Device and technology report
Validation of the Mindray VS9 Vital Signs Monitor in a
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1
combined adult and pediatric population according to ISO
Standard 81060-2:2018
Na Guoa,  *, Yihan Zhanga,  *, Weiqiang Chena, Hexian Zhongb, Liping Lia,
Hanbin Xiea, Wenxiu Zhua, Jun Liua and Shangrong Lia
We aimed to validate the accuracy of the Mindray
VS9 Vital Signs Monitor, which features the Mindray
TrueBP inflation algorithm for oscillometric blood
pressure (BP) measurement, to check if it complies
with the International Organization for Standardization
Standard (ISO 81060-2:2018) in a combined adult and
pediatric population. A total of 86 participants, including
both adult and pediatric subjects, were recruited. The
distribution of their ages, gender, BPs and limb sizes
all complied with the requirement of the ISO standard.
The inflation and deflation algorithms were validated
independently using the same-arm sequential BP
measurement method. For each subject, the BP was
first determined by two independent observers using
a mercury sphygmomanometer (R1). The BP of the
subject was then determined by the third observer
using the test equipment (T1). Then, using a mercury
sphygmomanometer, two independent observers were
asked to determine the subject’s BP (R2) again. R1-T1-R2
were considered a valid pair of data. This cycle continued
until 3 pairs of valid data were achieved. We collected 258
pairs of valid BP data for the validation of the inflation
and deflation algorithms respectively. For validation
Criterion 1, the mean ± SD of the differences between
the readings obtained from the test device and reference
BP was 0.0 ± 6.6/−1.8 ± 7.1 mmHg (systolic/diastolic)
when the deflation algorithm was used, and 2.4 ± 6.3/
Introduction
Non-invasive blood pressure (BP) monitoring using the
oscillometric method is the most common form of BP
estimation in use in the general clinical setting. This
method indirectly estimates BP by applying a specific
algorithm, which is derived from clinical experience [1].
Most devices use the deflation method of measurement,
in which the device inflates the cuff to a preset pressure,
and then gradually deflates the cuff. The preset pressure
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0.3 ± 6.9 mmHg (systolic/diastolic) when the inflation
algorithm was used. For validation Criterion 2, the SD
of the averaged BP differences between the test device
and the reference BP per subject was 5.35/6.33 mmHg
(systolic/diastolic) when the deflation algorithm was used,
and 5.17/5.75 mmHg (systolic/diastolic) when the inflation
algorithm was used. The VS9 Vital Signs Monitor fulfilled
all the criteria in the ISO Standard. Moreover, the inflation
algorithm had a shorter Measure Time (by 7–21 s) and
lower maximum inflation pressure (by 9.7–22 mmHg). The
VS9 Vital Signs Monitor fulfilled all the requirements of
the ISO Standard (ISO 81060-2:2018) in a combined adult
and pediatric population and is recommended for clinical
use. Blood Press Monit XXX: XXXX–XXXX Copyright ©
2024 Wolters Kluwer Health, Inc. All rights reserved.
Blood Pressure Monitoring XXX, XXX:XXXX–XXXX
Keywords: inflation algorithm, non-invasive blood pressure, oscillometry
a
Department of Anesthesiology, The Third Affiliated Hospital of Sun Yat-sen
University, Guangzhou and bShenzhen Mindray Bio-medicical Electronics Co.,
LTD., Shenzhen, Guangdong, China
Correspondence to Shangrong Li, MD, PhD, Department of Anesthesiology,
The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong
510630, China
Tel: +86 020 85253132; fax: +86 020 87580867;
e-mail: lishangr@mail.sysu.edu.cn
*Na Guo and Yihan Zhang contributed equally as first authors of this work.
Received 29 February 2024 Accepted 4 March 2024.
is generally higher than the patient’s systolic pressure,
and there is a risk of over-inflation, which may hinder
limb circulation, especially during repeated measure-
ment in children [2]. In recent years, a new algorithm
has been developed to estimate BP during cuff inflation
(inflation method). The inflation method takes less time
to obtain BP readings and is equally accurate [2,3].
Validating the accuracy of BP measurement is of utmost
importance before the clinical application of novel mon-
itoring devices, especially in special populations, such as
children between 3 and 12 years old. This study applies
an ISO Standard (ISO 81060-2:2018) to evaluate the
the Creative accuracy of the oscillometric BP measurement device
4.0 (CCBY-
VS9 Vital Signs monitor (Mindray, Shenzhen, China),
provided it is
commercially which uses the Mindray TrueBP inflation algorithm, in a
combined adult and pediatric population.
DOI: 10.1097/MBP.0000000000000704
 2 Blood Pressure Monitoring XXX, Vol XXX No XXX
Methods
Test device
The VS9 Vital Signs monitor is an automated oscillo-
metric BP monitor intended for use in adults and chil-
dren. The device is equipped with 4 sizes of cuffs for
limb circumferences 18–26 cm, 25–35 cm, 33–47 cm, and
