ModPG3 Adult and Pediatric AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms
Conditions: Blood Pressure
Sponsor: Welch Allyn

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
Page 1 of 30 
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Author: 
 
Version 
Sec, Pg, Para 
Changed 
Description of Change 
Reason for Change 
Date Version 
Created 
Version 
Created By 
(initials) 
A 
All 
Initial Release 
Initial Release 
 
 
B 
All pages 
Pg 5 
Pg 6-8  
Pg9  
Pg 11  
Pg 12-14  
Pg 24 CRF 
Pg 28 
Demographic 
sheet 
Included Sure and StepBP 
algorithms and updated 
signers 
General Info updated 
Cuff updates Per ISO. 
Changed work prototype to 
investigational device 
Design- Clarify 3rd observer 
added BP cuff note for 
clarity 
Updates to 
inclusion/exclusion criteria 
Updates to Limb size and 
update to steps 
CRF Updates 
Deleted inches and pounds 
to align with metric system 
ISO standard updates  
 
 
C 
All 
Updated the document to 
the new protocol format. 
Added clarifications to the 
document to make specifics 
about the protocol clearer. 
Template update  
 
 
D 
1. Required
Approvers
2.Pg 14, 
Section C1 
1.
 
 
2.
Updated consent 
criteria to include 
1. Team members changed
2. Inclusion criteria update 
to include large population 
that understands/speaks 
French language
 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
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Pg 16, VIIIB 
Appendix C, 
#3 
speaking French 
language. 
E 
1.Required 
Approvers 
2. Pg10 I.E.
3. Pg 16. C.2
Exclusion
Criteria last 
bullet. Pg 29 
Appendix C 
#16
4.VIII C Data 
Collection Pg 
19 
5.Pg 21. XA 
and pg 23. 
XH 
1. 
 
2.Added Publication and 
Disclosure section  
3.Exclusion Criteria and 
appendix C #16 updated to 
include Subject is pregnant 
and/or breastfeeding  
4.Elaborated on steps 20 
and 21-No further 
treatment needed post 
study participation  
5.Added Section A. Training 
of Investigator & Site Staff 
and Section XH 
Discontinuation of the Study 
per MOH 
recommendations.  
1. Team members changed
2. MOH recommendations
3. MOH recommendations
4.MOH recommendations 
5. MOH recommendations
 
 
F 
Pg 4. Sponsor 
Contact 
Pg.16 V.C. II. 
And Pg 28 
Appendix C 
#10 
Pg 16V.C. 
and Pg 28 
Appendix C 
Pg 27 
Appendix B 
 
Bullet: Subjects with clotting 
disorders or taking 
prescribed blood thinners. 
Added Right Arm as an 
inclusion criteria to take a 
blood pressure 
Added Gender to CRF 
Team member updates 
Updated exclusion criteria 
requirement to remove 
“prescribed blood thinners” 
Align with ISO requirements 
Align with ISO requirements 
 
 
G 
Pg 17 VIII A 
#2.1 and 5 
1.
Revised statement to 
add laying comfortably
with legs uncrossed and
1.
For clarification on 
positioning of subjects 
 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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Pg 18-Pg 19 
VIII C #1.2.1 
 
Pg 18 VIII C 
#2 
 
Pg 18 VIII C 
#6 
 
Pg 19 VIII C 
#9.2 
 
 
Pg 19 VIII C 
#18 
 
 
Pg 24,27, 28 
Appendix A-
C 
added “operated by 
Observer 3” 
 
2.Revised statement to add 
laying comfortably with legs 
uncrossed 
 
3.Revised statement to add 
prior to reference reading 
 
4.Revised statement to 
described how to measure 
the arms circumference 
 
 
5.Revised statement to 
define a subject with an 
irregular rhythm as a 
screening failure 
 
6.Revised statement to align 
target number of readings 
to the ISO 
 
 
 
 
7.Added ‘Sample’ to CRF 
and for clarification for 
Observer role  
 
2. For clarification on 
positioning of subjects 
 
3. For clarification on 
when to take a pulse 
 
4. For clarification on how 
to measure the arm to 
determine the cuff to 
use 
 
5. For clarification on how 
to manage a subject 
with an irregular 
rhythm 
 
6. For clarification on 
number of reference 
readings to take to 
complete a subject 
enrollment per ISO  
 
7. Admin change 
H 
Pg 12 III A 2 
Pg 28. CRF 
Reverted Child  Ref cuff 
range from 20-26 to 22-26 
Admin change: transcription 
error between versions 
 
 
J 
Pg 4- Clinical 
Sites  
Pg 14 V.a. 
Removed sites listed  
 
Added option to have 
internal recruitment 
Admin changes 
Expand option for 
recruitment. 
 
 
 
. 
Required Approvers 
  
 
 
 
 
 
 
 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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Regulatory Representative 
 
 
 
Risk Representative 
 
 
Clinical Lead 
 
 
ModPG3 Adult-Ped ISO 81060-2 Study 
 
Welch Allyn Products: 
 
 
 
Protocol Number: 
60115909  
 
Principal Investigator: 
 
 
 
 
 
 
Sponsor Local Contacts: 
 
 
 
 
 
 
 
Sponsor: 
 
 
 
 
 
 
 
