Instruments and Methods For Calibration of Oscillometric Blood Pressure Measurement Devices
Instruments and Methods For Calibration of Oscillometric Blood Pressure Measurement Devices
Instruments and Methods For Calibration of Oscillometric Blood Pressure Measurement Devices
Abstract—Most of automatic blood pressure measurement de- are already employing automated technology to measure BP
vices on the market implement an oscillometric method. This instead of the traditional mercury sphygmomanometers [1].
paper highlights the need for standardized calibration procedures Most of the automated noninvasive BP (NIBP) measurement
for these devices in order to reduce logistical difficulties, time-
consuming processes, and high costs involved in clinical vali- devices for clinical use rely on oscillometric techniques. Even
dations. A critical overview of researchers’ and manufacturers’ if the basic principle is the same as the Korotkoff method,
proposals to answer this need is presented as a contribution to the the cuff pressure is measured electronically, during inflation
IEEE P1721 project for a new standard on Objective Measure- or deflation phases, and used to estimate SBP and DBP by
ment of Systemic Arterial Blood Pressure in Humans. means of proprietary algorithms. Unfortunately, systematic
Index Terms—Blood pressure (BP), calibration, noninvasive uncertainty components affect oscillometric BP measurement
measurement, oscillometric method, simulators, standardization. devices (OBPMDs), too. In particular, they can be affected
both by lack of calibration of the electronic pressure sens-
I. I NTRODUCTION ing system and by the uncertainty due to the DBP and SBP
estimation algorithm. As the algorithms are confidential and
T HE IMPORTANCE of accurate blood pressure (BP) mea-
surement in the diagnosis of arterial hypertension and
in the antihypertensive treatment is largely acknowledged in
differ among instruments, clinical trials are adopted to validate
OBPMDs against manual auscultatory measurements carried
clinical practice [1]. out by applying the Korotkoff method [2]. Due to the scarce
The classic approach to BP measurement is based on use reproducibility of such calibration, adopted in all the inter-
of the mercury sphygmomanometer and the Korotkoff method. nationally available standards, OBPMDs can pass validation
A compression cuff wrapped around the patient’s arm is first tests despite producing clinically significant differences that
inflated until the circulation stops. Then, the cuff is slowly can be greater than 15 mmHg in some individuals [2]. This
deflated while the doctor listens at the sounds made from blood problem has to be considered even more serious since system-
flowing again in the patient’s artery by means of a stethoscope. atic uncertainty components in BP measurements caused by
Although it has been regarded as the gold standard for BP inadequate OBPMD calibration are a common cause of over-
measurement in a clinical setting for a long time [1], this and underdiagnose of hypertension [2].
method is known to be affected by a number of limitations Aware of this situation, the IEEE I&M Society TC-25 Sub-
due to measurement conditions, arm position, and observer’s committee on “Objective Blood Pressure Measurement” has re-
attitude. cently started the project P1721 “IEEE Standard for Objective
The observer-related biases could, in theory, be eliminated Measurement of Systemic Arterial Blood Pressure in Humans”
by using automated electronic devices, due to their capability of [3]. The standard in process aims to provide a comprehensive
providing printouts of systolic, diastolic, and mean BPs (SBP, guide to assess the uncertainty of automatic BP devices in an
DBP, and MBP, respectively) together with heart rate, time, objective way, independently from a group of human subjects
and date of measurement. Such an approach could eliminate or a specific clinical protocol [4].
interpretation errors, observer bias, and terminal digit prefer- A brief overview of the existing standards and protocols
ence [1]. Moreover, it allows 24-h monitoring of the patients’ aimed at the automated NIBP measurement device calibration
health with fixed time lapses. These potentialities, together has been introduced in [4] as a contribution to the new IEEE
with the capability of storing data for later analysis and/or standard. In particular, the carried-out analysis has highlighted
for remote transmission, promoted the diffusion of electronic that the device evaluation and calibration is mainly carried
BP measurement devices. A number of large research studies out by taking as a reference the measurements obtained on a
large number of people by two observers using stethoscope
and mercury sphygmomanometer. Moreover, the methods to
Manuscript received July 20, 2009; revised March 11, 2010; accepted do that do not always agree each other, producing questionable
April 17, 2010. Date of publication July 12, 2010; date of current version results [4].
