Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol
Phase: NA
Conditions: Blood Pressure
Sponsor: Hoon-Ki Park

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
1 
 
Study protocol and Statistical Analysis Plan 
 
Clinical evaluation of sphygmomanometer 
BN1(Bionet BNiBP module) according to ISO 
81060-2:2018 protocol 
 
Clinical Research Ethics Review Committee :  
Hanyang University Seoul Hospital IRB(Institutional Review Board) 
(IRB File No. HYUH 2020-02-034) 
Principal Investigator : Park, Hoon Ki 
02-2290-8740, hoonkp@hanyang.ac.kr 
 
 
December 7th, 2020 
Hanyang University Seoul Hospital 
Department of Family Medicine 
222-1, Wangsimni-ro Seongdong-gu, Seoul, Korea (04763) 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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Index 
1. Name and address of the clinical trial institution  ............................................................................ 3 
2. Purpose and background of clinical trials  ............................................................................................ 3 
3. Medical device information for clinical trials  ...................................................................................... 3 
4. indication  ............................................................................................................................................................. 7 
5. Research period ................................................................................................................................................ 7 
6. Method of clinical trial  .................................................................................................................................. 7 
6-1. Study subjects  .......................................................................................................................................... 7 
6-2. Research method overview  ................................................................................................................ 9 
7. Observation items, clinical examination items, and observational examination methods 
.......................................................................................................................................................................................13 
8. References ...........................................................................................................................................................16 
 
 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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1. Name and address of the clinical trial institution 
 Department of Family Medicine, Hanyang University Seoul Hospital / 
222-1, Wangsimni-ro Seongdong-gu, Seoul, Korea (04763) 
 
2. Purpose and background of clinical trials 
 A blood pressure monitor is a basic medical device that is essential for diagnosing cardiovascular 
diseases, and its importance is very high. Most of the electronic sphygmomanometer equipment or 
modules (components) used in Korea are foreign products. Recently, a new electronic 
sphygmomanometer module was developed by Bionet, a domestic company, and has been 
approved by the Ministry of Food and Drug Safety and is being applied to clinical practice. In order 
for a blood pressure monitor to be used as a medical device for diagnosis of various diseases, it is 
important to test the accuracy of blood pressure to know the exact degree of blood pressure 
measurement. In this study, a clinical study was conducted to investigate the performance of the 
equipment using the auscultation method used as a reference (gold standard) for non-invasive 
blood pressure measurement (NIBP) at the Department of Family Medicine at Hanyang University 
Hospital and the newly developed equipment at the same time. We want to help the industry. 
 
3. Medical device information for clinical trials 
 3-1. Medical device in test  
- 
Name/code name of drug/device/procedure method: BM5 with BN1 (BNiBP) (Bionet Co., 
Ltd., Korea) 
- 
Item name: Patient monitoring device 
- 
Purpose and efficacy: Displays biometric information such as electrocardiogram (ECG), 
non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature 
(TEMP), blood oxygen saturation (SPO2), and respiration (RESP) on the screen. It is a 
monitoring device that analyzes blood pressure values during vital sign measurement 
and displays Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP). 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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- 
 Other functions of BM5 are disabled and only the performance of NIBP function is 
evaluated. 
- 
 
- 
Cuff Specification and Method 
Cuff Type 
A Cuff (V0014C) 
B Cuff (V0013C) 
C Cuff (V0012C) 
Pictures 
Available arm 
circumference range 
27.5 ~ 36.5 cm 
20.5 ~ 28.5 cm 
13.8 ~ 21.5 cm 
Pictures 
Explanation 
-  The cuff is wrapped around the arm of the 
subject to be measured. 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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- When you press the NIBP operation button of 
the BM5, blood pressure measurement starts 
automatically. 
-(If necessary) If you press the NIBP operation 
button while measuring blood pressure, blood 
pressure measurement is stopped. 
 