 
 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
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2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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Contents 
I.
GENERAL INFORMATION .............................................................................................................................................. 7 
A.
PURPOSE ................................................................................................................................................................................... 7 
B.
INTENDED USE, INDICATIONS FOR USE, INTENDED PURPOSE ............................................................................................................ 7 
C.
DETERMINATION OF NONSIGNIFICANT RISK INVESTIGATION ............................................................................................................. 8 
D.
COMPLIANCE STATEMENT............................................................................................................................................................ 9 
E.
PUBLICATION AND DISCLOSURE .................................................................................................................................................. 10 
II.
STUDY OBJECTIVES ..................................................................................................................................................... 10 
A.
PRIMARY OBJECTIVE/ENDPOINT ................................................................................................................................................. 10 
III.
STUDY DESIGN ............................................................................................................................................................ 10 
A.
EQUIPMENT ............................................................................................................................................................................. 10 
B.
DESIGN ................................................................................................................................................................................... 11 
IV.
INFORMED CONSENT .................................................................................................................................................. 13 
V.
STUDY POPULATION ................................................................................................................................................... 14 
A.
STUDY SUBJECT DEMOGRAPHICS ................................................................................................................................................ 14 
B.
EXPECTED TIME REQUIREMENTS ................................................................................................................................................. 15 
C.
SUBJECT SELECTION CRITERIA ..................................................................................................................................................... 16 
VI.
SUBJECT CONFIDENTIALITY ......................................................................................................................................... 16 
VII.
SUBJECT REMUNERATION...................................................................................................................................... 17 
VIII.
STUDY PROCEDURES .............................................................................................................................................. 17 
A.
EQUIPMENT SETUP ................................................................................................................................................................... 17 
B.
INFORMED CONSENT AND HIPAA AUTHORIZATION ...................................................................................................................... 18 
C.
DATA COLLECTION .................................................................................................................................................................... 18 
IX.
DATA ANALYSIS AND REPORTING .............................................................................................................................. 20 
A.
CRITERION 1 ............................................................................................................................................................................ 20 
B.
CRITERION 2 ............................................................................................................................................................................ 21 
C.
OTHER REPORT REQUIREMENTS ................................................................................................................................................. 21 
X.
ADMINISTRATION OF THE STUDY .............................................................................................................................. 22 
A.
TRAINING OF INVESTIGATOR & SITE STAFF ................................................................................................................................... 22 
B.
MONITOR SITE VISITS ................................................................................................................................................................ 22 
C.
MAINTENANCE OF STUDY RECORDS ............................................................................................................................................ 23 
D.
RISK/SAFETY ASSESSMENT ......................................................................................................................................................... 23 
E.
ANTICIPATED BENEFITS TO SUBJECTS OR OTHERS .......................................................................................................................... 23 
F.
ADVERSE EVENTS ...................................................................................................................................................................... 23 
G.
UNANTICIPATED ADVERSE DEVICE EFFECTS .................................................................................................................................. 23 
H.
DISCONTINUATION OF THE STUDY ............................................................................................................................................... 23 
APPENDIX A: SAMPLE NIBP CYCLE RESULTS DATA SHEET ................................................................................................... 25 
APPENDIX B: SAMPLE DEMOGRAPHIC SHEET ..................................................................................................................... 28 
APPENDIX C: SAMPLE STUDY SUBJECT ELIGIBILITY FORM ................................................................................................... 29 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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I.
General Information
A. Purpose
Automated blood pressure cuff measurement is the standard in numerous medical settings today.
Oscillometric devices using deflation algorithms estimate the amplitude of pressure changes as the
cuff deflates from above the systolic pressure. The amplitude suddenly increases as the pulse breaks
through the occlusion of the artery. As the cuff pressure decreases further, the pulsations increase in
amplitude, reaching a maximum level (which approximates the mean pressure), and then diminishes. 
Studies show that, especially in critical cases (arrhythmia, vasoconstriction, hypertension, shock),
oscillometric devices are more accurate and consistent than devices using other non-invasive
measuring techniques. 
This study is designed to provide supporting documentation for the ModPG3 module operating with
SureBP and StepBP algorithms. Testing will be performed with a production equivalent CVSM modified
to use ModPG3 (ModPG3 investigational device), running the SureBP and StepBP algorithms using the 
FlexiPort Reusable Blood Pressure Cuff on an adult and pediatric population. The process described
below will be followed per algorithm in accordance with the same arm sequential method called out
in ISO 81060-2:2018 + A1:2020.
The purpose of this study is to test the algorithms contained in the ModPG3 on Adult and Pediatric
subjects to determine if they meet the requirements of ISO 81060-2:2018+A1:2020 Non-invasive
sphygmomanometers – Part2: Clinical investigation of automated measurement type.
This clinical study shall follow section 5 “Clinical investigation with an auscultatory reference
sphygmomanometer” from I.S. EN ISO ISO 81060-2:2018&A1:2020 Part 2: Clinical investigation of
intermittent automated measurement type -Amendment 1 (ISO 81060-2:2018/Amd 1:2020).  The
subject populations covered by this study are adult subjects defined as greater than 12 years old, and 
pediatric subjects defined as 3 to 12 years of age.
ISO 81060-2:2018/Amd 1:2020 defines two methods that can be used to test devices according to this
method.  This study will use the same arm sequential method as defined in section 5.2.4.1 of the
standard.
Testing of the ModPG3 on neonate and infant subjects under 3 years of age is not included in this
study.
B. Intended Use, Indications for Use, Intended Purpose
1. ModPG3 Investigational Device (Connex Vital Signs Monitor modified to include ModPG3) 
•
Intended Use:  ModPG3 is a noninvasive blood pressure measurement system that
measures a signal from which systolic, diastolic, and mean can be derived through the
use of a blood pressure cuff.
•
Indications for Use:  ModPG3 will provide interfaces to allow the host to implement
manual, long-term automated and short-term automated modes per ISO 80601-2-30.
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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ModPG3 also provides patient modes that support neonate, infant, pediatric, and 
adult patients as defined in ISO 81060-2. 
•
Intended Purpose:  ModPG3 will provide interfaces to allow the host to implement
manual, long-term automated and short-term automated modes per ISO 80601-2-30.
ModPG3 also provides patient modes that support neonate, infant, pediatric, and
adult patients as defined in ISO 81060-2.
2. Specific limitations pertaining to this study
The scope of this study is limited to subjects that are 3 years and older. This limits the use of the
ModPG3 investigational device to its adult/pediatric mode. A more detailed description of that
mode is as follows:
•
2 user selectable algorithms (SureBP or StepBP)
•
Patients 3 and up 
•
Total Limb Circumference Range 12 to 55 cm.
•
Cuffs:
Model Number 
Cuff Name 
Cuff Range (cm) 
REUSE-08 
Small Child 
12-16 
REUSE-09 
Child 
15-21 
REUSE-10 
Small Adult 
20-26 
REUSE-11 
Adult 
25-34 
REUSE-11L 
Adult Long 
25-34 
REUSE-12 
Large Adult 
32-43 
REUSE-12L 
Large Adult Long 
32-43 
REUSE-13 
Thigh 
40-55 
C. Determination of Nonsignificant Risk Investigation
The risks associated with the ModPG3 investigational device were assessed and documented in the
ModPG3 Hazard Analysis, 
.  All hazards and risks are accounted for in this protocol. The 
Hazard Analysis also supports the determination that this study is not a significant risk (NSR) study per 
21 CFR 812.3(m). 
For detailed risk analysis and risks for the investigational device in the monitor system, see Connex
Vital Signs Monitor (CVSM) Risk Assessment Summary (RAS), 
. Potential hazards for the 
ModPG3 investigational device were identified in the ModPG3 Hazard Analysis 
 with risk 
acceptance occuring in the CVSM RAS. 
Risks related to the Flexiport Cuffs used in this investigation are assessed in the BP Cuffs RAS 
. The CVSM was previously FDA cleared under 510(k)-K171621. The FlexiPort Reusable Blood 
Pressure Cuff is an FDA cleared device (510(k)- K070060. There are no anticipated risks or adverse
device effects to be further assessed. There are no contraindications for use in the proposed study /
study population (See description of Study Population below)
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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This study is a Non-Significant Risk (NSR) Investigation because the study devices do                                 
not present a potential for serious risk to the health, safety, or welfare of the subject. The study devices 
are not implants, do not support or sustain human life, and are not substantially important in 
diagnosing, curing, mitigating or treating disease or in preventing impairment to human health.   
This testing does not represent a potential for serious risk to the health, safety, or welfare of a 
subject. This assessment is based on the Code of Federal Regulations, Section 21, Part 812, Subpart 
A, as the testing: 
• 
Is noninvasive. 
• 
Does not require an invasive sampling procedure that presents significant risk.  
• 
The devices are not used in sustaining or supporting human life.   
• 
Does not by design or intention introduce energy into a subject. 
• 
During this testing, no reliance will be made on data collected via the ModPG3 investigational 
device for the purpose of making a medical diagnosis or clinical determinations.  
• 
Risks are minimized by using procedures which are consistent with sound research design and 
already being performed on the subject in the clinical environment. 
Furthermore, testing will be performed with intended users in their respective intended use 
environments and the data collected will not be used for clinical diagnostics or patient 
management. The device will also be labeled as an investigational device and not for clinical use.  
D. Compliance Statement 
This study will be conducted in compliance with the following regulations, standards, and guidance, as 
incorporated into Standard Operating Procedure (SOP)
 CGP—Good Clinical Practice: 
• 
I.S. EN ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good 
clinical practice 
• 
21 CFR 50 Protection of Human Subjects 
• 
21 CFR 54 Financial Disclosure by Clinical Investigators 
• 
21 CFR 56 Institutional Review Boards 
• 
21 CFR 812 Investigational Device Exemptions 
• 
Medical Device Regulation (EU) 2017/745 
• 
ICH E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) 
Institutional Review Board/Independent Ethics Committee (IRB/IEC) approval must be obtained from 
each institution’s IRB/IEC of record. Institutions that do not have an IRB/IEC of record may use an 
independent IRB. 
Health Insurance Portability and Accountability Act (HIPAA) authorization will be required as health 
information will be obtained from the human subjects. 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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E. Publication and Disclosure 
 