August 11, 2010. The Associate Editor coordinating the review process for this A general description of the oscillometric BP methods has
paper was Dr. Salvatore Baglio.
The authors are with the Department of Engineering, University of been provided in [5]. In particular, the differences that can
Sannio, 82100 Benevento, Italy (e-mail: balestrieri@unisannio.it; rapuano@ be found among different devices implementing, in different
unisannio.it). ways, the same basic idea in terms of general specifications and
Color versions of one or more of the figures in this paper are available online
at http://ieeexplore.ieee.org. accuracy have been carried out. The most promising approach
Digital Object Identifier 10.1109/TIM.2010.2050978 to a reproducible calibration of NIBP devices, i.e., to use
TABLE I
R ESULTS O BTAINED FOR S LOPE -BASED (W ITH AND W ITHOUT
C ONSTRAINTS A DDED ) AND H EIGHT-BASED M ETHODS FOR THE T HREE
D IFFERENT R EPRESENTATIONS OF O SCILLOMETRIC I NDEX C URVES OF
THE A RTERIAL P RESSURE P ULSES . C I S THE T OTAL N UMBER OF C ASES
C LASSIFIED AS G OOD ( UP TO 5-mmHg) D IFFERENCE B ETWEEN THE
E STIMATED AND THE M EASURED SBP AND DBP), F IS THE N UMBER OF
FAILED C ASES ( A D IFFERENCE OF A BOVE 10 mmHg), r IS THE L INEAR
R EGRESSION C ORRELATION, Δp ± SD IS THE M EAN D IFFERENCE AND
I TS S TANDARD D EVIATION IN mmHg, Epp IS THE MIN- TO -MAX
E NVELOPE OF THE O SCILLOMETRIC P ULSE, Epc IS THE C ENTERED OR
MIN- TO -COG E NVELOPE OF THE O SCILLOMETRIC P ULSE , AND Epd IS
Fig. 4. Three different oscillometric index (Epy ) representations of an os- THE COG- TO -MAX E NVELOPE OF THE O SCILLOMETRIC P ULSE [29]
cillometric pulse, where y is the envelope type, p is the pulse amplitude or
the MIN value of data to the MAX value of data for each pulsation, c is the
centered or MIN value of data to the COG value for each pulsation, and d is
the difference between p and c or the COG value to the MAX value of data for
each pulsation [29].
TABLE II
D ISTRIBUTION OF M EASUREMENT E RRORS FOR S EVERAL AUTOMATIC BP D EVICES [34]
extends determination time which can contribute to patient population mean error, which would be no more than 5 mmHg
discomfort. With stepped deflation, the deflation rate is based for either systolic or diastolic pressure. If this assumption is
on the patient’s pulse rate, which results in a constant number false, and the errors tend to cluster within persons (i.e., the
of samples for all pulse rates—no more or no less than the spread of the errors within a single person is less than that
number needed for an accurate and comfortable determina- for the entire population), then as more readings are gathered
tion. However, unfortunately, the stepped-deflation oscillomet- on a particular person, the average error will converge toward
ric measurements are contaminated with the stepped deflation that person’s true error. If that person’s error is more than
artifact arising mainly from bleed valve switching [32]. 5 mmHg, the monitor will do a poor job of providing an accu-
The OBPMD accuracy is usually classified as static and dy- rate average for that person, no matter how many measurements
namic. The static accuracy represents the accuracy with which are taken [34].
