Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
Conditions: Blood Pressure
Sponsor: Perin Health Devices

 
 
 
 
 
 
 
 
Validation of Cuffless Blood Pressure Measurements Using the Perin 
Health Patch 
June 03, 2024 
Perin Health Devices 
PI: Ian McLane, Ph.D. 
Co-I: Valerie Rennoll, Ph.D. 
 

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Table of Contents 
 
1.0 Objectives ................................................................................................................................. 3 
2.0 Background/Rationale ............................................................................................................... 3 
3.0 Study Design and Procedures ................................................................................................... 4 
3.1 Study Design ......................................................................................................................... 4 
3.2 Study Type ............................................................................................................................ 5 
3.3 Date Range of Data ............................................................................................................... 5 
3.4 Study Procedures ................................................................................................................... 5 
3.5 Process for Data/Specimen Procurement .............................................................................. 7 
3.6 Record Review ...................................................................................................................... 7 
3.7 Database Access .................................................................................................................... 7 
3.8 Data/Specimen Storage ......................................................................................................... 7 
4.0 Data/Specimen Analysis ........................................................................................................... 8 
4.1 Data Analysis Plan ................................................................................................................ 8 
4.2 Power Calculation ................................................................................................................. 9 
4.3 Data Integrity......................................................................................................................... 9 
5.0 Eligibility/Subject Enrollment .................................................................................................. 9 
5.1 Inclusion Criteria ................................................................................................................... 9 
5.2 Exclusion Criteria  ................................................................................................................. 9 
5.3 Age Range ............................................................................................................................. 9 
6.0 Consent Process & HIPAA Authorization ................................................................................ 9 
6.1 Consent Process..................................................................................................................... 9 
6.2 Waiver or Alteration of Consent Process ............................................................................ 10 
7.0 Confidentiality ........................................................................................................................ 10 
7.1 Confidentiality ..................................................................................................................... 10 
7.2 Data Security ....................................................................................................................... 10 
8.0 Risks and Benefits: ................................................................................................................. 10 
8.1 Risks .................................................................................................................................... 10 
8.2 Benefits................................................................................................................................ 11 
9.0 References ............................................................................................................................... 11 

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10.0 Appendices ............................................................................................................................ 12 
Appendix A- Consent Form .......................................................................................................... 13 
Appendix B- Participant Intake Form ........................................................................................... 19 
Appendix C- Device Survey ......................................................................................................... 20 
Appendix D- IDE Exemption Letter ............................................................................................. 21 
Appendix E- Pre-enrollment Form ............................................................................................... 23 
 
 
 
 

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1.0 Objectives 
The primary aim of the study is to validate a proprietary cuffless blood pressure algorithm using 
measurements from a chest-worn medical device, the Perin Health Patch (PHP). The study will 
compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for 
a 20-minute monitoring period and confirm that the wearable device performance meets AAMI 
standards. The specific objectives are: 
• To calculate the mean error and standard deviation of blood pressure (BP) measurements 
from the PHP relative to the ambulatory blood pressure cuff. 
• To determine the compliance of the PHP's mean absolute error (MAE) and standard 
deviation (SD) with AAMI standards: ≤ 5 mmHg MAE with ≤ 8 mmHg SD for systolic 
and diastolic BP. 
2.0 Background/Rationale 
 
Hypertension, or HBP, is a major modifiable risk factor for cardiovascular diseases (CVDs), 
which are the leading cause of death globally [1]. Continuous BP measurements are vital for the 
early prevention, detection, evaluation, and treatment of hypertension and related CVDs due to 
its prognostic value for BP variability (BPV) [2]. Non-invasive, continuous monitoring at home 
can enhance patient management by allowing timely therapy adjustments, early detection of 
cardiac issues, and better management of chronic cardiac conditions, leading to improved patient 
outcomes and reduced healthcare costs. 
 
Current hypertension guidelines emphasize the importance of out-of-office BP measurements 
to confirm elevated BP and monitor changes over time. Continuous monitoring of hemodynamic 
parameters traditionally requires invasive techniques such as arterial lines. These methods are 
impractical for home use due to the need for specialized equipment and skilled personnel, along 
with associated risks like infection and thrombosis [3], [4]. Traditional cuff-based home BP 
devices, which have been the standard for decades, face limitations such as patient adherence, 
cuff fit, measurement technique, and physical discomfort. Additionally, these devices cycle 
every 15-30 minutes and cannot reliably capture BP variability and rapid changes, which are 
crucial for high-risk patients, especially post-operative ones [5]. 
 
Recent advances in photoplethysmographic (PPG) sensors have enabled the development of 
non-invasive and continuous heart rate (HR) and BP monitoring devices. PPG detects blood 
volume variations in vessels by measuring changes in light absorption. BP is estimated from 
pulse transit time (PTT), the time taken by the arterial pulse to travel from the heart to a 
peripheral site. PTT is related to BP through the pulse wave velocity (PWV), which depends on 
the elastic modulus of the vessel wall, blood density, and arterial dimensions [6]. However, 
previous systems have failed to meet clinical thresholds set by the British Hypertension Society 
(BHS) and AAMI, which require a mean estimation error (MAE) of less than 5 mmHg and a 
standard deviation of less than 8 mmHg [7]. Challenges include inaccurate BP estimations, the 
need for regular recalibration, and the influence of complex biological processes like vascular 
tone on measurements [8], [9], [10]. 