In accordance with the Declaration of Helsinki, a description of the clinical investigation shall be 
registered in a publicly accessible database before the start of recruitment activities and the content shall 
be updated throughout the conduct of the clinical investigation. 
The data generated by this study are the property of the Sponsor. This data may be used by the Sponsor, 
now and in the future, for presentation or publication at the Sponsor’s discretion or for submission to 
regulatory agencies. In addition, the Sponsor reserves the right of prior review and approval of data from 
this study relative to the potential release of proprietary information to any publication or for any 
presentation. 
II. Study Objectives 
A. Primary Objective/Endpoint 
The primary objective of this study is to collect a combination of non-invasive blood pressure readings 
using the ModPG3 investigational device and by trained clinicians using the auscultatory method.  This 
data will be used to determine compliance of the ModPG3 with ISO 81060-2:2018/Amd 1:2020 on the 
adult and pediatric patient population.  
III. Study Design 
A. Equipment 
The equipment used in this study falls into 2 categories.  The first category is equipment used with the 
ModPG3 investigational device, and the second category is equipment needed by the clinicians to take 
auscultatory reference readings per ISO 81060-2:2018/Amd 1:2020. 
Note: Additional equipment that is not listed here may be necessary to complete testing.  The 
equipment used during testing will be documented on the corresponding equipment accountability 
log. 
1. ModPG3 Investigational Device 
• 
Connex Vital Sign Monitor with ModPG3  
• 
Laptop 
• 
Blood Pressure Data Collection Software (not used for test report analysis) 
• 
USB cable 
• 
Power strip 
• 
Welch Allyn FlexiPort Reusable Blood Pressure Cuffs 
Model Number 
Cuff Name 
Cuff Range (cm) 
REUSE-08 
Small Child 
12-16 
REUSE-09 
Child 
15-21 
REUSE-10 
Small Adult 
20-26 
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NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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REUSE-11 
Adult 
25-34 
REUSE-11L 
Adult Long 
25-34 
REUSE-12 
Large Adult 
32-43 
REUSE-12L 
Large Adult Long 
32-43 
REUSE-13 
Thigh 
40-55 
 
2. Auscultatory Equipment 
• 
Reference Sphygmomanometer1 
• 
Reference Cuffs2 
Model Number 
Cuff Name 
Usable Cuff Range (cm) 
5082-07 
Newborn 
10-14 
5082-03 
Infant 
14-20 
5082-42 
Child 
22-26 
5082-43 
Adult 
29-37 
5082-44 
Large Adult 
34-44 
5082-45 
Thigh 
41-58 
• 
Dual Auscultatory Stethoscope 
• 
Tape measure 
• 
Stopwatch 
Note 1: The reference sphygmomanometer used in this study will comply with the requirements 
of ISO 81060-2:2018/Amd 1:2020, except that the maximum permissible error will be +/-1 mmHg 
per NIST traceable calibration verification. 
Note 2: The newborn and infant two-piece cuffs are included in the study because of the need to 
cover the usable range of FlexiPort Reusable cuffs from size 8 (small child) to 13 (Thigh).  The ISO 
81060-2:2018/Amd 1:2020 provides limitations to the usable range for reference cuffs based on 
the size of the cuff’s bladder.  The small child cuff has a range of 12 to 16 cm and the child cuff has 
a range of 15 to 21 cm.  The usable range of the newborn two-piece cuff is 10 to 14 cm and the 
infant cuffs is 14 to 20 cm.  These cuffs are included to provide coverage for the entire 12 to 55 cm 
range of the device under test.  All readings will be taken on subjects 3 years or older and the name 
of the cuffs newborn and infant does not mean that those subjects shall be included in the study. 
B. Design 
1. Study Design 
This study is a multi-person, non-randomized study.  Data will be collected at clinical sites enrolled 
to participate in the study.   
The study will be conducted in 2 parts.   
• 
Part 1 will test subjects using the ModPG3 Investigational device with the SureBP algorithm 
enabled.   
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
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• 
Part 2 will test subjects using the ModPG3 Investigational device with the StepBP algorithm 
enabled. 
Each part of the study will be run in 2 phases.   
• 
Phase 1 will enroll a minimum of 30 subjects that meet the inclusion criteria.  At least 20 adult 
and at least 10 pediatric subjects will be included.  At the completion of phase 1 the data will 
be reviewed by the sponsor and the sponsor will decide whether to continue with phase 2.   
• 
Phase 2 will enroll a minimum of 55 more qualified subjects. 
The resulting dataset when combining phase 1 and phase 2 (for each Part of the study), at a 
minimum, will contain the following. 
• 
At least 85 subjects (Maximum 150) 
• 
35 pediatric subjects (3 – 12 years old) 
• 
Remaining subjects will be adult subjects (over 12 years old) 
A breakdown of all subject inclusion criteria is detailed in section V subsection C. 
The study requires three observers.  The first two observers take auscultatory readings that are 
averaged to use as reference blood pressures.  The third observer operates the ModPG3 
investigational device and records the readings for that device. 
The two clinicians taking reference readings will be blinded to each other’s readings and to the 
investigational device readings as required by section 5.2.2 of ISO 81060-2:2018/Amd 1:2020. 
2. Sample Size Justification 
This study is being conducted in accordance with ISO 81060-2:2018/Amd 1:2020. The justification 
for the sample size is defined in section 5.1.1 of Appendix A.  The following is an excerpt justifying 
the sample size of 85 subjects. 
The sample size of 85 was determined from the statistics for a normal distribution. 
A 98% confidence interval (α = 0,02) and a statistical power of 95% (β = 0,05) yield a sample 
size requirement of 85 subjects.  This requirement originated from the early work of the 
AAMI blood pressure committee dating from 1987. 
Additionally, a sample size of 85 can be determined from the statistics for a t-distribution.  A 
95% confidence interval (α = 0,05) and a statistical power of 98% (β = 0,02) yield a sample 
size of 85 subjects. 
3. Acceptance Criteria 
Each Part of the study (Part 1: SureBP Algorithm/Part 2: StepBP Algorithm) will be analyzed 
separately and accepted separately.  For each part (Part 1/Part 2), the ModPG3 investigational 
device shall meet Criterion 1 and Criterion 2 as defined in section 5.2.4.1.2 of the ISO 81060-
2:2018/Amd 1:2020 standard. 
The limits for Criterion 1 are: 
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NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
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• 
𝑥𝑥̅𝑛𝑛 shall be within or equal to ± 5.0 mmHg (±0.67 kPa), where 𝑥𝑥̅𝑛𝑛 is the mean value 
between the differences of the n individual paired determinations of the investigational 
device and the observers’ readings for all subjects (calculated separately for systolic and 
diastolic blood pressure). 
• 
𝑆𝑆𝑛𝑛 shall be no greater than 8.0 mmHg (1.07 kPa), where 𝑆𝑆𝑛𝑛 is the standard deviation. 
The limits for Criterion 2 are: 
• 
𝑆𝑆𝑚𝑚 Shall meet the values listed in table 1 or table 2, where for each of m subjects 𝑆𝑆𝑚𝑚is 
the standard deviation of the averaged paired determinations per subject of the 
investigational device and the observers’ readings. 
 
