Validation of Omron RS8, RS6, and RS3 home blood pressure monitoring devices, in accordance with the European Society of Hypertension International Protocol revision 2010

Figures & data

Table 1 Screening and recruitment details for the Omron RS8 (HEM-6310F-E) validation

Screening and recruitment			Recruitment ranges
			mmHg	All	Antihypertensive medication
Total screened	43	SBP
Total excluded	10	Low	<90	1	0
Complete ranges	0		90–129	10
Range adjustment	0	Medium	130–160	12	4
Arrhythmias	2	High	161–180	9	6
Device failure	0		>180	1
Poor quality sounds	1	DBP
Cuff size unavailable	0	Low	<40	0	0
Observer disagreement	0		40–79	12
Distribution	0	Medium	80–100	11	5
Other reasons	7	High	101–130	10	5
Total recruited	33		180	0

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

Table 2 Participant characteristics for the Omron RS8 (HEM-6310F-E) validation

Parameters	Mean ± SD	Range
Men:Women	20:13
Age (years)	50 ± 12.3	28–72
Arm circumference (mm)	286 ± 34	212–350
Wrist circumference (mm)	176 ± 20	137–212
Entry SBP (mmHg)	140 ± 32.5	88–219
Entry DBP (mmHg)	85 ± 19.9	50–118

Note: Data are expressed as the mean ± SD and the range (except gender ratio).

Abbreviations: SD, standard deviation; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Table 3 Comparison of results obtained using the Omron RS8 and a sphygmomanometer

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	76	90	97	Pass	1.5	5.8
DBP	74	96	99	Pass	−1.7	4.6
Part 2	2/3 ≤ 5 mmHg	0/3 ≤ 5 mmHg		Grade 2
Required	≥24	≤3
Achieved
SBP	26	1		Pass
DBP	26	1		Pass

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation.

Figure 1 Bland–Altman plots of the differences between Omron RS8 (HEM-6310F-E) and sphygmomanometer blood pressure (BP) measurements for systolic blood pressure (A) and diastolic blood pressure (B).

Table 4 Screening and recruitment details for the Omron RS6 (HEM-6221-E) validation

Screening and recruitment			Recruitment ranges
			mmHg	All	Antihypertensive medication
Total screened	41	SBP
Total excluded	8	Low	<90	0	0
Complete ranges	4		90–129	11
Range adjustment	0	Medium	130–160	11	5
Arrhythmias	3	High	161–180	8	2
Device failure	0		>180	3
Poor quality sounds	0	DBP
Cuff size unavailable	0	Low	<40	0	0
Observer disagreement	0		40–79	12
Distribution	0	Medium	80–100	11	2
Other reasons	1	High	101–130	9	5
Total recruited	33		>180	1

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

Table 5 Participant characteristics for the Omron RS6 (HEM-6221-E) validation

Parameters	Mean ± SD	Range
Men: Women	21:12
Age (years)	50 ± 11.6	28–70
Arm circumference (mm)	283 ± 42	200–410
Wrist circumference (mm)	178 ± 22	135–212
Entry SBP (mmHg)	142.1 ± 32.0	94–226
Entry DBP (mmHg)	86.8 ± 21.7	51–134

Note: Data are expressed as the mean ± SD and the range (except gender ratio).

Abbreviations: SD, standard deviation; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Figure 2 Bland–Altman plots of the differences between Omron RS6 (HEM-6221-E) and sphygmomanometer blood pressure (BP) measurements for systolic blood pressure (A) and diastolic blood pressure (B).

Table 6 Comparison of results obtained using the Omron RS6 and a sphygmomanometer

Part 1	≤5 mmHg	≤10 mmHg	≤5 mmHg	Grade 1	Mean (mmHg)	SD (mmHg)
Required
Two of	73	87	96
All of	65	81	93
Achieved
SBP	73	90	95	Pass	1.3	5.8
DBP	79	96	99	Pass	−0.3	4.5
Part 2	2/3 ≤ 5 mmHg	0/3 ≤ 5 mmHg		Grade 2
Required	≥24	≥3
Achieved
SBP	26	1		Pass
DBP	29	1		Pass

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation.

Table 7 Screening and recruitment details for the Omron RS3 (HEM-6130-E) validation

Screening and recruitment			Recruitment ranges
			mmHg	All	Antihypertensive medication
Total screened	81	SBP
Total excluded	48	Low	<90	0	1
Complete ranges	32		90–129	11
Range adjustment	0	Medium	130–160	10	3
Arrhythmias	7	High	161–180	9	4
Device failure	0		>180	3
Poor quality sounds	1	DBP
Cuff size unavailable	0	Low	<40	0	1
Observer disagreement	0		40–79	11
Distribution	0	Medium	80–100	12	4
Other reasons	8	High	101–130	10	3
Total recruited	33		>180	0

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

Table 8 Participant characteristics for the Omron RS3 (HEM-6130-E) validation

Parameters	Mean ± SD	Range
Men: Women	15:18
Age (years)	50 ± 11.8	32–75
Arm circumference (mm)	288 ± 48	199–382
Wrist circumference (mm)	170 ± 22	136–208
Entry SBP (mmHg)	144 ± 31.1	94–209
Entry DBP (mmHg)	87 ± 19.9	52–120

Note: Data are expressed as the mean ± SD and the range (except gender ratio).

Abbreviations: SD, standard deviation; SBP, systolic blood pressure; DBP, diastolic blood pressure.

Figure 3 Bland–Altman plots of the differences between Omron RS3 (HEM-6130-E) and sphygmomanometer blood pressure (BP) measurements for systolic blood pressure (A) and diastolic blood pressure (B).

Table 9 Comparison of results obtained using the Omron RS3 and a sphygmomanometer

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	81	93	98	Pass	1.8	4.3
DBP	72	94	99	Pass	1.7	4.5
Part 2	2/3 ≤ 5 mmHg	0/3 ≤ 5 mmHg		Grade 2
Required	≥24	≤3
Achieved
SBP	27	0		Pass
DBP	26	3		Pass

Abbreviations: SBP, systolic blood pressure; DBP, diastolic blood pressure; SD, standard deviation.