Doc. # 29A60X107

Confidential. For Esaote personnel only.

June 2011

Ultrasound Products: MyLabFive MyLab20Plus MyLab40

Software Release 12.02

Prepared by: Perry van Haaren Checked by: Marco Lagustena Approved by: Joop Geijsen

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Index 1. NOTES ............................................................................................................................................................... 1 

2. INTRODUCTION ............................................................................................................................................... 3 

3. CARDIAC APPLICATION ................................................................................................................................ 3 

3.1. CARDIOLOGIC REPORT IMPROVEMENTS ................................................................................................................ 3 3.2. CFR MEASUREMENTS ............................................................................................................................................ 4 3.3. INFERIOR VENA CAVA MEASUREMENTS ................................................................................................................. 5 

4. GENERAL IMAGING APPLICATION .............................................................................................................. 6 

4.1.DISPOSABLE NEEDLE GUIDES BY PROTEK ............................................................................................................. 6 4.2. DISPOSABLE NEEDLE GUIDES BY CIVCO ............................................................................................................. 7 

4.2.1. Fixed Angle and Multi-Angle Kits: .............................................................................................................. 7 4.2.2. Infinity Free Angle Kits: ............................................................................................................................... 8 

5. OB/GYN APPLICATION ................................................................................................................................... 9 

5.1. 3D/4D IMPROVEMENTS .......................................................................................................................................... 9 5.1.1. Plane Orientation and Reference .............................................................................................................. 9 5.1.2. TSI alternative layout ................................................................................................................................. 11 5.1.3. TSI automatic orientation .......................................................................................................................... 12 5.1.4. Volume Presentation in T-B ...................................................................................................................... 12 

5.2 VRA ON HYPOECHOIC STRUCTURES .................................................................................................................... 13 

6. GENERAL IMPROVEMENTS AND CHANGES ............................................................................................ 17 

6.1. NEW CODEC FOR CLIP EXPORT INCREASED COMPATIBILITY ............................................................................. 17 6.2. NEW PROBE COVERS (FOR TRT33 AND TEE PROBES) ...................................................................................... 17 

6.2.1. TRT33 sterile cover balloon ...................................................................................................................... 17 6.2.2. TEE Sterile cover ....................................................................................................................................... 18 

6.3. NEW DISINFECTION, CLEANING AND STERILIZATION PRODUCTS AVAILABLE ...................................................... 19 

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1. Notes Please find the introductory information regarding Software Release 12.02 for MyLab Units: MyLabFive, MyLab20Plus and MyLab40 The following matrix displays in more detail what improvements have been implemented and for which products they are applicable:

Application Changes MyLab40 MyLab20Plus MyLabFive Cardiac Cardiologic report improvements

Coronary measurements IVC measurements

OB/GYN 3D/4D improvements VRA on hypoechoic structures

General Imaging Biopsy kits New Codec

Important Upgrading Note This release is for the following systems: • MyLab40 with Processor board CI ≥ 21 • MyLab20Plus all models • MyLabFive all models

MyLab40Vet systems with processor configuration index older than CI21 CANNOT be upgraded to software 12.02. For systems with processor CI lower than 21, software 9.13 is the last software upgrade available.

Please refer to the Service protected web site for more detailed information. Downloading of Software Release 12.02 will be free. Installation has to be performed by qualified personnel, it is considered easy and takes approx 1hour. A Service Key is required. Remember to perform the <<Menu – General Preset – OK>> sequence at the end of the Software Upgrade procedure: please refer to the Service protected web-site for more detailed information about the complete Software Upgrade procedure.

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Important Security Note On MyLab units no antivirus software is installed, because it is not possible for the end user to run any external program. Moreover, Esaote software is distributed exclusively on DVD-ROM. The systems where these CD and DVD-ROM discs are produced, are protected with: - Operative Systems and programs updated with the last Security Patches available - Updated Antivirus - Firewall Anyone who downloads .ZIP and/or .ISO files from the Net, has to use only PCs where the above mentioned protections are present. Moreover, the downloaded files have to be loaded only on Read Only DVDs. Software Release 12.02 is contained in the same DVD for all the ultrasound platforms: the same DVD contains the Firmware and Software upgrade to Software Release 12.02 for MyLab40, MyLab20Plus and MyLab30Five. MyLabDesk MyLabDesk Software Setup can be downloaded directly from the ultrasound scanner while performing the COPY of, at least, one archived exam. MyLabDesk can be installed on Windows XP Home, Windows XP Professional, Windows Vista, Windows 7 Operating Systems (please refer to the Readme Text File available within the MyLabDesk Setup for more detailed information). MyLabDesk has to be considered a viewer only, not intended for diagnosis and/or second opinion done directly on the software itself. The intended use of the viewer MyLabDesk is to display the ultrasound studies available in a compatible Esaote Archive file (Esaote proprietary ultrasound studies are located in the folder ARCHIVE). The Software MyLabDesk is provided 'AS IS' and ESAOTE makes no warranty as to its use or performance External Monitor The MyLab family ultrasound systems have the possibility to be connected to a secondary monitor through the VGA output available on the rear panel of the systems. The secondary monitor cannot be used for diagnosis and/or second opinion. ESAOTE makes no warranty as to the secondary monitor use or performance