Table 1 – Averaged subject data acceptance (criterion 2) in mmHg 
𝒙𝒙ഥ𝒏𝒏 
Maximum permissible standard deviation, 𝑺𝑺𝒎𝒎, as a function of, 𝒙𝒙ഥ𝒏𝒏 
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 
̶ 
̶ 
̶ 
̶ 
̶ 
̶ 
̶ 
̶ 
̶ 
 
Table 2 – Averaged subject data acceptance (criterion 2) in kPa 
𝒙𝒙ഥ𝒏𝒏 
Maximum permissible standard deviation, 𝑺𝑺𝒎𝒎, as a function of, 𝒙𝒙ഥ𝒏𝒏 
mmHg 
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 0.9266 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 
̶ 
̶ 
For details on how to calculate 𝑥𝑥̅𝑛𝑛,  𝑆𝑆𝑛𝑛, and 𝑆𝑆𝑚𝑚 see section IX. 
IV. Informed Consent 
Documentation of Informed Consent is requested for all subjects participating in this study per 21 CFR 
50.27(a) and ICH E6(R2) 4.8. 
A copy of the Informed Consent document will be available to all participants for review and, if agreed 
upon, the study subject or legally authorized representative (LAR) will sign the IRB/IEC approved 
informed consent.  The patient subject or LAR will be given a copy of the signed consent to keep for their 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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records. They will be informed by the study staff that their participation is voluntary.  They may withdraw 
their participation at any time for any reason without loss of benefits to which they would be entitled.   
The Principal Investigator (PI), or an authorized representative, will be responsible for reviewing the 
informed consent document with the study subjects and LAR, answering all questions, and obtaining a 
signed informed consent for all participants. 
V. Study Population 
A. Study Subject Demographics 
For each part of this study (Part 1: SureBP Algorithm/Part 2: StepBP Algorithm) a full set of subjects as 
prescribed by ISO 81060-2:2018/Amd 1:2020 will be collected. 
 
 
 
 
This may include, but not limited to, malls, zoos, doctors’ offices, or 
retirement community centers. 
.  To 
reduce bias, no more than 15% of the total number of subjects may be recruited through the 
Baxter/Hillrom’s friends and family policy. External data collection will be executed at clinicals sites 
who consent to participating in the study.The demographics required are captured in a series of 
requirements defined in section 5.1 of the standard and are broken up into the following categories: 
number, gender, age, limb size, and blood pressure distribution.  The following sections of this 
document detail the requirements for each of those categories. 
1. Number 
• 
A minimum of 85 subjects shall be included in the study. 
• 
At least three paired blood pressure values shall be taken for each subject. 
• 
There shall be a minimum of 255 valid paired blood pressure values. 
2. Gender Distribution 
• 
At least 30% of the subjects shall be male. 
• 
At least 30% of the subjects shall be female. 
3. Age Distribution 
• 
No children less than 3 years old shall be included in the study. 
• 
35 subjects between 3 and 12 years shall be included in the study. 
• 
All remaining subjects shall be greater than 12 years old. 
4. Limb Size Distribution 
Limb circumference distribution has two requirements.  The first is based on the total limb 
circumference range which is defined as a 12 to 55 cm as noted in the table below.   
• 
At least 20% of the subjects shall have a limb circumference which lies within each quarter of 
the total limb circumference range. 
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NCT Number: NCT05654714

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Document Number: 60115909 
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Quarter Limb Circumference Range (cm) 
1 
12 to under 22.75 
2 
22.75 to under 33.5 
3 
33.5 to under 44.25 
4 
44.25 to 55 
• 
At least 10% of the subjects shall have a limb circumference that lies within the highest octile 
of the total limb circumference range. 
• 
At least 10% of the subjects shall have a limb circumference that lies within the lowest octile 
of the total limb circumference range. 
Octiles 
Limb Circumference Range (cm) 
Low 
12 to 17.375 
High 
49.625 to 55 
The second requirement is that all cuffs shall be tested on at least Ncuff subjects as calculated 
according to the following formula. 
𝑁𝑁𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐= 
𝑟𝑟𝑐𝑐𝑐𝑐𝑐𝑐𝑐𝑐
2 × 𝑟𝑟𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡
× 𝑁𝑁𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡𝑡 
• 
Ntotal is the total number of subjects in the study 
• 
rcuff is the size of the limb circumference range for the cuff  
Model Number 
Cuff Name 
Cuff Range (cm) 
rcuff (cm) 
REUSE-08 
Small Child 
12-16 
4 
REUSE-09 
Child 
15-21 
6 
REUSE-10 
Small Adult 
20-26 
6 
REUSE-11 
Adult 
25-34 
9 
REUSE-11L 
Adult Long 
25-34 
9 
REUSE-12 
Large Adult 
32-43 
11 
REUSE-12L 
Large Adult Long 32-43 
11 
REUSE-13 
Thigh 
40-55 
15 
• 
rtotal is the size of the total limb circumference range.  (55-12 = 43 cm) 
5. Blood Pressure Distribution 
• 
At least 5% of the reference systolic readings shall be less than or equal to 100 mmHg. 
• 
At least 5% of the reference systolic readings shall be greater than or equal to 160 mmHg. 
• 
At least 20% of the reference systolic readings shall be greater than or equal to 140 mmHg. 
• 
At least 5% of the reference diastolic readings shall be less than or equal to 60 mmHg. 
• 
At least 5% of the reference diastolic readings shall be greater than or equal to 100 mmHg. 
• 
At least 20% of the reference diastolic readings shall be greater than or equal to 85 mmHg. 
• 
 
