Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure
Phase: NA
Conditions: Low Blood Pressure, Blood Pressure, High Blood Pressure, Hypertension, Hypotension
Sponsor: SE Health

1 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
Amended protocol for: 
 
Observational Trial: Determining the accuracy of the HeartBeat Algorithm for calculating blood 
pressure 
 
Contents 
1. 
Introduction and Rationale .......................................................................................................... 2 
2. 
Study purpose .............................................................................................................................. 3 
3. 
Study Design/Methodology ......................................................................................................... 3 
Trial registration ............................................................................................................................... 3 
Protocol ............................................................................................................................................ 3 
Setting and clinicians ....................................................................................................................... 3 
Recruitment plan ............................................................................................................................. 4 
Interactions with participants and Data collection .......................................................................... 5 
Data Analysis .................................................................................................................................... 8 
5. 
Confidentiality and security of data ............................................................................................. 9 
6. 
Withdrawal from the study ........................................................................................................ 10 
List of Appendices .............................................................................................................................. 11 
References ......................................................................................................................................... 12 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
Observational Trial: Determining the accuracy of the HeartBeat Algorithm for calculating blood 
pressure 
 
Funder: Centre for Aging and Brain Health Innovation (CABHI) 
Investigator: Paul Holyoke 
Co-Investigator: Margaret Saari 
Research Associate: Karthika Yogaratnam  
Research Assistant: Elizabeth Kalles 
1. Introduction and Rationale 
The gold standard instrument for blood pressure measurement is a mercury-filled 
sphygmomanometer with cuff and stethoscope (Canadian Agency for Drugs and Technologies in 
Health; Canadian Electronic Library, 2012). However, such a device is not the most convenient for 
client self-monitoring or virtual (remote) care. Thus, there is a desire for an accurate, reliable 
alternative for the traditional mercury-containing sphygmomanometer. 
 
HeartBeat Technologies Ltd. (“Heartbeat”) has developed a novel approach to measuring blood 
pressure after an initial blood pressure reading using the conventional measurement method, 
supplemented by specific characteristics of a person (age, gender, height, weight, and heart rate), 
has established a “baseline measurement” for the person. The “novel approach” uses a finger 
pulse oximeter, the Contec CMS50EW device (Figure 1) (manufactured by Contec Medical Systems 
Co., Ltd., Shanghai, People’s Republic of China). The finger pulse oximeter detects the changes in 
blood volume directly below the person’s skin and indirectly measures oxygen saturation in the 
blood. The measurement is in the form of a photoplethysmogram (PPG) which is captured by the 
Contec oximeter and then, by Bluetooth technology, transmitted to a smartphone or tablet. A 
HeartBeat application, called MediBeat, on the smartphone or tablet then transmits the PPG to a 
server where a proprietary algorithm analyzes the baseline measurement for the person and the 
PPG to calculate the person’s current blood pressure.  
 
 
Figure 1. Contec CMS50EW. Source: 
http://www.contecmed.com/index.php?page=shop.product_details&flypage=flypage.tpl&product_
id=118&category_id=27&option=com_virtuemart&Itemid=618 

3 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
Heartbeat’s intent is that the current blood pressure reading would then be made available to 
both the client and the health provider through separate web-based interfaces. Providers would 
be able to log onto the HeartBeat web-based application from anywhere to review and monitor 
the blood pressure of multiple clients, while clients can log onto the application to track their own 
measurements. 
2. Study purpose 
Though the Contec finger pulse oximeter has been approved for use by Health Canada (Licence No. 
90629) and the FDA 
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=465210&lpcd=DQA), the 
proprietary algorithm developed by Heartbeat Technologies Ltd. has not been approved for use. 
The purpose of this study is to validate the accuracy of the algorithm as compared with the 
standard manual sphygmomanometer with stethoscope for measuring blood pressure. If the 
algorithm is shown to be accurate, Heartbeat Technologies Ltd. will apply to Health Canada and 
the FDA for approval for its use to measure blood pressure. 
3. Study Design/Methodology 
Trial registration 
This study will be registered with ClinicalTrials.gov as it is one of two registered bodies approved 
and recommended by Health Canada. This will serve as a publicly accessible platform for patients 
and practitioners to understand the current study’s objectives and goals, and be kept informed of 
the results. 
Protocol  
The European Society of Hypertension International Protocol revision 2010 for the validation of 
blood pressure measuring devices in adults (ESH-IP) (Appendix A) (O’Brien et al., 2010) will be 
followed precisely, except it will be modified to follow the extra guidance in the international 
consensus statement for validation (Appendix B) (Stergiou et al., 2018). The international 
consensus statement (Stergiou et al., 2018) reviewed the adequacy of the number of participants 
in a variety of established protocols including the ESH-IP, and recommended that, to increase 
study power and accuracy, the number of participants in a study following the ESH-IP should be at 
least 85 rather than 33 as in the 2010 version of the ESH-IP.  
Setting and clinicians 
Study site 
The study site will be a room with a comfortable temperature and with no noise or other 
influences that may cause disturbance, such as telephones. 
Health professionals involved  
A supervisor and two observers are required to take the necessary recordings for this study. Three 
registered nurses will be identified for the study, with training and experience in blood pressure 
measurement. One will act as the supervisor and two will act as the observers, as specified in ESH-
IP. These roles will be outlined below in the section entitled “Interactions with participants and 
data collection”. 

