A test device and method for the trigger flow rate of an oxygen concentrator in an oxygen-saving device.

Abstract

This invention belongs to the field of medical device testing technology, specifically relating to a testing device and method for the trigger flow rate of an oxygen concentrator in an oxygen-saving device. The invention drives a vacuum pump to perform a suction operation. Under the suction force, the duckbill valve closes simultaneously, and the negative pressure diaphragm collapses, thereby creating a vacuum negative pressure within the three-way valve body. This stimulates the oxygen concentrator to complete oxygen supply. During oxygen supply, the duckbill valve automatically opens to connect to a flow sensor to record single-cycle oxygen production data. Simultaneously, the negative pressure diaphragm acts as an isolation barrier, preventing oxygen from entering the vacuum pump and effectively avoiding damage to the vacuum pump due to oxygen contact. Ultimately, this protects both the vacuum pump and the oxygen concentrator, ensuring stable equipment operation.

Description

Technical Field

[0001] This invention belongs to the field of medical device testing technology, specifically relating to a testing device and method for the trigger flow rate of an oxygen concentrator in an oxygen-saving device. Background Technology

[0002] An oxygen concentrator filters the surrounding air, compresses it to the required density, and then delivers the purified medical-grade oxygen to the patient through a pulsed dosing system or a continuous flow system. Oxygen concentrators in oxygen-saving devices are essential infrastructure in the healthcare field. They often employ a pulsed oxygen supply mode, supplying oxygen on demand according to the individual's breathing rate, thus utilizing oxygen efficiently. They are widely used for high-altitude travel, outdoor hiking, and for those with COPD, weakened lung function, or requiring long-term oxygen therapy and daily health maintenance. They offer advantages such as stable oxygen concentration, compact and lightweight design, and energy-efficient pulsed oxygen supply.

[0003] Current oxygen concentrator standards for oxygen-saving devices (such as YY9706.269-2021 and ISO80601-2-67:2026) require different pulse signals to stimulate the oxygen supply when testing the accuracy of the trigger flow rate due to the inherent characteristics of these devices. Currently, the main devices capable of generating negative pressure are artificial lungs and adjustable-frequency vacuum pumps. Most artificial lungs integrate the inhalation and exhalation channels into a single channel, generating not only negative pressure at different frequencies but also positive pressure at the same frequency. When positive pressure is generated, it can damage the oxygen concentrator. The other type is the adjustable-frequency vacuum pump. Because the gas path is connected to the oxygen concentrator, the pulse signal from the vacuum pump can damage the pump when stimulating the oxygen supply, making it impossible to complete the accuracy test of the trigger flow rate of the oxygen concentrator in the oxygen-saving device.

[0004] Therefore, there is an urgent need to develop a testing device and method for the trigger flow rate of the oxygen concentrator in an oxygen-saving device, in order to fill the technical gap in the accuracy of the trigger flow rate of the oxygen concentrator in an oxygen-saving device, and to provide a reliable basis for its quality inspection and risk control. Summary of the Invention

[0005] The purpose of this invention is to provide a testing device and method for the trigger flow rate of the oxygen concentrator in an oxygen-saving device, so as to solve the problems mentioned in the background art.

[0006] The technical problem to be solved by the present invention is achieved by the following technical solution: a test device for the trigger flow of the oxygen concentrator of an oxygen-saving device, comprising an oxygen concentrator and an oxygen concentrator trigger module; The oxygen concentrator trigger module includes a gas transfer unit and a vacuum pump; The gas transfer unit includes a three-way main body, a sealing cap, a negative pressure diaphragm, and a duckbill valve; The three-way body is provided with an air inlet, an air outlet and an air extraction port. The three-way body is provided with a pressure regulating chamber on the side of the air extraction port. The negative pressure diaphragm is disposed in the pressure regulating chamber. The sealing cover is connected to the pressure regulating chamber and is sealed to the negative pressure diaphragm to form a pressure regulating cavity; The pressure regulating chamber is connected to the vacuum pump, and the vacuum pump is equipped with a controller; The duckbill valve is installed on the air outlet, which is connected to the delivery pipe. The delivery pipe is equipped with a pressure sensor and a flow sensor, and an adjustable flow limiter is installed on the delivery pipe. The air inlet is connected to the air outlet of the oxygen concentrator. A trigger control valve is installed on the front side of the air outlet of the oxygen concentrator, and the trigger control valve is connected to the trigger control system of the oxygen concentrator. The adjustable flow limiter simulates the respiratory resistance of a patient, which varies with age. In this invention, the duckbill valve can close when the vacuum pump creates a negative pressure environment and quickly open when the oxygen concentrator supplies oxygen. It is sensitive to gas pressure, has low opening resistance, and can effectively simulate the human respiratory system. This invention uses a vacuum pump to draw in the negative pressure diaphragm. After the negative pressure diaphragm deforms, a negative pressure environment is created inside the three-way valve body. At the same time, the negative pressure diaphragm prevents oxygen from entering the vacuum pump when the oxygen concentrator supplies oxygen, thus avoiding affecting the accuracy of the test.

