U-TruSignal SpO2 Testing in Neonates
Phase: NA
Conditions: Pulse Oximetry
Sponsor: GE Healthcare

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NCT03383757
Clinical Study Protocol: 
U-TruSignal SpO2 Testing in Neonates 
(STUDY NO. 123.04-2017-GES-0002) 
Version: 2.0; 01/Mar/2019 

 
 
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Clinical Study Protocol: 
U-TruSignal SpO2 Testing in Neonates 
(STUDY NO. 123.04-2017-GES-0002) 
Version: 2.0; 01/Mar/2019 
Sponsor: 
 
General Electric Company, acting through its GE Healthcare Business 
3000 N. Grandview Blvd 
Waukesha, WI 53188 
Sponsor Contact:  
Cynthia Hines-Sabol, Clinical Affairs Project Manager 
Tel:  
 
+1-262-422-1306 
E-mail:   
cynthia.A.hinessabol@ge.com 
Medical Monitor:  
Helena Haukilehto, MD, Medical Director 
Tel:  
 
+358 10 394 3609 
E-mail:   
helena.haukilehto@ge.com 

 
 
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Investigational Device/Product: U-TruSignal 
Modality: GE Healthcare (GEHC) -
- Monitoring Solutions 
 
FOR QUALIFIED INVESTIGATORS, STUDY STAFF, AND THEIR 
ETHICS COMMITTEE(S) ONLY 
CONFIDENTIALITY STATEMENT 
Information in this RESEARCH STUDY PROTOCOL is for investigators, site personnel involved with the 
study, ethics committee(s), and/or their authorized representative(s) except as required to obtain consent 
from study participants or as otherwise required by law. Once signed, the terms of the protocol are 
binding for all parties. 

Study Title: U-TruSignal SpO2 Testing in Neonates 
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The Sponsor and Investigator have approved this protocol version, and I confirm hereby to conduct the 
study according to the protocol and in accordance with applicable principles of the World Medical 
Association Declaration of Helsinki and Good Clinical Practice (GCP) guidelines as per ISO 14155:2011, 
any conditions of approval imposed by the reviewing Ethics Committee (EC) or governing regulatory 
body, and applicable laws and regulations. The Investigator should not deviate from this protocol except 
for emergency use. I have read and understood and agree to abide by all the conditions and instructions 
contained in this protocol. 
Local Principal Investigator at study site: 
 
Investigator Signature 
 
Date 
 
 
 
Print Name 
 
 
 
 
 
Site Name, Department, Address 

Study Title: U-TruSignal SpO2 Testing in Neonates 
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Table of Contents 
Document and Version Control 
................................................................................................. 
7 
List of Abbreviations and Terms 
............................................................................................... 
8 
Study Synopsis 
......................................................................................................................... 
10 
Administrative Structure of Investigation .............................................................................. 
12 
1. Background and Justification 
............................................................................................ 
13 
2. Device/Product Description 
............................................................................................... 
13 
 
Identity, Mechanism, and Function 
............................................................................................. 
13 
 
Intended Use 
............................................................................................................................... 
14 
 
Reference Standard 
.................................................................................................................... 
14 
 
Concomitant/Ancillary Administrations ....................................................................................... 
15 
 
Accountability 
.............................................................................................................................. 
15 
 
Anticipated Risks and Benefits 
................................................................................................... 
15 
3. Study Objectives and Endpoints 
....................................................................................... 
16 
 
Purpose of the Study .................................................................................................................. 
16 
 
Study Endpoints 
.......................................................................................................................... 
17 
 
Summary of Study Design 
.......................................................................................................... 
17 
4. Study Design 
....................................................................................................................... 
17 
 
Study Population 
......................................................................................................................... 
17 
 
Number Subjects ........................................................................................................................ 
17 
 
Protection of Vulnerable Subjects 
............................................................................................... 
17 
 
Eligibility Criteria ......................................................................................................................... 
18 
 
Recruiting and Screening ........................................................................................................... 
18 
 
Criteria for Withdrawal/Discontinuation....................................................................................... 
18 
5. Study Procedures ............................................................................................................... 
19 
 
Diagram of Procedures 
............................................................................................................... 
19 
 
Subject Preparation .................................................................................................................... 
19 
 
Description of Study Procedures 
................................................................................................ 
20 
 
Follow-up .................................................................................................................................... 
21 
6. Study Data Collection and Assessments ......................................................................... 
21 
 
Primary Assessment 
................................................................................................................... 
21 
 
Safety Assessments ................................................................................................................... 
21 
7. Qualification and Training Plan 
......................................................................................... 
21 
 
Staff Qualifications 
...................................................................................................................... 
21 
 
Training Plan for the Protocol and Research Device/Product 
.................................................... 
21 
8. Safety ................................................................................................................................... 
22 
 
Anticipated Adverse Events 
........................................................................................................ 
22 
 
Adverse Event Definitions 
........................................................................................................... 
22 
 
Documentation of Safety Events ................................................................................................ 
23 
 
Reporting of Safety Events 
......................................................................................................... 
23 
 
Device Deficiencies/Complaints ................................................................................................. 
24 
9. Ethical Conduct of the Study 
............................................................................................. 
24 
 
Ethics Committee 
........................................................................................................................ 
24 
 
Regulatory Agencies and Competent Authority(ies) 
................................................................... 
24 
 
Management of Protocol Modifications and Amendments 
......................................................... 
25 
 
Management of Protocol Deviations 
........................................................................................... 
25 
 
Participant Information and Informed Consent 
........................................................................... 
25 
 
Early Termination of the Study ................................................................................................... 
25 
 
Incidental Finding 
........................................................................................................................ 
25 
10. Statistical Methods ............................................................................................................. 
26 
 Statistical Hypothesis 
.................................................................................................................. 
26 

Study Title: U-TruSignal SpO2 Testing in Neonates 
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 Sample Size Determination 
........................................................................................................ 
26 
 Statistical Analysis 
...................................................................................................................... 
26 
 Handling of Missing Data 
............................................................................................................ 
27 
 Deviation(s) from the Original Statistical Plan 
............................................................................ 
28 
11. Quality Assurance and Control ......................................................................................... 
28 
 Data Management ...................................................................................................................... 
28 
12. Monitoring Plan 
................................................................................................................... 
29 
 Confidentiality and Data Protection ............................................................................................ 
29 
 Publication Policy 
........................................................................................................................ 
30 
References 
................................................................................................................................. 
31 
Appendix A – STUDY SCHEDULE 
........................................................................................... 
32 
Appendix B – Study Site and Investigator List ...................................................................... 
33 
Appendix C – Modified Fitzpatrick Scale 8 
.............................................................................. 
34 
Appendix D - Amendments (Protocol Version 1.0 to 2.0)...................................................... 
35 
 
List of Figures and Tables 
Figure 1 – U-TruSignal Device 
................................................................................................................... 
14 
Figure 2 – Diagram of Study Procedures 
................................................................................................... 
19 
Table A.1 - Schedule of Study Procedures 
................................................................................................ 
32 
Table A.1 - Schedule of Study Procedures 
................................................................................................ 
50 

Study Title: U-TruSignal SpO2 Testing in Neonates 
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DOCUMENT AND VERSION CONTROL 
This section records all changes made to the protocol for a specific study. In the table below, record every 
relevant change by indicating what changes were made. 
Revision 
Date 
Revision Author 
Comments/Changes 
1.0 
25/Apr/2017 
Catherine Cadogan 
Clinical Writer – This is the initial version. 
2.0 
01/Mar/2019 
Catherine Cadogan 
Clinical Writer – The purpose of this protocol 
amendment is to include the language required 
by the EU Data Protection Regulation 2016/679. 
Details of the changes can be found in Appendix 
D.   
 
