Philips HeartStart Intrepid 12-lead Electrocardiogram (ECG) Study - The ICE (Intrepid Clinical Engineering) Study
Phase: NA
Conditions: Sudden Cardiac Arrest
Sponsor: Philips Clinical & Medical Affairs Global

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
1 of 51 
Clinical Validation Protocol 
 
Philips HeartStart Intrepid 12-lead ECG Study – The ICE study 
Protocol ID: CC_TC_ECR_Intrepid 12Lead_2022_11549 
 
Version 2.0 
Date: 12-Sep-22 
 
 
Document Status: Final 
 
Author: Barbara Fink, MS, CCRP; Associate Director of Clinical Affairs 
Approver: See Page 2 
Prepared for:  
Emergency Care  - Professional 
22100 Bothell Everett Highway, Bothell, WA  98021 
 
Sponsor Approval 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
2 of 51 
 
 
 
 
 
Author Signature                          Date 
Barbara Fink, Associate Director  Clinical Affairs – 
Emergency Care, Clinical & Medical Affairs  
 
Reviewer Signature                        Date 
Tiffani Bowers, Clinical Operations Manager, Clinical 
Operations – Emergency Care, Clinical & Medical 
Affairs 
  
 
 
 
 
Reviewer Signature                        Date 
Kevin Najarian, Global Director of Biostatistics and 
Data Management, Clinical &  Medical Affairs 
Reviewer Signature                        Date 
Tim Johnson, Principal Regulatory Program Manager, 
Emergency Care  
 
 
 
 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
3 of 51 
Investigator Agreement 
As Investigator of the study entitled “Philips HeartStart Intrepid 12-lead ECG Clinical Engineering Study – 
The ICE study” Protocol ID: CC_TC_ECR_Intrepid 12Lead_2022_11549, I agree to conduct the trial as 
outlined in the protocol in accordance with and the Study’s Protocol; all applicable laws and regulations; 
ICH Guidelines for Good Clinical Practices, Standard EN-ISO 14155: 2020 and the Declaration of 
Helsinki; and any conditions of approval imposed by the reviewing IRB/EC  or FDA conditions of 
approval, and The Sponsor’s guidelines include, but are not limited to: 
• 
Provide Philips with current curriculum vitae including a statement regarding relevant experience. 
• 
Provide accurate financial disclosure information to allow Philips to make an accurate disclosure 
statement as required under 21 CFR, Part 54 for the course of the investigation and for up to one year 
after its completion  
• 
Provide supervision of all testing of the study device/product involving human subjects.   
• 
If applicable, provide Philips with information regarding past investigations or other research that 
was terminated, including an explanation of the circumstances that led to the termination.   
• 
Permission to allow Philips and/or regulatory agencies to inspect study facilities and pertinent 
records at reasonable times and in a reasonable manner that ensures subject confidentiality.  If this study 
is to be inspected by a regulatory agency, Philips is to be notified as soon as possible. 
• 
Submission of the proposed clinical investigation including the protocol and the consent form to 
an IRB/EC for approval and the acquisition of written approval for each subject ensuring that the 
requirements for obtaining informed consent are obtained prior to the use of any test articles. 
• 
Submission of any proposed change in or significant deviation from the protocol to the IRB using 
a signed formal amendment document prepared by the Sponsor.  Any proposed changes or deviations 
from the protocol require that the informed consent also reflects such changes or deviations and that the 
revised informed consent be approved by an IRB. 
• 
Documentation and explanation of individual protocol deviations and violations are captured with 
explanations as indicated. 
• 
Submission of reports of Adverse Events to the Sponsor and IRB/EC as outlined in the protocol. 
• 
Submission of timely progress reports to the IRB and Sponsor at appropriate intervals on a 
schedule determined by the IRB or Sponsor, as indicated. 
• 
Record keeping:  the Investigator will maintain adequate and accurate records designed to record 
completion of all study procedures, related observations and other key data (such as safety, compliance 
and product accountability) pertinent to the investigation on each subject enrolled.  The investigator must 
maintain these records for a period as specified by Philips following completion of the study report. 
I agree that all information provided to me by the Sponsor including pre-clinical data, protocols, electronic 
databases, CRFs, and verbal and written information will be kept strictly confidential and confined to the 
clinical personnel involved in conduct of the trial.  It is recognized that this information may be related in 
confidence to the IRB.  I also understand that reports or information about the trial or its progress will not 
be provided to anyone not involved in the trial other than the Sponsor or other legally constituted 
authority. I agree to: 
 
 
 
 
Investigator Signature:
 
Date:
 
 
Printed Name: 
 
TABLE OF CONTENTS 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
4 of 51 
TABLE OF CONTENTS ............................................................................................................... 3 
1. 
PROTOCOL SUMMARY ................................................................................................ 17 
1.1 
Synopsis .............................................................................................................. 17 
1.2 
Schema ............................................................................................................... 20 
1.3 
Schedule of Activities .......................................................................................... 20 
2. 
INTRODUCTION ............................................................................................................. 21 
2.1 
Rationale ............................................................................................................. 21 
2.2 
Background ......................................................................................................... 21 
3. 
STUDY OBJECTIVES .................................................................................................... 23 
3.1 
Endpoints ............................................................................................................ 23 
3.1.1 
Primary Endpoints ................................................................................... 23 
3.2 
Hypotheses ......................................................................................................... 23 
4. 
BOTH HYPOTHESES MUST BE MET FOR OVERALL STUDY SUCCESS. STUDY 
DESIGN ...................................................................................................................................... 24 
4.1 
Overall Design ..................................................................................................... 24 
4.2 
Rationale for Study Design .................................................................................. 24 
4.3 
Sample size ......................................................................................................... 24 
4.4 
Study Duration and End of Study Definition ........................................................ 24 
5. 
STUDY PARTICIPANTS ................................................................................................ 25 
5.1 
Study Sample Considerations ............................................................................. 25 
5.2 
Inclusion Criteria .................................................................................................. 25 
5.3 
Exclusion Criteria ................................................................................................ 25 
5.4 
Definitions of Enrollment and Screen Failures .................................................... 26 
5.5 
Strategies for Recruitment and Retention ........................................................... 26 
6. 
STUDY PRODUCT ......................................................................................................... 26 
6.1 
Description of Intervention ................................................................................... 26 
6.2 
Description of Other Study Products ................................................................... 28 
6.3 
Concomitant Therapy .......................................................................................... 30 
6.4 
Preparation, Handling, Storage, and Accountability ............................................ 31 
6.4.1 
Acquisition and Accountability ................................................................. 31 
6.4.2 
Formulation, Appearance, Packaging, and Labeling ............................... 31 
6.4.3 
Product Storage and Stability .................................................................. 31 
6.4.4 
Preparation .............................................................................................. 31 
6.5 
Measures to Minimize Bias ................................................................................. 32 
6.5.1 
Type of Randomization ............................................................................ 32 
6.5.2 
Implementation of Randomization ........................................................... 32 
7. 
STUDY PROCEDURES .................................................................................................. 32 
7.1 
Recruitment Procedures ...................................................................................... 32 
7.1.1 
Pre-screening .......................................................................................... 32 
7.1.2 
Consent ................................................................................................... 32 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
5 of 51 
7.2 
Study Visits .......................................................................................................... 33 
Study Visit 1 ........................................................................................................ 33 
7.3 
Adverse Event Surveillance ................................................................................ 35 
7.4 
Data Processing and Scoring .............................................................................. 35 
7.5 
Participant Compensation ................................................................................... 36 
8. 
ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ........................................... 36 
8.1 
Adverse Events and Serious Adverse Events ..................................................... 36 
8.1.1 
Definition of Adverse Events .................................................................... 36 
8.2 
Unanticipated Adverse Device Event .................................................................. 37 
8.3 
Classification of an Adverse Event or Adverse Device Event ............................. 37 
8.3.1 
Relationship to the Study or Device ......................................................... 37 
8.3.2 
Expectedness .......................................................................................... 38 
8.4 
Adverse Event Assessment and Follow-Up ........................................................ 38 
8.5 
Serious Adverse Event or Serious Adverse Device Event Reporting .................. 39 
8.6 
Device Deficiency ................................................................................................ 39 
8.7 
Unanticipated Problems ...................................................................................... 39 
8.7.1 
Definition of Unanticipated Problems ....................................................... 39 
8.7.2 
Unanticipated Problem Reporting ............................................................ 39 
9. 
RISK BENEFIT ASSESSMENT ..................................................................................... 40 
9.1 
Known Potential Risks ......................................................................................... 40 
9.2 
Risk Mitigation ..................................................................................................... 40 
9.3 
Known Potential Benefits .................................................................................... 40 
9.4 
Assessment of Potential Risks and Benefits ....................................................... 41 
10. 
STATISTICAL CONSIDERATIONS ............................................................................... 41 
10.1 
Sample Size Determination ................................................................................. 41 
10.2 
General Considerations ....................................................................................... 41 
10.3 
Participant Disposition ......................................................................................... 41 
10.4 
Analyses .............................................................................................................. 41 
10.4.1  Demographics and Baseline Characteristics ........................................... 41 
10.4.2  Analysis of the Primary Endpoints ........................................................... 42 
10.4.3  Adjustment for Multiplicity ........................................................................ 42 
10.4.4  Exploratory Analyses ............................................................................... 42 
10.4.5  Sensitivity Analyses ................................................................................. 42 
10.4.6  Safety Analyses ....................................................................................... 42 
10.5 
Planned Interim Analyses .................................................................................... 42 
10.6 
Study Termination ............................................................................................... 42 
10.7 
Missing Data ........................................................................................................ 42 
10.8 
Deviations from the Statistical Analysis Plan ....................................................... 43 
11. 
OPERATIONAL CONSIDERATIONS ............................................................................. 43 
11.1 
Early Termination of Participation........................................................................ 43 
11.1.1  Discontinuation (active drop-out) ............................................................. 43 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
6 of 51 
11.1.2  Withdrawal (by investigator) .................................................................... 43 
11.1.3  Impact of Early Termination on Recruitment and Enrollment .................. 43 
11.2 
Regulatory and Ethical Considerations ............................................................... 43 
11.2.1  Institutional Review Board ....................................................................... 43 
11.2.2  Informed Consent Procedure and Documentation .................................. 44 
11.2.3  Study Discontinuation and Closure .......................................................... 44 
11.2.4  Confidentiality and Privacy ...................................................................... 44 
11.2.5  Future Use of Stored Specimens and Data ............................................. 45 
11.3 
Study Oversight ................................................................................................... 45 
11.3.1  Safety Oversight ...................................................................................... 45 
11.3.2  Monitoring ................................................................................................ 45 
11.3.3  Vulnerable Populations ............................................................................ 46 
11.4 
Quality Assurance and Quality Control................................................................ 46 
11.4.1  Training .................................................................................................... 46 
11.4.2  Data Collection and Handling .................................................................. 46 
11.4.3  Data Management ................................................................................... 47 
11.4.4  Data Retention Period ............................................................................. 47 
11.5 
Protocol Deviations ............................................................................................. 47 
11.5.1  Emergency Deviations ............................................................................. 47 
11.5.2  Major Protocol Deviations ........................................................................ 47 
11.5.3  Minor Protocol Deviations ........................................................................ 48 
11.5.4  Reporting Protocol Deviations ................................................................. 48 
11.6 
Publication and Data Sharing .............................................................................. 48 
11.7 
Study Registration ............................................................................................... 48 
11.8 
Conflict of Interest Policy ..................................................................................... 48 
REFERENCES ........................................................................................................................... 48 
LIST OF APPENDICES .............................................................................................................. 50 
 
