CN110763810B - Quality inspection system of exhale analyzer - Google Patents
Quality inspection system of exhale analyzer Download PDFInfo
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- CN110763810B CN110763810B CN201911261066.5A CN201911261066A CN110763810B CN 110763810 B CN110763810 B CN 110763810B CN 201911261066 A CN201911261066 A CN 201911261066A CN 110763810 B CN110763810 B CN 110763810B
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- 238000005070 sampling Methods 0.000 claims abstract description 89
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- 230000000007 visual effect Effects 0.000 claims abstract description 25
- 238000004891 communication Methods 0.000 claims abstract description 5
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- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 27
- 238000012544 monitoring process Methods 0.000 claims description 19
- 229910052757 nitrogen Inorganic materials 0.000 claims description 12
- 238000009423 ventilation Methods 0.000 claims description 9
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- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 5
- 239000001301 oxygen Substances 0.000 claims description 5
- 229910052760 oxygen Inorganic materials 0.000 claims description 5
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- 238000012360 testing method Methods 0.000 description 21
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 6
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- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- RWSOTUBLDIXVET-UHFFFAOYSA-N Dihydrogen sulfide Chemical compound S RWSOTUBLDIXVET-UHFFFAOYSA-N 0.000 description 3
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- 206010006322 Breath holding Diseases 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/0004—Gaseous mixtures, e.g. polluted air
- G01N33/0006—Calibrating gas analysers
Abstract
The invention provides a quality inspection system of an expiration analyzer, which detects sampling quality and analysis quality of the expiration analyzer, and comprises: the device comprises an automatic air distribution unit, an expiration sampling quality inspection unit, an expiration analysis quality inspection unit and a total control unit; the automatic gas distribution unit is used for generating simulated exhaled gas with settable gas components, concentration, temperature, humidity and flow; the expiration sampling quality inspection unit can be connected with an expiration analyzer to be inspected, and detects the temperature, humidity, flow, pressure and time of the air distribution passing through the expiration analyzer; the expiration analysis quality inspection unit is used for detecting the concentration result of the gas detected by the expiration analyzer for analysis and judgment; the total control unit comprises a control module, a GPRS-4G communication module, a data storage module, a screen and a visual operation interface, and can complete automatic gas distribution and detection of breath sampling analysis quality according to input requirements, so that quality inspection of a breath analyzer is realized.
Description
Technical Field
The invention relates to a quality inspection system of an expiration analyzer.
Background
With the development of science and technology, molecular diagnosis based on expiration markers and related scientific achievements successively obtain 5 times of Nobel biomedical and chemical rewards, and one of the current 10 big medical innovation rewards is obtained at the world medical peak meeting held in the United states in 2011. In 2010, breath detection is promoted, various breath analyzers are developed, and by detecting various molecular components and concentrations of the gases exhaled by a known human body, a doctor can be assisted in diagnosing diseases of the patient, monitoring the disease states and observing treatment effects, and the noninvasive breath analyzer is safe, accurate and reliable and has remarkable social and economic benefits.
Currently, there are a large variety of breath analyzers in the market, and the two main fields of application are respiratory tract and digestive tract, because breath detection in these two fields is already a common detection item and forms a standard.
International technical standards for endogenous NO mouth or nose exhale sampling and analysis were established in 2005 by the american society of thoracic (ATS) and european society of respiratory (ERS), which recommended (1) that NO <5ppb of gas must be inhaled before testing, avoiding the impact of high concentration environmental NO on test results; (2) During testing, the mouth expiration pressure must be higher than 5cm H2O, the soft palate communicated with the upper respiratory tract and the lower respiratory tract is closed, the mixing of the upper respiratory tract gas and the lower respiratory tract gas is avoided, but the mouth expiration pressure is not higher than 20cm H2O, and a subject exceeding 20cm H2O feels uncomfortable; (3) The constant flow rate is required to be kept during the test, so that the influence of the change of the flow rate on the measurement result is avoided, the standard recommended flow rate is 50ml/s, and the flow range is required to be 45-55ml/s; (4) There must be sufficient expiration duration to exclude physiological dead space gases and thus obtain a reliable plateau requiring the expiratory flow to remain within the required range for at least 3 seconds. At the same time, requirements are placed on the accuracy and repeatability of the analysis and on the calibration of the instrument at regular intervals.
In 2007, the expert group consisting of experts in breath detection applications held a consensus conference in roman, promulgating the first statement of the consensus on roman hydrogen exhalations experiments. The recommended sampling mode is to deeply inhale first and then collect exhaled gas after 15 seconds of breath holding. It is stated that elements such as electrochemistry have a relatively short life and have no literature report on their stability for long term use, and therefore the accuracy of the instrument needs to be periodically assessed and the method and frequency of calibration determined.