4 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
Clinicians who participate in this study will be trained and experienced in blood pressure 
measurement. They will be instructed to follow the ESH-IP guidelines for data collection and 
record all blood pressure measurements to the nearest 2 mmHg. 
A familiarization session with the supervisor and the observers will be held in advance of 
interactions with participants. This session will involve a number of test measurements. The 
agenda for the session with the supervisor, who will be recording the data from the observers and 
from the novel approach, can be seen in Appendix C. 
Conventional equipment 
Two standard mercury sphygmomanometers, the components of which will be checked carefully 
before the study, will be used as the reference standards by the observers. They will be within 1m 
of where the observers will be when interacting with a participant, so that they will be able to 
follow the menisci at eye level from 40mmHg to 180 mmHg. Bladders of multiple sizes will be 
made available so that, on each subject, there is one of sufficient length to encircle 80%–100% of 
the arm circumference. The observers will be supplied with good quality non-electronic 
stethoscopes with well-fitting earpieces. 
Heartbeat equipment 
The pulse oximeter, the Heartbeat application (MediBeat), and the supervisor’s smartphone 
(Samsung Galaxy Xcover 4 with Bluetooth connectivity) will be charged, and tested each day of 
interactions with participants. Prior to conducting the study session, the equipment will have to be 
calibrated for each participant. The first step of the calibration process is to manually enter the 
reference data (date of birth, height, weight, baseline manual blood pressure reading and heart 
rate). Once data is entered, and participant has been given 10 minutes of rest, the nurse 
supervisor will ensure the participant is seated comfortably, with their legs uncrossed, back 
supported, and their arm rested on the table at heart level. The nurse supervisor will then attach 
the Contec finger pulse oximeter to the participant’s finger (opposite to the arm with the manual 
blood pressure cuff) and wait for a few seconds, to make sure a stable signal is received, and the 
device displays both the participant’s pulse and SpO2 values. Once the values are displayed, the 
nurse supervisor will hit the “Add session” button, and choose the correct device to connect to via 
Bluetooth. The calibration process will begin, indicated by the orange background, and the 
MediBeat application will display the participant’s heartrate and SpO2 values. It is critical that the 
participant does not move during the calibration process, which will last just over 1 minute. The 
background of the application will turn blue once calibration has completed successfully.  
Recruitment plan 
Inclusion/Exclusion Criteria 
Healthy participants who are over the age of 25 and live or work in the North Simcoe Muskoka and 
Markham regions will be recruited to participate in this study. As outlined in the ESH-IP, only 
healthy subjects will be included this study; those who have heart arrhythmias, atrial fibrillations 
or atrial flutters, an inaudible Korotkoff sound, wounds of the upper arms/wrists, missing fingers, 
and/or an arm circumference of more than 55 cm will be excluded, in advance if at all possible, 
and at the study site if not previously excluded.  

5 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
Recruitment will continue until the following quotas are met: 
1. Numbers: At least 85 who fully complete the study protocol, and fall within the 
parameters listed in #3 
2. Sex: At least 26 male and 26 female (each 30% of the total number of participants) 
3. Blood pressure range: 26 to 31 subjects in each of the three SBP and three DBP 
recruitment ranges as shown in Form 3 – Study Results (Appendix N): 
• 
Low blood pressure (systolic: 0-129, diastolic: 0-79) 
• 
Medium blood pressure (systolic: 130-160, diastolic: 80-100) 
• 
High blood pressure (systolic: 161 or higher, diastolic: 101 or higher).   
 
Participant Remuneration 
To thank participants for their valuable time, they will be provided with a $50 VISA pre-paid gift 
card at the end of the study visit. 
Recruitment Methods 
Recruitment flyers (Appendix E) will also be posted in public spaces at corporate offices and 
medical clinics, who have agreed to participate within Central Ontario, including Markham, 
Toronto, and North Simcoe Muskoka.  
 
Recruitment emails (Appendix F) will be sent to all relevant employees located at corporate offices 
and medical clinics, who have agreed to participate within Central Ontario, including Markham, 
Toronto, and North Simcoe Muskoka, with a link to HeartbeatStudy@sehc.com to indicate 
interest. Recruitment will be a two-step process. 
 
Clinical staff, from clinics who have agreed to participate, will be provided with a short script 
(Appendix G) and Frequently Asked Questions (FAQ) document (Appendix H) to assist with the 
recruitment process. Individuals interested in participating can submit a consent to contact form 
(Appendix I) to the clinic staff, who will scan and send the forms to the research team. Research 
assistant will call individuals who had expressed their interest in participating to further explain 
the study (Appendix J) and ask if they would like to participate. The research assistant will then 
inform them about the consent form (Appendix K) that they will be asked to sign at the study site. 
The research assistant will provide the participant with information about a scheduled time for 
participating in the study and directions. 
Interactions with participants and Data collection 
Form 1 - Device information 
Prior to the first interaction with a participant, the supervisor will fill in the information about the 
device in Form 1 of the ESH-IP (Appendix D). As noted above, the Contec CMS50EW device is an 
electronic finger pulse oximeter (Contec Medical Systems Co., Ltd, Qianhuangdao, China) that 
generates a PPG, which is then sent to HeartBeat’s proprietary algorithm to calculate blood 
pressure. 

6 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
Confirmation of appropriate setting conditions 
Before involving any participant in the study, the nurse supervisor and nurse observers 1 and 2 
will ensure that the following requirements for the study site and equipment outlined by ESH-IP 
are met (O’Brien, 2010): 
1. Environment 
a. Comfortable temperature 
b. No noises or disturbances (e.g. telephone, pagers) that could influence testing 
c. Ambient noises are not at a level that could interfere with testing  
2. Manual blood pressure device  
a. Stethoscopes for using the sphygmomanometer have well-fitting earpieces. 
Participant consent and interaction 
At the study site, the following activities will be undertaken: 
1. Nurse supervisor will provide the patient with the consent form and obtain the patient’s 
consent (Appendix L) (signed consent forms – Appendix K) to be enrolled into the study. 
The nurse supervisor will photograph and email the consent forms to the research 
assistant once signed and witnessed.  
 