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Our study aims to validate a proprietary cuffless BP measurement algorithm using a chest-worn 
medical device, the Perin Health Patch (PHP). This algorithm leverages the multimodal sensing 
capabilities of the wearable health patch, which combines noise-immune auscultation, 
electrocardiography (ECG), pulse oximetry via photoplethysmography (PPG), bioimpedance 
(BioZ), skin temperature, and motion and tilt sensors. The PHP integrates multiwavelength PPG 
(MWPPG) with blue, green, red, and IR LEDs, allowing for precise calculation of PTT, PWV, 
and related unique parameters such as pre-ejection period (PEP) and systemic vascular resistance 
(SVR). This comprehensive approach aims to improve the accuracy and long-term stability of 
BP estimations by incorporating biological system knowledge and modeling nonlinear 
relationships between measured and estimated BP values, consequently improving systolic BP 
(SBP) and diastolic BP (DBP) estimations. 
3.0 Study Design and Procedures  
This study will be conducted in strict accordance with the ethical principles outlined in the 
Declaration of Helsinki (2013). Ethics approval will be sought and obtained from the relevant 
institutional review board before the initiation of the study. All participants will be provided with 
detailed informed consent forms, ensuring that they fully understand the nature of the study, their 
rights as participants, and the potential risks and benefits involved. The consent forms will 
emphasize the voluntary nature of participation, ensuring that participants are free to withdraw 
from the study at any time without penalty. Additionally, measures will be implemented to 
protect the privacy and confidentiality of all participants, including the secure handling and 
storage of data. Throughout the duration of the study, the well-being, autonomy, and dignity of 
all participants will be upheld and respected. 
3.1 Study Design 
This is a prospective study designed to validate the PHP by comparing its BP 
measurements with those from an FDA-cleared ambulatory BP cuff (Norav NBP One) . 
The study will include 85 participants who will undergo a series of BP measurements 
over a 20-minute period while simultaneously wearing the PHP and ambulatory BP 
(ABP) cuff. This study will be conducted in home and office environments, including 
patients’ homes and the offices of Perin Health Devices (21241 Ventura Blvd., Suite 272, 
Woodland Hills, CA 91364). An initial BP measurement will be taken, followed by four 
reference BP measurements and three paired test device measurements.  
The study will also include an optional cold pressor test to further evaluate the device's 
performance on intra-patient variability. The cold stimulus activates afferent sensory 
pathways that, in turn, trigger a sympathetic response resulting in an increase in BP. If a 
subject elects to participate in the cold pressor test, the validation measurements will be 
repeated after placing their hand in ice water for one minute.  
According to AAMI standards, this study design will ensure the mean absolute error 
(MAE) between the PHP and the reference device does not exceed 5 mmHg with a 
standard deviation (SD) of ≤ 8 mmHg for both SBP and DBP. 

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3.2 Study Type 
This study is a Prospective Review: the data do not currently exist and will be collected 
over the course of this study to conduct the validation. 
3.3 Date Range of Data 
The study will be conducted from June 15, 2024 to September 15, 2024.  
3.4 Study Procedures 
The study will be conducted in environments where the PHP is expected to be used, 
including in participants’ homes, office environments, and clinical environments. The 
study will be conducted in a private environment away from other people. There will be 
no costs to subjects for participating in the study.  Subjects will not be compensated for 
their participation. 
The study will be conducted by the following steps: 
1. Participants will be identified through self-selection via an online form shared 
broadly across social media, email, and web. The online form will include: (1) a 
description of the study (2) overview of the risks and benefits (3) contact information 
form. See Appendix E for the online form overview. For participants who elect to 
participate, they will be contacted by the study team to schedule a time to conduct the 
study. If the participant is not able to be contacted by phone, a follow-up email will 
be sent. 
2. During the scheduled time, the participant will be provided with an overview of the 
study, including the study's purpose, procedures, risks, and benefits, and will be given 
the opportunity to ask questions. The participant will then be asked to sign and 
complete the consent form. The consent form will be scanned and stored securely in 
an electronic format for the study team.  The physical copy will be returned to the 
participant. 
3. The participant will complete an intake form to gather demographic and medical 
history information. Information collected will be any exclusion criteria, age, sex, 
height, weight, ethnicity, history of disease, history of smoking, and history of hyper- 
or hypotension. On this intake form, the subject will indicate whether they are willing 
and able to undergo the cold pressor test. 
4. For patients with significant chest hair that would occlude the optical measurement, 
the participant will be asked to shave the region where the device will be placed. The 
study team member will then measure the skin tone. This skin tone image will be 
taken against a calibration color palette to normalize all images and an objective skin 
tone will then be calculated using a detailed representation using a multidimensional 
measure of apparent skin color [11]. Study team members should be sure that the face 
is not captured in the skin color photo. 
5. The application site will be cleaned using an alcohol wipe and the PHP will be 
adhered to the participant's chest.  The ABP cuff will be placed on the left arm, 
following the procedure outlined in their instructions for use (IFU).   

