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Summary
ClinSpark supports a number of workflows that can involve reviews of ECG data. Standard reviews can be done on specific timepoints that allows qualified users to review static outputs of parameters and PDF renderings of ECG waveforms. However, more advanced ECG reviews are also possible allowing investigators and cardiologists the ability to further analyze and annotate ECGs, overlay multiple timepoints to look for trends, or change automatically placed calipers for a more accurate assessment of key ECG parameters for applicable trials.
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ClinSpark supports advanced reviews through all of the ECG file types supported by CalECG, which includes (but are not limited to) FDA XML, MUSE XML, CardioSoft XML, and Mortara XML.
Overview
The following video provides a high level overview of the advanced overread capabilities between ClinSpark and CalECG.
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Requirements for Use
Advanced overview capabilities are dependent on local user workstations having both CalECG and the ClinSpark Agent installed. The minimum required Agent version for the integration is 1.3.1, however, it’s recommended that users install the latest version of the Agent whenever possible. Details about Agent releases are in this help article.
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NCALECG-4_1_0-GOLDP4_BROCK 20210304173257
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To verify that the correct build is installed, users can open the CalECG4.exe executable in the installation directory:
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C:\Program Files (x86)\AMPS\CalECG
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Using the Help menu, select About CalECG4…
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Within the About screen, you will see the product name listed as CalECG-CS and Build Info reporting the unique build number, which is different from the commercial release.
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Installing CalECG
To acquire the installation files for the ClinSpark specific build of CalECG, customers must reach out to Foundry Health via the Service Desk to request a download link.
The installation process can be completed by running the application setup file. Selecting default installation settings is recommended.
Managing License Files
CalECG is a licensed product that requires a valid license file matching the version and build of CalECG being invoked. For example, a version 4.1.0 commercial license file will not work with the ClinSpark specific build of CalECG.
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Note: Upon any instance where CalECG is uninstalled / reinstalled, existing license files in the ‘Licenses’ directory are removed. It’s recommended that license files are backed up locally under any circumstances where a reinstall may be necessary.
Enabling Advanced Reviews
During onboarding, customers will work with Foundry Health to establish a proper set of environment configurations that enable the use of advanced reviews and configurations of CalECG features. These are some examples of applicable settings:
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With certain system configurations in place, users can also enable advanced reviews on a per-study basis by visiting the ECG > Configure component.
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Troubleshooting
ClinSpark users will receive an error message if attempting to invoke advanced review capabilities without the proper version of CalECG installed, or, without a valid license file.
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ClinSpark Agent log files may also contain logged statements if issues occur between ClinSpark and CalECG. It’s recommended that customers reach out to Foundry Health via the service desk to report any potential interface issues, and supply the ClinSpark Agent log files during that process to further troubleshoot.
Additional Resources
The User Manual and System Manual documents are provided to users via the CalECG installation process, accessibly within the application installation directory. They are also provided here for reference.
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