2. Nurse supervisor will explain to the participant how their blood pressure measurements 
will be taken using the “conventional” and the “alternative” approaches. 
 
3. Nurse supervisor will also complete the recruitment details in Form 2 in the “Recruitment 
details” section (Appendix M). Nurse supervisor will record the provided study 
participant’s identification number onto the consent form. 
 
4. The nurse supervisor will ask the participant to relax for 10–15 min. 
 
5. Nurse supervisor will log onto the HeartBeat application to create a new patient profile 
and enter all baseline data (age, gender, height, weight, and heart rate). 
 
6. After the period of relaxation, the nurse supervisor will make sure that the subject is 
seated with legs uncrossed and back supported, if the subject is not seated as described, 
the posture used must be recorded as a protocol adjustment. 
 
7. The nurse supervisor will put the blood pressure cuff on the participant’s left arm and 
ensure that the participant’s arm is supported at heart level. 
 
8. The nurse supervisor will put the Contec finger pulse oximeter on the participant’s right 
index finger (and the participant will keep device on during duration of the study). 
 
9. Blood pressure is measured as described in the following diagram: 

7 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
 
10. Observer measurements will be recorded simultaneously by the observers on separate 
sheets. They will be checked immediately by the nurse supervisor and, if they differ by 
more than 4 mmHg, they will be taken again. Observers will be blinded from each other's 
measurements and from the device measurements. 
 
11. Starting with the observers, the nurse supervisor will record the measurements 
sequentially by the supervisor, alternating between observers and the supervisors’ reading 
of the device in the order BPA, BPB, BP1, BP2, BP3, BP4, BP5, BP6 and BP7 on Form 2. 
 
12. The nurse supervisor will take a picture of the device measurements and those 
photographs will be emailed to the research assistant. 
 
13. On a separate sheet, the nurse supervisor will keep a running total of the number of 
subjects recruited in the Low (LL and L), Medium (M), and High (H and HH), ranges for SBP 
(Box 219) and DBP (Box 220) on Form 2. 
 
14. If any of the following occur during the study, the nurse supervisor will circle the 
appropriate item in Box 287 on Form 2 and exclude the subject:  
• 
Circle Arrhythmias if the subject is not in sinus rhythm throughout the study. 
• 
Circle Device failure if the device fails to record a measurement after three 
successive attempts. 
• 
Circle Poor quality sounds if the Korotkoff sounds are difficult to auscultate, 
regardless of the reason. 
• 
Circle Observers disagreement if the observers differ by more than 4 mmHg twice 
in the same subject. 
• 
Circle Other if the subject does not complete the study for any reason other than 
those listed and record the reason in Box 288. 
 
15. In the event that an abnormal blood pressure reading is detected (e.g. if the blood 
pressure is outside clinically normal range for a specific client), one of the observers will 

8 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
re-take the blood pressure to determine if the abnormal reading is accurate. If the 
abnormal blood pressure measurement is accurate, the nurse supervisor will take 
appropriate action as directed by professional standards. The abnormal blood pressure 
data will be recorded on Form 2. 
Data Checking 
During the data collection process, researchers will check the data daily to ensure the following as 
per the ESH-IP (O’Brien et al., 2010): 
1. Ensure that the difference between the range with the highest count and lowest count 
does not exceed 19. 
2. Ensure the overall systolic blood pressure is within the range of ≤100 to ≥170mmHg 
and the overall diastolic blood pressure is within the range of ≤50 to ≥120mmHg. 
3. If the participants have a blood pressure outside the range of 90–180mmHg for 
systolic blood pressure and 40–130mmHg for diastolic blood pressure, only a 
maximum of 4 blood pressures readings outside of this range can be included in the 
analysis.  
4. Ensure there are approximately 26-31 participants in each of the 3 blood pressure 
ranges (low blood pressure (systolic: 0-129, diastolic: 0-79), medium blood pressure 
(systolic: 130-160, diastolic: 80-100) and high blood pressure (systolic: 161 or higher, 
diastolic: 101 or higher)).  
 
Data Analysis  
The profile of the study participants will be described based on a demographic analysis conducted 
on data collected from the subject data form from the ESH-IP (Appendix M). 
All collected data on Forms 1 and 2 will be sent to the researchers at the SE Research Centre, who 
will consolidate the data from the Forms 1 and 2 and analyze the data as specified in Form 3, the 
Study Results form from the ESH-IP (Appendix N) (O’Brien et al., 2010).  
In order to pass the validation process, the device must pass both parts 1 and 2 based on the 
accuracy criteria table (Appendix O). 
Plots 
These are mean-difference plots, and the plots modelled from the data collected should be exactly 
as shown in the example plots below. 

