Method for making a profile of reliability tests for emergency medical equipment

Abstract

The present application relates to the technical field of reliability test, in particular to a reliability test profile making method for emergency treatment equipment. The life profile of medical equipment is appropriately cut to obtain a task profile, that is, a relationship diagram of corresponding environmental parameters and time when any task is completed. A third environmental parameter, that is, an environmental parameter of task execution, is introduced in the relationship diagram, which comprehensively covers the environmental factors experienced by the emergency treatment equipment in each specific stage, and can more truly and effectively simulate the actual use scene compared with the original traditional method.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of reliability test, in particular to an emergency treatment equipment reliability test profile making method. BACKGROUND

[0002] Emergency treatment equipment (such as monitor, breathing machine, blood gas analyzer, etc.) may experience various complex and harsh environments such as impact and vibration in the transportation process, severe natural climate conditions in emergency areas during the task, which requires the emergency treatment equipment to have the adaptability to various environmental changes. Since China has a vast territory and more complex environments, the environmental adaptability research and reliability test research of emergency treatment equipment are very important.

[0003] At present, the reliability test of domestic electromechanical equipment has been relatively perfect, and a complete evaluation specification and system have been formed, but the reliability test of medical equipment, especially the reliability evaluation method and specification of medical equipment in special application scenarios, is still relatively lacking. The existing reliability test of electromechanical equipment generally refers to GJB899A "Reliability Identification and Acceptance Test", since this standard is a general standard, mainly in cold days, hot days, and standard days, which cannot cover the climate environment of different regions and cannot truly simulate the specific environment of users in different use areas, and is not applicable to emergency treatment equipment. In addition, there is no corresponding test research in China at present. Therefore, for medical equipment in emergency treatment conditions, the development of environmental profile in different stages (such as transportation, transfer, clinical treatment, etc.) and the test scheme research are of great significance to improve the reliability of medical emergency treatment equipment. SUMMARY

[0004] The present application aims to provide an emergency treatment equipment reliability test profile making method, which is suitable for the generation of four comprehensive reliability test profiles of emergency treatment equipment in typical places, has the advantages of simplicity, simulation equivalence, high authenticity, etc., and solves the problems of current comprehensive environmental adaptability design, test verification, etc. of emergency treatment equipment.

[0005] To achieve the above-mentioned purpose, the present application adopts the following technical solutions:

[0006] 1. An emergency treatment equipment reliability test profile making method, characterized in that it comprises the following steps:

[0007] Step 1, determine the life profile of emergency treatment equipment, that is, the profile of the whole process experienced by each stage from production to use, and extract the task profile from the life profile; obtain the first environmental parameter according to the emergency equipment design specification and the expected use environment;

[0008] Step 2, obtaining a second environment parameter according to the task profile, the second environment parameter being environment information and time experienced during transportation of the emergency medical equipment, and obtaining a first environment profile according to the second environment parameter;

[0009] obtaining a third environment parameter according to the task profile, the third environment parameter being geographical environment information and time experienced at a task execution site of the emergency medical equipment, and obtaining a second environment profile according to the third environment parameter;

[0010] Step 3, adjusting and optimizing the first environment parameter, the second environment parameter, and the third environment parameter based on the test box technical parameters; wherein the temperature and humidity parameters in the second environment parameter should meet the corresponding requirements in the first environment parameter, the air pressure parameter in the second environment parameter changes linearly according to the starting air pressure and the ending air pressure; and the air pressure optimization formula of the second environment parameter and the third environment parameter is P i2 = max(P i1 , P a ), wherein P i1 and P i2 are the initial air pressure value and the final determined air pressure value of the i-th environment parameter, and P a is a standard air pressure value calculated by using the air pressure formula;

[0011] Step 4, synthesizing the first environment profile and the second environment profile into a test profile according to the time sequence;

[0012] Step 5, adjusting the test indexes of the emergency medical equipment by using the test profile, discarding the indexes that cannot be tested normally under the environment parameters at the execution site; applying comprehensive stress to the emergency medical equipment based on the test profile, and testing the performance of the emergency medical equipment by using the adjusted test indexes to obtain the reliability-related indexes.