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2. Introduction Software Release 12.02 introduces improvements and new features regarding Cardiac Application (IVC measurements, Coronary measurements, Cardiologic Report improvements), General Imaging Application (New Biopsy Kits available), Obstetrics and Gynecology Applications (VRA on hypoechoic structures).

3. Cardiac Application The main enhancements regarding Cardiac Application are the following: - Cardiologic Report Improvements - Coronary measurements CFR: Coronary Flow Reserve at baseline and Stress - IVC measurements Inferior Vena Cava measurements specially for Hemodyalisis patients

3.1. Cardiologic Report Improvements Major reorganization of the cardiac measurement package, consisting of: - More than 40 NEW measurements introduced in B-Mode for a more accurate and extensive chambers quantification in accordance with ASE Committee Recommendation for Chamber Quantification. More than 260 measurements are now available in the Esaote Advanced Cardiac Package - A Dedicated Doppler CFR (Coronary Flow Reserve) measure group has been introduced, together with the CFR Doppler and imaging setting already introduced on the devices, it represents an unique package targeting prevention and quantification in cardiovascular ultrasound - Introduction of dedicated B-Mode measurements for IVC (Inferior Vena Cava) - Introduction of MAPSE (Mitral annular plane systolic excursion) and TAPSE (Tricuspid annular plane systolic excursion) Measurement in M-Mode, and Cardiac Output, Cardiac Index, Stroke Volume, Stroke Index in LV M-Mode measurement group - Minor improvements on PAP (Pulmonary Artery Pressure) measurement

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3.2. CFR Measurements New measurements for Coronary Flow Reserve are available in Cardiac package (by default they are set as disabled). Measures: - PW Velocity at Rest of the Left Anterior Descending Coronary Artery Proximal segment (RLADP) - PW Velocity at Rest of the Left Anterior Descending Coronary Artery Middle segment (RLADM) - PW Velocity at Rest of the Left Anterior Descending Coronary Artery Distal segment (RLADD) - PW Velocity at Stress of the Left Anterior Descending Coronary Artery Proximal segment (PLADP) - PW Velocity at Stress of the Left Anterior Descending Coronary Artery Middle segment (PLADM) - PW Velocity at Stress of the Left Anterior Descending Coronary Artery Distal segment (PLADD) Results - Coronary Flow Reserve of the Left Anterior Descending Coronary Artery Proximal segment (CFRP) - Coronary Flow Reserve of the Left Anterior Descending Coronary Artery Middle segment (CFRM) - Coronary Flow Reserve of the Left Anterior Descending Coronary Artery Distal segment (CFRD)

Coronary Flow Reserve (CFR) is the study of coronary flow velocity during a Stress examination Flow velocity is measured on the Left Anterior Descending Coronary Artery (LAD) within the 3 segments (Proximal, Medial and Distal) during Rest, Dipyridamole Stress and Recovering Phases. Anyway, the assessment of Coronary Blood Flow characteristics is meaningful also regarding basal cardiac activity without any externally induced cardiac stress. Coronary Flow Reserve is performed using: 1) Phased Array probe 2) Color Doppler (for the visualization of the Coronary Artery Flow) 3) Pulsed Wave Doppler (for the Coronary Flow analysis)

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Typical Left Anterior Descending Coronary Artery blood flow velocities at basal cardiac activity can be seen in the following image:

3.3. Inferior Vena Cava measurements New Measurements for Inferior Vena Cava collapsibility index are available (by default they are set as disabled). Those measurements are mainly used for hemodyalisis patients Measures: - Maximum IVC Diameter in Subcostal View (IVCmx) - Minimum IVC Diameter in Subcostal View (IVCmi) Results - Indexed IVC size (VCDi) Formula (Body Surface Area required) - IVC Collapsibility Index Formula (IVCCI)

