sp (cm) # 0.8 f c (MHz) # # - 5 Dim of A aprt X (cm) # - 0.4 Y (cm) # - 0.9 Focal Length (cm) # - Mode CW Operating Frequency (MHz) 5 Control Focus 1 Conditions PRF (kHz) Power Max A-63

[Page 140] Transducer Model: TE022 Operating Mode: PW Global Maximum Index Value 1.1 a <1 - 1.1 b Pr .3 (MPa) 2.3 W o (mW) # 18 Acoustic Z sp (cm) 1.6 1.5 f c (MHz) 5 # - 3.3 Dim of A aprt X (cm) # - 1 Y (cm) # - 0.9 PD (mSec) 0.65 PRF (kHz) 2.1 Other P r @PII max (MPa) 3 Focal Length (cm) # - I PA.3 @MI max (W/cm 2 ) 183 Mode PW PW Operating Frequency (MHz) 5 3.3 Control Sample Depth (mm) 0 0 Conditions Sample Size (mm) 2 2 A-64

[Page 141] Acoustic Output Data according to IEC61157 PA230E (Reference:960 0165 000) Mode  Imaging Imaging Imaging Imaging CnTI D P D I D+BCFM BCFM BCFM MCFM MCFM CW Parameter B M B-TEI M-TEI P P I P I p _(MPa) 2 2 2.8 2.8 1.5 3.7 2.3 2.7 3.1 2.2 2.5 2.5 0.2 I spta (mW/cm 2 ) 77 463 257 1297 53 2295 2358 970 1019 1135 1536 1617 1726 F = 3 F = 3 F = 4 F = 4 F = 3 SD = 104 SD = 104 SD = 90 F = 4 F = 4 F = 3 F = 4 F = 4 I p (mm) 52 52 58 58 46 73 73 65 59 58 52 59 56 w pb6 (   ) (mm) 3 3 3.8 3.8 3.6 4.4 4.4 3.3 3.6 3.8 3 3.6 4.2 w pb6 ( | ) (mm) 6.5 6.5 4.5 4.5 6.2 4.4 4.4 4 4.5 4.5 6.5 4.5 5.4 prr (kHz) 5.6 5.6 5.6 5.6 5.6 2.1 5.6 4.8 5.6 5.6 5.6 5.6 1 srr (Hz) 125 - 125 125 66 - - - 53 53 - - - Output beam dimension ( || ) (mm) b 13.4 13.4 15.8 15.8 13.4 17.9 17.9 15.8 15.8 15.8 13.4 15.8 9.5 Output beam dimension ( | ) (mm) b 14 14 14 14 14 14 14 14 14 14 14 14 14 f awf (MHz) 2.3 2.3 2.1 2.1 1.8 2.4 2.4 2.3 2.3 2 2.3 2.3 2.5 APF c (%) - - - - - - - - - - - - - AIF d (%) 100 100 137 137 75 183 114 136 154 110 123 123 12 Maximum power e (mW) 93.7 93.7 322.5 322.5 114 330.4 339.4 209 448.1 480.5 169.6 215.9 244.8 I ob (mW/cm 2 ) 49.9 49.9 145.9 145.9 60.6 132.1 135.8 94.6 202.7 217.4 90.2 97.7 184.1 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - - - - - I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Inclusive modes B+M B+M B+D B+D B-CFM + B-CFM + B+CW B-CFM+D M-CFM M-CFM B-CFM+CW A-65

[Page 142] PA121E (Reference:960 0151 000) Mode  Imaging Imaging Imaging Imaging D P D I D+BCFM BCFM BCFM MCFM MCFM CW Parameter B M B-TEI M-TEI P P I P I p _(MPa) 2.4 2.4 1.6 1.6 4.5 2.2 3.5 3.8 2.7 3.6 3 0.2 I spta (mW/cm 2 ) 60 330 84 461 1730 1914 771 616 761 1367 1506 1587 F = 6 F =6 F = 6 F = 6 SD = 97 SD = 97 SD = 97 F = 6 F = 3 F = 3 F = 5 F = 6 I p (mm) 60 60 60 60 61 61 61 28 28 55 54 69 w pb6 (   ) (mm) 3.9 3.9 3.9 3.9 3.3 3.5 3.3 2.2 2.2 3 3.3 4.7 w pb6 ( | ) (mm) 7.7 7.7 6.8 6.8 7.1 6.1 7.1 10.4 10.4 8 7.5 5.9 prr (kHz) 5.6 5.6 5.6 5.6 2.1 5.6 4.8 5.6 5.6 5.6 5.6 1 srr (Hz) 125 - 125 125 - - 45 56 56 56 56 - Output beam dimension ( || ) (mm) b 14.1 14.1 14.1 14.1 14.1 14.1 14.1 9.4 9.4 12.9 12.9 8.1 Output beam dimension ( | ) (mm) b 13 13 13 13 13 13 13 13 13 13 13 13 f awf (MHz) 3.1 3.1 2.2 2.2 3.3 2.5 3.1 3.3 3.3 3.1 2.6 3.3 APF c (%) - - - - - - - - - - - - AIF d (%) 100 100 68 68 187 90 146 156 110 149 124 9 Maximum power e (mW) 107.6 107.6 141.3 141.3 248.5 259.3 176.6 269.7 333.3 218 231.7 237.2 I ob (mW/cm 2 ) 58.8 58.8 77.2 77.2 135.8 141.7 96.5 219.3 271 130.5 138.8 223.8 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - - - - I (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact ts Inclusive modes B+M B+M B+D B+D B-CFM + B-CFM + B+CW B-CFM+D M-CFM M-CFM B-CFM+CW A-66

[Page 143] PA122E (Reference:960 0152 000) Mode  Imaging Imaging D P D I D+BCFM BCFM BCFM MCFM CW Parameter B M P P I P - I p _(MPa) 2.7 2.7 6 6 4.2 4.4 3.1 4.2 0.3 I spta (mW/cm 2 ) 69 366 2237 2237 991 483 1265 1404 3005 F = 6 F =6 SD = 61 SD = 61 F = 7 F = 2 F = 8 F = 6 F = 5 I p (mm) 41 41 40 40 41 11 44 39 47 w pb6 (   ) (mm) 2.5 2.5 2.1 2.1 2.9 1 3.6 2.3 2.6 w pb6 ( | ) (mm) 4.7 4.7 4.2 4.2 4.1 8.5 3.2 4.4 2.4 prr (kHz) 5.6 5.6 2.1 2.1 5.6 5.6 5.6 5.6 1 srr (Hz) 125 - - - 59 42 59 63 - Output beam dimension ( || ) (mm) b 9.2 9.2 9.2 9.2 10 4.7 10.7 9.2 6.7 Output beam dimension ( | ) (mm) b 10 10 10 10 10 10 10 10 10 f awf (MHz) 4.4 4.4 4.8 4.8 4.4 4.6 3.4 4.4 5 APF c (%) - - - - - - - - - AIF d (%) 100 100 221 221 155 162 115 154 11 Maximum power e (mW) 49.2 49.2 132.1 132.1 96.7 104.3 233.5 95.3 130.3 I ob (mW/cm 2 ) 53.2 53.2 143 143 97.1 222.9 218.6 103.2 194.4 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - I (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact ts Inclusive modes B+M B+D B+D B-CFM + B+CW B-CFM+D M-CFM B-CFM+CW A-67

[Page 144] PA023E (Reference:960 0153 000) Mode  Imaging Imaging D P D I D+BCFM BCFM BCFM MCFM CW Parameter B M P P I P-I p _(MPa) 3.1 3 4.4 4.3 3.6 4.3 3 3.5 0.2 I spta (mW/cm 2 ) 84 341 1388 1629 931 1234 1283 1206 1509 F = 6 F =5 SD = 29 SD = 42 SD = 29 F = 6 F = 7 F = 6 F = 7 I p (mm) 23 20 24 27 24 22 24 22 23 w pb6 (   ) (mm) 2 1.6 1.6 1.7 1.6 1.9 2.7 1.9 1.8 w pb6 ( | ) (mm) 1.5 2.3 1.7 1.6 1.7 1.6 1.5 1.6 1.7 prr (kHz) 5.6 5.6 2.1 2.1 5.6 5.6 5.6 5.6 1 srr (Hz) 125 - - - 67 63 63 63 - Output beam dimension ( || ) (mm) b 6.1 5.5 5.5 6.1 5.5 6.1 6.7 6.1 5.6 Output beam dimension ( | ) (mm) b 6 6 6 6 6 6 6 6 6 f awf (MHz) 6.4 6.5 5.2 5.1 5.4 5.2 5.1 5.4 5 APF c (%) - - - - - - - - - AIF d (%) 100 98 141 140 116 140 98 114 7 Maximum power e (mW) 13.9 12.2 28 31 26.9 57.8 63.8 27.1 36.7 I ob (mW/cm 2 ) 37.9 36.9 85 84.8 81.6 157.9 158.7 74 107.9 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - I (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact ts Inclusive modes B+M B+D B+D B-CFM + B+CW B-CFM+D M-CFM B-CFM+CW A-68

[Page 145] LA522E (Reference:960 0163 000) Parameter B M B-TEI M-TEI P P I P - I p _(MPa) 3.4 3.4 2.6 2.8 4.9 4.9 4.1 4.9 3 3.9 I spta (mW/cm 2 ) 43 132 31 529 1346 1832 673 517 1242 1260 F = 3 F = 3 F = 3 F = 3 SD = 77 SD = 44 SD = 27 F = 3 F = 8 F = 3 I p (mm) 19 19 19 19 22 29 18 18 22 18 w pb6 (   ) (mm) 1.7 1.7 1.7 1.7 7.2 2.6 1.7 1.5 7.3 1.7 w pb6 ( | ) (mm) 1.9 1.9 2.1 2.1 1.6 1.9 1.8 1.6 1.6 1.8 prr (kHz) 1 1 6.7 6.7 2.1 2.1 5.6 5.6 5.6 5.6 srr (Hz) 34 - 34 34 - - - 23 23 - Output beam dimension ( || ) (mm) b 6.4 6.4 6.4 6.4 10.8 8.3 6.4 6.4 10.8 6.4 Output beam dimension ( | ) (mm) b 6 6 6 6 6 6 6 6 6 6 f awf (MHz) 4.8 4.8 4.1 4.1 4.8 4.9 4.6 4.8 4.9 4.6 AIF d (%) 100 100 76 81 143 142 118 144 88 114 Maximum power e (mW) 4.6 4.7 25.2 25.2 103.3 55.6 28.5 64 132 26.7 I ob (mW/cm 2 ) 12.1 12.5 66.4 66.4 158.9 111.3 75 168.3 203.1 70.2 ts A-69

[Page 146] LA523 (Reference:960 0156 000 / 960 0174 000) p _(MPa) 5.1 5.5 4.2 4 5.3 5.2 5.2 5.6 4.8 4.3 I spta (mW/cm 2 ) 25 120 21 400 1224 1399 1131 469 1218 1214 F = 3 F =3 F = 3 F = 4 SD = 18 SD = 29 F = 2 F = 2 F = 5 F = 3 I p (mm) 14 14 13 14 13 16 13 11 15 13 w pb6 (   ) (mm) 1.1 1.1 1.2 1.4 1.1 2.1 1.1 1.1 2.2 1.1 w pb6 ( | ) (mm) 1 1 1 1.1 0.8 0.9 0.8 1.2 0.9 0.9 prr (kHz) 6.7 1 1 6.7 2.1 2.1 5.6 5.6 5.6 5.6 srr (Hz) 36 - 34 34 - - 24 27 34 27 Output beam dimension ( || ) (mm) b 4.4 4.4 4.4 4.9 4.4 5.4 4.4 3.4 5.4 4.4 Output beam dimension ( | ) (mm) b 5 5 5 5 5 5 5 5 5 5 f awf (MHz) 6.7 6.7 5.4 5.4 6.6 6.6 6.5 6.5 6.6 6.5 AIF d (%) 100 110 84 78 105 102 104 111 95 85 Maximum power e (mW) 9.8 1.8 1.3 8.5 8.7 17.6 14.9 32.4 53.7 9.9 I ob (mW/cm 2 ) 44.8 8 5.9 34.1 39.4 65 67.5 190.5 199 45.2 ts A-70

[Page 147] 2 MHz CW (Reference: 960 0125 000) Mode  CW Parameter p _(MPa) 0.2 I spta (mW/cm 2 ) 1231 System settings a F = 1 I p (mm) 33 w pb6 (   ) (mm) 4.8 w pb6 ( | ) (mm) 3.9 prr (kHz) - srr (Hz) - Output beam dimension  (mm) b 13 f awf (MHz) 2 APF c (%) - AIF d (%) 99 Maximum power e (mW) 148.8 I ob (mW/cm 2 ) 212.5 Power-up Mode N/A Initialization mode CW Acoustic output freeze Yes I tt (mm) - I ts (mm) Contact Inclusive modes  defines diameter Acoustic initialization fraction controllable by the user A-71

[Page 148] 5 MHz CW (Reference: 960 0126 000) Mode  CW Parameter p _(MPa) 0.2 I spta (mW/cm 2 ) 937 System settings a F = 1 I p (mm) 6 w pb6 (   ) (mm) 2.4 w pb6 ( | ) (mm) 3.5 prr (kHz) - srr (Hz) - Output beam dimension  (mm) b 6.0 f awf (MHz) 5 APF c (%) - AIF d (%) 100 Maximum power e (mW) 43 I ob (mW/cm 2 ) 306.8 Power-up Mode N/A Initialization mode CW Acoustic output freeze Yes I tt (mm) - I ts (mm) Contact Inclusive modes  defines diameter Acoustic initialization fraction controllable by the user A-72

[Page 149] CA123 (Reference: 960 0158 000) p _(MPa) 3.9 3.9 2.8 2.7 2.9 2.1 4.6 4.4 2.2 3.5 I spta (mW/cm 2 ) 93 893 48 469 1479 1624 1042 199 457 1226 F = 3 F =3 F = 3 F = 3 SD = 32 SD = 41 F = 2 F = 2 F = 8 F = 4 I p (mm) 14 14 13 14 21 25 14 12 14 17 w pb6 (   ) (mm) 1.1 1.1 1.2 1.2 1.4 1.5 1 0.9 5 1.2 w pb6 ( | ) (mm) 1.6 1.6 1.7 1.6 1.5 1.7 1.7 1.9 1.4 1.4 prr (kHz) 5.6 5.6 5.6 5.6 5.6 11.1 5.6 5.6 5.6 5.6 srr (Hz) 102 - 103 93 58 58 35 35 58 35 Output beam dimension ( || ) (mm) b 4.9 4.9 4.9 4.9 6.3 6.7 4.2 4.2 7.4 5.6 Output beam dimension ( | ) (mm) b 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 f awf (MHz) 4.8 4.8 4.4 4.8 6.4 6.4 5.9 6.2 6.4 5.8 AIF d (%) 100 100 72 69 74 54 119 113 57 91 Maximum power e (mW) 25.4 23.5 14 12.9 23.7 31.3 23.4 26.5 40.4 16 I ob (mW/cm 2 ) 121 111.7 66.5 61.4 91.1 111.7 129.8 147.3 130.3 66.8 ts A-73