Document Control Page(s) 
Protocol Title:  Philips HeartStart Intrepid 12-lead ECG Study – The ICE study 
Protocol ID: CC_TC_ECR_Intrepid 12Lead_2022_11549 
 
Protocol Version: 2.0 
 
Version Date: 12SEP2022 
 
Author(s):  B. Fink 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
10 of 51 
administrative law) published in the Federal 
Register by the executive departments and 
agencies of the federal government of the 
United States. The CFR is divided into 50 
titles that represent broad areas subject to 
federal regulation. 
CPR 
Cardiopulmonary Resuscitation 
Cardiopulmonary resuscitation (CPR) is a 
series of lifesaving actions that improve the 
chance of survival following cardiac arrest, 
and has integrated chest compressions and 
rescue breathing with the goal of optimizing 
circulation and oxygenation. CPR improves 
the victim's chance of survival by providing 
heart and brain circulation until further 
measures are taken to restore spontaneous 
blood circulation and breathing. 
CRF 
Case Report Form 
A document, printed or electronic, designed to 
record all of the protocol-required information 
to be reported to the sponsor on each study 
subject.  CRF’s are a living document in the 
respect that new information on the subject is 
continually gathered throughout the study. 
CVD 
Cardiovascular Disease 
Class of diseases that involve the heart or 
blood vessels.  Cardiovascular disease 
includes coronary artery diseases (CAD) such 
as angina and myocardial infarction 
(commonly known as a heart attack). 
-- 
Device Deficiency 
Inadequacy of a medical device with respect 
to its identity, quality, durability, reliability, 
safety or performance. 
Note:  device deficiencies include 
malfunctions, use errors, and inadequate 
labeling.   
DXL 
Philips Algorithm  
12 lead diagnostic ECG algorithm used in 
Philips products for ECG monitoring.  They 
are distinct from the AED mode rhythm 
recognition detector. 
EC 
Ethics Committee 
An independent body (a review board or a 
committee, institutional, regional, national, or 
multi-national), consisting of medical/scientific 
professionals and non-medical/non-scientific 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
11 of 51 
members. Its responsibility is to ensure the 
protection of the rights, safety, and well-being 
of human subjects involved in a study. 
ECG 
Electrocardiogram 
The process of recording the electrical activity 
of the heart over a period of time using 
electrodes placed on the skin. These 
electrodes detect the tiny electrical changes 
on the skin that arise from the heart muscle's 
electrophysiologic pattern of depolarizing and 
repolarizing during each heartbeat. It is very 
commonly performed to detect any cardiac 
problems. 
EC or EC Pro  
Emergency Care or Emergency 
Care Professional 
Philips Business Group, Profession covers 
advanced life support devices 
EDC 
Electronic Data Capture 
Electronic recording of clinical study data 
typically using the internet.   
EMS 
Emergency Medical Services 
An emergency service who treat illnesses and 
injuries that require an urgent medical 
response, providing out-of-hospital treatment 
and transport to definitive care.  
EU 
European Union 
The European Union (EU) is a political and 
economic union of 28 member states that are 
located in Europe 
-- 
Event Review Pro  
Philips proprietary software for post event 
review of event files downloaded from Philips 
Defibrillators 
FDA 
Food and Drug Administration 
The US Department of Health and Human 
Services consumer protection agency 
responsible for ensuring safety and 
effectiveness of all drugs, biologics, vaccines, 
and medical devices to be used in humans.   
GCP 
Good Clinical Practice  
A standard for the design, conduct, 
performance, monitoring, auditing, recording, 
analysis, and reporting of clinical studies that 
provides assurance that the data and reported 
results are credible and accurate, and that the 
rights, integrity, and confidentiality of study 
subjects are protected. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
12 of 51 
GDPR 
General Data Protection 
Regulation 
The General Data Protection Regulation (EU) 
2016/679 is a regulation in EU law on data 
protection and privacy for all individuals within 
the European Union and the European 
Economic Area. It also addresses the export 
of personal data outside the EU and EEA 
areas. 
HHS 
Health and Human Services  
 