the internal pressure gauge can measure constant values of the In order to empirically estimate the proportion of people
cuff pressure. The dynamic accuracy represents the accuracy of for whom a validated NIBP measurement device produces
the device in taking actual readings on patients [22]. inaccurate readings, the raw data from three published val-
Testing of OBPMDs is currently performed by two methods. idation studies on both auscultatory and oscillometric auto-
The first method adopts a commercial test equipment man- mated monitors, according to AAMI and BHS protocols, have
aged by biomedical technicians. There are several commercial been examined in [34]. Both auscultatory and oscillometric
NIBP measurement device test instruments on the market. automated monitors were assessed. In particular, the examined
Such instruments usually feature static functions and simulate auscultatory monitors were the Schiller BR-102 produced by
oscillometric waveforms [23]. The second method is directed Schiller AG, operating in auscultatory mode, and the CH-Druck
to assess the dynamic OBPMD accuracy. In this second ap- produced by Disetronic Medical Systems. The examined oscil-
proach, the characterization is based on the comparison of the lometric monitors were instead the Schiller BR-102, operating
BP measurements carried out by means of the device under in oscillometric mode, and the Profilomat II produced by Dis-
test and those performed with a sphygmomanometer and a etronic Medical Systems. In Table II, the obtained distribution
stethoscope. Several guidelines have been developed to ensure of measurement errors (that are the differences between the
process reproducibility, usually requiring recruitment of a large monitor and observer readings) is shown. In particular, the
number of volunteers, extensive range of BPs, and of arm CH-Druck and Schiller BR-102 instruments for both SBP and
circumferences [4], [23]. Although a protocol, coming from the DBP, as well as the Schiller BR-102 using the oscillometric
European Society of Hypertension (ESH), has been developed, mode for DBP only, were within the validation criteria. For
requiring a limited number of volunteers (33), a comparison those NIBP measurement devices that passed the standard test
of the developed protocols on statistical basis has shown that thresholds, 19%–36% of the individual readings had errors
the reduced sample size results in a reduction of statistical outside the range of −5 to +5 mmHg, while 4%–10% had
power which brings into question the applicability of the ESH errors exceeding 10 mmHg in magnitude [34]. For the monitors
protocol [33]. that passed the validation criteria, 20%–38% of individuals
Moreover, also NIBP measurement devices that meet the had average measurements that were inaccurate (by more than
validation criteria specified in the international standards and 5 mmHg), and 2%–5% of individuals had average measure-
protocols may still be inaccurate as discussed in [34]. In partic- ments that were inaccurate by more than 10 mmHg. Analysis
ular, the analyses carried out by these validation criteria assess of the individual errors, using repeated measure analysis of
only the distribution of errors across the specified number variance, yielded estimates of between-person variance that
of individual readings, not the distribution of average errors accounted for 26%–63% of the total variance. This indi-
observed on each of the recruited participants. Implicitly, this cated that the errors of the measurements do tend to cluster
approach assumes that there is no between-person variance, i.e., within persons. From the obtained results, the authors affirm
no tendency for the monitor to be more accurate for some per- that the current validation standards for ensuring accuracy
sons and less accurate for others. This means that the average are inadequate to ensure that individuals receive accurate BP
error for a single person is assumed to converge toward the measurements [34]. Moreover, a two-stage validation is
BALESTRIERI AND RAPUANO: INSTRUMENTS AND METHODS FOR CALIBRATION OF OBPMDs 2397
proposed, first, by validation at the population level and, sec- Moreover, the accuracy of measurements must be traced to
ond, by validation in the physician’s office for the intended user. an accepted measurement reference source or standard. This is
the requirement of “traceability” that, according to the VIM, is
V. NIBP T EST S IMULATORS the property of the result of a measurement or the value of a
standard whereby it can be related to stated references, usually
As discussed in [4], a unified approach for the calibration
national or international standards, through an unbroken chain
procedure with acceptable execution time and costs is still
of comparisons, all having stated uncertainties.
