As a core medical device for clinical intravenous administration, the sealing performance of infusion sets is directly related to the sterility of medicinal liquids, the accuracy of drug delivery, and the safety of patients' medication. Tiny leaks may lead to air embolism caused by air entering blood vessels, affect infusion dosages due to liquid leakage, and increase the risk of infection from bacterial invasion, which seriously endangers patients' lives. The WY-012 Infusion Set Leakage Negative Pressure Tester is a dedicated testing equipment independently developed and produced by Jinan Vieleader Instruments Co., Ltd. It is strictly designed and manufactured in accordance with national and industry standards such as GB8368-2018 Single-use Infusion Sets for Gravity Infusion. Focusing on testing the sealing performance of medical infusion sets, it is widely used in medical device manufacturers, medical institutions, R&D institutions, and third-party testing organizations, providing accurate, efficient, and reliable testing solutions for the quality control of infusion sets and building a solid line of defense for clinical infusion safety.

The core of this equipment adopts a combined detection logic of negative pressure principle and pressure decay method. By simulating the negative pressure environment in clinical scenarios such as liquid aspiration during infusion, it accurately captures tiny leaks in infusion sets, realizing quantitative evaluation and qualification judgment of sealing performance. Its workflow is simple and efficient with full automated operation, requiring no complex manual intervention. First, key parts of the infusion set to be tested, including pipelines, connectors, and drip chambers, are sealed and fixed on special fixtures to ensure the test system is completely isolated from the outside world and avoid external interference affecting test results. Then, the built-in high-precision vacuum system of the equipment extracts air to make the internal pressure of the infusion set reach the set negative pressure value, which can be flexibly adjusted according to test standards. After reaching the preset negative pressure, the system automatically stops vacuuming and enters the pressure holding stage, monitoring pressure changes in real time. If the infusion set has defects such as pinholes or poor connector sealing, external air will infiltrate due to pressure differences, causing negative pressure drift. The equipment will automatically judge the product as unqualified, trigger an alarm, and record complete test data, achieving traceability and verifiability of the testing process.

In terms of core performance, the WY-012 Infusion Set Leakage Negative Pressure Tester has prominent advantages of high precision and stability. All technical parameters are strictly aligned with industry standards to ensure the accuracy and authority of test results. The equipment's negative pressure output range is -10～-30KPa, which can be flexibly adjusted according to different test requirements, with a negative pressure error of no more than ±0.5KPa, enabling accurate simulation of negative pressure environments in various scenarios. In terms of pressure holding performance, the negative pressure drift of the test system does not exceed ±0.5KPa within 3 minutes, effectively avoiding misjudgment caused by pressure fluctuations. The test duration can be arbitrarily adjusted between 1～60S with an error of no more than ±1S, adapting to the testing needs of infusion sets of different specifications and standard requirements. Equipped with high-precision pressure sensors and PLC programmable controllers, the equipment can quickly capture tiny pressure changes, accurately identifying even the smallest leaks and eliminating unqualified products from entering the market or clinical applications at the source.

In operation design, the equipment adheres to the concept of convenience, humanization, and standardization, greatly lowering the operation threshold and improving testing efficiency. It is equipped with an industrial-grade 7-inch capacitive touch screen with a Chinese menu-based operation interface, featuring friendly human-computer interaction. Parameter settings are clear and intuitive, allowing operators to get started quickly without professional training, achieving an easy-to-learn, easy-to-understand, and easy-to-operate user experience. The built-in professional control software has multi-level authority management functions, facilitating laboratory managers to standardize equipment use, prevent parameter modification errors, and ensure the standardization and seriousness of testing work. It also supports remote upgrade and maintenance, enabling software updates and troubleshooting without on-site disassembly, reducing equipment maintenance costs and extending service life. In addition, the equipment is equipped with a mini on-board printer that can print test results in real time, including key information such as negative pressure value, pressure holding time, and test conclusion, facilitating the retention and filing of test data and fully complying with the requirements of the GMP quality system for data traceability and integrity.

The equipment has strong compatibility, supporting test methods specified in various domestic and international standards such as GB, YY, and ASTM, and can meet the testing needs of infusion sets of different types and specifications. Whether it is conventional single-use infusion sets or special-specification infusion pipelines, accurate testing can be achieved. Its application scenarios cover the entire life cycle of infusion sets, providing comprehensive support for quality control in the medical device industry. In manufacturing enterprises, it can be used for full inspection or sampling inspection of infusion sets before leaving the factory, timely detecting leakage hazards caused by injection molding defects, improper heat-sealing processes, or missing sealing rings, optimizing production processes, ensuring each batch of products meets standard requirements, and preventing unqualified products from entering the market. In medical institutions, it can be used for quality sampling inspection when purchasing infusion sets, evaluating the sealing performance of infusion sets after storage and transportation, and ensuring the safety of clinical use. In R&D institutions, it can be used in the new product R&D stage to test the sealing performance of different design schemes and materials, providing scientific data support for product optimization. In third-party testing organizations, it can serve as a professional testing tool to issue legally effective test reports, helping enterprises achieve compliant production and market access.

In structural design and safety performance, the WY-012 Infusion Set Leakage Negative Pressure Tester also balances practicality and safety. The equipment has an overall dimension of 400mm(L)×270mm(W)×300mm(H) and a net weight of only 10kg, featuring a compact size and light weight, which is convenient for laboratory placement and movement without occupying excessive space. It adopts a high-quality cold-rolled steel plate shell with anti-corrosion surface treatment, which is wear-resistant and corrosion-resistant, adapting to the complex working environment of laboratories and extending equipment service life. Internal core components are all selected from high-quality components in the industry, undergoing strict quality inspection and aging tests to ensure long-term stable operation of the equipment and reduce the failure rate. At the same time, the equipment is equipped with vacuum alarm and automatic pressure relief functions. When the negative pressure value exceeds the set range or the test is completed, it automatically relieves pressure to prevent overpressure damage to samples and equipment, ensuring the safety of operators and the equipment, and complying with biosafety operation specifications.

As a dedicated equipment focusing on medical device testing, the WY-012 Infusion Set Leakage Negative Pressure Tester has always taken accurate testing and safety assurance as its core mission. Relying on stable performance, convenient operation, and wide compatibility, it has won widespread recognition in the industry. Compared with similar products, this equipment has significant advantages in precision control, operational convenience, and data traceability, which can not only meet the high-efficiency needs of batch testing but also ensure the accuracy and authority of test results, providing strong technical support for the quality control of infusion sets.

With the continuous development of the medical industry, quality standards for medical devices have become increasingly strict. The sealing performance testing of infusion sets has become a key link to ensure clinical safety. The WY-012 Infusion Set Leakage Negative Pressure Tester will continue to rely on advanced testing technology, continuously optimize product performance, improve the service system, provide higher-quality and more efficient testing solutions for medical device manufacturers, medical institutions, and testing organizations, help the standardized development of the industry, and safeguard the infusion safety of every patient.