B. Expected Time Requirements 
Commitment time for each subject is expected to be approximately 1 hour for the consent and data 
collection steps to be completed. 
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NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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C. Subject Selection Criteria 
1. Inclusion Criteria 
• 
Subjects must be able to provide an informed consent or have legally authorized 
representative consent to participate. 
• 
Subject must be willing and able to comply with the study procedures. 
• 
Subject must be ≥ 3 years of age 
• 
Subjects that are between 7 and 17 years of age must provide assent to participate in the 
study. 
• 
Subject or legally authorized representative must be able to read, write, speak in English, 
French or Italian. 
• 
Subjects must have an arm circumference in the range of 12-55 cm and fit into the usable 
range for the reference cuffs. 
• 
Subject must be able to have blood pressures measured on the Left or Right arm. 
2. Exclusion Criteria 
• 
Lack of Informed consent. 
• 
Subjects with deformities or abnormalities that may prevent proper application of the 
device under test. 
• 
Subject is evaluated by the investigator or clinician and found to be medically unsuitable for 
participation in this study. 
• 
Subjects with known heart dysrhythmias. 
• 
The subject is in acute distress, i.e., severe pain or, severe emotional distress or agitation 
that would inhibit him/her from participating in the study. 
• 
The subject has any known contraindication to blood pressure measurement. 
• 
Subjects with compromised circulation or peripheral vascular disease.  
• 
Subjects with clotting disorders. 
• 
Subjects that cannot tolerate sitting for up to 1 hour. 
• 
Subject with a blood pressure demographic that has already been filled. 
• 
Subjects with a severe contact allergy to cuff material.  
• 
Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, 
affecting the upper extremities that would affect the application of noninvasive blood 
pressure cuff. 
• 
Subjects whose arm circumference does not fall within the unusable range for the reference 
cuffs. 
• 
Subjects with no audible K5 sound. 
• 
Subject is pregnant and/or breastfeeding. 
VI. Subject Confidentiality 
All participant data will be kept confidential as much as possible. Data collected will include the 
participant identification number to minimize participant identification.  
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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A Participant Screening/Enrollment Log will be utilized to assign all participants with a participant 
identification number to be used to complete data forms. 
VII. Subject Remuneration 
The study sponsor will enter into a written Clinical Trial Agreement (CTA) with each study site. Clinicians 
who participate by collecting data from their patients for the external study will be compensated on a per-
patient basis at the Fair Market Value rate. The study site, its clinicians, or staff will not receive any 
additional payments for participating in this study. 
VIII. Study Procedures 
A. Equipment Setup 
 
Equipment Key  
1 
Dual stethoscope 
2 
Reference sphygmomanometer display 
3 
Reference sphygmomanometer hand pump 
4 
Sphygmomanometer under test 
 
Find a location and set up the equipment so that these requirements are met. 
1. The location shall be quiet enough to ensure the clinicians ability to hear the subject’s pulses when 
taking reference readings. 
2. The location shall have a seat for the subject that allows the subject 
2.1. to be sitting with feet flat on floor or laying comfortably with legs uncrossed  
2.2. has their back, elbow, and forearm supported, 
2.3. places the cuff level with the left ventricle of the heart. 
3. The location shall allow for the positioning of the reference sphygmomanometer in a way that 
allows both observers taking reference measurements to be able to read it and avoid errors due 
to positioning. 
4. The location shall allow sufficient space to ensure Observer 1 and Observer 2 keep their readings 
hidden from each other. 
5. The ModPG3 investigational device, operated by Observer 3, shall be positioned so that its 
readings are hidden from Observer 1 and Observer 2. 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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Once all equipment and space in the location is organized as listed above the equipment is considered 
set up. 
B. Informed Consent and HIPAA Authorization 
The Principal Investigator or his / her designee conducts the informed consent process. 
1. Verify that the subject acknowledges ability to read, write, speak in English, French or Italian. 
2. Instruct the subject to ask questions at any time during the process, especially about things they 
do not understand. 
3. Allow subject ample time to read the entire form and ask questions. 
4. Give a thorough description of the study and the subject’s involvement – especially explain that 
they may withdraw from the study at any time. 
5. After the subject has read the form ask if they understand everything 
6. Ask if they would like to take part in the study and if so explain that they may sign and date the 
form. 
7. Once the subject has signed and dated the informed consent, the principal investigator or 
authorized designee will sign and date the form. 
8. Give a copy of the informed consent to the subject. 
9. No procedure may be performed before the informed consent is signed by the subject. 
If an investigator uses a device without obtaining informed consent, the investigator shall report such 
use to the sponsor and the reviewing IRB/IEC within 5 working days after the use occurs. 
C. Data Collection 
Equipment shall be set up and the subject shall be consented before beginning these steps. 
1. Prepare the subject for the study. 
1.1. The subjects should be asked to empty their bladders prior to sitting down. 
1.2. The subject will be positioned such that the subject: 
1.2.1. Is to be sitting with feet flat on floor or laying comfortably with legs uncrossed 
1.2.2. has the back, elbow and forearm supported 
1.2.3. has the measurement site at the level of the left ventricle of the heart. 
1.3. Recommend that the subject be as relaxed as possible and that they avoid talking during 
the procedure.   
1.4. Before the first reading is taken, five minutes should elapse. 
2. Palpate subject’s pulse checking for a regular rhythm prior to each reference reading 
3. Record subject initials, subject number, and demographic information. 
4. Review the Subject Eligibility Form. If the subject meets the inclusion/exclusion criteria to the 
study, then accept into the study and continue. 
5. Record device information for tracking. (Manufacturer, model #, serial or lot, hardware/software 
control info).  
6. Measure the circumference of the upper arm and place the appropriate size reference blood 
pressure cuff on the bicep of the subject. The upper arm midpoint is first determined by marking 
the arm posteriorly at a point halfway between the acromion and olecranon, measured while the 
arm is flexed 90 degrees at the elbow with the palm facing up. The subject's upper arm 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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circumference shall be determined by measuring at the midpoint of the upper arm while the 
elbow is relaxed, and the arm is dangling freely to the side. 
7. Attach the reference sphygmomanometer to the connector hose on the appropriate port on the 
blood pressure cuff. 
8. Make sure the observers for the reference sphygmomanometer are positioned according to the 
instructions of the reference sphygmomanometer to avoid errors.  
9. An initial baseline reference blood pressure determination from Observer 1 and Observer 2 using 
a dual stethoscope shall be performed.  
9.1. The last audible Korotkoff sound, fifth phase or K5, will be used. If K5 is not audible, the 
subject shall be excluded. Record the baseline reference blood pressure reading. 
9.2. If the observer detects a significant irregular rhythm, they should mark it on the input sheet 
and the subject would be a screening failure. 
9.3. Observers 1 and 2 will show their reading to observer 3.  Observer 3 will confirm that the 
readings don’t differ by more than 4 mmHg and that neither observer marked the reading 
as having an irregular rhythm.  If the reading is good, Observer 3 will indicate it is good.  If 
they differ by more than 4 mmHg, the Observer 3 will indicate that it needs to be repeated. 
10. Once a successful reference reading is taken, apply the appropriate Device Under Test (DUT) cuff. 
11. Connect the DUT to the connector hose on the appropriate port of the blood pressure cuff. 
12. Power on the DUT. Wait at least 60 seconds and then take the initial baseline device-under-test 
blood pressure determination. During the 60-second delay, either Observer 1 or 2 shall measure 
the subject’s pulse rate. 
13. Observer 3 will record the data for the device-under-test when complete  
14. Power off the DUT. 
15. For each subsequent blood pressure determination, wait at least 60 seconds between the 
readings.  
16. The observers will start with the reference sphygmomanometer and will alternate with the DUT. 
The final reading should be on the reference sphygmomanometer. During the 60-second wait 
prior to the DUT reading, Observer 1 or 2 shall measure the subject’s pulse rate. 
17. Record each blood pressure determination and the pulse rate. 
18.  The target for the study is to get five reference readings surrounding four DUT readings for each 
subject.  Once that is achieved, the subject can be disconnected and released from the study.  If 
reference readings need to be replaced, no more than ten reference readings shall be taken.  If an 
eleventh reference reading is required, the subject shall be released from the study and excluded 
from the data analysis.  Make note of this in the notes section of the datasheet. 
19. The observer 1 or 2 will monitor the subject’s comfort level and the cuff test site throughout the 
duration of the study and upon removal of the cuff.     
20. The subject will be advised during the study that he/she may stop the test at any time, free of 
negative repercussions. 
21. All equipment will be removed from the subject. No further treatment will be required upon 
termination/completion of the study. 
22. The observers will record any final notes. The subject will be released with no follow-up required. 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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IX. Data Analysis and Reporting 
Data shall be analyzed according to the formulas called out in section 5.2.4.1.2 of ISO 81060-
2:2018/Amd 1:2020.  The following provides a summary of the formulas and calculations. 
A. Criterion 1 
Criterion 1 has two values that shall be calculated from the data collected in the study for both systolic 
and diastolic independently.  The first is 𝑥𝑥̅𝑛𝑛 which is the mean value of the differences between the 
ModPG3 investigational device and the paired reference reading. The second is 𝑆𝑆𝑛𝑛 which is the 
standard deviation of the errors. The acceptance criteria for this defined in section III Study Design, 
subsection B three. 
1. 𝑥𝑥̅𝑛𝑛 Calculation 
𝑥𝑥̅𝑛𝑛= 1
𝑛𝑛× ෍൫𝑝𝑝𝑆𝑆𝑆𝑆𝑆𝑆𝑖𝑖−𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑖𝑖൯
𝑛𝑛
𝑖𝑖=1
 
