Breath Analyzer Quality Control Using Human Reference Samples
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Solution Overview
Problem
Existing quality control methods for respiratory monitoring devices, such as breathalyzers, often rely on substitute samples and lack the ability to account for human physiological variations, leading to inconsistent measurement accuracy and potential malfunctions.
Innovation Solution
A method and device for quality control using human samples, involving a two-step process to qualify test subjects and verify the breathalyzer, utilizing thresholds based on mean and standard deviation of gas concentrations to ensure accurate and reliable measurements, with the ability to store reference values for subsequent checks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If substitute samples are used for quality control, then the measurement process can be performed, but the measurement accuracy is insufficient and inconsistent
Solution Approach 1:
The patent changes the fundamental parameter of the sample type from substitute samples to human breath samples. This parameter change enables the system to account for physiological variations and achieve consistent measurement accuracy that reflects actual human respiratory conditions, thereby resolving the contradiction between measurement precision and quality control reliability.
Solution Approach 2:
The patent uses human breath samples as copies of actual patient respiratory data for quality control purposes. By measuring human samples and comparing results against established reference ranges, the system creates accurate representations of real-world performance, enabling reliable verification of measurement accuracy without requiring complex synthetic substitutes.
2Adaptability or versatility
If fixed tolerance bands are used for quality control, then the control process is simple, but it cannot account for human physiological variations
Solution Approach 1:
The patent introduces dynamic tolerance bands that adapt to individual physiological characteristics rather than using fixed thresholds. The system calculates personalized reference ranges based on patient-specific parameters such as age, sex, and respiratory history, allowing the tolerance bands to dynamically adjust to each patient's normal variation range while maintaining manageable process complexity through automated calculations.
3Measurement precision
If human samples are used for quality control, then measurement accuracy improves, but the complexity of the quality control process increases
Solution Approach 1:
The patent implements self-service quality control where the breathalyzer automatically performs measurements on human samples, compares results against calculated reference ranges, and generates quality control reports without requiring manual intervention. The system self-verifies accuracy by automatically processing human samples through the complete measurement and evaluation pipeline, reducing operational complexity while maintaining high measurement precision.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Ensures consistently high-quality measurement results by accounting for interpersonal and intrapersonal physiological variations, enhancing reliability for asthma patients and preventing malfunctions by distinguishing between physiological fluctuations and device errors.
Implementation Method 1
The analytical unit can be configured to detect the amount of nitric oxide in the breath sample and display it as a measured value. This analytical unit can include sensors already used in breathalyzers.
Data Source
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AI summary
The invention relates to a method for quality control of a breath-measuring device (100), wherein the method comprises a step of comparing a test value (108) with a first threshold value and a second threshold value in order to obtain a comparative result (114). The first threshold value and the second threshold value represent values formed using a mean value and a standard deviation from reference values, wherein the test value (108) and the reference values represent gas concentrations measured using the breath-measuring device (100).