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Summary
RScribe Lite (FDA K120865 // Globally registered) is an embeddable API software version of RScribe PC ECG, distributed as an MSI software package. It is installed on a Windows host PC, and relies on ClinSpark for subject management and database storage.
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Additionally, RScribe Lite provides automatic interpretation and reporting of the ECG data.
RScribe Lite Kits
RScribe Lite works with standard Hillrom AM12 patient cables and lead sets. It can be made available to ClinSpark customers in two kit configurations.
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RScribe Lite Kit w/AHA Leads - 108089
1 RScribe Lite Software license, XML enabled
ECG Clip Adapter (set of 10) (9281-002-50)
Snap electrodes (PK/10) (108070)
AHA lead set with banana clips (9293-046-60)
AM12 ECG Acquisition Module (Repair Only: 9293-048-55)
RScribe Lite Kit w/IEC Leads - 108120
1 RScribe Lite Software license, XML enabled
ECG clip Adapter (set of 10) (9281-002-50)
Snap electrodes (PK/10) (108070)
IEC lead set with banana clips (9293-046-61)
AM12 ECG Acquisition Module (Repair Only: 9293-048-55)
Purchase, Pricing & Warranties, Lead Time
Kit Pricing
Only available from Foundry Health, an IQVIA company, Grafton WI, USA
$3000 each
Software support and maintenance
Optional support and maintenance: $560 site/year after the end of 1-year warranty
Warranties
AM12 - 1 year
Lead set - 90 days
Lead time
15 Business days
Support
Deployment Support
Foundry Health shall perform first line Customer deployment, training, and “go-live” support via its normal service desk channels
The scope of this support is limited to the configuration and use of RScribe Light with ClinSpark, and excludes the medical interpretation of ECGs
Hillrom shall provide second line support to Foundry Health as needed
Technical Support
Foundry Health shall perform first line support via its normal service desk channels
Hillrom shall provide second line support to Foundry Health whenever the component products do not perform correctly
Test and Inspection & Consumables
Test and Inspection
Local regional representatives of Hillrom can be contracted to perform field test and inspection of AM12 units and lead sets
Such contracts fall outside the scope of any agreements with Foundry Health
Consumables
Local regional representatives of Hillrom should be contacted for consumables
Foundry Health does not supply consumables
Demonstration
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Installation
The RScribe Lite installation package is a compressed ZIP directory that contains software and hardware drivers necessary to use the interface. This package must be acquired from an authorized supplier. ClinSpark customers that purchase RScribe Lite through Foundry Health should reach out via the service desk to request a download link.
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Although not required, it is recommended to restart the computer after install to ensure application properties were properly registered by Windows.
Default Installation Directory
The default installation directory is C:\Program Files(x86)\Mortara Instruments Inc\RScribe Lite\
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Of particular importance is a directory called ‘SlotFiles’. This folder contains all of the default (out of the box) set of configurations which influence certain settings of the interface and processes that produce PDF/XML order files.
Mortara PDF Generator Utility
In addition to the application itself, the installer package also includes several companion utilities necessary for proper order functions.
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The following video addresses some of the important points relating to the install process and related utilities:
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Directory Permissions
It is important that the Windows user account invoking the RScribe Lite application has write access to the C:\ProgramData\Mortara Instrument Inc\ directory and all sub-directories. This is the ‘working’ directory location that RScribe Lite uses for orders.
This directory may be hidden by File Explorer by default. Within a Windows Explorer window, the View settings can be used to show hidden files before being able to see this if needing to investigate directory permissions.
AM12 Drivers
When the AM12 device drivers are installed correctly, plugging in the AM12 via USB will prompt Windows to recognize the device and it will show up as a ‘USB Patient Cable’ in the Windows Devices area.
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Confirm that ‘include subfolder’ option is checked.
