A Prospective, Single Arm, Single Center, Non-randomized, Open Label Study to Evaluate the Accuracy of the Wrist Blood Pressure Monitor (H2-BP) Comparing With Aneroid Sphygmomanometer
Phase: NA
Conditions: Low Blood Pressure, Normal Blood Pressure, Prehypertension, Hypertension
Sponsor: Gangnam Severance Hospital

 
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[H2-BP] Clinical study Report V1.0 
 
 
Clinical Study Reports 
 
 
Studied by: Gangnam Severance Hospital 
 
Official Title: A prospective, made in public and randomly allocated clinical study for a 
single-arm in a single-center to assess the preciseness of a wrist band type blood pressure 
gauge, H2-BP for measuring the blood pressure on radial artery 
 
NCT number: NCT06491433 
 
 
 
Version 1.0 (10.07.2024) 
 
CONFIDENTIAL 
 
 
Overall information herein shall be strictly kept as confidential. 

 
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[H2-BP] Clinical study Report V1.0 
Contents 
 
1. 
Title of Study ..................................................................................................................................................... 6 
2. 
Summary of the protocol ............................................................................................................................... 6 
3. 
Research Background and Theoretical Basis ....................................................................................... 10 
4. 
Objectives of Study ........................................................................................................................................ 11 
5. 
Risk/Benefit Analysis .................................................................................................................................... 11 
5.1 
Risks of participating in research ................................................................................................... 11 
5.2 
Benefits of participating in research .............................................................................................. 11 
5.3 
Risk/Benefit Analysis ........................................................................................................................... 11 
6. 
Planned Sample Size ..................................................................................................................................... 12 
6.1 Wrist Circumference Distribution of Study Subjects...................................................................... 12 
6.2 Age Constitution .......................................................................................................................................... 13 
6.3 Gender Constitution of Study Subjects ................................................................................................ 13 
6.4 Upper Arm Circumference Distribution of Study Subjects .......................................................... 13 
7. 
Inclusion/Exclusion Criteria on Patients................................................................................................ 13 
7.1 Inclusion/Exclusion Criteria for Subjects of the Investigational Device ................................... 13 

 
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[H2-BP] Clinical study Report V1.0 
7.2 Inclusion/Exclusion Criteria for Users of the Investigational Medical Device ........................ 14 
8. 
Information and Management of a Medical Instrument for Clinical Study .............................. 14 
9. 
Study Design and Methodology ................................................................................................................. 15 
9.1 
Implementation of Monitoring for Subjects Using the Investigational Device ................ 15 
10. 
Study Procedures and Assessments ..................................................................................................... 17 
10.1 Clinical Study Schedule ........................................................................................................................... 17 
10.2 Observational Examination Method for Subjects Using the Investigational Device .......... 17 
10.3 Clinical Study Schedule ........................................................................................................................... 18 
11. 
Effectiveness Evaluation Parameter ................................................................................................... 19 
11.1 Primary Endpoint ..................................................................................................................................... 19 
11.2 
Secondary Endpoint............................................................................................................................. 20 
12. 
Anticipated Adverse Effects and Precautions for Use .................................................................. 21 
12.1 
Precautions for Use in Operating Environment ......................................................................... 21 
12.2 
Precautions During Use ...................................................................................................................... 22 
12.3 
Anticipated Adverse Effects .............................................................................................................. 22 
12.4 
General Precautions............................................................................................................................. 22 
13. 
Criteria on Termination and Early Suspension (Criteria on drop out in the middle and etc.) ....... 23 

 
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[H2-BP] Clinical study Report V1.0 
14. 
Criteria, Methods, and Reporting for the Assessment of Safety, Including Adverse Events .. 23 
14.1 
Safety Evaluation Variables .............................................................................................................. 23 
14.2 
Definitions of Adverse Events ........................................................................................................... 23 
14.3 
Safety Assessment Criteria and Methods ..................................................................................... 24 
14.4 
Safety Reporting Method ................................................................................................................... 25 
15. 
Points to be Considered in Data Analysis and Statistics .............................................................. 26 
15.1 Statistical Analysis Methods .................................................................................................................. 26 
15.2 Primary Endpoint ..................................................................................................................................... 27 
15.3 Secondary Endpoint ................................................................................................................................. 27 
15.4 Bland-Altman Analysis ........................................................................................................................... 27 
16. 
Measures for Data Confidentiality and Protection of Personal Information ........................ 28 
17. 
Collection, Management, Storage, and Disposal of Human-Derived Materials and Genetic 
Information ............................................................................................................................................................... 28 
18. 
Subject Recruitment Methods and Informed Consent Process ................................................. 28 
18.1 
Subjects for Investigational Device Application ......................................................................... 28 
19. 
Protection Measures for the Recruitment of Vulnerable Subjects ........................................... 29 
20. 
Plan for quality control and reliability assurance (Material Safety Monitoring Plan) ...... 29 

 
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[H2-BP] Clinical study Report V1.0 
21. 
Clinical Study plan(Schedule) ............................................................................................................... 30 
22. 
Informed Consent Form ......................................................................................................................... 31 
23. 
Management of Investigational Medical Devices............................................................................ 31 
24. 
References .................................................................................................................................................... 32 
 
 
 

 
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[H2-BP] Clinical study Report V1.0 
1. Title of Study 
A prospective, made in public and randomly allocated clinical study for a single-arm in a single-center to 
assess the preciseness of a wrist band type blood pressure gauge, H2-BP for measuring the blood pressure on 
radial artery.   
2. Summary of the protocol 
Objectives of Study 
Compare and assess the accuracy of wrist band type and stethoscope type 
blood pressure gauge by applying to the out subjects, hospitalized patients 
and applicants who show symptoms of hypotension, normal blood pressure, 
borderline hypertension and high blood pressure 
Overview of Study Design 
Prospective, single-arm, single-center, open-label, non-randomized study 
Clinical Trial Institution 
Gangnam Severance Hospital, Yonsei university 
Count of targeted subjects 
141subjects (Minimum 85 subjects) 
The subjects of this study should be recruited while taking the following into 
account 
 
1. Wrist Circumference Distribution of Study Subjects 1) 
• 
At least 20% of the experimenters shall have the circumference within 
1/4 of the entire limb circumference. (Minimum 17 subjects) 
• 
At least 10% of the experimenters shall have the circumference within 
top 1/8 of the entire limb circumference. (Minimum 9 subjects) 
• 
At least 10% of the experimenters shall have the circumference within 
lowest 1/8 of the entire limb circumference. (Minimum 9 subjects) 
 
H2-BP shall take the wrist circumference as the criterion of measuring as it 
is a wrist band type and measures the pressure by wearing on the wrist. The 
wrist circumference is marked in centimeter.  The minimum subjects in 
each sector are as follows as H2-BP is regulated for the people with 15-19cm 
wrist circumference to use the unit. 
• 
15.0–15.5625 cm: At least 10% (minimum 9 subjects) 
• 
15.5625–16.125 cm: At least 10% (minimum 9 subjects) 
• 
16.125–17.25 cm: At least 20% (minimum 17 subjects) 
• 
17.25–18.375 cm: At least 20% (minimum 17 subjects) 
• 
18.375–18.9375 cm: At least 10% (minimum 9 subjects) 
• 
18.9375–19.5 cm: At least 10% (minimum 9 subjects) 
 
2. Age Constitution1) 2) 
- Over 19 

 
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[H2-BP] Clinical study Report V1.0 
 
3. Gender Constitution of Study subjects 1) 2) 
- Minimum respective 30% of female and male shall constitute entire 
subjects 
 
4. Upper Arm Circumference Distribution of Study Subjects 1) 
- The bladder length of the comparator device should be 75–100% of the 
subject's upper arm circumference. 
- The bladder width of the comparator device should be 37–50% of the 
subject's upper arm circumference. 
Inclusion/Exclusion Criteria 
1. Inclusion/Exclusion Criteria for Subjects of the Investigational Device 
1) Inclusion Criteria 
(1) The out patients, hospitalized patients and applicants over 19 who show 
symptoms of hypotension, normal blood pressure, borderline 
hypertension and high blood pressure 
(2) Inclusion of patients who meet the count of the targeted patient and 
rationale of estimation, i.e. wrist circumference, age, gender and 
circumference of the upper arm (Refer to section 6)  
(3) Inclusion of patients who agreed in written form to decide the 
participation and comply the cautions after listening and understanding 
fully the details on this clinical study.  
 
