Mortara RScribe Lite

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.

The software acquires and analyzes ECG signal input. It allows users to collect the following information from a standard 12-lead ECG:

• PR Interval

• QRS Interval

• QT Interval

• QTc Interval

• QTcF Interval

• QTcB Interval

• Rate (Ventricular, BPM)

• RR Interval

• P-wave Axis orientation

• QRS Axis orientation

• T-Wave Axis orientation

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.

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 IQVIA

• $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

• IQVIA 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 IQVIA as needed

Technical Support

• IQVIA shall perform first line support via its normal service desk channels

• Hillrom shall provide second line support to IQVIA 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 IQVIA

Consumables

• Local regional representatives of Hillrom should be contacted for consumables

• IQVIA does not supply consumables

Demonstration

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 IQVIA should reach out via the service desk to request a download link.

When expanded, the root directory contains a folder expressing the current RScribe Lite version (1.0.2.3) and a ‘Files’ directory that contains the following:

1. RScribe Lite installation executable / MSI

2. AM12 drivers

3. Mortara PDF printer installation executable

For all standard installations, users should invoke either the ‘Setup.exe’ installation executable or the ‘RScribeLite.msi’ MSI installer. They perform the same installation process.

It is recommended that installation is performed by a user with elevated (Administrative) privileges on the local PC. Issues are likely to occur if the installation process is done without proper permissions.

The installer will ensure that dependencies, such as the AM12 drivers, are done so at the time of install. That said - it’s strongly recommended that users test out physical connections with AM12 devices immediately after installation to confirm that all device drivers are properly installed and ready for use. As necessary, users can also manually install the AM12 drivers using the provided files in the installation package. More details on that process are covered later in this document.

Click Next.

It is advised to keep the installation directory at the default “Program Files”. Click Next.

Click Next; if prompted, allow the installer permission to make changes to your computer.

Click Close.

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\

This directory contains all of the RScribe Lite application and configuration files. The directory is write-protected, meaning any modifications to folders/files in the directory require elevated user privileges.

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.

In particular, a printer driver/application called Mortara PDF Generator is installed which shows up as a printer named Mortara PDF in the Windows printers interface. This printer is a critical part of the application’s function to produce the PDF reports at the end of the ECG order process.

This printer driver can be further modified by an application that lives in the C:\Program Files(x86)\Mortara\ directory, which is separate/different from the default RScribe Lite install directory. If the ‘Mortara’ directory with the printer driver/utility is modified or deleted, you will not be able to un/install the printer driver necessary for generating PDFs again as it’s only created a single time from the initial install.

It’s important that any companion utilities installed (such as the PDF Generator) are left in tact after installation.

The following video addresses some of the important points relating to the install process and related utilities:

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.

Additionally, the device should also register and appear in the Windows Device Manager:

However, sometimes users may still experience issues where plugging in the AM12 device reveals a notification in Windows stating that ‘USB Patient Cable’ drivers are unavailable.

Windows Event Logs may also indicate a similar message.

Additionally, ECG recordings may present ‘flatline’ waveforms when using RScribe Lite. This is also symptomatic of a possible hardware issue with the AM12.

To address these issues, users should first check all physical cable connections between the lead-set on the AM12 device through to the USB connection on the computer and ensure everything is seated properly. Users may need to alternate connections between USB ports on the PC to find a connection that works. It’s typically recommended to wait 10-15 seconds after plugging in the AM12 to ensure a connection is properly recognized and waveforms appear in RScribe Lite.

Once physical connection issues are ruled out, users are encouraged to reinstall the AM12 drivers provided in the RScribe Lite installation package.

Users can use these drivers to manually update/reinstall via Windows Device Manager. The following process can be followed is for manual driver updates.

Through device manager on the device in question, select ‘Update Driver’ option.

Initiate the driver search manually.

Browse for the driver. Select the ‘WAM AM12 Driver’ folder included in the installation package.

Confirm that ‘include subfolder’ option is checked.

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.

RScribe Lite presents itself in an order screen as shown below:

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

Figure: Modify demographics button.

The first button from the top allows the user to add or modify subject information for the current order. The interface is designed to have ClinSpark automatically populates these fields, so it it not expected to be used. Any change to demographic information in this field could lead to undesirable results in the PDF/XML outputs for the current order (and possible discrepancies from the data source from ClinSpark). ClinSpark will not apply any demographic changes made in this function.