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6. The validation procedure starts with the subject seated comfortably and relaxed for at 
least 5 minutes, her/his back and arm supported with the middle of the upper arm at 
heart level, legs uncrossed, and feet flat on the floor. Talking and any other 
interference will be avoided throughout the entire validation procedure. 
7. A timer is started and an initial measurement is taken: a reference BP measurement 
(R0) followed by a test device measurement (T0) to confirm the PHP function. A 
calibration measurement using a third BP device will be taken when T0 is taken to 
calibrate the PHP.  
8. Four reference BP measurements follow, alternated by three test device 
measurements (R1-T1-R2-T2-R3-T3-R4) (See Table 1). Rx measurements will be 
performed with 2-minute intervals, with Tx measurements occurring 15 seconds after 
an Rx measurement. The recordings will be synchronized using absolute time 
measurements as well as a timer that is started.  
9. The participant will optionally undergo the cold pressor test if they indicated on the 
intake form that they are willing and able to participate. If they opt not to undergo the 
cold pressor test, skip to Step 10. If they do opt to undergo the cold pressor test, the 
hand contralateral to the arm with the ambulatory blood pressure cuff will be 
submerged in ice water (≤ 5 ⁰C) for at least 1 minute. The study team member will 
record the temperature of the ice water at the start of the cold pressor test. The 
participant may opt to remove their hand at any time if they are experiencing high 
levels of discomfort. After 1 minute the participant will be instructed to remove their 
hand. 
10. Validation measurements from Table 1 will be repeated as soon as the subject 
removes their hand. Four reference BP measurements follow, alternated by three test 
device measurements (R1-T1-R2-T2-R3-T3-R4) (See Table 1). Rx measurements will be 
performed with 2-minute intervals, with Tx measurements occurring 15 seconds after 
an Rx measurement.  
11. Following the completion of the measurements, the ABP cuff will be removed from 
the participant. The participant may also be provided with a hand warmer as the 
following steps are completed.  
12. The participant will complete a 5-question survey of Likert-type questions related to 
comfort and usability of the PHP (See Appendix C).  
13. The PHP will then be removed from the participant's chest. The study team members 
should be sure to use the adhesive remover to minimize any pain or discomfort from 
the removal of the adhesive. 
14. The participant will be discharged from the study and provided with follow-up 
contact information along with a copy of the consent form.  
If the investigator or participant notes an adverse reaction during the testing period, any 
monitoring devices will be removed immediately, and the subject will be discharged from 
the study. 
Table 1. Procedure for reference and test device BP measurements in sequential validation 
method.  

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Initial BP measurements for device function confirmation and calibration 
1.  
Take reference BP measurement from BP device. 
R0 
2.  
Take test device BP measurement, calibration measurement 
T0, C0 
Validation BP measurements for accuracy evaluation 
3.  
Take first reference BP measurement 
R1 
4.  
Take first test device BP measurement 
T1 
5.  
Take second reference BP measurement 
R2 
6.  
Take second test device BP measurement 
T2 
7.  
Take third reference BP measurement 
R3 
8.  
Take third test device BP measurement 
T3 
9.  
Take fourth reference BP measurement 
R4 
 
3.5 Process for Data/Specimen Procurement 
• Pre-enrollment contact information and screening will be conducted over Google 
Forms. The information will be collected on a digital spreadsheet. The Google 
form is shown in Appendix E. 
• Data from the ABP cuff will be collected using a PC computer program. The 
program will output SBP, DBP, and precise measurement time.  
• Data from the PHP will be collected using a Bluetooth-enabled tablet. The tablet 
will provide synchronized 30-second measurements of each measurement 
modality (PPG, ECG, BioZ, auscultation, motion, skin temperature) sampled at 
their respective pre-established sampling rates and the precise measurement time. 
• The intake form will be provided physically to the participants. Following the 
data collection, the values from the intake form will be captured in an electronic 
spreadsheet.  
• The consent forms will be scanned and saved in a secure, encrypted folder. The 
physical copies of the consent forms will be returned to the participant.   
3.6 Record Review 
N.A., no record review will be conducted as part of this study.   
3.7 Database Access 
N.A., no access to a pre-existing database will be conducted as part of this study.  
3.8 Data/Specimen Storage 
Pre-enrollment contact information and screening questions will not be retained/stored 
after the conclusion of the study.   
The patient will be assigned a random ID at enrollment and this random ID will be used 
to link the intake form, the ABP measurements, and the PHP measurements. No other 
identifier will be used other than the random ID. The random ID will not be included in 
the consent form.  
Raw data will be securely retained electronically for future secondary analysis. Due to the 
nature of this data and the use of this data in a regulatory approval, the electronic data 

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files will be maintained. The data will be stored in a local, encrypted database located at 
the offices of Perin Health Devices (21241 Ventura Blvd., Suite 272, Woodland Hills, 
CA 91364). Physical artifacts (completed intake forms) will be stored securely in a 
locked filing cabinet in a private office at the offices of Perin Health Devices for three 
years and then destroyed.  
Access to the data will be restricted to the study team. If any future or secondary analysis 
is conducted by other investigators, a formal approval process will be undertaken, 
including the validation of proper training certificates and data use plans. Training, 
requests, and approvals will be maintained in Perin Health Devices’ electronic quality 
management system (eQMS). PI McLane will be responsible for the oversight of the 
electronic and physical data.  
4.0 Data/Specimen Analysis 
4.1 Data Analysis Plan 
Blood pressure from the PHP will be calculated using a proprietary algorithmic approach. 
The steps include:  
1. Preprocessing: Areas of high motion, as determined by the accelerometer 
measurement are excluded from the analysis. For ECG and PPG signals, artifacts 
such as baseline wandering and respiratory components at lower frequencies, as well 
as power line harmonics and electromyogram artifacts at higher frequencies are 
removed. Auscultation signals are filtered to remove lung sound components and 
concentrate on heart sound components.  
2. Segmentation: Fiducials for the ECG, PPG, and auscultation signals are extracted 
using respective techniques.  
3. Depth-Resolved PPG: The time difference between the capillary component (blue 
LED) and the arteriolar component (red/IR LED is used to calculate arteriolar PTT 
and SVR.  
4. Feature Extraction: A combination of hand-crafted features and learned feature 
embeddings are extracted and concatenated into a single feature vector. 
5. Deep Learning Estimation: An LSTM-based model is used to estimate SBP and DBP 
from the calibration value and the input feature vector.  
The mean error and standard deviation of the SBP and DBP measurements from the PHP 
relative to the ambulatory blood pressure cuff will be calculated. Statistical analysis will 
include paired t-tests and Bland-Altman plots to assess the agreement between the two 
devices.  
The feature extraction and estimation analysis will be conducted by PI McLane, blinded 
to reference values to maintain data analysis integrity, pursuant of the company’s conflict 
of interest policies. The evaluation and statistical comparisons against the ABP cuff will 
be conducted by Co-I Rennoll with independent validation by Toon Prasertsit. RN, an 
independent reviewer. The criteria for validation will follow AAMI standards, where the 
mean difference must be ≤ 5 mmHg and the standard deviation ≤ 8 mmHg. 