 
 
 
 
 

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LIST OF ABBREVIATIONS AND TERMS 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ALARP 
As Low as Reasonably Practical 
AMA 
American Medical Association  
ARMS 
Accuracy Root Mean Square 
CA 
Competent Authority 
CAPM 
GE Clinical Affairs Project Manager 
CCG 
Case Report Form Completion Guidelines 
CFR 
Code of Federal Regulations 
CHF 
Clinical History File (synonymous with e-Trial Master File) 
COHb 
Carboxyhemoglobin 
CRF 
Case Report Form 
DCF 
Data Clarification Form 
EC 
Ethics Committee 
EU 
European Union 
FDA 
United States Food and Drug Administration 
FCOHb 
Fractional Carboxyhemoglobin 
FMetHb 
Fractional Methemoglobin 
FO2Hb 
Fractional Oxyhemoglobin 
GCP 
Good Clinical Practice (see ISO 14155:2011) 1 
GE 
General Electric 
GEHC 
General Electric Healthcare 
Hb 
Hemoglobin 
ICF 
Informed Consent Form 
ISO 
International Standards Organization 
LDR 
Legally Designated Representative 
MetHb 
Methemoglobin 
MWS 
GE MyWorkshop Internal Documentation System 
NICU 
Neonatal Intensive Care Unit 
O2Hb 
Oxyhemoglobin 
PI 
Principal Investigator 
PRT 
Protocol 
RHb 
Deoxyhemoglobin 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SaO2 
Oxygen Saturation of Arterial Blood (expressed as percentage) 

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SpO2 
Peripheral Capillary Oxygen Saturation [also called as: pulse oximetry oxygen 
saturation 2 or an estimate of arterial oxygen saturation (SaO2)] 
SPR 
System Problem Report 
tHb 
Total Hemoglobin 
U.S. 
United States 
USADE 
Unexpected Serious Adverse Device Effect 
 
 

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STUDY SYNOPSIS 
Sponsor: 
General Electric Company, acting through its GE Healthcare Business 
Research Type: 
This is a clinical, open label, non-randomized, prospective research study.  
Regulatory Status: 
This is a pre-market research study of the following devices/products: 
Pre-market:  
U-TruSignal 
Background and 
Rationale: 
Pulse oximetry has the unique advantage of continuously monitoring the 
saturation of hemoglobin with oxygen; easily and noninvasively providing a 
measure of cardio-respiratory function. 3 It is the preferred method of oxygen 
monitoring in neonates. 2 
At a neonatal intensive care unit (NICU), continuous health monitoring for the 
neonates provides crucial parameters for urgent diagnoses so that adequate 
medical treatment can be instituted. 4 The goal of SpO2 monitoring for premature 
neonates is to adequately deliver oxygen to the tissue without causing the 
complications of oxygen toxicity. Often, the SpO2 readings from neonates are 
labile and difficult to keep within a narrow range. 
The purpose of the study is to demonstrate proper function of the U-TruSignal 
device via clinical performance testing in a neonatal human subject population 
under standard clinical conditions. 
A study with human subjects will provide the needed clinical evidence for 
assessing the accuracy of the pulse oximeter as recommended by the United 
States Food and Drug Administration (FDA) Guidance Document (entitled: 
“Pulse Oximeters – Premarket Notification Submissions [510(k)s]: Guidance for 
Industry and Food and Drug Administration Staff”). 
Procedures/ 
Methods: 
After providing consent, no preparation beyond the investigational site’s 
standard of care is required before study procedures begin. At the start of the 
procedure, 1 to 2 sensors, upon the discretion of the Investigator, shall be 
applied to the subject. Record site/location of the sensors on the case report 
form. Allow readings to stabilize. After at least 10 minutes of data collection, 
collect arterial blood and analyze blood per hospital’s standard procedure. 
Continue collection of data post blood draw for 2 minutes. Clinician shall monitor 
and record information as specified in this protocol and obtain results of arterial 
blood draw. 
The duration of the subject’s participation in the study is dependent upon how 
long the arterial cannula is required for the subject. The period of data collection 
during the scheduled routine arterial blood draw (up to 3 independent arterial 
blood draws) is a minimum of 10 minutes and up to approximately 30 minutes 
from the application of the sensor to the subject. A maximum of 6 data pairs (3 
data pairs per sensor) can be collected from each subject. 

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Objectives: 
Primary:  
To compare SpO2 data from the U-TruSignal device to SaO2 
values from CO-Oximeter analysis of simultaneously drawn 
arterial blood. 
Secondary:  
To demonstrate U-TruSignal collects substantially continuous 
SpO2 measurements during a data collection interval, which is 
defined as the period in which SpO2 is collected. 
Safety: 
To collect safety information, including type and number of AE’s, 
SAEs, and device issues. 
 
Endpoints: 
Performance: 
The primary endpoint will be Accuracy Root Mean Square 
(ARMS), comparing the accuracy of SpO2 values from the 
investigational device to SaO2 values from CO-Oximeter 
analysis of simultaneously drawn arterial blood. 
The secondary endpoint will be the percent of invalid data 
referred to as gaps per data collection interval. 
Safety:   
Type and number of AEs, SAEs, and device issues. 
Eligibility criteria: 
Inclusion criteria: 
1) Parents or legally designated representative (LDR) can understand and 
provide written informed consent; AND 
2) Subjects are < 29 days old and requiring arterial blood samples per the 
site’s standard of care. 
Exclusion Criteria: 
1) Neonates with injuries, deformities or abnormalities may prevent proper 
application of the sensor; 
2) Neonates with inadequate heart pump function affecting blood 
circulation caused by identified cardiac or cardiovascular conditions 
such as patent ductus arteriosus, persistent pulmonary hypertension, 
septal defects, or congenital heart disease; 
3) Neonates with mean arterial blood pressure < 20mmHg; 
4) Neonates with congenital diaphragmatic hernia; OR 
5) Neonates under High frequency ventilation therapy. 
 
Sample size and 
Sites: 
This study is intended to collect blood samples from neonates under normal 
clinical conditions. The minimum number of subjects is 17 subjects. Maximum 
total enrollment for the study is 140 subjects. Subjects will be enrolled at 2 sites. 
Study duration: 
The study is expected to last 24 months. 
 
 
 

Study Title: U-TruSignal SpO2 Testing in Neonates 
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ADMINISTRATIVE STRUCTURE OF INVESTIGATION 
Clinical Affairs 
Project Manager 
(Sponsor Contact):  
Cynthia Hines-Sabol 
Tel:  
+1 262-422-1306 
E-mail:  cynthia.A.hinessabol@ge.com 
GE Healthcare (GEHC) 
Address:  3000 North Grandview 
Boulevard 
Waukesha, WI 53188-1696 
Research Manager:  
Jaana Vedenjuoksu 
Tel:  
+358-40-524-3886 
E-mail:  Jaana.Vedenjuoksu@ge.com  
GEHC Finland Oy 
Address:  Kuortaneenkatu 2 
FI-00510 Helsinki Finland 
Medical Monitor:  
Helena Haukilehto 
Tel: 
+358 10 394 3609 
E-mail:  
helena.haukilehto@ge.com 
GEHC Finland Oy 
Address:  Kuortaneenkatu 2 
FI-00510 Helsinki Finland 
Biostatistician: 
Bin Xing 
Tel:  
+1 262-420-8926 
E-mail:  
Bin.Xing@ge.com  
GE Healthcare (GEHC) 
Address:  3000 North Grandview 
Boulevard 
Waukesha, WI 53188-1696 
 
 
 