- When blood pressure measurement is finished, 
the result value is displayed at the bottom of the 
BM5 screen. 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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3-2. Auscultational measuring tool to be used as a reference 
- 
2 stethoscopes (connected to Y-piece or T-piece):  
Pictures 
Explanation 
- Product Name: Littmann Classic 2 
- Manufacturer : 3M | Littmann 
- Connect two stethoscopes with a T-piece 
so that two nurses required by the protocol 
can measure simultaneously. 
- 
Aneroid sphygmomanometer :  
Pictures 
Explanation 
 
 
- Product Name: Greenlight 300 
- Manufacturer: ACCOSON 
- 
Measurement 
method: 
non-mercury 
auscultation method 
- Shown to be compliant with the US standard for non-automated sphygmomanometers, 
 ANSI/AAMI SP9:1994, and has been approved by the FDA (K040410). 
- It has also been shown to be compliant with the European standards EN1060-1, EN1060- 
 2 and EN1060-3. 
- Approved by British Hypertension Society (www.dableducational.org) 
- 
Hose 
Pictures 
Explanation 
- A hose from one cuff to both the 
electronic sphygmomanometer and 
auscultation sphygmomanometer 
- Length: 2M 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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- 
Cuff Specification 
Cuff Type 
A Cuff (V0014C) 
B Cuff (V0013C) 
C Cuff (V0012C) 
Pictures 
Available arm 
circumference 
range 
27.5 ~ 36.5 cm 
20.5 ~ 28.5 cm 
13.8 ~ 21.5 cm 
 
4. Indication 
Normal blood pressure/Attention blood pressure/Pre-hypertension/Hypertension 
 
5. Research period 
From IRB approval to October 31st, 2021 
 
6. Method of clinical trial 
6-1. Study subjects 
      [Selection Criteria] 
- 
- Subjects who have consented to participate in the clinical trial and voluntarily consented 
in writing 
- 
- Subjects who meet the criteria presented in ISO 81060-2:2018 Protocol 5.1 Subject 
requirements 
◼ 
Number 
: In order to evaluate the accuracy of the electronic blood pressure monitor, the number 
of study subjects should be at least 85. 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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: Unless otherwise specified, at least three valid blood pressure data pairs should be 
obtained from each study subject, and therefore the number of valid data pairs should be 
at least 255. 
◼ 
Gender distribution 
: Male – more than 30%, Female – more than 
◼ 
Age distribution 
: Bionet's NIBP module includes adults and children (Children: 3 to 12 years). 
: Therefore, at least 35 children are included. 
◼ 
Limb size distribution 
: Each cuff should be evaluated for at least  
1
2×𝑐 of all subjects. (where c is the number of cuffs) 
: At least 40% of personnel with arm circumferences greater than half of the 
measurable range specified on the cuff. 
: At least 40% of personnel with arm circumferences less than half of the measurable 
range specified on the cuff. 
◼ 
Blood pressure distribution 
: At least 5% of the reference SBP data must be less than or equal to 100 mmHg. 
: At least 5% of the reference SBP data must be 160 mmHg or higher. 
: At least 20% of the reference SBP data must be 140 mmHg or higher. 
: At least 5% of the reference DBP data must be less than or equal to 60 mmHg. 
: At least 5% of the reference DBP data must be 100 mmHg or higher. 
: At least 20% of the reference DBP data must be 85 mmHg or higher. 
[Exclusion criteria] 
- Emergency surgery patient 
- Subjects with psychiatric disorders such as mental retardation or autism 
- Subjects whose blood pressure measurement is difficult or expected to be difficult 
- Subjects who did not consent to the study 
 
 
[Number of target subjects and basis for calculation] 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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- 
Number of target subjects 
: According to ISO 81060-2:2018 5.1 Subject requirements, the number of NIBP subjects 
for adults and children should be 85 or more, including 35 or more children. 
: Considering the dropout rate of 20%, 102 subjects (including more than 35 children) 
were recruited. 
- 
Method of recruiting research subjects and obtaining consent 
: Recruitment is made through the recruitment notice for patients and their guardians 
who visit Hanyang University Hospital. After giving a sufficient explanation in a language 
that the subject can understand and waiting for 15 to 30 minutes to understand the 
contents of the study, the principal investigator obtains written consent from the subject 
or his/her representative. In addition, we accept withdrawal from research participation 
at any time during the study participation period without loss of the research subject's 
refusal. 
- 
Random assignment method and blinding method 
: This clinical trial does not use randomization or blinding methods. 
 