[Page 150] CA430E (Reference: 960 0169 000) Mode  Imaging Imaging Imaging Imaging CnTI D P D I D+BCFM BCFM BCFM MCFM p _(MPa) 2.7 2.7 3.1 2.7 1 3.3 3.2 3.6 3.6 3.4 3.2 I spta (mW/cm 2 ) 104 724 162 202 35 1090 1428 834 520 765 1226 F =4 F = 4 F = 8 F = 6 F = 6 SD = 37 SD = 117 F = 8 F = 7 F = 6 F = 8 I p (mm) 30 30 49 33 33 31 49 50 49 40 52 w pb6 (   ) (mm) 3.5 3.5 5.9 5.8 5.3 3.6 6.2 6.9 5.8 5 6.9 w pb6 ( | ) (mm) 3.5 3.5 4.5 3.8 4 5 3.7 3.7 3.9 3.5 4 prr (kHz) 5.6 5.6 4.2 5.6 5.6 2.1 2.1 4.2 4.2 5.6 4.2 srr (Hz) 80 - 60 80 80 55 41 40 41 54 40 Output beam dimension ( || ) (mm) b 7.8 7.8 12.6 10.8 10.8 6.6 12 12.6 12 10.8 12.6 Output beam dimension ( | ) (mm) b 12 12 12 12 12 12 12 12 12 12 12 f awf (MHz) 2.1 2.1 1.9 1.7 1.7 2.4 2.4 2.2 2.3 2.4 2.2 APF c (%) - - - - - - - - - - - AIF d (%) 100 100 112 98 38 119 118 130 132 126 116 Maximum power e (mW) 109.5 109.5 253.5 261 45.9 107 199.4 147.6 206.7 266.2 199.4 I ob (mW/cm 2 ) 116.5 116.4 167.9 200.8 35.3 135.4 138.4 97.8 143.5 204.8 132 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - - - I (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact ts A-74

[Page 151] CA421(Reference: 960 0154 000) p _(MPa) 3.9 3.8 1.8 1.9 4.3 2.7 3.6 3.3 2.8 3.5 I spta (mW/cm 2 ) 150 1063 57 400 2102 2216 779 422 596 1608 F = 6 F = 6 F = 7 F = 6 SD = 116 SD = 108 F = 7 F = 5 F = 8 F = 5 I p (mm) 48 48 50 46 55 55 55 43 55 43 w pb6 (   ) (mm) 3.8 3.6 4.6 4.1 5 5 5 3.1 6.3 3.1 w pb6 ( | ) (mm) 4.5 4 4.3 4.4 3.3 3.3 3.3 5.2 3.9 5.2 prr (kHz) 5.6 5.6 5.1 5.6 2.1 5.6 4.2 5.6 4.2 5.6 srr (Hz) 78 - 71 72 32 32 32 46 42 46 Output beam dimension ( || ) (mm) b 10.8 10.8 12 10.8 12 12 12 9.6 12.6 9.6 Output beam dimension ( | ) (mm) b 12 12 12 12 12 12 12 12 12 12 f awf (MHz) 2.9 2.9 2.1 2.1 3.2 3.2 2.9 3.1 3.2 3 AIF d (%) 100 97 45 48 112 68 93 84 72 91 Maximum power e (mW) 259.4 211.2 95.5 95.6 231.8 244.4 150.8 251.9 290.7 182.4 I ob (mW/cm 2 ) 199.5 162.5 66.3 73.6 161 169.7 104.7 219.1 192.5 158.6 ts A-75

[Page 152] CA621(Reference: 960 0155 000) Mode  Imaging Imaging Imaging Imaging D P-I D+BCFM BCFM BCFM MCFM p _(MPa) 3.2 3.1 1.3 1.2 3.9 3.3 3.1 2.2 3.3 I spta (mW/cm 2 ) 379 507 41 316 2054 1395 632 716 1710 System settings a SS = 2 F = 5 F = 5 F = 7 F = 6 SD = 67 F = 6 F = 6 F = 5 F = 7 I p (mm) 42 48 55 49 52 54 49 43 60 w pb6 (   ) (mm) 3.5 3 6.5 3.7 3.1 3.5 3.7 3.5 6.6 w pb6 ( | ) (mm) 3.1 3.2 3.3 3.1 2.7 2.7 2.8 3.1 3 prr (kHz) 5.6 5.6 5.1 5.6 2.1 4.8 4.2 5.6 4.2 srr (Hz) 57 - 52 57 57 45 45 57 43 Output beam dimension ( || ) (mm) b 9.9 9.9 13.9 11.2 9.9 11.2 11.2 9.9 13.9 Output beam dimension ( | ) (mm) b 12 12 12 12 12 12 12 12 12 f awf (MHz) 2.5 3.2 2.5 2.6 3.2 3 3.1 2.5 3 APF c (%) - - - - - - - - - AIF d (%) 100 96 54 53 144 105 98 67 104 Maximum power e (mW) 119.4 71 67.6 55.5 137.7 188.2 181.3 231.7 250.5 I ob (mW/cm 2 ) 100.3 59.7 40.7 41.1 115.7 139.4 134.3 194.7 150.9 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - I (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact ts Inclusive modes B+M B+M B+D B-CFM + M-CFM A-76

[Page 153] LA532E(Reference: 960 0168 000) Mode  Imaging Imaging Imaging Imaging CnTI D P D I D+BCFM BCFM BCFM MCFM p _(MPa) 1.8 2 3.3 2.6 1.2 3.6 3.5 4.7 4.7 3.5 4.9 I spta (mW/cm 2 ) 16 55 112 1082 7 1106 1164 344 186 470 1427 F = 3 F = 3 F = 5 F = 6 F = 3 SD = 45 SD = 56 F = 5 F = 5 F = 6 F = 5 I p (mm) 18 18 22 27 16 23 26 31 28 30 28 w pb6 (   ) (mm) 1.9 1.9 3.4 4 2.1 3.3 2.6 2.3 2.6 3.3 2.6 w pb6 ( | ) (mm) 2 2 2.8 3.3 2.2 2.4 2.6 2.2 2.2 3.2 2.2 prr (kHz) 6.7 1 6.7 6.7 8.3 2.1 2.1 5.6 5.6 5.6 5.6 srr (Hz) 34 - 34 34 22 22 21 22 22 21 22 Output beam dimension ( || ) (mm) b 6.4 6.4 8.3 9.3 6.4 8.3 9.3 8.3 8.3 9.3 8.3 Output beam dimension ( | ) (mm) b 6 6 6 6 6 6 6 6 6 6 6 f awf (MHz) 3.2 3.2 2.6 2.6 2.6 3.2 3.2 4.1 4.6 3.2 4.1 APF c (%) - - - - - - - - - - - AIF d (%) 100 109 185 145 65 196 193 263 259 194 269 Maximum power e (mW) 12.7 2.4 117.5 153.2 12.6 52.5 55.1 18.4 29.3 139.7 53.5 I ob (mW/cm 2 ) 33.5 6.2 234.9 273.5 33.3 104.9 98.4 36.8 58.6 249.5 107 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - - - I (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact ts A-77

[Page 154] LA424(Reference: 960 0149 000) Mode  Imaging Imaging D P D I D+BCFM BCFM BCFM MCFM Parameter B M P P I P-I p _(MPa) 5.4 6.1 6 5.8 4.7 5 3.6 4.3 I spta (mW/cm 2 ) 36 131 1216 1228 761 359 736 947 F = 5 F = 5 SD = 29 SD = 26 F = 4 F = 4 F = 8 F = 3 I p (mm) 9 9 14 14 10 9 7 8 w pb6 (   ) (mm) 1.2 1.2 1.5 1.5 0.9 0.9 3.2 0.8 w pb6 ( | ) (mm) 1.1 1.1 1 1 1 1.2 1.6 1.5 prr (kHz) 6.7 1 2.1 2.1 5.6 5.6 5.6 5.6 srr (Hz) 34 - 33 33 33 33 40 33 Output beam dimension ( || ) (mm) b 3.6 3.6 4.4 4.4 3.2 3.2 4.8 2.8 Output beam dimension ( | ) (mm) b 3 3 3 3 3 3 3 3 f awf (MHz) 8.9 8.9 8 8 7.7 7.9 8 7.8 APF c (%) - - - - - - - - AIF d (%) 100 113 111 108 88 93 68 79 Maximum power e (mW) 13.4 2.3 13.7 13.8 9 21.7 49.7 7.1 I ob (mW/cm 2 ) 123.9 21.7 103.9 104.9 93.8 225.6 344.9 85.1 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - I (mm) Contact Contact Contact Contact Contact Contact Contact Contact ts Inclusive modes B+M B+D B+D B-CFM + A-78

[Page 155] EC123(Reference: 960 0157 000) Mode  Imaging Imaging Imaging Imaging D P-I D+BCFM BCFM BCFM MCFM MCFM Parameter B M B-TEI M-TEI P P I P I p _(MPa) 4.6 4.3 2.2 2.2 5.1 4.3 4.3 3.2 3.7 3.4 I spta (mW/cm 2 ) 150 960 22 168 1386 997 421 586 976 1036 System settings a SS = 2 F = 3 F = 3 F = 3 F = 3 SD = 46 F = 5 F = 5 F = 7 F = 6 F = 3 I p (mm) 10 10 12 12 18 13 13 14 14 13 w pb6 (   ) (mm) 1.3 1.3 1.6 1.6 2.9 1.6 1.7 2.8 2.6 1.3 w pb6 ( | ) (mm) 1.2 1.2 1.3 1.3 1.1 1.1 1.1 1.2 1.1 1.1 prr (kHz) 5.6 5.6 5.6 5.6 2.1 5.6 5.6 5.6 5.6 5.6 srr (Hz) 137 - 122 122 58 58 58 58 58 35 Output beam dimension ( || ) (mm) b 3.2 3.2 3.2 3.2 4.7 4 4 4.7 4.3 3.2 Output beam dimension ( | ) (mm) b 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 4.2 f awf (MHz) 5 5 4.9 4.9 6.3 5.1 5.1 5 5.8 5.9 AIF d (%) 100 94 48 47 112 92 94 69 79 74 Maximum power e (mW) 22.4 20.2 4.3 4.3 29.3 22.6 32.5 48.2 16.7 10.4 I ob (mW/cm 2 ) 160.3 144 30.7 31 146.5 133.2 191.3 241.1 92.9 74.1 I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact A-79

[Page 156] TE022 (Reference:960 0170 000) Mode  Imaging Imaging Imaging Imaging D D+BCFM BCFM BCFM MCFM CW Parameter B M B-TEI M-TEI P-I P P I P-I p _(MPa) 3.6 3.6 2.6 2.7 3.7 3.5 3.6 1.6 3.2 0.1 I spta (mW/cm 2 ) 64 375 19 266 692 536 142 224 839 452 F = 1 F = 1 F = 1 F = 5 SD = 21 SD = 21 F = 1 F = 2 F = 1 F = 1 I p (mm) 18 18 17 44 16 16 18 29 18 13 w pb6 (   ) (mm) 0.8 0.8 1.1 2.8 0.7 0.7 0.6 1.8 0.6 1.2 w pb6 ( | ) (mm) 5.9 5.9 5.6 3.3 5.5 5.5 5.9 4.9 5.9 5.4 prr (kHz) 5.6 5.6 5.6 5.6 2.1 5.6 5.6 5.6 5.6 1 srr (Hz) 125 - 66 66 - 42 42 63 42 - Output beam dimension ( || ) (mm) b 10.2 10.2 10.2 10.2 10.2 10.2 10.2 10.2 10.2 4.5 Output beam dimension ( | ) (mm) b 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 9.1 f awf (MHz) 4.7 4.7 4 3.5 5 4.9 4.9 3.3 5 5 AIF d (%) 100 100 72 74 103 96 99 44 87 3 Maximum power e (mW) 30.3 30.3 15.4 27.5 18.4 24.9 26.1 35.5 20.6 18.7 I ob (mW/cm 2 ) 32.6 32.6 16.6 29.6 19.8 26.7 28.1 38.2 22.1 39.8 I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Contact Inclusive modes B+M B+M B+D B+D B-CFM + B+CW B-CFM+D M-CFM B-CFM+CW A-80

[Page 157] LV513 (Reference: 960 0181 000) Mode  Imaging Imaging D P D I D+BCFM BCFM BCFM MCFM MCFM Parameter B M P P I P I p _(MPa) 5.1 5 6.7 6.6 3.8 6 3.8 4.3 4.1 I spta (mW/cm 2 ) 76 1353 2068 2192 713 544 1141 1552 1552 F = 3 F = 3 SD = 40 SD = 34 SD = 28 F = 3 F = 8 F = 3 F = 3 I p (mm) 16 18 27 25 21 18 18 18 18 w pb6 (   ) (mm) 1.4 1.2 2.4 1.6 1.1 1.2 6.2 1.2 1.2 w pb6 ( | ) (mm) 2.1 1.8 1.7 1.6 1.6 2 1.8 2 2 prr (kHz) 6.7 6.7 2.1 2.1 5.6 5.6 5.6 5.6 5.6 srr (Hz) 52 - 57 57 57 57 57 57 57 Output beam dimension ( || ) (mm) b 5.5 5.5 7.1 6.3 5.5 5.5 9.5 5.5 5.5 Output beam dimension ( | ) (mm) b 5 5 5 5 5 5 5 5 5 f awf (MHz) 4.8 5.6 6.3 6.3 5.8 6 6.4 5.7 5.7 APF c (%) - - - - - - - - - AIF d (%) 100 98 131 129 74 118 74 85 81 Maximum power e (mW) 68.4 47.5 67.5 48.9 20.2 70.7 144.2 27.9 27.9 I ob (mW/cm 2 ) 244.3 169.7 187.5 152.8 72.3 252.3 300.4 99.8 99.8 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - - I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact Contact Inclusive modes B+M B+D B+D B-CFM + B-CFM + B-CFM+D M-CFM M-CFM A-81

[Page 158] LP323/IOE323 (Reference: 960 0162 000 / 960 0160 000) Mode  Imaging Imaging D P D I D+BCFM BCFM BCFM MCFM Parameter B M P P I P-I p _(MPa) 5.1 5.4 3.8 3.1 5.6 5.6 3.4 4.3 I spta (mW/cm 2 ) 28 98 663 1323 1086 243 889 1106 F = 3 F = 3 SD = 20 SD = 30 F = 3 F = 3 F = 8 F = 3 I p (mm) 12 12 12 17 12 11 13 11 w pb6 (   ) (mm) 1.1 1.2 1.1 2 1.1 1.2 5.2 1.2 w pb6 ( | ) (mm) 1.4 1.4 1.2 1.3 1.2 1.5 1.3 1.5 prr (kHz) 6.7 1 2.1 5.6 5.6 5.6 5.6 5.6 srr (Hz) 52 - 18 25 18 18 25 18 Output beam dimension ( || ) (mm) b 4.3 4.3 4.3 5.4 4.3 4.3 7 4.3 Output beam dimension ( | ) (mm) b 4 4 4 4 4 4 4 4 f awf (MHz) 5.8 5.8 6.5 6.5 6.2 6.4 6.6 6.1 APF c (%) - - - - - - - - AIF d (%) 100 106 75 61 109 109 67 84 Maximum power e (mW) 11.8 2 7.7 26.4 23.4 36.2 87.2 14.3 I ob (mW/cm 2 ) 68.2 11.4 44.3 122.3 135.2 209.5 310.3 82.9 Power-up Mode N/A N/A N/A N/A N/A N/A N/A N/A Initialization mode B B B B B B B B Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes I tt (mm) - - - - - - - - I ts (mm) Contact Contact Contact Contact Contact Contact Contact Contact Inclusive modes B+M B+D B+D B-CFM + A-82

[Page 159] ESAOTE S.p.A. Rev.D June 2006 TRANSDUCERS AND CONSUMABLES OPERATOR MANUAL 8300375000

[Page 160]

[Page 161] Introduction This manual provides information about the probes and consumables that can be used with the Esaote MyLab devices. The manual is divided into the following chapters: • Chapter 1: Care of transducers The chapter describes how to handle, control, store and protect ESAOTE tranducers. • Chapter 2: Cleaning and disinfecting the transducers The chapter describes how to clean and disinfect non-invasive transducers and those used in semi-critical applications. • Chapter 3: Examinations with the transesophageal probe The chapter lists the specific safety requirements for examinations with the trans- esophageal probe. A description is also given on how to prepare the probe for the examination. • Chapter 4: Examinations with the endocavity probe The chapter lists the specific safety requirements for examinations with the endo- cavity probe. A description is also given on how to prepare the probe for the examination. • Chapter 5: The Intraoperative probe The chapter lists the specific safety requirements for examinations with the intraoperative probe. A description is also given on how to prepare the probe for the examination. • Chapter 6: The Laparoscopic probe The chapter lists the specific safety requirements for examinations with the laparoscopic probe. A description is also given on how to prepare the probe for the examination. • Chapter 7: Needle guides kits The chapter describes the procedures for assembling the kits. • Chapter 8 Accessories and Consumables The chapter describes how to check, clean and disinfect the ECG cable. The chapter also gives information about the characteristics of the consumables. • Appendix A: MyLab Probes The appendix details available models and their main characteristics. • Appendix B: Cables and Consumables The appendix details the ECG cables characteristics and recommended ECG single use electrodes. In this manual WARNING identifies a risk for the patient and/or the operator. The word CAUTION describes the precautions necessary for protecting the equipment. Make sure you understand and follow these instructions.