HIPAA 
Health Insurance Portability and 
Accountability Act of 1996 
A US law designed to provide privacy 
standards to protect patients' medical records 
and other health information provided to 
health plans, doctors, hospitals and other 
health care providers. 
ICH 
International Conference on 
Harmonization 
A joint initiative involving both regulators and 
industry representatives from Japan, EU, and 
US as equal partners in the scientific and 
technical discussions of the testing 
procedures, which are required to ensure and 
assess the safety, quality and efficacy of 
medicines. 
IEC 
Independent Ethics Committee 
See Ethics Committee. 
IRB 
Institutional Review Board 
Any board, committee, or other group formally 
designated by an institution to review 
biomedical research involving humans as 
subjects, to approve the initiation of and 
conduct periodic review of such treatment.   
ISO 
International Organization for 
Standardization 
An international standard-setting body 
composed of representatives from various 
national standards organizations. 
MEDDEV 
Medical Devices  
MEDDEV stands for Medical Devices 
Documents. The MEDDEV Guidance 
Documents are developed by various working 
groups on behalf of the European 
Commission to assist stakeholders in 
implementing directives related to medical 
devices. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
13 of 51 
MDCG 
Medical Device Coordination 
Group 
The Medical Device Coordination Group deals 
with key issues from the medical devices 
sector, from Notified Body oversight or 
standardization to market surveillance, 
passing by international matters, new 
technologies and clinical investigation 
NBP 
Non-Invasive Blood Pressure  
The HeartStart Intrepid measures blood 
pressure for both adult and infant/child 
patients using the oscillometric method. 
Systolic, diastolic, and mean measurements 
are provided. Alarms are available to alert of 
changes in the patient’s condition. 
OHCA 
Out of Hospital Cardiac Arrest 
Sudden loss of blood flow resulting from the 
failure of the heart to effectively pump that 
occurs when an individual is out of the 
hospital. 
 -- 
Patient 
An individual who participates in a clinical 
study, either as a recipient of the study 
product(s) or as a control.  Also referred to as 
subject or participant. 
PI 
Principal Investigator 
Physician responsible for the conduct and 
oversite of the clinical study.  
P&MC 
Protocol and Monitoring 
Committee 
All performance and safety data will be 
reviewed by Protocol and Monitoring 
Committee (P&MC).  The P&MC will consist 
of the Principal Investigator, biostatistician, 
principal scientist, clinical study manager and 
members of the project team, as needed.  
The P&MC will review device performance as 
assessed by the adjudication process, 
adverse events, adverse device effects, the 
rate of failure to detect a shockable rhythm 
per device specifications, the rate of failure to 
charge to deliver the shock, error codes, dose 
deliveries, etc.   
QA 
Quality Assurance 
All the planned and systematic actions that 
are established to ensure that a study is 
performed and the data are generated, 
documented, and reported in compliance with 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
14 of 51 
GCP and the applicable regulatory 
requirement(s).   
SADE 
Serious Adverse Device Effect  
Any serious adverse effect on health or safety 
or any life-threatening problem or death 
caused by, or associated with, a device, if that 
effect, problem, or death, was not previously 
identified in a nature, severity, or degree of 
incidence in the investigational plan or 
application (including a supplementary plan or 
application), or any other unanticipated 
serious problem associated with a device that 
relates to the rights, safety, or welfare of 
subjects (21 CFR 812.3(s)). 
SAE/SADE 
Serious Adverse Event  
An AE or suspected adverse reaction is 
considered serious if, in the view of either the 
investigator or Sponsor, it results in any of the 
following outcomes:  
-death,  
-a life-threatening AE,  
-inpatient hospitalization or prolongation of 
existing hospitalization,  
-a persistent or significant incapacity or 
substantial disruption of the ability to conduct 
normal life functions, or  
-a congenital anomaly/birth defect.  
Important medical events that may not result 
in death, be life-threatening, or require 
hospitalization may be considered serious 
when, based upon appropriate medical 
judgment, they may jeopardize the participant 
and may require medical or surgical 
intervention to prevent one of the outcomes 
listed in this definition.   
Note: planned hospitalization for a pre-
existing condition, or a procedure required by 
the study protocol, without serious 
deterioration in health is not considered a 
serious adverse event.   
SAS 
Statistical Analysis Software  
SAS (previously "Statistical Analysis System") 
is a software suite developed by SAS Institute 
for advanced analytics, multivariate analyses, 
business intelligence, data management, and 
predictive analytics.  

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
15 of 51 
SCA 
Sudden Cardiac Arrest  
A sudden loss of blood flow resulting from the 
failure of the heart to effectively pump.  
-- 
Significant Risk Device 
Significant risk device means an 
investigational device that: 
 
Is intended as an implant and 
presents a potential for serious 
risk to the health, safety or 
welfare of a subject; 
 
Is purported or represented to be 
for a use in supporting or 
sustaining human life and 
presents a potential for serious 
risk to the health, safety, or 
welfare of a subject;  
 
Is for a use of substantial 
importance in diagnosing, curing, 
mitigating, or treating disease, or 
otherwise preventing impairment 
of human health and presents a 
potential for serious risk to the 
health, safety or welfare of a 
subject; or 
 
Otherwise presents a potential for 
serious risk to the health, safety, 
or welfare of a subject. 
SpO2 
Functional Oxygen Saturation  
Pulse oximetry is a noninvasive method of 
continuously measuring functional oxygen 
saturation (SpO2) in arterial blood. SpO2 
readings indicate the percentage of 
hemoglobin molecules in arterial blood which 
are saturated with oxygen.  
SPSS 
Statistical Package for the Social 
Sciences  
SPSS (Statistical Package for the Social 
Sciences), also known as IBM SPSS 
Statistics, is a software package used for the 
analysis of statistical data. 
ST/AR 
Philips ST/AR Algorithm  
ST Segment and Arrythmia Recognition 
algorithm ECG algorithm used in Philips 
products for ECG monitoring, different from 
the AED mode rhythm recognition detector. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
16 of 51 
TMF 
Trial Master File  
A file that contains all the essential 
documents relating to a clinical study.  
USA 
United States of America  
A federal republic composed of 50 states, a 
federal district, five major self-governing 
territories, and various possessions.  
UADE 
Unanticipated Adverse Device 
Effect  
An unanticipated adverse device event 
(UADE) is defined in 21 CFR Part 812.3(s) as 
“any serious adverse effect on health or 
safety or any life-threatening problem or death 
caused by, or associated with, a device, if that 
effect, problem, or death was not previously 
identified in nature, severity, or degree of 
incidence in the investigational plan or 
application (including a supplementary plan or 
application), or any other unanticipated 
serious problem associated with a device that 
relates to the rights, safety, or welfare of 
subjects”. 
Other important medical events which may 
not result in any of the outcomes above, but 
which may require intervention to prevent one 
of the outcomes above, may in the opinion of 
the investigator, be considered a UADE. 
USADE 
Unanticipated Serious Adverse 
Device Effect  
See Serious Adverse Device Effect.  
USAE 
Unanticipated Serious Adverse 
Effect  
See Serious Adverse Event.  
 
 
 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
21 of 51 
2. 
INTRODUCTION 
2.1 
Rationale 
The Philips DXL ECG Algorithm, developed by Philips Advanced Algorithm Research Center 
(AARC), uses sophisticated analytical methods for interpreting cardiac data. In the HeartStart 
Intrepid Monitor/Defibrillator, the DXL ECG Algorithm analyzes 12 leads of simultaneously 
acquired ECG waveforms to provide an interpretation of rhythm and morphology across a wide 
variety of patient populations. 
The purpose of this study is to validate the Philips DXL ECG Algorithm works as intended in The 
HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address 
instances of high impedance. This study will also review diagnostic quality of the 12-lead ECG 
tracing from the HeartStart Intrepid Monitor/Defibrillator.   
The study will monitor for any adverse events and unanticipated device effects.  To ensure safety 
participants will be monitored using pulse oximetry (SpO2) and Non-invasive blood pressure 
(NBP). 
2.2 
Background 
Electrocardiography is now more than 100 years old and has become an essential diagnostic tool 
that is continually being refined and further developed (Fye, 1994). Early single-channel analog 
machines, first with photo galvanometers and then later with direct writing galvanometers, have 
evolved into multi-channel simultaneous digital acquisition systems with a variety of storage and 
report possibilities. Digital systems enable computerized measurement and interpretation of the 
acquired signals. 
Development of computer-assisted ECG analysis began in the 1960s. Initially used in research 
facilities, computer interpretation has become an accepted tool to aid physicians in arriving at a 
final interpretation based on clinical data and a review of the findings. 
The adult ECG Criteria Program began in 1971 as a combined development effort between 
engineers and a worldwide panel of cardiologists. Extensive pediatric analysis was added in 1990. 
Since then, the Philips algorithm has undergone several modifications and enhancements to not 
only take advantage of new computer technology and advanced developments in 
electrocardiography, but also to incorporate revised guidelines proposed by international 
committees. 
The Philips DXL ECG Algorithm provides an analysis of the amplitudes, durations, and 
morphologies of the ECG waveforms and the associated rhythm. ECG waveform analysis is 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
22 of 51 
based on standard criteria for interpretation of these parameters, calculations of the electrical 
axis, and the relationship between leads. 
The algorithm is highly age and gender specific. Patient age and gender are used throughout the 
program to define normal limits for heart rate, axis deviation, time intervals, and voltage values 
for interpretation accuracy in tachycardia, bradycardia, prolongation or shortening of PR and QT 
intervals, hypertrophy, early repolarization, ischemia, and myocardial infarction. 
Adult criteria apply if the patient age entered is 16 years old or older, or if no age is specified. 
Pediatric criteria apply if the patient age entered is younger than 16 years of age. Twelve different 
age ranges are used for the pediatric criteria to account for the rapid changes that occur in the 
first few days to months of life. 
While increasingly detailed and well developed, no automated analysis is completely reliable, and 
computerized ECG analysis should always be reviewed by a qualified physician. 
This study will utilize ECG monitoring via a 12-lead ECG, SpO2 and NBP. The 2015 European 
Resuscitation Council Guidelines for Advanced Life Support highlights the value of other 
defibrillation topics (cardioversion, pacing) and physiological monitoring (ECG, end-tidal CO2, 
SpO2, non-invasive blood pressure) to guide ALS interventions and provide the best cardiac arrest 
care pre-hospital and in-hospital settings (Soar, 2015). 
-  
ECG monitoring: Monitoring heart rhythm through pads, paddles or ECG 
electrodes is a standard part of ALS. Motion artifacts prevent reliable heart rhythm 
assessment during chest compressions forcing rescuers to stop chest compressions to 
assess the rhythm and preventing early recognition of recurrent VF/pVT. 
- 
SpO2: Pulse oximetry is a common standard of care to establish base line 
oxygenation and assessing oxygenation while receiving supplemental oxygen. Pulse 
oximetry is a key element to the initial assessment and treatment of a patient with an 
arrhythmia, normal readings range from 94% to 100%. 
- 
Non-invasive blood pressure: Blood pressure is a key element to the initial 
assessment and treatment of a patient with an arrhythmia. 
In the Philips HeartStart Intrepid Monitor/Defibrillator the 12-lead ECG is an optional function 
accessed while in monitor mode.  12-Lead function allows the preview, acquisition printing, 
copying, and storage of 12-Lead ECGs. In addition, the 12-Lead function provides computerized 
ECG analysis using one of two configuration options (under 16 years old and over 16 years old) 
of the DXL Algorithm. A report with measurements and interpretive statements from the analysis 
is displayed, stored and printed, as configured. 
The study will also utilize SpO2 and NBP monitoring.  Monitoring SpO2 Pulse oximetry is a 
Noninvasive method of continuously measuring functional oxygen saturation (SpO2 in arterial 
blood. SpO2 readings indicate the percentage of hemoglobin molecules in arterial blood which 
are saturated with oxygen. SpO2 can be monitored in all HeartStart Intrepid clinical modes and 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
23 of 51 
on both adult and infant/child patients.  NBP is measured with a blood pressure monitor, a 
sphygmomanometer, or blood pressure gauge. The meter uses an inflatable cuff to collapse the 
artery and then release it under the cuff. This measures the pressure at which blood flow is starting 
and at which pressure blood flow is unimpeded. The HeartStart Intrepid uses a mechanical 
manometer to measure automatically on a pre-set schedule or manually on demand.  For the 
purposes of this study, they will be taken every five (5) minutes for three (3) readings (0 minutes, 
5 minutes and 10 minutes). 
 