The calibration of the known expired air analyzer products adopts a regular standard steel cylinder gas calibration mode, but in the actual use process, the transportation and the use of the standard steel cylinder are very inconvenient, the detection range of the expired air analyzer instrument is usually low, the concentration used for the calibration is also low, for example, the calibration of an NO analyzer adopts the NO gas with the concentration of 50-75ppb, and the storage time and the accuracy of the standard steel cylinder with the low concentration are difficult to ensure.
In addition, the flow, the pressure and the time in the sampling process of the breath analyzer are not detected at present, and the deviation in the breath sampling process can influence the detection result, so that the accuracy of clinical diagnosis is influenced. And the expiration composition is complex, and there are some interference components that can influence the test result, such as NO, CO, H2S, methyl mercaptan, ethanol, water vapor, etc., simple standard steel cylinder gas test can not fully reflect the anti-interference capability and selectivity condition of the instrument.
To above problem, this patent proposes a quality inspection system of breath analyzer, can make the inspection and judge to breath analyzer's sampling process and analysis result to realize the quality control to breath analyzer.
Disclosure of Invention
The invention provides a quality inspection system of a breath analyzer, which can perform quality inspection on the sampling process and analysis result of the breath analyzer, wherein the quality inspection consists of two parts, namely the quality inspection of breath sampling is mainly to inspect the standard-specified breath flow, pressure and time; and secondly, the quality inspection of the expiration analysis is mainly to inspect the accuracy, selectivity and stability of target gas detection.
The quality inspection system of a breath analyzer is characterized in that: the breath analyzer quality monitoring system consists of an automatic gas distribution unit (100), an expiration sampling quality inspection unit (200), an expiration analysis quality inspection unit (300) and a total control unit (400); the automatic gas distribution unit (100) comprises at least two gas distribution pipelines and a flow sensor (151), and each gas distribution pipeline is connected to the flow sensor in parallel; the expiration sampling quality inspection unit (200) comprises a pressure sensor and is connected with an air outlet of the automatic air distribution unit through a pipeline; the total control unit (400) comprises a control module (410) and a screen and visual operation interface (420), and the detection of the automatic distribution and expiration sampling analysis quality is completed according to the detection requirements input by the screen and visual operation interface (420).
Each path of gas distribution pipeline of the automatic gas distribution unit (100) is provided with a gas cylinder, a pressure reducing valve and an electromagnetic proportional valve in series, and the gas cylinders, the pressure reducing valve and the electromagnetic proportional valve are all connected to the flow sensor (151) in parallel. The pressure reducing valve is used for reducing pressure of the gas cylinder, the connection port and the pressure configuration are adapted to the specification of the gas cylinder, and the use safety of the gas cylinder is ensured. The electromagnetic proportional valve is arranged behind the pressure reducing valve, and the flow rate of the air flow passing through the electromagnetic proportional valve is regulated according to the opening proportion, so that the air distribution requirement is met. The flow sensor (151) is arranged behind the plurality of parallel air distribution pipelines, so that the flow and the total flow of each air distribution pipeline meet air distribution requirements. The flow sensor (151) is a mass flow sensor or a volume flow sensor.
The number of the gas distribution pipelines can be set according to gas distribution requirements, at least two pipelines are arranged, and a high-concentration standard gas cylinder and a diluted gas cylinder are generally arranged. The gas distribution pipelines and the gas cylinders can be arranged to prepare target concentration standard gas for simulating the components of the exhaled breath of the human body. The gas distribution system for simulating the exhaled breath of the human body at least comprises three gas paths, namely a dilution gas path containing nitrogen and oxygen, a gas path containing gas to be detected, such as NO, CO, H2S, H2, CH4 and the like, and a gas path containing trace concentration of interference gas sources, such as NO, CO, H2S, methyl mercaptan, ethanol and the like. A heating and humidifying module (161) can be arranged on a gas distribution pipeline provided with the dilution gas, so that saturated steam can be humidified, and target gas simulating the humiture of the expired air can be obtained. Through the arrangement, the automatic gas distribution system can be used for generating simulated exhaled gas with settable gas components, concentration, temperature, humidity and flow.
The expiration sampling quality inspection unit (200) comprises a pressure sensor (210) and a pipeline, wherein the pressure sensor (210) is connected with an air outlet of the automatic air distribution unit through the pipeline, so that the air flow pressure condition of the expiration analyzer in the sampling process can be monitored. A temperature and humidity measuring module (220) can be correspondingly arranged behind the flow sensor (151) and used for feeding back and recording the temperature and humidity of the configuration gas. Through the arrangement, the expiration sampling quality inspection unit can be connected with an expiration analyzer to be inspected, and the temperature, humidity, pressure and sampling time of the configuration gas passing through the expiration analyzer are detected.
The expiration analysis quality inspection unit (300) is used for analyzing and judging the gas concentration result detected by the expiration analyzer through gas distribution and inspecting the accuracy, selectivity, repeatability and stability of the expiration analyzer.