[0013] Further, the life profile includes all events experienced by the emergency medical equipment from being put into use to the end of life or retirement, and the corresponding environment parameters and time parameters of each event, wherein the events include production, inspection and acceptance, loading and unloading, transportation, storage, clinical use, transfer, and maintenance, and the corresponding environment parameters of each event include temperature, humidity, vibration, and air pressure height; and the task profile refers to a relationship diagram of the corresponding environment parameters and time when any of the above tasks is completed.

[0014] Further, the first environment parameter is a specification parameter of the emergency medical equipment, including specification temperature, specification humidity, specification vibration, and specification air pressure height.

[0015] Further, the second environment parameter includes temperature during transportation, humidity during transportation, vibration during transportation, and pressure height during transportation, which are determined according to the actual transportation mode and transportation time.

[0016] Furthermore, the third environmental parameter includes the average values ​​of the highest temperature, the lowest relative humidity corresponding to the highest temperature, the lowest temperature, the highest humidity corresponding to the lowest temperature, and the average air pressure altitude for each season, obtained from historical weather data of the mission location.

[0017] This invention obtains a task profile by appropriately cropping the lifespan profile of medical equipment, which is a graph showing the relationship between environmental parameters and time when completing any task. A third environmental parameter (the environmental parameters of the task execution location) is introduced into the graph to comprehensively cover the environmental factors experienced by emergency medical equipment at each specific stage. Compared with traditional methods, this approach can more realistically and effectively simulate actual usage scenarios. Attached Figure Description

[0018] Figure 1 This is a flowchart illustrating the method for developing a reliability test profile for emergency medical equipment in an embodiment.

[0019] Figure 2 This is the lifespan profile of the emergency medical equipment as defined in the embodiments;

[0020] Figure 3 This is a vibration power spectral density diagram of the embodiment using air transport;

[0021] Figure 4 The embodiment obtains a comprehensive reliability test profile of the emergency medical equipment at the mission execution site, including temperature, humidity, vibration, and low air pressure. Detailed Implementation

[0022] The technical solution of the present invention will be described in detail below with reference to the accompanying drawings and embodiments.

[0023] like Figure 1 As shown in the figure, this embodiment provides a method for developing a reliability test profile for emergency medical equipment, which includes the following steps:

[0024] Step 1: Determine the life profile of the emergency medical equipment, that is, the profile of the entire process from production to use, and extract the mission profile from the life profile. For example... Figure 2As shown, the life profile includes all events experienced by the emergency medical equipment from being put into use to the end of life or retirement, and the corresponding environmental parameters and time parameters of each event, wherein the events include production, acceptance, transportation, storage, clinical use, and maintenance, and the corresponding environmental parameters of each event include temperature, humidity, vibration, and air pressure height. The task profile refers to a graph of the corresponding environmental parameters and time when completing any of the above tasks. In this embodiment, the stress parameter selection rule from the task profile to the environmental profile is as follows: the environmental stress is preferably the measured stress, followed by the estimated stress, and finally the recommended stress given in the standard. In implementation, a single task profile can be extracted according to the task requirements, or multiple task profiles can be extracted.

[0025] According to the emergency equipment design specification and the expected use environment, a first environmental parameter is obtained, which is a specification parameter of the emergency medical equipment. In this embodiment, the specification temperature obtained according to the standard GJB150.1A-2009 is 15℃-35℃, the specification humidity (RH) is 20%-80%, and the specification air pressure is 86kPa-106kPa, which corresponds to an altitude of 1362m or less.

[0026] Step 2, obtaining a first environmental profile and a second environmental profile

[0027] Obtaining the first environmental profile:

[0028] According to the task profile, a second environmental parameter is obtained, which is the environmental information and the time experienced during transportation of the emergency medical equipment. According to the second environmental parameter, a first environmental profile is obtained. The second environmental parameter includes temperature during transportation, humidity during transportation, vibration during transportation, and pressure height during transportation, which are determined according to the actual transportation method and transportation time.