2) Exclusion Criteria 
(1) The subjects who disagreed to participate into this study 
(2) The subjects likely not to maintain the constant blood pressure about 30 
minutes due to hypovolemia or quasi equivalent disease and situation 
(3) The subjects likely not to maintain the constant blood pressure about 30 
minutes due to short-termly active vasoactive agonist or quasi 
equivalent medication 
(4) Subjects with cardiac arrhythmia 
(5) Subjects who ate food within 30 minutes 
(6) The patients who took caffeine drink within 1 hour or smoked within 15 
minutes  
(7) The subjects who made exercise immediately before measuring the 
blood pressure 
(8) Other subjects who are inappropriate to this study by the decision of the 
research staff 
 

 
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[H2-BP] Clinical study Report V1.0 
2. Inclusion/Exclusion Criteria for Users of the Investigational Device 3) 
1) Inclusion Criteria 
(1) The subjects to be tested with the stethoscope type blood pressure 
gauge shall acquire appropriate hearing power and eyesight.   
(2) The subjects to be tested with the stethoscope type blood pressure 
gauge shall have training and experience on measuring.  
(3) The subjects who voluntarily agreed to sign after listening the 
explanation on the objective and procedure of the clinical study  
 
2) Exclusion Criteria 
The subjects who were decided as inappropriate for participating into the 
clinical study by the person in charge for the clinical study and other 
research staff 
Clinical study Period 
 
About 23 months 
- Study Protocol and IRB Approval: approximately 2 months 
- Study Contract and Administrative Procedures Execution: approximately 
1month 
- Subject Recruitment and Study Procedure Execution: approximately 19 
months 
- Analyze data and report results: approximately 1 month 
Investigational Device 
 
1. Investigational Device 
1) Model: H2-BP 
2) Product name(Product category No.) and class: Automatic electronic 
blood pressure gauge(A23010.04)/Class II 
3) Manufacturer: Charmcare Co., Ltd 
4) Shape and structure: 
-H: 81.5mm, L: 79.5mm, W: 25.5mm   
5) Storage conditions: Store at room temperature 
 
2. Comparator4) 
1) Model: big ben®  Sphygmomanometer 
2) Product name(Product category No.) and class: Aneroid type blood 
pressure gauge(A23010.01) / class I  
3) Manufacturer: Riester 
4) Shape and structure:  
- H: 250mm, L: 250mm, W: 250mm 
5) Storage conditions: Store at room temperature 
Instructions for use 
The Investigational Device will be applied to one wrist of the patient to 
measure blood pressure, followed by the application of the comparator to the 
upper arm of the same arm to measure blood pressure. The procedure for use 

 
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[H2-BP] Clinical study Report V1.0 
is as follows. 
1. Investigational Device (H2-BP) 
The device is applied to the subject's wrist, and pressure inflation begins 
when the button is pressed. Once the measurement is complete, the systolic 
and diastolic blood pressure values are displayed on the screen. For detailed 
instructions on usage, refer to Appendix 2_H2-BP User Manual0-42_Full 
Document. 
2. Comparator (big ben®  Sphygmomanometer) 
After placing the cuff around the upper arm, the pump is manually pressed to 
inflate the cuff. Two operator each using a separate stethoscope connected to 
the same cuff, independently measure the systolic and diastolic blood 
pressure. 
Test method 
This clinical study is a prospective, single-arm, single-center, open-label, 
non-randomized study conducted over one day. After providing a thorough 
explanation of the study, informed consent is voluntarily obtained in writing 
from outpatients, inpatients, and subjects aged 19 years or older with 
hypotension, normotension, borderline hypertension, or hypertension. 
Each 
subject 
is 
assigned 
a 
screening 
number, 
and 
eligibility 
(inclusion/exclusion) criteria are assessed. Demographic information (date of 
birth, age, and gender) is collected, and the use of prior or concomitant 
medications is reviewed. The wrist and upper arm circumference of the 
subjects are measured, and those deemed eligible are enrolled in the clinical 
study. 
 
1. test method 
The wrist band-type blood pressure monitor H2-BP and the auscultatory 
blood pressure measurement device are used to measure blood pressure on 
the same arm. The wrist band-type blood pressure monitor is operated by a 
single operator who records the measurement values, while the auscultatory 
blood pressure device is used by two independent operators who measure 
blood pressure simultaneously. 
For each subject, the H2-BP is worn on one wrist, and the auscultatory blood 
pressure device is applied alternately to the upper arm of the same arm. 
Measurements are repeated until three valid pairs of measurements are 
obtained from a single subject, with a maximum of eight measurement 
attempts allowed per subject. 
 
2. reading criteria 

 
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[H2-BP] Clinical study Report V1.0 
The two operators performing auscultatory blood pressure measurements 
must measure blood pressure independently for each subject, ensuring that 
they are blinded to each other’s readings. Additionally, the operators must 
not have access to the measurement values displayed by the investigational 
device during the procedure. 
For each subject, measurements are repeated for 10 to 30 minutes until three 
valid blood pressure readings are obtained. All recorded values are 
documented accordingly. 
Endpoint 
-Primary Endpoint : Average on difference between blood pressures 
measured with test device and reference device, Standard deviation on the 
blood pressures measured with test device and reference device. (Based on 
count of measurement) 
-Secondary Endpoint : Standard deviation on difference between blood 
pressures measured with test device and reference device. (Based on the 
count of the patients) 
Visit schedule 
2 days in total : Screening(Visit 1), Medical instrument application(Visit 2) 
If the screening process does not take a significant amount of time, both 
screening and medical device application may be conducted during Visit 1. 
 
3. Research Background and Theoretical Basis 
The cardio pulmonary diseases from hypertension, arteriosclerosis and cerebral apoplexy emerge one of the 
factors threatening the modernists’ health. According to the report from Statistics Korea in 2022, cardio 
pulmonary diseases ranked 2nd and 3rd in cause of death in Korea. According to the report from Statistics 
Korea in 2022, cardio pulmonary diseases ranked 2nd and 3rd in cause of death in Korea. 5) Over 610K 
people per annum in USA died for cardiac diseases.6) The blood pressure control is one of the important factors 
in monitoring such cardiac pulmonary diseases.7) The blood pressure is controlled by monitoring always with 
blood pressure measuring tool.  
The crucial point in blood pressure measuring is the preciseness. Inaccurately measured blood pressure not 
only reach to its inaccuracy but also can make bad influence on the health of normal patients and hypertension 
patients as well by resulting in unnecessary treatment and improper control. Accordingly, the righteous 
understanding on how to measure and how to manage the gauge lead to measure the blood pressure exactly. 
Moreover, measuring the blood pressure 1-2 times can be short for exact diagnosis and treatment as it fluctuates 
daily and changes every time every minute depending on the activities of the patients. The electronic blood 
pressure gauge has a merit for heightening the reliability in blood pressure data as a few times checking are 
easier.  
Lk++ 
 

 
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[H2-BP] Clinical study Report V1.0 
 
 
The H2-BP from Charmcare is a blood pressure gauge to measure the blood pressure at systolic and diastolic 
area of the adults non-invasively. It is configured with main body, cuff, band and charging cable. Repeated 
pressing on the measuring button pressurizes the cuff automatically and measures the highest and lowest blood 
pressure and pulse by using oscillometric. H2-BP is used by wearing on the wrist like a usual wrist watch. The 
convenience in using by the patient is improved and it provides the environment for more frequent monitoring. 
Therefore, the clinical test for the accuracy of H2-BP will be made by comparing the data measured by H2-BP 
and stethoscope type blood pressure gauge.    
4. Objectives of Study 
This study is purposed to compare and assess the accuracy of wrist band type and stethoscope type blood 
pressure gauge by applying to the out patients, hospitalized patients and applicants who show symptoms of 
hypotension, normal blood pressure, borderline hypertension and high blood pressure.  
 