The overall control unit (400) comprises a control module (410) and a screen and visual operation interface (420). The screen and visual operation interface (420) can be used for inputting gas configuration and detection requirements and inputting sampling and analysis results of the expiration analyzer. The quality detection is divided into two parts of sampling detection and analysis detection on the screen and the visual operation interface (420), different contents are input according to different items to be detected, and the monitoring system automatically gives out the detection steps and flows. The control module (410) can control the opening proportion of the electromagnetic proportional valve to complete automatic gas distribution according to the input requirement, can monitor and record the pressure condition of the gas flow in the sampling process, judges whether the gas flow pressure meets the specified requirement when the breath analyzer samples, and records the sampling time. The general control unit (400) can also be provided with a GPRS-4G communication module (430) for providing networking function and uploading monitoring data to the cloud platform in time. The overall control unit (400) may also be provided with a data storage module (440) for storing data.
In addition, many exhale the analysis appearance and all be provided with off-line sampling and the sampling mode that the nose was taken out the sample, all can take out the accuracy of air flow and put forward the requirement to the accuracy of guaranteeing the sampling, and reach the demand of detecting the tolerance. Thus, a branch may be provided between the gas distribution line and the flow sensor, and a solenoid valve (171) may be provided in the branch. The electromagnetic valve (171) is closed during air distribution, and is opened during detection of the extraction sampling flow of the exhalation analyzer, and whether the extraction flow meets the set requirement of the instrument is detected through the flow sensor (151).
The quality inspection system of the breath analyzer can make inspection and judgment on the sampling process and the analysis result of the breath analyzer according to the input gas distribution body configuration and detection requirements, thereby realizing the quality monitoring of the breath analyzer. The quality inspection system of the breath analyzer is arranged in the fixed-point hospital, so that the sampling process and the inspection of the analysis process of various breath analyzers can be finished regularly, the original complicated quality inspection operation is greatly simplified, and the inspection project that part of the inspection projects can only be finished in the factory can be finished more efficiently.
Drawings
Fig. 1 is a schematic diagram 1 of a quality inspection system of a breath analyzer.
Fig. 2 is a schematic diagram of the structure of a quality inspection system of a breath analyzer 2.
Fig. 3 is a schematic diagram of the structure of the quality inspection system of the breath analyzer 3.
Fig. 4 is a schematic diagram of the structure of the quality inspection system of the breath analyzer 4.
Detailed Description
For the purpose of promoting an understanding of the principles and advantages of the invention, reference will now be made in detail to the drawings and embodiments, the invention being further illustrated in the drawings and the drawings. In the following examples, a quality inspection system for an breath analyzer was used to inspect the quality of the breath analyzer. The quality inspection mainly comprises two parts, namely the quality inspection of the breath sampling is mainly to inspect the standard-specified breath flow, pressure and time; and secondly, the quality inspection of the expiration analysis mainly performs inspection on the accuracy, the selectivity, the repeatability and the stability of target gas detection.
First embodiment:
in the present embodiment, a quality inspection system of a breath analyzer is assembled using a structural diagram of the quality inspection system of the breath analyzer, and an exhalation analyzer for respiratory tract detection is subjected to quality inspection.
The quality inspection system of the breath analyzer used in the embodiment is composed of an automatic gas distribution unit (100), an expiration sampling quality inspection unit (200), an expiration analysis quality inspection unit (300) and a total control unit (400); the automatic gas distribution unit (100) comprises two gas distribution pipelines and a flow sensor (151), wherein each gas distribution pipeline is provided with a gas cylinder (111, 112), a pressure reducing valve (121, 122) and an electromagnetic proportional valve (131, 132) in series, and all the gas distribution pipelines are connected to the flow sensor (151) in parallel; the expiration sampling quality inspection unit (200) comprises a pressure sensor (210), and the pressure sensor (210) is connected with an air outlet of the automatic air distribution unit through a pipeline; the overall control unit (400) comprises a control module (410) and a screen and visual operation interface (420).
The flow sensor (151) is a mass flow sensor, the gas cylinder (112) is a high-concentration NO standard gas cylinder, the concentration is 1500ppb, the gas cylinder (111) is a nitrogen gas cylinder, and the connection ports and the pressure configurations of the pressure reducing valves (121, 122) are adapted to the specifications of the corresponding gas cylinders.
The breath analyzer quality inspection system (hereinafter referred to as quality inspection system) performs quality inspection (mainly, inspection of standard-specified breath flow, pressure and time) on the breath sampling process of the breath test function of the breath analyzer according to the following steps:
1) And inputting the flow range requirement and the pressure requirement of the sampling process on a screen and a visual operation interface of the quality inspection system. The flow range requirement was set to 40-60ml/s, the flow detection point was set to 9 points, and the air flow pressure requirement was set to >5cmH2O. During the quality inspection of the breath sampling process, the air flow is configured by using a nitrogen cylinder only.
2) The air inlet of the expiration analyzer is connected with the air outlet of the quality inspection system, so that air tightness is ensured.