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4.2 Power Calculation 
Based on the AAMI/ESH/ISO consensus standard, a sample size of 85 participants is 
sufficient to achieve a power of 80% with an alpha level of 0.05 to detect a mean 
difference in blood pressure measurements between the two devices.  
4.3 Data Integrity 
A proprietary signal quality index (SQI) will be used to confirm the quality of the signals 
during recording as well as during post-processing analysis. This SQI will be used to 
prospectively remove sections of data that may result in poor performance due to motion 
artifacts or other noise contaminations.  
5.0 Eligibility/Subject Enrollment 
5.1 Inclusion Criteria  
• Adults aged 18 years or older, 
• Willing and able to provide informed consent, 
• Able to comply with study procedure. 
5.2 Exclusion Criteria  
• Any member defined under ‘Special Population’ in the AAMI standards 
(Pregnant, children, arm circumference > 42 cm), 
• Patient with a pacemaker, 
• History of reactions to medical adhesives, 
• Inability to comply with the study procedure, 
• Non-English Speaker. 
5.3 Age Range  
Adults aged 18 years or older. 
6.0 Consent Process & HIPAA Authorization 
6.1 Consent Process  
Participants will be identified through self-selection via an online form shared broadly 
across social media, email, and web. The online form will include: (1) a description of the 
study (2) overview of the risks and benefits (3) contact information form. See Appendix 
E for the online form overview. For participants who elect to participate, they will be 
contacted by the study team to schedule a time to conduct the study. If the participant is 
not able to be contacted by phone, a follow-up email will be sent. 
The consent process will take place in a private setting before any study procedures are 
performed. Participants will be informed, in English, about the study's purpose, 
procedures, risks, and benefits, and will be given the opportunity to ask questions. 
Participants will be made aware that there will be no negative impacts if they refuse to 
participate. Consent will be obtained by either PI McLane or Co-I Rennoll from 
participants engaging in the study. The participant will be provided with a physical copy 
of the informed consent documentation and asked to provide a signature. The consent 
form will be scanned and stored securely in an electronic format for the study team.  The 

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physical copy will be returned to the participant. The study procedure may occur 
immediately after receiving consent.  
6.2 Waiver or Alteration of Consent Process 
N/A (no waiver or alteration of consent process requested). 
6.3 HIPAA Authorization and Waivers 
N/A (No HIPAA Authorization and Waiver is requested as no data are associated with or 
derived from a healthcare service event, data are not entered into medical records, and no 
PHI is collected or stored). 
 
7.0 Confidentiality 
7.1 Confidentiality 
Patient contact information will be stored securely. Digital copies will be encrypted, and 
access controlled. No physical copies of the information will be allowed. All digital 
copies of patient contact information will be permanently deleted at the end of the study. 
Data will be coded and de-identified at the time of collection to protect participant 
privacy. No link logs to the above identifying information will be created or retained. 
Raw data files will be retained securely electronically by randomized ID for future 
secondary analysis. Physical artifacts (completed intake forms) will be stored securely 
and separately for three years and then destroyed. Data will not be shared with third 
parties for any reason other than for formal auditing purposes.  
7.2 Data Security 
Ensuring data security throughout the study is crucial. Data security measures include: 
• Encryption: All data will be encrypted during storage and transmission using 
strong encryption protocols (e.g., AES-256). 
• Access Control: Restricted access to the data to authorized personnel only. 
Implement multi-factor authentication and role-based access controls for digital 
data. Physical artifacts will be stored securely in a locked filing cabinet in a 
private office. 
• Regular Audits: Conduct regular security audits to ensure that data protection 
measures are effective and up to date. 
• Training: Provide data security training for all personnel involved in the study to 
ensure they understand and adhere to data protection protocols. Authorized 
personnel will be required to complete data handling training prior to receiving 
authorization of access. 
8.0 Risks and Benefits: 
8.1 Risks  
Risks associated with the study include potential discomfort from BP measurements and 
the cold pressor test. Additional risks are associated with the adhesive from the PHP, 
including discomfort when placing or removing the adhesive or an adverse reaction to the 

