Introduction, Cautions and Warnings, Installation
Contents
1. Echolnsight Warnings and Precautions General WARNING Federal law restricts this device to sale distribution and use by or on the order of a A A physician Caution Access to the device should be limited to trained individuals suitably qualified to interpret echocardiographic examinations Users must be familiar with the contents of this User Manual prior to using this software Caution Do not attempt to update this software application except with installation update files and instructions provided by Epsilon Imaging Caution Performance of Echolnsight speckle tracking algorithms on tissue speckle in studies using contrast agents is dependent on the signal level of the tissue speckle which may be significantly reduced when contrast agents are used Accuracy of tissue tracking may be reduced in these studies Measurement Accuracy A Caution Linear distance measurement accuracy varies with the orientation of the measurement line and the maximum depth of its endpoints Typically vertical i e along beam measurements have better accuracy than horizontal i e lateral measurements Absolute distance measurement accuracy is limited by the input data s spatial resolution as determined by the originating ultrasound imagery collection system and the settings used for the collection Considering a typical machine with vertical along beam resolution of approximately 1 25mm and 5mm lateral resolution at 10cm dept2. e Collection parameters depth width frequency and the resulting imaging resolution e Frame rate effects include increased frame to frame speckle decorrelation at lower frame rates as well as potentially insufficient temporal sampling of high rate of change motion parameters e Data storage parameters smoothing or filtering data compression Further error inducing factors are inherent to Echolnsight analysis methods and TissueTrack speckle tracking processing that influence overall accuracy and precision of derived motion measures include e Size of ROIs via the number of included speckle suitable for tracking e Location of ROIs with respect to the desired physical object of measurement e Speed of motion being tracked combined with proximity of the motion measurement ROIs to the probe high speed motion close to the probe may not be tracked accurately e A nominal tissue sound velocity is assumed for all calculations analyzing tissue having sound propagation properties different from the nominal assumption may result in some error e Correct cardiac cycle definition Caution Area volume and ejection fraction measurements are subject to several error inducing factors which must be assessed by knowledgeable and trained users e Overall tracking quality e Accuracy of endocardial tracing e Validity of Simpson s Rule of Disks given the specific shape of the chamber WARNING Information on cardiac tissue motion p
3. COM IMAGIN G Echolnsight o Look for Microsoft NET Framework 4 5 If not present then execute dotNetFx45_Full_x86_x64 exe in the Support Software Installers folder e Install the MATLAB Compiled Run time environment MCR by executing the MCRInstaller64 exe installer file out of Support Software Installers folder Take all default configuration selections and respond affirmatively to each prompt e Install the security key USB driver software using the following steps Do NOT plug in the USB key until instructed to do so o Run Install exe from the Keylok folder in Support Software Installers Click in the USB Dongle checkbox in the pop up to select dongle type Another pop up appears click OK Click Begin Install Install the USB key in a USB port when next pop up instructs to do so Click Close Found New Hardware Wizard pop up will appear click Next o Click Finish on the last pop up e Run EcholnsightSuitelnstaller64 msi found on Echolnsight distribution media e License MultiTech software library for use on computer See instructions in Echolnsight Documents Additional Info folder on computer desktop e Copy Echolnsight_Test_Data folder from installation media device to the c ProgramData Epsilon Imaging folder e Install Adobe Reader by pointing a browser to http get adobe com reader uncheck optional offers and click Install now but
4. Echolnsight Thank you for choosing Echolnsight This brochure provides information you need to know about installing Echolnsight and important Warnings and Cautions about its operation and use AN Users must be familiar with the contents of the User s Manuals and Quick Reference Guides including all Warnings and Cautions contained therein prior to using this software These Warnings and Cautions are also provided in the next two pages of this brochure Instructions for installation of this software on customer hardware are provided here following the Warnings and Cautions If your delivery of Echolnsight includes Epsilon provided computer hardware these installation steps have already been performed by Epsilon Imaging All Echolnsight documentation User s Manuals and Quick Reference Guides and additional information is available in the Echolnsight Documents folder as PDF files installed on your computer s Desktop by the Echolnsight software installation process Manuals and guides are also available for viewing on Epsilon s website Printed versions of these manuals and guides are available and provided at no cost to customers within 7 days of request Epsilon Imaging Inc 3917 Research Park Drive Suite B 7 Ann Arbor MI 48108 Telephone 734 369 5100 Fax 734 369 5120 Email support epsilon imaging com EPSILON Website www epsilon imaging com IM A G N G U000299 Rev E Pagel IZ K ES sil COM IMAGIN G