3) After the expiration analyzer enters the expiration detection mode, the quality inspection system is started to configure the air flow with the flow rate of 40ml/s, the air flow pressure data is detected and recorded, the expiration analyzer starts to sample, and the flow rate indication is displayed on a screen. When the expiration analyzer finishes sampling, the pressure sensor of the quality inspection system detects pressure change, the electromagnetic proportional valve is immediately closed, and ventilation is finished. And displaying whether the sampling is successful or not on a screen of the expiration analyzer, displaying air flow pressure data and sampling time data on a screen of the quality inspection system, and inputting a result of whether the expiration analyzer is successful or not into the screen of the quality inspection system.
4) The test of the latter 8 flow detection points was continued, except that the flow of the air stream was changed, all the other things being the same.
5) After the detection of the 9 flow detection points is finished, the quality inspection system can give out analysis reports of the flow range, the pressure and the time of breath sampling of the breath analyzer, and give out advice of whether the flow and the pressure setting of breath analysis are not in accordance with the requirements or whether adjustment is needed.
A quality inspection system (hereinafter referred to as a quality inspection system) of the breath analyzer performs quality inspection (mainly, inspection of accuracy, repeatability and stability of target gas detection) on a sample analysis process of an oral-expiratory test function of the breath analyzer according to the following steps:
1) The concentration and flow requirements of the configuration gas are entered on a screen of the quality inspection system and a visual operation interface (420). The accuracy target concentration points are set to 15ppb, 60ppb, 250ppb, 1000ppb, each point being tested 3 times; the target concentration point of repeatability and stability is set to be 60ppb, the repeatability is continuously tested for 10 times, the stability is tested once every half hour, and the total test time is 5 times; the total flow requirement is set to be 50ml/s, namely 3000ml/min, and the quality inspection system automatically calculates the flow of each path to be configured according to the gas cylinder concentration, the target concentration and the total flow requirement.
2) The quality inspection system distributes gas according to the set concentration and flow requirements, firstly configures high-concentration NO standard gas flow, opens the electromagnetic proportional valve (132) and adjusts the opening proportion according to the feedback flow of the flow sensor (151) until the high-concentration NO standard gas flow is the flow which is required to be configured, and records the opening proportion of the electromagnetic proportional valve (132); then configuring nitrogen flow, closing an electromagnetic proportional valve (132), opening the electromagnetic proportional valve (131), and adjusting the opening proportion according to the feedback flow of a flow sensor (151) until the nitrogen flow is the flow to be configured; then the electromagnetic proportional valve (132) is opened according to the recorded starting proportion, the total flow of two paths is 3000ml/min, the ventilation is stable for 5 minutes, and the air flow is ensured to be stable.
3) After the expiration analyzer enters the expiration detection mode, the air inlet of the expiration analyzer is connected with the air outlet of the quality inspection system, so that air tightness is ensured. And the expiration analyzer starts sampling, the quality inspection system starts detecting and recording air flow pressure data, and after the expiration analyzer finishes sampling, the pressure sensor detects pressure change, the electromagnetic proportional valve is closed immediately, and ventilation is finished.
4) After the expiration analyzer enters an analysis mode to complete analysis, a detection result is displayed on an interface, and the result is input into a screen and a visual operation interface of the quality inspection system.
5) And (3) repeating the steps 2-4 until detection of all points is completed, and analyzing the accuracy, repeatability and stability results according to the input detection result data by the quality inspection system.
6) In combination with the analysis of the sampling process detected before, a breath sampling and analysis quality monitoring report of the breath analyzer can be given, and a printer can be connected for printing and outputting.
Specific embodiment II:
in the present embodiment, a quality inspection system of a breath analyzer is assembled using a structural diagram of the quality inspection system of the breath analyzer, and an exhalation analyzer for respiratory tract detection is quality-monitored.
The quality inspection system of the breath analyzer used in the embodiment is composed of an automatic gas distribution unit (100), an expiration sampling quality inspection unit (200), an expiration analysis quality inspection unit (300) and a total control unit (400); the automatic gas distribution unit (100) comprises three gas distribution pipelines and a flow sensor (151), wherein each gas distribution pipeline is provided with a gas cylinder (111, 112, 113), a pressure reducing valve (121, 122, 123) and an electromagnetic proportional valve (131, 132, 133) in series, and all the gas distribution pipelines are connected to the flow sensor (151) in parallel. The expiration sampling quality inspection unit (200) comprises a pressure sensor (210), and the pressure sensor (210) is connected with an air outlet of the automatic air distribution unit through a pipeline; a thermometry and hygrometry module (220) is provided after the flow sensor (151) for feeding back and recording the temperature and humidity of the configuration gas. The general control unit (400) comprises a control module (410), a GPRS-4G communication module (430), a data storage module (440) and a screen and visual operation interface (420).