9 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
 
The x-axis of these plots represents blood pressures in the systolic range 80mmHg–190mmHg and 
the diastolic range 30 mmHg–140 mmHg. The y-axes represent errors from – 30mmHg to 
+30mmHg. Horizontal reference lines will be drawn at 5mmHg intervals from +15mmHg to – 15 
mmHg. The mean of each device pressure and its corresponding observer pressure will be plotted 
against their difference with a point. Differences greater than 30mmHg will be plotted at 30 
mmHg. Differences less than – 30mmHg will be plotted at – 30 mmHg. The same scales will be 
used for both SBP and DBP plots. Where points are superimposed, these will be indicated either by 
proportionately larger points or by different symbols.   
5. Confidentiality and security of data 
Electronic data 
The data obtained from the pulse oximeter is captured by the Nurse supervisor’s smartphone via 
Bluetooth connection. The smartphones and tablets used by SE Health nurses meet the 
requirements for all custodians of personal health information in Ontario. The HeartBeat 
application on the clinicians’ smartphones or tablets encrypts the data for transmission to secure 
Google Servers within Canada, and the algorithm is also housed on those servers. The data outputs 
from the algorithm are then made available on a secure web-based password-protected portal to 
which only the researchers have access. The data will be downloaded by the researchers from the 
portal to password-protected computers which meet all the requirements for custodians of 
personal health information in Ontario.  
 
Paper data 
Paper data from the study will be photographed/scanned and emailed to the researchers at the SE 
Research Centre. Once received, the photographs, scans and emails will be deleted by the senders. 
The digital copies received in the SE Research Centre will be stored on a password protected 
computer that is accessible only by researchers from the SE Research Centre. All paper forms will 
be destroyed in keeping with SE Health’s standards for destroying paper materials in accord with 
Ontario’s Personal Health Information Protection Act. 
 
Storage and data destruction 

10 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
All electronic files will be kept secure on password protected computers and only research team 
members will have access to them. All paper-based data records will be photographed and stored 
electronically in password protected computers.  
 
Written records (lists of participants and their email addresses if they wish to receive information 
from the study) will be secured in a locked file cabinet in the SE Research Centre, and then 
scanned to create digital copies of the written records will be stored on computers secured by 
passwords known only to the members of the research team for analysis. After scanning, the 
written records will be destroyed securely in accord with SE Health Care’s procedure to comply 
with the standards of the Personal Health Information Protection Act of Ontario. 
 
When analysis has been completed, the data will be transferred to secure servers owned by SE 
Health, which comply with the standards of the Personal Health Information Protection Act. Digital 
records will be destroyed securely within 72 months of the research project’s end (i.e. in 2025) 
except those excerpts of the data used in final reports, publications, presentations and training 
materials. In the final reports, publications, presentation materials, and training materials that 
emerge from this research project, the data will be presented in such a way that the identity of the 
participant is not knowable by a reader or viewer. 
 
6. Withdrawal from the study 
Participants will be free to withdraw from the study at any time without penalty or affects to their 
care. Any data (e.g. blood pressure measurements) collected prior to the participant’s withdrawal 
from the study but before its use in the study will be deleted and not used. 
 
 

11 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
List of Appendices  
 
Appendix A – O’Brien (2010) European Society of Hypertension International Protocol (ESH-IP) 
Appendix B – Stergiou (2018) International Consensus Statement 
Appendix C – Training Agenda for Clinicians 
Appendix D – International Protocol Device & Study Details Form  
Appendix E – Recruitment Poster 
Appendix F – Recruitment Emails 
Appendix G – Brief information about the study 
Appendix H – Frequently Asked Questions (FAQ) 
Appendix I – Consent to contact for research 
Appendix J – Phone script for providing participant information  
Appendix K – Information and consent form for participants  
Appendix L – Script for obtaining participant consent 
Appendix M – International Protocol: Subject data form (amended) 
Appendix N– International Protocol Study Results Form 
Appendix O – International Protocol Accuracy Criteria Table 
 
 

12 
 
2019 11 04 MCD 307 Research protocol ver. 4 
SRHC REB #007-1920 
References 
 
Heart and Stroke Foundation of Ontario and Registered Nurses’ Association of Ontario (2005). 
Nursing Management of Hypertension. Toronto, Canada: Heart and Stroke Foundation of 
Ontario and Registered Nurses’ Association of Ontario. 
O'Brien, E., Atkins, N., Stergiou, G., Karpettas, N., Parati, G., Asmar, R., …, Shennan, A. (2010). 
European Society of Hypertension International Protocol revision 2010 for the validation of 
blood pressure measuring devices in adults. Blood Pressure Monitoring, 15(1), 23-38. 
doi:10.1097/MBP.0b013e3283360e98 
Roland, M. & Torgerson, D.J. (1998). Understanding controlled trials: What are pragmatic trials? 
BMJ, 316(7127), 285. 
Stergiou, G. S., Alpert, B., Mieke, S., Asmar, R., Atkins, N., Eckert, S., ... & Ioannidis, J. P. (2018). 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, 71(3), 368-374. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Form 2 – Subject data
This form is to be filled by the validation supervisor for each subject. Items in clear boxes are assessed directly. Items in shaded boxes are
calculated. All blood pressure measurements are recorded in mmHg and are carried out sequentially on one arm, whichever is more comfortable
for the subject. Including any time required to change cuffs, At least 30 seconds should be allowed between each measurement to avoid venous
congestion, but not more than 60 seconds or variability may be increased.
Prerequisites
On a separate sheet, keep a running total of the number of subjects recruited in the Low (LL and L), Medium (M), and High (H and HH) 
ranges for SBP (Box 219) and DBP (Box 220).
If any of the following occur during the study, circle the appropriate item in Box 287 and exclude the subject.
Circle Arrhythmias  if the subject is not in sinus rhythm throughout the study.
Circle Device failure if the device fails to record a measurement after three successive attempts.
Circle Poor quality sounds if the Korotkov sounds are difficult to auscultate, regardless of the reason.
Circle Observers disagreement if the observers differ by more than 4 mmHg twice in the same subject. 
 
