Automated Infusion Pump Compatibility Testing
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Solution Overview
Problem
The existing manual testing procedures for medical device systems, particularly in intensive care and anesthesia, are costly and prone to errors, as they require manual verification of compatibility after software updates and device modifications, and lack comprehensive verification of device combinations from different manufacturers.
Innovation Solution
An automated testing method using a testing device that sends test commands to medical devices via a communication protocol, comparing responses with pre-defined reference responses to ensure error-free operation, compatibility, and interface testing, allowing for fully automated function testing without modifying the devices.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual testing procedures are used to verify device compatibility, then comprehensive verification can be performed, but the process is costly and time-consuming
Solution Approach 1:
The medical device performs self-testing by executing test commands and generating responses automatically. The testing device sends test commands through the communication interface, and the device under test autonomously processes these commands and returns responses, eliminating the need for manual operation while maintaining comprehensive verification coverage.
Solution Approach 2:
The manual mechanical testing process is replaced with an automated electronic system. The testing device uses electronic communication protocols to send test commands and receive responses automatically, substituting the manual physical testing operations with automated digital communication and processing.
2Reliability
If manual testing is performed by operators, then device compatibility can be verified, but errors may occur and the process is prone to human mistake
Solution Approach 1:
The device automatically executes test commands and generates responses without requiring manual intervention. The testing device autonomously manages the entire testing process, including sending commands, receiving responses, and comparing results against reference values, thereby eliminating human error while maintaining operational simplicity.
Solution Approach 2:
The system implements automated feedback mechanisms where the device under test receives test commands, processes them, and returns responses that are automatically compared against reference responses. This closed-loop feedback system ensures accurate verification while removing manual operation steps that could introduce errors.
3Reliability
If devices are tested after software updates, then compatibility must be demonstrated for regulatory reasons, but the testing effort increases
Solution Approach 1:
The system performs compatibility testing automatically after software updates are installed. The testing device sends test commands to verify the updated software maintains proper compatibility, and this automated preliminary action ensures regulatory compliance without requiring manual testing effort, thereby maintaining high productivity.
Solution Approach 2:
The manual compliance testing process is replaced with automated electronic testing. The testing device uses communication protocols to automatically verify software update compatibility, substituting manual verification procedures with automated digital testing that maintains regulatory standards while improving efficiency.
4Adaptability or versatility
If devices from different manufacturers are combined into a global system, then system versatility increases, but verification of non-verified device combinations becomes risky
Solution Approach 1:
Each device in the global system performs self-testing when connected to another device. The testing device automatically sends test commands through communication interfaces to verify compatibility with connected devices from different manufacturers, enabling the system to self-verify combinations without manual intervention and thus maintaining both versatility and reliability.
Solution Approach 2:
The system implements automated feedback verification where devices exchange test commands and responses to verify compatibility. This feedback mechanism automatically confirms that device combinations from different manufacturers are reliable, allowing the system to safely integrate versatile components while maintaining verification reliability.
Data Source
AI summary
A testing device (10), an infusion pump or another medical device function testing method, to an anesthesia apparatus or respirator (AB) and to a computer program product are provided for testing the function of an infusion pump (G). The testing device (10) is preferably implemented on the anesthesia apparatus or respirator (AB) and comprises a memory (MEM), a test module (T) and a controller (C). The test module (T) sends a test command (20) to the infusion pump (FG), which sends a response (30) back to the controller (C) after execution of the command. The control (C) can then compare the response (30) received with a reference response (30′) for agreement in order to send a successful function test result.