[0007] Preferably, the present invention further includes a data acquisition system connected to the pressure sensor and the flow sensor, the data acquisition system being used to acquire the measured values ​​of the pressure sensor and the flow sensor in real time.

[0008] Preferably, the data acquisition system of the present invention has a sampling rate of not less than 200 times / second, which is the minimum requirement in ISO80601-2-67.

[0009] Preferably, in this invention, the rise time of the pressure sensor and flow sensor within the 10%~90% range is no more than 10ms. The time from 10% to 90% being no more than 10ms primarily reflects the sensor's sensitivity.

[0010] Preferably, in this invention, both the pressure regulating chamber and the negative pressure diaphragm are hemispherical.

[0011] This invention also discloses a method for testing the trigger flow rate of the oxygen concentrator in an oxygen-saving device, utilizing the aforementioned testing device for the trigger flow rate of the oxygen concentrator in an oxygen-saving device, comprising the following steps: S1. Set up the test scenario, keep the adjustable flow valve in the open state and adjust it to the set opening degree; ISO80601-2-67 requires the test to be in the fully open state, and adjust the opening degree of the adjustable flow valve according to different ages; S2. According to the test parameters in the first row of Table 1, adjust the vacuum pump to generate negative pressure at the corresponding frequency to simulate the human breathing frequency. Wait for the oxygen concentrator of the oxygen-saving device to reach steady-state output. The controller is used to control the vacuum pump, controlling the vacuum pump switching frequency and pressure. The stability of oxygen concentration and flow rate values ​​indicates that the oxygen concentrator has reached steady-state output. Table 1

[0012] Table 1 lists the requirements in ISO 80601-2-67; S3. From the start of negative pressure generation to the end of the oxygen capture time specified in Table 1, the oxygen output of the oxygen concentrator in a single delivery is calculated by the flow sensor. S4. Repeat step S3 for a total of 30 breaths, and calculate the average value of the 30 measurements; S5. Based on the measurement parameters in step S4, calculate the deviation between the actual oxygen output and the oxygen concentrator's indicated value. S6. For each row of parameters in Table 1, repeat steps S2 to S5; respiratory rates vary among different age groups, and the standard requires testing typical respiratory rates. S7. Repeat steps S2 to S6 for different speed settings of the oxygen concentrator in the oxygen-saving device; In order to accommodate different groups of people, oxygen concentrators are generally divided into multiple speed settings according to different flow rates. S8. The oxygen concentrator's breathing sensitivity is evaluated by applying a gradually decreasing negative pressure of -0.5 cmH2O (cm water column) per second within the three-way body 3 using a vacuum pump. By creating a small negative pressure, the minimum pressure value that triggers the oxygen concentrator to start outputting oxygen is recorded by a pressure sensor. The suction force and speed of the vacuum pump are controlled by the vacuum pump, and the values ​​on the controller main unit can be adjusted. If the flow sensor value increases, it means that oxygen has been output. S9. Record whether the trigger pressure in step S8 is less than the value indicated on the oxygen concentrator; if the trigger pressure is less than the value indicated on the oxygen concentrator, it means that the oxygen concentrator is sensitive to oxygen output. S10. Repeat steps S8 and S9 for a total of 10 breaths, and calculate the average of the 10 measurements. The 10 breaths are as specified in ISO 80601-2-67.

[0013] Compared with the prior art, the beneficial effects of the present invention are: the present invention can achieve unidirectional negative pressure at different frequencies. During operation, after the vacuum pump's suction frequency is set by the controller, the motor drives the vacuum pump to perform the pumping operation. Under the suction force, the duckbill valve closes synchronously, the negative pressure diaphragm is depressed, and a vacuum negative pressure is formed in the three-way body, thereby stimulating the oxygen concentrator to complete the oxygen supply.

[0014] During the oxygen supply process, the duckbill valve automatically opens to connect to the flow sensor to record the oxygen production data for each cycle. At the same time, the negative pressure diaphragm plays an isolation role to prevent oxygen from entering the vacuum pump, effectively avoiding damage to the vacuum pump due to contact with oxygen. Ultimately, this protects the vacuum pump and the oxygen concentrator, ensuring stable operation of the equipment. Attached Figure Description

[0015] Figure 1 A schematic diagram of the structure of a test device for triggering the flow rate of the oxygen concentrator in an oxygen-saving device; Figure 2 A schematic diagram of the oxygen concentrator trigger module; In the diagram, 1 is an oxygen concentrator, 2 is a vacuum pump, 3 is a three-way valve body, 4 is a sealing cap, 5 is a negative pressure diaphragm, and 6 is a duckbill valve. 31 Air inlet, 32 Air outlet, 33 Air extraction port, 34 Pressure regulating chamber; 100 Pressure regulating chamber, 7 Delivery pipe, 8 Pressure sensor, 9 Flow sensor, 10 Adjustable flow limiter, 11 Data acquisition system, 200 Trigger control valve. Detailed Implementation

[0016] The present invention will be further described in detail below with reference to the embodiments and accompanying drawings, but the embodiments of the present invention are not limited thereto.

