Devices and technology 225
Omron HEM-711 DLX home Blood pressure monitor passes
the European Society of Hypertension International
Validation Protocol
Clarence E. Grima and Carlene M. Grimb
The Omron HEM-711 DLX home Blood pressure monitor
was tested using the European Society of Hypertension
International Protocol in 33 patients. The average error was
0.9 ± 5.2 (SD) (range: – 12 to 10 mmHg)/ – 0.8 ± 5.6
( – 19 to 8). It can be recommended for use by patients.
With all automatic devices it is, however, important to
validate its accuracy in each individual patient who uses
it. Blood Press Monit 13:225–226
c 2008 Wolters Kluwer Tel: + 414 916 0841; e-mail: lowerbp2@aol.com
Health | Lippincott Williams & Wilkins.
Blood Pressure Monitoring 2008, 13:225–226
Background
The Omron HEM-711 DLX measures blood pressure (BP)
by the oscillometric method during deflation using a single
cuff for arms from 22 to 42 cm. We found no published
papers [1] stating that any of these devices has passed
either the Association for the Advancement of Medical
Instrumentation validation protocol [2] or the European
Society of Hypertension (ESH) validation protocol [3].
Methods
The ESH protocol was used for data collection and
analysis [3]. Phase 1 of the ESH requires 15 patients aged
30 years or older. Five must be in each of three systolic
and diastolic ranges: low (< 130/ < 80), medium (130–
r 160/80 –r 100), and high (Z 161/ Z 101). Phase 2
then adds 18 more patients, six in each of the BP
categories. Age must be more than or equal to 30 years
and the arm circumference within the recommended
range of 22–42 cm.
Purchase and selection of devices
We purchased three of the Omron HEM-711 DLX
devices from a third party online source. One was then
randomly selected and served as the test device
throughout this study.
Informed consent
The protocol and consents were submitted to and
approved by IntegReview Ethical Review Board (www.
integreview.com). Written informed consent was obtained
before each study was started.
Blood pressure observers and protocol
The left arm was used in all patients. Although viewing
the same mercury manometer two trained, standardized
1359-5237
c 2008 Wolters Kluwer Health | Lippincott Williams & Wilkins
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Keywords: home blood pressure devices
a
Medical College of Wisconsin and High Blood Pressure Consulting and
b
Shared Care Research and Education Consulting Inc., Milwaukee,
Wisconsin, USA
Correspondence to Professor Clarence E. Grim, BS, MS, MD, Senior Consultant
to Shared Care Research and Education Consulting Inc., High Blood Pressure
Consulting, LLC, 2821 N. 4th Street, Milwaukee, WI 53211, USA
Received 6 November 2007 Revised 29 January 2008
Accepted 29 January 2008
and experienced observers measured all BPs using the
bell of the stethoscope while viewing the same mercury
manometer and then recorded their results indepen-
dently. A third observer looked at both results and stated
‘OK’ (if the systolics and diastolics were within 4 mmHg)
or, ‘REPEAT’, if they exceeded 4 mmHg. The first
reading was taken by the human observers after 5 min
of rest. This baseline BP was used to classify the BP level
of the participant: low (< 130/ < 80), medium (Z 130–
r 160/ Z 80– r 100), high (Z 161/ Z 101). The cuff was
removed and the device to be tested was applied using
the cuff markings as the guide to arm size. On a signal
from the one who applied the cuff, the third observer
triggered the automatic device and then recorded the
device’s BP reading. This reading was not shared with the
human observers. Then, in an alternating manner, BP was
taken seven more times alternating human and machine
readings. The patient was then given the average
auscultatory BP results and paid for participating.
Cuff selection
The cuff used for the auscultatory method was based
on the arm circumference using the 40%/80% guidelines
from the American Heart Association [4]. Only patients
with an arm circumference in the range stated on the
device’s cuff was used for this testing (22–42 cm).
Patient recruitment and selection
Patients were recruited from the shared care database
of participants in other BP device studies and by word
of mouth. If this study was completed they were paid
US $50. Patients were entered into this study on the basis
of the baseline BP until each of the required bins were
filled for phase 1 and then phase 2 was carried out. As
over-subscription of some levels of pressure as entry in
 226 Blood Pressure Monitoring 2008, Vol 13 No 4

