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Table of Contents

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.

Note

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.

View file
nameImportant notification -- ECG recording device certification within ClinSpark SaaS.pdf

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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Info

One kit is needed per Windows laptop or tablet computerlaptop 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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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.