3. 
STUDY OBJECTIVES 
The objective of this study is to validate the Philips DXL ECG Algorithm works as intended in the 
HeartStart Intrepid Monitor/Defibrillator after a software update was completed to address 
instances of high impedance. This study will also determine the diagnostic quality of the 12-lead 
ECG tracing from the HeartStart Intrepid Monitor/Defibrillator. 
3.1 
Endpoints 
3.1.1 
Primary Endpoints 
Validation 
• 
Number of failures of ‘unable to obtain a 12-lead ECG’ with the Philips HeartStart 
Intrepid Monitor/Defibrillator 
• 
Number of diagnostic quality 12-lead ECG tracings from the Philips HeartStart Intrepid 
Monitor/Defibrillator 
Safety  
• 
Frequency and severity of unexpected adverse events 
• 
Unanticipated adverse device effects (UADE) 
3.2 
Hypotheses 
Hypothesis 1A:  We hypothesize that a 12-lead ECG will be obtained greater than 90% of the 
time with a target goal of 99%.  
H0A: πA ≤ 0.90 
H1A: πA > 0.90 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
24 of 51 
Hypothesis 1B:  We hypothesize that 12-lead ECG tracings will be of diagnostic quality greater 
than 90% of the time with a target goal of 99%. 
H0B: πB ≤ 0.90 
H1B: πB > 0.90 
4. 
BOTH HYPOTHESES MUST BE MET FOR OVERALL 
STUDY SUCCESS. STUDY DESIGN 
4.1 
Overall Design 
This is a clinical study performed in a single center for validation purposes, with all data collection 
occurring within a single visit. 
Up to 60 (sixty) participants will be enrolled, for 56 (fifty-six) to complete data collection.   
4.2 
Rationale for Study Design 
This clinical study is designed primarily as an engineering evaluation to validate the software 
functionality for the HeartStart Intrepid Monitor/Defibrillator. This study is necessary to confirm the 
device is functioning as designed prior to release of the software. 
4.3 
Sample size 
Up to 60 (sixty) participants will be enrolled, for 56 (fifty-six) participants to complete data 
collection. 
4.4 
Study Duration and End of Study Definition 
The total enrollment duration for an individual participant will not exceed one day; it is estimated 
that the entire study duration will not exceed one month. 
 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
25 of 51 
5. 
STUDY PARTICIPANTS 
5.1 
Study Sample Considerations 
The software change was created to help with high impedance experienced with some patients 
while obtaining a 12-lead ECG.  This high impedance can be a result of skin conditions (wet skin) 
or electrodes that have been exposed to air for extended periods of time.  Extended exposure to 
air will dry out the electrodes prematurely and reduce their adhesive and conductive properties. 
The study will utilize electrodes from an unopened package, a package open for 24 hours and 
package open for 30 days.  This will be a stratification factor for randomization.  
The inclusion/exclusion do not specify any clinical conditions for enrollment, as the study does 
not plan to diagnose or confirm any medical conditions.  
5.2 
Inclusion Criteria 
Inclusion criteria are as follows: 
 
Able to read, write, speak, and understand English 
 
Aged 29 days to 89 years  
 
Willing and able to provide informed consent and complete study procedures 
 
Willing to have Philips representatives present during study procedures. 
5.3 
Exclusion Criteria 
Exclusion criteria are as follows: 
 
Known allergy to medical adhesives, silicone, or latex (per self-report) 
 
Any limitation or medical condition, including but not limited to physical or cognitive 
disability, that would affect the participant’s ability to complete study activities (per 
investigator) 
 
At the time of enrollment, current enrollment in any other interventional research study 
 
An employee, or residing family member of an employee, of a company that designs, sells, 
or manufactures monitor/defibrillator technology or related products (including Philips) 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
26 of 51 
5.4 
Definitions of Enrollment and Screen Failures 
Potentially eligible participants will be consented, if willing (see Section 7.1.2), and all participants 
who sign the consent form will be considered enrolled.  Formal assessment of eligibility according 
to the criteria listed in Sections 5.2 and 5.3 will take place following consent, and any participants 
found to be ineligible at this point will be considered screen failures.  The following data will be 
reported for screen failures: 
 
Sociodemographic data (age, sex, and race/ethnicity); 
 
Adverse events during the enrollment period; 
 
Reason/s for ineligibility. 
Any participant that discontinues/is withdrawn from the study following randomization will be 
categorized as an early termination (see Section 11) rather than a screen failure, even if the 
discontinuation/withdrawal occurred prior to the participant beginning the study intervention. 
5.5 
Strategies for Recruitment and Retention 
The participants will be of both sexes, with a wide body mass index (BMI) range, to support 
generalizability of results.  Due to the small sample size, no firm parameters for these measures 
have been determined a priori. 
This study is not limited to adult patients.  It is anticipated that at least 30% of the sample will be 
under the age of 16.  
It is anticipated that racial/ethnic minorities will represent at least 30% of the sample. 
All participants will be enrolled within the US. Recruitment will be the responsibility of the site 
and will take place through recruitment of their internal databases.  As this study involves only 
one visit, it is not likely that participants will drop-out or be lost to follow-up before study 
completion.  No specific strategies for retention are required. 
 
6. 
STUDY PRODUCT 
6.1 
Description of Intervention 
The HeartStart Intrepid Monitor/Defibrillator Model 867172 is a lightweight, portable 
Monitor/Defibrillator with a large display. It provides four clinical modes of operation: Monitor, 
Manual Defibrillation/Synchronized Cardioversion, AED and Pacing.  The HeartStart Intrepid is 
powered by a rechargeable Lithium-Ion battery, AC Power or DC power with use of a special DC 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
27 of 51 
Power Module.  Available battery power is determined by viewing the battery power indicators 
located on the front of the device, the icon on the display, or by checking the gauge on the battery 
itself.  Additionally, AC Power may be applied as a secondary power source and for continual 
battery charging. 
This study will only utilize some of the monitoring functionality within the device. The HeartStart 
Intrepid Monitor/Defibrillator uses the Philips DXL ECG Algorithm. The Philips DXL ECG 
Algorithm produces precise and consistent ECG measurements that are used to generate 
interpretive statements. The process begins with the simultaneous acquisition of the twelve 
conventional leads along with patient demographic information.  
The HeartStart Intrepid Monitor/Defibrillator utilized in this study will have software version 
1.00.46.  This software has been modified from its released version to account for instances of 
high impedance.   
During the 12-lead ECG acquisitions, patients will have their SpO2 and blood pressure monitored.   
The Philips HeartStart Intrepid Monitor /Defibrillator is currently released for sale in the European 
market.  It will be submitted to the FDA for 510(k) clearance during the time of this study.  In the 
United States it is considered a Class II medical device.  For the purposes of this study, the device 
will only be able to be used for monitoring and no clinical decision will be made based on the 
results obtained.  None of the defibrillator accessories will be available for use.   The Philips 
HeartStart Intrepid Monitor /Defibrillator used for this study is considered an investigational 
medical device.  The sponsor considers this study to be a minimal risk study with a non-significant 
risk device. As monitor/defibrillator is not implantable, not supporting or sustaining life,  not curing, 
mitigating, or treating disease, or otherwise preventing impairment of human health, and does not 
otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
A 12-lead ECG will be acquired three times (3) for each participant.  The 12-lead ECG does not 
continuously record.  As the leads are connected to the electrodes, markers will be placed for the 
three-lead and five-lead configurations. The Philips HeartStart Intrepid Monitor /Defibrillator has 
a 12-lead ECG preview screen that will allow the site staff to determine if a 12-lead ECG can be 
acquired.  Once the ‘start acquire’ button is pushed, the recording will start and approximately 10 
to 12 seconds a 12-lead ECG will be recorded. If the 12-lead does not have a good signal, no 
recording will be able to be obtained.   
Participants will be randomized to electrodes that are either from an unopened package or have 
had the package open for 24 hours or 30 days.  The 30-day electrodes will have a window of 
being opened plus or minus 10 days.  The length of time the package is open is proportional to 
the amount of conductive gel that has dried on the electrode. The longer the electrode package 
is open, the drier the conductive gel and the higher the impedance. The dried electrodes will be 
used to simulate high impedance.  