missing and required. Since BP simulators that regenerate os-
Therefore, metrological calibration main purposes are the
cillometric waveforms promise an alternative to clinical trials,
following: 1) to ensure the readiness of test equipment to
provided that they include sufficient physiological and patho-
perform accurate measurements and provide valid data; 2) to
logical oscillometric waveforms, they could possibly upgrade
limit the number of erroneous test decisions; and 3) to maintain
or replace the current test methods of the OBPMDs [23].
overall measurement integrity and traceability. This involves
Research work [23], [35]–[37] seems to support the future
the following requirements:
replacement of clinical study validation in favor of simulator
evaluation. In order to reach the status of standard, however, 1) a clearly defined particular quantity that has been
the NIBP simulators should overcome several limits in terms of measured;
differences in reproducing the BP values. A possible solution 2) a complete description of the measurement system or
could be a general agreement about the waveforms to generate working standard used to perform the measurement;
and to take them from physiological databases. Therefore, 3) a stated measurement result or value, with a documented
the “ideal” simulator should be provided by a comprehensive uncertainty;
database of physiological waveforms, a validation protocol that 4) a complete specification of the stated reference at the time
assesses its accuracy over comprehensive range of conditions that the measurement system or working standard was
and its independent verification [35]. compared to it;
In the following, the measurement requirements for NIBP 5) establishing the status of the stated referencing at the time
test simulators to be a reliable reference for calibrating that the measurement system or working standard was
OBPMDs, the current situation of NIBP test simulators as compared to it [39].
well as some of the last research contributions concerning
physiological waveform databases, modeling, and simulation The main function of an oscillometric NIBP simulator is to
are presented. dynamically reproduce the pressure profile of a live subject
during a BP measurement cycle [40]. This seems making
A. NIBP Test Simulator as a Reference Standard them capable of possibly upgrading or replacing the current
test methods of the NIBP measurement devices, removing
Metrological calibration involves the process of measure- their serious drawbacks. However, most commercial simulators
ments and comparisons of a measurement standard to either generate artificial waveforms that significantly differ from the
another measurement standard or a device of unknown accuracy physiological ones, making these devices usable only for NIBP
(unit under test). According to International Vocabulary of monitor static calibration. Moreover, different NIBP simulator
Metrology (VIM) [38], calibration is the set of operations that manufacturers use different ways to create the pulse pressure
establish, under specified conditions, the relationship between envelopes.
the values of quantities indicated by a measuring instrument
and the corresponding values realized by standards. Impor-
tant information to be assessed in this operation concerns the B. Current NIBP Test Simulators
following. Commercial NIBP test simulators were introduced, for the
1) Accuracy—“closeness of agreement between a mea- first time, in the early 1990s for testing and evaluating oscil-
sured quantity value and a true quantity value of a lometric BP monitors. Two different types of simulators have
measurand” [38]. been developed since then: the artificial limb and the waveform
2) Precision—“closeness of agreement between indications generator. Limb simulators consist of an artificial limb, usually
or measured quantity values obtained by replicate mea- an arm, which incorporates an artificial artery with pulsating
surements on the same or similar objects under specified fluid. In order to test the OBPMD, its cuff is wrapped around
conditions” [38]. the artificial arm. Waveform simulators generate oscillometric
3) Repeatability—“condition of measurement, out of a set waveforms fed to the pneumatic hose of the OBPMD under test.
of conditions that includes the same measurement pro- The latter type of simulators is predominantly used today [41].
cedure, same operators, same measuring system, same However, unlike limb-type simulators, waveform simulators are
operating conditions, and same location, and replicate not capable of taking into account the transfer function between
measurements on the same or similar objects over a short arterial pressure in the limb, air pressure in the cuff, the effects
period of time” [38]. of cuff bladder size, placement of the cuff, and the material
4) Reproducibility—“condition of measurement, out of a set from which the cuff is made of. These variables could only be
of conditions that includes different locations, operators, assessed by performing clinical validation on human subjects,
and measuring systems, and replicate measurements on since currently available commercial waveform simulators are
the same or similar objects” [38]. not able to replay realistic human signals [42].
