超声诊断设备送检要点

结论：声输出和探头是两条与其他设备不同的主线

超声诊断设备的检测，电气安全和电磁兼容与其他医用电气设备一致，特有的是两条线：声输出与探头。

声输出关系到安全。 超声波进入人体会产生机械效应和热效应，输出过高可能造成组织损伤。所以声输出参数要测量并控制在限值内。

探头是与患者直接接触的应用部分，它同时涉及声学性能、电气安全、生物相容性、以及清洁消毒耐受。

其余项目（图像性能、功能、机械环境）与一般设备的逻辑类似。

项目的组织

声输出的考察

测量的参数。 声压、声强相关参数，以及由此计算的指数。

测量条件。 在规定的介质中、规定的位置测量。

各模式各设置的覆盖。 不同成像模式、不同深度、不同频率、不同功率设置下的输出都不同，要找出输出较高的组合。

限值的符合。 输出参数在规定限值内。

显示的准确性。 设备上显示的指数与实测值的一致性。

「找出输出较高的组合」是声输出测量的重点。 参数组合的数量很多，不可能全测，需要通过分析和摸底找出可能输出较高的组合，重点验证这些。

「显示的准确性」同样重要。 使用者根据显示的指数判断是否需要调整，显示不准会误导使用者。

探头表面温度

探头与患者皮肤或黏膜接触，表面温度是安全项：

测量条件。 在规定的条件下运行，测量接触面的温度。

不同工作模式。 某些模式（比如多普勒）的发热更明显。

空气中与介质中。 两种条件的温升不同，都要考察。

腔内探头的特殊要求。 与黏膜接触的探头，温度限值更严。

长时间运行。 连续工作时的温度累积。

「腔内探头的温度」要特别关注，因为接触部位是黏膜，耐受性低于皮肤，而且使用者可能无法及时感知和反馈。

图像性能的考察

分辨力。 轴向分辨力、侧向分辨力。

探测深度。 能分辨的深度范围。

灵敏度。 对弱回声的检测能力。

几何精度。 图像的几何失真。

均匀性。 图像各区域的一致性。

伪像。 是否产生明显的伪像。

测试通常使用专用的模体，模体中有已知尺寸和特性的目标，通过成像效果判断性能。

测量功能的精度

超声设备的测量功能直接用于临床判断：

距离测量。 线性尺寸的精度。

面积与体积。 计算结果的精度。

流速测量。 多普勒测量的精度。

角度的影响。 流速测量对角度敏感，要验证角度修正的正确性。

测量精度的验证用已知尺寸的模体，比较测量值与实际值。

探头相关的其他项目

生物相容性。 与皮肤或黏膜接触的材料。

清洁与消毒耐受。 探头需要频繁消毒，材料和密封要能耐受。

密封性。 探头的防液体侵入能力，特别是浸泡消毒的探头。

电缆的耐久。 探头电缆反复弯折的寿命。

连接器。 反复插拔的可靠性和接触电阻。

跌落。 探头跌落后的功能与安全。

「探头的密封性」在消毒环节很关键。 需要浸泡消毒的探头，如果密封失效，消毒液进入可能损坏探头并带来电气安全风险。这一项应当在消毒循环之后复测。

「电缆弯折寿命」是探头的常见失效点，日常使用中电缆反复弯曲，靠近探头根部的位置容易断线。

送检准备的建议

提供全部探头型号。 声称配套的探头都要送检。

说明各成像模式。 以及各模式的参数范围。

提供声输出的设计数据。 便于确定测量的重点组合。

提供软件版本信息。 声输出受软件控制。

说明消毒方法。 各探头允许的消毒方式。

准备配套附件。 探头保护套、耦合剂等。

「声输出的设计数据」有助于缩小测量范围，因为它能指出哪些组合的输出较高，测量可以聚焦在这些组合上。

软件与工作站

现代超声设备包含大量软件功能，相关的考察包括：

测量与计算软件。 各类测量工具和临床计算公式的正确性。

图像处理。 增强、降噪等处理对诊断信息的影响。

数据管理。 图像的存储、检索、导出、格式。

网络功能。 与影像系统的对接、数据传输。

软件版本管理。 版本与报告的对应。

「临床计算公式的正确性」值得验证，因为公式错误会直接给出错误的临床数据，而使用者通常不会去核算。

送检时的实用建议

声输出测量耗时较长，因为组合多、每个点都要测。建议提前与实验室沟通测量的组合范围，避免测试中反复调整。

探头数量影响周期。 探头越多，涉及的表面温度、生物相容性、消毒耐受项目越多。如果不是全部型号都急需，可以分批安排。

图像性能测试需要模体，如果有特殊的成像模式，可能需要专用模体，这一点要提前确认。

我们的做法

承接超声设备委托时，我们会先了解各成像模式和参数范围，通过摸底测量确定输出较高的组合，再对这些组合做正式测量，而不是盲目遍历所有组合。

探头方面，我们建议把消毒循环后的密封性和功能复测纳入项目，因为消毒是探头的高频工况，而消毒对密封和材料的影响是累积的。

如果你有超声类设备需要安排送检，想先理清项目和探头准备，可以把产品资料发过来一起讨论，或者直接联系：132 4819 8029。能力范围见服务介绍，送检要求见送检要求，流程见检测流程。

