Medical instrument production system

Abstract

The invention provides a medical instrument production system, and relates to the technical field of medical instrument production, the medical instrument production system comprises a first unit, a second unit, a third unit, a final product quality inspection module and a production environment regulation and control monitoring module, medical negative pressure balls are assembled through the first unit, the second unit and the third unit in sequence; and finally, sampling test quality inspection is carried out through the final product quality inspection module. The first unit, the second unit and the third unit respectively comprise a first-stage quality monitoring module, a second-stage quality monitoring module and a third-stage quality monitoring module. The system solves the problems that each unit of an existing medical instrument production system lacks an independent quality monitoring module, if one unit is wrongly assembled, a subsequent unit still performs assembly on the unit which is wrongly assembled, resources are occupied, the defective rate is increased while the production efficiency is reduced, and the production cost is reduced. And an existing medical instrument production system is generally lack of a production environment regulation and control monitoring module, so that the medical instruments face the pollution risk in the production process.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical device production, and in particular relates to a medical device production system. Background Art

[0002] A medical device production system is a system used to assemble medical device parts into medical devices, usually including several assembly units; Each unit in the existing medical device production system lacks a separate quality monitoring module. If one unit is assembled incorrectly, the subsequent units will still be assembled on the incorrectly assembled unit, which takes up resources, reduces production efficiency and increases the defective rate. In addition, the existing medical device production system usually lacks a production environment control and monitoring module, which causes medical devices to face contamination risks during the production process. Summary of the invention

[0003] The present invention provides a medical device production system to solve at least one of the above-mentioned technical problems.

[0004] In order to solve the above technical problems, the present invention discloses a medical device production system, including unit 1, unit 2, unit 3, a final product quality inspection module and a production environment control and monitoring module. The medical negative pressure ball is assembled in unit 1, unit 2 and unit 3 in sequence, and finally a sampling test quality inspection is carried out in the final product quality inspection module. Unit 1, Unit 2 and Unit 3 include a first-stage quality monitoring module, a second-stage quality monitoring module and a third-stage quality monitoring module, respectively. The first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module are used to judge the qualification of the first-stage assembly parts, the second-stage assembly parts and the third-stage assembly parts produced by Unit 1, Unit 2 and Unit 3, respectively.

[0005] Preferably, unit 1 comprises: Unit 11, used for installing the connecting neck from the feeding mechanism to the jig; 12 units for mounting the non-return valve on the connection neck; Unit 13, used to turn the connection neck with the non-return valve installed 180 degrees; 14 units, for mounting the plug on the connection neck; Unit 15, used to flip the plug into the connection neck hole; 16 units for inserting the cap into the connection neck to form a one-stage assembly.

[0006] Preferably, the second unit comprises: Unit 21 is used to install the sphere from the feeding mechanism to the fixture; Unit 22 is used to place the first-stage assembly of Unit 1 installed into the card position of the sphere; Unit 23, for placing the gland over the sphere; 24 units, used to tighten the gland; Unit 25 is used to flip the assembled sphere 90 degrees to finally form a second-stage assembly.

[0007] Preferably, the unit 3 comprises: Unit 31, used to insert the Robert clamp into the tail of the sphere on the second stage assembly; Unit 32, used to put the cap into the tail of the sphere; Unit 33, used to dip the tail tube of the sphere into alcohol; Unit 34, for inserting the Luer connector into the ball tailpiece; Unit 35 is used to collapse the sphere and then fasten the Robert clamp to finally form a three-stage assembly; Unit 36, used to import three-stage assembly into the final product quality inspection module.

[0008] Preferably, the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module all include: An image acquisition unit, used to acquire a panoramic scanning image of the assembly parts at the corresponding stage after the corresponding unit is assembled; An appearance judgment unit is used to judge the surface eligibility of all parts involved in the assembly process of each unit based on the panoramic scanning image of the assembly parts at the corresponding stage, and obtain the surface eligibility judgment result of the assembly parts at the corresponding stage based on the surface eligibility of all parts involved; An installation integrity judgment unit is used to mark the positions of all parts involved in the assembly process of each unit based on the panoramic scanning image of the corresponding unit assembly, judge whether any assembly omission occurs, and obtain the assembly integrity judgment result of the assembly parts at the corresponding stage; An assembly accuracy qualification judgment unit is used to judge whether there is an assembly position error or insufficient assembly accuracy of the assembly parts at the corresponding stage based on the panoramic scanning image of the assembly parts of the corresponding unit, and obtain the assembly accuracy judgment result of the assembly parts of the corresponding unit; The retention / removal judgment unit is used to judge whether the assembly at the current stage should enter the next stage based on the judgment results of the appearance judgment unit, the installation integrity judgment unit and the assembly accuracy qualification judgment unit. If the judgment results of the appearance judgment unit, the installation integrity judgment unit and the assembly accuracy qualification judgment unit are all qualified, the assembly at the current stage will enter the next stage; otherwise, it will be eliminated at the current stage.

