The most recent release of ECTb AI is v4.2 with a release date of 3/14/2019. Below you will find Electronic Instruction (eIFU). Note: IFU is provided in electronic format. The application and eIFU are provided for professional use only. The eIFU is in compliance with eIFU Regulation 207/2012 .The eIFU is updated when appropriate through customer feedback (emails or annual Post Market Survey) or when software changes are implemented that affect eIFU.
Dear Emory Cardiac Toolbox™AI User:
The Emory Cardiac Toolbox™ program provides for the analysis and display of myocardial PET and SPECT patient studies. The Emory Cardiac Toolbox ™ application and documentation can be downloaded from our web site at http://www.syntermed.com/client. The password to enter on this screen is Client123 and on the Client Portal screen click on the Emory Toolbox link to go to the installation page and follow the instructions listed there. Before implementing this program you must read the user manual and process the example patients as a quality control check of the software.
Additional information related to the application are listed below:
Initial execution of the application
Syntermed sales – Once the software is installed there will be a Syntermed icon on the desktop of the Windows PC. Click on that screen to launch the Master Control Program (MCP) and that is where the patients will be listed to launch into the Emory Cardiac Toolbox application for processing and display.
Original Equipment Manufacturer (OEM) sales – The OEM resellers have integrated the Emory Cardiac Toolbox into their operating system. The process of launching the Emory Cardiac Toolbox application on their system will be explained in the OEM User Manual.
Accessing the Electronic Instructions For Use (eIFU)
-Website – The eIFU documents can be accessed on our website from the client portal listed above. Once on the Emory Cardiac Toolbox page go to the link that is labelled Electronic Information For Use (eIFU) and click on that link to be directed to all of the eIFU information.
-In Real Time through the Application – The eIFU can also be accessed while executing the application in real time by go to the File/Help/Help Page and the Technical Reference page will be displayed.
-Request for Paper IFU - Customers may request the IFU in printed paper form at no additional cost. The customer should contact Syntermed by mail, email, or the phone number listed below and provide us with their address. The paper copy of the IFU will be sent back to them within 7 days of receipt of the request.
Hardware System Requirements
The system requirements are listed at the following link: www.syntermed.com/system-requirements.
Training and Support
Syntermed sales – Syntermed provides remote on-line training for the customer. Syntermed will provide the necessary training required until the customer is satisfied that all of their personnel are comfortable in the use of the application. Syntermed will provide on-site training for an additional fee. Syntermed also provides 24/7 on-line support for the first year of use and subsequent years if the customer has signed onto our Software Maintenance Plan.
Original Equipment Manufacturer (OEM) sales – The OEM handles all of the front line training and support for the application executing on their operating system. Syntermed will provide second level support if requested by the OEM.
Audio/Visual Training Aids – Audio/Visual aids for processing and display of the Syntermed applications are provided on our website at the following link: https://www.syntermed.com/learning
Additional Languages supported by the application and IFU
Application – The user interface for the application can be executed in the following languages: Dutch, English, French, German, Italian, Norwegian, Spanish, Swedish, Danish, Finnish, Chinese, Japanese, Russian, and Portuguese.
IFU – The IFU for the application is provided in English.
Medical Device Regulatory Compliance and Statement
United States – Syntermed is registered with the FDA (Number 1066019) and FDA Owner/Operator Number: 9041128. Syntermed has obtained the necessary Pre-Market Notification 510(k)’s for the application to comply with the FDA regulations allow for the commercial distribution of the application in the United States.
Europe – ISO certification 13485:2016 certificate number FM 670241. Notified body BSI (0086), CE Mark 696491. Authorized Representative in Europe is MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany. Syntermed has complied with all of the requirements related to ISO and CE Mark to allow for the commercial distribution of the application in Europe
Compliance Statement: Syntermed is in compliance with Directive 95/46/EC. The Syntermed eIFU are in compliance for protection of personal data, protection against software and hardware intrusions, and provide a version history of the eIFU.
Please contact us if you have any questions or comments related to the Emory Cardiac Toolbox application.
Kenneth Van Train
245 S. Owens Drive
Anaheim, CA 92808
888 263-4446 ext 102
Support: 888 263-4446 ext 101
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