46–66 cm. The test devices were operated according to
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the manufacturer’s instructions.
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Participants
The participants were recruited from The Third
Affiliated Hospital of Sun Yat-sen University (Guangzhou,
Guangdong, China) and The First Affiliated Hospital
of Jinan University (Guangzhou, Guangdong, China).
A total of 86 subjects (51 adults or adolescents aged 12
years or above, and 35 children aged 3 to 12 years old,
64% of whom were male and 36% female) were enrolled
in this trial.
Validation team
The study was conducted by a supervisor and 2 trained
observers, all of whom were experienced in BP measure-
ment research. They underwent a process of standardi-
zation for closer agreement on BP measurements before
the study began. During the study, each observer was
blinded to the extent or nature of their potential disa-
greement, as described in the ISO standard [4].
Reference BP
A stethoscope with dual earpieces was used by two
experienced independent double-blind observers.
A sphygmomanometer (Desktop manometer, Yuyue
Medical Instruments, Jiangsu, China), calibrated by the
manufacturer and inspected by the metrology institute
(Supplementary File 1, supplemental digital content 1,
http://links.lww.com/BPMJ/A217), was used to provide
simultaneous reference measurements of auscultatory
SBP and DBP. The inflatable bladder dimensions of the
4 cuffs were 9.8 cm × 18 cm, 13.1 cm × 23.5 cm, 16.5 cm
× 32 cm and 20.5 cm × 38 cm. With the exception of the
maximum cuff, all of the other cuffs meet the require-
ments in the ISO standard that the bladder length could
cover 75–100% of the circumference of the limb, and the
bladder width should cover 37–50% of the circumference
of the limb. Korotkoff K5 was used to determine the
DBP value.
Procedure
BP data were collected using the same-arm sequential
method described in the ISO standard [4]. At the begin-
ning of the procedure, the circumference of the chosen
limb of the subject was measured to determine which
cuff to use. The subject was kept in a comfortable posi-
tion and at rest for 5 min before the first measurement.
Specifically, if the upper arm was measured, we would
have the subject seated with his/her legs uncrossed
and feet placed flat on the floor and have the measured
arm supported at the heart level. If the lower limb was
measured, the subject would lie down on a bench and
maintain the measured limb at the same level as their
heart. During measurement, subjects did not speak or do
anything that might cause BP fluctuation. Each subject
participated in two independent rounds of trial, being
inflation measurement trial and deflation measurement
trial. The subjects rested for at least 5 min between the
two measurements.
Each round of the trial included several cycles. The ini-
tial cycle (R0) measured baseline BPs by auscultation
and using the test device. Data from this cycle were dis-
carded. After that, BP was measured on the same limb
cross-sequentially by auscultation and the test device.
First, two auscultatory BP readings (R1) measured by 2
experienced observers; then the BP measured by the test
device (T1) using the inflation algorithm or the deflation
algorithm; then another 2 auscultatory readings (R2). The
intervals between the two measurements exceeded 60 s.
The cycle continued until there a set of 3 pairs of valid
data points (R1-T1-R2, R2-T2-R3, R3-T3-R4, etc.) was
obtained.
The criteria for valid data were as follows. If the observ-
ers measured a difference greater than 4 mmHg in SBP
or DBP, the data were excluded. If any two systolic
pressure values measured using the reference method
on the same subject differed by more than 12 mmHg,
the data were excluded. If any two diastolic pressure
values measured using the reference method on the
same subject differed by more than 8 mmHg, the data
were excluded. If the data did not meet the require-
ments, more cycles of measurement were taken until
there were 3 pairs of valid data, or until a maximum of 8
cycles of measurement had been performed on a single
subject.
Analysis
Data analysis was performed following both criteria 1 and
2, as required in the ISO Standard (ISO 81060-2:2018).
Study approval
The study protocol was approved by the Institutional
Review Boards (IRBs) of both medical centers. All the
adult participants (≥18 years old) signed the informed
consent form. Three versions of informed consent, with
appropriate diction, were designed for children aged 3
to 7 years old, children/adolescents aged 8 to 17 years
old, and adults. All consent forms and wordings were
reviewed and approved by the IRBs. The informed con-
sent forms for child subjects aged 3 to 7 were signed by
their legal guardians; minors aged 8 to 17 signed their own
names together with their guardians. This conduct was in
accordance with the Good Clinical Practice regulations
issued by National Medical Products Administration of
 Validation of the Mindray VS9 Vital Signs Monitor Guo et al. 3