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
31 of 51 
6.4 
Preparation, Handling, Storage, and Accountability 
6.4.1 
Acquisition and Accountability 
The HeartStart Intrepid Monitor/Defibrillator and necessary accessories will be shipped to the 
investigator.  The HeartStart Intrepid devices will be returned to the Sponsor at the end of the 
study.  The unused accessories and re-usable used accessories will be returned to the sponsor, 
any used disposable accessories will be disposed of by the site after use.  An inventory of devices 
will be maintained. 
6.4.2 
Formulation, Appearance, Packaging, and Labeling 
The Device Label, User Manual and Operating Manual are included with the IRB submission.  
Some content of these documents may change before regulatory submission.  The Philips 
HeartStart Defibrillator monitor will be labeled with "CAUTION - Investigational device. Limited by 
Federal (or United States) law to investigational use." 
6.4.3 
Product Storage and Stability 
Allow for settling time if the device has been in extreme temperatures. The time required for the 
device to warm from -20°C before use is 80 minutes. The time required for the device to cool from 
70°C before use is 80 minutes. 
6.4.4 
Preparation 
The Philips HeartStart Intrepid Monitor/Defibrillator will be set up by a trained Philips Employee. 
The staff will be trained to use the ECG monitoring, 12-lead ECG, SpO2, NBP, and data 
management functions.  Proper skin preparation and electrode placement are important elements 
in producing a high quality 12-Lead ECG. See Appendix A for the Improving ECG Quality 
Application Note.  
The study staff will follow the product labeling regarding cleaning and disinfection of the Intrepid 
Monitor/Defibrillator and the accessories between each participant. See Appendix B for 
Instructions for Use. Each day prior to seeing participants, the site will ensure the device is ready 
for use by utilizing the ‘RFU’ indicator.  See Appendix B for Instructions for Use. 
At the beginning of each week of enrollment (except for the first training week) the study site will 
complete the operational check per the Instructions for use prior to any participant use. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
32 of 51 
6.5 
Measures to Minimize Bias 
6.5.1 
Type of Randomization 
Block randomization will be employed to ensure balance across subjects with regard to electrode 
age (new, 24 hours, 30 days). 
6.5.2 
Implementation of Randomization 
The randomization schedule will be incorporated into the database.  Assignment to an electrode 
will be apparent upon subject enrollment and entry into the database. 
7. 
STUDY PROCEDURES 
7.1 
Recruitment Procedures 
7.1.1 
Pre-screening 
Participants will be contacted by designated study staff from the site’s database of patients.  
Potential participants may also be found by utilizing advertisements.   
Phone screening 
Recruitment will be the responsibility of the site.  Potential participants will be screened over the 
phone for eligibility, and then scheduled for an enrollment visit. 
Phone screening will include questions regarding age, sex, height and weight (for calculation of 
BMI), to facilitate the recruitment of participants of all ages with a wide BMI range. 
A waiver of informed consent for screening will be submitted to the IRB for contacting these 
participants.  
7.1.2 
Consent 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in 
the study and continues throughout the individual’s study participation. Consent forms will be IRB-
approved, and the participant will be provided ample time to review the form prior to enrollment, 
including the opportunity to discuss potential enrollment with family or others.  For any participants 
under the age of 16, a parent will be asked to sign an Informed Consent Form on behalf of their 
child.   
During the phone screening a preliminary assessment of eligibility will be performed by the 
investigator or designee.  Once the participant arrives on site, the investigator or designee will 
describe the purpose of the study, all study procedures, possible risks of participation, and their 
rights as a research participant.  Participants must be informed that participation is voluntary and 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
33 of 51 
they may withdraw from the study at any time without prejudice, and the quality of their medical 
care will not be impacted by declining to enroll or withdrawing from the study for any reason.  After 
an opportunity to ask questions, willing and eligible participants will be asked to sign the consent 
form on paper.  It is anticipated that the consent process will take approximately 15 minutes to 
complete.  Apart from preliminary eligibility assessment, no study procedures will take place prior 
to consent. 
7.2 
Study Visits 
Study Visit 1   
Once the participant arrives, the study will be explained in full detail.  If the participant agrees, 
he/she will be consented into the study and the participant will be given a copy of the informed 
consent.  
Once consent is obtained the following study related procedures will be conducted: 
Demographics:  gender, age, ethnicity, height and weight will be collected. 
Inclusion/Exclusion Verification 
Skin pigmentation assessment: Skin pigmentation will be assessed with a Mexameter probe (C&K 
Electronic; Köln, Germany) a small hand-held tool held over the skin of the inner arm (an area 
with minimal sun exposure) for a few seconds that emits three light wavelengths to calculate 
melanin and hemoglobin content in arbitrary units on a scale of 0-999 (within ±5%). 
Skin assessment: The participants skin will be assessed with palpation to assess temperature, 
moisture, and texture. 
Medical History:  Participants will be asked if they have any relevant cardiac history (for example, 
a pacemaker). 
Enrollment into study: Once the above procedures are complete.  Participants will be randomly 
assigned (like the flip of a coin) to a set of ECG electrodes: brand new, package open for 24 hours 
and package open for 30 days 
12-lead ECG: Participants will have 10 electrodes placed on their body by a trained member of 
the study staff.  The electrodes will be placed similar to those used for out of hospital 12-lead 
ECGs.  One electrode is placed on the right shoulder, left shoulder, right waist, and left waist. Six 
V/C electrodes are placed on the chest. The right waist electrode is the reference electrode, as 
shown in the figure below.  The study team shall use the ‘Improving ECG quality’ application note 
for obtaining a good quality ECG.  Once the skin is prepped, all of the electrodes will be placed 
on the patient.  The cables will be connected to the electrodes in the following order 3 leads, 5 
leads, and chest leads. Once the 5 leads are place and prior to the acquisition of the 12-lead 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
34 of 51 
ECG, the 12-lead ECG preview screen will be made available, the study staff will then place the 
remaining electrodes and determine if a 12-lead ECG can be obtained.  If the 12-lead ECG cannot 
be obtained and the participant has been randomized to either the 1 day or 30 day electrodes, 
the electrodes will be swapped for electrodes from an unopened package.  If the 12-lead ECG 
cannot be obtained after the electrodes have been changed, this will be considered a ‘Fail.’   
 
 
After the ECG electrodes are placed, the patient will have their SpO2 and noninvasive blood 
pressure monitored as detailed in the instructions for use. The blood pressure cuff will be placed 
on the opposite arm from the SpO2 sensor.  
Once all electrodes and monitoring functionality is placed, the patient will be given time to relax. 
Once relaxed, the participant will be asked to lay quietly for up to 15 minutes while the device 
collects the ECG and other vitals are monitored.  See the table below for frequency.  After the 
readings are completed, all equipment will be removed and the participant will be free to leave 
the laboratory. 
Data Acquisition frequency.  
Monitoring Functionality  
Data Acquisition by device 
Non-Invasive Blood Pressure  
Minute 0, Minute 5, and Minute 10 
12-Lead ECG 
Immediately after the NBP cuff deflates 
(approximately minute 1, minute 6 and 
minute 11) 
SpO2 
Continuously (1 minute intervals) 
It is anticipated for the first 1 to 3 participants, that a Philips Engineer and members of the 
Philips Clinical Team will be on-site to observe the study.  The Philips Engineer will be able to 
troubleshoot any of the issues experienced with the capture of the 12-lead ECG on the 
HeartStart Intrepid.  