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1. BACKGROUND AND JUSTIFICATION 
Pulse oximetry arterial oxygen saturation (SpO2) has become the “fifth vital sign” in the examination of 
every newborn and infant with respiratory system presentation. 2 Pulse oximetry has the unique 
advantage of continuously monitoring the saturation of hemoglobin with oxygen; easily and noninvasively 
providing a measure of cardio-respiratory function.
 3 It is the preferred method of oxygen monitoring in 
neonates. 2 
In general, pulse oximeters use 2 wavelength absorption spectrophotometries to measure oxygen 
saturation. The wavelengths are selected to provide the best separation of absorbencies of 
oxyhemoglobin (O2Hb) and deoxyhemoglobin (RHb) states. The ratio of the 2 absorbencies is used to 
calculate the oxygen saturation (SpO2) value. The pulse oximeter can provide continuous non-invasive 
real time information, because an arterial sample of blood is not required to make the measurement. 
At a NICU, continuous health monitoring for the neonates provides crucial parameters for urgent 
diagnoses so that adequate medical treatment can be instituted.
 4 The goal of SpO2 monitoring for 
neonates is to ensure adequate oxygen delivery to the tissue without causing oxygen toxicity. Often, the 
SpO2 readings from neonates are labile and difficult to keep within a narrow range. The caregiver should 
aim to maintain the SpO2 levels within the narrow range.
 6 
The purpose of this study is to collect blood samples from neonates under normal clinical conditions to 
ensure proper function (clinical performance) with the U-TruSignal device per FDA Guidance Document: 
Pulse Oximeters – Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and 
Drug Administration Staff). 
5 Testing will follow ISO 80601-2-61 Annex EE.4.2. 
7 The study will include 
both the TruSignal AllFit Sensor and TruSignal Sensitive Sensor. 
A study with human subjects will provide the needed clinical evidence for assessing the accuracy of the 
pulse oximeter as recommended by the FDA Guidance Document: Pulse Oximeters – Premarket 
Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff). 
5 
2. DEVICE/PRODUCT DESCRIPTION 
 Identity, Mechanism, and Function 
Name:  
U-TruSignal 
Modality/Type: 
GE Healthcare (GEHC) -- Monitoring Solutions 
Manufacturer:  
GE Healthcare 
Software version: The software version of the U-TruSignal is investigational and may be 
revised during the study 
Regulatory Status:  pre-market 
Note: A record of number of devices issued, along with applicable identification numbers (e.g. 
serial/lot/batch) and components/accessories used in this study will be retained by the Sponsor as 
part of the clinical history file (CHF), as required by applicable laws and regulations. 
The U-TruSignal functions primarily by measuring continuous non-invasive arterial oxygen saturation 
(SpO
2) and pulse rate monitoring. The U-TruSignal calculates the SpO2 value and transmits the 
information to a patient monitor to display the calculated SpO
2 value. It is a smart cable device that 
consists of an over-molded circuit board, which includes the measurement electronics connectors for the 
SpO2 sensor and the USB interconnect cable. The U-TruSignal is attached to the computer/medical PC 
for data collection by a dedicated USB cable. Patient isolation is built into the U-TruSignal circuit board. 
The study will collect complete data pairs from neonate subjects utilizing released sensors TruSignal 
AllFit Sensor (model #TS-AF-25 or TS-AF-10) and TruSignal Sensitive Skin Sensor (model # TS-SE-3) 

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with the U-TruSignal investigational device. The sensors will be attached to the patient non-invasively. 
The U-TruSignal investigational device is not in direct contact with the patient. 
The research device, instructions for use, or packaging shall indicate that the research device is for use in 
a research investigation, in accordance with applicable regulations in the United States including 
applicable US FDA 21 CFR Part 812 for investigational devices, regulations in Europe under EN ISO 
14155:2011, and other applicable laws and regulations. The investigational device will be exclusively 
used for research purposes. 
The results of this study are intended for use in regulatory submission in the United States and Europe to 
obtain clearance for commercial use. Results may be used to help commercialize the product in other 
global regions in the future, at the discretion of the Sponsor. 
Figure 1 – U-TruSignal Device 
 
 Intended Use 
The investigational device is intended to be used for continuous monitoring and measuring of arterial 
oxygen saturation (SpO2) and peripheral pulse rate by non-invasive pulse oximetry. 
The sensors and accessories are biocompatible. TS-AF and TS-SE sensors that will be used in the study 
are cleared by the FDA for commercial use. The products can be traced through their respective 
(manufacturing) LOT numbers. 
The procedures conducted in this study are intended for research purposes and are not intended as a 
substitute for required medical care. The study staff will be trained in the use of the devices and will be 
provided with the instructions for use. 
 Reference Standard 
The reference standard for the SpO
2 accuracy as read by the test pulse oximetry system shall be 
traceable to SaO2 values obtained from CO-Oximeter analysis of simultaneously drawn arterial blood.
 7 
The SpO2 accuracy of the test pulse oximetry system is validated in comparison to “gold standard” 
measurements of blood SaO2 by a CO-Oximeter. 7 To achieve this, paired observations of SpO2 and 
SaO2 values over the specified SpO2 accuracy range (e.g. 70% to 100% SaO2) of the test pulse oximeter 
system are compared.
 7 The CO-Oximeter SaO2 value may be based on a single CO-Oximeter reading. If 

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more than one CO-Oximeter is used, the pairwise comparisons are separately performed for each CO-
Oximeter, and the data pairs are pooled together for the final accuracy assessment. 7 
 Concomitant/Ancillary Administrations 
 Medications and Biologic Products 
No medications or biologic products will be administered as part of study procedures. 
 Laboratory Tests and Sample Processing 
Laboratory tests required for this clinical study will be performed according to the site’s standard of care 
and will not be prescribed by the Sponsor. 
 Accountability 
Accurate and adequate records will be maintained for all devices, from time of shipment to the sites until 
return or disposal of all devices issued by the Sponsor as part of this study, as required by applicable 
laws and regulations. The Principal Investigator will be ultimately responsible for the security and integrity 
of research devices at the investigational site during the study. 
 Issuance 
The device and accessories will be provided by the Sponsor. Calibration/maintenance of study 
device/product(s) is not required. 
 Disposition 
The device(s)/product(s) will be dispositioned after the study by returning the investigational device to the 
Sponsor or other contractual disposition, in accordance with applicable laws and regulations. 
 Anticipated Risks and Benefits 
The product under study has undergone risk assessment, in accordance with International Standards 
Organization (ISO) 14971:2012, and risks are acceptable or mitigated to levels As Low As Reasonably 
Practical (ALARP). 
The U-TruSignal is an investigational device similar to commercially released pulse oximeters regarding 
the subject-device interface. The circuit board design is similar to standard pulse oximeters regarding 
device safety and functional parts of the board. Therefore, the risks related to the signal detection system 
and accessories are the similar for the released SpO
2 measurement modules and accessories. 
The risks of the U-TruSignal have been analyzed, mitigated, and verified by safety testing or labeling as 
recorded in the U-TruSignal instructions for use. Potential risks include failed isolation on the electrical 
board and excessive interface temperature. The risks are explained in the U-TruSignal instructions for 
use, which will be provided to the site. 
The sensors TruSignal Allfit Sensor and TruSignal Sensitive Skin Sensor are FDA cleared and CE 
marked medical devices. 
The risks of study participation are not expected to be greater than those of similar procedures routinely 
conducted in clinical practice. Post-trial care or follow-up is not required by this study. 
Subjects are not expected to benefit directly from study participation. The results may benefit future 
patients by helping to better understand the continuous monitoring and measuring of SpO2 and peripheral 
pulse rate. 