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Running RScribe Lite
The RScribe Lite interface is invoked through an ‘embedded’ workflow via API. It has been designed so that order workflows are launched via ClinSpark. The application interface cannot be launched or started in any standalone mode outside of ClinSpark workflows.
ClinSpark Agent
The ClinSpark Agent must be installed on the host PC in order for the interface to function. The Agent helps to facilitate data collection workflows by reviewing the XML/PDF outputs of RScribe Lite in certain local directories and populating the data collection fields automatically for users in ClinSpark. It also facilitates the use of ‘Offline Mode’ capabilities (explained in a later section of this document).
Without the Agent installed and/or running on the host PC, the interface will not function.
Interface Walkthrough
When users click the ‘Invoke Device’ button from an applicable connected device form in ClinSpark, the Agent will automatically facilitate the process to invoke the RScribe Lite executable, provide the order details, and begin the ECG capture workflow.
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The functionalities directed to in the image above, shown as interactive buttons on the right side of the interface, are described in the following sections.
Modify Demographics
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Figure: Modify demographics button.
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Figure: Example of modifying the local XML configurations.
Capture ECG Recording
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Figure: Capture ECG recording button.
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Immediately, the ClinSpark Agent accesses these files created by RScribe Lite and sends relevant order information from XML file back to the ClinSpark form items, as well as the final PDF report.
ClinSpark EDC Device Configurations
Changes applied to the device interface configuration within ClinSpark (via Devices > Configure) influence how RScribe Lite can be invoked via the Agent, and, how order files are processed. These ClinSpark configuration changes can only be done by a Foundry Health superadmin user.
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The following device settings should be discussed first with the Foundry Health team prior to a customer requesting their application/use in a given ClinSpark environment.
Setting Key | Setting Value (default) | Description |
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XmlInputDir | C:\ProgramData\Mortara Instrument Inc\RScribe Lite\Input | XML order input directory. This is where the ClinSpark Agent generates orders sent to RScribe Lite in XML format. |
XmlOutputDir | C:\ProgramData \Mortara Instrument Inc\RScribe Lite\Output | XML order output directory. The ClinSpark Agent polls for order results in this location. The XML from order output is used to populate the relevant ClinSpark form. This directory is the same for the PDF report, and therefore a PDF output directory configuration option is not available or necessary. |
RScribeExe | C:\Program Files (x86)\Mortara Instrument Inc\RScribe Lite | RScribe Lite executable invoked by the ClinSpark agent at launch. |
ArchiveDir | C:\ProgramData\Mortara Instrument Inc\RScribe Lite\Output\Processed | Archive directory where the ClinSpark Agent will move processed order XML and PDF files. |
ArchiveDir (Archive Directory)
For the archive directory, “processed” in this context means the XML and PDF file pairs that are sent to ClinSpark for form population. With this configuration, processed files can be sent to a local drive, or a shared network drive.
ArchiveDir follows the following naming hierarchy (If found, hierarchy terminates. If not found, keeps checking down the list, with the final naming convention defaulting to “unknownhost'):
yyyy-MM-dd is the name of the first folder within the specified Archive Directory. Below are the potential sub-directories of this directory:
Host name
User name
‘unknownhost’
InitScript
There is an ‘InitScript’ device setting that can be used to impact how certain parameters are passed to XML order files created by the Agent, when the ‘invoke device’ workflow is initialized from a connected form. This influences one of the order ‘inputs’ to RScribe and subsequently also the XML/PDF pairs produced when the order is completed.
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For further clarification on this setting, customers should reach out to Foundry Health support team members via service desk for assistance.
RScribe Lite Application Configuration Files
When RScribe Lite is installed, a standard ‘out of the box’ set of configurations (represented in XML files) and system settings are put in place to facilitate ECG order workflows. Most of these configurations are sufficient for standard use of the application, however, certain situations or environmental variables may require that these settings are modified for optimized use of the application.
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Understanding the management of ‘SlotFiles’ directory
At first run of RScribe Lite, it checks if the following directory exists:
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The above process will ensure that the latest set of configurations are copied from the ‘main’ installation directory and over to the ‘working’ directory for all future orders.