[Page 162]

[Page 163] Table of Contents 1 - Care of Transducers 1-1 Handling Transducers 1-1 Periodic Probe Control Schedule 1-1 Transducer Controls 1-2 Non-invasive Transducers 1-2 Invasive Transducers 1-3 Storing and Protecting the Transducers 1-7 Non-Invasive Transducers 1-7 Storing and Protecting the Transesophageal Probe 1-7 Storing and Protecting the Endocavity Probe 1-7 Storing and Protecting the Intraoperative and Laparoscopic Probe 1-7 Dispatching the Transducer 1-8 Needle Guide Kit Control 1-8 Storing and Protecting Needle Guide Kits 1-8 2 - Cleaning and Disinfecting Transducers and Biopsy Kits 2-1 Periodic Cleaning and Disinfecting Schedule 2-1 Agents 2-2 Probes Tightness to Liquids 2-2 Cleaning Probes Used in Non-Critical Applications 2-3 Disinfecting Probes Used in Non-Critical Applications 2-3 Cleaning and Disinfecting Probes Used in Semi-Critical Applications 2-4 Cleaning and Sterilization of Intraoperative, Laparoscopic probes and Needle Guide Kits 2-5 3 - The Transesophageal Probe 3-1 Characteristics and Components 3-1 Examination Safety 3-2 Temperature Control 3-4 Preparation of the Transesophageal Probe 3-5 Transducer Orientation 3-5 4 - The Endocavity Probe 4-1 Characteristics and Components 4-1 Examination Safety 4-1 Preparation of the Endocavity Probe 4-3 5 - The Intraoperative Probe 5-1 Characteristics and Components 5-1 Examination Safety 5-2 Preparation of the Intraoperative Probe 5-4 6 - The Laparoscopic Probe 6-1 Characteristics and Components 6-1 Examination Safety 6-2 Preparation of the Laparoscopic Probe 6-4 7 - Needle Guide Kits 7-1 Examination Safety 7-1 Mounting the Needle Guide for LA and CA Probes 7-2 Mounting the Endocavity Probe Needle Guide 7-4 Mounting the Intraoperative Probe Needle Guide 7-5 Kit assembling 7-5

[Page 164] 8 - Accessories and Consumables 8-1 ECG Cable 8-1 Checking the ECG Cable 8-1 Cleaning and Disinfecting the ECG Cable 8-1 Stand Off for Linear Probes 8-2 Gel 8-3 Sheaths 8-4 Accessory Kits 8-4 Appendix A - MyLab Probes A-1 Phased Array Probes A-1 Linear Probes A-1 Convex Probes A-2 Specialty Probes A-2 Doppler Probes A-2 Appendix B - Cables and Consumables B-1 ECG Cables B-1 Recommended Consumables B-1 Cleaning, Disinfections and Sterilizations Agents B-2 ii

[Page 165] Chapter 1 - Care of Transducers Damage caused by Handling Transducers dropping or knocking a probe against other Incorrect handling can seriously damage any transducer. Both the acoustic lens and objects, stepping on or the crystal elements can be damaged if the transducer is dropped or struck against twisting a cable or a another object. Cuts on the probe cable or breakage of the housing may jeopardize cable becoming the electrical safety of the transducer. entangled, are not covered by the There are several ways a probe can be damaged, for example: guarantee. • Dropping or knocking against another object • Contact with sharp edged objects • Contact with chemical agents • Contact with hot surfaces • Immersion in liquid substances • Exposure to high voltage discharge • Exposure to environmental conditions out of allowed range W A R N I N G S Do not use a probe if any of the above listed events occur until it has been established if any electrical damage to the probe has occurred by measuring the current leakage. Contact the Esaote Service Representative. Do not tug the probe cable or bend it. If the probes are carried around on a trolley, make sure that the wheels do not roll over the cable. Periodic Probe Control Schedule The following tables describe the periodic control that must be made on the probes. The frequency suggested for non-invasive probes is considered to be the minimum; very frequent usage requires more frequent controls. 1-1

[Page 166] Operation to be performed Frequency Physical control of non-invasive probes Every month or when the probe is dropped Physical control of transesophageal, endocavity, Before every examination intraoperative and laparoscopic probes Physical control of the biopsy kit Before every examination and if dropped Never use a probe, if it has been dropped, until you are sure that no electrical damage to the probe has occurred. This can be done by performing a leakage current test. Transducer Controls Non-invasive Transducers Non-invasive transducers are intended to be used on the external parts of the body only. A periodic control must be made on transducers to check that: • The housing is intact. If cracks or breaks are found, have the probe repaired immediately by contacting an ESAOTE technician. • The lens does not have any irregularities or is not broken. If any breaks are found on the scanning windows, do not use the probe again and have it repaired. • The probe cable is not broken or damaged. If any damage is found, do not use the probe again and have it repaired. Breaks to the probe casing or to the cable could result in risks to electrical safety. 1-2

[Page 167] • Do not touch the lens at the end of the probe Never exert force on the lens • The connector is not waterproof and should always be kept dry. The control unit, although waterproof, should not be unnecessarily immersed. After use, clean and/or disinfect the probe as specified in this manual. Invasive Transducers Invasive transducers penetrate the patient’s body through an orifice or through the surface of the body. C o n t r o l o f t h e T r a n s e s o p h a g e a l P r o b e The transesophageal probe must be carefully inspected before every examination. • Perform a manual and visual check of the endoscope while bending the tip in all possible directions; deflection must function according to characteristics and the guides must not protrude during these movements. • Check that the deflection mechanism functions in both modes (free or with friction). • Check that the connector pins are not bent. If the pins are damaged, do not use the probe and have it repaired. In case of incorrect operation of the flexion, do not use the probe and call Esaote Service Assistance. 1-3

[Page 168] • Before inserting the probe, do not rub or spray the tip of the probe with an anesthetic agent .. • When not in use, store the probe as specified in the next paragraph. After use, clean and disinfect the probe as specified in this manual. C o n t r o l o f t h e E n d o c a v i t y P r o b e The endocavity probe must be checked before every examination. • Perform both a visual and manual check to ensure that there are no holes, bulges, abrasions or dents. • Perform a visual and manual check of the probe cable; cuts or holes in the cable may jeopardize electrical safety. operator to an electrical safety risk. Physical damage to the probe may cause electric shock or mechanical injury to the patient. Protective sheaths DO NOT provide protection against such damage nor do they guarantee that the probe is insulated electrically. DO NOT USE the probe if it is known or suspected that it has been damaged; contact ESAOTE immediately. Do not attempt to dismantle the probe; any attempt to dismantle the probe may result in damage to the probe and will void the warranty and could compromise its safety. 1-4

[Page 169] After use, clean and disinfect the probe as specified in this manual. C o n t r o l o f t h e I n t r a o p e r a t i v e P r o b e The Intraoperative probe must be carefully inspected before every examination. • When not in use, store the probe as specified in the next paragraph. • When not in use, store the probe in its case. After use, clean and sterilize the probe as specified in this manual. 1-5

[Page 170] C o n t r o l o f t h e L a p a r o s c o p i c P r o b e The laparocopic probe must be carefully inspected before every examination. • Perform a manual and visual check of the endoscope while bending the tip in all possible directions; deflection must function according to characteristics and the guides must not protrude during these movements. In case of incorrect operation of the flexion, do not use the probe and call Esaote Service Assistance. damage it and will annul the guarantee. • When not in use, store the probe in its case. After use, clean and sterilize the probe as specified in this manual. 1-6

[Page 171] Storing and Protecting the Transducers Daily Storage and Protection Non-Invasive Transducers When not in use, the transducer must be stored in the special probes slot on the machine. If all the available slots are full, place the probe in its case. All gel must always be cleaned off the probe (see the next chapter for the relative instructions). Always keep the probe in its case. Otherwise it could be accidentally dropped or damaged. Storing and Protecting the Transesophageal Probe The probe must always be cleaned following the instructions provided in the next chapter. The probe must be kept in a clean environment and with the endoscope straight. In particular, we recommend using: • Wall-mounted supports • A storage drawer that is large enough to house the endoscope, bending it as little as possible Storing and Protecting the Endocavity Probe The probe must always be cleaned following the instructions provided in the next chapter. When not in use, the transducer must be stored in the special probes slot on the machine. If all the available slots are full, place the probe in its case. Always keep the probe in its case. Otherwise it could be accidentally dropped or damaged. Storing and Protecting the Intraoperative and Laparoscopic Probe The probe must always be cleaned following the instructions provided in the next chapter. When not in use, place the probe in its case. Always keep the probe in its case. Otherwise it could be accidentally dropped or damaged. Transport or Long-Term Storage and Protection All transducers are supplied with their own case that must always be used both when transporting the probe and for long-term storage. Clean the transducer carefully, following the procedures described in the following chapter before putting the probe away in its case. For long-term storage, check that the environmental requirements indicated on the label of the case are observed. 1-7

[Page 172] Always use the original case to store the transesophageal probe. The special shape of this case prevents damage to the gastroscope due to excessive bending. Dispatching the Transducer Contact Esaote personnel to ensure that the transducer is correctly packed before dispatching it. Needle Guide Kit Control Always check that: • The socket is not bent. Do not use the socket if it has been damaged. • The needle guide is not bent. Do not use the guide if it has been damaged. Storing and Protecting Needle Guide Kits All biopsy kits are supplied with their own case. We recommend leaving any unused needle guides in the case. The kits must always be sterilized after use (see the next chapter for procedures). Please refer to the procedures used on-site for storing sterile parts. 1-8

[Page 173] C hapter 2 - Cleaning and Disinfecting Transducers and Biopsy Kits Periodic Cleaning and Disinfecting Schedule The following table describes the periodic maintenance to be carried out on transducers and biopsy kits depending on their application. The risk of infection establishes the type of application. Device Application Operation Frequency Before the first use and after Cleaning Non-invasive probes Non-critical [1] each exam. Disinfection When necessary Transesophageal and Cleaning and Before the first use and after Semi-critical [2] Endocavity probes Disinfection each exam. Intraoperative and Cleaning and Before the first use and after Laparoscopic probes Critical [3] Sterilization each exam. Needle Guide kits Cleaning and Before the first use and after Critical [3] Sterilization each exam. [1] The application is considered non-critical when the device is used on intact skin. [2] The application is considered semi-critical when the device is used on the mucous membranes. [3] The application is considered critical when the device comes into contact with blood or compromised tissue. If non-invasive probes are used in semi-critical/critical applications and in a sterile field, apply protective sheaths during the examination. These sheaths are usually composed of latex (natural rubber). Make sure that patients who are allergic to latex are identified before each examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such reactions. 2-1

[Page 174] ESAOTE recommends disinfecting the probe, if the probe has not been used for an extended period. Do not immerse the probe cable or connector in water or other liquid. Immersion may compromise the electrical safety features. The probe can be inserted in water up to the Maximum Immersion Level. (see Appendix A). Probes and needle guides supplied by ESAOTE are neither disinfected nor sterilized. Agents Refer to Appendix B for a list of recommended cleaning, disinfection and sterilization agents. The disinfection/sterilization agents listed are recommended because of chemical compatibility with the probe materials, and not related to biological effectiveness. For information related to the biological effectiveness of a disinfectant, refer to the guidelines and recommendations of the disinfectant manufacturer. Use of solutions other than those referenced is not recommended. They may damage the probe housing or acoustic lens. Follow the instructions provided by the manufacturer of the agent for proper use. Personnel should adopt all necessary protective measures during the probe cleaning, disinfection and sterilization processes (i.e. gloves, protective glasses ….). Never attempt to clean or disinfect the probes while they are connected to the unit. Probes Tightness to Liquids See Appendix A for Do not immerse the probe cable or connector in water or other liquid. The probes description of probes can be inserted in water up to the Maximum Immersion Level that will not Maximum compromise a probe’s integrity: Immersion Level. Connector immersion in water or other liquid can compromise the safety feature of the probe. Damage caused by the probe immersion is not covered under the warranty. 2-2

[Page 175] Cleaning Probes Used in Non-Critical Applications The cleaning procedures described in this paragraph apply to all the probes used in non-critical applications. An application is considered non-critical when the device is used on intact skin. Cleaning • Disconnect the probe from the unit Procedure • Remove all residues of ultrasound gel from the probe using a soft Probes must be cleaned at regular cloth. intervals to ensure that they work • Clean the probe by rubbing it lightly with a soft cloth soaked in a properly. Esaote solution of water and mild soap. recommends removing the gel from the probe • Rub the probe with a soft damp cloth to remove any soap residue. between one examination and the • Dry the probe by rubbing it with a soft dry cloth. other; this keeps the probes clean between one complete cleaning Disinfecting Probes Used in Non-Critical procedure and the next. Applications The disinfection procedures described in this paragraph apply to all probes used in non-critical applications. The application is considered non critical when the device is used on intact skin. Low-level disinfection is sufficient for these applications. The probes can be disinfected using CIDEX OPA, following the manufacturer’s instructions. Disinfection • Disconnect the probe from the system. Procedure • Clean the probe as described in the previous paragraph. • Immerse the probe casing in CIDEX OPA, following the manufacturer’s instructions very carefully. Do not immerse the entire body of the probe. The probe is not waterproof and immersion may compromise the electrical safety characteristics (see Appendix A for Maximum Immersion Level). Do not soak the probe in the disinfection solution for periods beyond the time required to achieve a disinfection. Do not try to sterilize probes using the autoclave, ultra-violet rays, gamma rays or gas, steam or heat sterilization techniques. These sterilization methods can permanently damage the probe. Any damage to the probe caused by substances or methods not approved by ESAOTE is not covered by the guarantee. 2-3