China; it also complies with ICH E6(R3) Good Clinical
Practice guidelines.
Results
Eighty-six participants were enrolled. Their composition
met all the requirements for age, gender, BP, and cuff
distribution in the ISO standard. The participants’ char-
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presented in Table 3. A normalized Bland-Altman scat-
ter plot of the difference in test-reference BP relative to
their mean is shown in Fig. 1.
In addition to verifying the test data, we also compared
how long the measurement took (Measure Time), and
the maximum inflation pressure for each BP reading

(Table 4). Measure Time for the inflation algorithm was

acteristics are presented in Supplementary File 2, sup- 7–21 s faster than measurements taken using the defla-
plemental digital content 2, http://links.lww.com/BPMJ/
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tion algorithm. The maximum pressure in the cuff dur-

A218. The reference BP distribution and the test group ing inflation algorithm measurements was 9.7–22 mmHg
percentages for each range are shown in Table 1. lower than for the traditional deflation procedure.
The absolute difference between observers is
1.41 ± 1.34/1.47 ± 1.38 mmHg (systolic/diastolic, range Discussion
0 to 4 mmHg). The validation and analysis of the defla- The oscillometric method is widely used for automated
tion and inflation measurements are shown in Table 2. BP estimation [5]. Most devices that use the oscillo-
They are compliant with Criteria 1 and 2 requirements. metric method to measure BP inflate the cuff quickly
Validation for Criterion 1 for the 35 child participants is to a predetermined pressure, then gradually deflate
and collect oscillating waveforms until the BP can be
Table 1 Reference blood pressure distribution requirements calculated. Calculating BP during the inflation of the
Systolic reference blood pressure distribution requirements
cuff would offer several advantages, however, there are
technical difficulties in developing an inflation algo-
≤100 mmHg ≥160 mmHg ≥140 mmHg
5% of data 5% of data 20% of data rithm. For example, an ideal inflation procedure should
Requirement points points points include adjusting the speed of the air-pump to keep
Percentage of Deflation 30.6% 12.2% 22.3%
the pressure stable when different cuffs are used. To
data Inflation 31.4% 11.2% 21.1% date, only two inflation procedures have been devel-
Fulfills requirement Yes Yes Yes oped: one by Welch Allyn SureBP [2], and one by
Diastolic reference blood pressure distribution requirements Nihon Kohden Corporation [6,7]. Mindray TrueBP is
≤60 mmHg ≥100 mmHg ≥85 mmHg
a novel non-invasive BP measurement algorithm based
5% of data 5% of data 20% of on inflation procedure. In this study we validated its
Requirement points points data points accuracy in a combined adult and pediatric population,
Percentage of Deflation 33.5% 13.0% 20.5% and provided new information on the safety and accu-
data Inflation 32.4% 11.8% 21.9% racy of the algorithm in children aged between 3 and
Fulfils requirement Yes Yes Yes
12 years old.
Inflation speed is a major factor affecting measure-
Table 2 Validation results of the whole group
ment accuracy [8]. The slower the inflation measure-
ment speed, the higher the accuracy, but the longer the
Achieved
Measure Time. To minimize Measure Time while still
Pass requirement SBP DBP
keeping measurement error within the range required
Criterion 1 (258 comparisons) by the ISO standard, the TrueBP algorithm is used with
Mean BP ≤5 0.0 (Deflation) −1.8 (Deflation)
2.4 (Inflation) 0.3 (Inflation)
an inflation speed of 10 mmHg/s. At this rate, the average
difference
(mmHg) Measure Time for the TrueBP inflation measurement
SD (mmHg) ≤8 6.6 (Deflation) 7.1 (Deflation) is significantly shorter than for the deflation procedure,
6.3 (Inflation) 6.9 (Inflation)
Pass Pass and the accuracy of BP readings is still acceptable.
Criterion 2 (86 subjects)
SD (mmHg, ≤6.95/6.71 (Deflation) 5.35 (Deflation) 6.33 (Deflation) Over-inflation of the cuff during traditional deflation
SBP/DBP) ≤6.51/6.95 (Inflation) 5.17 (Inflation) 5.75 (Inflation) measurements may lead to patient discomfort and even
Pass Pass
Result Pass
serious ischemic or thrombotic complications [9]. In this
study, we evaluated the maximum inflation pressure and
found that using the Mindray TrueBP algorithm allowed
for significantly lower maximum inflation pressures than
Table 3 Validation results of the children subgroup (criterion 1) when using a deflation procedure. This improved clinical
Mean SBP Mean DBP safety, especially in adults and children with poor toler-
Number of comparisons difference ± SD difference ±
collected Method (mmHg) SD (mmHg)
ance or poor vascular status. Nevertheless, to ensure the
reliability and safety of the monitor, the VS9 monitor will
105 Deflation 1.99 ± 6.05 −0.99 ± 7.2
Inflation 2.40 ± 6.32 0.26 ± 6.88
automatically switch to the deflation mode to obtain the
BP when excessive artifacts are detected which could
 4 Blood Pressure Monitoring XXX, Vol XXX No XXX