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
35 of 51 
At the end of each day the device data will be downloaded utilizing the USB drive.  This data will 
be uploaded into the corresponding participant file for analysis.  Printed copies of the 12-lead 
ECG will be stored in the participant file.  Once the study is complete, the original paper files will 
be sent to the sponsor.  Copies of the originals will be maintained at the site.  
7.3 
Adverse Event Surveillance 
Safety monitoring will take place throughout the study.  Events that are reported by participants 
without prompting will also be captured and followed.   
All study procedures will take place during the initial visit, under the supervision of the Principal 
Investigator.  The Principal Investigator is a physician and all visits will take place at a clinical 
facility, allowing for clinical intervention if needed.  The risks associated with the study are 
immediate; that is, it is considered highly unlikely that a related adverse event will take place after 
the completion of a study visit. 
7.4 
Data Processing and Scoring 
Electrocardiograms from all ECG monitoring events are to be presented to the independent 
reviewer. Participant Number, age and gender are pre-printed on the ECG. The reviewer will 
make an assessment of each ECG and document the results in the case report form.  
ECGs will be examined in each of the following criteria. We have assumed that the HeartStart 
Intrepid Monitor/Defibrillator runs at a paper speed of 25 mm/s, that is, each second is represented 
by five large squares. 
a. 1mV calibration, any lead, as the number of large squares 
 
A number OR not readable. 
b. Heart rate, as displayed on the ECG 
 
A whole number, as beats per minute, OR missing. 
c. Heart rate, as the number of large squares in an RR interval 
 
A number OR not readable. 
Enter one small square as 0.2 large square. 
Enter a minimum and a maximum if the rhythm is irregular. 
d. Cardiac axis: 
 
 
not readable OR normal OR abnormal. 
e. Rhythm: 
 
 
 
not readable OR normal OR abnormal. 
f. 
P wave, any lead:  
 
not readable OR normal OR abnormal. 
g. PR interval, any lead: 
 
not readable OR normal OR abnormal. 
h. QRS complex, any lead:  
not readable OR normal OR abnormal. 
i. 
ST segment, any lead: 
 
not readable OR normal OR abnormal. 
j. 
T wave, any lead:  
 
not readable OR normal OR abnormal. 
k. QT interval, any lead: 
 
not readable OR normal OR abnormal. 
l. 
U wave, any lead:  
 
not readable OR normal OR abnormal. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
36 of 51 
m. Overall impression 
 
ONE OF not interpretable OR normal OR 
abnormal, but no action required OR abnormal and requires immediate action. 
An ECG from the printed patient record is considered to be of diagnostic quality when every part 
of the waveform in every lead is readable.   
SpO2 data and NBP data will be utilized to troubleshoot any 12-lead ECG tracings that are not 
readable or abnormal.   
7.5 
Participant Compensation 
Participants who complete the study will be reimbursed $100 in the form of a gift card for their 
time and participation in the study.  Pro-rated compensation will be provided to individuals whose 
participation is terminated early for any reason.  In that scenario, participants will be reimbursed 
according to the following schedule: 
 
Participant signs consent, but is found to be not eligible $25 
 
8. 
ADVERSE EVENTS AND UNANTICIPATED PROBLEMS 
8.1 
Adverse Events and Serious Adverse Events 
8.1.1 
Definition of Adverse Events 
An AE is any untoward medical occurrence associated with the use of an intervention in humans, 
whether or not considered intervention-related (21 CFR 312.32 (a)).  When an AE is deemed to 
be related to the study device, it is termed an adverse device event. 
1.1.1. Definition of Serious Adverse Events 
An AE or suspected adverse reaction is considered serious if, in the view of either the investigator 
or Sponsor, it results in any of the following outcomes: death, a life-threatening AE, inpatient 
hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or 
substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, they 
may jeopardize the participant and may require medical or surgical intervention to prevent one of 
the outcomes listed in this definition.  When a serious AE is deemed to be related to the study 
device, it is termed a serious adverse device event (SADE). 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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8.2 
Unanticipated Adverse Device Event 
An unanticipated adverse device event (UADE) is defined in 21 CFR Part 812.3(s) as “any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects”. 
Other important medical events which may not result in any of the outcomes above, but which 
may require intervention to prevent one of the outcomes above, may in the opinion of the 
investigator, be considered a UADE. 
8.3 
Classification of an Adverse Event or Adverse Device Event 
1.1.2. Severity of Event 
All AEs will be assessed by the study clinician using a protocol defined grading system as follows: 
 
Mild – Events require minimal or no treatment and do not interfere with the participant’s 
daily activities.  
 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
8.3.1 
Relationship to the Study or Device 
All AEs will have their relationship to study procedures and the study device assessed by the 
clinician who examines and evaluates the participant based on temporal relationship and his/her 
clinical judgment. The degree of certainty about causality will be graded using the categories 
below.  
 
Definitely Related – There is clear evidence to suggest a causal relationship, and other 
possible contributing factors can be ruled out. The clinical event occurs in a plausible time 
relationship to study intervention administration and cannot be explained by concurrent 
disease or other drugs or chemicals. The response to withdrawal of the study intervention 
should be clinically plausible.  
 
Probably Related – There is evidence to suggest a causal relationship, and the influence 
of other factors is unlikely. The clinical event occurs within a reasonable time after 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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administration of the study intervention, is unlikely to be attributed to concurrent disease 
or other drugs or chemicals. 
 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the 
event occurred within a reasonable time after the application of the electrodes). However, 
other factors may have contributed to the event (e.g., the participant’s clinical condition, 
other concomitant events). Although an AE may rate only as “possibly related” soon after 
discovery, it can be flagged as requiring more information and later be upgraded to 
“probably related” or “definitely related”, as appropriate. 
 
Unlikely to be related – A clinical event whose temporal relationship to study intervention 
administration makes a causal relationship improbable (e.g., the event did not occur within 
a reasonable time after administration of the study intervention) and in which other drugs 
or chemicals or underlying disease provides plausible explanations (e.g., the participant’s 
clinical condition, other concomitant treatments). 
 
Not Related – The AE is completely independent of study intervention administration, 
and/or evidence exists that the event is definitely related to another etiology. There must 
be an alternative, definitive etiology documented by the clinician). 
8.3.2 
Expectedness  
The Principal Investigator will be responsible for determining whether an AE is expected or 
unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the 
event is not consistent with the risk information previously described for the study intervention. 
8.4 
Adverse Event Assessment and Follow-Up 
All AEs including local and systemic reactions not meeting the criteria for a serious adverse event 
(SAE) will be captured on the appropriate (e)CRF. Information to be collected includes event 
description, time of onset, clinician’s assessment of severity, relationship to study product 
(assessed only by those with the training and authority to make a diagnosis), and time of 
resolution/stabilization of the event. All AEs occurring while on study must be documented 
appropriately regardless of relationship. All AEs will be followed to adequate resolution. 
Any medical condition that is present at the time that the participant is screened will be considered 
as baseline and not reported as an AE. However, if the study participant’s condition deteriorates 
at any time during the study, it will be recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of 
the event at each level of severity to be performed. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
39 of 51 
An incidental finding is an anatomical deviation which is found as a result of the 12-lead ECG 
acquisition with respect to the medical condition of the participant of which they were previously 
unaware. This study is not for diagnostic purposes, so if incidental health findings are discovered 
as part of a study the subject will be informed and advised to consult their physician. Further 
evaluation of such findings shall not be under the purview of the study and the investigators shall 
not be obliged to bear any further costs. In case of significant incidental finding the study site will 
have the Principal Investigator repeat the 12-lead ECG with a released device. Any incidental 
finding and communication to the participant will be noted in the AE form. 
8.5 
Serious Adverse Event or Serious Adverse Device Event 
Reporting  
The study investigator shall complete a SAE or UADE Form and submit to the Sponsor and to the 
reviewing IRB as soon as possible, but in no event later than 24 hours (for a SAE) or 10 working 
days (for a UADE) after the investigator first learns of the effect.  The Sponsor is responsible for 
conducting an evaluation of the SAE/UADE and shall report the results of such evaluation to the 
Food and Drug Administration (FDA) and to the  review IRB  or 10 working days (for a UADE) 
after the Sponsor first receives notice of the effect. Thereafter, the Sponsor shall submit such 
additional reports concerning the effect as FDA requests. 
8.6 
Device Deficiency 
All device deficiencies, use or user errors, and equipment failures will be documented.  Use or 
user errors will be captured as part of the source documentation.  Device deficiencies and 
equipment failures will be kept on a separate log.  The serial numbers and type of 
deficiency/failure will be captured. Unanticipated device deficiencies that lead or may lead to an 
SAE will be reported to the Sponsor within 24 hours of learning of the event. 
8.7 
Unanticipated Problems 
8.7.1 
Definition of Unanticipated Problems 
An unanticipated problem (UP) is any incident, experience, or outcome that for which the nature, 
severity, or frequency is unexpected for the subject population or research activities as described 
in the current IRB approved protocol, supporting documents, and the consent form. 
8.7.2 
Unanticipated Problem Reporting 
The Principal Investigator will submit to the Sponsor and to the reviewing IRB a report of any 
UADE occurring during an investigation as soon as possible, but in no event later than 10 working 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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days after the investigator first learns of the effect (21 CFR 812.150(a)(1)).  Under 812.46(b), the 
Sponsor shall report the results of such evaluation to the FDA and to all reviewing IRB's and 
participating investigators within 10 working days after the Sponsor first receives notice of the 
effect. Thereafter the Sponsor shall submit such additional reports concerning the effect as FDA 
requests (21 CFR 812.150(b)(1)). 
9. 
RISK BENEFIT ASSESSMENT 
9.1 
Known Potential Risks 
A. Loss of confidentiality/privacy is a risk in all studies collecting personal and/or sensitive 
data. 
B. The only anticipated adverse event (AE) related to the 12-lead ECG is skin irritation or 
discomfort associated with the electrodes. It is possible the 12-lead ECG may uncover a 
medical condition in which the participant was previously unaware. This is considered an 
incidental finding.  Refer to Section 8.4 for handling 
C. During blood pressure monitoring, some participants may feel some discomfort as the 
blood pressure cuff loosens and tightens during the assessment.  
D. There are no associated adverse events with pulse oximetry monitoring.  
9.2 
Risk Mitigation 
A. Efforts to protect participant confidentiality are described in section 11.2.4.  Privacy 
breaches will be reported to the relevant participant/s and will be treated as an 
unanticipated problem despite being listed here (see Sections 8.7 and 11.2.4) 
B. Participants reporting a history of allergic reactions to medical adhesives will not be 
recruited. 
Participants will be monitored by study staff during the study procedure, if at any point the 
participant wants to stop, the study will be stopped, and the participant may withdraw from the 
study.  
9.3 
Known Potential Benefits 
Participation in this study will not result in direct benefit to the participant. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
41 of 51 
9.4 
Assessment of Potential Risks and Benefits 
It is the opinion of the Sponsor and the Principal Investigator that the benefits of this protocol 
outweigh the risks. 
 
