Validation of four automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension

Figures & data

Table 1 BP ranges for entry BP

	SBP (mmHg)	DBP (mmHg)
Low	90–129	40–79
Medium	130–160	80–100
High	161–180	101–130

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure.

Table 2 Age, arm circumference distribution, and BP values for all four devices populations

	Omron M1 Plus	Omron M6 Comfort	Spengler KP7500D	Microlife BP A100 Plus
Age (years)	58 ± 13	52 ± 15	59 ± 13	57 ± 13
Arm circ. distribution (cm)	28 ± 4	29 ± 4	30 ± 4	29 ± 4
Arm circ. range (cm)	19–38	19–34	23–40	24–38
BP (SBP/DBP) (mmHg)	136.5 ± 20.9/89.6 ± 16.4	133.8 ± 24.2/85.2 ± 13.9	138 ± 20.2/83.6 ± 17.0	141.9 ± 24.5/84.5 ± 16.4

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure.

Table 3 Results of the OMRON M1 Plus (HEM-4011C-E) device

Phase 1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.
Required	One of	25	35	40
Achieved	SBP	41	44	45	Continue
	DBP	39	44	45	Continue
Phase 2.1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.	Mean diff.	SD
Required	Two of	65	80	95
	All of	60	75	90
Achieved	SBP	83	97	99	Pass	−1.4	5.5
	DBP	80	93	98	Pass	−0.4	4.8
Phase 2.2		2/3 ≤ 5 mmHg	0/3 ≤ 5 mmHg		Recomm.
Required		≥22	≤3
Achieved	SBP	29	0		Pass
	DBP	27	1		Pass

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; Recomm., recommendation; Mean diff., mean difference (mmHg); SD, standard deviation (mmHg).

Figure 1 Plots for systolic blood pressure (SBP) difference between the test device readings and the mean of the two observer readings in 33 participants (n = 99) versus the mean of the devices and the mercury sphygmomanometer readings: (a) Omron M1 Plus (HEM 4011C-E), (b) Omron M6 Comfort (HEM-7000-E), (c) Spengler KP7500D, (d) Microlife BP A100 Plus.

Figure 2 Plots for diastolic blood pressure (DBP) difference between the test device readings and the mean of the two observer readings in 33 participants (n = 99) versus the mean of the devices and the mercury sphygmomanometer readings: (a) Omron M1 Plus (HEM 4011C-E), (b) Omron M6 Comfort (HEM-7000-E), (c) Spengler KP7500D, (d) Microlife BP A100 Plus.

Table 4 Results of the OMRON M6 Comfort (HEM 7000-E) device

Phase 1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.
Required	One of	25	35	40
Achieved	SBP	32	37	40	Continue
	DBP	38	43	45	Continue
Phase 2.1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.	Mean diff.	SD
Required	Two of	65	80	95
	All of	60	75	90
Achieved	SBP	67	81	90	Pass	−2.1	7.4
	DBP	73	93	99	Pass	0.1	4.9
Phase 2.2		2/3 ≤ 5 mmHg	0/3 ≤ 5 mmHg		Recomm.
Required		≥22	≤3
Achieved	SBP	25	3		Pass
	DBP	25	3		Pass

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; Recomm., recommendation; Mean diff., mean difference (mmHg); SD, standard deviation (mmHg).

Table 5 Results of the Spengler KP7500D device

Phase 1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.
Required	One of	25	35	40
Achieved	SBP	40	40	42	Continue
	DBP	42	43	44	Continue
Phase 2.1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.	Mean diff.	SD
Required	Two of	65	80	95
	All of	60	75	90
Achieved	SBP	86	92	96	Pass	−1.4	8.6
	DBP	93	96	98	Pass	−0.1	3.5
Phase 2.2		2/3 ≤ 5 mmHg	0/3 ≤ 5 mmHg		Recomm.
Required		≥22	≤3
Achieved	SBP	29	1		Pass
	DBP	31	1		Pass

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; Recomm., recommendation; Mean diff., mean difference (mmHg); SD, standard deviation (mmHg).

Table 6 Results of the Microlife BP A100 Plus device

Phase 1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.
Required	One of	25	35	40
Achieved	SBP	40	45	45	Continue
	DBP	42	45	45	Continue
Phase 2.1		≤5 mmHg	≤10 mmHg	≤15 mmHg	Recomm.	Mean diff.	SD
Required	Two of	65	80	95
	All of	60	75	90
Achieved	SBP	84	96	98	Pass	1.6	4.2
	DBP	91	99	99	Pass	0.54	2.8
Phase 2.2		2/3 ≤ 5 mmHg	0/3 > 5 mmHg		Recomm.
Required		≥22	≤3
Achieved	SBP	30	2		Pass
	DBP	33	0		Pass

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; Recomm., recommendation; Mean diff., mean difference (mmHg); SD, standard deviation (mmHg).