[0009] Preferably, the installation integrity judgment unit includes: A reference component positioning subunit is used to determine the morphological features of the corresponding unit assembly based on the panoramic scanning image of the corresponding unit assembly, and to locate the reference components of the current unit assembly based on the morphological features of the corresponding unit assembly and the panoramic scanning model of the standard assembly of the corresponding unit; Traverse the sub-units, use the located reference parts as the origin to establish a positioning coordinate system, and judge whether the corresponding unit assembly has missed parts in the standard assembly of the corresponding unit based on the morphological characteristics of the corresponding unit assembly and the panoramic scanning model of the standard assembly of the corresponding unit. If missed, locate them through the positioning coordinate system, and remove them in time through the retention judgment unit. At this time, the judgment output result is that the assembly integrity of the corresponding stage assembly is unqualified; Otherwise, the output result is judged to be that the assembly integrity of the assembly parts at the corresponding stage is qualified.

[0010] Preferably, the assembly accuracy qualification judgment unit includes: The component cutting subunit is used to cut the panoramic scanning image of the corresponding unit assembly to generate a local image corresponding to each component; A feature recognition subunit performs shape feature recognition and size feature recognition on each component based on a local image corresponding to each component; The component assembly position comparison subunit determines whether each component is the same as the corresponding standard component based on the shape characteristics of each component and the standard component model corresponding to each position. If so, the output indicates that the assembly position of the corresponding unit assembly is correct; otherwise, the output indicates that the assembly position of the corresponding unit assembly is wrong. The component assembly accuracy judgment subunit judges whether the three-dimensional size of each component meets the size requirements of the corresponding standard component based on the size characteristics of each component and the standard component model corresponding to each position. If so, it outputs that the assembly accuracy of the corresponding unit assembly is qualified; otherwise, it outputs that the assembly accuracy of the corresponding unit assembly is unqualified. The assembly accuracy conformity output sub-unit is used to output the assembly accuracy judgment result of the corresponding unit assembly based on the output results of the parts assembly position comparison sub-unit and the parts assembly accuracy judgment sub-unit. If the output results of the parts assembly position comparison sub-unit and the parts assembly accuracy judgment sub-unit are qualified, the output result is that the assembly accuracy of the corresponding unit assembly is qualified; otherwise, the output result is that the assembly accuracy of the corresponding unit assembly is unqualified.

[0011] Preferably, an auxiliary monitoring module is also included, and the auxiliary monitoring module includes: A tracking and proofreading unit and a unit fault alarm unit, both of which are electrically connected to the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module; The tracking and proofreading unit is used to track the assembly parts that need to be rejected based on the judgment results of the retention and removal judgment units corresponding to the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module respectively. If the assembly parts that need to be rejected enter the next stage, an installation ignore instruction is generated and sent to the unit control module of the next stage and the retention and removal judgment unit of the unit of the next stage, so as to control the unit of the next stage to ignore it and remove it through the retention and removal judgment unit of the unit of the next stage; The unit fault alarm unit is used to determine whether the rejected products exceed the standard in the current stage based on the maximum number of rejected products within the preset monitoring time of each stage. If so, it sends a suspected fault signal of the current unit to the operation and maintenance management end; When the number of suspected fault signals of the current unit received by the operation and maintenance management terminal exceeds the preset number within the preset time period, the operation and maintenance management terminal will issue an alarm prompt for the corresponding unit.

[0012] Preferably, the production environment control and monitoring module includes: The environment collection unit is used to collect the temperature, humidity, air quality and cleanliness parameters of the medical device production environment in real time, and calculate the real-time temperature and humidity evaluation value a, the real-time air quality evaluation value b and the real-time cleanliness evaluation value c of the medical device production environment based on the collection results; based on the real-time temperature and humidity evaluation value a, the real-time air quality evaluation value b and the real-time cleanliness evaluation value c of the medical device production environment, calculate the real-time comprehensive environmental evaluation value d of the medical device production environment: (1); among which, is the weight of the real-time temperature and humidity assessment value, is the weight of the real-time air quality assessment value, is the weight of the real-time cleanliness assessment value; The environmental prediction unit sorts the calculated real-time environmental comprehensive evaluation values ​​of the medical device production environment based on the time series, and uses them as the first row of the environmental comprehensive evaluation value prediction matrix, and respectively calculates the difference between the arranged real-time environmental comprehensive evaluation values ​​of the medical device production environment and the corresponding real-time environmental comprehensive evaluation values ​​on the left and right sides thereof, to obtain the left difference value and the right difference value corresponding to each real-time environmental comprehensive evaluation value, and uses the left difference value as the second row of the environmental comprehensive evaluation value prediction matrix, and uses the right difference value as the third row of the environmental comprehensive evaluation value prediction matrix, to construct the environmental comprehensive evaluation value prediction matrix; The environmental control unit predicts the environmental comprehensive assessment value of the next cycle based on the environmental comprehensive assessment value prediction matrix, and compares the environmental comprehensive assessment value of the next cycle with the benchmark environmental comprehensive assessment value. If the environmental comprehensive assessment value of the next cycle is lower than the benchmark environmental comprehensive assessment value, the medical device production environment will be adjusted in advance.