[0017] like Figure 1 and Figure 2 As shown, a test device for the trigger flow of an oxygen concentrator in an oxygen-saving device includes an oxygen concentrator 1 and an oxygen concentrator trigger module.

[0018] The oxygen concentrator trigger module includes a gas transfer unit and a vacuum pump 2.

[0019] The gas transfer unit includes a three-way body 3, a sealing cap 4, a negative pressure diaphragm 5, and a duckbill valve 6.

[0020] The three-way body 3 is provided with an air inlet 31, an air outlet 32 ​​and an air extraction port 33. The three-way body 3 is provided with a pressure regulating chamber 34 on one side of the air extraction port 33, and the negative pressure diaphragm 5 is disposed in the pressure regulating chamber 34.

[0021] The sealing cap 4 is connected to the pressure regulating chamber 34 and is sealed to the negative pressure diaphragm 5 to form a pressure regulating cavity 100. Both the pressure regulating chamber 34 and the negative pressure diaphragm 5 are hemispherical. The sealing cap 4 is threaded to the pressure regulating chamber 34, and the open end of the negative pressure diaphragm 5 is located between the sealing cap 4 and the inner wall of the pressure regulating chamber 34, forming a sealing structure. The negative pressure diaphragm 5 is made of rubber and is deformable. The tee body 3 is made of rigid materials such as plastic or metal.

[0022] The pressure regulating chamber 100 is connected to the vacuum pump 2 via an external interface on the sealing cover 4, and the vacuum pump 2 is equipped with a controller.

[0023] The duckbill valve 6 is installed on the air outlet 32, which is connected to the conveying pipe 7. The duckbill valve 6 is located inside the conveying pipe 7. The conveying pipe 7 is equipped with a pressure sensor 8 and a flow sensor 9, and an adjustable flow limiter 10.

[0024] The air inlet 31 is connected to the air outlet of the oxygen concentrator 1. A trigger control valve 200 is provided on the front side of the air outlet of the oxygen concentrator 1, and the trigger control valve 200 is connected to the trigger control system of the oxygen concentrator 1. When the trigger pressure set by the oxygen concentrator 1 is reached, the trigger control system automatically controls the trigger control valve 200 to open and start supplying oxygen. The oxygen is sent into the delivery pipe 7 through the duckbill valve 6.

[0025] The oxygen concentrator trigger flow test device of the oxygen-saving device also includes a data acquisition system 11 connected to the pressure sensor 8 and the flow sensor 9. The data acquisition system 11 is used to acquire the measured values ​​of the pressure sensor 8 and the flow sensor 9 in real time.

[0026] The data acquisition system has a sampling rate of no less than 200 times per second.

[0027] The rise time of the pressure sensor 8 and the flow sensor within the range of 910%~90% is no more than 10ms.

[0028] A method for testing the trigger flow rate of an oxygen concentrator in an oxygen-saving device, utilizing the testing device for the trigger flow rate of the oxygen concentrator in the oxygen-saving device described in this embodiment, includes the following steps: S1. Set up the test scenario and keep the adjustable flow valve in the open state, and adjust it to the set opening degree.

[0029] S2 and Table 1 are the oxygen delivery measurement parameters. According to the test parameters in the first row of Table 1, the vacuum pump is adjusted to generate negative pressure at the corresponding frequency, thereby simulating the human breathing frequency, and waiting for the oxygen concentrator 1 of the oxygen-saving device to reach steady-state output.

[0030] Table 1

[0031] S3. From the start of negative pressure generation until the end of the oxygen capture time specified in Table 1, the oxygen output of oxygen concentrator 1 in a single delivery is calculated by flow sensor 9.

[0032] S4. Repeat step S3 for a total of 30 breaths, and calculate the average of the 30 measurements.

[0033] S5. Based on the measurement parameters in step S4, calculate the deviation between the actual oxygen delivery output and the indicated value.

[0034] S6. Repeat steps S2 to S5 for each row of parameters in Table 1.

[0035] S7. Repeat steps S2 to S6 for different gears of the oxygen concentrator 1 of the oxygen-saving device.