[Page 176] • Extract the probe, rinse it with sterile water and clean the probe handle and cable with a soft cloth dampened with isopropyl alcohol or with a mild detergent solution. • Dry the probe carefully using a soft cloth or leave it to air dry for at least 30 minutes. Cleaning and Disinfecting Probes Used in Semi- Critical Applications The procedures described in this paragraph apply to all probes used in semi-critical applications. The application is considered semi-critical when the device is used on the mucous membranes. The use of sterile sheaths for this type of application is recommended, and high-level disinfection is necessary. Wearing gloves is recommended during probe cleaning and disinfecting operations. The probe must be disinfected before it is used for the first time. The probe must be cleaned and disinfected after every examination. Esaote recommends • Disconnect the probe from the system. disinfecting the probe before it is used for • Remove the protective sheath; clean the probe handle, the transducer the first time after and the endoscope with the recommended agent. prolonged storage periods Handle any examination waste (protective sheath, gloves…) as if potentially infected and treat it accordingly. • If the probe is contaminated by body fluids, disinfect it before and after cleaning. • Immerse the probe casing in CIDEX OPA, following the manufacturer’s instructions very carefully. Do not leave the probe immersed in the disinfectant for longer than the time indicated by the manufacturer for high-level disinfection. Do not immerse the entire body of the probe. The probe is not waterproof and immersion may compromise the electrical safety characteristics (see Appendix A for Maximum Immersion Level). • Extract the probe, rinse it with sterile water and clean the probe handle and cable with a soft cloth dampened with a mild detergent solution. • Dry the probe carefully using a soft cloth or leave it to air dry for at least 30 minutes. 2-4

[Page 177] Any damage to the probe caused by substances or methods not approved by ESAOTE, such as steam (autoclave), ethylene oxide or radiation, are not covered by the guarantee. These sterilization methods can permanently damage the probe. For information on how to store disinfected parts, refer to the locally applicable procedures. Cleaning and Sterilization of Intraoperative, Laparoscopic probes and Needle Guide Kits The procedures described in this paragraph apply to the intraoperative and laparoscpic probes and all the kits used in critical applications. The application is considered critical when the device comes into contact with blood or compromised tissue. Sterilization is stipulated for this type of procedure. Wearing gloves is recommended during cleaning and sterilization operations. Personnel should adopt all necessary protective measures during the probe cleaning, disinfection and sterilization processes (i.e. gloves, protective glasses ….). The probe and the kit must be sterilized before it is used for the first time. They must be cleaned and sterilized after every examination. Esaote recommends • Dismantle the kit from the probe. sterilizing the probe and the kit before • Clean the kit or the probe carefully with mild soap. they are used for the first time after • Follow the instructions of the manufacturer of the sterilization agent. prolonged storage periods. The material used for needle guide kits can undergo all the sterilization methods used for surgical instruments. The type of tissue the transducer comes into contact with establishes the disinfection level. For information on how to store sterilized parts, refer to the locally applicable procedures. 2-5

[Page 178] 2-6

[Page 179] C hapter 3 - The Transesophageal Probe The transesophageal probe ( TEE022 ) is a Type BF part. The probe must be physically intact and the system correctly grounded for the electrical safety of the patient and operator. Read the Safety and Standards Manual carefully: all the safety characteristics, cautions and warnings listed also apply to the use of this In particular, remember that: The system must be correctly grounded: it must be supplied from a socket equipped with a protective earth connection . Mobile configurations are fitted with insulated supply sockets for supplying documentation systems without increasing the current leakage. Incorrect connections or failure to use insulated sockets may compromise electrical safety. In case of doubts about the protective earth connection, DO NOT use the probe and contact ESAOTE immediately. Characteristics and Components This probe is designed for transesophageal imaging of the heart in adult patients. The transesophageal probe incorporates an array transducer which can be rotated 180° to easily obtain all imaging planes. The probe tip can also be deflected for optimal coupling. This probe is equipped with a temperature sensor; MyLab models are designed to use these sensor thermal data to prevent probe tip overheating. Components 1. Probe cable and system connector 2. Probe handle with the probe tip deflection control and the transducer rotational knob 3. Locking device 3-1

[Page 180] 4. Probe shaft; this shaft has a length of 100 cm and is labeled in 10 cm increments 5. Probe tip with the ultrasound transducer The TEE is delivered with a carrying case. 1 5 Examination Safety The user must know The transesophageal examination is to be carried out by operators who how to recognize have been specially trained to insert the probe and interpret the images. contraindications to Carefully review current medical provisions and follow their precautions and the examination and recommendations concerning the preparation and positioning of the patient, probe any possible complications, such as insertion and manipulation techniques. tip buckling. Before the Examination Before each examination : • Perform a manual and visual inspection of the entire probe (see Chapter 2 of this manual). DO NOT use the probe if it has been damaged or if damage is suspected. NOT USE the probe if you know or suspect that it has been damaged. • Check that the probe deflection controls function correctly in all directions and that they have not jammed. • Make sure that the probe tip is free to move; the probe handle provides a locking device which must be set to “loose” position. • Use protective sheaths during the examination. These sheaths are mainly composed of latex (natural rubber). 3-2

[Page 181] Make sure that patients who are allergic to latex are identified before each examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such reactions. • Always use a bite-proof mouthpiece to protect the probe from the patient’s teeth. Physical damage to the probe can cause electrical or mechanical injury to the patient. Damage caused to the probe due to failure to use a protective mouthpiece is not covered by the guarantee. Be familiar with the mechanical and thermal indices display and the ALARA principle ( A s L ow A s R easonably A chievable) before using the probe. The patient must be exposed to ultrasound for as short a time as possible and only for as long as it takes to achieve the diagnostic information. During the Examination Before probe use, check to be sure that the probe name shown on the monitor is correct. Esaote recommends the Operator to: • Never force the probe during manipulation and extraction; if there is any resistance in introducing the probe, interrupt the examination. Make sure that the tip is straight and released before inserting or removing the probe. Insertion, manipulation or forced removal can seriously damage the patient’s esophagus. • Do not leave the probe against the esophagus wall for prolonged periods. • Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro-organisms is suspected. • If it is necessary to use the defibrillator, disconnect and remove the probe from the patient. Electric scalpels used during the TEE Electric scalpels and other devices that introduce radio frequency or electro- examination interfere magnetic current fields into the patient interfere with ultrasound images. with the 2D and make it impossible to High frequency signals used by ultrasound can interfere with the functioning of use Doppler pacemakers. procedures. Even if the possibility of interference is remote, interrupt the examination W A R N I N G immediately if interference with a pacemaker is noticed. 3-3

[Page 182] While using the system in combination with high frequency devices (like electro- surgical units), be aware that a failure in the surgical device or a damage to the transducer lens can cause electro-surgical currents that can burn the patient. Thoroughly check the system and the probe before applying HF surgical currents to the patient. Disconnect the probe when not imaging. damage nor do they guarantee that the probe is insulated electrically. Perform a manual and visual check before each examination to ensure that the probe is intact. At the End of the Examination At the end of the examination, Esaote recommends the Operator to: • Clean and disinfect the probe, according to the instructions provided in Chapter 2 of this manual. • Store the probe as indicated in Chapter 1 of this manual. Temperature Control The transesophageal probe is equipped with a temperature sensor, to provide continuous feed-back on the temperature of the probe tip; the ultrasound scanner Th T he e A Ad dv va an nc ce ed d constantly samples and displays the probe temperature. Op O pe er ra at ti io on n m ma an nu ua al l in i nd di ic ca at te es s s sp pe ec ci if fi ic c in i nf fo or rm ma at ti io on n Once the probe is connected, the temperature is displayed on the screen. ap a pp pl li ic ca ab bl le e t to o y yo ou ur r M M yL y La a b b m m o o d d el e l. . To ensure patient safety, the ultrasound scanner “allows” a maximum temperature of 42.5° C ( 108.5 °F); if the probe reaches this limit, the system automatically de- activates and displays a warning message. As soon as the temperature goes down below the thermal limit, the message disappears and the probe starts working again. The Operator should either wait for the probe to cool down or interrupt the procedure and remove the probe from the patient. How to Minimize In normal conditions, the probe does not reach the thermal limit; the limit may be Probe Heating reached in patients with fever or due to breakage of the thermal sensor. A list of recommendations follows to prevent the probe from over-heating: • Set the B-Mode angle at maximum • The CFM mode is the greatest heat “generator”; limit the use of the CFM as much as possible in patients with a high body temperature. 3-4

[Page 183] • Trans-gastric projections reduce heat dissipation; repositioning the probe in the esophagus may make the probe cool down quickly. Preparation of the Transesophageal Probe Follow the instructions below to prepare the transesophageal probe. The Operator is recommended to wear gloves during the probe preparation procedure. See Chapter on The use of latex transducer covers is strongly recommended, along with a bite Consumables for guard to protect the probe shaft. These items are available as accessory kits, which selecting these also contain items that facilitate placement of the probe cover on the transducer. accessory kits • Place the tip of the probe in a straight position and release it. • Apply a sufficient quantity of ultrasound gel inside the sheath. • Completely unroll the sheath along the transducer body, making it adhere, so as to avoid air pockets. • Secure the sheath with the rubber band provided. Transducer Orientation The probe handle wheels can be used to rotate the transducer inside the tip or to change the tip position. Transducer The rotation of the transducer is controlled by the smallest knob and is adjustable Rotation from 0 ° to 180 ° . In the zero position, the transducer will scan the transversal plane. The zero, 90 ° and 180 ° positions are marked on the knob. The MyLab system screen displays the transducer’s current orientation. 3-5

[Page 184] Tip Position The probe tip can be oriented to optimize tissue contact. The articulation of the flexibile part of the probe is controlled by the largest knob; up- and back-wards adjsutments are feasable: • 120 ° upwards (clockwise rotation of the knob) • 90 ° backwards (counter- clockwise rotation of the knob) The zero position is marked on the knob. This knob can be locked into position by engaging the locking device, located next to the knob. This locking device has two color coded positions: on red, the tip is locked, on grey the tip is loose. During probe insertion, make sure that the tip is unlocked (grey locking device) 3-6

[Page 185] C hapter 4 - The Endocavity Probe The endocavity probe ( EC123 ) is a Type BF part. As per directive EN60601-1, the probe must be physically intact and the system correctly grounded for the electrical safety of the patient and operator. Read the Safety and Standards Manual carefully: all the safety characteristics, cautions and warnings listed also apply to the use of this In particular, remember that: The system must be correctly grounded: it must be supplied from a socket W A R N I N G S equipped with a protective earth connection. Mobile configurations are fitted with insulated supply sockets for supplying documentation systems without increasing the leakage current. Incorrect connections or failure to use insulated sockets may compromise electrical safety. In case of doubts about the protective earth connection, DO NOT use the probe and contact ESAOTE immediately. Characteristics and Components The EC123 incorporates a high frequency convex transducer for sagittal (transverse) endorectal or endovaginal scanning. The probe is delivered with the following accessories: • Storage case • Tubing kit (60 cc syringe with IV extension tubing and stopcock) Examination Safety Endocavity probes must be used by operators who have been specially trained to insert the probe and interpret the images. Carefully review current 4-1

[Page 186] medical provisions and follow their precautions and recommendations concerning the preparation and positioning of the patient, probe insertion and manipulation techniques. Before the Examination Before each examination Esaote recommends the Operator to: • Perform a manual and visual inspection of the entire probe before using it (see Chapter 2 of this manual). DO NOT use the probe if it has been damaged or if you suspect damage. the patient. Protective sheaths DO NOT provide protection against these damages nor do they guarantee that the probe is insulated electrically. DO NOT USE the probe if you know or suspect that it has been damaged. • Use protective sheaths during the examination. These sheaths are mainly composed of latex (natural rubber). Esaote recommends use of sterile sheaths in intravaginal examinations. Make sure that patients who are allergic to latex are identified before each examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such reactions. The Operator should be familiar with the mechanical and thermal indices display and the ALARA principle ( A s L ow A s R easonably A chievable) before using the probe. The patient must be exposed to ultrasound for as short a time as possible and only for as long as it takes to achieve the diagnostic information. During the Examination Before probe use, check to be sure that the probe name shown on the monitor is correct During the examination Esaote recommended the Operator to: • Never force the probe during insertion or removal. Forced insertion or removal may wound the patient. 4-2

[Page 187] • Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro-organisms is suspected. Electric scalpels used Electric scalpels, and other devices that introduce radio frequency or electro- during the magnetic current fields into the patient, interfere with ultrasound images. examination may interfere with the 2D While using the system in combination with high frequency devices (like electro- and make it impossible to use surgical units), be aware that a failure in the surgical device or a damage to the Doppler procedures. transducer lens can cause electro-surgical currents that can burn the patient. Thoroughly check the system and the probe before applying HF surgical currents to the patient. Disconnect the probe when not imaging. damage nor do they guarantee that the probe is insulated electrically. Perform a manual and visual check before each examination to ensure that the probe is intact. At the End of the Examination At the end of the examination, Esaote recommends the Operator to: • Clean and disinfect the probe, according to the instructions provided in Chapter 2 of this manual. • Store the probe as indicated in Chapter 1 of this manual. Preparation of the Endocavity Probe Follow the instructions below for preparing the endocavity probe. The Operator is recommended to wear gloves during the probe preparation procedure See Chapter on consumables for selecting the gel and sheathes. • Apply a sufficient quantity of ultrasound gel inside the sheath. • Completely unroll the sheath along the transducer body, making it adhere, so as to avoid air pockets. 4-3

[Page 188] • Secure the sheath with the rubber band provided. • To make it easier to insert the endocavity probe, apply some water-based lubricating gel on the tip of the transducer. Water Stand-Off The endocavity probe has two communicating holes, one at the tip and one at the base, that make it possible to use water stand-off to optimize probe adherence in transrectal examinations. The probe is equipped with a 60 cc syringe with tubes that allow water to be injected. • Cover the part of the probe that can be immersed with the stand-off cap and attach it with the rubber band provided at about 5 cm. from the tip; make sure the water intake hole is below the band. • Fill a 60 cc syringe with sterile water. • Apply the tap valve to the syringe. • Connect a section of the IV tube to one end of the tap; the other end of the IV tube must be inserted into the probe-filling hole. • Open the tap; inject about 30 cc of water into the probe. • To eliminate air bubbles, turn the probe upwards holding it by the handle; the bubbles will rise towards the water intake hole. Eliminate the air bubbles between the • Suck air back into the syringe; close the tap to remove the syringe and transducer and the sheath; air bubbles expel the air. impede the transmission of • Repeat this procedure until all the air bubbles have been eliminated. ultrasound. • Replace water, without air, back into the syringe and close the valve; leave the tube and the syringe connected. • Apply ultrasound examination gel to the tip of the stand-off. • Cover the portion of the probe that is to be inserted with the protection cap. • To make insertion easier, apply some lubricating gel to the tip of the Once the probe is in the correct position, fill the stand-off with water again. To optimize image quality, use enough water to ensure that the probe adheres as well as possible to the rectal wall. Do not remove the probe from the rectum if the probe tip is still full of water. 4-4