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adhesive. There is also a risk of breach of confidentiality, which will be mitigated 
through secure data handling practices. 
The PHP device is not FDA approved. However, we have determined that the device 
does not introduce any significant risk to the participant and therefore does not require an 
IDE (i.e., the device is IDE Exempt). See Appendix D for the IDE Exemption 
justification.  
8.2 Benefits 
Participants may not receive direct benefits from the study, but the findings could 
contribute to the development of improved BP monitoring technologies, benefiting 
society and the field of medical research.   
9.0 References  
[1] “The top 10 causes of death.” Accessed: Dec. 21, 2021. [Online]. Available: 
https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death 
[2] G. Parati, J. E. Ochoa, C. Lombardi, and G. Bilo, “Assessment and management of blood-
pressure variability,” Nat. Rev. Cardiol., vol. 10, no. 3, Art. no. 3, Mar. 2013, doi: 
10.1038/nrcardio.2013.1. 
[3] R. Klabunde, Cardiovascular Physiology Concepts. Lippincott Williams & Wilkins, 2011. 
[4] P. Palatini and R. Asmar, “Cuff challenges in blood pressure measurement,” J. Clin. 
Hypertens., vol. 20, no. 7, pp. 1100–1103, 2018, doi: 10.1111/jch.13301. 
[5] L. Lonjaret, O. Lairez, V. Minville, and T. Geeraerts, “Optimal perioperative management 
of arterial blood pressure,” Integr. Blood Press. Control, vol. 7, pp. 49–59, Sep. 2014, doi: 
10.2147/IBPC.S45292. 
[6] D. Buxi, J.-M. Redouté, and M. R. Yuce, “A survey on signals and systems in ambulatory 
blood pressure monitoring using pulse transit time,” Physiol. Meas., vol. 36, no. 3, p. R1, 
Feb. 2015, doi: 10.1088/0967-3334/36/3/R1. 
[7] G. S. Stergiou et al., “A Universal Standard for the Validation of Blood Pressure Measuring 
Devices: Association for the Advancement of Medical Instrumentation/European Society of 
Hypertension/International Organization for Standardization (AAMI/ESH/ISO) 
Collaboration Statement,” Hypertension, vol. 71, no. 3, pp. 368–374, Mar. 2018, doi: 
10.1161/HYPERTENSIONAHA.117.10237. 
[8] J.-R. Hu et al., “Validating cuffless continuous blood pressure monitoring devices,” 
Cardiovasc. Digit. Health J., vol. 4, no. 1, pp. 9–20, Feb. 2023, doi: 
10.1016/j.cvdhj.2023.01.001. 
[9] J. Grensemann, “Cardiac Output Monitoring by Pulse Contour Analysis, the Technical 
Basics of Less-Invasive Techniques,” Front. Med., vol. 5, p. 64, Mar. 2018, doi: 
10.3389/fmed.2018.00064. 
[10] G. M. London and M. E. Safar, “Autonomic nervous system and large conduit arteries,” in 
The Arterial System in Hypertension, vol. 144, M. E. Safar and M. F. O’Rourke, Eds., in 
Developments in Cardiovascular Medicine, vol. 144. , Dordrecht: Springer Netherlands, 
1993, pp. 181–194. doi: 10.1007/978-94-011-0900-0_12. 
[11] W. Thong, P. Joniak, and A. Xiang, “Beyond Skin Tone: A Multidimensional Measure of 
Apparent Skin Color.” arXiv, Oct. 03, 2023. Accessed: May 13, 2024. [Online]. Available: 
http://arxiv.org/abs/2309.05148 

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10.0 Appendices  
• Appendix A- Consent Form 
• Appendix B- Participant Intake Form 
• Appendix C- Device Survey  
• Appendix D- IDE Exemption Letter 
 
 

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Appendix A- Consent Form  
 
Consent for Research Participation 
Title: Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch 
Investigator/Researcher(s): Ian McLane, Ph.D.; Valerie Rennoll, Ph.D. 
Investigator/Researcher Contact Information: +1 (818) 606-9389, 
imclane@phasemargin.com 
Sponsor: Phase Margin, Inc. 
 
KEY INFORMATION FOR YOU TO CONSIDER 
We (the researchers) are asking if you would like to be in a research study. Some key 
information is provided in the boxes below to help you decide if you want to participate or not. 
Read the entire form and ask questions before you decide. The researchers will go over this form 
with you and you can ask any questions.  
What is the purpose 
of this research? 
The purpose of this research is to see if a new chest-worn medical 
device called the Perin Health Patch (PHP) can measure blood 
pressure accurately without using a traditional arm cuff. We want to 
compare the PHP's measurements to those from a regular blood 
pressure cuff to make sure it meets the standards for accuracy. The 
PHP is not FDA-approved, but the results from this research will be 
used for a future FDA submission and approval.  
What will happen to 
you during the 
study? 
During the study, you will fill out an intake form with information like 
your age, sex, height, ethnicity, and medical history. If you have a 
significant amount of chest hair, we will ask that you shave the device 
placement area. We will place the Perin Health Patch (PHP) on your 
chest and take a calibration measurement followed by four blood 
pressure measurements using both the PHP and a regular blood 
pressure cuff, with a 2-minute break between each measurement. 
If you agree, you will put your hand in ice water for 1 minute as part 
of a cold pressor test and then repeat the four blood pressure 
measurements.  
Finally, you will complete a short survey about the comfort and 
usability of the PHP before we remove the PHP from your chest, and 
you will be done with the study.  
How long will you 
be in the research? 
You will be in the research study for about 10 minutes for the initial 
measurements. If you choose to do the cold pressor test, it will take an 
additional 10 minutes. So, the total time you might spend in the study 
may be about 20 minutes. 
Could being in this 
research harm you? 
 