Wherein the flow sensor (151) is a volumetric flow sensor; the gas cylinder (113) is a high-concentration NO standard gas cylinder, and the concentration is 1500ppb; the gas cylinder (112) is a simulated exhalation gas cylinder containing a trace concentration of an interference gas source, and contains components which possibly interfere with detection in human exhalation, such as CO, H2S, methyl mercaptan and ethanol; the gas cylinder (111) is a dilution gas cylinder containing 79% of nitrogen and 16% of oxygen sources; the connection ports and the pressure configurations of the pressure reducing valves (121, 122, 123) are adapted to the corresponding gas cylinder specifications.
The quality inspection system of the breath analyzer is basically consistent with the first embodiment in terms of the quality inspection of the breath sampling process of the breath analyzer with the breath test function, and the air flow is configured only by using the dilution air bottle when the quality inspection of the breath sampling process is repeated.
A quality inspection system (hereinafter referred to as a quality inspection system) of the breath analyzer performs quality inspection (mainly, inspection of selectivity, accuracy, repeatability and stability of target gas detection) on a sample analysis process of an oral-expiratory test function of the breath analyzer according to the following steps:
1) The concentration and flow requirements of the configuration gas are entered on a screen of the quality inspection system and a visual operation interface (420). The accuracy target concentration points are set to 15ppb, 60ppb, 250ppb, 1000ppb, each point being tested 3 times; the target concentration point of repeatability and stability is set to be 60ppb, the repeatability is continuously tested for 10 times, the stability is tested once every half hour, and the total test time is 5 times; the total flow requirement is set to be 50ml/s, namely 3000ml/min, and the quality inspection system automatically calculates the flow of each path to be configured according to the gas cylinder concentration, the target concentration and the total flow requirement.
2) The quality inspection system of the breath analyzer is used for distributing gas according to the set concentration and flow requirements, the electromagnetic valve (171) is closed during gas distribution, the high-concentration NO standard gas flow is firstly configured, the electromagnetic proportional valve (133) is opened, the opening proportion is adjusted according to the feedback flow of the flow sensor (151) until the high-concentration NO standard gas flow is the flow which is required to be configured, and the opening proportion of the electromagnetic proportional valve (133) is recorded; then configuring the flow of the simulated expiratory gas cylinder, closing the electromagnetic proportional valve (133), and opening the electromagnetic proportional valve (132) to adjust the opening proportion according to the feedback flow of the flow sensor (151) until the flow of the simulated expiratory gas cylinder is the opening proportion of the electromagnetic proportional valve (132) for the flow record to be configured; then configuring nitrogen flow, closing an electromagnetic proportional valve (132), opening the electromagnetic proportional valve (131), and adjusting the opening proportion according to the feedback flow of a flow sensor (151) until the nitrogen flow is the flow to be configured; then opening an electromagnetic proportional valve (132) and an electromagnetic proportional valve (133) according to the recorded starting proportion, and stably ventilating for 5 minutes to ensure the stable air flow.
3) After the expiration analyzer enters the expiration detection mode, the air inlet of the expiration analyzer is connected with the air outlet of the quality inspection system, so that air tightness is ensured. And the expiration analyzer starts sampling, the quality inspection system starts detecting and recording air flow pressure data, and after the expiration analyzer finishes sampling, the pressure sensor detects pressure change, the electromagnetic proportional valve is closed immediately, and ventilation is finished.
4) After the expiration analyzer enters an analysis mode to complete analysis, a detection result is displayed on an interface, and the result is input into a screen and a visual operation interface of the quality inspection system.
5) And (3) repeating the steps (2-4) until detection of all points is completed, and analyzing and judging the gas concentration result detected by the gas distribution through the expiration analyzer by the quality inspection system to obtain a result of selectivity, accuracy, repeatability and stability.
6) In combination with the analysis of the sampling process detected before, a breath sampling and analysis quality monitoring report of the breath analyzer can be given, and a printer can be connected for printing and outputting.
7) The quality monitoring data is stored in the data storage module (440), and the GPRS-4G communication module (430) can upload the quality monitoring data to the cloud platform in time.
Third embodiment:
in the present embodiment, a quality inspection system of a breath analyzer is assembled using a structural diagram of the quality inspection system of the breath analyzer, and an exhalation analyzer for digestive tract detection is quality-monitored.
The quality inspection system of the breath analyzer used in the embodiment is composed of an automatic gas distribution unit (100), an expiration sampling quality inspection unit (200), an expiration analysis quality inspection unit (300) and a total control unit (400); the automatic gas distribution unit (100) comprises three gas distribution pipelines and a flow sensor (151), wherein each gas distribution pipeline is provided with a gas cylinder (111, 112, 113, 114), a pressure reducing valve (121, 122, 123, 124) and an electromagnetic proportional valve (131, 132, 133, 134) in series, and all the gas distribution pipelines are connected to the flow sensor (151) in parallel. The two gas distribution pipelines are provided with heating and humidifying modules (161, 162) so as to obtain target gas simulating the humidity of expired air. The expiration sampling quality inspection unit (200) comprises a pressure sensor (210), and the pressure sensor (210) is connected with an air outlet of the automatic air distribution unit through a pipeline; a thermometry and hygrometry module (220) is provided after the flow sensor (151) for feeding back and recording the temperature and humidity of the configuration gas. The overall control unit (400) comprises a control module (410) and a screen and visual operation interface (420).
