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Quality Control And Performance Testing Of High Frequency Electric Surgical Unit ​

Time:2023-08-13 16:37:44

The high-frequency electrosurgical knife is an electrosurgical instrument that replaces the mechanical scalpel for tissue cutting. The high-frequency high-voltage current generated by the electrode tip contacts the body, heats the tissue, and realizes the separation and coagulation of the body tissue, thereby cutting. It has many advantages, such as fast cutting speed, good hemostasis effect, improved operation efficiency and wide application range.


At present, high-frequency electrosurgery is widely used in surgical operations in major hospitals in my country, but high-frequency electrosurgery is a high-risk device. The quality control and performance testing of electrosurgery cannot be ignored. Therefore, it is recommended to conduct regular overhaul on the electric knife to ensure its performance and stability.


1. Testing environment control

In the specific high-frequency electrosurgical detection practice, the environment has a significant impact on the detection results. Therefore, it is very necessary to control the environment to meet the specific requirements of the detection. At present, when testing, it is usually required that the temperature be controlled at about 15~35 °C, the relative humidity of the area should be less than 80%, and the atmospheric pressure of the testing environment should be maintained at 86~106 kPa, and the testing area should try to avoid mechanical vibrations that affect the normal operation of the verification system. or electromagnetic interference.


2. Determine the frequency of inspection

Determining the inspection frequency can make quality control orderly and planned, and facilitate the management of personnel resource allocation. In June 2020, the State Food and Drug Administration issued the "Notice on Issuing the Standard for Writing Regular Risk Assessment Reports for Medical Devices", which provides systematic and standardized guidance for regular risk assessment of medical devices, and stipulates that medical devices that have been approved for registration or filed for the first time, The registrant shall complete the regular product risk assessment report of the previous year within 60 days after each full year. Typically, electrosurgery manufacturers also recommend semi-annual preventive maintenance testing to ensure equipment performance.


3. Test item reference

Appearance: In addition to checking the name, manufacturer, specification, model, production number and production information of the equipment, it is also necessary to check the appearance of the equipment to determine whether the equipment is complete, whether the keys are flexible, and whether various contact switches are operable.


Output power: The output power detection is the central content of the specific detection, including many items, such as the measurement of the unipolar output power of the rated load, during the measurement process, it is necessary to check the connection method of the circuit to determine whether the connection is in good condition. The power needs to be determined whether the error is within the standard range.


For the detection of unipolar output power of different loads, under different load environments, the specific requirements for the error value are different, so the error calculation should be performed based on the standard to realize the detection.


For the detection of bipolar output power, the specific error should be calculated after the circuit connection detection is completed to determine whether it meets the requirements.


High frequency leakage detection:


Monopolar loading surgical electrode: It can detect the connection of the circuit, then adjust the specific content in the system, record the relevant content, and detect the specific value.


Unipolar loading neutral electrode: mainly use the equipment to detect the specific value in the connected circuit to obtain the detection result.


Unipolar no-load surgical electrode: Detect the corresponding connection circuit, and continue to adjust the specific content in the circuit to make it in a standard state to obtain accurate detection data.


Safety alarm: During the detection process, it is necessary to disconnect the load and the high-frequency generator, and observe whether the high-frequency generator alarms in this state.


CF: The connection method of the circuit for measuring CF is consistent with the connection method of the measured power. In the case of unipolar measurement, the rated output power of the tested equipment is set to be 100 W in the case of electric cutting and coagulation, and the non-inductive resistance is 100 W. 300Ω.


Ω: During bipolar measurement, set the rated output power to 50 W and the non-inductive resistance to 100 Ω; after setting, excite the electromagnetic and record the data to obtain the specific CF value.


The high-frequency electrosurgical knife can be linked with an argon gas device to be upgraded to an argon gas knife to perform APC surgery, meeting the needs of general surgery, hepatobiliary surgery and other open surgeries, as well as rapid and large-area hemostasis under digestive endoscopy.


Full suspension output, equipped with instant fault alarm function, the contact area of the electrode plate drops to a dangerous level, and the host immediately cuts off the output, making the clinic more comfortable.


It is a warm reminder that the performance testing and quality control of high-frequency electrosurgical units are not difficult. The key is to conduct inspections in a standardized and planned manner. The inspectors fully understand the principles, structures and parameters of the electrosurgical units to be tested., and carefully and strictly follow the operating procedures and testing specifications, so that the products can better serve the medical units.



Quality Control And Performance Testing Of High Frequency Electric Surgical Unit ​
The high-frequency electrosurgical knife is an electrosurgical instrument that replaces the mechanical scalpel for tissue cutting. The high-frequency high-voltage current generated by the electrode ti
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