You should understand the risks of this research study before you 
decide to participate.  
 

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If you participate in this study, you might experience some minor risks 
and discomforts that might include the following: 
• Wearing the Perin Health Patch (PHP) on your chest might feel 
a bit uncomfortable. 
• You may have a reaction to the adhesive from the PHP. 
• The regular blood pressure cuff might cause slight discomfort 
when it inflates. 
• If you do the cold pressor test, putting your hand in ice water 
for 1 minute might feel very cold and uncomfortable. 
 
This research is no more than minimal risk. The level of risk is about 
the same as risks of daily life or a physical exam. 
Will being in this 
study help you in 
any way? 
 
You will not benefit directly from being in this study. However, the 
information we learn from the study could help develop better ways to 
measure blood pressure without using a traditional cuff, which might 
benefit other people in the future. 
Are there any costs 
to participate? 
 
It does not cost anything to be in the study.  
How do researchers 
protect your 
information? 
Researchers keep your personal information confidential and stored 
securely. Only the researchers approved to be on this study may see 
your information. 
 
Will you get any test 
results? 
The results of research tests are not given to you. Results of research 
tests have no clear meaning for your health care. 
  
 
ADDITIONAL DETAILED INFORMATION 
What will happen to you if you decide to be in the study? 
1. You will complete an intake form to gather demographic and medical history information. 
On this intake form, you will indicate if you are willing and able to undergo the cold pressor 
test. 
2. You may be asked to shave the region where the device will be placed. The study team 
members will then measure the skin tone where the PHP will be placed.  
3. The application site will be cleaned using an alcohol wipe and the PHP will be adhered to 
your chest.   
4. You will be asked to stay seated comfortably and relaxed for at least 5 minutes, with your 
back and arm supported with the middle of the upper arm at heart level, legs uncrossed, and 
feet flat on the floor. Talking will be avoided throughout the entire process. 
5. Blood pressure measurements from the blood pressure cuff and the PHP will be taken several 
times over the course of 10 minutes.  

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6. If you indicated on the intake form that you are willing and able to participate in the cold 
pressor test, the hand opposite the arm with the cuff will be placed in ice water for at least 1 
minute. You can remove your hand at any time if you are very uncomfortable. After 1 
minute, the study team member will tell you to remove your hand. 
7. Blood pressure measurements from the blood pressure cuff and the PHP will be taken again 
several times over the course of 10 minutes.  
8. The cuff will be removed after the last measurement.  
9. You will be asked to complete a 5-question survey of Likert-type questions related to 
comfort and usability of the PHP.  
10. The PHP will then be removed from your chest and you will be done with the study. 
 
Could being in this research harm you? (Detailed Risks) 
You may experience discomfort from the blood pressure cuff when inflating.  
You may experience skin irritation from the PHP adhesive.  
You may experience some pain or discomfort when removing the PHP from your chest.  
You may experience some discomfort when placing your hand in the ice water for the cold 
pressor test.  
Please let the study team member know if at any moment you feel discomfort. It is okay if 
you wish to discontinue your participation at any time. 
There may be unknown risks in this research.  Tell the researchers if you develop a new 
condition or injury. 
 
Is there any available medical treatment or compensation if injured in the study?  
This study is no greater than minimal risk, so no medical treatment or compensation will be 
available. 
How many people will participate in this research study? 
The researchers hope to enroll up to 85 people. 
 
Who can you talk to about the research? 
Contact the researcher listed on the first page if you have questions, concerns, complaints, or get 
hurt. 
Pearl Institutional Review Board (IRB) oversees this research. You may call (317) 899-9341 to 
speak to the IRB for any reason, such as:  
• 
You have questions about your rights. 
• 
Your questions, concerns, or complaints are not being answered by the research team. 
• 
You cannot reach the research team. 
• 
You want to talk to someone besides the research team. 
• 
You want to get more information.  

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• 
You want to provide your input about this research. 
 
Will the researchers return results and incidental findings to you? 
 
In general, we will not give you any individual results from the study of the samples you give us. 
If we find something of urgent medical importance to you, we will inform you, although we 
expect that this will be a very rare occurrence. 
 
Are there any conflicts of interests reported for this study? 
 
Dr. McLane is an officer of the sponsor institution, Perin Health Devices, but does not contain 
any financial ownership in Perin Health Devices. The outcome of this research study could be of 
interest to Perin Health Devices. The IRB oversees the conflict of interest policies. In accordance 
with these policies, the IRB has determined that Dr. McLane’s interests create no significant risk 
to the welfare of participants in this study or to the integrity of the research. If you want more 
information about this, please contact the IRB. 
 
How do researchers protect your information? 
 
The researchers will keep information about you in a secure location with limited access. If the 
results of this study are made public, information that identifies you will not be used.  
 
What Protected Health Information will be used or disclosed? 
 
Federal law protects your right to privacy concerning PHI. There are certain things you need to 
know. PHI is any information from your medical record or obtained from the study linked to you 
and that refers to your mental or health conditions in the past, the present or the future. No PHI 
will be collected in relation to this study.  
 
What information about this study is available to the public? 
 
A description of this clinical study will be available on http://www.ClinicalTrials.gov. This Web 
site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
Can your participation end early? 
 
You may end your participation in this study at any time by communicating with the 
investigator. There will be no consequences if you choose to withdraw from the study. 
 