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4. General Imaging Application The main enhancement regarding General Imaging Application is the introduction of new Disposable Biopsy Kits. The Disposable Biopsy Kits compatibility on MyLab40Vet and MyLabFiveVet with Software Release 12.02 is the following: 4.1.Disposable Needle Guides by Protek For more information: www.protekmedical.com

Probe Fixed Angle

Esaote Kit Manufacturer’s kit

CA123 15º DBSC12X 7356 CA421 CA430 CA431

20º 30º

DBS421/431 7352

CA621 CA631

25º 35º

DBS621/631 7354

LA424 LA435

45º DBS424/435 7350

LA523 LA522 LA532

45º 60º 75º

DBS523 7351

EC1123 0º DBSE12X 6360

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4.2. Disposable Needle Guides by CIVCO For more information www.civcomedical.com 4.2.1. Fixed Angle and Multi-Angle Kits:

Probe Fixed Angle

Multi Angle Esaote Kit Manufacturer’s kit

CA123 20º, 35º CBSC12X 639-028 CA421 CA430 CA431

20º 30º CBSC43X 639-018

CA631 20º, 30º CBSC63X 639-019 CA1421 36.3º ABS1421 610-137 LA332 25º, 40º, 50º CBSL33X 639-015 LA435 50º, 60º, 70º CBSL43x 639-023 LA523 LA522 LA532

40º, 55º, 70º CBSL52X 639-022

LA533 40º, 60º CBSL53X 639-034 E8-5 R10P 3º 610-543

EC123 EC1123 3.8º 610-693

EC1123 0º CBSE12X 639-012

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4.2.2. Infinity Free Angle Kits:

Probe Insertion Angle range

Esaote Kit Manufacturer’s kit

CA421 CA430 CA431

42º ÷ 64º IKC43X 639-014

CA631 42º ÷ 68º IKC63X 639-024 LA332 42º ÷ 79º IKL33X 639-026 LA435 42º ÷ 80º IKL43X 639-021 LA522 LA523 LA532

42º ÷ 80º IKL53X 639-016

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5. OB/GYN Application The main enhancements regarding OB/GYN Application (used for reproduction) are the following: - 3D/4D improvements - VRA on hypoechoic structures 5.1. 3D/4D improvements The main improvements regarding 3D/4D are the following: - Plane Orienting and Reference - TSI alternative layout - TSI automatic orientation - Volume Presentation in T-B 5.1.1. Plane Orientation and Reference 3D Planes orienting and their position respect to the patient are now clearer thanks to new graphic reference arrow displayed in the TPI/TMP/TSI interface. Following some simple rules it is possible to establish the relationship between 3D plane and Patient orientation. Below are shown the anatomical planes reference and orientation:

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Considering a Fetal acquisition, if the B-Mode plane reveals the Sagittal Fetal Plane and Cranial (Cr) is on the same side of the , then the TPI,YSI planes will be references as

Considering a Transvaginal (GYN) acquisition, if the B-Mode plane reveals the Sagittal Plane and the Posterior (P) is on the same side of the , then the TPI,TSI planes will be references as

The same volume side on the three 2D planes is indicated with colored arrows.

A

Cr (Sagittal) Ca

P

R

Cr (Coronal) Ca

L

A

R (Axial) L

P

Ca

A (Sagittal) P

Cr

R

A (Axial) P

L

Ca

R (Coronal) L

Cr

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5.1.2. TSI alternative layout In TSI it is now available a 1x2 format. This allows to work with a higher magnification to see the effect of the Thick Slice moving/resizing on the volume window:

Breast Tumor (inversion Mode) Fetal Enhanced Structures

The arrows indicate the same side of the volumetric dataset when represented in the 2D view system

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5.1.3. TSI automatic orientation The Thick slice is always oriented 90° respect to the screen. Each rotation performed on the bidimensional windows does not change the orientation of the thick slice.

