Medical Device Test Module for Real-Time Fault Detection
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Solution Overview
Problem
Medical device arrangements face challenges in reliably detecting random faults that occur during operation, which can lead to undetected malfunctions and compromised patient safety, especially in safety-critical applications where systematic faults are already addressed before device delivery.
Innovation Solution
A medical device arrangement with a test module that processes test data sets in parallel to medical data sets, comparing results with reference data to detect discrepancies and output warning information, allowing for real-time detection of malfunctions such as bit flips caused by cosmic radiation or power interruptions, and enabling continuous monitoring of analysis module operability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If systematic testing is performed before device delivery, then manufacturing precision is improved, but reliability during operation deteriorates because random faults cannot be detected
Solution Approach 1:
The test module is pre-configured with test data sets and reference results during manufacturing, enabling it to perform self-testing during operation without requiring external testing equipment or intervention
Solution Approach 2:
The medical device arrangement tests itself during normal operation by processing test data sets through the same analysis modules that process medical data sets, allowing the system to autonomously detect random faults without external testing resources
2Reliability
If multiple analysis modules are used to process medical data sets, then reliability is improved through redundancy, but device complexity increases
Solution Approach 1:
The test module combines multiple functions into a single integrated component: it generates test data sets, processes them through analysis modules, compares results with reference values, and generates warnings - all within one modular unit that works alongside the medical data processing pipeline
Solution Approach 2:
The analysis modules serve dual purposes: they process both real medical data sets and test data sets through the same processing logic, eliminating the need for separate testing hardware and reducing overall system complexity
3Reliability
If test data sets are processed in parallel with medical data sets during operation, then reliability is improved through real-time fault detection, but productivity decreases due to additional processing requirements
Solution Approach 1:
The system processes test data sets partially - using simplified test data that requires less processing power than full medical data sets, while still exercising all critical processing paths and comparison logic needed to detect random faults
Solution Approach 2:
The test module operates continuously during medical device operation, processing test data sets in parallel without interrupting or pausing the processing of real medical data sets, ensuring both functions occur simultaneously and continuously
Data Source
AI summary
A medical device arrangement (100) tests processing of data sets to be processed during operation of the medical device arrangement. The arrangement includes a data interface (110), analysis modules (120) and a test module (130). The analysis modules process a received medical data set (105). Each analysis module (122, 123, 124) forms a processing instance (390) for the medical data set or for the medical data set (125, 125′) already preprocessed by at least one other analysis module. The test module outputs a test data set (132) to one of the analysis modules during operation such that this analysis module processes the test data set in the same manner as the medical data set. The test module compares a correspondingly outputted, processed test data set (134) with a reference result (136) associated with the test data set and determines a test result (137) based on this comparison.


