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Summary
Mortara has been acquired several times in recent years and has been owned by Welch Allyn, Hillrom and is now owned by Baxter. All references to any of the above in this context are equivalent.
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IQVIA was recently notified by Baxter that they have decided to not pursue CE mark renewal via EU MDR on their RScribe Lite Software. Please reach out to your project manager or relationship lead to review the best option for your future requirements. Please see the attached notice for more detail.
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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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RScribe Lite works with standard Hillrom AM12 patient cables and lead sets. It can be made available to ClinSpark customers in two kit configurationsAM12 patient cables and lead sets. It can be made available to ClinSpark customers in two kit configurations.
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One kit is needed per Windows laptop or tablet computer. There are no physical license files or keys with am RScribe Lite kit. Purchasing ‘x’ kits ‘licenses’ the user to use ‘x’ instances of RScribe Lite on ‘x’ laptops. It is the responsibility of the user to ensure that no more than the purchased number of kits are installed. Failure to comply is in breach of the terms of use of the kit. |
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RScribe Lite Kit w/AHA Leads - 108089
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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
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Support
Deployment Support
Foundry Health 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 Foundry Health IQVIA as needed
Technical Support
Foundry Health IQVIA shall perform first line support via its normal service desk channels
Hillrom shall provide second line support to Foundry Health IQVIA whenever the component products do not perform correctly
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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 HealthIQVIA
Consumables
Local regional representatives of Hillrom should be contacted for consumables
Foundry Health IQVIA does not supply consumables
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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 IQVIA should reach out via the service desk to request a download link.
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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 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 Foundry Health IQVIA team prior to a customer requesting their application/use in a given ClinSpark environment.
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For further clarification on this setting, customers should reach out to Foundry Health IQVIA support team members via service desk for assistance.
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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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Figure 3: Screenshot demonstrating that ECGs can be captured out of order, resulting in the ClinSpark Agent populating the ECG form with the wrong ECG data.
Looking at the example - in the tabs at the top of the form, it can be seen that 3 ECGs have been taken in RScribe Lite. The first ECG being at 2:25:26, the second (labeled “4)") at 2:25:43, and the third (labeled “5)") being at 2:25:27. So if the user were to end RScribe Lite and click “OK” on the ClinSpark web app’s prompt to fill the ECG data form, it would populate the associated form item group timepoint with the ECG at the timestamp of 2:25:43.
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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.
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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
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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 scenarios you may see a thicker flat green line in the waveform. See image below from the device user interface.
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If this occurs, this could be indicative of lead failure or possible issues with AM12 drivers. Please check hardware status and drivers.