2398 IEEE TRANSACTIONS ON INSTRUMENTATION AND MEASUREMENT, VOL. 59, NO. 9, SEPTEMBER 2010
is very stable [42], they are able to assess the measurement TABLE III
NIBP S IMULATOR T EST R ESULTS FOR H YPERTENSIVE S ETTING [47].
repeatability and reproducibility. SYS I S THE S YSTOLIC B LOOD P RESSURE , DIA I S THE D IASTOLIC
Basic procedures for evaluating an NIBP simulator assess- B LOOD P RESSURE , M EAS . MAP I S THE M EASURED M EAN A RTERIAL
ing its suitability and quality have been proposed in [42]. P RESSURE , C AL . MAP I S THE C ALCULATED M EAN A RTERIAL
P RESSURE , AND HR I S THE H EART R ATE
In static conditions, in fact, NIBP simulator performance is
almost always sufficient to provide a reference for BP mea-
surements. On the other hand, in dynamic conditions, there
are differences among different simulators. Therefore, both a
static calibration and a dynamic evaluation are proposed for
the NIBP simulator testing in [42]. In particular, in order to
evaluate a simulator, the process is divided into two parts. The
first part is evaluation under static conditions, which includes
static calibration, repeatability, and reproducibility tests of its
transducer. The second part includes dynamic testing of the
simulator to determine the stability of simulator output and
qualitatively assess the stability of the generated oscillometric
envelope shape, dependence of the envelope from the generated
pressure magnitude and heart rate, etc. [42].
However, since commercial simulators generate specific
shapes of pressure signals, a simulator output cannot always
be a good enough reference for the calibration. NIBP mon-
itors can only be calibrated (in terms of determining NIBP
monitor accuracy) using a certain, suitable, and prescribed
simulator [42].
In [47], a protocol to test the performance limits of five
NIBP simulators of different brands, most commonly used by
NIBP developers, medical monitoring companies, and biomed-
ical engineering departments throughout the world, by using
ten Advantage Model 2 OEM NIBP modules produced by
Suntech Medical, is presented. Performance limits have been
provided for both measured and calculated MBPs for four
preset simulations: hypotensive, normotensive, hypertensive,
and a neonatal setting. Each simulator setting was performed
three times per module for a total of 30 simulations per setting.
Statistical analysis was done by calculating the mean (average)
and standard deviation of SBP, DBP, and MBP for each group
of 30 simulations. The mean shows the shift from the target
value, and the standard deviation was used to determine the
span between the minimum and maximum limits. Low-quality
NIBP simulators have wider hypertension limits, and high-
quality NIBP simulators have tighter limits [47]. In Table III,
test results for hypertensive setting are shown. According to the
results, the authors of the paper recommend Fluke Biomedical
Cufflink and the Clinical Dynamics SmartArm. The Bio-Tek
BP Pump is also considered an acceptable instrument, but is
no longer commercially available, while the Fluke Biomedical
BP Pump 2 and the Metron QA-1290 are not recommended
since they present, respectively, maximum standard deviations
of 3.72 and 5.04 for the SBP [47].
Fig. 7. (Top) Human signal, Morlet wavelet, SBP = 83 mmHg, DBP = 58 mmHg, HR = 74 bpm, and CuffLink signal. (Bottom) Morlet wavelet, SBP =
80 mmHg, DBP = 50 mmHg, and HR = 80 bpm [51].