[0036] S8. By applying a gradually decreasing negative pressure of -0.5 cmH2O per second in the three-way body 3 through a vacuum pump, the breathing sensitivity of the oxygen concentrator 1 is evaluated. By creating a small negative pressure, the minimum pressure value that triggers the oxygen concentrator 1 to start outputting oxygen is recorded by the pressure sensor 8, which is the minimum negative pressure provided by the vacuum pump that triggers the oxygen concentrator 1 to start outputting oxygen.

[0037] S9. Record whether the trigger pressure in step S8 is less than the indicated value.

[0038] S10. Repeat steps S8 and S9 for a total of 10 breaths, and calculate the average of the 10 measurements.

[0039] The test method of this invention refers to the corresponding parameters of standard ISO80601-2-67.

Claims

1. A test device for the trigger flow rate of an oxygen concentrator in an oxygen-saving device, characterized in that: Includes an oxygen concentrator (1) and an oxygen concentrator trigger module; The oxygen concentrator trigger module includes a gas transfer unit and a vacuum pump (2). The gas transfer unit includes a three-way body (3), a sealing cap (4), a negative pressure diaphragm (5), and a duckbill valve (6). The three-way body (3) is provided with an air inlet (31), an air outlet (32) and an air extraction port (33). The three-way body (3) is provided with a pressure regulating chamber (34) on one side of the air extraction port (33). The negative pressure diaphragm (5) is provided in the pressure regulating chamber (34). The sealing cover (4) is connected to the pressure regulating chamber (34) and is sealed to the negative pressure diaphragm (5) to form a pressure regulating cavity (100). The pressure regulating chamber (100) is connected to the vacuum pump (2), and the vacuum pump (2) is equipped with a controller; The duckbill valve (6) is installed on the air outlet (32), which is connected to the delivery pipe (7). The delivery pipe (7) is equipped with a pressure sensor (8) and a flow sensor (9), and an adjustable flow limiter (10) is installed on the delivery pipe (7). The air inlet (31) is connected to the air outlet of the oxygen concentrator (1). A trigger control valve (200) is provided on the front side of the air outlet of the oxygen concentrator (1). The trigger control valve (200) is connected to the trigger control system of the oxygen concentrator (1).

2. The test device for the trigger flow rate of the oxygen concentrator in the oxygen-saving device according to claim 1, characterized in that: It also includes a data acquisition system (11) connected to the pressure sensor (8) and the flow sensor (9), the data acquisition system (11) being used to acquire the measured values ​​of the pressure sensor (8) and the flow sensor (9) in real time.

3. The test device for the trigger flow rate of the oxygen concentrator in the oxygen-saving device according to claim 2, characterized in that: The data acquisition system has a sampling rate of no less than 200 times per second.

4. The test device for the trigger flow rate of the oxygen concentrator in the oxygen-saving device according to claim 2, characterized in that: The rise time of the pressure sensor (8) and flow sensor (9) for the range of 10%~90% is no more than 10ms.

5. The test device for the trigger flow rate of the oxygen concentrator in the oxygen-saving device according to claim 1, characterized in that: Both the pressure regulating chamber (34) and the negative pressure diaphragm (5) are hemispherical.

6. A method for testing the trigger flow rate of an oxygen concentrator in an oxygen-saving device, using the testing device for the trigger flow rate of an oxygen concentrator in an oxygen-saving device according to any one of claims 1 to 5, characterized in that, Includes the following steps: S1. Set up the test scenario, keep the adjustable flow valve in the open state, and adjust it to the set opening degree; S2. According to the test parameters in the first row of Table 1, adjust the vacuum pump to generate negative pressure at the corresponding frequency, thereby simulating the human breathing frequency, and wait for the oxygen concentrator (1) of the oxygen-saving device to reach steady-state output. Table 1 S3. From the start of negative pressure generation to the end of the oxygen capture time specified in Table 1, the oxygen output of the oxygen concentrator (1) per delivery is calculated by the flow sensor (9). S4. Repeat step S3 for a total of 30 breaths, and calculate the average value of the 30 measurements; S5. Based on the measurement parameters in step S4, calculate the deviation between the actual oxygen delivery output and the indicated value; S6. Repeat steps S2 to S5 for each row of parameters in Table 1. S7. Repeat steps S2 to S6 for different gears of the oxygen concentrator (1) of the oxygen-saving device. S8. By applying a gradually decreasing negative pressure of -0.5 cmH2O per second in the three-way body (3) through a vacuum pump, the breathing sensitivity of the oxygen concentrator (1) is evaluated, and the minimum pressure value that triggers the oxygen concentrator (1) to start outputting oxygen is recorded by the pressure sensor (8). S9. Record whether the trigger pressure in step S8 is less than the indicated value; S10. Repeat steps S8 and S9 for a total of 10 breaths, and calculate the average of the 10 measurements.

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