5. Risk/Benefit Analysis 
5.1 Risks of participating in research 
In this study, subjects will have their blood pressure measured using standard methods and will additionally 
have their blood pressure measured using the H2-BP wrist band blood pressure monitor. Blood pressure 
measurement is a non-invasive test and poses little additional risk to subjects from participating in the study.8) 9) 
5.2 Benefits of participating in research 
While there is no direct benefit to you as a participant in this clinical study, you may benefit from the results 
of this study, which will help validate the accuracy of wearable blood pressure monitors for convenient blood 
pressure measurement and provide information about more convenient and useful products for people with 
related conditions. 
5.3 Risk/Benefit Analysis 
There is no additional risk of harm from this study, and the benefits to society outweigh the anticipated 
inconvenience of the research. 
 

 
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[H2-BP] Clinical study Report V1.0 
6. Planned Sample Size 
Planned Sample Size: 141 Subjects (Minimum Enrollment: 85 Subjects) 
 
Rationale for Sample Size Calculation: According to the guidelines outlined in ISO 81060-2 Third Edition 2018-
11 (Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement 
type [including: Amendment 1 (2020)]) and EN 1060-4 (Non-invasive sphygmomanometers - Part 4: Test 
procedures to determine the overall system accuracy of automated non-invasive sphygmomanometers), a 
minimum of 85 subjects must be enrolled to evaluate the accuracy of electronic sphygmomanometers. 
Considering potential data loss due to withdrawal of consent and other unforeseen circumstances, an anticipated 
dropout rate of approximately 40% has been applied. Accordingly, a total of 141 subjects will be recruited for 
this study. 
 
Composition of Study Subjects: In accordance with the ISO 81060-2 Third Edition 2018-11 international 
standard for the clinical validation of electronic sphygmomanometers, the enrolled subjects must meet the 
following composition criteria. 
The investigator is responsible for continuous monitoring of subject enrollment status to ensure compliance with 
the required composition. If the composition criteria are not met, additional subjects may be recruited as 
necessary to fulfill the requirements. 
 
6.1 Wrist Circumference Distribution of Study Subjects 
1) 
At least 20% of the experimenters shall have the circumference within 1/4 of the entire limb 
circumference. (Minimum 17 subjects) 
2) 
At least 10% of the experimenters shall have the circumference within top 1/8 of the entire limb 
circumference. (Minimum 9 subjects) 
3) 
At least 10% of the experimenters shall have the circumference within lowest 1/8 of the entire limb 
circumference. (Minimum 9 subjects) 
 
H2-BP shall take the wrist circumference as the criterion of measuring as it is a wrist band type and measures 
the pressure by wearing on the wrist. The wrist circumference is marked in centimeter.  The minimum subjects 
in each sector are as follows as H2-BP is regulated for the people with 15-19cm wrist circumference to use the 
unit.  
• 
15.0–15.5625 cm: At least 10% (minimum 9 subjects) 
• 
15.5625–16.125 cm: At least 10% (minimum 9 subjects) 
• 
16.125–17.25 cm: At least 20% (minimum 17 subjects) 
• 
17.25–18.375 cm: At least 20% (minimum 17 subjects) 
• 
18.375–18.9375 cm: At least 10% (minimum 9 subjects) 
• 
18.9375–19.5 cm: At least 10% (minimum 9 subjects) 

 
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[H2-BP] Clinical study Report V1.0 
6.2 Age Constitution 
 Over 19 
6.3 Gender Constitution of Study Subjects 
Minimum respective 30% of female and male shall constitute entire subjects 
6.4 Upper Arm Circumference Distribution of Study Subjects 
• 
The bladder length of the comparator device should be 75–100% of the subject's upper arm 
circumference. 
• 
The bladder width of the comparator device should be 37–50% of the subject's upper arm 
circumference. 
7. Inclusion/Exclusion Criteria on Patients  
7.1 Inclusion/Exclusion Criteria for Subjects of the Investigational Device 
1) Inclusion Criteria 
(1) The out patients, hospitalized patients and applicants over 19 who show symptoms of hypotension, normal 
blood pressure, borderline hypertension and high blood pressure 
(2) Inclusion of subjects who meet the count of the targeted patient and rationale of estimation, i.e. wrist 
circumference, age, gender and circumference of the upper arm (Refer to section 6) 
(3) Inclusion of subjects who agreed in written form to decide the participation and comply the cautions after 
listening and understanding fully the details on this clinical study.  
 
2) Exclusion Criteria 
(1) The subjects who disagreed to participate into this study 
(2) The subjects likely not to maintain the constant blood pressure about 30 minutes due to hypovolemia or 
quasi equivalent disease and situation 
(3) The subjects likely not to maintain the constant blood pressure about 30 minutes due to short-termly active 
vasoactive agonist or quasi equivalent medication 
(4) Subjects with cardiac arrhythmia 
(5) Subjects who ate food within 30 minutes 
(6) The subjects who took caffeine drink within 1 hour or smoked within 15 minutes  
(7) The subjects who made exercise immediately before measuring the blood pressure 
(8) Other subjects who are inappropriate to this study by the decision of the research staff 
 
 
 

 
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[H2-BP] Clinical study Report V1.0 
7.2 Inclusion/Exclusion Criteria for Users of the Investigational Medical Device 
1) Inclusion Criteria 
(1) The subjects to be tested with the stethoscope type blood pressure gauge shall acquire appropriate hearing 
power and eyesight.   
(2) The subjects to be tested with the stethoscope type blood pressure gauge shall have training and experience 
on measuring.  
(3) The subjects who voluntarily agreed to sign after listening the explanation on the objective and procedure 
of the clinical study  
 
2) Exclusion Criteria 
(1) The subjects who were decided as inappropriate for participating into the clinical study by the person in 
charge for the clinical study and other research staff  
 
8. Information and Management of a Medical Instrument for Clinical Study 
1) 
Investigational Device 
(1) Model: H2-BP 
(2) Product name(Product category No.) and class: Automatic electronic blood pressure gauge(A23010.04) 
/ class II 
(3) Manufacturer: Charmcare Co., Ltd 
(4) Shape and structure 
-H: 81.5mm, L: 79.5mm, W: 25.5mm 
(5) Storage conditions: Store at room temperature 
 
2) 
Comparator 
(1) Model: big ben®  Sphygmomanometer 
(2) Product name(Product category No.) and class: Aneroid type blood pressure gauge(A23010.01) / class I 
(3) Manufacturer: Riester 
(4) Shape and structure 
-H: 250mm, L: 250mm, W: 250mm 
(5) Storage conditions: Store at room temperature 
 
The investigational device used in this clinical trial is provided by Charmcare Co., Ltd. The Investigational 
Device Manager (hereinafter referred to as the "Manager") is responsible for the receipt, inventory management, 
application and use, and return of the investigational device. The Manager shall document all relevant activities 
and periodically report them to the Principal Investigator (PI).  
In accordance with Good Clinical Practice for medical device clinical study, the Manager shall record the 
application period, lot number or serial number, expiration date (if applicable), Unique Device Identification, 
and Subject Identification Code for each subject using the investigational device.  