pulses at certain pressure levels; and 3) to form BP profiles, forms (built into the machine) [51]. In order to investigate
studied by fuzzy sets determined by neural networks [49]. A such difference, in [51], five oscillometric waveforms have been
lot of research work deals with the application of the wavelet captured from real patients with a variety of measured BPs and
transform to the arterial BP signal analysis [49], [50], since compared with five oscillometric waveforms produced with a
wavelets have finite duration (compact support) as contrasted CuffLink simulator. In each case, the CuffLink simulator has
with Fourier methods based on sinusoids of infinite duration been configured in order to achieve the best match between the
[50]. Owing to the wavelet transform, it has also been possible simulated and the measured waveform [51]. Then, the analysis
to discern between human and simulated oscillometric wave- using continuous wavelet transform has been performed us-
forms to understand better the limitations found in current BP ing MATLAB wavelet toolbox. In Fig. 7, an example of the
simulators [51]. achieved results is reported showing a pair of human/simulated
In particular, considering that the random fluctuations in signals. The authors affirm that the most noticeable differences
the human body’s physiology are not modeled and reproduced were observed with a Morlet mother wavelet, in the ranges of
by a simulator, the presence of these fluctuations can serve scale 41–53 as well as 17–33. By observing Fig. 7, in fact, the
as a means to differentiate between real and machine-made repetitive pattern of the machine-generated signal—nearly iden-
oscillometric waveforms. tical for each heart beat—is readily observable. On the human-
In fact, the signals contained within each pulse period of generated signal, instead, there are clear variations of the
a machine-made signal (between two successive oscillometric position of the transform peaks with respect to scale. This indi-
waveform peaks) are some combination of scaled stored wave- cates some beat-to-beat variation that the machine is not capable
BALESTRIERI AND RAPUANO: INSTRUMENTS AND METHODS FOR CALIBRATION OF OBPMDs 2401
of generating. These variations are most prominent at the larger These are, in fact, amplified for the purpose of displaying
scaling factors, which are related to lower frequency compo- on the oscilloscope. If the true amplitudes for these signals
nents. These variations were present in all five human wave- were to be employed instead, it would create problems due to
forms tested but absent in all machine-generated signals [51]. their small values, compared with the system noise. A linear
Recently, it has been shown that certain important patterns approximation routine was created for each physiological signal
can be discovered by observing a few dominant harmonics of for the purpose of scaling the amplitudes, with the exception
the arterial BP waveforms, acquired using a catheter–transducer of the electrocardiogram. The user can vary the systolic and
pressure measuring system [49]. In particular, there are two diastolic pressures of the arterial BP in the ranges of 90–106
major harmonics at work with all patients and all data sets and 50–65 mmHg, respectively [54].
considered in the paper. These two harmonics represent a total Various BP simulators have been proposed to evaluate and
of about 92% of the total energy of the arterial BP signal and improve the performance of an automatic sphygmomanometer
have been verified by analysis using Matlab. The power density [55]. However, as shown before, the pressure pulse waveform
is distributed to the first and second harmonics in such a manner produced in the automatic sphygmomanometer differs from
that the system seems to keep the total percentage of energy in the actual pulse produced in the human body. In general, it
the first and second harmonics stable and constant. is very difficult to reproduce the very low BP waveforms
Through the years, several contributions dealing with physio- using a fluid flowing in low-pressure tubes such as blood
logical signal models and simulators, coming from the research, in the human vessels [55]. To overcome such limitation, an
have been developed. improved simulator has been proposed in [55], including an
Nonlinear models for generating realistic BP signals [52], artificial arm model capable of feeding appropriate fluids that
also providing the generation of 24-h versions of them [53], can generate the BP waveform to test the full range of the
have been proposed. In particular, model parameters are ini- automatic sphygmomanometer. The schematic diagram of the
tialized using realistic distributions that can be modified so BP simulator is shown in Fig. 9. First of all, the oil used to
that different seeds produce different but repeatable biomedical transmit the pressure wave is sent to a pressure tank using a
signals. Since each of the parameters of each model has a circulation pump, and then, pressure is applied to the oil using
very clear physiological meaning, the performance of signal a compressor. The pressurized oil flows from the tank into a
processing algorithms (such as how they respond to specific pipe through a proportional control valve. The pressure wave
changes or contaminants) can be tested on a variety of artificial in the pipe is produced by opening and closing of the valve.