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 Risk Category and Rationale 
Under the United States FDA (USFDA) Guidance Document on Pulse Oximeters for Premarket 
Notification Submissions [510(k)], USFDA “believes pulse oximeters addressed by the guidance 
document are non-significant risk devices; therefore, the study would be subject to the abbreviated 
requirements of 21 CFR 812.2(b).” 
5 Hence, it can be stated that the U-TruSignal device, accessories, 
and components, as used in this study, are not considered a significant risk device, per the USFDA 21 
CFR §812.3(m) definition: 
1) it is not intended as an implant; 
2) is not purported or represented to be for a use in supporting or sustaining human life; 
3) is not for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health; 
4) and it does not otherwise present a potential for serious risk to the health, safety, or welfare of a 
subject. 
The application of risk management analysis to the U-TruSignal conforms to ISO 14971:2007 and EN 
ISO 14971:2012. For continued safe use of the U-TruSignal, the instructions in the User’s Manual shall 
be followed. 
 Device/Product Classification and Rationale 
The U-TruSignal and SpO2 sensors are intended for use in the measurement of oxygen saturation (SpO2) 
by non-invasive pulse oximetry. The FDA has classified such devices as Class II. 
The U-TruSignal conforms to the provisions of the Council Directive 93/42/EEC concerning medical 
devices amended by 2007/47/EC and fulfills the essential requirements of Annex I of this directive. The 
U-TruSignal is considered an active device, and are in Class IIb, per Classification Rule 10 of the Council 
Directive 93/42/EED Annex IX. Classification Rule 10 states: “Active devices intended to allow direct 
diagnosis or monitoring of vital physiological process, unless they are specifically intended for monitoring 
of vital physiological parameters, where the nature of variations is such that it could result in immediate 
danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS in which 
case they are in Class IIb.” 
3. STUDY OBJECTIVES AND ENDPOINTS 
 Purpose of the Study 
The purpose of the study is to demonstrate proper function of the U-TruSignal device via clinical 
performance testing in a neonatal human subject population under standard clinical conditions. For the 
purposes of this study, proper function will be defined by accuracy (i.e. ARMS value), substantially 
continuous measurement abilities, and safety profile. 
 Primary Objective 
To compare SpO2 data from the U-TruSignal device to SaO2 values from CO-Oximeter analysis of 
simultaneously drawn arterial blood. 
 Secondary Objective 
To demonstrate U-TruSignal collects substantially continuous SpO2 measurements during a data 
collection interval, which is defined as the period in which SpO
2 is collected. 
 Safety Objective 
To collect safety information, including type and number of AEs, SAEs, and device issues. 

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 Study Endpoints 
 Primary Endpoint 
The primary endpoint will be Accuracy Root Mean Square (ARMS), comparing the accuracy of SpO
2 
values from the investigational device to SaO2 values from CO-Oximeter analysis of simultaneously drawn 
arterial blood.
 
 Secondary Endpoint 
The secondary endpoint will be the percent of invalid data, referred to as gaps, per data collection 
interval. 
 Safety Endpoints 
Type and number of AEs, SAEs, and device issues. 
 Summary of Study Design 
This is a pre-market, clinical, open label, prospective, non-randomized research study conducted at 2 
sites. 
4. STUDY DESIGN 
 Study Population 
Subjects that will be enrolled are neonatal patients <29 days old requiring arterial blood draw as part of 
their routine care. 
 Number Subjects 
This study is intended to collect blood samples from neonates under normal clinical conditions. The 
minimum number of subjects is 17 subjects. Maximum total enrollment for the study is 140 subjects. 
 Protection of Vulnerable Subjects 
Vulnerable subjects are individuals whose willingness to volunteer in a clinical investigation 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. 
The Sponsor shall avoid improper influence on, or inducement of, the subject, monitor, any 
Investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
All investigators shall avoid improper influence on, or inducement of, the subject, Sponsor, monitor, other 
Investigator(s), or other parties participating in, or contributing to, the clinical investigation. 
The study activities cannot otherwise be performed without the use of vulnerable populations. 
Neonates: Neonates will be subjects in this study. The purpose of this study involves meeting the health 
needs of these populations. These subjects are considered a vulnerable research population since 
neonates cannot provide valid informed consent to which their parent or LDR must provide written 
informed consent for their child’s participation. 
Studying subject populations as specified in the inclusion and exclusion criteria set forth in this protocol is 
necessary, because SpO2 monitoring is a routine part of these population’s clinical assessment. The 

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study staff will be present during all study procedures and no subject will be left alone during any part of 
the study procedure. 
This research is approved by the EC prior to the start of the clinical study. 
 Eligibility Criteria 
 Inclusion Criteria 
Subjects who meet all the following inclusion criteria may be included: 
1) Parents or LDR can understand and provide written informed consent; AND 
2) Subjects are < 29 days old and requiring arterial blood samples per the site’s standard of care. 
 Exclusion Criteria 
Subjects who meet any of the following exclusion criteria will be excluded: 
1) Neonates with injuries, deformities or abnormalities may prevent proper application of the sensor; 
2) Neonates with inadequate heart pump function affecting blood circulation caused by identified 
cardiac or cardiovascular conditions such as patent ductus arteriosus, persistent pulmonary 
hypertension, septal defects, or congenital heart disease; 
3) Neonates with mean arterial blood pressure < 20mmHg; 
4) Neonates with congenital diaphragmatic hernia; OR 
5) Neonates under High frequency ventilation therapy. 
 Recruiting and Screening 
Subjects, who are neonates, will be recruited for potential enrollment in this study per the standard 
procedures of the investigational site, unless otherwise specified by the Sponsor in this study protocol. 
The parent(s) or LDR(s) of the neonate patient will be asked to volunteer their child to participate in this 
research study and provide written informed consent. All participation will be voluntary. 
Subjects will be screened for enrollment in this study against the inclusion and exclusion criteria per the 
standard procedures of the investigational site. 
Following recruitment, a subject will be considered enrolled (the point of enrollment) once the parent/LDR 
signs and dates the informed consent form (ICF). Once enrolled, the subject will be assigned a unique 
subject number, which will not contain information that could identify the subject (such as subject name or 
date of birth). The unique subject number will be used to label case report form (CRF) data for the subject 
throughout his/her participation in the study. 
 Criteria for Withdrawal/Discontinuation 
The parent(s) or LDR(s) may withdraw their child from study participation at any time, for any reason. The 
Investigator may withdraw a subject at any time, for any reason. The reasons for withdrawal and 
discontinuation for any subject shall be recorded. These will be reported to the Sponsor. The EC should 
be notified per their notification of subject withdrawal policy. 

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5. STUDY PROCEDURES 
 Diagram of Procedures 
Figure 2 – Diagram of Study Procedures 
 
Notes: 
1 Subject is considered enrolled once the informed consent has been signed. 
2 After the parent/LDR signed the informed consent form, subjects that did not completely fulfill the 
inclusion/exclusion criteria will be considered withdrawn. 
3 Adverse Event monitoring and reporting begins when the subject’s parent/LDR signed the 
informed consent form through study completion. 
Study Completion or Subject’s End of Study is defined as the last data collection as 
determined by the Investigator and/or study staff by recording the study completion date and 
time. 
4 The duration of the subject’s participation in the study is dependent upon how long the arterial 
cannula is required for the subject. Data collection for a data pair (3 data pairs per sensor) is a 
minimum of 10 minutes and up to approximately 30 minutes from the application of the sensor to 
the subject. 
5 Investigator or designee can determine when a longer data collection is needed. 
6 Removal of the investigational device may or may not be the end of the study and the end of AE 
monitoring and reporting – see definition Study Completion/Subject’s End of Study under Note#3 
above. 
7 Procedure may be repeated at the time of arterial blood draw to collect a maximum of 6 data pair 
(3 data pairs per sensor).  
 