By default, this capability to modify demographics in the user interface is allowed by ‘out of the box’ configuration settings. This capability can be disabled with an update to the ‘ModalityPermissionsTable.xml’ configuration file by changing the ‘ModifyPatientDemographics’ and ‘ModifyExam’ parameters from true to false. A more detailed demonstration of how to modify this configuration setting can be seen in the video later in this document covering RScribe Lite configuration changes.

Figure: Example of modifying the local XML configurations.

Capture ECG Recording

Figure: Capture ECG recording button.

The second button ends the initial view of real time streaming ECG, and proceeds to the screen intended for reviewing a selection of the ECG recording.

RScribe Lite will next bring users to an ECG review screen. Two addition buttons appear on this ECG review screen after initial capture is completed, allowing users to review prior to returning to ClinSpark.

Figure: ECG capture worfklow in RScribe Lite.

The user has the ability to select any available section of ECG in the current recording. Wherever the user places the rectangular marker in the ECG stream in the lower section of the interface is where it will pull ECG data from.

Figure: Plot best 10 seconds button.

The button with the “10” plots the ten best consecutive PQRST waves over the whole span of data collection (at that point in time), and generates a graph exactly like the one above.

To do additional ECG captures after the first ECG capture, you have to navigate the bottom section of the interface (the ECG data stream) which provides a wider view of all the ECG data collected so far. Simply click on the map where you want to capture ECG data (it captures the data within the rectangle), and then click on the blue button that says “Select” to generate a plot like the one seen in Figure 2. This way, you are not forced to only use the “ten best” function after the first ECG capture.

Figure: Print generated plot PDF button.

The button third from the top allows you to print the generated plot in PDF format. This is typically not used in the interface workflow.

Figure: Print full disclosure PDF button.

The button fourth from the top allows users to print a Full Disclosure form. This is typically not used in the interface workflow.

Figure: Exit RScribe workflow button.

The last button allows users exit RScribe Lite. It also fully ends the ECG review and capture workflow.

If terminated early, prior to collection and review of a 10 second ECG recording, it will terminate the workflow and return the user back to ClinSpark with NO results.

If the exit button is used after the capture and review of at least 10 second ECG, closure of RScribe Lite creates the collected ECG data outputs (XML/PDF pairs) to its output directory.

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 IQVIA superadmin user.

Typically, all the default set of configuration parameters are sufficient for most customers, which means that no unique EDC device settings will be needed in a given environment.

The following device settings should be discussed first with the IQVIA team prior to a customer requesting their application/use in a given ClinSpark environment.

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.

This setting can only be defined and established by superadmin users.

Based on certain customer and/or study requirements, it may be necessary to leverage this device setting to ensure that certain Form metadata (such as the Form name) appear on PDF reports.

For further clarification on this setting, customers should reach out to IQVIA 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.

All of the default RScribe Lite configuration XML files exist in this directory:

C:\Program Files (x86)\Mortara Instrument Inc\RScribe Lite\SlotFiles

Changes can be applied locally to these configuration XML files present on the data collection PC where orders/ECG capture is performed. Local file changes must be done by a user with elevated (administrative) privileges, as ‘SlotFiles’ is a write-protected directory.

The following video demonstrates at a high level how to review and modify certain configurations in the SlotFiles directory, and apply those changes to the working directories that reference the configuration settings for each order.

Understanding the management of ‘SlotFiles’ directory

At first run of RScribe Lite, it checks if the following directory exists:

C:\ProgramData\Mortara Instrument Inc\RScribe Lite\SlotFiles\

If that folder does not exist, it creates it by copying the content from:

C:\Program Files (x86)\Mortara Instrument Inc\RScribe Lite\SlotFiles\

For every subsequent order workflow (each time RScribe Lite is invoked via ClinSpark), it will use the configurations in the SlotFiles directory here:

C:\ProgramData\Mortara Instrument Inc\RScribe Lite\SlotFiles\

Therefore, if there is ever a need to change the main/standard set of configurations and apply to all future ECG workflows, the order of operations is the following:

1. Update the main/source configuration file in this directory: C:\Program Files (x86)\Mortara Instrument Inc\RScribe Lite\SlotFiles\

2. Delete the ‘SlotFiles’ folder in this directory: C:\ProgramData\Mortara Instrument Inc\RScribe Lite\SlotFiles\

3. Run RScribe Lite again (invoke via ClinSpark)

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.

Permissions to the temporary location used to create PDF documents (for example: C:\Windows\Temp) may be removed or modified due to the rolling out of Group Policies by facility enterprise IT departments or via periodic Windows 10 Feature Updates.