biomedical time series and may aid the teaching of the under- The fluid flows also in the vessels of an artificial human arm
lying mechanisms [53]. Moreover, open source C, Matlab, and manufactured with silicon, which is connected in parallel with
Java codes for these models are available from Physionet. the pipe, and then, it flows through a thin tube connected to the
A smart physiological signal simulator that is capable of end of the pipe and is stored again in the tank. The pressure
generating and displaying five physiological signals (electro- of the fluid flowing in the artificial arm is controlled in order
cardiogram, arterial BP wave, pulmonary artery wave, airway to reproduce the human BP, by means of a closed loop using a
pressure signal, and the phonocardiogram) onto an oscilloscope pressure transducer to monitor the pressure in the pipe.
has been proposed in [54] for didactic aims. It does this by The work described in [56], funded by the project of “The
first generating the physiological signals on a microcontroller establishment of new measurement standards for demands”
by linearly approximating their amplitudes and then generating from the Korean Research Institute of Standards and Science
the signals in real time for the oscilloscope using a high- (KRISS), developed a BP simulator for the monitoring of OBP-
speed multiplexing hardware interface. Fig. 8 shows the high- MDs and compared this KRISS simulator with commercial
level block diagram of the simulator. The microcontroller user simulators. The simulator consisted of a stepping motor, a lever
interface consists of standalone switches that are used as an assembly, a bellows, and a pressure transducer. To check the
alternative to control the simulator, and the microcontroller-to- accuracy of the proposed system, a pressure gauge was used
oscilloscope interface is the electronics used to produce phys- as a reference (Digiquartz/model No.6000-15G, Paroscientific
iological signals for displaying purposes. A series of lookup Inc.) having an error below 0.01% and traceable to the national
tables is used to generate the physiological signals that the user standard of Korea by the authors themselves. The measured
will view on their PC or oscilloscope. Each lookup table is signal was digitized (model No. 6671-003, Paroscientific Inc.)
200 bytes long and describes the digital equivalent of the analog and recorded in a notebook computer. The data acquisition
amplitude representation for each of the physiological signals. was controlled by a software written in LabView. From the
2402 IEEE TRANSACTIONS ON INSTRUMENTATION AND MEASUREMENT, VOL. 59, NO. 9, SEPTEMBER 2010
results, authors concluded that the simulator could work accu- Digital recordings are ideal for these purposes [57]. By making
rately for pressure generation because the simulator showed a well-characterized clinical data available to researchers, these
relative repeatability error below 0.1%, which was defined as databases make it possible to formulate and answer numerous
the ratio between the standard deviation and the average value physiological questions, without the necessity of developing a
of the generated pressure signals [56]. The KRISS simulator new set of reference data [57]. In 1999, researchers at Boston’s
was compared with three commercial simulators by controlling Beth Israel Deaconess Medical Center, Boston University,
each device to generate a systolic pressure of 120 mmHg, a McGill University, and MIT inaugurated Physionet, a Web site
diastolic pressure of 80 mmHg, and a pulse rate of 75 beats for the biomedical research community, under the auspices
per second. For this comparison, a commercial OBPMD (model of the National Center for Research Resources of the U.S.
770A, Omron Co.) was connected to the four simulators under National Institutes of Health [58]. PhysioBank, one of the three
test, and each value of BP was recorded five times for each Web site components, is a database collection of a variety of
simulator. The results showed that each simulator generated digitized physiological signals. It includes the Multi-parameter
different values in spite of the same conditions and same Intelligent Monitoring for Intensive Care II database, providing
OBPMD. The authors suppose this difference due to the dif- nursing data from over 30 000 patients, together with high-
ference both in accuracy of pressure sensors adopted in each resolution waveform data (mainly electrocardiogram and
simulator and in the algorithms used in each simulator for signal arterial BP) from over 2700 of these patients. Unfortunately,
generation [56]. oscillometric BP waveforms are not included in the collection
Finally, the measurement repeatability of six models of com- yet [23].