[Page 189] C hapter 5 - The Intraoperative Probe The intraoperative probe ( IOE323 ) is a Type BF part. The probe must be physically intact and the system properly grounded for the electrical safety of the patient and operator. Read the Safety and Standards Manual carefully: all the safety SS S S characteristics, cautions and warnings listed also apply to the use of this In particular, remember that: The system must be properly grounded: it must be supplied from a socket equipped with a protective ground connection. Mobile configurations are fitted with insulated supply sockets for supplying electricity to the systems without increasing the leakage current. Incorrect connections or failure to use insulated sockets may compromise electrical safety. If in doubt about the protective ground connection, DO NOT use the probe and contact ESAOTE immediately. Characteristics and Components The IOE323 incorporates a high frequency linear transducer for intraoperative scanning. The probe is delivered with the following accessories: • Storage case • Handle attachment • Finger attachment • Sled attachment 5-1

[Page 190] • Biopsy attachment. The IOE323 probe is designed to form an angle of 45° between the head, which houses the transducer and the terminal portion where the cable is connected. The terminal portion of the probe has a square shape to accommodate accessories available for use with the probe, offering maximum comfort during surgical ultrasonography. The probe accessories are shaped in a manner to prevent rotation and to improve patient safety. 4 flat facets at 90° 45° angle Probe’s Cable Examination Safety The intraoperative examination is to be carried out by operators who have been specially trained to use the probe and interpret the images. Carefully review current medical provisions and follow their precautions and recommendations concerning the preparation and positioning of the patient, probe insertion and manipulation techniques. Do not use the intraoperative probe in direct contact with the heart, the central circulatory system and the central nervous system. Before the Examination Before each examination : • Perform a manual and visual inspection of the entire probe prior to use (see Chapter 2 of this manual). DO NOT use the probe if it has been damaged or if damage is suspected. 5-2

[Page 191] the patient. Protective sheaths DO NOT provide protection against these damages nor do they guarantee that the probe is insulated electrically. DO NOT USE the probe if damage is known or suspected. • Use protective sheaths during the examination. These sheaths are usually composed of latex (natural rubber). Make sure that patients who are allergic to latex are identified before each W A R N I N G examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such reactions. Esaote recommends use of sterile sheaths in intraoperative examinations. The operator must be familiar with the mechanical and thermal indices display and the ALARA principle ( A s L ow A s R easonably A chievable) before using the probe. The patient must be exposed to ultrasound for as short a time as possible and only for as long as necessary to achieve the diagnostic information. During the Examination Before probe use, check to be sure that the probe name shown on the monitor is correct During the examination, Esaote recommends that the Operator: • Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro-organisms is suspected. Electric scalpels used Electric scalpels and other devices that introduce radio frequency or electro- during the IOE magnetic current fields into the patient interfere with ultrasound images. examination interfere with the 2D and While using the system in combination with high frequency devices (like electro- make it impossible to surgical units), be aware that a failure in the surgical device or a damage to the use Doppler transducer lens can cause electro-surgical currents that can burn the patient. procedures. Thoroughly check the system and the probe before applying HF surgical currents to the patient. Disconnect the probe when not imaging. damage nor do they guarantee that the probe is insulated electrically. Perform a manual and visual check before each examination to ensure that the probe is intact. 5-3

[Page 192] At the End of the Examination At the end of the examination, Esaote recommends that the Operator: • Clean and sterilize the probe, according to the instructions provided in Chapter 2 of this manual. • Store the probe as indicated in Chapter 1 of this manual. Preparation of the Intraoperative Probe Follow the instructions below for preparing the intraoperative probe. The operator is recommended to wear gloves during the probe preparation procedure See Chapter 8 on consumables for selecting the gel and sheathes. • Apply a sufficient quantity of ultrasound gel inside the sheath. The protective sheaths available on the market often contain latex. Make sure that patients who are allergic to latex are identified before each examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such reactions. Esaote recommends use of sterile sheaths in intraoperative examinations. • Completely unroll the sheath along the transducer body, making it adhere, so as to avoid air pockets. • Secure the sheath with the rubber band provided. 5-4

[Page 193] The handle attachment, is inclined 30 degrees, and can be placed on the probe in Handle four different positions to form four different shapes (profiles) A, B, C and D as attachment shown below and on the following pages: 4 facets at 90° Probe’s Holder 30° inclination 5-5

[Page 194] Probe’s Transducer A B C D 5-6

[Page 195] Finger attachment The Finger Attachment allows manipulation of the Intraoperative IOE323 probe for use with only two fingers. The 4 facets, at 90 degrees, allow the user to obtain four different insertion methods with the probe. 4 facets @ 90° finger attachment finger attachment transducer The finger attachment can be used in four different configurations in order to more closely adapt to the surface being evaluated. In intraoperative applications, it is possible to insert the probe below, adjacent to, or on top of the structure of interest. 5-7

[Page 196] Following are the four different IOE323 probe attachment designs. Sled attachment The sled attachment has been developed to provide easier manipulation of the probe during both intraoperative and superficial scanning. The attachment corresponds to the ergonomics of the probe, and is the same length as the transducer. The correct position of the SLED attachment is shown below. 5-8

[Page 197] To place the attachment on the probe, follow the procedure described below. The sequence is also shown in the following design. 1. Place the sled attachment at the tip of the transducer. 2. Rotate the sled attachment around the probe until it is safely in place between the two lateral extensions of the attachment. 3. Press the transducer inside the holder, hearing a click, to assure secure and complete insertion. 4. To remove the sled attachment, reverse the procedure. 5-9

[Page 198] 5-10

[Page 199] C hapter 6 - The Laparoscopic Probe The laparoscopic probe ( LP323 ) is a Type BF part. The probe must be physically intact and the system properly grounded for the electrical safety of the patient and operator. Read the Safety and Standards Manual carefully: all the safety characteristics, cautions and warnings listed also apply to the use of this In particular, remember that: The system must be properly grounded: it must be supplied from a socket equipped with a protective ground connection. Mobile configurations are fitted with insulated supply sockets for supplying electricity to the systems without increasing the leakage current. Incorrect connections or failure to use insulated sockets may compromise electrical safety. If in doubt about the protective ground connection, DO NOT use the probe and contact ESAOTE immediately. Characteristics and Components The LP323 incorporates a high frequency linear transducer for laparoscopic scanning. The probe is delivered with the following accessories: • Storage case • Polyurethane laparoscopic cover • Syringe filled with transmission gel, • Extension tube 6-1

[Page 200] • Cable cover and fixing tape LP323 Probe The LP323 probe has an articulation that allows a double movement of its extremity in order to position the transducer directly on to the surface of the organ under evaluation. This movement is adjustable by two control levers located on the probe handle. Examination Safety The laproscopic examination is to be carried out by operators who have been specially trained to use the probe and interpret the images. Carefully review current medical provisions and follow their precautions and recommendations concerning the preparation and positioning of the patient, probe insertion and manipulation techniques. Do not use the laparoscopic probe in direct contact with the heart, the central circulatory system and the central nervous system. Before the Examination Before each examination : • Perform a manual and visual inspection of the entire probe prior to use (see Chapter 2 of this manual). DO NOT use the probe if it has been damaged or if damage is suspected. the patient. Protective sheaths DO NOT provide protection against these damages nor do they guarantee that the probe is insulated electrically. DO NOT USE the probe if damage is known or suspected. • Use protective sheaths during the examination. These sheaths are usually composed of latex (natural rubber). 6-2

[Page 201] Esaote recommends use of sterile sheaths in laparoscopic examinations. Make sure that patients who are allergic to latex are identified before each W A R N I N G examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such reactions. Be familiar with the mechanical and thermal indices display and the ALARA principle ( A s L ow A s R easonably A chievable) before using the probe. The patient must be exposed to ultrasound for as short a time as possible and only for as long as necessary to achieve the diagnostic information. During the Examination Before probe use, check to be sure that the probe name shown on the monitor is correct During the examination, Esaote recommends that the Operator: • Never force the probe during insertion or removal. Before introducing the LP323 probe into the Trocar verify that there is no mechanical play of the tip of the probe. While inserting the LP323 probe into the Trocar, the tip of the probe should be in a straight position. Forced insertion or removal may harm the patient. • Cover the probe handle with a disposable cloth during examinations in which the presence of pathogenic micro-organisms is suspected. Electric scalpels used Electric scalpels and other devices that introduce radio frequency or electro- during the LP magnetic current fields into the patient interfere with ultrasound images. examination interfere with the 2D and While using the system in combination with high frequency devices (like electro- make it impossible to surgical units), be aware that a failure in the surgical device or a damage to the use Doppler transducer lens can cause electro-surgical currents that can burn the patient. procedures. Thoroughly check the system and the probe before applying HF surgical currents to the patient. Disconnect the probe when not imaging. damage nor do they guarantee that the probe is insulated electrically. 6-3

[Page 202] Perform a manual and visual check before each examination to ensure that the probe is intact. At the End of the Examination At the end of the examination, Esaote recommends that the Operator: • Clean and disinfect the probe, according to the instructions provided in Chapter 2 of this manual. • Store the probe as indicated in Chapter 1 of this manual. Preparation of the Laparoscopic Probe Follow the instructions below for preparing the laparoscopic probe. The Operator is recommended to wear gloves during the probe preparation procedure See Chapter 8 on consumables for selecting the gel and sheathes. • Apply a sufficient quantity of ultrasound gel inside the sheath. The protective sheaths available on the market often contain latex. Make sure that patients who are allergic to latex are identified before each examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such reactions. Esaote recommends use of sterile sheaths in intraoperative examinations. • Completely unroll the sheath along the transducer body, making it adhere, so as to avoid air pockets. • Secure the sheath with the rubber band provided. 6-4

[Page 203] C hapter 7 - Needle Guide Kits Consult your MyLab “Advanced Operations” manual for correct use of the needle guide. ESAOTE supplies a series of optional adaptors for the biopsy needle guide, fitted with special couplings for connection to the probe. The following table lists the available kits. Biopsy adaptor Probe Kit contents ABS421 CA421 1 20° coupling, 1 30° coupling+ 5 needle guides CA430 CA431 ABS621 CA621 1 25° coupling, 1 35° coupling + 5 needle guides ABS523 LA523 1 coupling (45° angle) + 5 needle guides LA522 LA532 ABS424 LA424 1 coupling (45° angle) + 5 needle guides LA435 ABS123 EC123 1 coupling + 1 needle guide ABS15 IOE323 1 coupling (45° angle) + 5 needle guides See Appendix A in this manual for probes references. The kits for LA, CA and Intraoperative probes include 14, 18, 20, 21, and 22 gauge needles; the kit for the endocavity probe has a guide for a 16 gauge needle. Do not use needle guides other than those described in this manual. ABS421, ABS424, ABS523, ABS621 and ABS15 kits are composed of stainless steel; the ABS123 needle guide kit is composed of titanium. Examination Safety All safety information related to the use of the needle guide kits is in addition to the safety procedures described for the system and for the probes. Consult your MyLab “Safety & Standard” manual for additional safety information. Before the Examination Before each examination, Esaote recommends that the Operator: • Handle the biopsy kit and the probe with sterile gloves. 7-1

[Page 204] • Perform a visual check of the adaptor and needle guides: do not use them if any damage or distortion is found. • Use protective sheaths during the examination. These sheaths are primarily composed of latex (natural rubber). Using sterile sheaths is recommended for intraoperative and biopsy procedures. Make sure that patients who are allergic to latex are identified before each examination. Serious allergic reactions to latex have been reported; the Operator should be prepared to handle such a reaction. During the Examination Pay particular attention to the ultrasound image during the insertion of the needle into the body, checking that the needle follows the displayed line. The lines displayed on the monitor only provides an indication of the needle direction, according to the selected guide. Pay particular attention to the ultrasound image during the insertion of the needle into the body and be sure that the needle always stays within the displayed area. Before performing the biopsy-test, check for the correct assembly and positioning of the biopsy kit. Also, check that the insertion angle is equal to the angle selected via the user interface software. Needle insertion in a guide with an insertion angle other than that of the selected angle involves risks to patient safety. At the End of the Examination At the end of the examination Esaote recommends that the Operator: Chapter 2 provides • clean and sterilize the kit, cleaning, disinfection and sterilization • clean and disinfect the probe used during the biopsy. instructions. Mounting the Needle Guide for LA and CA Probes Adaptors for LA and CA biopsy probes are composed of two parts: the coupling to be connected to the relative probe and the needle guide device. 7-2

[Page 205] • Make sure that the probe has been disinfected. • Apply ultrasound examination gel to the probe or to the tip of the protection cap. • Cover the probe and the needle guide device with the protective cap; secure with the rubber band provided. the Operator should be prepared to handle such a reaction. • Connect the kit to the probe, positioning the two alignment pins on the special notches on the probe: The guide device for inserting the needle must be on the same side of the probe as the LED. The coupling must click into the special notch on the probe. Needle Fixture screw for the needle guide The following figures show an example of how the ABS523 is assembled on the LA523. Fixture screw for the coupling Make sure the bottom cone shaped part (at the bottom of the bracket) is screwed into the indentation at the bottom of the top curved portion of the probe. If the user does not perform this operation correctly, the insertion angle can be wrong causing a risk to patient safety. For disassembly of the biopsy kit, reverse the previous procedure. 7-3

[Page 206] Mounting the Endocavity Probe Needle Guide The endocavity biopsy probe is composed of two parts: the coupling to be connected to the probe and the needle guide device. Biopsy kit for the EC123 probe • Make sure that the probe has been disinfected. • Apply ultrasound examination gel to the probe or to the tip of the protection cap. • Cover the probe and the needle guide device with the protective cap; secure with the rubber band provided. the Operator should be prepared to handle such a reaction. • Connect the kit to the probe, positioning the two alignment pins on the special notches on the probe. Needle Needle g uide Holder Needle g uide fixing A lignment Hinge Hinge fixing • Close the clamp and tighten it using the special ratchet. • Insert the needle guide and tighten it onto the coupling. 7-4

[Page 207] The EC123 kit is also available with a disposable biopsy kit. The kit can be ordered from CIVCO. Manufacturer Manufacturer’s Contents kit code CIVCO 1 Medical 610-693 Disposable sterile kit with needle guide, Instruments, Inc, Kalona, IA 2x20cm sheath, 3.5x20cm sheath, seal and gel. (USA) The assembly procedure for this kit is identical to that of the metal biopsy kit; the biopsy kit must be attached to the probe using the alignment pivots. The plastic disposable guide is sterile, but cannot be re-sterilized. Mounting the Intraoperative Probe Needle Guide The ABS15 needle guide kit consists of two components: one bracket to hook the needle guide to the probe handle attachment and a needle guide to attach to the bracket. These two components can be disassembled to enable easier cleaning and sterilization. Kit assembling The ABS15 biopsy kit can only be placed on the probe handle attachment as shown below. Check the integrity of the probe and needle guide and assemble the biopsy kit as follow: • Once the biopsy kit has been positioned on the handle attachment as shown in picture 1, insert the biopsy bracket into the grooves on the handle attachment by sliding the biopsy bracket to the end of the groove. Attach the bracket with the screw provided. • Choose the needle guide acceptable for the diameter of the needle to be used and insert it into the bracket. 1 Civco Medical Instruments, Kalona Iowa; www.civcomedical.com 7-5

