Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol

Figures & data

Figure 1 The Omron HEM-1026 (HCR-1901T2/HCR-1902T2).

Table 1 Screening and Recruitment Details

Total screened	101
Total Excluded	9
Arrhythmias	0
Poor quality sounds	0
Cuff size unavailable	1
Movement during BP measurement	0
Blood pressure variation	6
Observers’ determination with difference	0
Others: Poor physical condition of the subject)	1
Others: Error in evaluation method	1
Total Recruited	92

Table 2 Baseline Characteristics of the Subjects

Female (%)	53.3
Age (years)	63.2 ± 10.6 (39–81)
Arm circumference (cm)	25.1 ± 4.5 (17.0–32.0)
Limb size distribution
17.0–20.7 cm (%)	27.2
20.8–24.5 cm (%)	20.7
24.6–28.2 cm (%)	20.7
28.3–32.0 cm (%)	31.4
17.0–18.8 cm (%)	10.9
30.2–32.0 cm (%)	16.3

Table 3 Blood Pressure Distribution

SBP (mmHg)	126.0 ± 24.4 (77.8–202.5)
≥160 mmHg (%)	7.6
≥140 mmHg (%)	30.4
≤100 mmHg (%)	15.6
DBP (mmHg)	77.0 ± 13.9 (51.5–118.3)
≥100 mmHg (%)	5.1
≥85 mmHg (%)	30.1
≤60 mmHg (%)	14.1

Table 4 Validation Results

	[Mean ± SD (Min - Max)]
Criterion 1
SBP (mmHg)	−2.1 ± 7.24 (−31.0–19.5)
DBP (mmHg)	−0.6 ± 5.63 (−16.0–13.5)
Criterion 2
SBP (mmHg)	−2.1 ± 5.71 (−23.3–9.8)
DBP (mmHg)	−0.6 ± 4.81 (−13.7–10.1)

Figure 2 The upper panels depict the Bland-Altman plots of the differences between the Omron HEM-1026 (HCR-1901T2/HCR-1902T2) readings and the observer measurements for (A) systolic blood pressure (SBP) and (B) diastolic blood pressure (DBP). The lower panels are scattergrams showing the relationship between arm circumference and differences between Omron HEM-1026 (HCR-1901T2/HCR-1902T2) readings and observer measurements for (C) systolic blood pressure (SBP) and (D) diastolic blood pressure (DBP).