mercial OBPMDs from five companies using the KRISS simu- A database of validated oscillograms is one of the objec-
lator was investigated, too. In particular, the KRISS simulator tives of the EU project “Simulator for NIBP” [35], [59]. This
was controlled to generate two conditions: 1) systolic pressure European Commission funded multicenter study is aimed at
of 120 mmHg—diastolic pressure of 80 mmHg—pulse of 75 developing an NIBP simulator that is able to reproduce realistic
and 2) systolic pressure of 150 mmHg—diastolic pressure of BPs, based on a library of prerecorded waveforms from a range
94 mmHg—pulse of 75. The measurement was then conducted of patient groups. This digital database shall represent typical
five times for each condition. For each measurement, the max- oscillations taken for representative groups of subjects, due to
imum pressure difference was 8 mmHg for condition 1). The age, sex, disease, measuring conditions (rest, movement, venti-
authors suppose this difference due to the different algorithms lated, etc.), and artifacts (from the patient or the environment)
of BP simulators adopted by each manufacturer to calibrate [59]. At 2006, more than 1000 signals from more than 600
each OBPMD. This hypothesis seems to be borne out by similar subject were gathered [35].
results shown by two models from the same company [56]. The concept of oscillometric pulsation waveform database,
The authors expect to develop a BP simulator for Korean by allowing the test of various algorithms aiming to characterize
the collection of clinical data from the Koreans [56]. the oscillometric BP waveforms in order to distinguish between
healthy people and people with cardiovascular problems (ar-
teriosclerosis, etc.), has been introduced in [31]. The concept
D. Physiological Waveform Databases
is based on oscillometric data retrieving during cuff deflation
Researchers, developers, and evaluators of algorithms and and on reference BP measurements by auscultation. The data
systems for the physiological data analysis require physiolog- which are collected about each of the considered patients are,
ical signal databases as essential resource [57]. Testing proce- e.g., date and time of measurement, age, gender, height, weight,
dures, in fact, need to operate on realistic data and to satisfy diagnosis and medication of the measured person, auscultation
repeatability and reproducibility requirements to establish if an and oscillometric values of BP, etc. Together with the data,
observed difference in the results can be due to a difference in oscillometric pulsations and cuff pressure are saved into the
the objects under test or to a difference in the input data. database [31].
BALESTRIERI AND RAPUANO: INSTRUMENTS AND METHODS FOR CALIBRATION OF OBPMDs 2403
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using a blood pressure simulator,” J. Hum. Hypertens., vol. 19, no. 3, degree (with honors) in electronic engineering and
pp. 197–203, Mar. 2005. the Ph.D. degree in computer science, telecommu-
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for the functional evaluation of oscillometric non-invasive blood pressure University of Salerno, Salerno, Italy.
monitors,” J. Med. Eng. Technol., vol. 19, no. 5, pp. 162–176, Sep. 1995. Since 2002, he has been an Assistant Professor of
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Spacelabs 90207 non-invasive blood pressure monitors using a test simu- of Engineering, University of Sannio, Benevento,
lator,” J. Hum. Hypertens., vol. 11, no. 3, pp. 163–169, Mar. 1997. Italy. His research interests include digital signal
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limits with the advantage OEM NIBP module series,” Eynsham, U.K., data-converter characterization, distributed measure-
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Everett, WA, 2007. [Online]. Available. http://news.fluke.com/busen/ Society TC-10, Secretary of the TC-23 Working Group on e-tools for Education
home/default.htm in Instrumentation and Measurement, and the Cochairman/Official Reporter
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pressure system modeling and signal analysis,” in Proc. IEEE Int. Symp. was the recipient of the IEEE Instrumentation and Measurement Society
Comput. Intell. Robot. Autom., Jacksonville, FL, Jun. 2007, pp. 386–391. Outstanding Young Engineer Award in 2007.