The flow sensor (151) is a volume flow sensor, the gas cylinder (114) is a high-concentration CH4 standard gas cylinder, the concentration is 100ppm, the gas cylinder (113) is a high-concentration H2 standard gas cylinder, the concentration is 200ppm, the gas cylinder (112) is a nitrogen gas cylinder, the gas cylinder (111) is an air cylinder with the oxygen concentration of 21%, and the connection ports and the pressure configuration of the pressure reducing valves (121, 122, 123 and 124) are matched with the specifications of the corresponding gas cylinders.
The breath analyzer quality inspection system (hereinafter referred to as quality inspection system) performs quality inspection (mainly, inspection of standard-specified breath flow, pressure and time) on the breath sampling process of the breath test function of the breath analyzer according to the following steps:
1) And inputting the flow range requirement and the pressure requirement of the sampling process on a screen and a visual operation interface of the quality inspection system. The flow range requirement is set to 50-150ml/s, the flow detection point is set to 5 points, the air flow pressure requirement is set to >5cmH2O, and the sampling time is set to >8s. During the quality inspection of the breath sampling process, the air flow is configured by using a nitrogen cylinder only.
2) The air inlet of the expiration analyzer is connected with the air outlet of the quality inspection system, so that air tightness is ensured.
3) After the expiration analyzer enters the expiration detection mode, the quality inspection system is started to configure the air flow with the flow rate of 80ml/s, the air flow pressure data is detected and recorded, the expiration analyzer starts to sample, and the flow rate indication is displayed on a screen. When the expiration analyzer finishes sampling, the pressure sensor of the quality inspection system detects pressure change, the electromagnetic proportional valve is immediately closed, and ventilation is finished. And displaying whether the sampling is successful or not on a screen of the expiration analyzer, displaying air flow pressure data and sampling time data on a screen of the quality inspection system, and inputting a result of whether the expiration analyzer is successful or not into the screen of the quality inspection system.
4) The test of the latter 4 flow detection points was continued, except that the flow of the air stream was changed, all the other things being the same.
5) After the detection of the 5 flow detection points is finished, the quality inspection system can give out analysis reports of the flow range, the pressure and the time of breath sampling of the breath analyzer, and give out advice of whether the flow and the pressure setting of breath analysis are not in accordance with the requirements or whether adjustment is needed.
A quality inspection system (hereinafter referred to as a quality inspection system) of the breath analyzer performs quality inspection (mainly inspection of accuracy of target gas detection) on a sample analysis process of an oral-expiratory test function of the breath analyzer according to the following steps:
1) The concentration and flow requirements of the configuration gas and the pressure monitoring requirements are input on a screen of a quality inspection system and a visual operation interface (420) of the breath analyzer. Target H2, CH4 and O2 concentrations were set to 20ppm, 10ppm and 15% respectively, tested 3 times; the total flow requirement is set to be 100ml/s, namely 6000ml/min, the system automatically calculates the flow of each path to be configured according to the gas cylinder concentration, the target concentration and the total flow requirement, and the requirement of gas humidification is set.
2) The quality inspection system of the breath analyzer is used for distributing gas according to the set concentration and flow requirements, the electromagnetic valve (171) is closed during gas distribution, the high-concentration CH4 standard gas flow is firstly configured, the electromagnetic proportional valve (134) is opened, the opening proportion is adjusted according to the feedback flow of the flow sensor (151) until the high-concentration CH4 standard gas flow is 600ml/min, and the opening proportion of the electromagnetic proportional valve (134) is recorded; then, configuring high-concentration H2 standard air flow, closing an electromagnetic proportional valve (134), opening the electromagnetic proportional valve (133), adjusting the opening proportion according to the feedback flow of a flow sensor (151) until the high-concentration H2 standard air flow is 600ml/min, and recording the opening proportion of the electromagnetic proportional valve (133); then configuring nitrogen flow, closing an electromagnetic proportional valve (133), opening the electromagnetic proportional valve (132) to adjust the opening proportion according to the feedback flow of a flow sensor (151) until the nitrogen flow is 514ml/min, and recording the opening proportion of the electromagnetic proportional valve (132); then air flow is configured, an electromagnetic proportional valve (132) is closed, an electromagnetic proportional valve (131) is opened, and the opening proportion is adjusted according to the feedback flow of a flow sensor (151) until the air flow is 4286ml/min; then, the electromagnetic proportional valve (132), the electromagnetic proportional valve (133) and the electromagnetic proportional valve (134) are opened according to the recorded starting proportion, the humidifying modules (161, 162) are opened, the ventilation is stable for 5 minutes, and the air flow stability is ensured.
