Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou.
Shenzhen Mindray Bio-medicical Electronics Co., LTD., Shenzhen, Guangdong, China.
Blood Press Monit. 2024 Aug 1;29(4):207-211. doi: 10.1097/MBP.0000000000000704. Epub 2024 Mar 25.
We aimed to validate the accuracy of the Mindray VS9 Vital Signs Monitor, which features the Mindray TrueBP inflation algorithm for oscillometric blood pressure (BP) measurement, to check if it complies with the International Organization for Standardization Standard (ISO 81060-2:2018) in a combined adult and pediatric population. A total of 86 participants, including both adult and pediatric subjects, were recruited. The distribution of their ages, gender, BPs and limb sizes all complied with the requirement of the ISO standard. The inflation and deflation algorithms were validated independently using the same-arm sequential BP measurement method. For each subject, the BP was first determined by two independent observers using a mercury sphygmomanometer (R1). The BP of the subject was then determined by the third observer using the test equipment (T1). Then, using a mercury sphygmomanometer, two independent observers were asked to determine the subject's BP (R2) again. R1-T1-R2 were considered a valid pair of data. This cycle continued until 3 pairs of valid data were achieved. We collected 258 pairs of valid BP data for the validation of the inflation and deflation algorithms respectively. For validation Criterion 1, the mean ± SD of the differences between the readings obtained from the test device and reference BP was 0.0 ± 6.6/-1.8 ± 7.1 mmHg (systolic/diastolic) when the deflation algorithm was used, and 2.4 ± 6.3/ 0.3 ± 6.9 mmHg (systolic/diastolic) when the inflation algorithm was used. For validation Criterion 2, the SD of the averaged BP differences between the test device and the reference BP per subject was 5.35/6.33 mmHg (systolic/diastolic) when the deflation algorithm was used, and 5.17/5.75 mmHg (systolic/diastolic) when the inflation algorithm was used. The VS9 Vital Signs Monitor fulfilled all the criteria in the ISO Standard. Moreover, the inflation algorithm had a shorter Measure Time (by 7-21 s) and lower maximum inflation pressure (by 9.7-22 mmHg). The VS9 Vital Signs Monitor fulfilled all the requirements of the ISO Standard (ISO 81060-2:2018) in a combined adult and pediatric population and is recommended for clinical use.
我们旨在验证迈瑞 VS9 生命体征监护仪的准确性，该监护仪采用迈瑞 TrueBP 充气算法进行示波法血压（BP）测量，以检查其在成人和儿科混合人群中是否符合国际标准化组织标准（ISO 81060-2：2018）。共有 86 名参与者，包括成人和儿科受试者，他们的年龄、性别、血压和肢体大小分布均符合 ISO 标准的要求。充气和放气算法是使用相同手臂顺序血压测量方法独立验证的。对于每个受试者，首先由两名独立观察者使用水银血压计（R1）确定血压。然后，由第三名观察者使用测试设备（T1）确定受试者的血压（T1）。然后，使用水银血压计，两名独立观察者被要求再次确定受试者的血压（R2）。R1-T1-R2 被认为是一对有效的数据。这个循环一直持续到获得 3 对有效数据为止。我们分别收集了 258 对有效的血压数据来验证充气和放气算法。对于验证标准 1，当使用放气算法时，从测试设备和参考血压读数中获得的读数之间的差异的平均值±SD 为 0.0±6.6/-1.8±7.1mmHg（收缩压/舒张压），而当使用充气算法时为 2.4±6.3/0.3±6.9mmHg（收缩压/舒张压）。对于验证标准 2，当使用放气算法时，每个受试者测试设备和参考血压之间的平均 BP 差异的 SD 为 5.35/6.33mmHg（收缩压/舒张压），而当使用充气算法时为 5.17/5.75mmHg（收缩压/舒张压）。VS9 生命体征监护仪符合 ISO 标准中的所有标准。此外，充气算法的测量时间更短（缩短 7-21 秒），最大充气压力更低（降低 9.7-22mmHg）。VS9 生命体征监护仪在成人和儿科混合人群中符合 ISO 标准（ISO 81060-2：2018）的所有要求，推荐用于临床使用。