PDF Writer ‘Temp’ Directory
RScribe Lite uses a temporary directory to perform certain operations with PDF file creation.
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https://vimeo.com/582108984/60a91eaceb
Updating Registry Settings for PDF/XML Output
During the last step when processing the order files, RScribe Lite references the path of the outgoing results directory in the following registry location:
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The registry key is created at installation, if it does not exist, and populated with the default value. The path indicated is used to store the output resting ECG .pdf and .xml files.
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Modifying AC Filter Setting (50Hz, 60Hz, or None) or Low Pass Filter
Users of RScribe Lite in different regions of the world may want to modify the default AC filter configurations to ensure they do not have any power-line noise in ECG capture. In large parts of the world this is 50 Hz, although in the Americas it is typically 60 Hz.
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If users have stored exams where this setting needs to be changed, there will be a RestingSystemSettings.xml file with that stored exam, and it will need to be modified as described above.
Modifying Default Lead Layout Setting
Similar to above, the default lead layout presented on the .pdf generated after capturing an ECG can be modified using the RestingSystemSettings.xml file found in:
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_3_1_Channel
_3_3_Channel
_6_Channel
_12_Channel
_6_6_Channel
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Modifying PDF Output
The following video shows end-to-end how to make an RScribe Lite update to change the default PDF layout.
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RScribe Lite Log Files
RScribe Lite log files are created and stored in the C:\ProgramData\Mortara Instrument Inc\RScribe Lite\LogFiles directory.
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This is important to understand for support purposes when needing to troubleshoot issues that may have occurred on a specific date/time. The window of time to review those before they get replaced with another month’s log entries is small.
Interface Inputs
When “Invoke Device” is clicked in ClinSpark, the web client contacts the ClinSpark server, and retrieves an order number that is associated with a row in the ClinSpark database. This row is to be filled in with ECG data for the specific subject, as specified during study setup.
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The XML order file is stored in the RScribe Lite “Input” directory. From there, RScribe Lite uses this as ECG input. It should be noted that once an input file is picked up by RScribe Lite, it promptly deletes that input order so that only one order ever is available to be received at a time. This prevents the possibility of input and output order numbers mismatching, and prevents data mismatch.
Interface Outputs
Once RScribe Lite (via user input) is done capturing ECG data, it compiles and exports its own XML and PDF files (can be one pair of XML and PDF documents, or many pairs depending on how many ECGs are captured) containing both subject information, order number, and ECG analysis/plots to its designated “outputs” folder.
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To access the PDF in ClinSpark, users then click “Save and Return” after the form has been populated. A “download attachment” button will appear next to the Item field EGPDF.
Architecture Diagram
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Typical Order Workflow
The ClinSpark Agent receives messages from the ClinSpark browser (in JSON format, sent after “Invoke Device” has been clicked) containing relevant information for the ECG order.
The Agent generates an XML file (“input XML”) with this information, and locates input and output directories in RScribe Lite.
The Agent then locates the RScribe Lite EXE, and sends the input XML to the input directory. Then the RScribe Lite executable is run.
RScribe Lite begins running simultaneously as the Agent clears any and all files in the input directory (to ensure only one order can ever be processed at a time).
RScribe Lite runs and functions based on user input. Upon completion (and termination), stores output PDF and XML files in the output directory.
The ClinSpark Agent pulls in the most recently time stamped XML and PDF files, and archives any additional files in this output directory.
The ClinSpark Agent then parses the XML data into JSON, and sends all relevant information back to the ClinSpark browser for ECG form population (including the PDF file).
The ClinSpark Agent then saves the XML and PDF files to RScribe Lite’s “Processed” folder, or the configured Archive Directory (ArchiveDir). This Archive Directory can include a local drive, or a shared network drive.