Circle Other if the subject does not complete the study for any reason other than those listed and record the reason in Box 288.
Starting with the observers, measurements are recorded sequentially alternating between observers and the device in the order BPA, BPB,
BP1, BP2, BP3, BP4, BP5, BP6 and BP7.
If possible, a permanent record of device measurements should be kept. If software is provided, device measurements should be
downloaded daily. 
Observer measurements should be recorded simultaneously by the observers on separate sheets. They must be checked immediately
and, if they differ by more than 4mmHg, they should be taken again. Only enter final measurements on this sheet. Observers must be
blinded from each other's measurements and from the device measurements throughout the study.
Recruitment details
Date and time
201
Study number and
Subject number
202
203
Date of birth
204
Age
205
Sex
Male
Female
206
On antihypertensive 
medication
207
Arm circumference cm
208
Cuff for test device
209
Wrist circumference cm
210
Box 209:
Box 210: This is only required for wrist devices.
This is only required for arm devices. If the arm circumference is such that no suitable cuff is available, circle Cuff  size unavailable
in Box 287 and exclude the subject.
Yes
No
Small
Standard
Other
Large
Entry measurements
Ask the subject to relax for 10–15 min. Then make sure that the subject is seated with legs uncrossed and back supported. Ensure that the
arm is supported at heart level. If a wrist device is being tested, the wrist must be supported according to the manufacturer’s instructions. If the
subject is not seated as described, the posture used must be recorded as a protocol adjustment.
Device
 
Observer 1
Observer 2
SBP
DBP
SBP
DBP
SBP
DBP
SBP
DBP
SBP
DBP
SBP
DBP
BPA
4
1
2
3
1
2
2
1
2
1
1
2
BPB
215
216
Count
Category
Observer Mean
BPA
217
218
LL  L  M  H  HH
219
LL  L  M  H  HH
220
221
222
Boxes 217, 218:
Enter the rounded up averages of Boxes 211 and 213 and of Boxes 212 and 214 respectively.
Box 219:
Circle the range according to the BP in Box 217. LL: < 90, L: 90–129, M: 130–160, H: 161–180, HH: >180.
Box 220:
Circle the range according to the BP in Box 218. LL: < 40, L: 40–79, M: 80–100, H: 101–130, HH: >130.
Boxes 221, 222:
Update the running totals, for the ranges (counting LL and L together and counting HH and H together) in Boxes 219
and 220, and enter them respectively.
If one of Box 221 or Box 222 is greater than 12 but the other is not, it may be necessary to include this subject, and remove another, in
order to achieve the correct range distribution; in the removed subject, circle Range adjustment in Box 287.
If both Box 221 and Box 222 are greater than 12 or if an LL or HH is circled and there are already 4 such items circled, circle Ranges
complete in Box 287 and exclude the subject.
International Protocol for device validation O’Brien et al.
27
Height ft, in
Weight lbs
Heart Rate bpm
APPENDIX M

Validation measurements
Boxes 239–246:
Boxes 247–254:
Boxes 261–266:
Boxes 267–272:
Each device measurement is compared to the nearer of the previous and next observer measurement. As described below, the smaller
error is circled and the  corresponding observer measurement is copied to aid the analysis.
Box 273:
Boxes 274–278:
Box 279:
 Enter the number of ‘A’s circled in Boxes 273, 275 and 277.
Box 280: 
Enter the number of ‘A’s circled in Boxes 274, 276 and 278.
Box 281:
 Enter the value in Box 239 if Box 261 is circled or Box 241 if Box 267 is circled.
The numbers of ‘A’s, ‘B’s and ‘C’s will be used in the analysis to calculate the number of device-observer differences within 5 mmHg,
10 mmHg and 15 mmHg.
Box 282:
 Enter the value in Box 240 if Box 262 is circled or Box 242 if Box 268 is circled.
Box 283:
 Enter the value in Box 241 if Box 263 is circled or Box 243 if Box 269 is circled.
Box 284:
 Enter the value in Box 242 if Box 264 is circled or Box 244 if Box 270 is circled.
Box 285:
 Enter the value in Box 243 if Box 265 is circled or Box 245 if Box 271 is circled.
Box 286:
 Enter the value in Box 244 if Box 266 is circled or Box 246 if Box 272 is circled.
First, circle the smaller value, in absolute terms, of Boxes 261 and 267 (Box 261 if both are the same).
Then circle A if this is less than or equal to 5, B if this is 6–10, C if this is 11–15 or D if this is greater than 15.
Circle A, B, C or D, as described for Box 273, based on the smallest absolute values (also circled) of Boxes 262
and 268, Boxes 263 and 269, Boxes 264 and 270, Boxes 265 and 271and Boxes 266 and 272 respectively.
Enter the rounded up averages of Boxes 223 and 231, of Boxes 224 and 232, of Boxes 225 and 233, of Boxes 226
and 234, of Boxes 227 and 235, of Boxes 228 and 236, of Boxes 229 and 237 and of Boxes 230 and 238 respectively.
Enter the differences Box 223–Box 231, Box 224–Box 232, Box 225–Box 233, Box 226–Box 234, Box 227–Box 235,
Box 228–Box 236, Box 229–Box 237, and Box 230–Box 238 respectively.
Enter the ‘Device–Previous Observer Mean’ differences. These are Box 255–Box 239, Box 256–Box 240,
Box 257–Box 241, Box 258–Box 242, Box 259–Box 243, and Box 260–Box 244 respectively.
Enter the ‘Device–Next Observer Mean’ differences. These are Box 255–Box 241, Box 256–Box 242, Box 257–Box 243,
Box 258–Box 244, Box 259–Box 245, and Box 260–Box 246 respectively.
BP1
BP3
BP5
BP7
SBP
DBP
SBP
DBP
SBP
DBP
SBP
DBP
Observer 1
Observer 2
Observer mean
Observer 
difference
Difference
A
0–5 mmHg
B
6–10 mmHg
C
11–15 mmHg
D
> 15 mmHg
Device
Device–Previous 
observer
Device–Next 
observer
Within 5 mmHg
SBP
DBP
Error group
Observer value
BP2
BP4
BP6
SBP
DBP
SBP
DBP
SBP
DBP
A  B  C  D
A  B  C  D
A  B  C  D
A  B  C  D
A  B  C  D
A  B  C  D
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
Signoff
Please use the comments to explain unlisted subject exclusion or any problems during the procedure
Excluded 
e
r
uliaf 
e
civ
e
D
s
ai
m
h
ty
h
rr
A
etelp
m
o
c s
e
g
n
a
R
Poor quality sounds
Cuff size unavailable
Observer disagreement
Distribution
Other
Comments
288
Supervisor signature
Note: Subjects initially included may be excluded due to changes in pressure. See observer measurements in each recruitment range
in Form 3 – Study Results. 
Range adjustment
287
289
If a printout of test device data is possible, print the device data for this subject and attach it to this form.
28
Blood Pressure Monitoring
2010, Vol 15 No 1

