The use of medical devices plays a certain auxiliary role in medical treatment. It is an instrument, equipment, appliance, material or other item used on the human body alone or in combination, and plays an important role in the prevention, diagnosis or treatment of diseases.People not only have safety requirements for its use, but also have requirements for accuracy and precision.Medical equipment must comply with the IEC62353 standard.In addition to ensuring the integrity and non-hazardous nature of the equipment, its air tightness is also very important.
Hirays Technology has made great achievements in sealing testing in the field of medical equipment. Today we will share the application of sealing testers in the medical industry, hoping it can be a reference for everyone.
1. Requirements for sealing testing in the medical industry
1. There is a feature that cannot be ignored in the field of medical industry equipment, that is, different testing plans need to be formulated based on its usage, size, characteristics, etc. Due to the particularity of the medical industry, compressed air testing is generally used, or in order to ensure the safety of testing, dry impurity-free gas can be used to act on the inside of the medical equipment, which has very high requirements for the operating instruments and operating methods.
2. For smaller medical devices, there are certain requirements for the number of instrument stations.Medical equipment that is larger in size and has a special shape requires special tooling equipment, or it is necessary to observe whether there is a docking interface inside the product that can directly connect to the testing equipment.
3. Medical equipment has requirements for non-destructiveness, safety, and accuracy of test results for sealing testing, which is quite difficult in the field of sealing testing.
2. Application examples of Hirays sealing tester in the medical industry
1. Teeth scaler
As a medical product that directly acts on the oral teeth, the sealing test and safety of the dental scaler play a very important role.The shape of the dental scaler is quite special. When testing, it is necessary to take into account its shape and high-precision materials to formulate a corresponding plan. Hirays uses a mold to seal it for indirect testing. Such testing will not damage the material of the instrument and can better ensure the accuracy of the results;
2. Medical flushing gun
Medical flushing is strongly used for wound cleaning. As a water outlet and quilt, it must have good air tightness. Good air tightness can prevent bacteria and dirt from remaining inside the gun body. Since the appearance of this instrument is relatively complex and is not conducive to direct vehicle inspection, Hirays Technology customized a specially fixed device for it to solve the problem of fixing and placing the detection product;
3. Electronic stethoscope
The shape of the electronic stethoscope is a cylinder, and its material is highly precise. This shape requires the use of corresponding molds to hold it during testing. After the upper and lower molds are closed, a sealed testing space will be formed. The mold can also protect the electronic stethoscope from damage during testing.At this time, after the tooling connected to the mold is started, a certain volume of gas is injected into the mold through the air source. When the detected air pressure is reached, the air supply is automatically cut off and the pressure is stabilized. At this time, the Heruis Technology sealing detection system will monitor the air pressure in the mold and determine the sealing based on the amount of leakage.
1. Advantages and parameters of sealing tester
1. High-sensitivity pressure sensing and adjustment unit, combined with advanced differential pressure software algorithm, the minimum resolution can reach 0.1Pa. This algorithm has obtained a national patent.
2. Patented technology independently developed by Hirays,"IVT pneumatic sealing valve island", greatly improving the test accuracy, ensuring the stability of the instrument, and the inflation speed is also greatly improved.
3. Multiple test functions: The instrument integrates two pressure forms, positive and negative, and 8 test methods: two pressure forms and five test methods can be programmed into more than 20 test functions.
4. It has more than 200 groups of subroutines. Each group of subroutines can be programmed independently, single selected and combined to meet various complex testing requirements.
5. Full-touch large-screen intelligent operating system, graphical UI design based on the detection process, the operation interface is simple and clear, easy to teach and learn.
6. A variety of pressure adjustment components and ranges are optional, with a wide air pressure range (-80KPA—1MPa) optional.The optional electronic pressure regulating valve can realize multiple sets of pressure sequential tests.
7. Multiple communication interfaces: built-in RS232 serial port, RJ45 network port, USB communication interface, LTP external I/O control port, supporting multiple communication protocols.
8. Optional barcode scanning function and printer are available to facilitate product data management and quality traceability. The instrument history record can reach up to 200,000 items and can be exported to the computer in batches.
9. The standard volume identification function can automatically identify the volume of the sample to be tested, and measure and judge the leakage rate in a volumetric manner.
10. Ultra-high stability and ease of use have passed the rigorous test of the market.
11. A variety of accessories are available, including inflatable bypass, quick connector, and standard leak hole. At the same time, the instrument supports third-party calibration and can issue a calibration report.
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