6-2. Research method overview 
[Prepares] 
- The auscultation-type blood pressure monitor used as a comparison target in accuracy evaluation 
 must satisfy international standards. 
- Prior to evaluating the accuracy of the electronic blood pressure monitor, two measurers should 
 be trained to detect the same auscultation sound for each study subject. 
 e.g. British and Irish Hypertension Society: BP Measurement auscultatory tutorials 
- Two measurers must undergo an audiogram hearing test.  
 
[Measurement considerations] 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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- 
The auscultation method has the following sources of error and should be considered 
when measuring. 
◼ 
Improper combination of cuff size and arm width 
◼ 
The stethoscope or transducer is not positioned over the brachial artery 
◼ 
Measurer's hearing loss or incorrect technique 
◼ 
Fast cuff deflation 
[Measurement method] 
- 
Use the sequential measurement method. 
- 
The test configuration comparing the accuracy of the electronic blood pressure monitor and 
the auscultation method blood pressure measurement is prepared to measure one arm of a 
subject at the same time using a Y-piece or a T-piece as shown in the figure. Since the exhaust 
speed of the automatic sphygmomanometer is fast and it is impossible to measure with the 
electronic sphygmomanometer and auscultate at the same time, a method of sequentially 
measuring the electronic sphygmomanometer and the auscultation method is taken. 
◼ 
In the sequential measurement method, the procedure for measuring the reference 
value and the blood pressure of the test equipment is as follows. 
First blood pressure measurement 
1. 
Reference blood pressure measurement by two observers 
R0 
2. 
test medical device blood pressure measurement 
T0 
Blood pressure measurement to evaluate accuracy 
3. 
First reference blood pressure measurement by two observers 
R1 
4. 
First test medical device blood pressure measurement 
T1 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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5. 
Second reference blood pressure measurement by two observers 
R2 
6. 
Second test medical device blood pressure measurement 
T2 
7. 
Third reference blood pressure measurement by two observers 
R3 
8. 
Third test medical device blood pressure measurement 
T3 
9. 
Fourth reference blood pressure measurement by two observers 
R4 
     : Reference (R0 ~ R4) is the average value of the blood pressure measurement values  
      by auscultation method of two measurers. 
     : Measure R0 and T0 to check the function of the test medical device. 
     : Blood pressure measurement for accuracy evaluation. Measure in order of R1, T1,  
      R2, T2, R3, T3, R4. 
     : Measure at least 1 minute apart. 
     : Each study subject has the following three data pairs. 
T1 vs (R1, R2 mean), T2 vs (R2, R3 mean), T3 vs (R3, R4 mean) 
◼ 
Other 
: If the reference SBP value of any two pairs is greater than 12 mmHg or the reference 
DBP value is greater than 8 mmHg, all data of the subject should be excluded. 
: Despite these requirements, if the reference blood pressure of the subject does not 
meet the above criteria during the trial period, two consecutive pairs of reference 
blood pressure that meet the above criteria may be used. 
: The number of study subjects using 2 pairs of reference blood pressure should be 
less than 10% of the number of study subjects using 3 pairs of reference blood 
pressure. 
: If there are data to be excluded by both measurers (observers), additional measures 
are made, and up to 8 times per study subject is possible. 
: To measure the circumference of the upper arm, with the forearm facing upward, 
and keeping the elbow angle at 90 degrees, measure the circumference at ④, the 
midpoint between ① and ②, as shown in the figure below. 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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: During the test, follow the American Heart Association (AHA) measurement 
guidelines below. 
American Heart Association (AHA) measurement guidelines 
Recommend 
Explanation 
The patient sits comfortably on his 
back. 
Don’t cross your legs. 
Arms are supported. 
The patient sits and rests for at least 5 
minutes before measurement. 
DBP is high in a sitting position, and SBP is high in a 
standing position. 
A non-recumbent position can increase DBP, and a 
cross-legged position can increase SBP. 
In the case of elderly patients, blood pressure in the 
sitting and standing state is periodically measured to 
differentiate orthostatic hypotension. 
Arms should be supported at heart 
level. 
The meter is placed in the center of 
the sternum. 
If the arm is lower than the right atrium, the blood 
pressure is measured too high, and if the arm is higher 
than the heart, the blood pressure is measured too low. 
If your arm is not supported, your blood pressure will 
be high. 
The cuff wraps more than 80% of the 
patient's arm circumference. 
A blood pressure cuff that is small relative to the 
patient leads to measurement errors, and a cuff that is 
too small leads to a deviation of 2 to 10 mmHg or 
more. 
The mercury meter deflates at a rate 
of 2 to 3 mmHg per second. 
When subtracting more than 2 mmHg per second, the 
SBP is lower than the actual value and the DBP is higher 
than the actual value. 
Measure SBP and DBP at the first and 
last beating sounds, respectively. 
Measures with an accuracy of up to 2 mmHg. 
Neither the patient nor the measuring 
person should speak. 
Deviations may occur in measurements. 
Just by listening, it rises above 10 mmHg. 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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Factors causing deviations in measurement include 
exercise, smoking, drinking, muscle tension, bladder 
distension, room temperature, and ambient noise. 
 