[0013] Preferably, the environmental comprehensive assessment value prediction matrix is: (2); among which, is the prediction matrix of comprehensive environmental assessment value, is the comprehensive evaluation value of the real-time environment in the first cycle, is the comprehensive evaluation value of the real-time environment in the second cycle, is the comprehensive evaluation value of the real-time environment in the nth cycle, is the left difference corresponding to the real-time comprehensive environmental evaluation value of the first cycle, is the left difference corresponding to the real-time comprehensive environmental evaluation value of the second cycle, is the left difference value corresponding to the comprehensive evaluation value of the real-time environment in the nth cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the first cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the second cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the nth period; Obtain the mean of all matrix elements in the third row of the comprehensive environmental assessment value prediction matrix, use it as the replacement value, and replace all the values ​​in the last column of the comprehensive environmental assessment value prediction matrix with the replacement value to obtain a new matrix, and use the rank of the new matrix as the comprehensive environmental assessment value of the next period.

[0014] Compared with the prior art, the present invention has the following beneficial effects: The working principle and beneficial effects of the above technical solution are as follows: the present invention assembles the first unit, the second unit and the third unit into a first-stage assembly, a second-stage assembly and a third-stage assembly respectively, and monitors the quality of the first-stage assembly, the second-stage assembly and the third-stage assembly respectively through the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module, thereby ensuring the qualification of the first-stage assembly, the second-stage assembly and the third-stage assembly, and finally performs sampling test quality inspection through the final product quality inspection module, and monitors and controls the production environment in real time during the production process through the production environment control monitoring module, thereby ensuring that the medical device will not be contaminated during the production process; Therefore, the present invention solves the problem that each unit of the existing medical device production system lacks a separate quality monitoring module. If one of the units is assembled incorrectly, the subsequent units will still be assembled on the incorrectly assembled unit, which takes up resources, reduces production efficiency and increases the defective rate. In addition, the existing medical device production system usually lacks a production environment control and monitoring module, which leads to the technical problem that medical devices face contamination risks during the production process. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the embodiments of the present invention, they are used to explain the present invention and do not constitute a limitation of the present invention. In the accompanying drawings: Figure 1 This is an overall schematic diagram of a medical device production system proposed by the present invention; Figure 2 This is a schematic diagram of the structure of the medical negative pressure ball proposed by the present invention.

[0016] In the figure: 1, Unit 1; 2, Unit 2; 3, Unit 3; 4, Medical negative pressure ball; 40, Connecting neck; 41, One-way valve; 42, Plug; 43, Protective cap; 44, Ball; 45, Pressure cover; 46, Robert clamp; 47, Cover cap; 48, Luer connector; 49, Ball tail pipe. DETAILED DESCRIPTION

[0017] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention, and are not used to limit the present invention.

[0018] In addition, in the present invention, the descriptions of "first", "second", etc. are only used for descriptive purposes, and do not specifically refer to the order or sequence, nor are they used to limit the present invention. They are only used to distinguish components or operations described with the same technical terms, and cannot be understood as indicating or implying their relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In addition, the technical solutions and technical features between the various embodiments can be combined with each other, but they must be based on the ability of ordinary technicians in the field to implement them. When the combination of technical solutions is contradictory or cannot be implemented, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection required by the present invention.

[0019] The present invention provides the following embodiments Example 1 The embodiment of the present invention provides a medical device production system, such as Figure 1-2As shown, it includes unit 1, unit 2, unit 3, final product quality inspection module and production environment control monitoring module. The medical negative pressure ball 4 is assembled in unit 1, unit 2 and unit 3 in sequence, and finally undergoes sampling test quality inspection in the final product quality inspection module. Unit 1, Unit 2 and Unit 3 respectively include a first-stage quality monitoring module, a second-stage quality monitoring module and a third-stage quality monitoring module, which are used to judge the qualification of the first-stage assembly parts, the second-stage assembly parts and the third-stage assembly parts produced by Unit 1, Unit 2 and Unit 3 respectively.

[0020] Preferably, unit 1 comprises: Unit 11 is used to install the connecting neck 40 on the jig by the feeding mechanism; 12 units for mounting the non-return valve 41 to the connecting neck 40; Unit 13 is used to turn the connection neck 40 on which the one-way valve 41 is installed by 180 degrees; 14 unit, used for installing the plug 42 to the connecting neck 40; Unit 15 is used to flip the plug 42 into the hole of the connecting neck 40; 16 units are used to insert the protective cap 43 into the connecting neck 40 to finally form a one-stage assembly.

[0021] Preferably, the second unit 2 comprises: Unit 21 is used to install the ball 44 from the feeding mechanism to the jig; Unit 22 is used to place the first-stage assembly of unit 1 installed in the snap-in position of the sphere 44; Unit 23, for placing a gland 45 above the sphere 44; Unit 24, used for pressing the gland 45; Unit 25 is used to flip the assembled sphere 44 by 90 degrees to finally form a second-stage assembly.

