Validation of two automatic devices, Omron HEM-6232T and HEM-6181, for self-measurement of blood pressure at the wrist according to the ANSI/AAMI/ISO 81060-2:2013 protocol and the European Society of Hypertension International Protocol revision 2010

Figures & data

Figure 1 Omron HEM-6232T (left) and Omron HEM-6181 (right).

Table 1 Screening and recruitment details according to the ANSI/AAMI/ISO 81060-2:2013 protocol

	Omron HEM-6232T	Omron HEM-6181
Total screened	94	92
Total excluded	9	7
Arrhythmias	0	0
Poor quality sounds	0	0
Cuff size unavailable	0	0
Movement during BP measurement	0	0
BP variation	9	7
Total recruited	85	85

Abbreviation: BP, blood pressure.

Table 2 Baseline characteristics of the subjects according to the ANSI/AAMI/ISO 81060-2:2013 protocol

	Omron HEM-6232T	Omron HEM-6181
Women (%)	55	61
Age (years), mean ± SD (min to max)	57±12.7 (23 to 80)	55±12.2 (23 to 84)
Wrist circumference (cm), mean ± SD (min to max)	17.0±2.2 (13.5 to 21.4)	17.1±2.2 (13.5 to 21.4)
13.5–17.4 cm (%)	59	56
17.5–21.5 cm (%)	41	44
13.5–15.4 cm (%)	32	31
19.5–21.5 cm (%)	20	20

Table 3 Blood pressure distribution according to the ANSI/AAMI/ISO 81060-2:2013 protocol (n=255)

	Omron HEM-6232T	Omron HEM-6181
SBP (mmHg), mean ± SD (min to max)	123±21.8 (83 to 197)	124±25.9 (85 to 195)
≥160 mmHg (%)	5	11
≥140 mmHg (%)	20	28
≤100 mmHg (%)	12	18
DBP (mmHg), mean ± SD (min to max)	80±14.2 (52 to 112)	81±16.2 (50 to 118)
≥100 mmHg (%)	9	15
≥85 mmHg (%)	26	35
≤60 mmHg (%)	8	9

Table 4 Validation results according to the ANSI/AAMI/ISO 81060-2:2013 protocol

	Omron HEM-6232T, (mean ± SD [min – max])	Omron HEM-6181, mean ± SD (min – max)
Criterion 1
SBP (mmHg)	−0.4±6.7 (−33 to 19)	−0.7±6.2 (−19 to 16)
DBP (mmHg)	1.6±5.4 (−12 to 18)	−0.7±5.2 (−19 to 12)
Criterion 2
SBP (mmHg)	−0.4±5.6 (−24 to 10)	−0.7±5.2 (−13 to 9)
DBP (mmHg)	1.6±4.8 (−10 to 14)	−0.7±4.7 (−17 to 9)

Figure 2 Bland–Altman plots of the differences between the Omron HEM-6232T readings and the observer measurements for: (A) SBP and (B) DBP according to the ANSI/AAMI/ISO 81060-2:2013 protocol.

Table 5 Screening and recruitment details according to the ESH IP2

	Omron HEM-6232T	Omron HEM-6181
Total screened	46	37
Total excluded	13	4
Range complete	0	0
Range adjustment	9	3
Arrhythmias	1	0
Device failure	0	0
Poor quality sounds	0	0
Cuff size unavailable	0	0
Observer disagreement	1	0
Other reasons	2	1
Total recruited	33	33

Abbreviation: ESH IP2, European Society of Hypertension International Protocol revision 2010.

Table 6 Baseline characteristics of the subjects according to the ESH IP2

	Omron HEM-6232T	Omron HEM-6181
Women (%)	48	48
Age (years), mean ± SD (min–max)	54±9.6 (42–76)	54±12.1 (25–74)
Wrist circumference (cm), mean ± SD (min–max)	17.7±1.6 (15.3–21.2)	17.3±2.0 (13.9–20.8)
SBP (mmHg), mean ± SD (min–max)	142±26.4 (92–210)	141±26.7 (89–178)
Low (n) (<90 mmHg)	0	1
(90–129 mmHg)	12	10
Medium (n) (130–160 mmHg)	10	12
High (n) (161–180 mmHg)	10	10
(>180 mmHg)	1	0
DBP (mmHg), mean ± SD (min–max)	89±17.8 (46–122)	87±19.6 (56–118)
Low (n) (<40 mmHg)	0	0
(40–79 mmHg)	11	12
Medium (n) (80–100 mmHg)	11	11
High (n) (101–130 mmHg)	11	10
(>130 mmHg)	0	0

Abbreviation: ESH IP2, European Society of Hypertension International Protocol revision 2010.

Table 7 Observer measurements in each recruitment range according to the ESH IP2

	Omron HEM-6232T	Omron HEM-6181
SBP (mmHg)
Overall range (low : high)	87:205	90:188
Low (<130 mmHg)	33	36
Medium (130–160 mmHg)	41	38
High (>160 mmHg)	25	25
Maximum difference	16	13
DBP (mmHg)
Overall range (low : high)	50:122	49:120
Low (<80 mmHg)	33	33
Medium (80–100 mmHg)	37	38
High (>100 mmHg)	29	28
Maximum difference	8	10

Abbreviation: ESH IP2, European Society of Hypertension International Protocol revision 2010.

Table 8 Validation results according to the ESH IP2 for the Omron HEM-6232T

Part 1	≤5 mmHg	≤10 mmHg	≤15 mmHg	Grade 1	Mean (mmHg)	SD (mmHg)
Required
Two of	73	87	96
All of	65	81	93
Achieved
SBP	70	91	97	Pass	−0.9	5.7
DBP	73	96	98	Pass	0.5	4.9
Part 2	2/3≤5 mmHg		0/3≤5 mmHg		Grade 2	Grade 3
Required	≥24		≤3
Achieved
SBP	24		1		Pass	Pass
DBP	25		0		Pass	Pass

Abbreviation: ESH IP2, European Society of Hypertension International Protocol revision 2010.

Figure 3 Bland–Altman plots of the differences between the Omron HEM-6232T readings and the observer measurements for: (A) SBP and (B) DBP according to the ESH IP2.

Abbreviation: ESH IP2, European Society of Hypertension International Protocol revision 2010.

Figure 4 Bland–Altman plots of the differences between the Omron HEM-6181 readings and the observer measurements for: (A) SBP and (B) DBP according to the ANSI/AAMI/ISO 81060-2:2013 protocol.

Table 9 Validation results according to the ESH IP2 for the Omron HEM-6181

Part 1	≤5 mmHg	≤10 mmHg	≤15 mmHg	Grade 1	Mean (mmHg)	SD (mmHg)
Required
Two of	73	87	96
All of	65	81	93
Achieved
SBP	78	96	98	Pass	0.2	4.6
DBP	81	99	99	Pass	1.4	3.5
Part 2	2/3≤5 mmHg		0/3≤5 mmHg		Grade 2	Grade 3
Required	≥24		≤3
Achieved
SBP	27		0		Pass	Pass
DBP	28		1		Pass	Pass

Abbreviation: ESH IP2, European Society of Hypertension International Protocol revision 2010.

Figure 5 Bland–Altman plots of the differences between the Omron HEM-6181 readings and the observer measurements for SBP (A) and DBP (B) for ESH IP2.