𝑥𝑥̅𝑛𝑛 
Is the mean value of the differences 
𝑝𝑝𝑆𝑆𝑆𝑆𝑆𝑆𝑖𝑖−𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑖𝑖 Is the difference between the ith paired blood pressure value.   
𝑝𝑝𝑆𝑆𝑆𝑆𝑆𝑆𝑖𝑖 
Is the ModPG3 investigational device determination. 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑖𝑖 
Is the reference blood pressure for the ith value as calculated according to the 
following formula. 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑖𝑖= 1
4 × ൫𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑖𝑖,1 + 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑖𝑖,2 + 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑖𝑖+1,1 + 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑖𝑖+1,2൯ 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑖𝑖,1 
Is the blood pressure determined by Observer 1 for the ith reading. 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑖𝑖,2 
Is the blood pressure determined by Observer 2 for the ith reading. 
In summary the 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑖𝑖 is the average of the observer readings surrounding the ModPG3 
investigational device determination. 
2. 𝑆𝑆𝑛𝑛 Calculation 
𝑆𝑆𝑛𝑛= ඩ
1
𝑛𝑛−1 × ෍(𝑥𝑥𝑖𝑖−𝑥𝑥̅𝑛𝑛)2
𝑛𝑛
𝑖𝑖=1
 
𝑥𝑥̅𝑛𝑛 
Is the mean value of the differences as calculated above for criterion 1. 
𝑛𝑛 
Is the number of determinations  
𝑥𝑥𝑖𝑖 
Is 𝑝𝑝𝑆𝑆𝑆𝑆𝑆𝑆𝑖𝑖−𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑖𝑖 where i is the ith paired blood pressure determination. 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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B. Criterion 2 
Criterion 2 calculates a single value 𝑆𝑆𝑚𝑚 for systolic and diastolic. 𝑆𝑆𝑚𝑚 represents the standard deviation 
of the averaged paired determinations per subject. The acceptance criteria for this defined in section 
III Study Design, subsection B three. 
1. 𝑆𝑆𝑚𝑚 Calculation 
𝑆𝑆𝑚𝑚= ඩ
1
𝑚𝑚−1 × ෍൫𝑥𝑥𝑗𝑗−𝑥𝑥̅𝑛𝑛൯
2
𝑚𝑚
𝑗𝑗=1
 
𝑥𝑥̅𝑛𝑛 
Is the mean value of the differences as calculated above for criterion 1.  
𝑚𝑚 
Is the number of subjects in the study. 
𝑗𝑗 
Is the index for the individual subject. 
𝑥𝑥𝑗𝑗 
Is the average error for the subjects as calculated by the following formula.   
𝑥𝑥𝑗𝑗= 1
𝑑𝑑× ෍ቀ𝑝𝑝𝑆𝑆𝑆𝑆𝑆𝑆𝑗𝑗,𝑘𝑘× 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑗𝑗,𝑘𝑘ቁ
𝑑𝑑
𝑘𝑘=1
 
𝑑𝑑 
Is the number of determinations per subject. 
𝑘𝑘 
Is the index for the individual element. 
𝑝𝑝𝑆𝑆𝑆𝑆𝑆𝑆𝑗𝑗,𝑘𝑘 
Is the kth device reading for the individual subject. 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑗𝑗,𝑘𝑘 
Is the reference blood pressure calculated according to the following formula. 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑗𝑗,𝑘𝑘= 1
4 × ቀ𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑗𝑗,𝑘𝑘,1 + 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑗𝑗,𝑘𝑘,2 + 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑗𝑗,𝑘𝑘+1,1 + 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑗𝑗,𝑘𝑘+1,2ቁ 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑗𝑗,𝑘𝑘,1 
Is the blood pressure determined by observer 1 for the kth reading for the jth subject. 
𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅𝑗𝑗,𝑘𝑘,2 
Is the blood pressure determined by observer 2 for the kth reading for the jth subject. 
In summary the 𝑝𝑝𝑅𝑅𝑅𝑅𝑅𝑅−𝑠𝑠𝑠𝑠𝑗𝑗,𝑘𝑘 is the average of the observer readings surrounding the ModPG3 
investigational device determination. 
C. Other Report Requirements 
The report shall also include a plot of Arm circumference vs Reading Error for both systolic and diastolic 
where cuff borders are marked with vertical lines. 
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NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
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X. Administration of the Study 
A. Training of Investigator & Site Staff 
The Study Monitor will ensure that the Investigator and study site personnel have understood all 
requirements of the protocol and his/her regulatory responsibilities as an Investigator. Training may 
be provided at an investigator’s meeting, at the study site, and/or by instruction manuals. In addition, 
the Study Monitor will be available for consultation with the Investigator and serve as the liaison 
between the study site and the Sponsor. 
The Investigator is responsible for the conduct of all aspects of the study at the study site and verified 
by signature the integrity of all data transmitted to the responsible party. Whenever the term 
‘investigator’ is noted in the protocol text, it may refer to either the Principal Investigator (PI) at the 
site, or an appropriately qualified, trained and delegated individual of the investigational site. Sub-
investigators or other authorized study personnel are eligible to sign for the Investigator, except where 
the Investigator’s signature is specifically required. No additional clinical training is needed for the use 
of the investigational device. 
 