The investigator may terminate a subject’s participation without regard to the subject’s consent 
for any of the following reasons: 
• If you are a female who becomes pregnant 
• If the research becomes harmful 
• If you do not follow the instructions or adhere to the research requirements given to you 
by the study doctor or study staff 

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June 03, 2024 
 
 
 
 
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• You do not take medication as instructed 
• You do not keep study appointments 
 
 
Will you receive anything for being in the research? 
 
You will NOT receive any gifts, rewards, compensation, or reimbursement for your participation 
in this research study. 
 
May the researchers share your coded information for future research?  
• The researchers approved for this current study will deidentify your materials immediately.  
• The researchers doing future research with the deidentified materials cannot identify you. 
• The following materials may be used in future research: raw recordings from the PHP, blood 
pressure measurements from the cuff, information from the intake form.  
• Future research may include time series analysis of ECG, PPG, auscultation, BioZ, motion, 
or temperature; refinement of blood pressure estimation algorithms.  
• Your deidentified information will be maintained for as long as it is useful for research 
purposes, after which time the specimen and information will be destroyed. 
• You will not be able to get individual research results about you because the researchers who 
receive your materials will not have your identifiers.  
Please initial the ONE option that you choose below:  
_____ (initials)  YES. 
You still have the right to withdraw this authorization later.  
_____ (initials)  NO. 
 
SIGNATURES 
 
You have read this document and were told of the risks and benefits and a member of the 
research team answered questions to your satisfaction. A member of the research team will 
answer any future questions. You voluntarily agree to join the study and know that you can 
withdraw from the study at any time without penalty. You do not waive any legal rights by 
signing this form. 
 
You will receive a signed copy of this document. 
 
 
_________________________ 
Print the Name of the Adult Research 
Participant  
(18 years of age or older) 
 
 
_________________________ 
Signature of the Adult Research 
Participant 
 
 
____________ 
Date Signed 
 
Completed by the Investigator obtaining informed consent: 
 In addition to advising the person authorizing the research about any appropriate alternatives to research 
participation, I have offered an opportunity for further explanation of the risks and discomforts which are, or 
may be, associated with this research, and to answer any further questions. 

Cuffless BP Measurement with PHP 
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 Check to confirm participant agreed to participate in the study and signed the informed consent form(s) 
and all questions were answered. 
Check options pertaining to remote consent if applicable: 
 Check if remote consent (conference call or video conference). 
 Check if the informed consent document was not retained, due to contamination of the document by 
infectious material. 
 Check to confirm participant was asked to mail, fax, or e-mail a copy of the signed consent to the research 
team. 
 
_________________________ 
Print Name of Investigator Obtaining 
Informed Consent 
 
_____________________________ 
Signature of Investigator Obtaining 
Informed Consent 
 
 
____________ 
Date Signed 
 
 
 

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Appendix B- Participant Intake Form 
 
PATIENT ID: 
______________________ 
 
 
 
 
 
AGE: 
______________________ 
☐ Over 90 or older 
 
 
 
 
DO ANY OF THE 
FOLLOWING APPLY 
TO YOU? 
I am pregnant. 
I have a pacemaker. 
I have previously had a reaction to adhesives. 
I cannot complete this study for other reasons.  
☐ YES 
☐ NO 
 
 
 
 
 ------------------If you answered yes to the above question, please stop and inform the study team member.--------------- 
 
 
 
 
BIOLOGICAL SEX: 
☐ Male 
☐ Female 
 
 
 
 
 
HEIGHT: 
______ ft ______ in 
WEIGHT: 
_________ lbs 
 
 
 
 
ETHNICITY:  
☐ American Indian or Alaska Native 
 
(Check all that apply) 
☐ Asian 
 
 
☐ Black or African American 
 
 
☐ Hispanic or Latino 
 
 
☐ Native Hawaiian or Other Pacific Islander 
 
 
☐ White (non-Hispanic) 
 
 
☐ Other 
 
 
 
 
 
HISTORY OF 
HYPERTENSION (High 
Blood Pressure): 
☐ Yes 
☐ No 
 
 
 
 
 
HISTORY OF 
HYPOTENSION 
(Low Blood Pressure): 
☐ Yes 
☐ No 
 
 
 
 
 
ARE YOU ON ANY BLOOD PRESSURE MEDICINE OR BLOOD THINNERS? 
 
☐ Yes 
☐ No 
 
 
 
 
 
HISTORY OF DISEASE: 
(Check all that apply) 
☐ Coronary artery disease 
☐ Congestive heart failure 
☐ Arrhythmias (e.g., atrial 
fibrillation) 
☐ Other cardiovascular 
disease 
☐ Chronic obstructive 
pulmonary disease (COPD) 
☐ Asthma 
☐ Diabetes mellitus 
☐ Peripheral artery disease 
☐ Chronic kidney disease 
☐ Other: 
 
 
____________ 
 
 
 
 
HISTORY OF 
SMOKING: 
☐ Yes 
☐ No 
 
 
 
 
 
ARE YOU WILLING AND ABLE TO UNDERGO THE COLD PRESSOR TEST? 
 