 
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[H2-BP] Clinical study Report V1.0 
The Manager and relevant personnel shall maintain and document medical records verifying the device is used 
in accordance with the clinical study protocol for each subject The investigational site is responsible for ensuring 
that records related to medical device management are retained in compliance with applicable regulations and 
guidelines. The Principal Investigator is ultimately responsible for managing the investigational devices used in 
this study. 
9. Study Design and Methodology 
This clinical study is a single-arm, single-center, open-label, non-randomized, prospective, single-day study. 
The investigational device will be applied for blood pressure measurement in outpatients, inpatients, and 
volunteers aged 19 years or older who present with hypotension, normotension, borderline hypertension, or 
hypertension. 
 
9.1 
Implementation of Monitoring for Subjects Using the Investigational Device 
For subjects undergoing monitoring (or their legally authorized representatives, if applicable), screening shall be 
conducted after obtaining written informed consent for participation in the clinical study. Based on the screening 
assessment, subjects who meet the inclusion criteria and do not meet the exclusion criteria will be enrolled in the 
study. 
 
Blood pressure measurements will be performed in a seated position, alternating between the investigational 
device and the comparator device. The measurement procedure follows the steps below: 
1. Using the comparator device, one valid pair of systolic and diastolic blood pressure (BP) values will be 
obtained from the upper arm as shown in Figure 1. 
2. The investigational device will then be applied to the same arm's wrist, and one valid pair of systolic 
and diastolic BP values will be obtained. 
3. Steps 1 and 2 will be repeated until three valid pairs of BP values are collected for each subject. A 
minimum interval of 60 seconds will be maintained between each measurement. 
4. The same procedure will be followed for all other enrolled subjects. 
 
Figure 1. ①Stethoscope ②Comparator Device Manometer ③Pump ④Investigational Device 

 
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[H2-BP] Clinical study Report V1.0 
The investigational device measurement is recorded by a single operator. In contrast, the comparator device 
measurement is recorded by two independent operators, each using a separate stethoscope to simultaneously 
assess and document the blood pressure readings. 
When measuring diastolic blood pressure (DBP) using auscultation, Korotkoff Phase V should be recorded. If 
Korotkoff Phase V is not audible, the subject shall be excluded from the study. 
The two operators using the auscultatory blood pressure measurement method must conduct their measurements 
independently, ensuring that they cannot communicate or be aware of each other's recorded values for each 
subject. Additionally, during the measurement process, the operators must not have access to the investigational 
device's readings. 
* If the difference between the two simultaneous measurements exceeds the following thresholds, the 
corresponding blood pressure value pair shall be excluded: 
• 
If the systolic blood pressure (SBP) difference between the two operators is greater than 4 mmHg, the 
value pair is excluded. 
• 
If the diastolic blood pressure (DBP) difference between the two operators is greater than 4 mmHg, 
the value pair is excluded. 
To ensure validity and representativeness of the blood pressure measurements, the final collected values from the 
comparator device must meet the following distribution criteria: 
1) At least 5% of SBP values should be ≤100 mmHg. 
2) At least 5% of SBP values should be ≥160 mmHg. 
3) At least 20% of SBP values should be ≥140 mmHg. 
4) At least 5% of DBP values should be ≤60 mmHg. 
5) At least 5% of DBP values should be ≥100 mmHg. 
6) At least 20% of DBP values should be ≥85 mmHg. 
 
 

 
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[H2-BP] Clinical study Report V1.0 
10. Study Procedures and Assessments 
10.1 Clinical Study Schedule 
1) 
Any procedure in this observatory study shall not start before having patient’s agreement letter (Letter of consent on using 
information). Voluntary agreement shall be made preferentially by the patient, but for impossibility of making the agreement letter due 
to emergencies (Endotracheal intubation and cardio pulmonary resuscitation), the agreement letter may be obtained from the legal 
proxy person. In this case, additional agreement letter shall be taken from the patient after stabilization or finalization of the emergent 
situation to the patient.  
2) 
Check the selection/exclusion criteria, obtain demographic information, check the medication taken in advance or under taking and 
measure the wrist circumference and circumference of upper arm after screening numbering.  
3) 
Demographic survey: Survey the demographic information (Date of birth, age and gender).  
4) 
Check the medication taken in advance or under taking: Collect overall information on advanced medication and taken medication 
before applying the clinical study medical instrument from 2 weeks before screening till applying clinical study medical instrument.  
5) 
Survey the abnormal reactions from the first test related procedure (Namely, signing date of the patient on the agreement letter) till the 
last assessment date.  
6) 
Screening the visit and the medical instrument applying visit can be processed concurrently. 
 
10.2 Observational Examination Method for Subjects Using the Investigational Device 
1) Assignment of Screening and Enrollment Numbers 
A Screening Number shall be assigned only to subjects who have provided written informed consent for 
participation in this clinical trial. Screening numbers will be assigned in the order of consent acquisition. If 
multiple subjects provide consent on the same day, the screening numbers will be assigned based on the 
order of arrival.  
The Screening Number shall consist of a single-digit site identifier, the letter ‘S’ (indicating Screening), and 
a three-digit sequential subject number, assigned according to the following method 
Site Number 
S 
- 
Three-digit number assigned sequentially 
based on Screening order 
Gangnam Severance Hospital: 1 
S 
- 
001,002,003, … 
Example: The Screening Number for the first subject screened at Gangnam Severance Hospital is 1S-001. 
 
 
 
Screening 
Medical instrument application 
Assessment 
Study Visit 
Visit1 6) 
Visit2 6) 
Day 
-2W-Day1 
Day1 
Obtain agreement letter1) 
O 
 
 
Screening numbering 
O 
 
 
Check selection/exclusion criteria2) 
O  
 
 
Obtain demographic information3) 
O 
 
 
Check medication taken or under taking 4) 
O 
 
 
Measure wrist circumference 
O 
 
 
Check circumference of upper arm  
O 
 
 
Measure blood pressure 
 
O 
(H2-BP, stethoscope type blood 
pressure gauge) 
O 
 
Check taking medication 
 
O 
 
Check abnormal examples5) 
 
O 
 

 
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[H2-BP] Clinical study Report V1.0 
For subjects enrolled after Screening, an Enrollment Number will be assigned, consisting of a single-digit 
site identifier, the letter ‘R’ (indicating Registration), and a three-digit sequential subject number, 
according to the method described below. The target sample size will be counted based on the number of 
enrolled subjects, regardless of the total number of screened subjects. 
Site Number 
R 
- 
Three-digit number assigned sequentially 
based on Screening order 
Gangnam Severance Hospital: 1 
R 
- 
001,002,003, … 
Example: The Screening Number for the first subject screened at Gangnam Severance Hospital is 1R-001. 
 
2) Demographic Data Collection 
At the time of Screening (Visit 1), detailed demographic information of the subject will be collected and 
recorded. The demographic data will include the subject's date of birth, age, and gender. 
 
3) Adverse Event Monitoring 
The investigator will observe for the occurrence of adverse events (AEs) throughout the clinical study 
period, starting from Visit 2 (application of the investigational medical device). Any adverse events 
identified will be documented in the Case Report Form (CRF), including the onset date, resolution date, 
severity, causal relationship, and actions taken. 
 