[0022] Preferably, the unit 3 comprises: Unit 31, for inserting Robert's clamp 46 into the tail of ball 44 on the second stage assembly; Unit 32, used for inserting the cap 47 into the tail of the sphere 44; Unit 33, for dipping the sphere tail pipe 49 into alcohol; Unit 34, for inserting the Luer connector 48 into the ball tail tube 49; Unit 35 is used to collapse the ball 44 and then snap the Robert clamp 46 together to finally form a three-stage assembly; Unit 36, used to import three-stage assembly into the final product quality inspection module.

[0023] The working principle and beneficial effects of the above technical solution are as follows: the present invention assembles the first unit 1, the second unit 2 and the third unit 3 into a first-stage assembly, a second-stage assembly and a third-stage assembly respectively, and monitors the quality of the first-stage assembly, the second-stage assembly and the third-stage assembly respectively through the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module, thereby ensuring the qualification of the first-stage assembly, the second-stage assembly and the third-stage assembly, and finally performs sampling test quality inspection through the final product quality inspection module, and monitors and controls the production environment in real time through the production environment control and monitoring module during the production process, thereby ensuring that the medical device will not be contaminated during the production process; Therefore, the present invention solves the problem that each unit of the existing medical device production system lacks a separate quality monitoring module. If one of the units is assembled incorrectly, the subsequent units will still be assembled on the incorrectly assembled unit, which takes up resources, reduces production efficiency and increases the defective rate. In addition, the existing medical device production system usually lacks a production environment control and monitoring module, which leads to the technical problem that medical devices face contamination risks during the production process.

[0024] Example 2 Based on Example 1, the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module all include: An image acquisition unit, used to acquire a panoramic scanning image of the assembly parts at the corresponding stage after the corresponding unit is assembled; An appearance judgment unit is used to judge the surface eligibility of all parts involved in the assembly process of each unit based on the panoramic scanning image of the assembly parts at the corresponding stage, and obtain the surface eligibility judgment result of the assembly parts at the corresponding stage based on the surface eligibility of all parts involved; An installation integrity judgment unit is used to mark the positions of all parts involved in the assembly process of each unit based on the panoramic scanning image of the corresponding unit assembly, judge whether any assembly omission occurs, and obtain the assembly integrity judgment result of the assembly parts at the corresponding stage; An assembly accuracy qualification judgment unit is used to judge whether there is an assembly position error or insufficient assembly accuracy of the assembly parts at the corresponding stage based on the panoramic scanning image of the assembly parts of the corresponding unit, and obtain the assembly accuracy judgment result of the assembly parts of the corresponding unit; The retention / removal judgment unit is used to judge whether the assembly at the current stage should enter the next stage based on the judgment results of the appearance judgment unit, the installation integrity judgment unit and the assembly accuracy qualification judgment unit. If the judgment results of the appearance judgment unit, the installation integrity judgment unit and the assembly accuracy qualification judgment unit are all qualified, the assembly at the current stage will enter the next stage; otherwise, it will be eliminated at the current stage.

[0025] The working principle and beneficial effects of the above technical solution are as follows: the present invention uses a first-stage quality monitoring module, a second-stage quality monitoring module and a third-stage quality monitoring module to respectively judge the appearance, integrity and assembly accuracy of the first-stage assembly parts, the second-stage assembly parts and the third-stage assembly parts corresponding to the No. 1 unit 1, the No. 2 unit 2 and the No. 3 unit 3, and makes a final decision on whether to keep or not based on the judgment unit. If the judgment results of the appearance judgment unit, the installation integrity judgment unit and the assembly accuracy qualification judgment unit are all qualified, the assembly parts of the current stage enter the next stage, otherwise, they are eliminated in the current stage. Timely elimination of unqualified assembly parts can avoid them occupying the resources of subsequent units, and at the same time can avoid the waste of subsequent parts, effectively improving production efficiency; After the medical negative pressure ball 4 is assembled and monitored at each production stage, it is finally monitored by the final product quality inspection module, which can effectively reduce the defective rate and improve the reliability of the system.

[0026] Example 3 Based on Example 2, the installation integrity judgment unit includes: A reference component positioning subunit is used to determine the morphological features of the corresponding unit assembly based on the panoramic scanning image of the corresponding unit assembly, and to locate the reference components of the current unit assembly based on the morphological features of the corresponding unit assembly and the panoramic scanning model of the standard assembly of the corresponding unit; Traverse the sub-units, use the located reference parts as the origin to establish a positioning coordinate system, and judge whether the corresponding unit assembly has missed parts in the standard assembly of the corresponding unit based on the morphological characteristics of the corresponding unit assembly and the panoramic scanning model of the standard assembly of the corresponding unit. If missed, locate them through the positioning coordinate system, and remove them in time through the retention judgment unit. At this time, the judgment output result is that the assembly integrity of the corresponding stage assembly is unqualified; Otherwise, the output result is judged to be that the assembly integrity of the assembly parts at the corresponding stage is qualified.

