Devices and technology 157
Validation of the Microlife BPA100 Plus device for self-home
blood pressure measurement according to the
International Protocol
George S. Stergiou, Periklis P. Giovas, Michalis S. Neofytou and
Dionysios N. Adamopoulos
Objective Current guidelines recommend that only vali-
dated devices for blood pressure measurement should be
used. This study presents the validation results of the
Microlife BPA100 Plus monitor for self-home blood
pressure measurement, according to the European Society
of Hypertension International Protocol.
Methods Fifteen study participants were included in phase
1 and an additional 18 in phase 2 (total 33). Simultaneous
blood pressure measurements were taken by two
trained observers (Y tube connected mercury
c 2006
sphygmomanometers) four times, sequentially with three
measurements taken using the tested device. Absolute
differences between observer and device blood pressure
were classified into three zones (within 5, 10 and
15 mmHg). The number of readings with a difference within
5 mmHg was calculated for each individual.
Results In phase 1, the device produced 32, 42 and 43
measurements within 5, 10 and 15 mmHg, respectively, for
systolic blood pressure and 31, 45 and 45 for diastolic
blood pressure. In phase 2.1, the device produced 71, 87
and 96 measurements within 5, 10 and 15 mmHg,
respectively, for systolic blood pressure, and 71, 98 and 99
measurements for diastolic blood pressure. In phase 2.2,
26 participants had at least two of their differences within
5 mmHg and three participants had no differences within
Introduction
Self-monitoring of blood pressure by patients at home is
being increasingly used in many countries. Hypertension
societies have endorsed its use as a supplementary source
of information to the practicing physician [14] and
recommended that such measurements should be taken
using validated electronic devices [1,4]. Few of the
available electronic devices for self-home blood pressure
measurement, however, have been subjected to indepen-
dent validation and were found to be accurate [5].
The Association for the Advancement of Medical
Instrumentation (AAMI) [6] and the British Hyperten-
sion Society [7] developed validation protocols for blood
pressure monitors. On the basis of the experience
obtained by several validation studies conducted using
1359-5237
c 2006 Lippincott Williams & Wilkins
Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
5 mmHg for systolic blood pressure, whereas for diastolic
blood pressure 24 and three participants, respectively.
Mean systolic blood pressure differences were
2.0 6.0 mmHg and diastolic blood pressure differences
were 3.1 4.1 mmHg.
Conclusions The Microlife BPA100 Plus device for self-
home blood pressure measurement comfortably passes
the validation requirements of the International Protocol
and therefore can be recommended for clinical use in the
adult population. Blood Press Monit 11:157160
Lippincott Williams & Wilkins.
Blood Pressure Monitoring 2006, 11:157160
Keywords: accuracy, European Society of Hypertension, home blood
pressure, International Protocol, Microlife, self-measurement, validation
Hypertension Center, Third University Department of Medicine, Sotiria Hospital,
Athens, Greece.
Correspondence and requests for reprints to George S. Stergiou, MD,
Hypertension Center, Third University Department of Medicine, Sotiria Hospital,
152 Mesogion Avenue, Athens 11527, Greece
Tel: + 30 210 771 9975; fax: + 30 210 771 9981; e-mail: gstergi@med.uoa.gr
Sponsorship: This work was funded by a grant from Microlife, Heerbrugg,
Switzerland.
Received 8 November 2005 Accepted 9 November 2005
the above-mentioned protocols, the European Society of
Hypertension Working Group on Blood Pressure Mon-
itoring developed the International Protocol [8] that has
been simplified in terms of the number of participants
required (33 versus 85 participants in the older protocols)
and the blood pressure range for study inclusion. Several
devices have already been validated using the Interna-
tional Protocol [5].
This paper presents the results of a validation study
of the Microlife BPA100 Plus oscillometric device
(Microlife, Heerbrugg, Switzerland) for self-home mea-
surement of blood pressure according to the European
Society of Hypertension International Protocol
for Validation of Blood Pressure Measuring Devices in
Adults [8].
 158 Blood Pressure Monitoring 2006, Vol 11 No 3