[Page 208] • Attach the needle guide to the bracket with the screw provided. • The needle can then be inserted into the hole formed between the bracket and the attached needle guide. If necessary, the needle guide attachment can be removed from the handle attachment without removing the needle. For disassembly of the biopsy kit reverse the previous procedure. 7-6

[Page 209] C hapter 8 - Accessories and Consumables ECG Cable The leads on the ECG cable supplied by Esaote are equipped with a pliers terminal. Any button electrode can be used with the ECG cable. We recommend using disposable Ag/AgCl electrodes. Read the manufacturer’s instructions carefully for correct use of the electrodes. Checking the ECG Cable A periodic check should be made of the ECG cable. ECG Cable Disconnect the cable from the system and check that there are no breaks or slits. Inspection Esaote recommends replacing the ECG cable if there are any breaks or slits. Cleaning and Disinfecting the ECG Cable Periodically clean the ECG cable and electrodes so that they remain in optimal working order. Never try to clean or disinfect the ECG cable when it is still connected to the unit. Equipment The equipment listed in the following table will be necessary for periodic maintenance procedures. CIDEX OPA ® is Agent Destined for a Johnson & Johnson Solution of mild soap and water Cleaning the ECG cable and electrodes Ltd. Registered brand. CIDEX OPA Disinfecting the ECG cable Indicated by the manufacturer Disinfecting the electrodes 8-1

[Page 210] Cleaning • Disconnect the cable from the system. Procedure • Dust the cable coupling with a soft cloth. • Clean the cable by rubbing it gently with a soft cloth dampened with water and a mild detergent. Do not immerse the ECG cable further than the start of the leads. The cable is not waterproof. • Rub the cable gently with a soft cloth slightly dampened with a mild detergent solution or alcohol. • Dry the cable by rubbing it gently with a soft, dry cloth. Disinfection The ECG cable can be disinfected using CIDEX OPA, following the manufacturer’s Procedure instructions. • Disconnect the cable from the system. • Clean the cable as explained in the previous paragraph. • Immerse the ECG cable leads in CIDEX OPA. When using the disinfectant substance, carefully follow the manufacturer’s instructions. Stand Off for Linear Probes The stand off part number 9650030000 allows to keep some distance between the probe head and the skin, thus moving the focus area of the probe. The use of a stand off is therefore valuable when studying the tissue surface in musculo-skeletal and vascular applications. The stand off can be mounted on all MyLab linear probes with size 4 e 5 cm (LA 4XX and LA5XX probe families). 8-2

[Page 211] To get the desired distance the operator has to fill with water (preferably sterile) or ultrasound gel the contact pocket equipped with a cock.. The pocket can be filled and emptied using a syringe which perfectly suits into the cock opening. During the exam, check that the cock is perfectly closed and correctly mounted on its case, to avoid fluid leaks or air bubbles. Using the Stand- • Immerse the stand off into water before each use. Off • Apply ultrasound gel on the probe. • Place the stand off on the probe sliding it till some gel comes out from the lower part of the pocket, on the base of the filling tube. • Apply ultrasound gel on the stand off (between the contact pocket and the patient). When the stand off is not used, it is recommended to store it far from light sources, to avoid early ageing of the rubber. Cleaning and The stand off is made of natural rubber and can be cleaned with a mild soap. Thoroughly Disinfecting rinse it with water , expecially after each contact with disinfectant agents. The use of germicidal lamps and/or disinfectant agents containing quaternary ammonium compound is not recommended as they could damage the stand-off. To dry the stand off, use warm air at 60° or a clean cloth. Sterilizing Sterilization cam be performed in autoclave at 134°C for 20 minutes, if the contact pocket doesn’t contain ultrasound gel. Gel Transmission gel must always be applied to probes to obtain correct probe-patient contact. Esaote recommends only using water or glycerine-based ultrasound gel. Do not use gels containing the substances listed below. The transducer could be damaged if such gels are used. Substances to Be • acetone Excluded • methanol, ethanol, isopropyl alcohol • denatured ethyl alcohol • mineral oil • iodine • any lotion or gel containing perfume • glycol 8-3

[Page 212] The following table indicates ultrasound gels that have tested compatibility with MyLab . Product Supplier Aquasonic ® Parker Laboratories, Inc. Scan ® New Jersey, USA Sheaths The use of protective sheaths is recommended in all clinical situations where there is a risk of infection. Specific sheaths are available on the market for most types of Esaote probes. The sheaths listed below are produced by CIVCO Medical Instruments Inc., Kalona, IA (USA). Refer to the manufacturer’s instructions for the characteristics and use of the protective sheaths. See later for sheaths included in accessory kits. LA and CA Probes Probes Manufacturer’s Measurements Sterile Latex kit code LA523, LA522, LA532, 610-001 8.9 x 61 cm Yes No LA424 CA421, CA621, CA430 610-002 14 x 61 cm Yes No EC123 Probe Manufacturer’s code Measurements Sterile Latex 610-006 It can be reduced from Yes No 11.9 to 4.6 x 61 cm 610-007 It can be reduced from No No 11.9 to 4.6 x 61 cm 610-214 3.5 x 20 cm Yes Yes 610-010 3.5 x 20 cm No Yes 610-075 2 x 20 cm Yes Yes 610-039 2 x 20 cm No Yes IOE323 Probe The intraoperative probe uses the Esaote sterilized sheath Ref.1000000065. LP323 Probe TheLaparoscopic probe uses the Esaote sterilized sheath Ref.7900000210. Accessory Kits The kits listed below are produced by CIVCO Medical Instruments Inc., Kalona, IA (USA). Refer to the manufacturer’s instructions for the characteristics and use of the kits. TEE022 Probe Manufacturer’s code Content Sterile Latex 610-840 Bite-guard and sheath No No with application kit 8-4

[Page 213] A ppendix Appendix A - MyLab Probes This chapter provides a list of MyLab probes with their main characteristics; system G G S S dependent features are described in your model documentation. Phased Array Probes Probe ID Maximum immersion level PA230 Up to 3 cm from transducer head PA121 Up to 3 cm from transducer head PA122 Up to 3 cm from transducer head PA023 Up to 3 cm from transducer head Linear Probes Probe ID Maximum immersion level LA522 Up to 3 cm from transducer head LA532 Up to 3 cm from transducer head LA523 Up to 3 cm from transducer head LA424 Up to 3 cm from transducer head LA435 Up to 3 cm from transducer head A-1

[Page 214] Convex Probes Probe ID Maximum immersion level CA421 Up to 3 cm from transducer head CA431 Up to 3 cm from transducer head CA430 Up to 3 cm from transducer head CA621 Up to 3 cm from transducer head CA123 Up to 3 cm from transducer head Specialty Probes Transesophageal Probe ID TEE022 Type Phased Array Imaging plane 0-180 0 Maximum immersion level Up to 1 m from transducer head Endocavity Probe ID EC123 Type Convex Array Imaging plane Sagittal Maximum immersion level Up to 25 cm from transducer head Intraoperative Probe ID IOE323 Type Linear Array Maximum immersion level Up to 10 cm from transducer head Laparoscopic Probe ID LP323 Type Linear Array Maximum immersion level Up to 10 cm from transducer head BiScan Convex Probe ID BC431 Type Convex Array Maximum immersion level Up to 9.5 cm from transducer head Doppler Probes Continuous Wave Probe ID Maximum immersion level 2 CW Up to 6 cm from transducer surface 5 CW Up to 6 cm from transducer surface A-2

[Page 215] A ppendix Appendix B - Cables and Consumables ECG Cables This chapter provides a list of MyLab ECG cables with their main characteristics; G G S S refer to your system documentation for ECG capabilities.. Reference Description 9630028000 3-Leads ECG Cable - IEC Colours 9630028010 3-Leads ECG Cable - AHA Colours Recommended Consumables Below is the recommended single use electrodes; the product has been tested for compatibility with the ESAOTE MyLab systems. Type Product Manufacturer Single Use Electrodes Excel 3040.050 Ludlow Technical Products Massachusetts, USA B-1

[Page 216] Cleaning, Disinfections and Sterilizations Agents Use the agents listed in the following table for periodic maintenance procedures. CIDEX OPA ® is Agent Destined for a Johnson & Johnson Solution of mild soap and water Cleaning non-invasive probes, Ltd. Registered transesophageal and endocavity probes brand. Pera ® Safe is CIDEX OPA * Disinfecting non-invasive probes, a Antec transesophageal and endocavity probes International PeraSafe Sterilizing intraoperative and laparoscopic Limited registered probes and needle guide kits brand. * FDA Approved CIDEX OPA is produced by ASP, a Johnson & Johnson company, PeraSafe is produced by Antec International Limited, Chilton Industrial Estate, Sudbury, Suffolk (UK)1. 1 ASP: www.sterrad.com; Antec: www.antechh.com B-2

[Page 217] ESAOTE S.p.A. Rev. B February 2005 SAFETY AND STANDARDS OPERATOR MANUAL 8300372000

[Page 218] Introduction This manual provides information on Safety and Standards for the MyLab product line. This manual is organized in the following chapters: • Chapter 1: Operator Safety This chapter describes the situations that could affect the operator safety when an ultrasound system is used. • Chapter 2: Patient Safety This chapter describes the situations that could affect the patient safety when an ultrasound system is used. • Chapter 3: Standards This chapter lists with which standards MyLab complies. It also lists with which standards the peripherals connected to the device have to comply. In this manual a WARNING pertains to possible injury to a patient and/or the operator. A CAUTION describes the precautions, which are necessary to protect the equipment. Be sure that you understand and observe each of the cautions and warnings.

[Page 219] Table of Contents 1 - Operator Safety 1-1 Installation Requirements 1-1 Electrical Safety 1-1 Environmental Safety 1-2 Moving the Equipment 1-2 Explosive Hazard 1-3 Transducers 1-3 Biocompatibility and Infection Control 1-4 Repetitive Strain Injury 1-4 Working with Video Display 1-5 Safety Symbols 1-5 2 - Patient Safety 2-1 Electrical Safety 2-1 Electromagnetic Compatibility 2-2 Biocompatibility and Infection Control 2-2 Ultrasound Safety 2-3 Glossary and Definition of Terms 2-12 3 - Devices Standards 3-1 Medical Device Directive 3-1 Medical Electrical Equipment Standard 3-1 Electromagnetic Compatibility 3-1 Biocompatibility 3-1 Standards Summary Table 3-2 Acoustic Output 3-2 Peripherals Standard Requirements 3-2

[Page 220]

[Page 221] Chapter 1 - Operator Safety Installation Requirements The “Getting Started” manual provides detailed instructions to correctly install and G G S S connect your specific MyLab model. The same manual also contains all information on the recommended peripherals that may be connected to the system. If help is needed, ESAOTE personnel will be glad to provide you with the necessary assistance to install your system. Incorrect installation of the system may cause operator hazard. Carefully follow the MyLab “Getting Started” manual instructions for installing your device Electrical Safety The equipment label, placed on the rear panel, specifies the device electrical requirements. Incorrect connections to the main power may compromise the electrical safety of the system. • Electrical shock hazard. Do not remove the system or the monitor W A R N I N G S cover. Refer servicing and internal adjustments to qualified  Observe the ESAOTE personnel only. following warnings • Always turn the equipment off before cleaning it. for maximum safety Cautions • To prevent further damage to your system and the accessories, C A U T I O N S turn the unit’s power off if it does not start up correctly.  Observe these precautions to • If your system incorporates an LCD, note that the screen is fragile and must be treated accordingly. prevent damage to your system 1-1

[Page 222] Environmental Safety Information about Reusing/Recycling This symbol identifies a recyclable component. Depending on the dimensions of a recyclable component, this symbol and the component’s material are printed on the component by ESAOTE. In this system, packing materials are reusable and recyclable; the unit and display devices casings (plastic) and most of the cart components (plastic) are also recyclable. Refer to the MyLab “Getting Started” manual for any additional information on G G S S special waste that has to be disposed of according to local regulations. Exam Waste Regard any exam waste as potentially infectious and dispose of it accordingly Moving the Equipment MyLab systems are designed to be easily moved by the operator. However the G G S S equipment weight could require assistance during transportation. The MyLab “Getting Started” manual details the weight and dimensions of your configuration. MyLab products can be classified as portable and mobile: • Portable means that the system is equipped with a handle, whose size and weight allow it to be used to carry the system. The term “portable” is always used with this meaning in these manuals. • A mobile model or configuration is equipped with wheels allowing to carry the system from one room to another. The term “mobile” is always used with this meaning in these manuals. Portable One can carry the console directly by its handle; observe the following precautions: • make sure the console is turned off, • if built-in, make sure the system display is secured prior to and during transportation, • disconnect any cable or item (probes, ECG cable) attached to the system, • should the console need to be put on the ground, lay it straight or flat, • secure the system in a flat position if transporting it in a vehicle. 1-2

[Page 223] Mobile The MyLab system complies with the EN60601-1: it is not unbalanced by a 10° Configuration inclination. Observe the following precautions when transporting the system: • make sure the system is turned off, • unlock the cart’s wheels prior to moving the system, • avoid unnecessary shocks to the unit when rolling it over door jambs or in and out of elevators, • when transporting the system with the probes attached, make sure the cables are not dragging on the floor and that the probes are properly positioned in the cart probe holder, • always use the handle to move the system. Never push the system from its sides. Transportation in Observe the following precautions when transporting the system in a vehicle: Vehicle • disconnect any cable or item (probes, ECG cable, …) attached to the system and place the transducers in their cases, • a portable model should be packed in the original shipment case (or other protective devices as available through ESAOTE) during transportation, • for mobile systems, make sure the cart wheels are blocked and the cart secured during transportation. Explosive Hazard The equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide. Do not use the system in the presence of flammable anesthetics. Explosion is a hazard under such conditions. Transducers Use only ESAOTE approved transducers with the equipment. The MyLab G G S S and AO A O “ Getting Started” manual lists which probes can be connected to the system. MyLab “Advanced Operations” explains system related special features, when applicable. The “Transducers and Consumables” manual covers all aspects concerning transducer cleaning and disinfecting. 1-3