[0027] In this embodiment, the morphological feature is the shape of the target part, and the target part is any one of the components involved in the corresponding unit assembly that is manually identified. If the reference component positioning subunit determines that the target part is missing, that is, the target reference component is not found, then any one of the remaining components involved in the corresponding unit assembly is used as the target part, and the reference component is positioned again.

[0028] The working principle and beneficial effects of the above technical solution are as follows: the reference component positioning subunit of the present invention can accurately determine the position of the reference component by comparing the panoramic scanning image with the standard assembly model, ensuring that subsequent inspections are based on precise reference points. The traversal subunit checks all components and can fully identify whether there are any omissions, ensuring that each standard component is inspected, thereby improving the comprehensiveness and accuracy of the inspection.

[0029] Example 4 On the basis of Example 2, the assembly accuracy qualification judgment unit includes: The component cutting subunit is used to cut the panoramic scanning image of the corresponding unit assembly to generate a local image corresponding to each component; A feature recognition subunit performs shape feature recognition and size feature recognition on each component based on a local image corresponding to each component; The component assembly position comparison subunit determines whether each component is the same as the corresponding standard component based on the shape characteristics of each component and the standard component model corresponding to each position. If so, the output indicates that the assembly position of the corresponding unit assembly is correct; otherwise, the output indicates that the assembly position of the corresponding unit assembly is wrong. The component assembly accuracy judgment subunit judges whether the three-dimensional size of each component meets the size requirements of the corresponding standard component based on the size characteristics of each component and the standard component model corresponding to each position. If so, it outputs that the assembly accuracy of the corresponding unit assembly is qualified; otherwise, it outputs that the assembly accuracy of the corresponding unit assembly is unqualified. The assembly accuracy conformity output sub-unit is used to output the assembly accuracy judgment result of the corresponding unit assembly based on the output results of the parts assembly position comparison sub-unit and the parts assembly accuracy judgment sub-unit. If the output results of the parts assembly position comparison sub-unit and the parts assembly accuracy judgment sub-unit are qualified, the output result is that the assembly accuracy of the corresponding unit assembly is qualified; otherwise, the output result is that the assembly accuracy of the corresponding unit assembly is unqualified.

[0030] The working principle and beneficial effects of the above technical solution: the present invention generates a local image through the component cutting sub-unit, which can accurately identify the shape and size of each component. Based on the shape characteristics of each component and the standard component model corresponding to each position, it is judged whether each current component is the same component as the corresponding standard component. If so, the output of the assembly position of the corresponding unit assembly is correct; otherwise, the output of the assembly position of the corresponding unit assembly is wrong. At the same time, based on the size characteristics of each component and the standard component model corresponding to each position, it is judged whether the three-dimensional size of each current component meets the size requirements of the corresponding standard component. If so, the output of the assembly accuracy of the corresponding unit assembly is qualified; otherwise, the output of the assembly accuracy of the corresponding unit assembly is unqualified. By judging the assembly position and assembly accuracy of the components and outputting the assembly accuracy qualification result, the quality consistency of the product can be significantly improved, the production efficiency is optimized, and the production cost is reduced.

[0031] Example 5 On the basis of Example 2, an auxiliary monitoring module is also included, and the auxiliary monitoring module includes: A tracking and proofreading unit and a unit fault alarm unit, both of which are electrically connected to the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module; The tracking and proofreading unit is used to track the assembly parts that need to be rejected based on the judgment results of the retention and removal judgment units corresponding to the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module respectively. If the assembly parts that need to be rejected enter the next stage, an installation ignore instruction is generated and sent to the unit control module of the next stage and the retention and removal judgment unit of the unit of the next stage, so as to control the unit of the next stage to ignore it and remove it through the retention and removal judgment unit of the unit of the next stage; The unit fault alarm unit is used to determine whether the rejected products exceed the standard in the current stage based on the maximum number of rejected products within the preset monitoring time of each stage. If so, it sends a suspected fault signal of the current unit to the operation and maintenance management end; When the number of suspected fault signals of the current unit received by the operation and maintenance management terminal exceeds the preset number within the preset time period, the operation and maintenance management terminal will issue an alarm prompt for the corresponding unit.

[0032] The working principle and beneficial effects of the above technical solution are as follows: the tracking and proofreading unit of the present invention tracks the assemblies that need to be rejected to ensure that these unqualified components will not enter the next production stage, and automatically generates installation ignore instructions, thereby reducing manual intervention, improving processing efficiency and the reliability of the auxiliary monitoring module; the unit fault alarm unit monitors the number of rejected products and can promptly identify potential equipment failures or production problems to ensure the reliability of the production line; and determines whether to issue an alarm prompt based on the number of suspected fault signals of the current unit, thereby increasing the accuracy and reliability of the alarm.

