Validation of the Omron HEM-1040 Blood Pressure Monitor According to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization 81060-2:2013 Protocol

Figures & data

Figure 1 Omron HEM-1040 blood pressure measuring device.

Table 1 Screening and Recruitment Details

Total screened	97
Total excluded	12
Arrhythmias	3
Poor quality sounds	2
Cuff size unavailable	1
Movement during BP measurement	0
BP variation	6
Difference in observers’ determinations	0
Others (participant requested to quit during testing)	0
Total recruited	85

Table 2 Baseline Characteristics and Blood Pressure Distribution

Women (%)	44
Age (years)	46 ± 13.2 (24–71)
Arm circumference (cm)	30.0 ± 5.3 (22.3–40.8)
Size distribution
22.0–32.0 cm (%)	60.0
32.1–42.0 cm (%)	40.0
22.0–27.0 cm (%)	40.0
37.1–42.0 cm (%)	21.2
SBP (mmHg)	123 ± 24.2 (84–208)
≥160 mmHg (%)	8.2
≥140 mmHg (%)	21.2
≤100 mmHg (%)	16.5
DBP (mmHg)	78 ± 15.9 (51–126)
≥100 mmHg (%)	12.5
≥85 mmHg (%)	29.4
≤60 mmHg (%)	15.7

Table 3 Validation Results

	[Mean ± SD (Min–Max)]
Criterion 1
SBP (mmHg)	−2.7 ± 7.14 (−23.5–19.0)
DBP (mmHg)	−3.3 ± 5.70 (−22.5–12.8)
Criterion 2
SBP (mmHg)	−2.7 ± 5.89 (−19.6–9.8)
DBP (mmHg)	−3.3 ± 4.99 (−19.6–7.8)

Figure 2 Bland-Altman plots of the differences between the Omron HEM-1040 readings and the observer measurements for (A) systolic blood pressure (SBP) and (B) diastolic blood pressure (DBP).