7. Observation items, clinical examination items, and 
observational 
examination methods 
[Basic items] 
- Date and time 
- Clinical trial number & subject number 
- date of birth 
- age 
- gender 
- On antihypertensive medication 
- arm circumference 
- Pulse 
- Cuff Size (A Cuff, B Cuff, C Cuff)  
[Items excluded from clinical trials] 
- Complete blood pressure range recruitment (Range complete) 
- Arrhythmia 
- Device failure 
- Cuff size unavailable 
- Poor quality of Korotkoff sounds 
- Observers disagreement 
- Other factors  
 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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[Record blood pressure readings] 
- 
All blood pressure units are recorded in mmHg, and the measurement interval, including 
the time required for cuff replacement, should be at least 60 seconds. A separate sheet 
is used to record the study subject's running total according to the blood pressure range. 
[Compare] 
- 
It is evaluated by statistically comparing the blood pressure measured by the test medical 
device with the blood pressure measured by the auscultation method. 
[Statistical analysis] 
- 
For 85 or more study subjects, the following two criteria must be satisfied for more than 
255 valid data pairs by measuring 3 times per subject with a test medical device and 
auscultation method. 
- 
Criterions 1 
◼ 
It is calculated separately for SBP and DBP, and the difference between the data pairs 
for n test medical devices and auscultation-type blood pressure measurement values 
of all subjects must satisfy the following conditions. 
: The average value 𝑥̅𝑛 for the difference between the test medical device and the 
auscultation method blood pressure calculated according to Equation (1) should be 
within ±5.0 mmHg. 
: The standard deviation 𝑠𝑛of the data pair calculated according to Equation (2) 
should be within 8.0 mmHg. 
: 𝑥̅𝑛 and 𝑠𝑛 must be expressed in units of at least 0.1 mmHg. 
𝑥̅𝑛= 1
𝑛× ∑(𝑝𝑆𝑈𝑇𝑖−𝑝𝑅𝐸𝐹−𝑠𝑞𝑖)
𝑛
𝑖=1
 
(1) 
𝑠𝑛= √
1
𝑛−1 × ∑(𝑥𝑖−𝑥̅𝑛)2
𝑛
𝑖=1
 
(2) 
 
𝑝𝑆𝑈𝑇𝑖−𝑝𝑅𝐸𝐹−𝑠𝑞𝑖 : Difference between the i-th blood pressure data pair 
 
𝑖 : Index to individual element 
 
𝑛 : number of measurements 
 
𝑝𝑅𝐸𝐹−𝑠𝑞𝑖 : The i-th reference blood pressure measurement calculated  
         according to equation (3) 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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𝑝𝑅𝐸𝐹−𝑠𝑞𝑖= 1
4 × (𝑝𝑅𝐸𝐹𝑖,1 + 𝑝𝑅𝐸𝐹𝑖,2 + 𝑝𝑅𝐸𝐹𝑖+1,1 + 𝑝𝑅𝐸𝐹𝑖+1,2 
(3) 
 