[0033] Example 6 Based on Example 1, the production environment control and monitoring module includes: The environment collection unit is used to collect the temperature, humidity, air quality and cleanliness parameters of the medical device production environment in real time, and calculate the real-time temperature and humidity evaluation value a, the real-time air quality evaluation value b and the real-time cleanliness evaluation value c of the medical device production environment based on the collection results; based on the real-time temperature and humidity evaluation value a, the real-time air quality evaluation value b and the real-time cleanliness evaluation value c of the medical device production environment, calculate the real-time comprehensive environmental evaluation value d of the medical device production environment: (1); among which, is the weight of the real-time temperature and humidity assessment value, is the weight of the real-time air quality assessment value, is the weight of the real-time cleanliness assessment value; The environmental prediction unit sorts the calculated real-time environmental comprehensive evaluation values ​​of the medical device production environment based on the time series, and uses them as the first row of the environmental comprehensive evaluation value prediction matrix, and respectively calculates the difference between the arranged real-time environmental comprehensive evaluation values ​​of the medical device production environment and the corresponding real-time environmental comprehensive evaluation values ​​on the left and right sides thereof, to obtain the left difference value and the right difference value corresponding to each real-time environmental comprehensive evaluation value, and uses the left difference value as the second row of the environmental comprehensive evaluation value prediction matrix, and uses the right difference value as the third row of the environmental comprehensive evaluation value prediction matrix, to construct the environmental comprehensive evaluation value prediction matrix; The environmental control unit predicts the environmental comprehensive assessment value of the next cycle based on the environmental comprehensive assessment value prediction matrix, and compares the environmental comprehensive assessment value of the next cycle with the benchmark environmental comprehensive assessment value. If the environmental comprehensive assessment value of the next cycle is lower than the benchmark environmental comprehensive assessment value, the medical device production environment will be adjusted in advance.

[0034] In this embodiment, the temperature and humidity related parameters of the medical device production environment include temperature and humidity; Parameters involved in air quality include air particle concentration, harmful gas concentration and oxygen concentration; Parameters involved in cleanliness include the number of particles per unit space and the cleanliness of the equipment surface.

[0035] In this embodiment, the real-time temperature and humidity evaluation value a, the real-time air quality evaluation value b, and the real-time cleanliness evaluation value c of the medical device production environment are calculated based on the collected results: a=optimal temperature / |temperature-optimal temperature|+optimal humidity / |humidity-optimal humidity|; b=optimal air particle concentration / |air particle concentration-optimal air particle concentration|+optimal harmful gas concentration / |harmful gas concentration-optimal harmful gas concentration|+optimal oxygen concentration / |oxygen concentration-optimal oxygen concentration|; c=optimal number of particles per unit space / |number of particles per unit space-optimal number of particles per unit space|+optimal equipment surface cleanliness / |equipment surface cleanliness-optimal equipment surface cleanliness|.

[0036] The working principle and beneficial effects of the above technical solution are as follows: the present invention conducts real-time monitoring and regulation of parameters such as temperature and humidity, air quality and cleanliness of the medical device production environment, and timely adjusts environmental equipment by predicting and comparing the comprehensive environmental evaluation values ​​to maintain the stability of the production environment and meet production requirements, thereby providing comprehensive environmental protection and optimization for the medical device production process, and helping to improve overall production efficiency and product quality.

[0037] Example 7 Based on Example 6, the environmental comprehensive assessment value prediction matrix is: (2); among which, is the prediction matrix of comprehensive environmental assessment value, is the comprehensive evaluation value of the real-time environment in the first cycle, is the comprehensive evaluation value of the real-time environment in the second cycle, is the comprehensive evaluation value of the real-time environment in the nth cycle, is the left difference corresponding to the real-time comprehensive environmental evaluation value of the first cycle, is the left difference corresponding to the real-time comprehensive environmental evaluation value of the second cycle, is the left difference value corresponding to the comprehensive evaluation value of the real-time environment in the nth cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the first cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the second cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the nth period; Obtain the mean of all matrix elements in the third row of the comprehensive environmental assessment value prediction matrix, use it as the replacement value, and replace all the values ​​in the last column of the comprehensive environmental assessment value prediction matrix with the replacement value to obtain a new matrix, and use the rank of the new matrix as the comprehensive environmental assessment value of the next period.

[0038] The working principle and beneficial effects of the above technical solution are as follows: the present invention can timely identify and control potential environmental risks through real-time monitoring and prediction, reduce quality problems and safety hazards that may occur in the production process, and by calculating the mean of the elements of the third row of the matrix, reduce the interference of a single outlier on the prediction result, so that the new comprehensive environmental evaluation value is more representative and stable, thereby improving the accuracy of the prediction. The construction of the new matrix and the calculation of the rank can reflect the latest environmental changes, and timely adjust the evaluation of the next cycle environment to ensure that the environmental control system can respond in time. By continuously updating the comprehensive environmental evaluation value prediction matrix, continuous optimization of the production environment can be achieved to keep it in the best state at all times, thereby ensuring the production quality and safety of medical devices. The construction of the environmental comprehensive assessment value prediction matrix not only improves the stability and accuracy of environmental prediction, but also enhances the system's adaptability, reduces the demand for equipment and resources, and improves the intelligence level and reliability of the entire medical device production environment.