 Subject Preparation 
Study staff will confirm that the subject is eligible and complies with applicable site requirements prior to 
starting study procedures. 
Informed 
Consent 1
Screening 
Procedures 2
Active Enrollment 
Begins3
Apply sensors to the 
subject
Data Collection 4, 5
(arterial blood draw 
will be performed per 
site's standard of care, 
and not presecribed 
by the Sponsor)
Active Enrollment 
Ends/Study 
Completion6
(End of data collection 
is when a maximum of 
6 data pairs [3 per 
each sensor] have 
been reached. See 
definition of study 
completion) 
7
Subject End 
of Study 
3 
Subject Start 
of Study 

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After providing consent, no preparation beyond the investigational site’s standard of care is required 
before study procedures. 
 Description of Study Procedures 
The following are the steps to be performed: 
1) To document the case, photographs of the position of the measurement sensors and other 
equipment may be taken at the request of the Sponsor at any point of the procedure, when 
necessary. 
Note: photographs are taken in a way that the subject cannot be identified from the pictures. 
2) Apply sensor(s) to the subject as appropriate. No more than one SpO
2 sensor placed on the 
same limb, and no sensor placed close to blood draw site/IV cannulation (same limb). Record site 
of sensor(s) placed on the CRF. 
3) Allow the clinical environment and readings to stabilize. 
4) Start data collection using the data collection tool. 
5) Collect data using the data collection tool for a minimum of 10 minutes prior to routine arterial 
blood draw, per the data collection tool. Record possible accidental annotations in CRF. 
Note: The arterial blood draw collected during this study will be performed according to the site’s 
standard of care and will not be prescribed by the Sponsor. 
6) When routine arterial blood draw is conducted, mark arterial blood draw time with data collection 
tool. The blood sample will be processed through hospital’s standard procedure. Record possible 
accidental annotations in CRF. 
7) After arterial blood draw, continue collecting data using the data collection tool for a minimum of 2 
minutes. Record possible accidental annotations in CRF. Stop data collection. 
8) Remove sensor(s) from the subject. 
9) Monitor and record the following information using the data collection tool or recording on CRF 
during steps 4-7): 
a. clinical status notes; i.e., frequent apnea, hemodynamic instability, abnormal heart 
rhythm, or other status; 
b. environmental conditions such as changes in lightning conditions, ongoing care moving 
the neonate outside blood sampling, excessive clinical signs such as agitation, 
readjustment of a sensor; AND 
c. notes regarding data collection such as accidental annotations. 
10) Obtain results of the arterial blood draw and record possible errors during standard procedure for 
blood sampling and analysis. 
11) Repeat Steps 1-10 up to 3 times to obtain a maximum of 6 data pairs, 3 data pairs per sensor 
aiming to collect equal data for each sensor. 
Note: Alternate the sensors used; e.g.; if TS-AF was used first, then TS-SE should be used at the 
next data collection. 
NOTE: Study Completion or Subject’s End of Study is defined as the last data collection determined by 
the Investigator and /or study staff by recording the study completion date and time. 
GE Healthcare engineering representatives may be present during study procedures, depending upon 
their need to observe the functioning of the investigational device (their need to observe will depend upon 
the study staff indicating there is an issue for the engineers to look at). These representatives will always 
be accompanied by study staff. These visits will be agreed upon and arranged by the Research Manager 
and the Investigator on a case-by-case basis. 

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 Follow-up 
No follow-up will be conducted. The subject will be followed for AEs from the time consent has been 
provided to study completion/end of study. (See definition of study completion.) 
6. STUDY DATA COLLECTION AND ASSESSMENTS 
 Primary Assessment 
The Investigator or designated study staff will perform the collection of SpO2 and pulse rate, that will be 
recorded in the U-TruSignal Data Collector. Laboratory results from arterial blood draw will be collected 
from the hospital’s medical records. 
The following data will be collected on the CRF: 
1) Demographics:  date of birth, gender, length, and weight, skin tone (see Appendix C – Modified 
Fitzpatrick Scale); 
2) U-TruSignal Serial Number, Sensor Type, LOT Number, and Attachment Location of the Sensor; 
3) Notes regarding data collection e.g. incorrect annotation of data file or several data files; 
4) Relevant information on the clinical status affecting hemodynamic stability such as frequent 
apnea, hemodynamic instability, abnormal heart rhythm; 
5) Environmental conditions e.g. open bed, changing lightning conditions, ongoing care causing 
movements, readjustment of a sensor. 
The laboratory results will include and to be collected from the hospital’s medical record: 
1) Co-Oximeter information, 
2) Functional SaO2 (%), 
3) Fractional oxyhemoglobin (FO2Hb) [%], 
4) Fractional carboxyhemoglobin (FCOHb) [%], 
5) Fractional methemoglobin (MetHb) [FMetHb] [%], 
6) Total hemoglobin (tHb) (ctHb) [g/L] 
7) Fetal hemoglobin (Hb) [g/L] (calculated), and 
8) Fractional fetal hemoglobin [%]. 
 Safety Assessments 
The description, severity, and device relatedness of any AE or SAE during the study will be recorded. 
Subjects will, if necessary, be provided with emergency care. In the event of any device issues, the event 
will be recorded. Safety reporting will be conducted as described in this protocol. 
7. QUALIFICATION AND TRAINING PLAN 
 Staff Qualifications 
All members of the study staff participating in the conduct of the clinical investigation shall be qualified by 
education, training and/or experience to perform their tasks, and this shall be documented appropriately, 
as per ISO 14155:2011 for clinical studies. 
 Training Plan for the Protocol and Research Device/Product 
Before starting the study, the study staff and hospital department staff will be trained on the clinical 
investigation requirements set forth in this study protocol according to the following requirements. 
• Title of Training 

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• Training objectives 
• Training logistics (who conducts training and training method) 
• Target audience (who will be trained) 
• Training content (including device operation and set-up, protocol review and understanding)Any 
personnel that will be involved in the study must receive protocol training prior to participating in 
the study. Additional training may be provided as needed. 
Study staff directly operating or maintaining the research device will be trained based on the operator 
manual and/or qualified based on experience as qualified by the hospital/clinical site policy.  A training log 
will be provided and maintained for the study. 
The Principal Investigator will be ultimately responsible for execution of this study in accordance with the 
protocol and for device/product use in this study by members of the study staff. 
8. SAFETY 
 Anticipated Adverse Events 
Being in this study involves some foreseeable risks. 
Pulse Oximetry Sensor placement involves positioning pulse oximetry sensors on the volunteer subject in 
the same manner used with released SpO2 cables. The U-TruSignal investigational device is not in direct 
contact with the patient. The sensors that will be in contact with the subject are cleared for commercial 
use. The sensors may be warm to the touch. Under normal operating conditions (no fault conditions), the 
sensors are not expected to overheat. If the Investigator or delegate conducting the study senses the 
sensor is too warm or the subject is experiencing discomfort the sensor will be removed immediately and 
the area of concern will be massaged, and the sensor will be replaced at the discretion of the study staff, 
the sensor may be removed, and the study procedures discontinued at any time. Sensors may cause 
irritations to the skin in some subjects. The risk in the use of pulse oximetry sensors is considered 
minimal. 
There is always a chance of unexpected risks. Throughout the study, the Sponsor will evaluate and 
update safety information in study documents. 
 Adverse Event Definitions 
Adverse Event (AE): any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device [ISO 14155:2011 3.2]. This includes events related to the 
investigational device or the comparator and to the procedures involved. For users or other persons, this 
is restricted to events related to the investigational medical device. 
Serious Adverse Event (SAE): an AE that led to death; led to a serious deterioration in the health of the 
subject, that either resulted in a life-threatening illness or injury, a permanent impairment of a body 
structure or a body function, or in-patient or prolonged hospitalization, or medical or surgical intervention 
to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; 
or led to fetal distress, fetal death or a congenital abnormality or birth defect. Planned hospitalization for a 
pre-existing condition, or a procedure required by the protocol without serious deterioration in health, is 
not considered a SAE [ISO 14155:2011 3.37]. 
Adverse Device Effect (ADE): an AE related to the use of an investigational medical device [ISO 
14155:2011 3.1]. This includes any AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. This includes any event that is a result of a user error or intentional misuse of the investigational 
device [ISO 14155:2011 3.43]. 