5.1.4. Volume Presentation in T-B A 3D acquisition performed in Top-Bottom mode will present the volume 180° rotated with respect to the Z-axis, the Endometrium in GYN application is presented correctly avoiding a manual volume reverse:

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5.2 VRA on Hypoechoic Structures New Volumetric measurement has been introduced in the VRA package: Counting “VRA Counting” has been developed specifically to calculate with accuracy and reproducibility the volume of a set of Hypoechoic structures, allowing then a fast identification of their morphology and position. Each measure performed has associated a predefined color that is shared between the 3D surface and the text label indicating the measure output value. The method to calculate each volume is derived from the well-consolidated VOLUME BY AXIS measure, already available since release 10.01. Activation No licenses are needed for VRA Counting. Here below the complete procedure to perform a “Volume Counting” measurement. Step_1: Find the best projection on the three planes of the first target to measure. Do this before selecting the VRA icon

Step_2: Press VRA icon, and select the COUNTING menu’ item

Select COUNTING measure mode, from VRA measure menu

Navigation Target well positioned in the center of the first Hypoechoic target that is clearly visible over all the three TPI planes

Note VRA icon have not been selected yet. TPI environment is active

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Step_3: Use the navigation cursor to select one of the three views where to start the measurement

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It is possible to perform a maximum of Eight measures

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VRA COUNTING measure has an intended use of Generic Measure. It is possible to use the ADD TO REPORT capability to have the result in the Worksheet and Report

Nice 3D Visualization can be obtained combining the Original 3D acquisition with the surfaces obtained from the previous measurements. The following picture reports the original volume in Triplanar and the VRA COUNTING surfaces:

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6. General Improvements and Changes The main general improvements and changes available with the present Software Release 12.02 are the following: - New Codec for Clip Export Increased Compatibility - New probe covers for TEE Probes - New Disinfection, Cleaning and Sterilization Products available 6.1. New Codec for Clip Export Increased Compatibility A new Codec is available for the Export of Clips in PC-compatible format. The user has the possibility to choose among three different codecs. The new one is the MS-WMV9 Codec which represents an optimized choice for good compression and improved compatibility with external software. 6.2. New probe covers (for TRT33 and TEE Probes) 6.2.1. TRT33 sterile cover balloon A new endocavity balloon from CIVCO (P/N 610-898), NOT COMPATIBLE with biopsy procedure, is now available to be used with TRT33 probe Follow the detailed instructions inside the CIVCO packaging before the use. Each package contains 10 units. The Endocavity Balloon was designed to provide a snug fit to endocavity transducers, providing a small insertion profile to minimize patient discomfort. The balloon features adjustable inflation control to maximize user control over prostate shape and height, speed set-up and allow gland positioning to an optimal focal length to enhance the ultrasound image. The latex-free balloon's user-friendly "easy purge" system overcomes the trapped air disadvantages of other inflatable standoffs.

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6.2.2. TEE Sterile cover A new sterile cover from CIVCO (P/N 610-933) is now available to be used with our TEE probes. Follow the detailed instruction inside the CIVCO packaging before the use. Each packaging contains 12 units. These latex-free transesophageal echocardiography (TEE) covers feature a custom tapered design to provide a tighter fit to adult and pediatric TEE transducers. The new improved covers provide a defense against cross-contamination, while protecting the transducer. The adult form-fitting covers are preloaded on the applicator for ease of application to TEE transducers. Bite blocks provide a safe passage through the patient's mouth

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6.3. New Disinfection, Cleaning and Sterilization Products available Tristel Duo and Tristel Sporicidal Wipes are recommended Cleaning and Disinfecting agents for Endocavity Probe EC123 and EC1123, Intraoperative Probe IOE323, Transesophageal Probes TEE122, TEE132 and TEE022 Tristel Stella is a recommended Sterilization tool for Intraoperative Probe IOE323, Transesophageal Probes TEE122, TEE132 and TEE022 The main ingredient of the Stella products is Chlorine Dioxide. The Tristel products and system are not FDA approved

Tristel DUO

Tristel Sporicidal Wipes

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Tristel Stella Automated Disinfection System for Transesophageal and Endocavity Probes:

Stella Disinfection System fits neatly on a bench top and is designed to be used with Tristel Fuse for Instruments (5 minute contact time). A track and traceability system is available for extra security. It is unique in enabling and recording all steps of the disinfection process and is to be used for the high-level disinfection of all small to medium size instruments such as TEE probes, trans-vaginal/trans-rectal ultrasound probes For more information about Tristel Stella, visit the following Web-sites: - http://www.stella-performance.com/ - http://www.tristel.com/stella.html The Stella disinfection system is available in the following countries: Belgium, China, Germany, Greece, Ireland, Israel, Italy, Luxemburg, Malaysia, Netherlands, New Zealand, Pakistan, Russia, Singapore, Spain, United Arab Emirates, United Kingdom For more information about Tristel Stella distributors visit: - http://www.tristel.com/partners.html