[Page 224] W A R N I N G S • If you drop or strike a probe against another object, do not use it Damage caused by until an electrical leakage current measurement test has dropping a probe, demonstrated that the electrical safety has not been compromised. striking it against another object, • Do not immerse the entire transducer in liquid to clean it. The pinching, kinking or transducer is not watertight and immersion may compromise the twisting the cable are not covered under electrical safety features of the probe. warranty. Cautions • Never expose the probes to gas, heat or liquid sterilization C A U T I O N S procedures. These methods can permanently damage the probe.  Observe these precautions to • Do not connect or disconnect an active probe during live scanning; the system must be in freeze mode or turned off to prevent damage to connect or disconnect a probe. your system • Carefully follow the “Probes and Consumables” manual instructions to clean or disinfect a probe. Biocompatibility and Infection Control Probes and electrodes intended to be used on intact skin have very limited probabilities to propagate infections; basic procedures as described in the “Transducers and Consumables” manual are sufficient for infection control. Endocavity and transesophageal transducers require specific cleaning and disinfecting procedures. See the “Transducers and Consumables” manual for complete details on these procedures. Repetitive Strain Injury Musculoskeletal disorders have been reported by the clinical literature 1 as a result of repetitive scanning. These musculoskeletal disorders are also described by the term Repetitive Strain Injury (RSI). To prevent the risk of RSI, it has been recommended: • to maintain a balanced position while scanning, • not to grip the transducer with excessive force, • to take work breaks to allow your muscles to relax, • to introduce routine exercises such as gentle passive stretching. 1 Necas M. “Musculoskeletal symptomatology and Ripetitive Strani Injuries in Diagnostic Medical Sonographers”, Journal of Diagnostic Medical Sonography 12, p. 266-273, 1996 Pike I, Russo A., Berkowitz J et al. “ the prevalence of musculoskeletal disorders among Diagnostic Medical Sonographers”, Journal of Diagnostic Medical Sonography 13, p. 219-227, 1997 1-4

[Page 225] Working with Video Display Scanning can require long sessions in front of a display screen. Consequently visual problems such as eyestrain and irritation can result 2 . Visual discomfort is reduced when the following recommendations are observed : • orientate the display so that it can be comfortably observed while scanning, • take rest breaks after a long scanning session. Safety Symbols The MyLab device uses the EN60601-1 safety symbols for medical electronic devices to classify a connection or to warn of any potential hazards. On (power) Off (power) Type CF applied part (suitable for cardiac application) Type B applied part Type BF applied part Equipotentiality High Voltage This symbol generically means "Attention". Read carefully the appropriate sections of user manuals before using any function labeled with this symbol. The footswitch is watertight. IP68 2 See for example OSHA 3092 “Working safely with video terminals display” 1997 1-5

[Page 226] 1-6

[Page 227] Chapter 2 - Patient Safety Electrical Safety W A R N I N G S • The system must be properly grounded to prevent shock hazards. Protection is provided by grounding the chassis with a three-wire cable  Observe the and plug; the system must also be powered through a properly following warnings grounded receptacle. for maximum safety • Do not replace the system fuses with types different from those specified by the MyLab “ Getting Started” manual. • Mobile configurations provide insulated plugs and connectors to G G S S manage optional hard copy devices (VTR, printers). Follow the instructions in the “Getting Started” manual to install such a device. Incorrect connections may compromise the electrical safety of the system. • If the Operator plans to use hard-copy devices with a portable model, and one plans to utilize hard-copy devices, read and carefully follow the instructions in the “Getting Started” manual to install such devices. Incorrect connections or use of peripherals with improper safety characteristics may compromise the electrical safety of the system. • MyLab models are not watertight and provides a class IP(X)0 degree of protection to liquids; do not expose the system to rain or moisture. Avoid placing liquid containers on the system. • Remove probes and electrocardiography leads from patient contact before applying a high voltage defibrillation pulse. • MyLab systems use high frequency signals. Pacemakers could interfere with these signals. The user should be aware of this minimal potential hazard and immediately turn the unit off if interference with the pacemaker operation is noted or suspected. • While using the system in combination with high frequency devices (like electro-surgical units), be aware that a failure in the surgical device or a damage to the transducer lens can cause electro-surgical currents that can burn the patient. Thoroughly check the system and the probe 2-1

[Page 228] before applying HF surgical currents to the patient. Disconnect the probe when not imaging Electromagnetic Compatibility Ultrasound systems require special precautions regarding EMC and must be installed and put into service according to the provided information. Sensitivity to Ultrasound units are designed to generate and receive radiofrequency (RF) energy interference is more and are, therefore, susceptible to other RF sources. As an example, other medical noticeable in Doppler devices, information technology products or TV/radio transmitters may cause modes. interference with the ultrasound system. In the presence of RF interference, the physician must evaluate the image degradation and its diagnostic impact. W A R N I N G S • Portable and mobile RF communication equipment may cause interference with the ultrasound system. Do not use these devices in GS G S the vicinity of ultrasound equipment. The “Getting Started” manual • Use of accessories and cables other than those specified in the MyLab provides the table for “Getting Started” manual may result in increased emission or equipment distance requirements. decreased immunity of the system. If an ultrasound system causes interference (This can be identified by turning the system off and on) with other devices, the user could try to solve the problem by: • relocating the system, • increasing the separation from other devices, • powering the ultrasound system from an outlet different from the one of the interfering device, • contacting ESAOTE Service personnel for help. E l e c t r o - S u r g i c a l U n i t s ( E S U s ) Electro-surgical units or other devices that introduce radiofrequency electromagnetic fields or currents into the patient may interfere with the ultrasound image. An electro-surgical device in use during ultrasound imaging will grossly affect the 2D image and render Doppler modalities useless. Biocompatibility and Infection Control Before each exam properly clean the probes. Refer to the “Transducers and Consumables” manual for further details on cleaning and disinfecting probes, kits and electrodes. 2-2

[Page 229] Items in Contact with Patient ESAOTE probes and electrodes materials that are in contact with the patient have been proved to comply with EN ISO 10993 “Biocompatibility Tests Requirements”, according to their intended use. No negative reactions to these materials have been reported. Latex Sensitive Patient The USA Food and Drug Administration (FDA) has issued an alert on products composed of latex, because of reports of severe allergic reactions. ESAOTE probes and electrodes do NOT contain latex. The transducer protective covers used during the patient exam are usually composed of latex. Carefully read the protective cover package labeling to verify the material used. Be certain to identify latex sensitive patients prior to the exam. Serious allergic reactions to latex have been reported and the user should be ready to react accordingly. Ultrasound Safety Introduction ESAOTE has adopted the more recent requirements and recommendations GS G S established by the USA Food and Drug Administration and by the American MyLab “Getting Institute of Medicine and Biology. MyLab is equipped with the Acoustic Output Started” manual provides data about Display feature to provide the user with real-time, on-line information on the the acoustic power actual power of the system. The following sections describe the rationale of this levels. methodology. ESAOTE recommends the use of the ALARA principle (see below), which is extensively covered in this manual. Clinical Safety Refer to the glossary In the USA, in more than three decades of use, there has been no report of injury at the end of this to patients or operators from medical ultrasound equipment. chapter for specific terms. American Institute for Ultrasound in Medicine (AIUM) Statement on Clinical Safety: October 1982, Revised March 1983, October 1983 and March 1997. Diagnostic ultrasound has been in use for over 25 years. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use: 2-3

[Page 230] No confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound instruments have been reported. Although the possibility exists that such biological effects may be identified in the future, current data indicate that the benefits to patients deriving from the prudent use of diagnostic ultrasound outweigh the risks, if any, that may be present. The ALARA ( A s L ow A s R easonably A chievable) principle is the guideline for prudent use: during an exam, the user should use for the shortest duration the least amount of acoustic output to obtain the necessary clinical information for diagnostic purposes. Ultrasound Bioeffects Although diagnostic ultrasound has an excellent history of safety, it has been known for a long time that ultrasound, at certain levels, can alter biological systems. The AIUM Bioeffects Committee describes two fundamental mechanisms by which ultrasound may induce biological effects: non-thermal or mechanical mechanisms 1 and thermal effects. Non-thermal bioeffects, also referred to as mechanical bioeffects , seem to be caused by the tissue alternate expansion and contraction induced when ultrasound M E C H A N I C A L pressure waves pass through or near gas. The majority of these non-thermal interactions, also known as cavitation, deal with the generation, growth, vibration, B I O E F F E C T S and possible collapse of microbubbles within the tissue. The occurrence of “Cavitation” phenomenon cavitation depends on a number of factors, such as the ultrasonic pressure and frequency, the ultrasonic field (focused or unfocused, pulsed or continuous), the nature and state of the tissue and boundaries. Mechanical bioeffects are a threshold phenomenon, occurring only when a certain level of output is exceeded. However, the threshold level varies depending on the tissue. The potential for mechanical effects is thought to increase as peak rarefactional pressure increases, but to decrease as the ultrasound frequency increases. Although there have been no adverse mechanical bioeffects in humans from diagnostic ultrasound exposure, it is not possible to specify thresholds at which cavitation will occur in mammals. Thermal bioeffect is the rise in temperature of tissue when exposed to acoustic T H E R M A L energy. The acoustic energy is absorbed by body tissue; absorption is the B I O E F F E C T conversion of this energy into heat. If the rate of energy deposition in a particular Rise in temperature of region exceeds the ability to dissipate the heat, the local temperature will rise. The rise in temperature will depend on the amount of energy, the volume of exposure, tissue exposed to acoustic and the thermal characteristics of the tissue. energy. 1 American Institute of Ultrasound in Medicine Bioeffects Committee, Bioeffects Considerations for the Safety of Diagnostic Ultrasound , J. Ultrasound Med., 1988, 7 Suppl. 2-4

[Page 231] On-screen Real-Time Acoustic Output Display Until recently, application-specific output limits 2 established by the USA Food and Drug Administration (FDA) and the user's knowledge of equipment controls and patient body characteristics have been the means of minimizing exposure. Now, more information is available through a new feature, named the Acoustic Output Display. The output display provides users with information that can be specifically applied to ALARA. It eliminates some of the guesswork and provides both an indication of what may actually be happening within the patient (i.e. the potential for bioeffects), and what occurs when system control settings are changed. This makes it possible for the user to get the best image possible while following the ALARA principle and thus to maximize the benefits/risks ratio. MyLab incorporates a real-time acoustic output display according to the O D S AIUM 3 /NEMA 4 "Standard for Real-Time Display of Thermal and Mechanical Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment" publication, Indices display to assist in adopted in 1992 by both institutions. This output display standard is intended to provide on-screen display of these two indices, which are related to ultrasound making informed thermal and cavitation mechanisms, to assist the user in making informed risk (i.e. risk/benefit decisions patient exposure)/benefit (diagnostically useful information) decisions. Considering the type of exam, patient conditions and the case study level of difficulty, the system operator decides how much acoustic output to apply for obtaining diagnostically useful information for the patient; the thermal and mechanical indices real-time display is intended to provide information to the system operator throughout the examination so that exposure of the patient to ultrasound can be reasonably minimized while maximizing diagnostic information. For systems with an output display, the FDA currently regulates only the maximum output. MyLab system has been designed to automatically default the proper range of intensity levels for a particular application. However, within the limits, the user may override the application specific limits, if clinically required. The user is responsible for being aware of the output level that is being used. The MyLab real-time output display provides the user with relative information about the intensity level. The Mechanical Index The Mechanical Index ( MI ) is defined as the peak rarefactional pressure in MPa M I (derated by a tissue attenuation coefficient of 0.3 dB/cm/MHz) divided by the Estimates mechanical square root of the probe central frequency in MHz. bioeffects With the MI, the user can keep the potential for mechanical bioeffects as low as reasonably achievable while obtaining diagnostically adequate images. The higher the index, the larger the potential. However, there is not a level to indicate that 2 Also known as the preamendments limits, those values were established on the basis of acoustic output of equipment on the market before 1976. 3 American Institute for Ultrasound in Medicine. 4 National Electric Manufacturers Association. 2-5

[Page 232] bioeffect is actually occurring: the index is not intended to give an "alarm" but to use it to implement the ALARA principle. The Thermal Index The purpose of the Thermal Index (TI) is to keep the user aware of conditions that T I may lead to a temperature rise under certain defined assumptions. It is the ratio Relates to temperature rise between the total acoustic power to the power required to raise tissue temperature by 1°C, estimated on thermal models. There are currently three thermal indices (each based on a specific thermal model) used to estimate temperature rise whether at the surface, within the tissues, or at the point where the ultrasound is focusing on bone: 1. The Soft Tissue Thermal Index ( TIS ) provides information on temperature increase within soft homogeneous tissue. 2. The Cranial Bone Thermal Index ( TIC ) indicates temperature increase of bone at or near the surface, as may occur during a cranial exam. 3. The Bone Thermal Index ( TIB ) provides information on temperature increase of bone at or near the focus after the beam has passed through soft tissue. As with the Mechanical Index, the thermal indices are relative indicator of temperature rise: a higher value represents a higher temperature rise; they indicate that the possibility for an increase in temperature exists and they provide a relative magnitude that can be used to implement ALARA. Acoustic Output Display The acoustic output indices are displayed during live scanning to the right of the screen, together with the transmit power setting. The following abbreviations are used: Indices are displayed Index Abbreviation in 0.1 increments. Soft Tissue Thermal Index TIS Cranial Bone Thermal Index TIC Bone Thermal Index TIB Mechanical Index MI The output display is organized to provide meaningful information to implement ALARA without "distracting" the user with unnecessary data. During the entry of the patient ID, the user is provided with a choice of applications (Cardio, Vascular, OB, etc.); depending on the selection, the system will default the appropriate indices. Index values below 0.4 are NOT displayed by this system. To optimize ALARA, index values equal or higher than 0.4 are displayed even if the maximal index value does not exceed 1.0. 2-6

[Page 233] The Output Display In combined modes The following table shows the indices used for each clinical application. Indices are (ex.: 2D+Doppler), displayed in 0.1 increments. the indices will show the highest value Application MI TIS TIB TIC between the two modes. OB/Fetal Yes Yes Yes No Neonatal 5 Yes Yes Yes Yes Adult Cephalic Yes Yes No Yes All others Yes Yes Yes 6 No The Output Default Settings System default settings depend upon the probe, the mode of operation and the application which is selected during the patient ID procedure. The MyLab defaults the transmit power to obtain output levels that are below the historic Ispta limits established by the FDA for the selected application. Methodology and Accuracy of Display The displayed indices values must be interpreted as relative information to help the user to achieve the ALARA principle. Initial data are derived from laboratory measurements based on the AIUM standard. Then the indices are calculated beginning from these measurements according to the AIUM/NEMA "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment" publication. Many of the assumptions used for measurements and calculation are conservative in nature. The measured water tank values are derated using the conservative attenuation coefficient established by the standard (0.3 dB/cm/MHz). Over-estimation of actual in-situ exposures is thus part of the calculation process. Accuracy: ± 14% for the MI, ± 30% for the TI A number of factors influence the I N D I C E S estimation of the accuracy of the displayed indices, the most significant ones being A C C U R A C Y the variability between probes and the laboratory measurements accuracy (hydrophone, operator, algorithms, etc.) itself, while variability of the system pulser and efficiency is a minor contributor. The accuracy estimate, based on the variability range of probes and systems, and on the inherent modeling and measurements errors, is 14% for the MI and 30% for TI indices; this accuracy estimate does not consider errors in/or caused by measuring with the AIUM standard. 5 Includes Neonatal Head studies 6 Only when TIB ≠ TIS 2-7

