Abstract：
There is intense effort to develop cuffless blood pressure (BP) measuring devices, and several are already on the market claiming that they provide accurate measurements. These devices are heterogeneous in measurement principle, intended use, functions, and calibration, and have special accuracy issues requiring different validation than classic cuff BP monitors. To date, there are no generally accepted protocols for their validation to ensure adequate accuracy for clinical use.
This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common.
Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position.
The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension.
This statement by the European Society of Hypertension (ESH) Working Group on BP Monitoring and Cardiovascular Variability recommends procedures for validating intermittent cuffless BP devices (providing measurements every >30 sec and usually 30-60 min, or upon user initiation), which are most common.
Six validation tests are defined for evaluating different aspects of intermittent cuffless devices: static test (absolute BP accuracy); device position test (hydrostatic pressure effect robustness); treatment test (BP decrease accuracy); awake/asleep test (BP change accuracy); exercise test (BP increase accuracy); and recalibration test (cuff calibration stability over time). Not all these tests are required for a given device. The necessary tests depend on whether the device requires individual user calibration, measures automatically or manually, and takes measurements in more than one position.
The validation of cuffless BP devices is complex and needs to be tailored according to their functions and calibration. These ESH recommendations present specific, clinically meaningful, and pragmatic validation procedures for different types of intermittent cuffless devices to ensure that only accurate devices will be used in the evaluation and management of hypertension.
摘要：
背景：开发无袖口血压（BP）测量设备的工作非常努力，和几个已经在市场上声称他们提供准确的测量。这些设备在测量原理上是异质的，预期用途,功能,和校准，和有特殊的准确性问题需要不同的验证比经典袖带血压监测仪。迄今为止,没有普遍接受的方案进行验证,以确保临床使用的足够准确性.
目的：欧洲高血压协会（ESH）血压监测和心血管变异性工作组的这一声明推荐了验证间歇性无袖带血压装置的程序（每30秒，通常30-60分钟提供一次测量，或在用户启动时)，这是最常见的。
■定义了六种验证测试，用于评估间歇性无袖带设备的不同方面：静态测试（绝对BP精度）；设备位置测试（静水压力影响鲁棒性）；治疗测试（BP降低精度）；清醒/睡眠测试（BP变化精度）；运动测试（BP增加精度）；和重新校准测试（袖带校准随时间的稳定性）。对于给定的设备,并非所有这些测试都是必需的。必要的测试取决于设备是否需要个人用户校准，自动或手动测量，并在多个位置进行测量。
结论：无袖带BP装置的验证很复杂，需要根据其功能和校准进行量身定制。这些ESH建议提出了具体的，临床意义,以及针对不同类型的间歇性无袖设备的实用验证程序，以确保仅将准确的设备用于高血压的评估和管理。
目的：欧洲高血压协会（ESH）血压监测和心血管变异性工作组的这一声明推荐了验证间歇性无袖带血压装置的程序（每30秒，通常30-60分钟提供一次测量，或在用户启动时)，这是最常见的。
■定义了六种验证测试，用于评估间歇性无袖带设备的不同方面：静态测试（绝对BP精度）；设备位置测试（静水压力影响鲁棒性）；治疗测试（BP降低精度）；清醒/睡眠测试（BP变化精度）；运动测试（BP增加精度）；和重新校准测试（袖带校准随时间的稳定性）。对于给定的设备,并非所有这些测试都是必需的。必要的测试取决于设备是否需要个人用户校准，自动或手动测量，并在多个位置进行测量。
结论：无袖带BP装置的验证很复杂，需要根据其功能和校准进行量身定制。这些ESH建议提出了具体的，临床意义,以及针对不同类型的间歇性无袖设备的实用验证程序，以确保仅将准确的设备用于高血压的评估和管理。