[0029] If air transportation (jet transportation aircraft) is used as the transportation method, the temperature and humidity are determined based on the reference standard MH7005-95, and the parameters are as follows: the temperature is maintained at 25℃ and the relative humidity is 60% during summer transportation, and the temperature is maintained at 20℃ and the relative humidity is 25% during winter transportation. The air pressure height is based on the reference standard GJB150.2A-2009, and the parameters obtained are as follows: the air pressure height change rate is 10m / s when the jet transportation aircraft is transported; the cargo compartment pressure is 4.57km, which corresponds to an atmospheric pressure of 57kPa. The vibration during transportation is determined as follows: as shown in Figure 3 The vibration stress recommended in the standard GJB150.16A is applied to each axis for vibration exposure, so as to obtain the vibration parameter during transportation, and the vibration exposure time is the transportation time.

[0030] If the transportation mode is highway transportation, ship transportation or railway transportation, the temperature and humidity in the transportation are determined based on GB / T 14710-2009, the temperature in the transportation is kept at 23℃, the relative humidity in winter is 45%, and the relative humidity in summer is 75%. When the transportation mode is highway or railway transportation, the air pressure height linearly changes from the starting point to the destination; when the transportation mode is ship transportation, the air pressure height is the corresponding value of the reference condition. The vibration in the transportation is determined by the following method: the vibration stress recommended in the standard GJB150.16A is applied to each axis to perform vibration exposure; wherein the exposure duration of each axis of the highway truck transportation is 60min per 1600km of highway transportation, and the vibration exposure duration of each axis of the other road section combined double-wheel trailer transportation is 32min per 51km of highway transportation.

[0031] The second environmental parameter table of the emergency treatment equipment is obtained according to the above method, as shown in Table 1.

[0032] Table 1 Environmental parameter table of emergency equipment transportation process

[0033]

[0034]

[0035] Obtain the second environmental profile:

[0036] The third environmental parameter is obtained according to the task profile, which is the geographical environmental information of the task execution site and the time experienced, and the second environmental profile is obtained according to the third environmental parameter.

[0037] The third environmental parameter includes the temperature extreme value of each season obtained according to the historical weather data of the task execution site, and the relative humidity extreme value corresponding to the temperature extreme value. The historical weather data of the task execution site is queried from the official historical meteorological data. The temperature extreme value includes the maximum temperature and the minimum temperature, the maximum temperature in 12 to 16 hours in a day is taken as the maximum temperature of the third environmental parameter, and the minimum relative humidity corresponding to the temperature is taken as the minimum humidity; the minimum temperature in 3 to 8 hours in a day is taken as the minimum temperature of the third environmental parameter, and the maximum relative humidity corresponding to the temperature is taken as the maximum humidity. The height (low air pressure) can be taken as the average height of the site.

[0038] Step 3, based on the test box technical parameters, the first environmental parameter, the second environmental parameter, and the third environmental parameter are adjusted and optimized. The temperature and humidity parameters in the second environmental parameter should meet the corresponding requirements in the first environmental parameter, and the air pressure parameter of the second environmental parameter linearly changes from the starting point air pressure to the terminal air pressure. The air pressure optimization formula of the second environmental parameter and the third environmental parameter is: P i2 =max(P i1, P a ), wherein P i1 and P i2 are the initial value and the final determined value of the air pressure of the i-th environmental parameter, respectively, and P a is the standard air pressure value calculated by using the air pressure formula.

[0039] Step 4, combining the adjusted first environmental profile and the second environmental profile into a test profile according to the time sequence.

[0040] Step 5, adjusting the test indexes of the emergency treatment equipment by using the test profile, discarding the indexes that cannot be normally tested under the environmental parameters of the execution site; applying comprehensive stress to the emergency treatment equipment based on the test profile, and testing the performance of the emergency treatment equipment by using the adjusted test indexes to obtain the reliability-related indexes.