4) Concomitant Medication Monitoring 
Information on all prior medications administered within 2 weeks prior to Screening (Visit 1) and before the 
application of the investigational device, as well as on concomitant medications administered after the 
application of the investigational device, will be collected. For both prior and concomitant medications, the 
following details will be recorded: drug name (active ingredient), purpose of administration, daily dosage, 
route of administration, and duration of administration. 
 
10.3 Clinical Study Schedule 
1) Visit 1 (Screening, Day 0) 
Complete the following Screening procedures before the application of the investigational device: 
1. Obtain written informed consent from the subject or their legal representative (proxy) prior to 
conducting any study procedures. 
2. Assign a Screening number after obtaining the subject's consent. 
3. Review the inclusion and exclusion criteria following the assignment of the Screening number. 
4. Collect demographic information. 
5. Verify prior/concomitant medications. 

 
19 
[H2-BP] Clinical study Report V1.0 
6. Measure the wrist circumference. 
7. Measure the upper arm circumference. 
2) Visit 2 (Day 1) 
Subjects assigned a Screening number and enrolled in the clinical trial will undergo the application of the 
investigational device on Day 1. Note that the Screening date and Day 1 may occur on the same day. 
1. Measure blood pressure using the H2-BP device and an auscultatory blood pressure monitor. 
2. Verify concomitant medications. 
3. Monitor for adverse events (AEs). 
11. Effectiveness Evaluation Parameter 
Evaluate the accuracy by adopting the following evaluation parameters by measuring the blood pressure in 
three times at systolic and diastolic area from total 141 subjects. The qualification decision shall be pursuant to 
the following criteria. (The minimum subjects shall be over 85 and measured data shall be over 255 cases.) 
 
11.1 Primary Endpoint 
(1) Average on difference between blood pressures measured with investigational device and comparator 
  
n=Count of measurement Ex) For 85 subjects-> n=255 
i is a separate index for count of measurement.  
 
𝑝comparator−𝑠𝑞𝑖= 1
4 × (𝑝comparator𝑖,1 + 𝑝comparator𝑖,2 + 𝑝comparator𝑖+1,1 + 𝑝comparator𝑖+1,2) 
𝑝comparator𝑖,1 is the blood pressure data measured at i −th time by the operator  1 
𝑝comparator𝑖,2is the blood pressure data measured at i −th time by the operator  2 
[Formula for calculating the primary endpoint]  
𝐴𝑣𝑒𝑟𝑎𝑔𝑒 𝑜𝑓 𝑑𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒(𝑥𝑛) = 1
𝑛× ∑(𝑝𝐼𝑛𝑣𝑒𝑠𝑡𝑖𝑔𝑎𝑡𝑖𝑜𝑛𝑎𝑙 𝑑𝑒𝑣𝑖𝑐𝑒𝑖−𝑝comparator−𝑠𝑞𝑖)
𝑛
𝑖=1
 
 
Corresponding endpoint shall have error range less than ±0.67 kPa.  
 
 
 

 
20 
[H2-BP] Clinical study Report V1.0 
(2) Standard deviation on the blood pressures measured with investigational device and comparator. (Based on 
count of measurement) 
 
n= Count of measurement Ex) For 85 subjects -> n=255 
i is a separate index for count of measurement.  
 
[Formula for calculating the primary endpoint]  
𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑 𝑑𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛 𝑜𝑓 𝑑𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑏𝑎𝑠𝑒𝑑 𝑜𝑛 𝑐𝑜𝑢𝑛𝑡 𝑜𝑓 𝑡ℎ𝑒 𝑚𝑒𝑎𝑠𝑢𝑟𝑒𝑚𝑒𝑛𝑡𝑠(𝑠𝑛) = √
1
𝑛−1 × ∑(𝑥𝑖−𝑥𝑛)2
𝑛
𝑖=1
 
 
Corresponding endpoint shall have error range less than 1.07 kPa.  
 
11.2 Secondary Endpoint 
(1) Standard deviation on difference between blood pressures measured with investigational device and 
comparator. (Based on the count of the subjects) 
 
m= Count of measurement Ex) For 85 subjects -> n=255 
j is a separate index for count of measurement. 
d is the count of measurement per experimentee.  
k is an index for the individual factor.  
𝑥𝑗= 1
d × ∑(𝑝𝑖𝑛𝑣𝑒𝑠𝑡𝑖𝑔𝑎𝑡𝑖𝑜𝑛𝑎𝑙 𝑑𝑒𝑣𝑖𝑐𝑒𝑗,𝑘−𝑝𝑐𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟−𝑠𝑞𝑗,𝑘)
d
𝑘=1
 
 
𝑝𝑐𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟−𝑠𝑞𝑗,𝑘= 1
4 × (𝑝𝑐𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟𝑗,𝑘,1 + 𝑝𝑐𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟𝑗,𝑘,2 + 𝑝𝑐𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟𝑗,𝑘+1,1 + 𝑝𝑐𝑜𝑚𝑝𝑎𝑟𝑎𝑡𝑜𝑟𝑗,𝑘+1,2) 
 
 
[Formula for calculating the secondary endpoint]  
𝑆𝑡𝑎𝑛𝑑𝑎𝑟𝑑 𝑑𝑒𝑣𝑖𝑎𝑡𝑖𝑜𝑛 𝑜𝑓 𝑑𝑖𝑓𝑓𝑒𝑟𝑒𝑛𝑐𝑒 𝑏𝑎𝑠𝑒𝑑 𝑜𝑛 𝑐𝑜𝑢𝑛𝑡 𝑜𝑓 𝑡ℎ𝑒 𝑠𝑢𝑏𝑗𝑒𝑐𝑡𝑠(𝑠𝑚) = √
1
𝑚−1 × ∑(𝑥𝑗−𝑥𝑛)2
𝑚
𝑗=1
 
 
The secondary endpoint shall meet the Table 1 or 2 based on ISO 81060-2 standard depending on the blood 
pressure data.  
 
 

 
21 
[H2-BP] Clinical study Report V1.0 
Table 1 – Average subject data acceptance (criterion 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 
6,90 
6,89 
6,88 
±1, 
6,87 
6,86 
6,84 
6,82 
6,80 
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 
6,30 
±3, 
6,25 
6,20 
6,14 
6,09 
6,03 
5,97 
5,89 
5,83 
5,77 
5,70 
±4, 
5,64 
5,56 
5,49 
5,41 
5,33 
5,25 
5,16 
5,08 
5,01 
4,90 
±5, 
4,79 
- 
- 
- 
- 
- 
- 
- 
- 
- 
Example For mean of ±4,2mmHg the maximum permissible standard deviation is 5,49 mmHg.  
 
Table 2 – Average subject data acceptance (criterion 2) in kPa 
𝑥̅𝑛 
Maximum permissible standard deviation, 𝑠𝑚, as function of, 𝑥̅𝑛 kPa 
0,000 
0,010 
0,020 
0,030 
0,040 
0,050 
0,060 
0,070 
0,080 
0,090 
±0,0 
0,9266 
0,9266 
0,9266 
0,9266 
0,9226 
0,9246 
0,9233 
0,9223 
0,9213 
0,9203 
±0,1 
0,9193 
0,9183 
0,9173 
0,9163 
0,9152 
0,9138 
0,9119 
0,9099 
0,9079 
0,9059 
±0,2 
0,9039 
0,9007 
0,8989 
0,8970 
0,8946 
0,8906 
0,8878 
0,8855 
0,8826 
0,8785 
±0,3 
0,8756 
0,8723 
0,8679 
0,8641 
0,8601 
0,8562 
0,8519 
0,8471 
0,8414 
0,8374 
±0,4 
0,8333 
0,8283 
0,8226 
0,8169 
0,8119 
0,8059 
0,7999 
0,7933 
0,7853 
0,7793 
±0,5 
0,7739 
0,7669 
0,7599 
0,7531 
0,7463 
0,7388 
0,7319 
0,7237 
0,7157 
0,7077 
±0,6 
0,6999 
0,6891 
0,6802 
0,6723 
0,6670 
0,6595 
0,6488 
0,6386 
- 
- 
Example For mean of ±0,520kPa the maximum permissible standard deviation is 0,7599 kPa.  
 