5. h the lateral resolution at other depths can be estimated by the formula lateral resolution 0 05 x depth Data originating from other ultrasound machines may have different fundamental resolution characteristics Caution Linear distance measurement accuracy is limited by the originating collection system s fundamental axial and lateral resolutions Full understanding and estimation of the accuracy of a linear distance measurement requires that the user know the resolution limits of the data source for the data being analyzed Distance measurement accuracy of the caliper tool is based on the assumption of ideal tissue that is a tissue characterized by a sound velocity of 1540 m s Therefore caliper measurements are subject to an additional error due to sound velocity variation Sound velocity may vary from approximately 1450 m s in fatty tissue to 1585 m s in muscle This can in simple cases give rise to errors of up to 6 for linear measurements This inaccuracy may be further increased by refraction occurring at tissue boundaries U000299 Rev E Page2 Dl ES sil COM IMAGIN G Echolnsight Warnings and Precautions continued Caution Measurements are subject to many sources of variability most of which result from data quality impacts on tissue motion tracking including e Image quality signal level noise nearfield clutter reverberation physiologic artifacts e g lung obscuration breathing induced motion probe motion
6. hanges Unpack set up workstation equipment Power up workstation Login as local Admin on workstation obtain credentials from site IT personnel for customer provided hardware or from Epsilon Imaging for Epsilon provided workstations Configure workstation for integration into site network domain if required by site IT person Customer supplied computer Perform software installation below Configure DICOM parameters in Epsilon application software for site PACS connectivity See Echolnsight User s Manual Appendix A Test all DICOM data transfers via all configured transfer method s Click on the Echolnsight Suite icon on your desktop to get started using Echolnsight Software Installation if not pre installed Determine if all the required software libraries NET 4 5 Visual C 2013 and 2010 are already installed if not install them Use Control Panel gt Add Remove Programs to inspect your computer You will need Administrator privileges to perform installations Installation files for these support software utilities may be found in the Support Software Installers folder on the Echolnsight distribution media o Look for Microsoft Visual C 2013 Redistributable and 2010 versions in list of Currently installed programs and updates if not present then execute vcredist_x64 2013 exe and vcredist_x64 2010 in the Support Software Installers folder U000299 RevE Page 4 Dl ES sil
7. rovided by Echolnsight analysis application software is subject to several confounding factors and must be interpreted and judged by a physician properly trained in echocardiography and its limitations as well as in the use of and proper operation of EchoInsight analysis applications Users must be familiar with the contents of the User s Manuals prior to using this software U000299 RevE Page 3 WS 4 ES sil COM IMAGIN G Echolnsight System Requirements A Workstation class desktop or laptop computer Processor Intel i5 or i7 processor 2 7 gigahertz or better Memory 8 gigabytes or more Storage 500 gigabytes Monitor Specifications Resolution 1920 x 1080 Brightness Luminance At least 250 CD m2 Contrast ratio At least 500 1 View angle At least 160 deg Operating System Windows 7 Pro 64 bit Spare USB port Compliance with safety amp interference standards for commercial office computer equipment including Class B per Part 15 of FCC regulations UL 60950 1 WARNING Installation and use of the software on computers not having the required characteristics should not be attempted Incorrect operation and erroneous output may occur Workstation Installation Instructions Site personnel who should be present or on call available during installation o Clinical Systems Manager o Site IT responsible individual o PACS responsible individual someone with ability to make PACS configuration c
8. ton e Configure DICOM parameters in Epsilon application software for site PACS connectivity See Echolnsight User s Manual Appendix A e Click on the Echolnsight Suite icon on your desktop to start using Echolnsight O O O O 1 Installation Verification Instructions e See User s Manuals Appendix B for verifications that should be performed for software only installations on user provided hardware U000299 RevE Page5
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