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Serious Adverse Device Effect (SADE): an ADE that has resulted in any of the consequences 
characteristic of a SAE [ISO 14155:2011 3.36]. 
Device deficiency: an inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance, such as malfunctions, use errors, and inadequate labeling [ISO 
14155:2011 3.15]. 
Unanticipated serious adverse device effect (USADE): a SADE, which by its nature, incidence, 
severity, or outcome has not been identified in the current version of the risk analysis report [ISO 
14155:2011 3.42]. In the United States, 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 study documents, will be 
reported in accordance with 21 CFR §812.3 and applicable laws and regulations. 
 Documentation of Safety Events 
All AEs, including all SAEs, are required to be collected, investigated, and documented during the study 
reporting period, as defined in the study procedure set forth in this protocol. Documentation will include: 
• Description of Event 
• Date of onset and resolution 
• Severity (mild, moderate, or severe) 
▪ Mild:  Symptom(s) barely noticeable to the subject or does not make the subject 
uncomfortable. The AE does not influence performance or functioning. Prescription drugs 
are not ordinarily needed for relief of symptom(s). 
▪ Moderate:  Symptom(s) of a sufficient severity to make the subject uncomfortable. 
Performance of daily activities is influenced. Treatment of symptom(s) may be needed. 
▪ Severe:  Symptom(s) of a sufficient severity to cause the subject severe discomfort. 
Treatment for symptom(s) may be given. 
• Serious (yes/no) 
• Causal relationship to investigational medical device? (not related, possibly related, or related) 
▪ Not related:  The AE is reasonably expected to be related to (or caused by) a concurrent 
illness, effect of another device/drug or other cause, and is unlikely related to the 
investigational product. 
▪ Possibly related:  The AE is reasonably expected to be related to the investigational 
product, and an alternative etiology is equally or less likely compared to the potential 
relationship to investigational product. 
▪ Related:  There is a strong relationship to investigational product or recurs on re-
challenge, and another etiology is unlikely or there is no other reasonable medical 
explanation for the event. 
• Treatment given and/or action taken (procedure stopped, withdrawn from study, or no action) 
• Anticipated (yes/no) 
 Reporting of Safety Events 
The following events are to be reported to the Sponsor within 72 hours of the event occurrence and to the 
EC per their policy: 
• All SAEs and USADEs 
• All device issues that could possibly lead to an SAE 
The following information is the Sponsor contact for SAEs and/or UADEs: 
Helena Haukilehto, MD 

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Fax: 
+1 262-364-2544 (24 hours) 
E-mail: SAE@ge.com 
Additional follow-up information including the medical records of the subject may be requested by the 
Sponsor. In addition, safety information may be shared with regulatory agencies and other participating 
sites, as required by applicable law and regulation. 
 Device Deficiencies/Complaints 
Device deficiencies related to the investigational device should be reported directly to the engineering 
team, after each case by the Investigator or study staff, who finishes the case. Device deficiencies related 
to the approved or cleared device should be reported to the study Sponsor. 
Sponsor contact for device complaints: 
Cynthia Hines-Sabol, Clinical Affairs Project Manager 
Tel: 
+1 262-422-1306 
E-mail: cynthia.A.hinessabol@ge.com 
All device deficiencies will be collected, fully investigated, and documented in the source document and 
appropriate CRF during the study reporting period. The Principal Investigator is responsible for notifying 
the Sponsor if there is any device issue that could potentially lead to a SAE. 
9. ETHICAL CONDUCT OF THE STUDY 
The study will be carried out in accordance with the protocol and with principles enunciated in the current 
version of the Declaration of Helsinki; the guidelines of GCP for medical devices, as set forth by ISO 
14155:2011 and ISO 14971:2012; European Directive on medical devices 93/42/EEC for studies 
conducted in Europe; and applicable local regulatory authority’s requirements of Finland – Valvira. 
The study will be conducted and reported in accordance with applicable policies of the local EC and 
governing regulatory authorities in Finland and India (when India
's law comes into effect). 
If national or regional EC requirements are less strict than the requirements of GCP, such as ISO 
14155:2011 for medical devices, the Sponsor shall apply the requirements of this International Standard 
to the greatest extent possible, irrespective of any lesser requirements, and shall record such efforts. 
 Ethics Committee 
The responsible Principal Investigator at each site will ensure that approval from an appropriately 
constituted EC is attained for the clinical study prior to enrolling subjects, and Principal Investigator will 
ensure that documentation of approval is maintained for the duration of the study. 
The Principal Investigator will ensure that the Sponsor is notified of any withdrawal of EC approval within 
5 working days of such occurrence. If approval is terminated or suspended, the Principal Investigator will 
promptly notify the Sponsor and provide written explanation. 
 Regulatory Agencies and Competent Authority(ies) 
The Sponsor will obtain approval from the local regulatory agency or competent authority before the start 
of the clinical trial, if necessary, per applicable local laws and regulations. Any additional requirements 
imposed by the EC or regulatory authority shall be followe d, if applicable. Documentation of notification 
will be maintained in the Site Regulatory Binder. 
For clinical studies conducted in Finland, per the local regulatory agency or competent authority 
requirements the Sponsor will notify Valvira, the local regulatory agency or competent authority, before 
the start of the clinical trial, if necessary, per applicable local laws and regulations. 

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 Management of Protocol Modifications and Amendments 
Substantial amendments will only be implemented after approval of the EC. 
 Management of Protocol Deviations 
A deviation is any instance(s) of failure to follow, intentionally or unintentionally, the requirements of the 
protocol. Under emergency circumstances, deviations from the protocol to protect the rights, safety, and 
well-being of human subjects may proceed without prior approval of the Sponsor and the EC. Such 
deviations shall be documented and reported to the Sponsor and the EC as soon as possible. Deviations 
will be reported as: 
• Critical Deviations: Deviations that significantly affect the safety, efficacy, integrity, or conduct of 
the study. These deviations must be reported to the Sponsor no later than 5 working days from 
awareness of occurrence and reported to the EC per the deviation reporting policy. 
• Non-Critical Deviations: Protocol deviations that do not significantly affect the safety, efficacy, 
integrity, or conduct of the trial. These deviations must be documented on the CRF Protocol 
Deviation page and will be reviewed by the study monitor. 
Non-substantial modifications may be made during the normal course of device optimization, 
maintenance, and feasibility testing. Non-substantial modifications will be communicated to the CA as 
soon as possible, if applicable, and to the EC per their policy. 
 Participant Information and Informed Consent 
The investigators will explain to each participant’s parent(s) or LDR(s) the nature of the study, its purpose, 
the procedures involved, the expected duration of exposure to the investigational device, the potential 
risks and benefits, and any potential discomforts. Each participant’s parent(s) or LDR(s) will be informed 
that participation in the study is voluntary, that he/she/they may withdraw his/her/their child from the study 
at any time, and that withdrawal of consent will not affect his/her/their child’s subsequent medical 
assistance and treatment. The participant’s parent(s) or LDR(s) must be informed that his/her/their child’s 
medical records may be examined by authorized individuals other than their treating physician. 
All participant’s parent(s) or LDR(s) for the study will be provided an informed consent form, describing 
the study and providing sufficient information, to allow the participant’s parent(s) or LDR(s): (i) to make an 
informed decision about his/her/their child’s participation in the study, and (ii) to be fully aware of his/her 
rights under the applicable law. Informed consent documents will be subject to approval by the EC prior to 
enrolling subjects in the study. 
The participant’s parent(s) or LDR(s) should read and consider the statement before signing and dating 
the ICF and shall be given a copy of the signed document. The ICF must also be signed and dated by the 
Investigator (or his/her designee), and it shall be retained as part of the study records. 
 Early Termination of the Study 
The Sponsor may terminate the study prematurely according to certain circumstances. Examples of such 
circumstances include ethical concerns, insufficient participant recruitment, participant safety concerns, 
alterations in accepted clinical practice that make the continuation of a clinical trial unwise, early evidence 
of benefit or harm of the research product, or for any other reason. 
 Incidental Finding 
Incidental findings observed during the study conduct shall be processed under the purview of the 
Principal Investigator through the investigational site’s standard of practice. 