Form 3 – Study results
The data from Form 2 – Subject Data for each subject should be appropriately analysed so that the results on this form can be completed. All references
to boxes 201–289 refer to values obtained from all of the Forms 2 from the relevant subjects. All blood pressure measurements are in mmHg.
Table 1 Screening and recruitment details
s
e
g
n
a
r tn
e
m
tiu
r
c
e
R
tn
e
m
tiu
r
c
e
r 
d
n
a 
g
nin
e
e
r
c
S
Total screened
301
mmHg
All
On Rx
Total excluded
302
SBP
Low
< 90
314
324
Ranges complete
303
90–129 
315
Range adjustment
304
Medium 130–160 
316
325
Arrhythmias
305
High
161–180 
317
326
Device failure
306
> 180
318
Poor quality sounds
307
Cuff size unavailable
308
DBP
Low
< 40
319
327
Observer disagreement
309
40–79 
320
Distribution
310
Medium
80–100 
321
328
Other reasons∗
311
High
101–130 
322
329
Total recruited
312
> 130
323
∗Explanation summary
313
Box 301:
The total number of subjects screened, regardless of whether or not they were included in the study.
Box 302:
The total number excluded. This equals the sum of Boxes 303–311.
Box 303:
The number of subjects excluded with Ranges complete circled in Box 287 (Form 2 for each excluded subject).
Box 304:
The number of subjects excluded with Range adjustment circled in Box 287.
Box 305:
The number of subjects excluded with Arrhythmias circled in Box 287.
Box 306:
The number of subjects excluded with Device failure circled in Box 287.
Box 307:
The number of subjects excluded with Poor quality sounds circled in Box 287.
Box 308:
The number of subjects excluded with Cuff size availability circled in Box 287.
Box 309:
The number of subjects excluded with Observer disagreement circled in Box 287.
.
Box 310:
The number of subjects excluded with Distribution circled in Box 287.
Box 311:
The number of subjects excluded with Other reasons circled in Box 287. A summary of those reasons must be provided in Box 313.
Box 312:
The total recruited equals the number screened (Box 301) less the number excluded (Box 302). This should equal 33 except
in validations in some specific populations.
Box 313:     A summary of why those counted in Box 311 were excluded (Box 288).
Boxes 314–323: In a completed study in a general adult population, the sum of Boxes 314 and 315, Box 316, the sum of Boxes 317 and 318,
the sum of Boxes 319 and 320, Box 321 and the sum of Boxes 322 and 323 must each be between 10 and 12. The sum of
Boxes 314, 318, 319 and 323 must be at most 4. The sum of Boxes 314–318 and the sum of Boxes 319–323 must each
be exactly 33. Studies in specific populations may have different restrictions and totals (Boxes 219 and 220 – Form 2 for
each included subject ).
Boxes 324–329: The number of subjects in each range on antihypertensive medication (Boxes 207, 219 and 220).
International Protocol for device validation O’Brien et al.
29
APPENDIX N

