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Overview

What is <Device Name>?

Include high level information such as device field (ECG, CGM, etc), high level use cases, output types, etc. This can also be marketing material from the manufacturer.

High level description of how device integrates with ClinSpark ie Agent, Mobile, SparkPlug

Device Interface

Description on how device is interfaced through ClinSpark. This should be examples of screens to invoke, functional screen descriptions, etc. This should also include any Study/Subject Requirements needed to properly use the device within ClinSpark.

Installation

Directions on installing the device software. Include any System Requirements for hardware (firmware, memory, etc), Agent Version, SparkPlug, mobile firmware versions, etc.

Configuration Options

List all configuration options and Device Parameters within ClinSpark.

Inputs

Describe how the interface (Agent, Mobile, SparkPlug, etc) interacts with device output to convert to ClinSpark inputs ie JSON → Object IDs and data, etc. Include the file types and any other pertinent info to the process ie directories, etc.

Describe any User Inputs needed for process to be invoked ie Study, Form, Subject Setup, etc.

Outputs

Describe the output to ClinSpark once the device captures data. This should include output file types ie. JSON converted to XML/PDF, etc.

Describe the interface process to grab the output files. This should include directories in which files are saved, etc.

Describe how the Clinspark application/client uses the output files and populates data/forms/etc.

Architecture Diagram

Create an architecture diagram. See example of below.

Workflow

Create a workflow to summarize the info and process. See example workflow below:

  1. The ClinSpark Agent receives messages from the ClinSpark Client (in JSON structure, 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 Device.

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

  4. Device 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. Device runs and functions based on user input. Device, upon completion (and termination), stores output PDF and XML files in its output directory.

  6. The Agent pulls in the most recently time stamped XML and PDF files, and clears out any additional files in this output directory (this is done to minimize the possibility of the Agent picking up the wrong output file, and causing error in the whole of the system when future ECG tests are run). 

  7. The Agent then parses the XML data into JSON, and sends all relevant information back to the ClinSpark app for ECG form population (including the PDF file).

  8. The Agent then saves the XML and PDF files to Device's "Processed" folder, or the configured Archive Directory (ArchiveDir). This Archive Directory can include a local drive, or a shared network drive.

Data

Describe the data types and names included in output data files received by ClinSpark. The should include examples and locations of the data types within the output files. See example of Device below.

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 Device)

  • EGDTC (DDMMMYYYY HH:MM:SS)

  • EGPDF (PDF Document).

Where in the XML is this Data?

Found in the <ECG> 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 the ClinSpark Application.

Reports/Dashboards

List all reports and dashboards that can be used “off the shelf” with this device.

Supported Devices / Models / Hardware

List all device / models supported by this integration and any other additional hardware requirements.

Notes

Include any relevant notes that you may reference above.

Example Files

Attach examples of input/output/ClinSpark files.

Related Jira tickets

Add links to related Jira tickets.

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