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10. STATISTICAL METHODS 
 Statistical Hypothesis 
Summary statistics will be used to summarize the data. No statistical hypothesis is being tested in this 
study. 
 Sample Size Determination 
This study is to collect blood samples from neonates under normal clinical conditions. The minimum 
number of subjects is seventeen (17) subjects. Maximum total enrollment for the study is one hundred 
forty (140) subjects. 
Per ISO 80601-2-61:2011, 7 at least 200 data pairs from at least 10 subjects is required for the adult 
desaturation test, with SaO2 values distributed on 5 saturation plateaus spanning the range of 70-100%.  
Unlike the invasive controlled desaturation test on adults in a laboratory environment in which the SaO2 
can range from 70% to 100%, the SaO2 collected in this study is expected to be around 90%. Since SaO2 
values in this study may be clustered in 1 plateau around 90%, a minimum of 50 data pairs is considered 
adequate to ensure proper function/clinical performance with neonates with U-TruSignal device. Up to 3 
data pairs may be collected on an individual patient per sensor, patients with a minimum of one data pair 
will be included in the study.  The TruSignal AllFit Sensor (model #TS-AF-25 or TS-AF-10) and TruSignal 
Sensitive Skin Sensor (model # TS-SE-3) will be used. The study is targeted to obtain 50 to 70 
SpO2/SaO
2 data pairs from 17 to 70 neonatal subjects per sensor.     
 Statistical Analysis 
 General Statistical Methods 
The study data will be presented in tables, listings, and figures. Data will be summarized using descriptive 
statistics. The descriptive statistics for continuous variables will include mean, standard deviation, 
median, Q1 and Q3, minimum, maximum, and sample size. Categorical variables will be described with 
counts, percentages, and sample size. A 95% confidence interval may be presented, when necessary. 
 Analysis Set(s) 
The study analysis will include all valid data collected from all participating subjects. 
 Analysis of Primary Endpoint 
Data analysis for the data collection interval, which is defined as the 5 second period starting after a 
twelve (12) second technical delay from the time sampling occurs, will follow ISO80601-2-61, 2011, 
Annex EE and the FDA Guidance Document for Pulse Oximeters (FDA Guidance, March 4, 2013). 
Separate analysis will be performed for each sensor type. 
The ARMS calculation is used as a means to define the SpO2 Accuracy. Arms will be calculated as
n
i
i
Arms
n
i
f
DUT

−
=
=
1
2)
Re
(
 
, where 
Refi = Reference CO-Oximeter Functional SaO2 of data pair i 
DUTi = Device Under Test SpO2 of data pair i 

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The difference between SpO2 and SaO2 will be summarized using mean, minimum and maximum. 
Number of subjects and number of data pairs will also be presented. 
A least squares regression of SpO
2 on SaO2 will be performed and results be presented with a regression 
plot and table. 
Bland-Altman graphical plots, error (SpO2 – SaO2) versus average SaO
2 will be generated with mean, 
and upper 95% and lower 95% limits of agreement according to Section 3 of “Agreement Between 
Methods Of Measurement With Multiple Observations Per Individual“ by Bland and Altman in 2007 
Journal of Biopharmaceutical Statistics.  Individual test subjects will be color coded in the Bland-Altman 
graphical plot. 
Data listed below will be excluded from analysis: 
▪ Data with SaO2 < 70%, tHb < 10g/L, MetHb > 2%, COHb > 3%; 
▪ Draws with values smaller than -0.5% in any of the Hb values; 
▪ Artefacts/other external error sources indicated by clinical documentation or derived from the 
collected data around sampling including but not limited to: 
o changes in sensor fit; 
o excessive movement during draw; 
o low perfusion (mod% < 0.5%); 
o irregular plethysmographic waveform or artefacts in the waveform; 
▪ Data with error conditions on CO-Oximeter analysis indicated by clinical documentation e.g. air 
bubbles in syringe, clots, violation of hospital’s standard procedure; 
▪ Data with error conditions on pulse oximeter; 
▪ Unstable SpO2 readings from the respective device under test: 
o SpO2 max-min ≥ 4% in time window during 30 sec prior/after the blood sample; 
o SpO2 max-min ≥ 8% in time window during 10 minutes prior to the blood sampling time; 
A rationale will be provided for any data that is excluded from the data analysis. 
 Analysis of Secondary Endpoint 
Invalid data will be characterized during the data collection interval, which is defined as the period in 
which SpO2 is collected excluding annotated invalid data periods.  Gaps in the data collection interval will 
be seen in the e-data file as invalid (negative number) as identified by GE engineering. 
o Invalid data < 10% 
 Safety Analysis 
Safety events will be presented as a listing, and frequency of instances will be calculated. This will be 
conducted for all subjects. 
 Handling of Missing Data 
Analysis will be based on collected data, and no imputation will be done for missing data. The Investigator 
is obligated to provide written documentation of any missing data to the Sponsor and to provide 
clarification upon Sponsor request if possible. 

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 Deviation(s) from the Original Statistical Plan 
Any changes or deviations from the original statistical plan specified in this protocol will be described and 
justified in the statistical analysis plan (SAP) and study final report, per ISO 14155:2011. 
11.  QUALITY ASSURANCE AND CONTROL 
 Data Management 
Data management processes for handling study data will be maintained by the Sponsor. 
 Completion of Case Report Forms (CRFs) 
The data reported on the CRFs (eCRFs) shall be derived from source documents and be consistent with 
these source documents. Paper CRFs and/or electronic CRFs (eCRFs) will be used to collect data. The 
Sponsor will provide CRFs (eCRFs) and train study staff on completion of CRFs (eCRFs) using Good 
Documentation Practices (GDP). CRF Completion Guidelines (CCG) may be provided by the Sponsor to 
help facilitate training. 
CRFs (eCRFs) are to be completed as information becomes available at the site. CRFs (eCRFs) should 
be signed by indicated parties, in indicated area(s), to certify the contents of the form. The Principal 
Investigator is ultimately responsible for ensuring completion of CRFs (eCRFs). 
If discrepancies are discovered on paper CRFs during monitoring, the Sponsor’s representative will 
ensure that the study staff makes necessary corrections directly to the paper CRF(s) prior to collection. 
The original copies of paper CRF shall be sent to the Sponsor after the study monitor has completed data 
verification. Photo copies of the paper CRF shall be kept by the site along with the study documents. 
Upon receipt of the paper CRF by the Sponsor, the Sponsor will review the data. A Data Clarification 
Form (DCF) may be provided to the site to correct or clarify discrepancies. 
If a site discovers discrepancies after paper CRF collection, the site may notify the Sponsor and request 
data modification. 
In the event that any discrepancies are discovered on the eCRF, whether during monitoring or during 
data review by the study team, a query will be raised, and the site shall make the correction within the 
electronic database, noting the reason for change. Data will be considered clean once all queries are 
answered and closed. 
If the Sponsor discovers discrepancies on eCRFs, a query will be raised, and necessary corrections will 
be made by the site. The reason for any changes will be noted. All queries will be resolved prior to study 
completion. 
There will be electronic data collected by the U-TruSignal data collection tool to which only authorized 
personnel will have access. Data collected by the data collection tool will be fully de-identified; i.e., all 
personal identifying information has been removed and replaced by using the subject identification 
number assigned to the subject. Electronic data will be transferred to GEHC as indicated in the Data 
Management Plan. A copy of this electronic data shall be provided to the site to which the site will store 
with the subject’s study documents. 
 Data Handling and Record Keeping 
All documents and data shall be produced and maintained in a manner that assures control and 
traceability. 

