Validation of the SunTech Medical Advantage Model 2 Series Automated Blood Pressure Module in Pregnancy

Introduction The Ideal Life BP Manager™ measures BP and automatically transmits results to the patient’s medical record independent of internet access, but has not been validated. Our objective was to conduct a validation study of the Ideal Life BP Manager™ in pregnant women using a validation protocol. Methods Pregnant participants were enrolled into three subgroups per the AAMI/ESH/ISO protocol: normotensive (systolic blood pressure (SBP) <140 and diastolic blood pressure (DBP) < 90), hypertensive without proteinuria (SBP ≥ 140 or DBP ≥ 90), and preeclampsia (SBP ≥ 140 or DBP ≥ 90 with proteinuria). Two trained research staff used a mercury sphygmomanometer to validate the device, alternating sphygmomanometer and device readings for a total of 9 measurements. Results Among 51 participants, the mean SBP and DBP differences and standard deviations between the device and the mean staff measurements for all participants were 1.7 ± 7.1 and 1.5 ± 7.0 mmHg, respectively. The standard deviations of the individual participant’s paired device and mean staff SBP and DBP measurements were 6.0 and 6.4 mmHg, respectively. The device was more likely to overestimate rather than underestimate BP [SBP: Mean Difference=1.67, 95% CI (-12.15 to 15.49); DBP: Mean Difference= 1.51, 95% CI (-12.26 to 15.28)]. Most paired readings had a difference of less than 10 mmHg across averaged paired readings. Conclusion The Ideal Life BP Manager™ met internationally recognized validity criteria in this sample of pregnant women.

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Validation of the AViTA BPM636 upper arm blood pressure monitor in adults and pregnant women according to the ANSI/AAMI/ISO 81060-2:2013

Lee

Huang³

2023

Blood Pressure Monitoring

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Objective To evaluate the accuracy of the AViTA oscillometric upper arm home blood pressure (BP) monitor in adult and pregnant populations according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/ International Organization for Standardization (ANSI/AAMI/ISO) Universal Standard (ISO 81060-2:2013). Methods BP measurements on the upper arm were performed on 85 adult subjects and 46 pregnant subjects. The AViTA BPM636 and a standard mercury reference sphygmomanometer were applied and followed the same arm sequential BP measurement method. The universal cuff of the test device was used for arm circumference of 22–42 cm. Results For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 1.1 ± 5.49/2.9 ± 5.17 mmHg (systolic/diastolic) for adults; and -2.2 ± 5.93/1.5 ± 4.92 mmHg (systolic/diastolic) for pregnant women. For criterion 2, the SD of the averaged BP differences between the test device and reference BP per adult subject was 4.45/4.20 mmHg (systolic/diastolic) and per pregnant women was 4.66/3.96. Conclusion The AViTA BPM636 had passed the criteria of the ANSI/AAMI/ISO 81060-2:2013 protocol and can be recommended for home BP measurements in adults and pregnant populations.

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Validation of the SunTech Medical Advantage Model 2 Series Automated Blood Pressure Module in Pregnancy

Abstract: 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.

Cited by 3 publications

References 18 publications

Shop-to-Stop Hypertension: A multicenter cluster-randomized controlled trial protocol to improve screening and text message follow-up of adults with high blood pressure at health kiosks in hardware retail stores

Shop-to-Stop Hypertension: A multicenter cluster-randomized controlled trial protocol to improve screening and text message follow-up of adults with high blood pressure at health kiosks in hardware retail stores

Validation of a Remote Monitoring Blood Pressure Device in Pregnancy

Validation of the AViTA BPM636 upper arm blood pressure monitor in adults and pregnant women according to the ANSI/AAMI/ISO 81060-2:2013

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