ECG Printout Digitization and Quality Validation for SaMD
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Solution Overview
Problem
Patients often receive ECG data in analog printouts rather than digital formats, hindering the direct integration of ECG data into diagnostic Software as a Medical Device (SaMD) systems, necessitating a quality check method for ECG printouts to enable proper SaMD functionality.
Innovation Solution
An apparatus and method that utilizes a processor and memory to receive an ECG image, extract parameters using OCR, convert to digitized signals, validate the signals, and determine an accuracy status by comparing extracted and calculated parameters, classifying them into pass or fail statuses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If ECG data is provided in analog printout format, then patients can receive ECG results, but direct integration into SaMD systems is hindered and quality verification is difficult
Solution Approach 1:
The patent uses OCR technology to create a digital copy of the ECG parameters from the analog printout. The system captures an image of the ECG printout and extracts parameter text through OCR, converting it into machine-readable digital format that can be integrated with SaMD systems without requiring direct digital output from the ECG device.
Solution Approach 2:
The patent introduces an intermediary processing system that bridges the analog printout and digital SaMD systems. This intermediary includes image capture, OCR processing, and quality verification components that translate the analog format into a form suitable for digital systems, enabling integration without direct connection to the ECG device.
2Quantity of substance
If ECG printouts are used, then ECG data can be obtained, but quality check and validation are challenging
Solution Approach 1:
The patent implements a feedback mechanism where extracted ECG parameters are validated by comparing them against quality criteria. The system provides quality verification feedback by determining whether the extracted parameters meet acceptable standards, and can indicate when re-capture or re-extraction is needed due to poor quality.
Solution Approach 2:
The patent performs preliminary quality verification of the ECG printout image before proceeding with parameter extraction. The system checks image quality metrics such as blur, brightness, and contrast beforehand, and only processes images that meet minimum quality thresholds, preventing wasted processing on unusable images.
3Productivity
If manual parameter extraction from ECG printouts is performed, then ECG data can be digitized, but the process is time-consuming and error-prone
Solution Approach 1:
The patent replaces manual mechanical reading and transcription of ECG parameters with automated optical character recognition technology. The OCR system automatically extracts parameter values from the printed ECG image, eliminating manual intervention and its associated errors while significantly increasing processing speed.
Solution Approach 2:
The patent enables the ECG printout to serve itself by using OCR to automatically extract its own parameter information without requiring manual transcription. The system processes the printed parameters directly from the image, allowing the document to be self-digitized through automated recognition of its printed content.
Data Source
AI summary
An apparatus and method for generating a quality diagnostic of analog ECG (electrocardiogram) data. The apparatus includes at least a processor and a memory communicatively connected to the at least a processor, wherein the memory contains instructions configuring the at least a processor to receive ECG data, extract a plurality of ECG parameters from the ECG data, convert the ECG data to one or more digitized ECG signals, validate the digitized ECG signals, wherein validating includes classifying the plurality of digitized ECG signals to a plurality of preliminary ECG parameters and determining an accuracy status of the extracted plurality of ECG parameters by comparing the plurality of preliminary ECG parameters to the extracted plurality of ECG parameters, and generate a quality diagnostic of the ECG data based on validation of the digitized ECG signals.