𝑝𝑅𝐸𝐹𝑖,1 : i-th blood pressure reading by measurer 1 
 
𝑝𝑅𝐸𝐹𝑖,2 : i-th blood pressure reading by measurer 2 
 
- 
Criterions 2 
◼ 
For m study subjects, the standard deviation 𝑠𝑚 of the average value of the 
difference between data pairs of each study subject calculated according to Equation 
(4) must satisfy Table 1 below. 
𝑠𝑚= √
1
𝑚−1 × ∑(𝑥𝑗−𝑥̅𝑛)
2
𝑚
𝑗=1
 
(4) 
 
𝑝𝑆𝑈𝑇𝑖−𝑝𝑅𝐸𝐹−𝑠𝑞𝑖 : Difference between the i-th blood pressure data pair 
 
𝑗 : Index to individual element 
 
𝑚 : Number of study subjects 
 
𝑥𝑗 : Test medical device blood pressure measurement calculated   
    according to Equation (5)  
𝑥𝑗= 1
𝑑× ∑(𝑝𝑆𝑈𝑇𝑗,𝑘−𝑝𝑅𝐸𝐹−𝑠𝑞𝑗,𝑘)
𝑑
𝑘=1
 
(5) 
 
𝑑 : Number of measurements per subject  
 
𝑘 : Index to individual element 
 
𝑝𝑅𝐸𝐹−𝑠𝑞𝑗,𝑘 : Reference blood pressure calculated according to  
          equation (6) 
𝑝𝑅𝐸𝐹−𝑠𝑞𝑗,𝑘= 1
4 × (𝑝𝑅𝐸𝐹𝑗,𝑘,1 + 𝑝𝑅𝐸𝐹𝑗,𝑘,2 + 𝑝𝑅𝐸𝐹𝑗,𝑘+1,1 + 𝑝𝑅𝐸𝐹𝑗,𝑘+1,2 
(6) 
 
Table 1. Averaged subject data acceptance (Criterions 2) in 𝒎𝒎𝑯𝒈 
𝑥̅𝑛 
Maximum permissible standard deviation, sm, as function of, 𝑥̅𝑛 𝑚𝑚𝐻𝑔 
0.0 
0.1 
0.2 
0.3 
0.4 
0.5 
0.6 
0.7 
0.8 
0.9 
±0 
6.95 
6.95 
6.95 
6.95 
6.93 
6.92 
6.91 
6.9 
6.89 
6.88 
±1 
6.87 
6.86 
6.84 
6.82 
6.8 
6.78 
6.76 
6.73 
6.71 
6.68 
±2 
6.65 
6.62 
6.58 
6.55 
6.51 
6.47 
6.43 
6.39 
6.34 
6.3 
±3 
6.25 
6.2 
6.14 
6.09 
6.03 
5.97 
5.89 
5.83 
5.77 
5.7 
±4 
5.64 
5.56 
5.49 
5.41 
5.33 
5.25 
5.16 
5.08 
5.01 
4.9 
±5 
4.79 
- 
- 
- 
- 
- 
- 
- 
- 
- 
 

Clinical Evaluation of Bionet Sphygmomanometer Module BN1 Based on ISO 81060-2:2018 Protocol 
ClinicalTrials.gov ID: NCT06609486 
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8. References 
[1] BS Alpert, Validation of the Welch Allyn Spot Vital Signs blood pressure device according 
to the ANSI/AAMI SP10:2002. Accuracy and cost-efficiency successfully combined. Blood 
Press Monit. 2007. 12(5): p.345-7. 
[2] Andrew C., et al, Validation of the Omron 705IT(HEM-759-E) oscillometric blood presusre 
monitoring device according to the British Hypertension Society protocol. Blood Press 
Monit. 2006 11(1): p.27-32 
[3] Guidelines for Accuracy Evaluation of Electronic Sphygmomanometers – KFDA Food and 
Drug Administration 
[4] O’Brien et al., European Society of hypertension international protocol revision 2010 for 
the validation of blood pressure measuring devices in adult, BPM, 2010, pp.23-38 
[5] Stergiou et al., A universal standard for the validation of blood pressure measuring 
devices: Association for the advancement of medical instrumentation/European Society 
of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) 
Collaboration statement, Journal of Hypertension, 2018, 36(3), pp.472-478.