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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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One kit is needed per Windows laptop or tablet computercomputer. 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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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.