Development of radiofrequency ablation device for surgical hepatocellular carcinoma treatment in agreement with Brazilian standards

Abstract

Introduction: Many studies have been carried out on the main causes of hepatocellular carcinoma (HCC) to identify suitable diagnosis methods and treatments to combat the disease. However, high equipment costs and the lack of hepatic-ablation technologies manufactured in Brazil encourage the design and implementation of a solution based on normative principles. Methods: The analysis and description of equipment features were the first steps in defining the design requirements and constraints. Equipment functionalities were evaluated with three assays set by NBR-IEC 60601-2-2. Results: The assays of output control adjustment accuracy, output control adjustment monotonicity, and signal quality evaluation using the crest factor (CF) for the equipment showed thresholds superior to the aforementioned standard. Conclusion: State-of-the-art studies have contributed the equipment construction. The construction process was validated by assays to ensure the equipment functionality with raw materials at acceptable costs. The test results showed the superiority of the equipment in relation to the assays proposed by the standard NBR-IEC 60601-2-2. However, to convert the prototype into a commercial product, other analyses are necessary.