Automated Medical Device Testing System With Persistent Checklists
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Solution Overview
Problem
Manual testing of medical devices is time-consuming and prone to errors, with varying requirements based on whether the device will have contact with a patient, necessitating a more efficient and accurate testing process.
Innovation Solution
A system comprising a test device and a user computing system that generates and manages checklists for medical device testing, allowing for wireless communication, persistent options, and data entry, with the ability to simulate patient vital signs and store test results, enabling efficient and standardized testing procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual testing procedures are used for medical devices, then flexibility in handling different testing scenarios is maintained, but time consumption increases and error rates rise
Solution Approach 1:
The patent replaces manual mechanical testing procedures with an automated computer-based system that generates, manages, and executes testing checklists electronically. This substitution eliminates manual errors while reducing testing time through automated workflow management and persistent data storage capabilities.
Solution Approach 2:
The testing system enables self-service through persistent options that automatically retain user preferences and configurations across sessions. The system automatically manages checklist states, stores test results, and maintains testing protocols without requiring manual reconfiguration, thereby reducing time consumption while ensuring consistent accurate testing.
2Reliability
If comprehensive testing checklists are implemented for all medical devices, then testing completeness is improved, but system complexity increases
Solution Approach 1:
The patent segments the testing process into structured checklists with distinct steps, persistent options, and modular components. Each checklist can be independently configured and managed, allowing comprehensive testing coverage while maintaining system organization and reducing perceived complexity through clear structural division.
Solution Approach 2:
The testing system provides universal functionality through a single integrated platform that handles multiple testing scenarios, device types, and checklist configurations. The persistent options and standardized checklist structure enable the system to manage comprehensive testing requirements across diverse medical devices without proportionally increasing complexity.
3Ease of operation
If persistent options are saved for future checklist sessions, then user convenience is improved, but data storage requirements increase
Solution Approach 1:
The patent implements persistent options by creating and storing digital copies of user preferences and checklist configurations in computer-readable memory. This copying mechanism enables rapid retrieval and reuse of testing parameters, significantly improving user convenience while the efficient data structures keep storage requirements manageable for typical testing scenarios.
Data Source
AI summary
Systems, devices, and methods for testing medical devices comprising: a test device configured for testing a medical device; and a user computing system in communication with the test device, where the user computing system comprises a processor having addressable memory, where the processor is configured to: display a deployed checklist for the medical device to be tested, where the deployed checklist comprises one or more test steps; display one or more persistent options for the displayed checklist, where selecting or deselecting the one or more persistent options changes the one or more test steps for the displayed checklist, and where selecting or deselecting the one or more persistent options saves the changes a next time the deployed checklist is displayed; receive input for each step of the one or more test steps of the displayed checklist; and provide instruction for the one or more test steps of the displayed checklist.