B. Monitor Site Visits 
Once the clinical site begins to screen and enroll subjects that are willing to participate, the site will 
also be responsible for data collection. The sponsor will be responsible for monitoring the site and 
verifying that the site is following Welch Allyn’s Standard Operating Procedures for study monitoring 
in accordance with Good Clinical Practice (GCP) recommendations and FDA regulatory requirements.  
If the site is not meeting the minimum requirements to conduct the study or has administrative, 
procedural, or data quality deficiencies that require correction in order to comply with regulatory 
requirements, the protocol, or to meet the requirements of the sponsor, the site will be notified in 
writing of the deficiencies and permitted a reasonable opportunity to rectify deficient conditions. The 
inability of the site to rectify seriously deficient conditions in a timely manner or to maintain 
compliance with regulatory requirements may be the cause for termination of the study activities, 
closure of the investigational site, and notification of that decision to the relevant Institutional Review 
Board (IRB), Independent Ethics Committee (IEC), and other regulatory authorities as appropriate. 
The participating site will have an initial qualification visit by the sponsor, routine interim monitoring 
in person or via WebEx and/or phone calls by the sponsor during the study, and a study close-out 
meeting conducted by the sponsor. Additional monitoring meetings may be scheduled as needed. 
Each monitoring meeting will utilize a standard checklist of elements to be reviewed at the site, 
tailored to the specific requirements of the study. Site monitoring visits will routinely review the 
participating site staff roster, study administrative and financial documents, required regulatory 
documentation, status of IRB approvals, changes or actions taken since any previous visit, participant 
recruitment status, documentation of informed consent for each participant, review of adverse 
events, investigational product storage conditions, outstanding data clarification, and a review of data 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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elements against source documentation. Site visits follow standard Welch Allyn procedures, and a 
report will be prepared for study records. 
C. Maintenance of Study Records 
All study-related files must be maintained in a secure storage area to which only authorized personnel 
have access. Welch Allyn must maintain all Clinical Investigation Files for two years following the life of 
the device or seven years whichever is greater. 
D. Risk/Safety Assessment 
There are minimal risks to subjects, as described in Section I, C, Determination of Non-Significant 
Risk.  
E. Anticipated Benefits to Subjects or Others 
There are no direct benefits to subjects for taking part in this study. However, subjects may help Welch 
Allyn develop a new device to help benefit patients in the future.  
F. Adverse Events 
Adverse Events (AEs) will be documented and reported per FDA requirements.  AEs will be recorded 
on the appropriate form per procedure. The appropriate follow-up and safety measures will be 
completed and documented. 
G. Unanticipated Adverse Device Effects 
An Unanticipated Adverse Device Effect (UADE) is any serious adverse effect on health or safety, or 
any life-threatening problem or death caused by, or associated with, a device, to a subject if: 
1. That effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application, or 
2. Any other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects. 
Welch Allyn must conduct an evaluation of any UADE and report the results of the evaluation to the 
FDA, IRB/IEC, and Investigator within 10 working days after receipt of notice.  Where appropriate, 
Welch Allyn will review UADEs for potential impact on clinical test results. 
H. Discontinuation of the Study 
If a clinically significant safety finding is identified during the clinical study, the Investigator or the IRB 
may determine if any change in patient management is needed. The Sponsor shall review AEs and 
assess risks during the conduct of a clinical investigation. The Sponsor shall terminate the clinical 
investigation if an unacceptable risk is confirmed. Decision to restart the study will be made jointly by 
Sponsor, the regulatory authority, the site-specific IRB, and the PI, following evaluation of the problems 
encountered. 
The Investigator may terminate a patient’s study participation at any time during the study if he/she 
judges it to be in the patient’s best interest. 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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If a patient is withdrawn from the study, the study Monitor must be informed in the shortest possible 
time, regardless of the reason for withdrawal. In addition, a patient or the patient’s legally authorized 
representative may discontinue his or her participation at any time during the study. If a patient’s 
participation is discontinued, the reason(s) must be recorded in the source documents and on the 
CRFs. 
If a patient is prematurely removed from the study, all data prior to discontinuation should be 
recorded in the CRF and all available data will be included in the statistical analyses. 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version J 
 
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APPENDIX A: Sample NIBP Cycle Results Data Sheet  
The following sheets are to be used by the 3 observers to record data take for each subject 
 
Observer (Sign):   
 
 
 
 
 
 
Date:   
 
 
Clinical Site:   
Principal Investigator:  
Date:  __ __ __ __        __ __         __ __ 
            Y   Y   Y   Y          M   M          D   D 
Subject ID:  ________________________________ 
Reading 
# 
Reading 
Source: 
 
Time 
(Military) 
Pulse 
Rate 
Systolic 
Pressure 
(mmHg) 
Diastolic 
Pressure 
(mmHg) 
Arm Used 
R-Right arm 
L- Left arm* 
preferred 
Irregular 
pulse 
Cuff Size:  
___________ 
 
Notes: 
SAME ARM SEQUENTIAL METHOD/ DETERMINATION – Observer 1 _____________________ 
BP1 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP2 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP3 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP4 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP5 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP6 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP7 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP8 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP9 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP10 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP11 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP12 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP13 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP14 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP15 
Auscultatory 
 
 
 
 
 
Y or N 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version: J 
 
Page 26 of 30 
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Clinical Site:   
Principal Investigator:  
Date:  __ __ __ __        __ __         __ __ 
            Y   Y   Y   Y          M   M          D   D 
Subject ID:  ________________________________ 
Reading 
# 
Reading 
Source: 
 
Time 
(Military) 
Pulse 
Rate 
Systolic 
Pressure 
(mmHg) 
Diastolic 
Pressure 
(mmHg) 
Arm Used 
R-Right arm 
L- Left arm* 
preferred 
Irregular 
pulse 
Cuff Size:  
___________ 
 
Notes: 
SAME ARM SEQUENTIAL METHOD/ DETERMINATION – Observer 2 _____________________ 
BP1 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP2 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP3 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP4 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP5 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP6 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP7 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP8 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP9 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP10 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP11 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP12 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP13 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP14 
Auscultatory 
 
 
 
 
 
Y or N 
 
BP15 
Auscultatory 
 
 
 
 
 
Y or N 
 
 
Observer (Sign):   
 
 
 
 
 
 
Date:   
 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version: J 
 
Page 27 of 30 
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Observer (Sign):   
 
 
 
 
 
 
Date:   
 
 
 