this study progressed, patients who met only one of the Table 2 Results of ESH phase 1 and phase 2 validation
range criteria were included only for that range. Only the Phase 1: n = 15 patients: analysis of three readings on each patient = 45
first five patients who met each bin criteria were used readings
Error in each pair of Within Within Within
for phase 1 analysis and then the next six patients who readings- 5 mmHg 10 mmHg 15 mmHg
met each bin criteria were used for phase 2 analyses. A Required: at least Count Count Count Recom-
one of- Z 25 Z 35 Z 40 mendation
total of 35 patients were required to reach the required HEM-711 Systolic 33 40 44 Continue
11 patients in each BP group. DLX
Diastolic 34 39 42 Continue
Phase 2.1: n = 33 patients: analysis of 99 paired readings
Results Within Within Within
Table 1 contains the mean, SD and range of the age, BMI, 5 mmHg 10 mmHg 15 mmHg
Required: at least Count Count Count Recom-
arm circumference, and the BP and BP error. one of- Z 65 Z 80 Z 95 mendation
Required: all of- 60 75 90
Table 2 reports the results on phase 1 and phase 2 of HEM-711 Systolic 72 92 99 Pass
DLX
the ESH protocol. The Omron HEM-711 DLX passed all Diastolic 75 94 99 Pass
phases for both systolic and diastolic pressure. Phase 2.2 n = 33 patients: analysis of each of three readings in each patient
2/3 r ± 5a count All readings
must be Z 22 > ± 5 mmHgb count
Discussion must be r 3
Count Decision Count Decision
The HEM-711 DLX passed both phase 1 and phase 2 Systolic HEM-711 DLX 25 Pass 2 Pass
of the ESH protocol. Nevertheless in two patients this
device made a systemic error of more than 5 mmHg in all Diastolic HEM-711 DLX 23 Pass 2 Pass

three pairs of readings in both systolic and diastolic a

readings. Thus before this device can be accepted as
accurate in the individual patient it should be tested in
each patient. Although there is no standard method to
test a device in an individual patient we suggest that the
practitioner use the same method as carried out in both
the ESH and the Association for the Advancement of
Medical Instrumentation protocol taking a series of
alternating readings (five human readings that bracket
four machine readings). The error in each of last three
pairs should be calculated using the ESH protocol and if
Table 1 Demographics and blood pressure
HEM-711 DLX n = 33
In all three readings on a patient the error must be r ± 5 mmHg in at least 22 of
the 33 (67%) patients tested.
b
In all three readings on each patient the error can exceed ± 5 mmHg in only
three of the 33 (9%) patients tested.
ESH, European Society of Hypertension.
it exceeds 5 mmHg in all three the tested device should
not be used in this patient.
Conclusion
The Omron HEM-711 DLX passed both phases of the
ESH validation protocol and can be recommended for
patient use.

Mean SD Range
References
Age (years) 51 12 31–73 1 dableducational.com for list of validated devices. [Accessed 7/1/07]
BMI 29 5.8 17–44 2 Association for the Advancement of Medical Instrumentation. Electronic or
Arm circumference 34 4 26–39 automated sphygmomanometers. ANSI/AAMI SP10-1992. Arlington (Vir.):
AAMI, 1993. American National Standard.
Human systolic 143 24 96–186
3 O’Brien E, Pickering T, Asmar R, Myers M, Parati G, Staessen J, et al. Working
Machine systolic 144 23 100–181
group on blood pressure monitoring of the European Society of Hypertension
Systolic error + 0.9 5.2 – 12 to 10
International Protocol for validation of blood pressure measuring devices in
adults. Blood Press Monit 2002; 7:3–17.
Human diastolic 90 18 60–122
4 Perloff D, Grim C, Flack J, Frohlich ED, Hill M, McDonald M, Morgenstern BZ,
Machine diastolic 89 16 61–116
Diastolic error – 0.8 5.6 – 19 to + 8 for the Writing Group. Human blood pressure determination by
sphygmomanometry. Circulation 1993; 88:2460–2467.

Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.