3) After the expiration analyzer enters the expiration detection mode, the air inlet of the expiration analyzer is connected with the air outlet of the quality inspection system, so that air tightness is ensured. And the expiration analyzer starts sampling, the quality inspection system starts detecting and recording air flow pressure data, and after the expiration analyzer finishes sampling, the pressure sensor detects pressure change, the electromagnetic proportional valve is closed immediately, and ventilation is finished.
4) After the expiration analyzer enters an analysis mode to complete analysis, a detection result is displayed on an interface, and the result is input into a screen and a visual operation interface of the quality inspection system.
5) And (3) repeating the steps (2-4) to finish 3 times of detection, and analyzing and judging the gas concentration result detected by the gas distribution through the expiration analyzer by the quality inspection system to obtain an accurate result.
6) In combination with the analysis of the sampling process detected before, a breath sampling and analysis quality monitoring report of the breath analyzer can be given, and a printer can be connected for printing and outputting.
Fourth embodiment:
in the present embodiment, a quality inspection system of a breath analyzer is assembled using a structural diagram of the quality inspection system of the breath analyzer, and an exhalation analyzer for respiratory tract detection is quality-monitored.
The quality inspection system of the breath analyzer used in the embodiment is composed of an automatic gas distribution unit (100), an expiration sampling quality inspection unit (200), an expiration analysis quality inspection unit (300) and a total control unit (400); the automatic gas distribution unit (100) comprises two gas distribution pipelines and a flow sensor (151), wherein each gas distribution pipeline is provided with a gas cylinder (111, 112), a pressure reducing valve (121, 122) and an electromagnetic proportional valve (131, 132) in series, and all the gas distribution pipelines are connected to the flow sensor (151) in parallel; a branch is arranged between the gas distribution pipeline and the flow sensor (151), and an electromagnetic valve (171) is arranged on the branch; the expiration sampling quality inspection unit (200) comprises a pressure sensor (210), and the pressure sensor (210) is connected with an air outlet of the automatic air distribution unit through a pipeline; the overall control unit (400) comprises a control module (410) and a screen and visual operation interface (420).
The flow sensor (151) is a mass flow sensor, the gas cylinder (112) is a high-concentration NO standard gas cylinder, the concentration is 1500ppb, the gas cylinder (111) is a nitrogen gas cylinder, and the connection ports and the pressure configurations of the pressure reducing valves (121, 122) are adapted to the specifications of the corresponding gas cylinders.
The breath sampling of the breath analyzer and the quality inspection of the breath analysis process by the quality inspection system of the breath analyzer used in the embodiment are basically the same as those of the first embodiment, and the repeated description is omitted.
The quality inspection system of the breath analyzer used in the embodiment can also perform quality monitoring on the nasal aspiration test or offline test function of the breath analyzer according to the following steps:
1) The air inlet of the expiration analyzer is connected with the air outlet of the quality inspection system, so that air tightness is ensured.
2) The pumping flow monitoring requirements are input on a screen of a quality inspection system of the breath analyzer and a visual operation interface (420). The suction flow rate was set to 10ml/s, i.e. 600ml/min.
3) After the breath analyzer enters a nasal air extraction test or off-line test function, air extraction is started, a pressure sensor (210) of a quality inspection system of the breath analyzer detects negative pressure, an electromagnetic valve (171) is opened, and an air extraction flow is detected and recorded by a flow sensor (151).
4) The quality inspection system of the breath analyzer can give out an analysis result of the sampling flow of the air extraction and give out a quality monitoring report of the breath analyzer, and can be connected with a printer for printing and outputting.
The above embodiments show that the present invention is indeed capable of making a test and judgment on the sampling process and analysis result of an breath analyzer, thereby enabling quality detection of the breath analyzer.
The invention is not limited to the embodiments shown and described, but any variations and modifications are intended to be within the scope of the appended claims.