10. 
STATISTICAL CONSIDERATIONS 
The statistical analysis plan has been incorporated into this protocol.  It is not a stand-alone 
document. 
10.1 
Sample Size Determination 
Each hypothesized endpoint estimates a target proportion of 99% with an expectation to be 
statistically better than 90%.  Using a one-sided exact test, with 80% power and alpha of 0.025, 
a sample size of 56 evaluable subjects is required. 
Both hypothesized endpoints must be met for study success, therefore alpha level adjustments 
are not necessary to address familywise error. 
10.2 
General Considerations 
Continuous data will be presented by mean, standard deviation, median, minimum and maximum 
observation, and 95% confidence interval.  Categorical data will be presented as frequencies, 
percentages, and the 95% Clopper-Pearson confidence interval.  Significance tests will be 
conducted at a two-sided significance level (alpha) of 0.05, or a one-sided significance level of 
0.025. 
10.3 
Participant Disposition 
Participant disposition, including the total number of participants enrolled, randomized, and 
completed, along with reasons for early terminations, will be compiled. 
10.4 
Analyses 
10.4.1 Demographics and Baseline Characteristics 
Participant demographics (age, sex, race/ethnicity) and descriptive characteristics will be 
summarized for all participants enrolled and for evaluable participants. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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10.4.2 Analysis of the Primary Endpoints 
Endpoint 1A:  Obtaining the 12-lead ECG 
Endpoint 1B:  Diagnostic quality of the 12-lead ECG tracings 
A one-sided exact binomial test will be used to assess each of the primary endpoints.  Both 
endpoints must be met for study success. 
10.4.3 Adjustment for Multiplicity 
Both hypothesized endpoints must be met for study success, therefore alpha level adjustments 
are not necessary to address familywise error. 
10.4.4 Exploratory Analyses 
Exploratory analyses are not planned. 
10.4.5 Sensitivity Analyses 
Sensitivity analyses are not planned. 
10.4.6 Safety Analyses 
Adverse events will be collected and summarized using descriptive statistics. 
10.5 
Planned Interim Analyses 
No interim analyses will be undertaken.  After the first 3 (three) participants, if a 12-lead ECG was 
not able to be obtained, the study will be paused and the software will be re-evaluated.  In addition, 
the first 3 ECGs will be reviewed for diagnostic quality.  If they are not found to be of adequate 
quality, the study will be paused and the software will be re-evaluated.  
10.6 
Study Termination 
There are no statistical criteria for terminating the study.  The study may be paused to re-evaluate 
the software if the first three participants have ECG tracings were not able to be obtained by the 
device or if they were not found to be of adequate quality (as assessed in section 7.4).  
10.7 
Missing Data 
Missing data will not be imputed. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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10.8 
Deviations from the Statistical Analysis Plan 
Any deviations from the original statistical plan will be noted in the clinical study report.  
11. 
OPERATIONAL CONSIDERATIONS 
11.1 
Early Termination of Participation 
11.1.1 Discontinuation (active drop-out) 
A participant may opt to discontinue participation at any time, and they are not required to provide 
a reason.  If a reason is provided, it will be recorded.  If a participant wishes to withdraw their own 
data from the dataset, this request should be made in writing, and the requirement for this request 
should be communicated to the participant. 
11.1.2 Withdrawal (by investigator) 
An investigator may withdraw a participant from the study for the following reasons: 
 
If any AE, or other medical condition or situation occurs such that continued participation 
in the study would not be in the best interest of the participant; 
 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation. 
The reason for participant withdrawal from the study will be recorded.  AE surveillance (see 
Section 7.3) will continue until resolution.  Withdrawal of a participant for a reason other than what 
is listed here will be considered a major protocol deviation (see Section 11.5.2). 
11.1.3 Impact of Early Termination on Recruitment and Enrollment 
Recruitment and enrollment will continue until 60 participants complete all study procedures. 
11.2 
Regulatory and Ethical Considerations 
11.2.1 Institutional Review Board 
The IRB for this study is: 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
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Allendale Investigational Review Board (AIRB)  
30 Neck Road 
Old Lyme, CT 06371  
Office: 
 
 
11.2.2 Informed Consent Procedure and Documentation 
The procedure for seeking informed consent is described in Section 7.1.2.  A copy of the signed 
consent form will be provided to each participant for their records.  The informed consent process 
will be conducted and documented in the source document (including signature and date), prior 
to undergoing any study procedures other than those described in Section 7.1.1 required for 
preliminary eligibility assessment. 
11.2.3 Study Discontinuation and Closure 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  If the study is suspended or terminated, the Sponsor will be responsible for 
informing the IRB, and the investigator at each site will be responsible for informing all participants 
and providing guidance as to the remainder of the study procedures if necessary. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of excessive risk to participants; 
 
Insufficient compliance to protocol requirements; 
 
Data that are not sufficiently complete and/or evaluable; 
 
Demonstration of efficacy that would warrant stopping (if described in Section 10.6); 
 