[0039] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A medical device production system, characterized in that: It includes a unit 1 (1), a unit 2 (2), a unit 3 (3), a final product quality inspection module and a production environment control and monitoring module. The medical negative pressure ball (4) is assembled in the unit 1 (1), the unit 2 (2) and the unit 3 (3) in sequence, and finally undergoes a sampling test quality inspection in the final product quality inspection module; The unit 1 (1), the unit 2 (2) and the unit 3 (3) respectively include a first-stage quality monitoring module, a second-stage quality monitoring module and a third-stage quality monitoring module, and the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module are respectively used to judge the qualification of the first-stage assembly parts, the second-stage assembly parts and the third-stage assembly parts produced by the unit 1 (1), the unit 2 (2) and the unit 3 (3).

2. A medical device production system according to claim 1, characterized in that: The unit 1 (1) comprises: Unit 11, used for installing the connecting neck (40) from the feeding mechanism onto the jig; 12 units for mounting the non-return valve (41) on the connecting neck (40); Unit 13, used for turning the connection neck (40) on which the one-way valve (41) is installed 180 degrees; Unit 14, used for mounting the plug (42) on the connecting neck (40); Unit 15, used for flipping the plug (42) into the hole of the connecting neck (40); 16 units are used to insert the protective cap (43) into the connecting neck (40) to finally form a one-stage assembly.

3. A medical device production system according to claim 1, characterized in that: The second unit (2) comprises: Unit 21 is used to install the sphere (44) onto the jig from the loading mechanism; Unit 22, used to place the first-stage assembly of the first unit (1) installed in the snap-in position of the sphere (44); Unit 23, used for placing the gland (45) above the sphere (44); Unit 24, used for pressing the gland (45); Unit 25 is used to flip the assembled sphere (44) by 90 degrees to finally form a second-stage assembly.

4. A medical device production system according to claim 3, characterized in that: The unit 3 (3) comprises: Unit 31, for inserting the Robert clamp (46) into the tail of the ball (44) on the second stage assembly; Unit 32, used for inserting the cap (47) into the tail of the spherical body (44); Unit 33, used to dip the spherical tail tube (49) into alcohol; Unit 34, for inserting the Luer connector (48) into the ball tail tube (49); Unit 35 is used to collapse the sphere (44) and then snap the Robert clamp (46) together to form a three-stage assembly; Unit 36, used to import three-stage assembly into the final product quality inspection module.

5. A medical device production system according to claim 1, characterized in that: The first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module all include: An image acquisition unit, used to acquire a panoramic scanning image of the assembly parts at the corresponding stage after the corresponding unit is assembled; An appearance judgment unit is used to judge the surface eligibility of all parts involved in the assembly process of each unit based on the panoramic scanning image of the assembly parts at the corresponding stage, and obtain the surface eligibility judgment result of the assembly parts at the corresponding stage based on the surface eligibility of all parts involved; An installation integrity judgment unit is used to mark the positions of all parts involved in the assembly process of each unit based on the panoramic scanning image of the corresponding unit assembly, judge whether any assembly omission occurs, and obtain the assembly integrity judgment result of the assembly parts at the corresponding stage; An assembly accuracy qualification judgment unit is used to judge whether there is an assembly position error or insufficient assembly accuracy of the assembly parts at the corresponding stage based on the panoramic scanning image of the assembly parts of the corresponding unit, and obtain the assembly accuracy judgment result of the assembly parts of the corresponding unit; The retention / removal judgment unit is used to judge whether the assembly at the current stage should enter the next stage based on the judgment results of the appearance judgment unit, the installation integrity judgment unit and the assembly accuracy qualification judgment unit. If the judgment results of the appearance judgment unit, the installation integrity judgment unit and the assembly accuracy qualification judgment unit are all qualified, the assembly at the current stage will enter the next stage; otherwise, it will be eliminated at the current stage.

6. A medical device production system according to claim 5, characterized in that: The installation integrity judgment unit includes: A reference component positioning subunit is used to determine the morphological features of the corresponding unit assembly based on the panoramic scanning image of the corresponding unit assembly, and to locate the reference components of the current unit assembly based on the morphological features of the corresponding unit assembly and the panoramic scanning model of the standard assembly of the corresponding unit; Traverse the sub-units, use the located reference parts as the origin to establish a positioning coordinate system, and judge whether the corresponding unit assembly has missed parts in the standard assembly of the corresponding unit based on the morphological characteristics of the corresponding unit assembly and the panoramic scanning model of the standard assembly of the corresponding unit. If missed, locate them through the positioning coordinate system, and remove them in time through the retention judgment unit. At this time, the judgment output result is that the assembly integrity of the corresponding stage assembly is unqualified; Otherwise, the output result is judged to be that the assembly integrity of the assembly parts at the corresponding stage is qualified.

