节点文献
国产和进口品牌临床在用超声诊断设备关键部件超声探头性能检测对比分析
Comparative Analysis of the Performance Detection of Key Components of Ultrasound Probes in Clinical Use of Domestic and Imported Brands of Ultrasound Diagnostic Equipment
【摘要】 目的 为评估在临床环境中国产与进口品牌超声诊断设备的性能差异,并为临床选择及超声诊断设备的使用提供依据,对超声探头的灵敏度和中心频率进行对比分析。方法 基于脉冲回波法,通过First Call 2000和自主研发的超声探头检测系统,采用对比研究方法,随机抽取54例临床在用的超声探头,选取灵敏度和中心频率这2个对探头性能具有关键影响的指标构建评价标准,并对超声探头的检测结果展开分析与评价。结果 研究发现,国产和进口品牌腹部探头灵敏度比较,差异无统计学意义(P>0.05);在使用年限达5年及以上时,国产浅表探头灵敏度优于进口品牌,且差异有统计学意义(P<0.05)。此外,国产与进口探头的中心频率偏差比较,差异无统计学意义(P>0.05)。结论 本研究为评估国产超声探头的性能提供了科学方法和数据支持,为超声诊断设备的临床有效性和性能检测一致性评价提供了研究基础,有助于建立更完善的临床在用超声再评价机制。
【Abstract】 Objective To evaluate the performance differences between domestic and imported brand ultrasound diagnostic equipment in clinical settings and provide a basis for the clinical selection and use of ultrasound diagnostic equipment, to conduct a comparative analysis of the sensitivity and center frequency of ultrasound probes. Methods Based on the pulse-echo method, through FirstCall 2000 and the self-developed ultrasound probe detection system, a comparative study method was adopted. Fifty-four ultrasound probes in clinical use were randomly selected. Two key indicators, namely sensitivity and center frequency, which have a significant impact on the performance of the probes, were chosen to construct the evaluation criteria, and the detection results of the ultrasound probes were analyzed and evaluated. Results The study found that there was no statistically significant difference in the sensitivity of abdominal probes between domestic and imported brands(P>0.05). When the service life reached 5 years or more, the sensitivity of domestic shallow probes was superior to that of imported brands, and the difference was statistically significant(P<0.05). In addition, there was no statistically significant difference in the center frequency deviation between domestic and imported probes(P>0.05). Conclusion This study provides scientific methods and data support for evaluating the performance of domestic ultrasound probes, offers a research foundation for the consistency evaluation of clinical effectiveness and performance detection of ultrasound diagnostic equipment, and is conducive to establishing a more complete re-evaluation mechanism for in-use ultrasound in clinical practice.
【Key words】 ultrasonic diagnostic equipment; ultrasonic probe; quality inspection; performance evaluation; domestic brands; imported brand;
- 【文献出处】 中国医疗设备 ,China Medical Devices , 编辑部邮箱 ,2025年09期
- 【分类号】R197.39
- 【下载频次】24