Claims (6)
1. A quality inspection system for a breath analyzer, comprising: the breath analyzer quality monitoring system consists of an automatic gas distribution unit, an expiration sampling quality inspection unit, an expiration analysis quality inspection unit and a total control unit; the automatic gas distribution unit comprises at least two gas distribution pipelines and a flow sensor, wherein each gas distribution pipeline is provided with a gas cylinder, a pressure reducing valve and an electromagnetic proportional valve in series and is connected to the flow sensor in parallel; the expiration sampling quality inspection unit comprises a pressure sensor, wherein the pressure sensor is connected with an air outlet of the automatic air distribution unit through a pipeline and is used for monitoring the air flow pressure in the sampling process of the expiration analyzer; when the expiration analyzer finishes sampling, the pressure sensor detects pressure change, the electromagnetic proportional valve is immediately closed, and ventilation is finished; the main control unit comprises a control module, a screen and a visual operation interface, and the detection of automatic distribution and expiration sampling analysis quality is completed according to the detection requirements input by the screen and the visual operation interface;
the expiration sampling quality inspection unit is used for inspecting the expiration flow, pressure and time specified by the standard; the expiration analysis quality inspection unit is used for inspecting the accuracy, selectivity, repeatability and stability of target gas detection;
the number of the gas distribution pipelines is two, and the gas distribution pipelines comprise a high-concentration standard gas cylinder and a diluted gas cylinder; or (b)
The number of the distribution pipelines is three, namely a dilution gas circuit containing nitrogen and oxygen, a gas circuit containing a gas source of the gas to be tested, and a gas circuit containing a trace concentration interference gas source, and the simulated human body exhaled gas is obtained through the allocation of the three gases;
the screen and the visual operation interface are used for inputting gas configuration and detection requirements, inputting sampling and analysis results of the breath analyzer and displaying a quality detection report of the breath analyzer; the control module controls the opening proportion of the electromagnetic proportional valve to complete automatic air distribution according to the input requirement, monitors and records the pressure condition of the air flow in the sampling process, judges whether the air flow pressure meets the specified requirement when the breath analyzer is used for sampling, and records the sampling time.
2. The breath analyzer quality inspection system of claim 1, wherein: the pressure reducing valve is used for reducing pressure of the gas cylinder, the connection port and the pressure configuration are adapted to the specification of the gas cylinder, and the use safety of the gas cylinder is ensured; the electromagnetic proportional valve is arranged behind the pressure reducing valve, and the flow rate of the air flow passing through the electromagnetic proportional valve is regulated according to the opening proportion, so that the air distribution requirement is met; the flow sensor is arranged behind the plurality of parallel air distribution pipelines, so that the flow and the total flow of each air distribution pipeline meet air distribution requirements.
3. The breath analyzer quality inspection system of claim 2, wherein: the flow sensor is a mass flow sensor or a volume flow sensor.
4. The breath analyzer quality inspection system of claim 1, wherein: a heating and humidifying module is arranged on a dilution gas path of the gas distribution pipeline, so that target gas simulating the humiture of the expired gas can be obtained; and a temperature and humidity measuring module is arranged behind the flow sensor and is used for detecting the temperature and humidity of the configuration gas.
5. The breath analyzer quality inspection system of claim 1, wherein: the general control unit is provided with a GPRS-4G communication module to provide a networking function, and timely uploads monitoring data to the cloud platform; the total control unit is provided with a data storage module for storing data.
6. A quality inspection system for a breath analyzer, comprising: the breath analyzer quality monitoring system consists of an automatic gas distribution unit, an expiration sampling quality inspection unit, an expiration analysis quality inspection unit and a total control unit; the automatic gas distribution unit comprises at least two gas distribution pipelines and a flow sensor, wherein each gas distribution pipeline is provided with a gas cylinder, a pressure reducing valve and an electromagnetic proportional valve in series, the gas distribution pipelines are connected to the flow sensor in parallel, a branch is arranged between the gas distribution pipeline and the flow sensor, and an electromagnetic valve is arranged on the branch; the expiration sampling quality inspection unit comprises a pressure sensor, wherein the pressure sensor is connected with an air outlet of the automatic air distribution unit through a pipeline and is used for monitoring the air flow pressure in the sampling process of the expiration analyzer; when the expiration analyzer finishes sampling, the pressure sensor detects pressure change, the electromagnetic proportional valve is immediately closed, and ventilation is finished; the main control unit comprises a control module, a screen and a visual operation interface, and the detection of automatic distribution and expiration sampling analysis quality is completed according to the detection requirements input by the screen and the visual operation interface;
the expiration sampling quality inspection unit is used for inspecting the expiration flow, pressure and time specified by the standard; the expiration analysis quality inspection unit is used for inspecting the accuracy, selectivity, repeatability and stability of target gas detection;
the number of the gas distribution pipelines is two, and the gas distribution pipelines comprise a high-concentration standard gas cylinder and a diluted gas cylinder; or (b)
The number of the distribution pipelines is three, namely a dilution gas circuit containing nitrogen and oxygen, a gas circuit containing a gas source of the gas to be tested, and a gas circuit containing a trace concentration interference gas source, and the simulated human body exhaled gas is obtained through the allocation of the three gases;
the screen and the visual operation interface are used for inputting gas configuration and detection requirements, inputting sampling and analysis results of the breath analyzer and displaying a quality detection report of the breath analyzer; the control module controls the opening proportion of the electromagnetic proportional valve to complete automatic air distribution according to the input requirement, monitors and records the pressure condition of the air flow in the sampling process, judges whether the air flow pressure meets the specified requirement when the breath analyzer is used for sampling, and records the sampling time.
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| CN111595609A (en) * | 2020-06-19 | 2020-08-28 | 中国计量科学研究院 | Respiratory rhythm generating device, detection system with same and detection method |
| CN113504361A (en) * | 2021-01-19 | 2021-10-15 | 广州瑞普医疗科技有限公司 | Automatic detection method and system |
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