If this situation occurs, appropriate permissions will need to be re-established to the existing location used by the PDF application, however the situation may occur again at some point in the future whenever group policies or Windows Feature Updates are applied.

To ensure permissions to the PDF temporary storage location are not interrupted, users can edit the “setup.ini” file at the following location to specify a distinct folder where appropriate permissions exist for read/write access in order for PDF documents to be created.

Note: Users should do NOT use %TEMP% system variable for this preference, as this may point to a folder location where proper read/write permissions are not in place.

C:\Program Files (x86)\Mortara\setup.ini

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:

When installed on a X86 system:

• HKEY_LOCAL_MACHINE\SOFTWARE\Mortara Instrument, Inc.\RScribe Lite

When installed on a X64 system:

• HKEY_LOCAL_MACHINE\SOFTWARE\Wow6432Node\Mortara Instrument, Inc.\RScribe Lite

Key settings:

• Name: Output Path

• Type: REG_SZ

• Default: C:\ProgramData\Mortara Instrument Inc\RScribe Lite\Output

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.

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.

To control things out of the box, users will need to modify:

C:\Program Files (x86)\Mortara Instrument Inc\RScribe Lite\SlotFiles\RestingSystemSettings.xml

The AC filter setting is passed into RScribe Lite through RestingSystemSettings.xml, tag which can be one of the following values:

• None

• _50Hz

• _60Hz

The Low Pass filter setting is passed into RScribe Lite through RestingSystemSettings.xml, tag which can be one of the following values:

• _40Hz

• _150Hz

• _300Hz

During the exam, the user can also modify it (or verify its setting) through the right-click menu.

If there is a need to update this setting in the field after first use, the easiest thing to do is to update the file under Program Files (x86), but then also delete the C:\ProgramData\Mortara Instrument Inc\RScribe Lite\SlotFiles\ folder so that RScribe Lite grabs the new template for any new exams done after that.

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:

C:\ProgramData\Mortara Instrument Inc\RScribe Lite\SlotFiles\RestingSystemSettings.xml

The setting within this file controls the default. This setting is case-sensitive, and all potential values are listed below.

• _3_1_Channel

• _3_3_Channel

• _6_Channel

• _12_Channel

• _6_6_Channel

Modifying PDF Output

The following video shows end-to-end how to make an RScribe Lite update to change the default PDF layout.

Here is an example configuration file that used to change the layout.

RScribe Lite Log Files

RScribe Lite log files are created and stored in the C:\ProgramData\Mortara Instrument Inc\RScribe Lite\LogFiles directory.

This video demonstrates how to find them:

Log files are created for each day of a given month when RScribe Lite is invoked. For example, if RScribe Lite is invoked on 1st day of a given month, a log file called ‘RScribeLite_01’ will be created.

Example:

Log files however are NOT continuous when writing new entries on the same date in a following month.

If a log file exists from a given day, and RScribe Lite is invoked on that same day in the following month, the previous log file is overwritten with a NEW log file.  All previous entries from the day in prior month(s) would be gone.

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.

The order number and subject information are delivered to the ClinSpark Agent over a web socket, and through an assigned port (where all communication will now exist in this session between the web client and the Agent). This information that comes into the Agent is structured as JSON, and 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.

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.

The ClinSpark Agent then grabs the most recent XML and PDF files, (meaning the capture in RScribe Lite whose timestamp is latest) and saves these files to the output directory’s sub-directory called “Processed”, typically here:

C:\ProgramData\Mortara Instrument Inc\RScribe Lite\Output\Processed

All other outputs that were generated in the RScribe Lite output directory are deleted.

Then, through the aforementioned port and web socket, the Agent uploads the final XML (by converting XML to JSON) to the ClinSpark application, and then the ClinSpark web client populates the form’s fields based on this information (the PDF file is also uploaded, but is simply an attachment to view the last ECG capture, while the XML provides all the input into the ECG form).

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

Typical Order Workflow

1. 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.

2. The Agent generates an XML file (“input XML”) with this information, and locates input and output directories in RScribe Lite.

3. The Agent then locates the RScribe Lite EXE, and sends the input XML to the input directory. Then the RScribe Lite executable is run.

4. 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).

5. RScribe Lite runs and functions based on user input. Upon completion (and termination), stores output PDF and XML files in the output directory.

6. The ClinSpark Agent pulls in the most recently time stamped XML and PDF files, and archives any additional files in this output directory.