[Page 234] Maximum Acoustic Output This system does not use the historic FDA limits for Isppa and Imax, but rather M A X I M U M the recently adopted MI, which is now considered a better relative indicator of O U T P U T non-thermal bioeffect mechanisms. The maximum MI is below 1.9 (see the ο MI < 1.9 “Getting Started” manual for your model actual maximum); the FDA has 2 recognized this value as equivalent to preamendments Isppa limits. The maximum ο Ispta<720 mW/cm output for Ispta is limited to the preamendments FDA limit for peripheral vascular applications (720 mW/cm 2 ). Other application limits have been established as per this table: Application Preamendments Ispta MyLab Maximum Limits (mW/cm 2 ) (mW/cm 2 ) OB/Fetal 94 430 Cardiac 430 720 Pediatric 94 430 Peripheral Vascular 430 720 Other 94 720 The maximum output for a given probe can be less than the system limit, since the maximum depends on various elements (crystal efficiency, mode of operation, …). Acoustic Output Controls Control features may be divided into three categories: 1. controls which directly affect the intensity ( direct controls) 2. controls which indirectly affect the intensity ( indirect controls) 3. controls, which do not affect the intensity, such as the gains and the processing curves. C o n t r o l s W h i c h D i r e c t l y A f f e c t t h e I n t e n s i t y This category includes two system controls: D I R E C T • the application selection, which establishes the appropriate range of C O N T R O L S intensities (see maximum output section); the application also ο the Application establishes the indices to be displayed; ο the POWER • the POWER control, which allows an increase or decrease in the output intensity within the range of the selected application. This parameter will affect both the MI and the TI values. C o n t r o l s W h i c h I n d i r e c t l y A f f e c t t h e I n t e n s i t y This category includes controls, which change several aspects of the transmitted I N D I R E C T ultrasonic field rather than the intensity. Intensity is affected because of the field C O N T R O L S variations. Each mode has its own pulse repetition frequency (PRF) and intensity ο PRF level; moreover, for each mode, a number of parameters will indirectly affect the transmitted field. ο Focal Point ο Frequency ο CFM Process ο Sample Volume 2-8

[Page 235] The TI index display depends on the application and on the mode. 2D The MI may increase whenever the PRF is decreased, i.e. when the field of view is increased. MyLab allows the user to set the transmit focal point which will affect both indices by varying the beam profile. Generally, higher MI's and TI's will occur with closer focal points. If more than one transmit focal point is activated, MI and TI values will each correspond to the zone with the largest value. In addition, all system probes can image at two frequencies; both indices are usually different, depending on the probe bandwidth. TEI The same controls described for 2D affect the acoustic output. Because the tissue response is a non-linear phenomenon, this modality usually requires higher acoustic outputs than conventional imaging. While using this mode, the MI is your primary concern; a deeper transmit focal point helps to keep the MI value as low as possible. M-Mode In M-Mode, the transmitted field is only affected by the transmit focal point and the frequency. If M-Mode is displayed with 2D and the 2D is updated, the system may show the latter mode MI (and TI if available) if higher. 2D-CFM The MI is primarily dependent on 2D settings, i.e. the depth (which will determine the 2D and color PRF) and the transmit focal point. The MI may also be increased by a decrease in the color PRF. The TI may be increased by increasing the color CFM. Increasing the color frame rate may increase the TI while decreasing the MI. Finally, probes can provide color at two frequencies; the outcome in terms of transmitted field is marginal and largely unpredictable. TVM This mode optimizes CFM settings in order to image the movement of tissue, thus the same controls described for 2D-CFM affect the acoustic outputs. Pulsed Wave In PW, the sample volume depth automatically sets the Doppler PRF and the focal Doppler point. Deeper sample volumes will cause lower PRF; the MI may, however, not increase since the focal point is far, while the TI is generally reduced. The TI may, however, change if the sample volume size is varied. This factor accounts generally for a MI modification. TV TV Doppler optimizes your settings to analyse tissue motion. Finally, most probes provide Doppler at two frequencies; the outcome in terms of transmitted field is marginal and largely unpredictable. 2-9

[Page 236] Continuous Wave In CW, the only "variable" factor is the Doppler frequency. As stated before, most Doppler probes provide Doppler at two frequencies; the outcome in terms of transmitted field is marginal and largely unpredictable. The user can vary the spectral velocity range; this does NOT, however, change the system’s PRF. In Doppler modes, if the tracings are displayed with an updated 2D, the 2D values are used if higher than the Doppler indices. Implementing ALARA with MyLab Prudent use implies that during an exam the user should use for the shortest time the least amount of acoustic output to obtain the necessary clinical information for diagnostic purposes. In other words, the goal is to keep the TI and the MI indices as low as possible for the shortest time while obtaining the necessary clinical information. This section does not cover the patient and technique factors, which may influence the indices such as the patient body size, the tissue perfusion characteristics, the presence or the absence of fluid, etc. ALARA Guidelines • Select the appropriate Application when you enter the patient data. • Depending on the patient characteristics and the type of exam (see Intended Use Section) select the appropriate probe and frequency. Use the system capabilities to preset the MyLab system to default each mode according to your needs or specific applications; this will reduce the need for real- time interactions and help to obtain useful images quickly thus reducing ultrasound exposure. • Start scanning with a low output level and optimize the focusing, the GS G S gains and all other system adjustments; if this is not adequate for See the “Getting Started” manual for diagnostic purposes, then increase the output level. In cardiac studies, your system controls. use Tissue Enhancement Imaging if acoustic noise is affecting the images’ readability. • Use the output display feature to guide your settings; remember that the indices do not consider TIME exposure: the higher your indices, the shorter the patient exposure should be. W h i c h I n d e x W h e n In cardiac, vascular, In cardiac , vascular and general purpose ( abdominal , small parts, abdominal and small musculoskeletal ) exams, the system displays the TIS in addition to the MI. In parts examinations, imaging and CFM modes, the primary concern is in keeping the "cavitation" MI is the primary concern in imaging predictor as low as possible. You can minimize the MI by reducing the power to modes, while the TIS the lowest possible level, and adjusting the TGC and general gain controls. Use the is the principle index transmit focal point to enhance resolution and sensitivity in the area of interest: this in Doppler. 2-10

[Page 237] may increase the MI, but because of the enhanced sensitivity, you may be able to reduce the transmit power, thus reducing the MI. Decreasing the imaging depth as low as possible may allow the system to increase the PRF and thus reduce the MI. In Doppler modes, if you are working with a 2D + Doppler display, the MI will show the 2D value (because it is higher than the Doppler one) and the Doppler TIS; the latter parameter should be your primary concern: the MI value reflects the energy to which the patient is exposed only for a minimal time, i.e. between every sweep. You may want however to remember that whenever varying the Doppler speed: increasing the speed will cause the 2D to be refreshed more often. You may eventually freeze the 2D or switch to a full screen mode; however, this will probably increase the time to actually find the desired signal, and therefore the exposure time. In OB, the TIB In OB exams, this system displays both the MI and the TIB in imaging and CFM should be considered modes. While the MI will remain your primary concern in those modes, you when scanning a should also consider the TIB in imaging a second or third trimester fetus as a second or third trimester fetus, while conservative estimate of the actual temperature rise. In PW Doppler, the latter the TIS is more value is the primary parameter to consider for second or third trimesters reliable for earlier pregnancies while the TIS is a more reliable indicator for earlier exams. The general exams. guidelines already expressed for the previous exams remain valid. The TIB is a better For Neonatal Head studies, the MI and the TIB may be significant in imaging predictor during and CFM modes, while the MI and both TIS and TIB are displayed for Doppler neonatal head modes. Because of the chance of focusing near the base of the skull, the TIB studies, while the TIC is more should be conservatively considered the ideal thermal index. As usual the MI is the significant in adult primary concern in imaging modes, and the TIB in Doppler. The general transcranial studies. guidelines expressed above are valid. In Adult Cephalic , because of the skull, the TIC is considered the most significant index for this application. The general guidelines expressed above are valid. Acoustic Output Tables According to the IEC61157 and EN 60601-2-37, the acoustic output tables give G G S S the acoustic output data for each probe in every operating mode. These tables are in the MyLab “Getting Started” manual. 2-11

[Page 238] Glossary and Definition of Terms "In Situ" Intensities Calculations The intensity When determining the possible effects of the ultrasound beam on tissue, the measurements made intensity encountered at the tissue site must be calculated. Because of attenuation in water in the of the beam within the body, the intensity at the tissue site ("in situ") may be 10 to laboratory must be derated to reflect the 100 times less than if it was measured at the same location in water. The amount of effects of attenuation. attenuation from experience by an ultrasound beam as it travels through the body tissue is determined by three factors: 1. Type of tissue along the beam path 2. Frequency of the ultrasound energy 3. Distance covered by the beam In order to achieve a conservative approximation of attenuation due to these three factors, the FDA requires the application of the following formula: Id = Iw exp (-0.23 a f z ) • Id is the estimated "in situ" intensity at the tissue site • Iw is the intensity measured in water at a distance "z", measured in cm • a is the attenuation coefficient 7 expressed in dB/cm/MHz • f = acoustic frequency in MHz of the ultrasound beam Definition of Terms The acoustic intensity generated by an ultrasound probe is usually described as follows: Ispta The Spatial Peak Time Average Intensity is an ultrasound intensity averaged over time at the point in the acoustic field where the pulse average intensity is at maximum. Isppa The Spatial Peak Pulse Average Intensity is an ultrasound intensity averaged over the pulse transmission time at a point in the acoustic field where the pulse average intensity is at maximum. Imax The Maximum Intensity is an average intensity during the half-cycle with the greatest amplitude during the pulse. 7 As per the FDA, this coefficient is equal to 0.3 dB/cm/MHz 2-12

[Page 239] Mechanical Index The Mechanical Index is defined as the peak rarefactional pressure in MPa (derated by a tissue attenuation coefficient of 0.3 dB/cm/MHz) divided by the square root of the probe central frequency in MHz. Thermal Index The Thermal Index is the ratio between the acoustic power and the power required to raise tissue temperature by 1°C, estimated on thermal models. Peak Rarefactional The peak rarefactional pressure (pr in MPa) is the temporal peak rarefactional Pressure pressure amplitude at a specified point. Pulse Intensity The Pulse Intensity Integral (PII) is the time integral of instantaneous velocity for Integral any specific point and for any specific pulse, integrated over the time in which the envelope of acoustic pressure or the envelope of hydrophone signal for the specific pulse is non-zero. It is equal to the energy fluence per pulse. 2-13

[Page 240] Indices Equations Parameter Equation Soft Tissue at Surface W TIS(scanned 8 ) 210 TIB (scanned 6 ) f c Large Aperture (A aprt > 1 cm ) TIS (unscanned 9 ) max [ min ( W ( z ); I ( z ) x 1 cm ) ] . 3 TA . 3 z > zbp f c Small Aperture (A aprt ≤ 1 cm ) W 0 TIS (unscanned 7 ) 210 f c Bone at Focus TIB ⎧ ⎫ ⎪ W . 3 ( z B . 3 ) I TA . 3 ( z B . 3 ) w ( z ) ⎪ (unscanned 7 ) min ⎨ ; . 3 B . 3 ⎬ ⎪ ⎩ 50 4 . 4 ⎪ ⎭ where z is the depth that maximizes W (z)I (z), or, B.3 .3 TA.3 equivalently, the depth of I . SPTAB.3 Bone at Surface TIC W 40 D eq Mechanical Index (MI) p r . ( 3 z sp ) f c where p r.3 (z sp ) is the peak rarefactional pressure (in MPa) derated by 0.3 dBcm -1 MHz -1 to the point on the beam axis z sp where pulse intensity integral (PII.3) is maximum, and f c is the center frequency (in MHz). 8 The scanned mode (or autoscanning) is the electronic or mechanical steering of successive ultrasonic pulses or series of pulses, through at least two dimensions. 9 The unscanned mode (or nonautoscanning) is the emission of ultrasonic pulses in a single direction, where scanning in more than one direction would require moving the transducer assembly manually. 2-14

[Page 241] Symbols Used in Indices Equations Symbol Definition A aprt (cm ) Active aperture area d eq (z) (cm) Equivalent beam diameter 4 W . 3 ( z ) π I TA . 3 ( z ) D eq (cm) Equivalent aperture diameter 4 A aprt f c (MHz) Center frequency. I (mW/cm 2 ) Equivalent to the spatial peak temporal average derated SPTAB.3 (0.6 dBcm -1 MHz -1 ) intensity I (z) (mW/cm 2 ) Temporal average intensity derated to depth z TA.3 W (mW) Time average acoustic power at source W 01 (mW) Time average acoustic power at the source emitted from the central centimeter of the active aperture W .3 (z) (mW) Time average acoustic power derated to depth z W Acoustic power per unit linear length (for example of a (mW/cm) linear array) z (cm) Depth from the surface along the beam axis z bp (cm) Break point depth (minimum depth for intensity measurements in the TIS(unscanned) models) z bp = 1.5D eq z (cm) Depth of the maximum temperature rise in the bone at B.3 focus model p (z sp ) Peak rarefactional pressure (in MPa) derated by 0.3 r.3 dBcm -1 MHz -1 to the point on the beam axis z where sp pulse intensity integral (PII.3) is maximum 2-15

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[Page 243] Chapter 3 - Devices Standards Medical Device Directive This system complies with the Medical Device Directive (MDD) 93/42/EEC, according to which ESAOTE has classified this device as a Class IIa device. Note for U.S. Customers U.S. Federal Law restricts these devices to sale, distribution and use by or on the order of a physician. Medical Electrical Equipment Standard As defined in EN60601-1 (IEC Standard 60601-1, Safety of Medical Electrical Equipment), MyLab models are classified as Class I, with applied parts of type B or BF (probes), and of Type CF (ECG). These devices also comply with the EN 60601-2-37 (IEC 60601-2-37) “Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment”. Electromagnetic Compatibility Each MyLab model complies with the EN60601-1-2 (Electromagnetic G G S S Compatibility). Refer to the MyLab “Getting Started” manual for the electromagnetic emissions classification of the devices and electromagnetic immunity compliance levels. Biocompatibility The probe and electrode material that is in contact with patients, complies with the applicable requirements of EN ISO 10993-1, according to their intended use. No negative reactions to these materials have been reported. 3-1

[Page 244] Standards Summary Table Standard Title EN60601-1 Medical Electrical Equipment – General requirements for Safety EN60601-2-37 Medical Electrical Equipment – Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment EN60601-1-2 Medical Electrical Equipment – General requirements for Safety – Electromagnetic compatibility – Requirements and Test EN60601-1-1 Medical Electrical Equipment – General requirements for Safety - Safety requirements for medical electrical systems - requirements and tests EN ISO 10993-1 Biological evaluation of medical devices – Guidance on selection of tests EN61157 Requirements for the declaration of the acoustic output of medical diagnostic ultrasonic equipment AIUM/NEMA UD-3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Acoustic Output MyLab acoustic output complies with the requirements of FDA Track 3 guidance. Peripherals Standard Requirements When peripherals are connected to an ultrasound system, they become part of a medical system. Therefore they must comply with the below mentioned standards to maintain the overall system conformity. Safety Your device must: meet the EN60601-1 OR in accordance with EN60601-1-1: z the device must meet the applicable safety standards for its category; z the device must be powered through an isolation transformer designed for medical applications If your configuration is equipped with the cart, the isolation transformer requirement is fulfilled by powering the device through one of the cart’s insulated plugs. Electromagnetic Compatibility Your peripheral device must: z meet the EN55011 or 55022 emission limits, according to the environment where the system is used; z meet the EN50082-1 or EN61000-6-1 immunity requirements 3-2