掌上超声设备基本性能及其超声图像研究分析

Research and analysis of basic performance and ultrasound image of handheld ultrasound device

目的:分析研究国内外不同批次掌上超声设备的基本性能和超声图像质量,了解掌握国内已上市的掌上超声设备临床使用性能,以满足临床诊断需求。方法:根据国家标准GB10152-2009《B型超声诊断设备》、行业标准YY0767-2009《超声彩色血流成像系统》对国内外14个厂家28批次掌上超声设备的基本性能指标及临床常用检查部位进行性能测试,评价超声图像质量;测定和评价掌上超声设备探测深度、侧向分辨力、轴向分辨力、几何位置精度、多普勒血流探测深度及血流速度准确性等指标;依据《掌超设备遴选考核内容及评分标准》对掌上超声设备临床常用检查部位甲状腺、颈动脉及肝脏的超声图像质量进行评价。结果:测试的28批次产品中26批次(占92.85%)产品能够满足国家现行强制标准要求,不合格率占比仅为7.69%;超声图像质量盲评中无评分优秀和不合格,评分良好12家(占85.71%),评分合格2家(占14.28%)。结论:测试的掌上超声设备基本性能指标大部分达到国家和行业标准的要求,超声图像质量优良,具备常规超声诊断仪的基本功能,能够满足临床检查的基本要求。

Objective:To analyze and research the basic performance and the quality of ultrasonic image of handheld ultrasound device of different batches at home and abroad,and grasp the clinical usability of that on sale at home so as to meet the requirement of clinical diagnosis.Methods:According to the national standard GB 10152-2009"B mode ultrasonic diagnostic equipment"and the industry standard YY 0767-2009"Ultrasound colour flow imaging systems",the performances of the clinically common detection point and basically performance indicators of handheld ultrasound device of 28 batches from 14 manufacturers at home and abroad were tested,and the qualities of ultrasound images were further evaluated.The detection depth,the resolutions of side direction and axial direction,the precision of geometric position,the accuracies of the depth and blood flow velocity of Doppler blood flow detection of the handheld ultrasound device were measured and evaluated.The qualities of ultrasound images of the thyroid,carotid artery and liver which were clinically common detection point of handheld ultrasound devices were evaluated according to“The examination content and scoring standard of selecting handheld ultrasound device”.Results:In tested products of 28 batches,26 batches(92.85%)could meet the requirements of the current national compulsory standards.The unqualified rate was only 7.69%.In the results of blind evaluation of ultrasound image quality,there were no excellent and unqualified product,and 12 batches were favorable that accounted for 85.71%,and 2 batches were qualified scores that accounted for 14.28%.Conclusion:Most of the basic performance indicators of the tested handheld ultrasound device can meet the requirements of national and industrial standards,which ultrasound image qualities are excellent and favorable.The handheld ultrasound device has the basic functions of conventionally ultrasound diagnostic equipment and can meet the basic requirements of clinical examination.