Radiation Protection & Radiology Physics, United Lincolnshire Hospitals NHS Trust, Greetwell Road, Lincoln, United Kingdom; Multi-Medix, Unit 56 Hayhill Industrial Estate, Barrow upon Soar, Leicestershire, United Kingdom.
Multi-Medix, Unit 56 Hayhill Industrial Estate, Barrow upon Soar, Leicestershire, United Kingdom.
Ultrasound Med Biol. 2019 Oct;45(10):2844-2850. doi: 10.1016/j.ultrasmedbio.2019.06.416. Epub 2019 Jul 18.
A growing number of repaired and refurbished diagnostic ultrasound probes are supplied by a small number of original equipment manufacturers (OEMs) and many third-party vendors. OEMs ensure that their devices meet regulatory requirements; any repairs using non-OEM materials carry the risk of non-compliance. The aim of this study was to test examples of probe repairs using methods selected to illustrate their possible impact on function. Of 3212 used probes assessed, 21 were found to have undergone repair involving functional parts: 9 incorrectly wired, 11 non-OEM arrays and 1 relensed probe. For repairs not involving functional parts, before and after electronic probe testing may be sufficient to determine that no damage has occurred. For repairs involving functional parts, a more comprehensive suite of tests is necessary to determine that the materials, parts and final product match the performance of the OEM probe and meet regulatory requirements.
越来越多经过修复和翻新的诊断超声探头由少数原始设备制造商 (OEM) 和许多第三方供应商提供。OEM 确保其设备符合监管要求；任何使用非 OEM 材料的维修都存在不合规的风险。本研究的目的是测试使用选定方法进行的探头修复示例，以说明其对功能的潜在影响。在所评估的 3212 个二手探头中，有 21 个发现经过了涉及功能部件的修复：9 个接线不正确，11 个非 OEM 探头和 1 个探头重新密封。对于不涉及功能部件的维修，在进行电子探头测试之前和之后，可能足以确定没有损坏。对于涉及功能部件的维修，需要更全面的测试套件来确定材料、部件和最终产品与 OEM 探头的性能相匹配，并符合监管要求。