 
12. Anticipated Adverse Effects and Precautions for Use 
12.1 Precautions for Use in Operating Environment 
Do not use in locations exposed to moisture. 
• 
Do not use the device with wet hands. 
• 
Do not store the device in direct sunlight. 
• 
Do not store near heating appliances. 
• 
Avoid storing in areas with sudden humidity changes or poor ventilation. 
• 
Do not store in locations where the device may be subjected to excessive impact or vibration. 
• 
Use the device within an ambient temperature of 5–40°C and relative humidity of 5–95%. 
• 
Consider ambient temperature and humidity during use, and keep the device away from dust, chemicals, 
and flammable substances. 
• 
Do not disassemble or dismantle the device. 
 

 
22 
[H2-BP] Clinical study Report V1.0 
12.2 Precautions During Use 
• 
Do not drop or subject the device to strong impacts. 
• 
Do not measure blood pressure after smoking, drinking alcohol, exercising, bathing, eating, or consuming 
caffeine. 
• 
Do not activate the device when it is not worn on the wrist. 
• 
Dispose of the device, components, and accessories in accordance with local regulations to prevent 
environmental pollution. 
• 
Check for any visible abnormalities on the blood pressure monitor. 
• 
Inspect the charging cable for visible damage or abnormalities. 
 
12.3 Anticipated Adverse Effects 
• 
Using the device during an MRI scan may result in severe burns. Do not wear the device during MRI 
procedures. If this occurs during proper use, immediately remove the device from the patient. 
• 
Avoid placing the blood pressure cuff over sites with arterial catheters or intravenous lines. 
• 
Individuals with severe hematological disorders or blood conditions should use the device under a doctor’s 
supervision. Temporary bruising or bleeding may occur due to cuff compression. 
 
12.4 General Precautions 
• 
Do not adjust medication dosage based on the measurement results. 
• 
Take medications only as prescribed by a doctor. The diagnosis and treatment of hypertension can only be 
performed by a physician. 
• 
Consult a doctor before using this device if you experience any of the following conditions: 
• 
Arrhythmias such as atrial or ventricular extrasystoles or atrial fibrillation, arteriosclerosis, reduced arterial 
elasticity, diabetes, advanced age, pregnancy, preeclampsia (eclampsia or pre-eclampsia), or kidney disease. 
• 
Movement, tremors, or chills during measurement may affect blood pressure readings. 
• 
Do not use the device simultaneously with other electronic medical devices. 
• 
Do not measure blood pressure on wrists that are injured or under treatment. 
• 
If you experience pain or other unusual skin sensations while using the device, stop using it immediately 
and consult a doctor. 
 
For more details, refer to Appendix 2_H2-BP User Manual0-42_Full Document. 
 
 

 
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[H2-BP] Clinical study Report V1.0 
13. Criteria on Termination and Early Suspension (Criteria on drop out in the middle and etc.) 
The test may be terminated or stopped in the middle for the patients falling on the following cases.    
• 
When the subject withdrew the agreement for participation 
• 
When the study is discontinued due to severe abnormal reaction or contingent accident 
• 
When the subject does not visit and follow the procedures specified in the plan or at impossibility of those 
matters  
• 
Difficulties on continuing the study due to the severe complication occurrence 
• 
When the subject inappropriate to the selection criteria participated into the study 
• 
When the subject falling on the exclusion criteria participated into the study 
• 
When the blood pressure difference measure with the reference device is over the following error range  
- 
Entire data from the experimenters is excluded when any pair of the blood pressure data at the 
systolic area measured with the reference device is differed over 1.60kPa.  
- 
Entire data from the experimenters is excluded when any pair of the blood pressure data at the 
diastolic area measured with the reference device is differed over 1.07kPa.  
• 
Other cases decided as disturbing the consistent study by the researcher-in-charge.  
The experimenter is entitled to stopping the study freely when the experimenter withdraws the agreement for 
participating. The reasons and the data related to the clinical study shall be recorded and kept when the study is 
suspended.    
14. Criteria, Methods, and Reporting for the Assessment of Safety, Including Adverse Events 
14.1 Safety Evaluation Variables 
1) 
Adverse Events (AEs) 
Any clinically significant medical condition or abnormality observed after the application of the blood 
pressure monitor will be recorded as an Adverse Event (AE). Clinically significant abnormalities identified 
during safety assessments, such as vital sign monitoring or physical examinations, will also be classified as 
AEs. If a clinically significant medical condition or abnormality confirmed before the application of the 
investigational device worsens after its application, it will be considered a new AE. 
 
14.2 Definitions of Adverse Events 
1) 
Adverse Event (AE) 
An AE refers to any unintended sign (e.g., abnormal laboratory finding), symptom, or disease that occurs in a 
subject during the clinical trial, whether or not it is causally related to the investigational device. 
 
2) 
Adverse Device Effect (ADE) 
An ADE refers to any harmful and unintended reaction caused by the investigational device, for which a 
causal relationship with the device cannot be excluded. 
 
 
 

 
24 
[H2-BP] Clinical study Report V1.0 
3) 
Unexpected Adverse Device Effect  
A Unexpected Adverse Device Effect is an ADE that differs in nature or severity from the information 
provided in the investigator’s brochure, device labeling, or other available medical device documentation. 
 
4) 
Serious Adverse Event/Serious Adverse Device Effect (Serious AE/ADE) 
An SAE/SADE refers to an AE or ADE that meets any of the following criteria: 
(1) Results in death or poses a life-threatening risk 
(2) Requires hospitalization or prolongation of existing hospitalization 
(3) Results in permanent or significant disability or functional impairment 
(4) Causes a congenital anomaly or birth defect 
(5) Involves other medically significant conditions 
 
For medically significant situations that are not explicitly listed but are deemed to have a serious impact on the 
subject's health and well-being, the determination of SAE will depend on the medical judgment of the 
investigator and relevant experts. Pre-planned hospitalizations or treatments, as well as hospitalizations for 
unchanged pre-existing conditions during the trial, will not be classified as SAEs. 
 
14.3 Safety Assessment Criteria and Methods 
Consider the frequency and severity of adverse events described in the supporting documentation, together 
with any abnormal findings if other clinical tests are performed. Adverse events should be recorded and 
categorized according to the medical glossary for regulated adverse events and documented in the case record, 
including whether the event occurred, the name of the event, the date of occurrence, the outcome, the date of 
disappearance, whether it was a serious adverse event (SAE), the severity of the event, the causal relationship to 
the investigational device, the treatment involved, and whether it was treated. 
1) 
Severity of Adverse Events 
The severity of AEs will be assessed using the following criteria: 
(1) Mild: Causes minimal discomfort that does not interfere with normal daily activities and is easily 
tolerated by the subject. 
(2) Moderate: Causes noticeable discomfort that significantly interferes with daily activities. 
(3) Severe: Causes discomfort that makes normal daily activities impossible. 
Expected adverse reactions will also be classified as AEs, and their severity will be categorized as mild, 
moderate, or severe. Other adverse effects due to surgical interventions will be managed through medication 
or surgical treatment, and the investigator may decide to terminate the trial if necessary. 
2) 
Causal Relationship Between Adverse Events and the Investigational Device 
(1) Definitely related: The temporal relationship between the event and device use is plausible, and no 
other cause better explains the event. The AE resolves upon discontinuation of device use and 
reoccurs upon reapplication (if reapplication is feasible). Additionally, the AE is consistent with 
previously known information about the device. 