English version

Conclusion. For diagnostic ultrasound equipment, electrical safety and electromagnetic compatibility follow the same logic as other medical electrical equipment, and two lines are distinctive: acoustic output and the transducer. Acoustic output bears on safety, since ultrasound entering the body produces mechanical and thermal effects and excessive output can damage tissue, so output parameters must be measured and kept within limits. The transducer is the applied part in direct contact with the patient and involves acoustic performance, electrical safety, biocompatibility and tolerance of cleaning and disinfection simultaneously. The remaining items, covering image performance, function and mechanical and environmental testing, follow the usual logic.

Organising the items. Electrical safety covers leakage current, dielectric strength, earthing, temperature rise and single fault conditions. Applied parts cover transducer classification and isolation. Electromagnetic compatibility covers emissions and immunity. Acoustic output covers pressure, intensity and the derived indices. Transducer surface temperature covers the rise at the patient contact area. Image performance covers resolution, sensitivity and geometric accuracy. Measurement accuracy covers distance, area, volume and velocity. Function covers each imaging mode. Biocompatibility covers patient-contacting transducer materials. Cleaning and disinfection cover transducer tolerance. And mechanical and environmental testing covers drop, vibration, temperature and humidity.

Examining acoustic output. Measure the parameters, covering pressure, intensity-related quantities and the indices computed from them. Measure under specified conditions, in a specified medium at specified positions. Cover modes and settings, since output differs with imaging mode, depth, frequency and power setting, and combinations producing higher output must be identified. Confirm conformity with limits. And verify display accuracy, comparing the indices the equipment displays against measured values. Identifying higher-output combinations is the focus of acoustic output measurement: the number of parameter combinations is large and exhaustive testing impossible, so analysis and survey measurement must find the combinations likely to produce higher output for detailed verification. Display accuracy matters equally, since users judge whether to adjust settings from the displayed indices and an inaccurate display misleads them.

Transducer surface temperature. The transducer contacts skin or mucosa, making surface temperature a safety item. Measure under specified operating conditions at the contact surface. Cover operating modes, since some, such as Doppler, produce more heating. Measure both in air and in a medium, since temperature rise differs. Note the stricter limits for intracavity transducers contacting mucosa. And examine prolonged operation and cumulative heating. Intracavity transducer temperature deserves particular attention: mucosa tolerates less than skin, and the user may be unable to perceive and report a problem promptly.

Examining image performance. Resolution covers axial and lateral resolution. Penetration depth covers the range over which structures can be resolved. Sensitivity covers detection of weak echoes. Geometric accuracy covers distortion in the image. Uniformity covers consistency across the image. And artefacts cover whether obvious artefacts are produced. Testing normally uses purpose-made phantoms containing targets of known size and characteristics, with performance judged from the resulting images.

Measurement accuracy. Measurement functions feed clinical judgement directly. Distance measurement covers linear accuracy. Area and volume cover the accuracy of computed results. Velocity measurement covers Doppler accuracy. And angle effects matter, since velocity measurement is angle-sensitive and angle correction must be verified. Verification uses phantoms of known dimensions, comparing measured against actual values.

Other transducer items. Biocompatibility covers materials contacting skin or mucosa. Cleaning and disinfection tolerance matters because transducers are disinfected frequently and materials and seals must withstand it. Sealing covers resistance to liquid ingress, particularly for transducers disinfected by immersion. Cable durability covers the life of the cable under repeated flexing. Connectors cover the reliability and contact resistance of repeated mating. And drop testing covers function and safety after a transducer is dropped. Transducer sealing is critical for disinfection: where a transducer disinfected by immersion loses its seal, disinfectant entering can damage it and create an electrical safety risk, so this should be re-measured after disinfection cycling. Cable flex life is a common transducer failure point, since cables flex repeatedly in use and conductors break near the transducer end.

Preparing for submission. Provide every transducer model claimed as compatible. Describe each imaging mode and its parameter ranges. Provide acoustic output design data to help establish which combinations to measure. Provide software version information, since acoustic output is software-controlled. Describe disinfection methods permitted for each transducer. And prepare accessories including transducer covers and coupling gel. Design data help narrow the measurement scope by indicating which combinations produce higher output, allowing measurement to focus there.

How we handle it. For ultrasound equipment we establish the imaging modes and parameter ranges first and use survey measurement to identify higher-output combinations, then measure those formally rather than traversing every combination blindly. On transducers we suggest including sealing and functional re-measurement after disinfection cycling, since disinfection is a high-frequency condition for transducers and its effect on seals and materials accumulates.

Send us the product documentation and we will work through the items and transducer preparation. Phone or WeChat: +86 132 4819 8029.