[0041] In this embodiment, taking the winter rescue from Chengdu to Turpan as an example, the task profile extracted according to step 1 includes three task profiles of transportation, transfer and clinic. The selected transportation mode is air transportation, and the second environmental parameters are obtained, i.e., the temperature is kept at 20℃ and the relative humidity is kept at 25% during the transportation process, and the vibration spectrum is referred to Figure 3 The air pressure height change rate during takeoff and landing is 10 m / s when the plane is transported by default, the cargo compartment air pressure is 57 kPa when the plane is stably flying, and the emergency treatment equipment should be in a non-working state at this time, which corresponds to the 0h-4h stage in Figure 4 . Secondly, the transfer stage is analyzed, wherein the vibration parameters are referred to step 3; finally, the third environmental parameters are obtained according to step 4 in the clinic stage, wherein the emergency treatment equipment is in a working state, which corresponds to the 4h-7h stage in Figure 4 . The total test time in the above embodiment is only for reference, which can be lengthened or shortened by 24h as a step according to the specific circumstances. The test profile obtained can better adapt to the related test box equipment compared with the profile obtained by directly using the environmental parameters. Finally, the four comprehensive test boxes are used to apply comprehensive stress according to the test profile, the emergency treatment equipment is placed in the four comprehensive test boxes, and the appearance inspection and performance test are performed every certain time until the emergency treatment fails or the test profile is completed.

[0042] The above description is only used to illustrate the preferred examples of the present application, but not to limit the present application. Other modifications or equivalent replacements to the technical solutions of the present application made by those skilled in the art should be covered in the scope of the claims of the present application as long as they do not deviate from the spirit and scope of the present application.

Claims

1. A method for developing a reliability test profile for emergency medical equipment, characterized in that, Includes the following steps: Step 1: Determine the life profile of the emergency medical equipment, that is, the profile of the entire process from production to use, and extract the mission profile from the life profile; obtain the first environmental parameters according to the emergency equipment design specifications and the expected use environment. Step 2: Obtain the second environmental parameters based on the mission profile. The second environmental parameters are the environmental information and the time spent during the transportation of emergency medical equipment. Obtain the first environmental profile based on the second environmental parameters. The third environmental parameter is obtained from the mission profile. The third environmental parameter is the geographical environment information of the mission site where the emergency medical equipment performs the mission and the time it has experienced. The second environmental profile is obtained from the third environmental parameter. Step 3: Based on the test chamber's technical parameters, adjust and optimize the first, second, and third environmental parameters; the temperature and humidity parameters in the second environmental parameter should meet the corresponding requirements of the first environmental parameter, and the air pressure parameter of the second environmental parameter should change linearly according to the starting and ending air pressures; the air pressure optimization formulas for the second and third environmental parameters are as follows: =max( ),in and The first i The initial and final determined values ​​of air pressure for each environmental parameter. This is the standard atmospheric pressure value calculated using the atmospheric pressure formula; Step 4: Combine the first environmental profile and the second environmental profile into a single experimental profile according to the time sequence; Step 5: Adjust the test indicators of the emergency medical equipment using the test profile, discarding indicators that cannot be tested normally under the environmental parameters of the execution site; apply comprehensive stress to the emergency medical equipment based on the test profile, and use the adjusted test indicators to test the performance of the emergency medical equipment to obtain its reliability-related indicators.

2. The method for developing a reliability test profile for emergency medical equipment according to claim 1, characterized in that: The lifespan profile includes all events experienced by the emergency medical equipment from its commissioning to the end of its lifespan or retirement, as well as the environmental and time parameters corresponding to each event. The events include production, inspection and acceptance, loading and unloading, transportation, storage, clinical use, transfer, and maintenance. The environmental parameters corresponding to each event include temperature, humidity, vibration, and atmospheric pressure and altitude. The mission profile refers to the relationship between environmental parameters and time when any of the above events is completed.

3. The method for developing a reliability test profile for emergency medical equipment according to claim 2, characterized in that: The first environmental parameter is the standard parameter of the emergency medical equipment, including standard temperature, standard humidity, standard vibration, and standard air pressure altitude.

4. The method for developing a reliability test profile for emergency medical equipment according to claim 3, characterized in that: The second environmental parameter includes temperature, humidity, vibration, and pressure height during transportation, which are determined based on the actual transportation method and time.

5. The method for developing a reliability test profile for emergency medical equipment according to claim 3, characterized in that: The third environmental parameter includes the average values ​​of the highest temperature, the lowest relative humidity corresponding to the highest temperature, the lowest temperature, the highest humidity corresponding to the lowest temperature, and the air pressure altitude for each season, obtained from historical weather data of the mission location.

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