Fig. 1
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Standardized Bland-Altman scatterplots of the Test-Reference BP differences against their average. (a) SBPs with deflation algorithm; (b) DBP with
deflation algorithm; (c) SBPs with inflation algorithm; (d) DBP with inflation algorithm.

Table 4 Comparison of the measure time and maximum inflation pressure between deflation and inflation algorithms
Average measure time (s) Maximum Inflation Pressure (mmHg)
Systolic pressure Deflation Inflation Deviation of Deflation Inflation Deviation of maximum
distribution (mmHg) measurement measurement measure time (s) measurement measurement inflation pressure (mmHg)

<100 25.8 11.7 14.1 124.3 108.4 15.9

100–109 26.5 13.3 13.2 137.9 121.0 17.0
110–119 29.3 17.0 12.3 146.1 131.8 14.3
120–129 29.1 15.2 14.0 158.1 140.9 17.2
130–139 32.4 21.2 11.2 163.5 153.8 9.7
140–149 38.8 17.5 21.3 180.4 160.8 19.6
150–159 34.1 20.2 13.9 192.9 170.2 22.7
160–169 30.2 18.5 11.7 194.4 178.5 15.9
170–180 26.5 19.7 6.8 205.7 184.8 20.8
>180 32.0 21.0 11.0 219.0 197.0 22.0
Average time 28.8 15.2 13.6 148.9 132.7 16.2

cause inaccurate results. However, we did not observe
any mode transitions during this study.
There are several points we would like to address. First,
the bladder size of the maximum reference cuff is
20.5 cm×38 cm. This cuff is mainly used when measuring
BP in the thighs, and it could not meet the width require-
ment (37–50%) stated in the ISO standard. The ausculta-
tory readings can be inaccurate when using this maximum
cuff. This is a common issue for manufacturers worldwide
since people with large limb circumference are often obese
and the limb length is short relative to the circumference
[10]. Tronco-conically shaped cuffs may better fit the arm
shape of these people, but are not available with our refer-
ence sphygmomanometer. The intra-arterial measurement
could be considered as the gold standard for reference BP
measurement in this population, but this method has its
own methodological pitfalls in comparison with cuff-based
BP measurements [10]. In addition, the majority of the sub-
jects in this study were healthy volunteers, so arterial cath-
eterization without therapeutic purposes remains to be an
ethical concern. Therefore, we did not choose this method.

Secondly, no children in this study fell in the hypertension
categories ≥140 mmHg and ≥160 mmHg, posing a potential
risk of data imbalance. However since there is no specific
requirement in the ISO standard for hypertensive pediatric
cases, we did not intentionally recruit such subjects. And
we did not come across any hypertensive children during
recruitment. Oscillometric devices have been demon-
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strated to be suitable alternatives to auscultation for initial
BP screening in the pediatric population [11], but the vali-
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dation reports of novel devices in children are still relatively
scarce. During the last five years, only a few studies vali-
dated novel BP monitoring devices in children [12–14]. We
are pleased that our study can somehow serve to fill this gap.
Finally, although 6 subjects over 60 years old were enrolled
in this trial, accounting for 11% of the adult subjects, the
number of elderly subjects in this special subgroup is insuf-
ficient to draw an ‘accurate’ conclusion. However, from the
perspective of safety and applicability, we can deduce from
the data of the adult population that it is preliminarily used
for people over 65 years old. We will collect more data from
the application of this device in the future.
Conclusion
Mindray VS9 Vital Signs monitor fulfills the accuracy cri-
teria of the ISO Standard (ISO 81060-2:2018) in adults
and children and can be recommended for clinical use.
TrueBP technology incorporated in VS9 can significantly
reduce the Measure Time for non-invasive BP measure-
ment without sacrificing accuracy.
Acknowledgements
Conflicts of interest
There are no conflicts of interest.
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