 
25 
[H2-BP] Clinical study Report V1.0 
(2) Probably related: There is evidence of device use, the temporal relationship between device use and 
AE occurrence is plausible, reapplication is unnecessary, and the AE resolves upon discontinuation 
of the device. 
(3) Possibly related: There is evidence of device use, and the temporal relationship is plausible, but 
other potential causes cannot be ruled out. The AE resolves upon discontinuation of the device. 
(4) Possibly not related: There is evidence of device use, but a more probable alternative cause exists. 
The AE resolves upon discontinuation of the device, or the causality remains unclear. Additionally, 
if reapplication is performed (where feasible) and the AE does not recur, or the causality remains 
unclear, the event is considered possibly not related. 
(5) Definitely not related: The device was not used, or the temporal relationship between device use and 
AE occurrence is implausible, or a clear alternative cause is identified. 
(6) Unknown: Information is insufficient or conflicting, and further investigation is not feasible or 
cannot confirm causality. 
3) 
Treatment and progress 
During this clinical study, the principal investigator and personnel in charge shall ensure the safety of the 
subjects, and in the event of a serious adverse medical device event (SADE), prompt and appropriate measures 
shall be taken to minimize the adverse event, and the principal investigator may stop the trial in consultation with 
the sponsor. All adverse events occurring during the clinical study period, even if not related to the medical 
device, shall be recorded in detail in the case record, including symptoms and signs, onset/end date, severity, 
treatment and outcome, and relationship to the test device. In addition, the adverse event shall be observed, as far 
as possible, until the adverse event returns to the condition or baseline value prior to the application of the 
medical device, or until the principal investigator or responsible person can determine that the adverse event has 
normalized, or until further observation is deemed unnecessary. 
 
14.4 Safety Reporting Method 
The Principal Investigator (PI) shall educate the study personnel, subjects, and legally authorized 
representatives on all potential adverse events (AEs) that may occur following the use of the investigational 
device. Subjects shall also be instructed to report any events that occur post-use. 
During the clinical study, the investigator must report all Serious Adverse Events (SAEs) and Serious Adverse 
Device Effects (SADEs) to the designated monitor within 24 hours of becoming aware of the event, regardless of 
their causal relationship with the investigational device. The investigator must also report the event to the 
Institutional Review Board (IRB) according to the safety reporting procedures of the clinical trial site. To protect 
subject confidentiality, the subject identification code shall be used instead of personal identifiers such as name, 
social security number, or address. 
The designated monitor shall submit a written report to the sponsor within 24 hours of receiving the 
SAE/SADE report. The sponsor and IRB shall review the initial report, and if necessary, contact the investigator 
for further details. The sponsor will assess the causal relationship between the adverse event and the 
investigational device. 

 
26 
[H2-BP] Clinical study Report V1.0 
If the investigator considers the event to be serious, unexpected, and potentially related to the use of the 
investigational device, the event shall be documented as an Unexpected Serious Adverse Device Effect (USADE) 
and reported to the Ministry of Food and Drug Safety (MFDS) within the following timeframes: 
(1) Death or life-threatening events: Must be reported within 7 days of awareness, with a follow-up detailed 
report submitted within 8 days of the initial report. 
(2) All other serious or unexpected adverse device effects: Must be reported within 15 days of awareness. 
Events that do not immediately threaten life, result in death, or require hospitalization but are deemed medically 
significant and necessitate immediate intervention based on medical judgment shall also be classified as SAEs. 
For emergency room visits exceeding 24 hours, hospitalization criteria shall be met. However, the following 
situations shall not be classified as SAEs: 
(1) Emergency room visits lasting less than 24 hours 
(2) Pre-planned hospitalizations prior to investigational device application 
(3) Hospitalization for cosmetic surgery 
(4) Scheduled surgeries or procedures without adverse events 
(5) Planned hospitalizations or extended stays for pre-scheduled surgeries or examinations 
 
15. Points to be Considered in Data Analysis and Statistics 
15.1 Statistical Analysis Methods 
(a) Efficacy Analysis Population 
A. Intention-To-Treat (ITT) Population 
All subjects who were randomly assigned for the clinical study must be included in the primary analysis. 
Complete follow-up of all randomized subjects is required. 
B. Full Analysis Set (FAS) Population 
This population adheres most closely and completely to the ITT principle. It includes subjects who 
provided informed consent, participated in the study, received the investigational device, and were 
assessed for the efficacy evaluation variables. 
C. Per Protocol (PP) Population 
This population consists of subjects from the FAS group who completed the trial without major protocol 
deviations. Major protocol deviations include violations of inclusion/exclusion criteria, missing efficacy 
evaluation variables, and other critical deviations. Subjects with significant protocol violations will be 
reviewed and determined in the analysis population adjudication meeting prior to analysis. 
(b) General Principles of Outcome Analysis 
The primary efficacy analysis is performed based on the PP population. For statistical hypothesis testing, a 
two-sided test is conducted with a significance level of 5%, and a two-sided 95% confidence interval is 
presented. 
 

 
27 
[H2-BP] Clinical study Report V1.0 
(c) Handling of Missing Data 
If missing data occur due to dropout or other reasons, no imputation is performed. Analyses will be conducted 
only on the collected data. 
(d) Handling of Outliers 
Outliers are defined as cases where the subject's blood pressure remains inconsistent. Such cases will not be 
reflected in the efficacy evaluation. For criteria regarding inconsistent blood pressure, reference should be 
made to the exclusion criteria and dropout criteria. 
 
15.2 Primary Endpoint 
(1) Average on difference between blood pressures measured with investigational device and comparator 
(2) Standard deviation on the blood pressures measured with investigational device and comparator. (Based on 
count of measurement) 
 
15.3 Secondary Endpoint 
(1) Standard deviation on the blood pressures measured with investigational device and comparator. (Based on 
count of subjects) 
 
15.4 Bland-Altman Analysis 
For the data measured with H2-BP and stethoscope type blood pressure gauge, it is desirable to follow the 
analysis procedures suggested Bland and Altman(1986).10) 11) Make the respective scatter plot on averages of 
blood pressure data at the systolic and diastolic area to compare by matching with the data from H2-BP and 
stethoscope type blood pressure gauge. (See the example of the scatter plot). Make respective plot for the 
systolic and diastolic area.   
Difference between the data from H2-BP and Stethoscope type gauge  
 
Average of data measured with H2-BP and stethoscope type blood pressure gauge 
Average 

 
28 
[H2-BP] Clinical study Report V1.0 
 
Example of scatter plot. N = 255, SD = Standard Deviation to check matching level between the data measured 
at systolic area with H2-BP and stethoscope type blood pressure gauge 
 
 “Average” on the above plot means the average of the data measured with H2-BP and stethoscope type blood 
pressure gauge at each point, and the “difference” is the one between data measured with H2-BP and stethoscope 
type blood pressure gauge at each point. The average should be known from each scatter plot and the horizontal 
line should be drawn to find ±SD and ±2SD.  
16. Measures for Data Confidentiality and Protection of Personal Information 
If the subject consents to the collection of personal information, their data will be coded using a unique 
identification number, excluding any personally identifiable information, to ensure privacy protection. All 
research data will be kept confidential and stored in a secure, access-controlled environment, such as a restricted-
access computer system or a secure physical location, to prevent unauthorized access by individuals other than 
authorized study personnel. 
 