☐ Yes 
☐ No 
 

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June 03, 2024 
 
 
 
 
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Appendix C- Device Survey 
 
PATIENT ID: 
______________________ 
 
Please rate your level of agreement with the following statements:  
 
1. I found that the patch was noticeable when wearing it. 
☐ Totally disagree 
☐ Disagree 
☐ Neutral 
☐ Agree 
☐ Totally agree 
 
 
2. I found the patch irritating on my skin.  
☐ Totally disagree 
☐ Disagree 
☐ Neutral 
☐ Agree 
☐ Totally agree 
 
 
3. I found that wearing the patch was painful.  
☐ Totally disagree 
☐ Disagree 
☐ Neutral 
☐ Agree 
☐ Totally agree 
 
 
4. I prefer the patch to the blood pressure cuff for monitoring my blood pressure. 
☐ Totally disagree 
☐ Disagree 
☐ Neutral 
☐ Agree 
☐ Totally agree 
 
 
5. I would wear the patch continuously for one month to help manage my care. 
☐ Totally disagree 
☐ Disagree 
☐ Neutral 
☐ Agree 
☐ Totally agree 
 
 
 

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 Appendix D- IDE Exemption Letter 
 
Study Title:  Validation of Cuffless Blood Pressure Measurements Using the 
Perin Health Patch 
Study Devices: Perin Health Patch 
 
Sponsor Justification of Non-Significant Risk Device:  
The Perin Health Patch in conjunction with its labeling, device classification and indications for 
use, does NOT meet any of the four criteria set out by the FDA to define a significant risk 
device. For these reasons, the Perin Health Patch is considered a non-significant risk (NSR) 
device and is therefore exempt from Investigational Device submissions and FDA oversight.  
Definition of a Significant Risk (SR) device under 21 CFR Part 812.3.: 
The study device(s) as listed above: 
• Is not intended as an implant which would thereby present potential for serious risk to the 
health, safety, or welfare of a subject; 
• Is not purported or represented to be for use in supporting or sustaining human life which 
would thereby present potential for serious risk to the health, safety, or welfare of a 
subject; 
• Is not used for use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health which would thereby 
present potential for serious risk to the health, safety, or welfare of a subject; and 
• Does not otherwise present potential for serious risk to the health, safety, or welfare of a 
subject. 
Non-Significant Risk (NSR)  
• Non-Significant Risk devices are investigational devices that do not pose a significant 
risk to the human subjects and do not meet the definition of a SR device. 
Sponsors of studies involving non-significant risk devices are not required to submit an IDE 
application to the FDA for approval. Submissions for non-significant device investigations are 
made directly to the IRB of each participating institution. The FDA considers an investigation of 
a non-significant risk device to have an approved IDE when the IRB concurs with the non-
significant risk determination and approves the study. 
The sponsor must comply with the abbreviated IDE requirements under 21 CFR 812.2(b): 
• 
Labeling - The device must be labeled in accordance with the labeling provisions of the IDE 
regulations (812.5) and must bear the statement "CAUTION - Investigational Device. 
Limited by Federal (or United States) law to investigational use." 
• 
IRB Approval – The sponsor must obtain and maintain Investigational Review Board (IRB) 
approval throughout the investigation as a non-significant risk device study (812.2 (b)). 

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June 03, 2024 
 
 
 
 
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• 
Informed Consent – The sponsor must assure that investigators obtain and document 
informed consent from each subject according to 21 CFR 50, Protection of Human Subjects, 
unless documentation is waived by an IRB in accordance with 56.109(c). 
• 
Monitoring - All investigations must be properly monitored to protect the human subjects 
and assure compliance with approved protocols (812.46).  
• 
Records and Reports - Sponsors are required to maintain specific records (812.140(b) (4) and 
(5) and make certain reports as required by the IDE regulations 812.150(b) (1), (2), (3), (5), 
(6), (7), (8), (9) and (10). 
• 
Investigator Records and Reports – The sponsor must assure that participating investigators 
maintain records (812.140(a)(3)(i) and make reports as required (812.150(a) (1), (2), (5) and 
(7); and 
• 
Prohibitions –Commercialization, promotion, test marketing, misrepresentation of an 
investigational device, and prolongation of the study are prohibited (812.7). 
 
The Perin Health Patch thus has No Major Risks Anticipated.   
The Perin Health Patch is a chest-worn device measuring 65 x 35 mm. The device records 
several vital signs, including skin temperature, electrocardiogram (ECG), pulse oximetry, and 
heart and lung auscultation. The device is powered from a lithium manganese oxide battery for 
16 days of continuous use in a home environment. The electronics module is adhered to the chest 
with a certified long-term wear adhesive for up to 28 days of wear time. 
Perin Health believes it has adequately mitigated anticipated risks through the process outlined in 
ISO 14971, a nine-part standard which first establishes a framework for risk analysis, evaluation, 
control, and review for medical devices. 
Please feel free to reach out with any further questions regarding the Perin Health Patch or the 
IDE Exemption and Study Risk Determination. 
 
Ian McLane, Ph.D. 
Chief Technology Officer 
Perin Health Devices 
+1 (818) 606-9389 
 
 

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Appendix E- Pre-enrollment Post Copy & Form 
 
Copy: 
 
Help validate a new cuffless blood pressure monitoring device! Please complete this 
pre-enrollment survey to learn more about the study, see if you qualify, and to express 
interest in participating: [survey link]. 

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Figure 1. Page 1 of the pre-enrollment form, which provides an overview of the study and its 
risks and benefits. 

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Figure 2. Page 2 of the pre-enrollment form, which outlines the eligibility criteria for the study. 

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Figure 3. Page 3 of the pre-enrollment form, which collects contact information from subjects, 
including their name, e-mail, and phone number 

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Figure 4. Page 4 of the pre-enrollment form which thanks subjects for their participation.