In the previous article, we learned about the product structural materials and structural material properties of low-temperature plasma cutting heads. Next, we will explore other related content.

Structural Product Safety Design

Insulation Design: To prevent current leakage from harming the patient, the design of the lead insulation structure is very critical. Ceramic and other insulating materials are used to wrap the electrode to ensure that the thickness and integrity of the insulation layer meets safety standards. The insulation layer must be able to withstand the high voltage during surgery, and a voltage withstand test is performed during design to ensure reliable insulation performance.

Blade shape and size: The shape of the blade is designed according to surgical needs, such as a sharp blade for fine cutting and a blunt blade for separating tissue. The size must be ergonomic and easy for the surgeon to use, while ensuring flexible use in a small surgical space. The blade is firmly attached to the handle to prevent it from falling off during surgery.

Temperature control structure: Plasma generates heat, and an effective temperature control structure must be designed. Through the design of the cooling channel, circulating water or gas cooling is used to ensure that the blade temperature is within a safe range to avoid thermal damage to tissue.

Product Production Risk Control

Material Quality Control: The quality of raw materials directly affects the performance of the cutter head. Strictly control material procurement and provide quality certification documents. Test the chemical composition and mechanical properties of each batch of materials. Establish a material traceability system so that the source of raw materials can be traced if there is a problem with the product.

Processing risk: Stainless steel machining can cause problems such as work hardening and tool wear, which affect dimensional accuracy and surface finish. Optimise processing parameters, select suitable tools and maintain processing equipment regularly. Ceramic materials are difficult to machine and are prone to defects such as cracking. Advanced processing technologies, such as laser processing, are used and process detection is strengthened.

Assembly risk: When assembling the cutter head, it is important to ensure that the positions of all components are accurate and the joints are strong. Detailed assembly procedures are developed, operators are rigorously trained, quality control points are established during the assembly process, and dimensional measurements and electrical performance tests are carried out.

Product Design Standards

International standards: Comply with International Electrotechnical Commission (IEC) standards for medical electrical equipment, such as the IEC 60601 series. This series of standards is widely recognised worldwide and includes detailed provisions for the electromagnetic compatibility and biocompatibility of the blade. It also complies with the relevant International Organisation for Standardisation (ISO) medical device standards, such as the ISO 10993 biocompatibility evaluation standard.