Table 2 Subject details
Male:Female
Sex
330
Age (years)
Range (Low :High)
331
Mean (SD)
332
Arm circumference (cm)
Range (Low :High)
333
Mean (SD)
334
Cuff for test device
(Upper arm devices only)
Small 
335
Standard 
336
Large
337
____ –
cm
____
____ –
cm
____
____ –
cm
____
____ –
cm
____
Other
338
Wrist circumference (cm)
(Wrist devices only)
Range (Low :High)
Range (Low :High)
339
Mean (SD)
SBP
DBP
340
Recruitment BP (mmHg)
341
342
Mean (SD)
343
344
Note: The values in Boxes 314–380 refer only to the final recruited subjects, each of whom contributes SBP and DBP 
measurements for analysis. Excluded subjects are not included in any of this analysis.
Box 330:
Enter the number of males, a colon and the number of females. They should total 33 except in validations in some
specific populations. If the minimum requirements (10 for a general population) are not met, subjects must be replaced as
necessary (Box 206).
Box 331:
Enter the age of the youngest subject, a colon and the age of the oldest subject e.g. 31:74. Subjects outside the required
range (25 and over for a general population) are not permitted (Box 205).
Box 332:
Enter the mean and, in parentheses, the SD of the subject ages. Values should be rounded up to one decimal place
e.g. 52.3 (11.9) (Box 205).
Box 333:
Enter the smallest arm circumference, a colon and the largest arm circumference e.g. 24:34 (Box 208).
Box 334:
Enter the mean and, in parentheses, the SD of the subject arm circumferences. Values should be rounded up to one decimal
place e.g. 29.0 (3.1) (Box 208).
Box 335:
If a small cuff was supplied, enter the number of subjects on whom it was used. If it was not supplied, enter an ‘X’.
Enter the arm sizes for which it is recommended beside it. (Applicable only for arm devices) (Box 209).
Box 336:
Enter the number of subjects on whom a standard (or medium) cuff was used. Enter the arm sizes for which it is
recommended beside it. (Applicable only for arm devices) (Box 209).
Box 337:
If a large cuff was supplied, enter the number of subjects on whom it was used. If it was not supplied, enter an ‘X’.
Enter the arm sizes for which it is recommended beside it. (Applicable only for arm devices) (Box 209).
Box 338:
If a different size cuff was supplied, enter the number of subjects in whom it was used. If no such cuff was supplied, enter an
‘X’. Enter the arm sizes for which it is recommended beside it. (Applicable only for arm devices) (Box 209).
Box 339:
Enter the smallest wrist circumference, a colon and the largest wrist circumference e.g. 15:22 (Applicable only for wrist
devices) (Box 210).
Box 340:
Enter the mean and, in parentheses, the SD of the subject wrist circumferences. Values should be rounded up to one decimal
place e.g.18.1(2.3) (Applicable only for wrist devices) (Box 210).
Boxes 341–342: 
Enter the lowest pressure, a colon and the highest pressure from BPA measurements only e.g.104:180.
 (Boxes 217 and 218).
Boxes 343–344: 
Enter the mean and, in parentheses, the SD of the subject pressures from BPA measurements only. Values should be
 rounded up to one decimal place e.g. 140.4 (20.3). (Boxes 217 and 218).
30
Blood Pressure Monitoring
2010, Vol 15 No 1

Table 3 Distribution
SBP
DBP
Overall range (Low :High)
345
Overall range  (Low : High)
350
Low (<130)
346
Low (<80)
351
Medium (130–160)
347
Medium (80–100)
352
High (>160)
348
High (>100)
353
Maximum difference
349
Maximum difference
354
This section analyses the distribution of comparative measurements.
Box 345:
Enter the lowest pressure, a colon and the highest SBP from the observer measurements (Boxes 281, 283 and 285).
Boxes 346–348: The observer measurements (three per subject) for SBP are categorised similarly to the recruitment ranges. Enter the counts
of measurements falling into each range. These must total 99 (Boxes 281, 283 and 285).
Box 349:
Subtract the smallest value from Boxes 346 to 348 from the largest one and enter the result.
Box 350:
Enter the lowest pressure, a colon and the highest DBP from the observer measurements (Boxes 282, 284 and 286).
Boxes 351–353: The observer measurements (three per subject) for DBP are categorised similarly to the recruitment ranges. Enter the counts
of measurements falling into each range. These must total 99 (Boxes 282, 284 and 286).
Box 354:
Subtract the smallest value from Boxes 351 to 353 from the largest one and enter the result.
Table 4 Observer differences
This section is for the differences in pressures between the two observers
SBP
DBP
Repeated 
measurements
Observer 2–Observer 1 
Range (Low :High)
355 
Mean (SD)
357 
356
359
358
Boxes 355–356: Enter the lowest difference, a colon and the highest difference between the observers. Include the signs e.g. – 3: + 4. (Boxes
             247, 249, 251 and 253 and Boxes 248, 250, 252 and 254). If the range is outside – 4: + 4, then this is a violation. Relevant
            subjects should be excluded, by reason of Observer Disagreement, and replaced.
Boxes 357–358: Enter the mean and, in parentheses, the SD of the observer differences. Values should be rounded up to one decimal place
e.g. 0.3 (1.2) (Boxes 247, 249, 251 and 253 and Boxes 248, 250, 252 and 254).
Boxes 359:    Enter the number of measurements that were repeated in the included subjects because observers were more than
4 mmHg apart.
 
In validations carried out in specific populations requiring more than 33 subjects but with similar blood pressure distributions, similar 
proportions should be used. If the blood pressure distribution in the specific population differs from the standard distribution, ignore this
table but comment on the distribution in the discussion.
The overall SBP range must be from ≤ 100 mmHg to ≥ 170 mmHg and the overall DBP range must be from ≤ 50 mmHg to ≥ 120 mmHg.
If not, further recruitment will be necessary. Subjects to be excluded will be the last recruited within the  relevant ranges.
The minimum number of replacements should take place. If a subject is replaced for either of these reasons, circle Distribution
in Box 287 of Form 2 for that subject.
In order to ensure a uniform distribution, there must be at least 22 measurements and at most 44 measurements (Boxes 346 to 348 and
351 to 353) in each of the low, medium and high ranges and the maximum differences (Boxes 349 and 354) must be at most 19. If not,
further recruitment will be necessary. Subjects to be excluded will be those whose pressures drifted from recruitment pressures.
International Protocol for device validation O’Brien et al.
31