7. 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).

8. 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

• RATE (labeled “VENT_RATE”)

• RR (labeled “AVERAGE_RR”)

• EGDTC (labeled “ACQUISITION_TIME_XML”)

Found in the “Typical Cycle” section of the XML Doc

• PR (labeled “PR_DURATION”)

• QRS (labeled “QRS_DURATION)

• QT (labeled “QT”), QTc (labeled “QTC”)

• QTcF (labeled “QTCF”), QTcB (labeled “QTCB”)

• P_Axis (labeled “P_AXIS”)

• QRS_Axis (labeled “QRS_AXIS”)

• T_Axis (labeled “T_AXIS”)

EGTXT

Contents are found in the <Automatic_Interpretation…/> section, and the <Interpretation…/> section of the XML Doc.

EGPDF

Located at the very bottom of the XML Doc, in the section <Associated_REPORT_DOCUMENT…/>. This points to the directory in which the PDF is saved.

The ClinSpark Agent is responsible for sending both the XML and the PDF to ClinSpark.

Example XML / PDF Files

Example Input XML File:

Example Output XML File:

Example PDF:

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.

Additional Notes

Handling Multiple ECG Segments

RScribe Lite allows users to optionally pick and review multiple 10-second segments of ECGs for recordings. Users are able to preview each of the selected ECGs before ending the order workflow and submitting a 10-second segment back to ClinSpark.

When handling multiple ECG segments, the user might be looking across several different tabs of data, each represented with a different number sequence and acquisition time value.

Prior to ending the order workflow in RScribe Lite, to bring a 10second segment back to ClinSpark, users are advised to close all of the irrelevant tabs that are not intended to be used. The only ECG tab (segment) that should remain open is the user-selected 10 seconds intended for the timepoint in ClinSpark.

Closing all irrelevant tabs will help the user make sure the correct ECG is importing into the system. If multiple tabs are left in view when leaving the RScribe Lite order workflow, there may be a possibility that wrong 10-second segment is selected by Rscribe Lite and brought back into ClinSpark. Therefore, selection of only one ECG in view is recommended.

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.

The resulting symptoms of this are ECG order workflows that fail to complete between ClinSpark and RScribe Lite, typically with the last steps of the process where a PDF is being generated. Under these conditions, full order data (PDF/XML pairs) cannot be properly created and routed back to ClinSpark from RScribe Lite. Errors may also manifest within RScribe Lite log files with similar messaging to the following:

Error Failed to execute RestReportPreview.exe. ExportPDFReport():Access is denied Error RScribe modality exited successfully but failed to generate PDF

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:

And the RScribe log files show a similar message to the following:

Info	RestReportPreview.exe return code -532462766
Error	Failed to create PDF.  

This may be due to an improper installation of the Mortara PDF/printer driver and utilities. The installer package includes several companion utilities necessary for proper creation of PDF at the end of an order workflow, which this error may be suggestive of.

To troubleshoot:

• Check to confirm that the PDF utilities are installed in this directory: C:\Program Files (x86)\Mortara

• Verify the existence of the Mortara PDF printer in the system settings

If the printer utilities are missing, you can try these options:

• Using the installer MSI as an elevated user, right click the .MSI, and select ‘Repair’

• Fully uninstall, and then reinstall RSL, using elevated system privileges

The following screencast also demonstrates order failures when the PDF printer driver is missing.

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.

However, if the XML file contains any characters that are not accepted by RSL, the order process fails immediately. Symptoms of this manifest in the user interface where the Invoke workflow will notify the user that an order has been created, but RSL does not start or display waveforms to users.

In ClinSpark log files, the following message is displayed:

And within RScribe logs:

This suggests that the order did not complete successfully due to malformed XML. RScribe logs will reveal the row and column within the XML document where the issue is.

Certain characters that are acceptable in the ClinSpark UI, such as dashes, long dashes, em dashes, en dashses, etc. are NOT acceptable characters for input into the RSL order process. Additionally, other non ascii characters (such as no-break space) can create malformed XML.

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. If the max size is exceeded the information will be excluded from the PDF and the field will be empty.

• LastName (ClinSpark study)

• PatientID (ClinSpark Subject ID)

• FirstName (ClinSpark study event)

Flat Waveforms Detected

In certain failure instances you may see a thicker flat green line in the waveform. See image below from the device user interface.

If this occurs, this could be indicative of lead failure or possible issues with AM12 drivers. Please check hardware status and drivers.