Division of Maternal-Fetal Medicine, Center for Women's Reproductive Health, University of Alabama at Birmingham, Birmingham, Alabama.
SunTech Medical, Inc., Morrisville, North Carolina.
Am J Perinatol. 2019 Jan;36(1):67-73. doi: 10.1055/s-0038-1660510. Epub 2018 Jun 15.
We sought to validate the SunTech Medical Advantage Model 2 Series with firmware LX 3.40.8 algorithm noninvasive blood pressure module in a pregnant population, including those with preeclampsia.
Validation study of an oscillometric noninvasive blood pressure module using the ANSI/AAMI ISO 81060-2:2013 standard guidelines. Pregnant women were enrolled into three subgroups: normotensive, hypertensive without proteinuria, and preeclampsia (hypertensive with random protein-to-creatinine ratio ≥ 0.3 or a 24-hour urine protein > 300 mg). Two trained research nurses, blinded to each other's measurements, used a mercury sphygmomanometer to validate the module by following the protocol set forth in the ANSI/AAMI ISO 81060-2:2013 standard guidelines.
A total of 45 patients, 15 in each subgroup, were included. The mean systolic and diastolic differences with standard deviations between the module and the mean observers' measurements for all participants were -2.3 ± 7.3 and 0.2 ± 6.5 mm Hg, respectively. The systolic and diastolic standard deviations of the mean of the individual patient's paired module and observers' measurements were 6.27 and 5.98 mm Hg, respectively. The test device, relative to a mercury sphygmomanometer, underestimated the systolic blood pressure in patients with preeclampsia by at least 10 mm Hg in 24% (11/45) of paired measurements.
The SunTech Medical Advantage Model 2 Series with firmware LX 3.40.8 algorithm noninvasive blood pressure module is validated in pregnancy, including patients with preeclampsia; however, it may underestimate systolic blood pressure measurements in patients with preeclampsia.
我们旨在验证 SunTech Medical Advantage Model 2 系列血压模块（配备 LX 3.40.8 算法Firmware）在包括子痫前期孕妇在内的妊娠人群中的准确性。
使用 ANSI/AAMI ISO 81060-2：2013 标准指南，对一种基于示波法的无创血压模块进行验证研究。将孕妇分为三组：正常血压孕妇、无蛋白尿高血压孕妇和子痫前期孕妇（随机蛋白尿与肌酐比值≥0.3 或 24 小时尿蛋白>300mg 的高血压孕妇）。两名接受过培训的研究护士使用水银血压计，根据 ANSI/AAMI ISO 81060-2：2013 标准指南中的协议进行测量，从而对该模块进行验证。
共有 45 名患者入组，每组 15 名。所有参与者的模块与平均观察者测量值之间的平均收缩压和舒张压差异分别为-2.3±7.3mmHg 和 0.2±6.5mmHg。个体患者的模块和观察者测量值配对的平均收缩压和舒张压标准差分别为 6.27mmHg 和 5.98mmHg。与水银血压计相比，测试设备至少在 24%（45 例患者中的 11 例）配对测量中低估了子痫前期患者的收缩压，差值至少为 10mmHg。
SunTech Medical Advantage Model 2 系列血压模块（配备 LX 3.40.8 算法Firmware）在妊娠中得到验证，包括子痫前期患者；然而，它可能会低估子痫前期患者的收缩压测量值。