A data safety monitoring assessment will be conducted every three months to evaluate the status of the study 
records. The collected data may be shared with co-investigators, and once data usage and analysis are complete, 
the related documents will be securely stored in a locked facility at Gangnam Severance Hospital. The data will 
be retained for three years following the completion of the clinical study and will be disposed of thereafter. 
 
17. Collection, Management, Storage, and Disposal of Human-Derived Materials and Genetic 
Information 
Not applicable 
18. Subject Recruitment Methods and Informed Consent Process 
18.1 Subjects for Investigational Device Application 
: Subjects for the investigational device application shall include outpatients, inpatients, and volunteers aged 
19 years or older who present with hypotension, normotension, borderline hypertension, or hypertension. 
Voluntary informed consent from the subject is prioritized; however, if the subject is unable to express their 
consent due to endotracheal intubation, cardiopulmonary resuscitation (CPR), or other critical medical 
conditions, informed consent may be obtained from the legally authorized representative (LAR). In such 
cases, additional consent shall be obtained directly from the subject once their condition stabilizes or the 
emergency situation has resolved before discharge. 
If informed consent is obtained from a legally authorized representative, the rationale for obtaining LAR 
consent must be documented in the electronic medical record (EMR) with supporting documentation. 
Informed consent shall be obtained by the Principal Investigator (PI) or designated research personnel in an 

 
29 
[H2-BP] Clinical study Report V1.0 
independent setting where subjects are provided with adequate and clear verbal and/or written information 
about the nature, purpose, potential risks, and benefits of the study. 
Subjects shall be informed that, even after providing written consent, they may withdraw from the study at 
any time without any penalty or consequences 
19. Protection Measures for the Recruitment of Vulnerable Subjects 
: This study involves the collection of blood pressure data and does not impose any additional risk or discomfort 
on the subjects. There are no interventions or invasive procedures added due to participation in the study, and 
participation does not pose any harm to the subjects. 
Regardless of the study’s progress, any abnormal situations that may arise during the subject’s biometric 
monitoring will be managed with emergency medical care, independent of the study’s continuation. 
Even after obtaining informed consent from the subject or proxy consent from a legally authorized representative 
(LAR), the subject retains the right to withdraw consent at any time. Withdrawal from the study will not affect 
the subject’s standard medical care or treatment in any way. 
20. Plan for quality control and reliability assurance (Material Safety Monitoring Plan) 
All study data will be securely stored in restricted-access locations under the responsibility of the Principal 
Investigator (PI). 
 
1. 
Subject data will be coded using a unique identification number different from the enrollment number, 
ensuring that personally identifiable information remains protected. 
2. 
Medical records and test results will be documented in the Case Report Form, with only the necessary 
study variables recorded to prevent exposure of confidential subject information. 
3. 
Under the supervision of the Principal Investigator, data safety monitoring will be conducted every 
three months to ensure the integrity of all subject-related data. The study documentation, including 
source documents, CRFs, and the study protocol, will be cross-verified to ensure data completeness, 
and subject safety data will be reviewed accordingly. 
 
 

 
30 
[H2-BP] Clinical study Report V1.0 
21. Clinical Study plan(Schedule) 
Developm
ent details 
Detailed milestones (19 months) 
2
0
2
2 
2023 
2024 
1
2 
1 
2 
3 
4 
5 
6 
7 
8 
9 
1
0 
1
1 
1
2 
1 
2 
3 
4 
5 
6 
7 
8 
9 
1
0 
1
1 
12 
Study 
Protocol 
and IRB 
Approval 
█ █  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study 
Contract 
and 
Administrat
ive 
Procedures 
Execution 
 
 
█  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subject 
Recruitmen
t and 
Study 
Procedure 
Execution 
 
 
 
█ █ █ █ █ █ █ █ █ █ █ █ █ █ █ █ █ █ █ █ █ █ 
Analyze 
data and 
report 
results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
█ 
 
 
 

 
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[H2-BP] Clinical study Report V1.0 
22. Informed Consent Form 
The clinical study investigator shall provide a comprehensive explanation to the subjects regarding the purpose 
and methodology of the study, the effects of the investigational device, and any potential adverse events. 
Informed consent shall be obtained from the subjects after they have received sufficient information. 
 
Appendix 1: Subject Information Sheet and Informed Consent Form 
23. Management of Investigational Medical Devices 
The Principal Investigator (PI) shall be designated as the person responsible for managing the investigational 
device (H2-BP, manufactured by Charmcare). Records shall be maintained regarding the receipt, use, and 
transfer of the investigational device, including the date of receipt, product serial number, name of the recipient 
or user, quantity used, and reason for use. Upon completion of the clinical study, the investigational device and 
control device shall be returned to Charmcare in accordance with the procedures established by the manufacturer. 
The device manager shall ensure that the power status and operational condition of the device are checked 
regularly. When not in use, the device shall be stored with the power turned off, following the instructions in the 
user manual. The investigational device (H2-BP by Charmcare) shall be stored in an environment with a 
temperature range of 10°C to 40°C and a humidity range of 15% to 90%. 
 
 
 

 
32 
[H2-BP] Clinical study Report V1.0 
24. References 
1. ISO 81060-2 Third edition 2018-11 Non-invasive sphygmomanometers - Part 2: Clinical investigation of 
intermittent automated measurement type [including: Amendment 1 (2020)] 
2. EN 1060-4 Non-invasive sphygmomanometers — Part 4: Test procedures to determine the overall system 
accuracy of automated non-invasive sphygmomanometers. 
3. O’Brien E.Working Group on Blood Pressure Monitoring of the European Society of Hypertension. 2010) 
European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure 
measuring devices in adults, Blood Press. Monit. 15, pp.23–38 
4. M. Haghayegh, N. Behzadfar and G. Shahgholian, "Clinical Validation of the Saadat NIBP Module 
According to the BS EN ISO 81060-2 Protocol," 2020 17th International Conference on Electrical 
Engineering/Electronics, Computer, Telecommunications and Information Technology (ECTI-CON), 2020, 
pp. 173-176, doi: 10.1109/ECTI-CON49241.2020.9158130. 
5. Demographic trend and statistical results on death cause on 2022 by Social Statistics Bureau, Statistics 
Korea, September 21, 2023 
6. Centers for Disease Control and Prevention, Heart Disease Facts, Centers for Disease Control and 
Prevention, 2022 Jul. 
7. Committee of treatment guidelines in The Korean Society of Hypertension, Hypertension treatment 
guidelines 2018, The Korean Society of Hypertension, November 2018  
8. Choo Jina "A Clinical Evaluation on the Accuracy of Electronic Blood Pressure Gauge for Home Use” 
Journal of Korean Academy of Fundamentals of Nursing 9.1 (2002): 101-112. 
9. Lithell H, Berglund L. Validation of an oscillometric blood pressure measuring device: a substudy of the 
HOT 
Study. 
Hypertension 
Optimal 
Treatment. 
Blood 
Press. 
1998 
May;7(3):149-52. 
doi: 
10.1080/080370598437358. PMID: 9758084. 
10. Medical Instrument Division, Guidelines for Evaluation on Accuracy of Electronic Blood Pressure Gaguge 
Ministry of Food and Drug Safety, June 2007 
11. Kuwabara M, Harada K, Hishiki Y, Ohkubo T, Kario K, Imai Y. Validation of a wrist-type home nocturnal 
blood pressure monitor in the sitting and supine position according to the ANSI/AAMI/ISO81060-2:2013 
guidelines: Omron HEM-9601T. J Clin Hypertens. 2020;22:970–978 
12. Bland JM, Altman DG. Measuring agreement in method comparison studies. Stat Methods Med Res. 1999 
Jun;8(2):135-60. doi: 10.1177/096228029900800204. PMID: 10501650.