Clinical Site: 
Principal Investigator: 
Date:  __ __ __ __        __ __         __ __ 
Y     Y    Y    Y             M   M             D    D 
Subject ID:  ________________________________ 
Reading 
# 
Reading 
Source 
 
 
Ref 
Within 
4 mmHg 
Time 
(Military) 
Pulse 
Rate 
Systolic 
Pressure 
(mmHg) 
Diastolic 
Pressure 
(mmHg) 
Arm Used 
R-Right arm 
L- Left arm* 
preferred 
Cuff Size: 
____________________ 
 
File: 
SAME ARM SEQUENTIAL METHOD/ DETERMINATION – Device Observer _____________________ 
BP1 
DUT 
☐ 
 
 
 
 
 
File #: 
BP2 
DUT 
☐ 
 
 
 
 
 
File #: 
BP3 
DUT 
☐ 
 
 
 
 
 
File #: 
BP4 
DUT 
☐ 
 
 
 
 
 
File #: 
BP5 
DUT 
☐ 
 
 
 
 
 
File #: 
BP6 
DUT 
☐ 
 
 
 
 
 
File #: 
BP7 
DUT 
☐ 
 
 
 
 
 
File #: 
BP8 
DUT 
☐ 
 
 
 
 
 
File #: 
BP9 
DUT 
☐ 
 
 
 
 
 
File #: 
BP10 
DUT 
☐ 
 
 
 
 
 
File #: 
BP11 
DUT 
☐ 
 
 
 
 
 
File #: 
BP12 
DUT 
☐ 
 
 
 
 
 
File #: 
BP13 
DUT 
☐ 
 
 
 
 
 
File #: 
BP14 
DUT 
☐ 
 
 
 
 
 
File #: 
BP15 
DUT 
☐ 
 
 
 
 
 
File #: 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version: J 
 
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APPENDIX B: Sample Demographic Sheet  
The following sheet will be filled out for each subject.  It captures the demographic information for the subject 
including what cuff is used and the arm circumference. 
 
 
 
Welch Allyn Protocol ID:  DIR 60115909 Ver ___ 
Clinical Site:  
Principal Investigator:   
Subject ID:   
Date:(YYYY/MM/DD): 
Time of Consent (00:00 24 hr) 
Observer Initials  
#1____________ 
#2_____________ 
#3______________ 
Subject Age (years): 
__________                  Subject Gender: Male/Female 
Subject Height: 
__________ cm  
 
 
Subject Weight: 
__________ kg      
Time of Assessment  (00:0024hr) 
Race:   
 White 
 Black or African American 
 
 
 American Indian or Alaska Native      
 Asian       
 Native Hawaiian or Other Pacific Islander  
Other:  
 
 
 
 
BP Cuff Placement:   
Limb Used  
  Left 
  Right  
Arm measurement: 
Length: 
__________ cm                      
Circumference:  __________ cm     
FlexiPort – Reusable Cuff (DUT) Size Selected:  
  Cuff Size 8:  12-16cm 
  Cuff Size 9:  15-21cm 
   Cuff Size 10:  20-26 cm 
 
   Cuff Size 11/11L: 25-34 cm 
  Cuff Size 12/12L:  32-43 cm 
  Cuff Size 13:  40-55 cm 
Note: For 11L and 12L please circle that when used, otherwise 11 or 12 will be assumed. 
2 Piece – Cuff Size Selected (Auscultatory):  
  Newborn:  10-14 cm 
   Infant:  14-20 cm  
   Child: 22-26 cm 
   Adult: 29 – 37 cm 
   Large Adult: 34-44 cm 
   Thigh: 41-58 cm 
Note: If subject falls in a gap for the 2 Piece cuff they should be excluded from the study. 
Cuff Lot #: ________________________ 
If largest available cuff was not used, please state why:   
 
 
 
 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version: J 
 
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APPENDIX C: Sample Study Subject Eligibility Form  
Welch Allyn Protocol 
 
 
Welch Allyn Protocol Number:  60115909 Ver___ 
Clinical Site:    
PI / Clinician:  
 Date:   __  __  __ __   __ __    __ __ 
                  Subject ID:  _____   _____   _____   _____  _____   _____   _____   _____ 
         
                Y    Y     Y    Y    M M     D  D 
Assigned Subject ID Numbers will be consecutive. The Subject ID consists of an eight-digit alpha-numeric number.  
• 
Digit 1 = investigative population (P = pediatric, A = adult) 
• 
Digit 2, 3, 4, 5 = 
 
• 
Digit 6, 7, 8 = Numbers are assigned consecutively (e.g., 001, 002, 003). 
Inclusion Criteria 
(In order to include the subject in the study, all criteria should be checked YES.) 
YES 
NO 
1. 
The subject is greater than or equal to 3 years of age (pediatric) to geriatric adult. 
2. 
The subject and/or legal guardian completes consent / assent process as required. 
3. 
The subject or legal guardian providing consent can read, write, speak in English, French or Italian.  
4. 
The subject must have an arm circumference in the range of 12-55cm and fit into the usable range for 
the reference cuffs. 
5. 
The subject must be able to have blood pressures measured on the Left or right Arm. 
Exclusion Criteria 
(In order to include the subject in the study, all criteria should be checked NO.) 
         
YES 
        
NO 
1. 
The subject or legal guardian refuses to allow the study subject to participate for any reason.  
2. 
The study subject is unable to sit still for a blood pressure for up to 1 hour.  
3. 
The subjects with deformities or abnormalities that may prevent proper application of the device under 
test. 
4. 
The subject is in acute distress, i.e., severe pain or, severe emotional distress or agitation that would 
inhibit him/her from participating in the study. 
5. 
The subject has any known contraindication to blood pressure measurement. 
6. 
The subject is not alert or unable to follow simple commands. 
7. 
The subject is evaluated by the investigator or clinician and found to be medically unsuitable for 
participation in this study 
8. 
The subject has known heart dysrhythmias 
9. 
The subject has compromised circulation or peripheral vascular disease 
10. The subject has known clotting disorders. 
11. The subject blood pressure demographic has already been filled 
12. The subject has severe contact allergy to sensors or cuff material 
2023 OCT 10 
NCT Number: NCT05654714

Document Description:  ModPG3 Adult-Ped ISO 81060-2 Study Protocol 
Document Number: 60115909 
Version: J 
 
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13. The subject has a history of skin fragility or breakdown, such as ecchymosis or lacerations affecting the 
upper extremities that would affect the application of noninvasive blood pressure cuff. 
14. The subject whose arm circumference falls within the unusable range for the refence cuffs 
15. The subject has no audible k5 sound.  
16. Subject is pregnant and/or breastfeeding. 
 
   The subject meets all inclusion criteria and does not meet any of the exclusion criteria.   
 
Therefore, the subject is eligible to participate in the study.   
   The subject does not meet all inclusion criteria and/or meets at least one of the exclusion criteria. Therefore, the subject 
is not eligible to participate in the study.  
 
PI / Clinician (Print): _________________________ Date: _______________________ 
 
 
PI / Clinician (Sign):  _____________________________________________________ 
 
2023 OCT 10 
NCT Number: NCT05654714