Methods arrhythmia were excluded. All participants gave informed

Tested device consent for taking part in the study.
The Microlife BPA100 Plus is an oscillometric device for
self-home blood pressure measurement taken on the Procedure
upper arm. It measures blood pressure at rest at a range The validation study was conducted in an isolated room
between 30 and 280 mmHg and pulse rate between 40 in which disturbing noise was avoided. After 1015 min
and 200 beat/min. Inflation is performed by an automatic sitting rest, blood pressure was measured by the two
electric pumping system and deflation by an automatic observers (entry blood pressure). This measurement was
pressure release valve. The device has a large liquid used to classify participants into the low, medium and
crystal digital display (5  7 cm) on which systolic and high range, separately for systolic and diastolic blood
diastolic blood pressure and heart rate are displayed pressure, as described above. Device detection measure-
simultaneously. It is powered by four 1.5 V batteries or an ment was followed by the supervisor, in order to ensure
AC adaptor and has a memory capacity for 200 measure- that the device was able to measure blood pressure of
ments. Three cuffs are available to be used with the each individual. Using the double-headed stethoscope
device: small cuff (for arm circumference 1722 cm), and the mercury sphygmomanometer, the two observers
standard (2232 cm) and large cuff (3242 cm). Three took readings BP1, BP3, BP5 and BP7. The supervisor
devices were obtained from the manufacturer for the took readings BP2, BP4 and BP6 using the test device.
purpose of this study. These last seven measurements (BP1 to BP7) were used
in the validation analysis.
Blood pressure measurements
Two trained observers and one supervisor experienced in
Analysis
blood pressure measurement were involved in the study.
Each pair of observer measurements was averaged and
Before the study, observers were tested for agreement in
was then subtracted from the device measurement. The
blood pressure measurement according to the British
absolute differences between BP2BP1, BP2BP3, BP4
Hypertension Society protocol [7]. Two standard mercury
BP3, BP4BP5, BP6BP5 and BP6BP7 were calculated
sphygmomanometers (Baumanometer, WA Baum Co Inc,
and paired according to the device reading. For each pair,
New York, New York, USA), the components of which
the one with the smaller difference was used in the
have been carefully checked before the study, and a
analysis. These blood pressure differences were classified
teaching Littman stethoscope were used for simulta-
into three zones (within 5, 10 and 15 mmHg), separately
neous (Y tube) observer-taken reference blood pressure
for systolic and diastolic blood pressure, for 15 partici-
measurements. The supervisor measured blood pressure
pants in phase 1 and for all the 33 in phase 2.1. For each
with the tested device and also checked the agreement of
individual participant, the number of readings with a
blood pressure measurements taken by the observers.
difference within 5 mmHg was also calculated (phase
Cuffs of the tested device were used for all measure-
2.2). Statistical analysis was performed using the MINI-
ments (using the tested and the mercury device)
TAB Inc Statistical Software (release 13.31) (Stage
according to the manufacturers instructions to fit each
College, Pennsylvania, USA).
individuals arm circumference. All blood pressure
measurements were taken on the left arm, which was
supported at heart level. The protocol was approved by
the hospital scientific committee. Results
Study participants
Study participants A total of 44 participants were recruited. Two participants
According to the International Protocol, in phase 1 a total were excluded because their entry blood pressure was out
of 15 treated or untreated participants are included who of the range required for study inclusion, and one of them
fulfill the age, sex and entry blood pressure range was included later in the study after treatment modifica-
requirements (age 30 years or older, at least five men tion. A total of 43 participants completed the study.
and five women, five participants with entry blood
pressure within each of the ranges 90129, 130160 Table 1 Characteristics of participants in study phase 1 and 2
and 161180 mmHg for systolic and 4079, 80100 and Participants Mean Mean arm Entry Entry
101130 mmHg for diastolic blood pressure). If analysis (men/women) age SD circ SD SBP SD DBP SD
of these data is successful, additional participants are (years) (cm) (range) (mmHg) (mmHg)
(range) (range) (range)
recruited until a total of 33 participants fulfill the age, sex
and entry blood pressure range requirements for phase 2 Phase 1 15 50.0 14.2 29.8 2.5 145.6 23.4 90.0 15.1
(9/6) (3375) (2434) (97178) (65113)
(age 30 years or older, at least 10 men and 10 women, 11 Phase 2 33 49.4 13.7 28.8 3.8 143.0 26.5 90.1 17.7
participants with entry blood pressure within each of the (17/16) (3075) (2240) (97178) (57130)
above-mentioned blood pressure ranges for systolic and SBP, systolic blood pressure; DBP, diastolic blood pressure; arm circ, arm
diastolic blood pressure). Participants with sustained circumference.