7. A medical device production system according to claim 5, characterized in that: The assembly accuracy qualification judgment unit includes: The component cutting subunit is used to cut the panoramic scanning image of the corresponding unit assembly to generate a local image corresponding to each component; A feature recognition subunit performs shape feature recognition and size feature recognition on each component based on a local image corresponding to each component; The component assembly position comparison subunit determines whether each component is the same as the corresponding standard component based on the shape characteristics of each component and the standard component model corresponding to each position. If so, the output indicates that the assembly position of the corresponding unit assembly is correct; otherwise, the output indicates that the assembly position of the corresponding unit assembly is wrong. The component assembly accuracy judgment subunit judges whether the three-dimensional size of each component meets the size requirements of the corresponding standard component based on the size characteristics of each component and the standard component model corresponding to each position. If so, it outputs that the assembly accuracy of the corresponding unit assembly is qualified; otherwise, it outputs that the assembly accuracy of the corresponding unit assembly is unqualified. The assembly accuracy conformity output sub-unit is used to output the assembly accuracy judgment result of the corresponding unit assembly based on the output results of the parts assembly position comparison sub-unit and the parts assembly accuracy judgment sub-unit. If the output results of the parts assembly position comparison sub-unit and the parts assembly accuracy judgment sub-unit are qualified, the output result is that the assembly accuracy of the corresponding unit assembly is qualified; otherwise, the output result is that the assembly accuracy of the corresponding unit assembly is unqualified.

8. A medical device production system according to claim 5, characterized in that: It also includes an auxiliary monitoring module, which includes: A tracking and proofreading unit and a unit fault alarm unit, both of which are electrically connected to the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module; The tracking and proofreading unit is used to track the assembly parts that need to be rejected based on the judgment results of the retention and removal judgment units corresponding to the first-stage quality monitoring module, the second-stage quality monitoring module and the third-stage quality monitoring module respectively. If the assembly parts that need to be rejected enter the next stage, an installation ignore instruction is generated and sent to the unit control module of the next stage and the retention and removal judgment unit of the unit of the next stage, so as to control the unit of the next stage to ignore it and remove it through the retention and removal judgment unit of the unit of the next stage; The unit fault alarm unit is used to determine whether the rejected products exceed the standard in the current stage based on the maximum number of rejected products within the preset monitoring time of each stage. If so, it sends a suspected fault signal of the current unit to the operation and maintenance management end; When the number of suspected fault signals of the current unit received by the operation and maintenance management terminal exceeds the preset number within the preset time period, the operation and maintenance management terminal will issue an alarm prompt for the corresponding unit.

9. A medical device production system according to claim 1, characterized in that: The production environment control and monitoring module includes: The environment collection unit is used to collect the temperature, humidity, air quality and cleanliness parameters of the medical device production environment in real time, and calculate the real-time temperature and humidity evaluation value a, the real-time air quality evaluation value b and the real-time cleanliness evaluation value c of the medical device production environment based on the collection results; based on the real-time temperature and humidity evaluation value a, the real-time air quality evaluation value b and the real-time cleanliness evaluation value c of the medical device production environment, calculate the real-time comprehensive environmental evaluation value d of the medical device production environment: (1); among which, is the weight of the real-time temperature and humidity assessment value, is the weight of the real-time air quality assessment value, is the weight of the real-time cleanliness assessment value; The environmental prediction unit sorts the calculated real-time environmental comprehensive evaluation values ​​of the medical device production environment based on the time series, and uses them as the first row of the environmental comprehensive evaluation value prediction matrix, and respectively calculates the difference between the arranged real-time environmental comprehensive evaluation values ​​of the medical device production environment and the corresponding real-time environmental comprehensive evaluation values ​​on the left and right sides thereof, to obtain the left difference value and the right difference value corresponding to each real-time environmental comprehensive evaluation value, and uses the left difference value as the second row of the environmental comprehensive evaluation value prediction matrix, and uses the right difference value as the third row of the environmental comprehensive evaluation value prediction matrix, to construct the environmental comprehensive evaluation value prediction matrix; The environmental control unit predicts the environmental comprehensive assessment value of the next cycle based on the environmental comprehensive assessment value prediction matrix, and compares the environmental comprehensive assessment value of the next cycle with the benchmark environmental comprehensive assessment value. If the environmental comprehensive assessment value of the next cycle is lower than the benchmark environmental comprehensive assessment value, the medical device production environment will be adjusted in advance.

10. A medical device production system according to claim 9, characterized in that: Environmental comprehensive assessment value prediction matrix: (2); among which, is the prediction matrix of comprehensive environmental assessment value, is the comprehensive evaluation value of the real-time environment in the first cycle, is the comprehensive evaluation value of the real-time environment in the second cycle, is the comprehensive evaluation value of the real-time environment in the nth cycle, is the left difference corresponding to the real-time comprehensive environmental evaluation value of the first cycle, is the left difference corresponding to the real-time comprehensive environmental evaluation value of the second cycle, is the left difference value corresponding to the comprehensive evaluation value of the real-time environment in the nth cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the first cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the second cycle, is the right difference value corresponding to the real-time comprehensive environmental evaluation value of the nth period; Obtain the mean of all matrix elements in the third row of the comprehensive environmental assessment value prediction matrix, use it as the replacement value, and replace all the values ​​in the last column of the comprehensive environmental assessment value prediction matrix with the replacement value to obtain a new matrix, and use the rank of the new matrix as the comprehensive environmental assessment value of the next period.

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