Data
Data included in the output XML file, and received by ClinSpark
PR (ms)
QRS (ms)
QT (ms)
QTc (ms)
QTcF (ms)
QTcB (ms)
RATE (BPM)
RR (ms)
P_Axis (degrees)
QRS_Axis (degrees)
T_Axis (degrees)
EGTXT (this is an auto-interpretation of ECG results by R-Scribe)
EGDTC (DDMMMYYYY HH:MM:SS)
EGPDF (PDF Document).
Where in the XML is Data?
Found in the section at the top of the XML Doc
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The ClinSpark Agent is responsible for sending both the XML and the PDF to ClinSpark.
Example XML / PDF Files
Example Input XML File:
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Offline Mode
It is possible to use the RScribe Lite interface in an offline mode in the event that ClinSpark were to be unreachable by the internet at a site. This functionality is supported on data collection machines using ClinSpark Agent version 1.2 or greater.
Most of our customers work in facilities with backup power and with multiple redundant internet access, so the chances of invoking offline mode are considered to be extremely low. However, in the event of no internet connectivity, the following video demonstrates how ‘offline mode’ would function.
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Additional Notes
Handling Multiple ECGs in RScribe Lite
Only the most recent ECG in regards to the timestamp (established within RScribe Lite) is saved, and will have its data populated into the applicable ECG form item group in ClinSpark. That means if more than one ECG was taken, only the last one (timestamp wise) is usable and saved through ClinSpark. Please refer to the figure and accompanying text below for a better understanding:
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A very easy way to know which ECG will be used is by looking at the order of tabs. The tab furthest to the right is the ECG that will be used to populate the associated form item group in ClinSpark.
Accessing Uploaded ECG data locally
If you wish to view the XML and PDF of the ECG that populated the ECG form in the ClinSpark web app, you can navigate to RScribe Lite’s “Processed” folder and access it there:
C:\ProgramData\Mortara Instrument Inc\RScribe Lite\Output\Processed
Lead Failure Detection & RL
Lead failure is detected by front end devices, such as the AM12, and then communicated to RScribe Lite.
Specifically for RL lead fail, this is not reported by the AM12 or WAM. RL is not used for measurement or ECG data, rather it is used for noise cancellation. The RL lead is driven to achieve superior common mode rejection and to bias the amplifier inputs but is not used to provide differential ECG data.
Anti-malware conflicts
There are known issues with deploying and using RScribe Lite on site PCs where there are anti-malware and/or endpoint protection programs in use. While the full contents of the RScribe Lite installation “package” are safe for use, anti-malware applications will sometimes report false positives and block the successful invocation of executables throughout order workflows.
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It’s strongly recommended for customers to consider reviewing their anti-malware and endpoint protection deployment to ensure there are no conflicts with installed RScribe components.
Failure to create PDFs with return code -532462766
Under conditions where the order workflow fails to produce a PDF file with the following symptom:
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The following screencast also demonstrates order failures when the PDF printer driver is missing.
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Orders fail to create/succeed due to malformed XML
During the order creation workflow, ClinSpark crafts a message for Rscribe Lite that contains order number and subject information. This information is comprised of data from ClinSpark such as Study Event, Study, Subject ID, etc. All of this is delivered to the ClinSpark Agent structured as JSON. The Agent converts this JSON into object code, and correspondingly generates an XML file that contains the ClinSpark subject information and a unique order number. From there, RScribe Lite uses this as input.
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The most common modality of these erroneous characters being put into the ClinSpark interfaces are when they are cut and paste from external sources like Microsoft Word documents. Standard keyboard inputs would rarely ever produce a non-acceptable value in the order workflow.
Configuration settings that influence ClinSpark study/subject details on PDF
In the CFD.en.xml file there exists a MaxSize value which can allow up to 48 characters to appear on the demographic fields which are on the generated PDF.
LastName (ClinSpark study)
PatientID (ClinSpark Subject ID)
FirstName (ClinSpark study event)