Determination of futility (if described in Section 10.6). 
It may be possible for the study to resume once concerns about safety, protocol compliance, or 
data quality are addressed satisfactorily and approved by the Sponsor, IRB, and any other 
regulatory bodies. 
11.2.4 Confidentiality and Privacy 
Participant confidentiality and privacy will be held strictly in trust by the participating investigators, 
their staff, and the Sponsor.  This confidentiality is extended to cover testing of biological samples 
and genetic tests in addition to descriptive and clinical information relating to participants. The 
study protocol, documentation, data, and all other information generated will therefore be held in 
strict confidence.  No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the Sponsor. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
45 of 51 
The study monitor, other authorized representatives of the Sponsor, representatives of the IRB, 
and other regulatory agencies, may inspect all documents and records required to be maintained 
by the investigator, including but not limited to, medical records (office, clinic, or hospital) and 
pharmacy records for the participants in this study. Each participating site will permit access to 
such records. 
Each study participant’s contact information will be securely stored at each clinical site for internal 
use during the study. At the end of the study, all records will continue to be kept in a secure 
location for as long a period as dictated by the reviewing IRB, institutional policies, or Sponsor 
requirements.  All other research data will be coded with a unique identifier and provided to the 
Sponsor.  A unique source record will be available for each study participant including 
documentation of the informed consent form review process, HIPAA completion to ensure patient 
privacy (United States), medical history, and concomitant medications review.  All research 
activities will be conducted in as private a setting as possible.  The privacy of each subject and 
confidentiality of data shall be preserved in reports and when publishing any data. 
Data management procedures are described in Section 11.4.3. 
11.2.5 Future Use of Stored Specimens and Data 
All study data received from participating sites will be stored and may be used by the Sponsor for 
future analyses.  This possibility will be captured in the consent form 
11.3 
Study Oversight 
11.3.1 Safety Oversight 
Adverse event surveillance procedures are described in Section 7.3, and definitions and reporting 
procedures are described in Section 8. Subsequent to monitoring of site records and reports, 
Philips will review and classify adverse events and ensure ongoing safety evaluation of the clinical 
study as described in ISO 14155 Safety Evaluation and Reporting.   
11.3.2 Monitoring 
Monitoring visits (on site or remote) will be performed by authorized Sponsor representative/s 
periodically.  The site staff will ensure that the monitor is supplied with original study participant 
records and other documentation as requested.  The monitor will verify that 100% of the study 
participants were appropriately consented using the IRB-approved consent form.  The monitor 
will verify treatment assignment or randomization was completed accurately, and will review all 
adverse events, unanticipated problems, device deficiencies, and protocol deviations.  The 
monitor will also document review and reconciliation of investigational product/s if needed.  
Monitoring reports, discrepancies, and resolution will be documented in the trial master file. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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11.3.3 Vulnerable Populations 
According to ISO 14155, a vulnerable subject is an individual whose willingness to volunteer in a 
clinical study could be unduly influenced by the expectation, whether justified or not, of benefits 
associated with participation or of retaliatory response from senior members of a hierarchy in case 
of refusal to participate.   
This may include those individuals with lack of or loss of autonomy due to immaturity, mentally 
disabled individuals, persons of nursing homes, children, impoverished persons, subjects in 
emergency situations, ethnic minority groups, homeless persons, nomads, refugees, those 
incapable of giving informed consent, university students, subordinate hospital/laboratory 
personnel, sponsor employees, members of the armed forces, persons kept in detention, etc.   
 
Participants under the legal age to give consent will be enrolled in the study 
 
All participants under the legal age to give consent will have the study and any risks 
and/or benefit explained. Following this discussion, the child/adolescent will be asked to 
sign an Assent in the presence of a parent or guardian complete  
 
Allendale IRB will review all versions of Assent to ensure safeguards and language is 
appropriately expressed 
 
As this study is a non-interventional, non-diagnostic effort, it is not anticipated any 
additional medical care will be provided.  However, if there is an incidental finding the 
participant will be informed and advised to consult their physician 
 
11.4 
Quality Assurance and Quality Control 
11.4.1 Training 
The investigator and all research staff will be trained to the study protocol, devices, trial master 
file documents, monitoring plan, CRFs and/or eCRFs, data entry, and all additional Sponsor 
expectations, as applicable.  In addition, training related to data privacy, data protection laws, 
HIPAA, and redacting any patient identifiers in data required for transmission to the Sponsor will 
be documented.  Once complete, training and delegations will be documented for all personnel. 
11.4.2 Data Collection and Handling 
Data collection and handling is the responsibility of the staff at the site under the supervision of 
the site investigator.  Only staff that have been delegated by the investigator are authorized to 
enter or make changes to data in the CRFs.  The investigator is responsible for ensuring the 
accuracy, completeness, legibility, and timeliness of the data reported. 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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11.4.3 Data Management 
All data will be entered into DataTrak, a 21 CFR Part 11-compliant data capture system provided 
by the Sponsor. The data will be housed within a secure server (based in Virginia, USA) and 
accessible only to the sponsor, study personnel, and investigators.  Access to the EDC system 
will be secured through logins managed by a system administrator and appropriated training will 
be provided. The EDC system provides the capability to perform data management activities 
within a consistent, auditable, and integrated electronic environment (data security, data entry, 
data validation). Data entries and modifications will be recorded via an audit trail. If the data 
manager or study monitors identify data errors or inconsistencies, they will generate queries that 
will be sent to the Principal Investigators and study staff. After queries are resolved, the database 
will be locked, and the data will be imported into a statistical software and analyzed by 
biostatisticians. 
11.4.4 Data Retention Period 
Hard copies of all study documentation will be kept on site for at least two years after study 
completion.  The Sponsor will maintain study records indefinitely in a secure location. 
11.5 
Protocol Deviations 
A protocol deviation is any departure from the IRB-approved protocol, made with or without prior 
IRB approval. 
11.5.1 Emergency Deviations 
An emergency deviation is any departure from the approved procedures that is undertaken to 
protect the life or physical wellbeing of a participant.  In such cases, there is not enough time to 
seek IRB approval for the deviation.  All emergency deviations should be reported as a UP+AE 
(see Section 8). 
11.5.2 Major Protocol Deviations 
A major protocol deviation is any event which leads to the following: 
 
Participant withdrawal (by the investigator) for a reason other than what is listed in Section 
11.1.2; 
 
Absence of a valid primary endpoint for a given participant.  This protocol includes multiple 
primary endpoints (see Section 3.1.1), both/all of which need be missing to be considered 
a major protocol deviation; 
 
Enrolment of an ineligible participant; 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
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 
Enrolment of more than the IRB-approved sample size specified in Sections 4.3 and 10.1. 
All major protocol deviations require prior approval as a planned protocol deviation by the IRB.  A 
planned deviation occurs when the investigator prospectively and intentionally plans to deviate 
from study procedures.  Most, but not all, planned protocol deviations are one-off requests that 
apply to a single participant. 
11.5.3 Minor Protocol Deviations 
Minor protocol deviations are those that do not impact the scientific soundness of the study or the 
rights, safety, or welfare of participants. 
11.5.4 Reporting Protocol Deviations 
By definition, emergency deviations are considered to be UPs, and will be reported as such.  Major 
protocol deviations that did not receive approval as planned protocol deviations will be reported 
within 24 hours of the learned event per Allendale IRB’s policy.  Minor protocol deviations will be 
collated and reported to the IRB, DSMB, and FDA at each annual review.  Reporting procedures 
will follow those described for AEs and UPs. 
11.6 
Publication and Data Sharing 
11.7 
Study Registration 
This study meets the definition of an Applicable Clinical Trial per 42 CFR Part 11 and will be 
registered on ClinicalTrials.Gov.  The possibility of study registration will be included in the 
consent form. 
11.8 
Conflict of Interest Policy 
The independence of this study from any actual or perceived influence is critical.  Therefore, any 
actual conflict of interest (apart from that related to Philips) of persons who have a role in the 
design, conduct, analysis, publication, or any aspect of this study will be disclosed and managed.  
Furthermore, persons who have a perceived conflict of interest will be required to have such 
conflicts managed in a way that is appropriate to their participation in the design and conduct of 
this trial. 
 
REFERENCES 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
49 of 51 
Fye, W. (1994). “A History of the Origin, Evolution, and Impact of Electrocardiography. American Journal 
of Cardiology, 73:937-949. 
Soar, J. J. (2015). European Resuscitation Council Guidelines for Resuscitation 2015: Section 3. Adult 
Advanced Life Support. Resuscitation , 95. 
 
 
 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
50 of 51 
LIST OF APPENDICES 
Appendix A: Application Note 
Improving ECG
Q
lit A
li
ti  
Appendix B:  Instructions for Use 
 
 
 

Clinical Study Protocol 
The ICE Study 
 
 
 
Document 
ID: 
CC_TC_ECR_Intrepid 
12Lead_2022_11549 
Document title: Philips HeartStart Intrepid 12-lead ECG 
Study – The ICE study Protocol 
Classification: 
For internal use 
Clinical Protocol  
Modified: 
12SEP2022 
Author: 
B. Fink 
Version: 
2.0 
Approver: 
Ref to Page 2 
Status: 
Final 
Page: 
51 of 51 
Appendix B:  
Internal Review Signatures 
 
 
Reviewer Signature                        Date 
Dawn Jorgenson, Principal Scientist, Research & 
Development, Emergency Care & Resuscitation 
 
Reviewer Signature                        Date 
Marc Rubinstein, MD 
Medical Affairs Director,, Connected Care 
 
 
 
 
Reviewer Signature                        Date 
Edward 
Kompare, 
Senior 
Medical 
Solutions 
Specialist, Medical Affairs, Emergency Care & 
Resuscitation 
Reviewer Signature                        Date 
Sen Zhang, Project Manager, Emergency Care - 
Professional 
 
 
 
 
 
 
 
Reviewer Signature                        Date 
Rui Jin, Advanced Electrical Engineer, Emergency 
Care & Resuscitation 
Reviewer Signature                        Date 
Vicky Wang, Senior Regulatory Affairs Engineer, 
Emergency Care - Professional