Breath-Based Device Function Verification Using Human Reference Standards

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Solution Overview

Problem

The existing methods for testing the function and accuracy of devices measuring gaseous compounds in exhaled breath, such as nitric oxide, are costly and inconvenient due to the need for specialized reference gases, which are expensive to manufacture, store, and handle, and often have limited shelf life.

Innovation Solution

A method using human subjects as reference persons, where the concentration of the gaseous substance in exhaled breath is measured to determine if it falls within a specified range, with deviations indicating device malfunction, and a moving average is calculated from previous measurements to confirm normal conditions and device functionality.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If reference gases are used to test device function, then measurement accuracy can be verified, but cost and handling complexity increase significantly

Engineering Contradiction:
Improvedevice function verification accuracyVSAvoidtesting system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces expensive reference gases with human subjects as living reference standards. Healthy individuals naturally produce breath with known gaseous compound concentrations within specific ranges, serving as a copy or alternative to manufactured reference gases. This eliminates the need for complex gas cylinder storage, handling, and calibration systems while maintaining verification accuracy.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent uses human subjects who naturally produce breath samples without requiring expensive, long-lived reference gas cylinders. Each breath sample is a fresh, disposable test source that eliminates the need for costly manufacturing, storage, and shelf-life management of reference gases.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Measurement precision

If reference gases are used for device testing, then calibration can be performed, but time consumption and logistical burden increase

Engineering Contradiction:
Improvedevice calibration accuracyVSAvoidtesting and handling time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent enables human subjects to serve themselves as reference standards by simply providing breath samples. This self-service approach eliminates the need for external gas cylinder delivery, storage setup, and handling procedures. The testing system becomes self-sufficient using readily available human breath as the calibration reference.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent establishes predetermined concentration ranges for healthy individuals before actual device testing. These pre-established reference ranges allow for immediate device verification without requiring real-time reference gas preparation or complex calibration procedures during the testing process.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If specialized reference gases are manufactured and stored, then accurate testing is possible, but manufacturing cost and storage requirements increase

Engineering Contradiction:
Improvetesting accuracyVSAvoidreference gas consumption and storage
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent replaces manufactured reference gases with human subjects as natural reference sources. Instead of producing and storing chemical reference gas mixtures, the system uses the naturally occurring gaseous compounds in human breath as a renewable, cost-free reference standard with known concentration ranges.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent eliminates the need for expensive, long-duration reference gas storage by using human breath samples that are generated on-demand. Each breath provides a fresh reference source without requiring investment in gas cylinder inventory, storage facilities, or shelf-life management.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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

This approach significantly reduces costs and handling issues while maintaining high accuracy, with a low rate of false positives and effective detection of faulty instruments, using healthy individuals to validate device function with a high probability of detecting deviations.

Implementation Method 1

Different techniques and sensors have been suggested for use in the determination of NO concentration. Examples include, but are not limited to chemiluminescence

Methodology Applied
Scientific EffectChemiluminescence: Chemiluminescence

Implementation Method 2

Different techniques and sensors have been suggested for use in the determination of NO concentration. Examples include, but are not limited to semiconductor-based sensors

Methodology Applied
Scientific EffectSemiconductor-based detection:

Implementation Method 3

Different techniques and sensors have been suggested for use in the determination of NO concentration. Examples include, but are not limited to electrochemical sensors

Methodology Applied
Scientific EffectElectrochemical detection:

Implementation Method 4

US 2007/278110 A1 shows the use of a moving average in the context of oxygen concentration measurements

Methodology Applied
Scientific EffectStatistical averaging:

Data Source

PatentEP2223105B1Method for testing the function of a device
Publication Date: 2018.05.02 CIRCASSIA AB
  • EP2223105B1 patent drawingFigure 1a~1b
  • EP2223105B1 patent drawingFigure 2a~2b
  • EP2223105B1 patent drawingFigure 3a~3b

AI summary

The function of a measuring device can be tested using a healthy person as an external control, provided that this person fulfils certain criteria and that particular method steps are adhered to.