In order for the device to pass, all protocol requirements must be fulfilled. A fail in any part will result in an overall fail
.
Box 360:             Enter the number of SBP differences (at most 99) between observer and device measurements falling within 5 mmHg.
(The total number of Boxes 273, 275 and 277 circled A in the 33 subjects)
Box 361: 
   Enter the number of SBP differences (at most 99) between observer and device measurements falling  within 10 mmHg. 
(The total number of Boxes 273, 275 and 277 circled A or B in the 33 subjects)
Box 362: 
   Enter the number of SBP differences (at most 99) between observer and device measurements falling within 15 mmHg.
(The total number of Boxes 273, 275 and 277 circled A, B or C in the 33 subjects)
Box 363:             If Boxes 360, 361 and 362 fulfil the Pass requirements, then this is ‘Pass’; otherwise, it is ‘Fail’.
Boxes 364–365: Enter the mean and standard deviation respectively  of the 99 SBP differences between observer and device
measurements. (Use data from circled Boxes 261 or 267, 263 or 269 and 265 or 271) 
Box 366:             Enter the number of DBP differences (at most 99) between observer and device measurements falling within 5 mmHg.
(The total number of Boxes 274, 276 and 278 circled A in the 33 subjects)
Box 367:             Enter the number of DBP differences (at most 99) between observer and device measurements falling within 10 mmHg.
(The total number of Boxes 274, 276 and 278 circled A or B in the 33 subjects)
Box 368:             Enter the number of DBP differences (at most 99) between observer and device measurements falling within 15 mmHg.
(The total number of Boxes 274, 276 and 278 circled A, B or C in the 33 subjects)
Box 369:             If Boxes 366, 367 and 368 fulfil the Pass requirements, then this is ‘Pass’; otherwise, it is ‘Fail’.
Boxes 370–371: Enter the mean and standard deviation respectively of the 99 DBP differences between observer 
and device measurements. (Use data from circled Boxes 262 or 268, 264 or 270 and 266 or 272) 
Box 372:             Enter the number of subjects (at most 33) with two or three of the absolute differences between observer and device 
SBP measurements within 5 mmHg. (Box 279 is 2 or 3) 
Box 373: 
   Enter the number of subjects (at most 33) with none of the absolute differences between observer and device SBP
measurements within 5 mmHg. (Box 279 is 0) 
Box 374: 
   If Boxes 372 and 373 fulfil the Pass requirements, then this is ‘Pass’; otherwise, it is ‘Fail’.
Box 375: 
   If Boxes 363 and 374 are both ‘Pass’, then this is ‘Pass’; otherwise, it is ‘Fail’.
Box 376: 
   Enter the number of subjects (at most 33) with two or three of the absolute differences between observer and device 
DBP measurements within 5 mmHg. (Box 280 is 2 or 3) 
Box 377: 
   Enter the number of subjects (at most 33) with none of the absolute differences between observer and device DBP
measurements within 5 mmHg. (Box 280 is 0) 
Box 378: 
   If Boxes 376 and 377 fulfil the Pass requirements, then this is ‘Pass’; otherwise, it is ‘Fail’.
Box 379: 
   If Boxes 369 and 378 are both ‘Pass’, then this is ‘Pass’; otherwise, it is ‘Fail’.
Box 380: 
   If Boxes 375 and 379 are both ‘Pass’, then this is ‘Pass’; otherwise, it is ‘Fail’. 
In validations carried out in specific populations requiring more than 33 subjects, proportionally equivalent passing criteria should be used.
Part1
≤
≤ 3
Pass 
requirement
Two of
73
87
96
Achieved
SBP
DBP
Pass 
requirement
Achieved
SBP
DBP
Part 3
Result
≤
≤
≥ 24
371
379
378
377
376
370
369
368
367
366
380
Table 5 Validation results
All of
65
81
93
≤ 5mmHg
≤ 10mmHg
≤ 15mmHg
Grade 1
Mean
SD
Part 2
Grade 3
Grade 2
0/3 ≤ 5mmHg
2/3 ≤ 5mmHg
365
364
363
362
361
360
375
374
373
372
32
Blood Pressure Monitoring
2010, Vol 15 No 1

Appendix O – International Protocol Accuracy Criteria Table June 28, 2019 ver. 1 
Appendix O – International Protocol Accuracy Criteria 
ESH International Protocol 2010 
Sequential Measurements 
IP Grading Part 1 - Minimum Requirements (at least 255 pairs of individual measurements) 
N 
≤ 5 mmHg 
≤ 10 mmHg 
≤ 15 mmHg 
Two of 
188 
224 
247 
All of 
167 
209 
240 
IP Grading Part 2 (85 subject mean pressures) 
N 
2/3 ≤ 5 mmHg 
0/3 ≤ 5 mmHg 
At least 
62 
At most 
8 
Recruitment Ranges (n = 85) 
SBP 
DBP 
mmHg 
Subjects 
mmHg 
Subjects 
90*...129 
26 – 31 
40*...79 
26 – 31 
130...160 
26 – 31 
80…100 
26 – 31 
161…180* 
26 – 31 
101…130* 
26 – 31 
* 
Altogether, up to 4 recruitment pressures are permitted to be outside these 
limits. 
Test Measurement Distribution 
SBP 
DBP 
mmHg 
Measurements 
mmHg 
Measurements 
≤ 100 
≥ 3 
≤ 50 
≥ 3 
< 130 
57 – 113* 
< 80 
57 – 113* 
130...160 
57 – 113* 
80…100 
57 – 113* 
> 160
57 – 113* 
> 100
57 – 113* 
≥ 170 
≥ 3 
≥ 120 
≥ 3 
* 
The difference between the maximum and minimum of these 3 counts for SBP 
and, separately, for DBP, must be less than or equal to 19.