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 Microlife home monitor validation Stergiou et al. 159

Table 2 Results of the validation analysis

Phase 1 r 5 mmHg r 10 mmHg r 15 mmHg Recommendation Mean difference SD
Required One of 25 35 40
Achieved SBP 32 42 43 Continue 1.6 5.7
DBP 31 45 45 Continue 3.0 4.1
Phase 2.1 r 5 mmHg r 10 mmHg r 15 mmHg Recommendation Mean difference SD
Required Two of 65 80 95
All of 60 75 90
Achieved SBP 71 87 96 Pass 2.0 6.0
DBP 71 98 99 Pass 3.1 4.1
Phase 2.2 2/3 r 5 mmHg 0/3 r 5 mmHg Recommendation
Required Z 22 r3
Achieved SBP 26 3 Pass
DBP 24 3 Pass

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

Data from the first 15 recruited participants (45 read- Fig. 1

ings), who fulfilled the International Protocol criteria
30

Device observer measurement (mmHg)

with regard to sex and systolic and diastolic entry blood
25 Systolic BP
pressure range, were included in the analysis of phase 1.
20
Analysis of phases 2.1 and 2.2 was based on the first 33
15
participants (99 blood pressure readings), who fulfilled
10
the study inclusion criteria with regard to sex and entry
5
blood pressure. The characteristics of participants in
0
study phases 1 and 2 are presented in Table 1.
5
10
Validation criteria 15
The use of the tested device was straightforward and 20
there were no operational problems during the study. The 25
requirements of the International Protocol for phases 1, 30
2.1 and 2.2 and the results of the validation analysis are 80 90 100 110 120 130 140 150 160 170 180 190
presented in Table 2. The differences in blood pressure Mean device and observer measurement (mmHg)
between the tested device and the observer readings (99
30
Device observer measurement (mmHg)

readings) for systolic and diastolic blood pressure are

25 Diastolic BP
presented in Fig. 1.
20
15
In phase 1, the tested device passed all the three criteria
10
(one required), for both systolic and diastolic blood
5
pressure. The mean blood pressure differences between 0
the tested device and the reference method were 5
1.6 5.7 mmHg for systolic and 3.0 4.1 mmHg for 10
diastolic blood pressure. In phase 2.1, the device 15
comfortably satisfied all the six criteria (five required), 20
for both systolic and diastolic blood pressure. The mean 25
blood pressure differences between the device and the 30
reference method in all the 33 participants were 30 40 50 60 70 80 90 100 110 120 130 140
2.0 6.0 mmHg for systolic and 3.1 4.1 mmHg for Mean device and observer measurement (mmHg)
diastolic blood pressure. In phase 2.2, the device also
passed all the protocol criteria for systolic and diastolic BlandAltman plots presenting differences in blood pressure between
blood pressure. The criterion of the minimum number of the tested device and the observer readings (99 readings). Recruitment
limits regarding entry blood pressure ranges (low, medium and high) are
participants with none of the three measurements lying indicated by the vertical lines. BP, blood pressure.
within 5 mmHg was marginally met by the device for both
systolic and diastolic blood pressure.

Discussion systolic and diastolic blood pressure and therefore can be

This study provided information on the accuracy of a new recommended for clinical use in the adult population.
device for self-home blood pressure measurement. It showed
that the Microlife BPA100 Plus monitor passes the validation Given that the mean difference in blood pressure
requirements of the International Protocol [8] for both between the device and the observer measurement was

Copyright Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
 160 Blood Pressure Monitoring 2006, Vol 11 No 3
lower than 5 mmHg with a standard deviation lower than
8 mmHg, the tested device also fulfils the validation
criterion of the AAMI protocol [6] (Table 2). It should be
mentioned, however, that, according to the International
Protocol, this study included fewer patients than required
for the AAMI protocol.
To date, only very few manufacturers have succeeded in
producing accurate devices for self-home blood pressure
monitoring [4,5]. Unfortunately, the vast majority of the
devices available on the market has not been subjected to
independent validation using the established protocols, or
has been shown to be inaccurate [5]. As home blood
pressure monitoring is becoming increasing popular and
has been shown to be a useful adjunct to office
measurements [4,9], there is an urgent need for more
devices to be validated.
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