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 Source Data and Documents 
Source data includes information in original records, certified copies of original records of clinical findings, 
observations, or other activities for the study. Source documents for each subject must be retained 
throughout the investigation, including printed or electronic documents containing source data. Elements 
should include: 
• Source data and documentation relevant to data recorded for subject screening and CRF 
corroboration. 
• Subject records containing the completed ICFs, CRFs, and electronic data copied from the data 
collection tool. 
• Regulatory binder containing the protocol and any subsequent amendments, EC submissions 
and approvals, blank ICF(s), and site logs. 
• Reference manuals containing Investigator responsibilities, Sponsor, AE/SAE and informed 
consent guidelines, applicable study aids and training materials, and operator’s manuals. 
The Principal Investigator or institution shall provide direct access to source data during and after the 
clinical investigation for monitoring, audits, EC review, and regulatory authority inspections. 
 Archiving 
All study data must be archived for the period defined by local law after study termination or premature 
termination of the clinical trial. No source documents or study records will be destroyed without Sponsor 
notification and approval. 
12. MONITORING PLAN 
In collaboration with the site, the Sponsor will ensure proper monitoring of the study to confirm that all the 
research requirements are met. Monitoring visits will oversee the progress of a clinical investigation and 
ensure that it is conducted, recorded, and reported in accordance with the protocol, written procedures, 
GCP ISO 14155:2011, and the applicable regulatory requirements. 
 Confidentiality and Data Protection 
The Investigator affirms and upholds the principle of the participant
's right to privacy, and the Investigator 
shall comply with applicable privacy laws. Especially, anonymity of the participants shall be guaranteed 
when presenting the data at scientific meetings or publishing data in scientific journals. 
Individual subject medical information obtained as a result of this study will be considered confidential, 
and disclosure to third parties will be prohibited. Subject confidentiality will be further ensured by utilizing 
subject identification code numbers. For data verification purposes, authorized representatives of the 
Sponsor, a competent authority (CA), or an EC may require direct access to parts of the medical records 
relevant to the study, including subject medical history. 
 Storage of Images and Associated Health Data 
Electronic data from the U-TruSignal Data Collector and associated data will be collected and disclosed 
to the Sponsor as part of this study. Fully de-identified data, which has had all personal identifying 
information removed, may be stored and used by the Sponsor indefinitely. The Sponsor and/or its 
authorized representatives may use any de-identified data collected in this study for future technology 
and engineering development, marketing purposes, education, regulatory submissions, publications, or 
other possible uses. 

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 Publication Policy 
The results of this study may be used in future publications. The conditions of publication are described in 
a separate contractual agreement. 
 
 

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REFERENCES 
1. 
ISO. Clinical investigation of medical devices for human subjects - Good Clinical Practice: 
International Organization for Standardization; 2011. ISO 14155:2011(E). 
2. 
Kugleman A, Wasserman Y, Mor F, Goldinov L, Geller Y, and Bader D. Reflectance Pulse 
Oximetry from Core Body in Neonates and Infants: Comparison to Arterial Blood Oxygen 
Saturation and to Transmission Pulse Oximetry. Journal of Perinatology. April 2004;24:366-371. 
3. 
Kamat V. Pulse Oximetry. Indian J. Anaesth. August 2002;46(4):261-268. 
4. 
Chen W, Ayoola I, Oetomo S, Feijs L. Non-invasive blood oxygen saturation monitoring for 
neonates using reflectance pulse oximeter. Paper presented at: 2010 Design, Automation & Test 
in Europe Conference & Exhibition, 2010; Dresden. 
5. 
FDA -- U.S. Food and Drug Administration. Guidance Documents (Medical Devices and 
Radiation-Emitting Products). March 4, 2013. 
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocument
s/ucm081352.pdf. Accessed May 11, 2016. 
6. 
The Royal Children's Hospital Melbourne. Royal Children's Hospital Melbourne Clinical 
Guidelines (Nursing). December 2012. 
http://www.rch.org.au/rchcpg/hospital_clinical_guideline_index/Oxygen_Saturation_SpO2_Level_
Targeting_Premature_Neonates/. Accessed October 31, 2014. 
7. 
ISO. Medical electrical equipment--Part 2-61: Particular requirements for basic safety and 
essential performance of pulse oximeter equipment: Internal Organization for Standardization; 
2011. ISO 80601-2-61. 
8. 
Fitzpatrick T. Soleil et peau. J Med Esthet. 1975;2(33034). 
 
 
 
 
 

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APPENDIX A – STUDY SCHEDULE 
Table A.1 - Schedule of Study Procedures 
Evaluation 
Visits* 
Screening 
(enrollment) 
Study Procedure 
Written Informed Consent 
X 
 
Patient Demographics 
X 
 
Inclusion criteria 
X 
 
Exclusion criteria 
X 
 
Blood draw 
 
X 
*Subjects will be followed for AE reporting purposes from the time the parent(s) or LDR(s) provided 
written consent to end of study procedures. There will be no follow-up after the completion of the study. 
 
 

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APPENDIX B – STUDY SITE AND INVESTIGATOR LIST 
The following investigators at each study site will be responsible for the conduct of this study: 
Investigator(s):1 
 
Rajiv Agarwal, MD 
Director & Senior Consultant Pediatrics and 
Neonatology 
MBBS (AIIIMS), Pediatrics (AIIMS) 
Principal Investigator 
Tel:  
+91 80 7122 2360 
E-mail:  rajiv.aggarwal.dr@narayanahealth.org  
NH Narayana Multispecialty 
Hospital 
Unit of Narayana Health, 
Mazumdar Shaw Medical 
Center  
Address:  258/A Bommasandra 
Industrial Area, Anekal 
Taluk, Hosur Road, 
Bangalore 560099 
Karnaktaka 
 
Outi Tammela, MD 
Principal Investigator 
Tel: 
+358-3-311-66334 
E-mail: outi.tammela@pshp.fi 
Tampere University Hospital 
(TAYS) 
Address:  Teiskontie 35 
33520 Tampere, 
Finland 
1 The role of the Principal Investigator is to implement and manage the conduct of the investigation as well as 
ensure data integrity and the rights, safety, and well-being of humans involved in the study [ISO 14155:2011 9.1]. Co-
Investigators share all responsibilities of the Principal Investigator, and Sub-investigators share only those 
responsibilities designated by the Principal Investigator. 
 
 

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APPENDIX C – MODIFIED FITZPATRICK SCALE 8 
 
Modified Fitzpatrick Scale 8 excluding the skin’s sensitivity to the sun and only utilizing the color 
descriptions: 
Type I 
White; very fair; freckles; typical albino skin 
Type II 
White; fair 
Type III 
Beige, very common 
Type IV 
Beige with a brown tint; typical Mediterranean Caucasian skin 
Type V 
Dar brown/black 
 
 

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APPENDIX D - AMENDMENTS (PROTOCOL VERSION 1.0 TO 2.0) 
A detailed amendment is provided for version 1.0 to version 2.0. Version 1.0 was the first version to 
receive EC approval and was active at the site. 
Purpose of Amendment: 
1) To extend the duration of the study. 
2) To include the required language by the EU Data Protection Regulation 2016/679. 
3) To replace the former Project Manager, Research Manager, and Biostatistician. 
4) To make general typographical/formatting corrections, in accordance with current standard style 
guides, American Medical Association (AMA) style, and internal standards of the Sponsor. 
These changes are not expected to increase subject or operator risk or to adversely impact the scientific 
integrity or conduct of the study. 
In the table below, point-by-point revisions are shown as additions in double-underline (double-underline) 
and deletions in strikethrough (strikethrough) for each change made in this amendment from the previous 
version. 
 
Ite
m 
Section 
Revision or Clarification 
Justification 
1 
Cover Page 
Changes to the Protocol Version number and date 
were changed throughout the protocol: 
Version:  2.01.0; 01/Mar/201925/Apr/2017 
This correction made 
indicate the next version 
number and date of the 
protocol amendment. This 
correction does not impact 
the study design or risk. 
2 
Cover page – Sponsor 
Contact 
Cynthia Hines-SabolStephanie Karwedsky, Clinical 
Affairs Project Manager 
Tel:  +1-262-422-1306+1-262-443-7008 
E-mail:  cynthia.A.hinessabol@ge.com 
Stephanie.Karwedsky@ge.com 
This change does not 
impact the study design or 
risk. 
3 
Principal Investigator – 
signature page 
The Sponsor and Investigator have approved this 
protocol version, and I confirm hereby to conduct 
the study according to the protocol and in 
accordance with applicable principles of the World 
Medical Association Declaration of Helsinki and 
Good Clinical Practice (GCP) guidelines as per ISO 
14155:2011, any conditions of approval imposed by 
the reviewing EC/IRB or governing regulatory body, 
and applicable laws and regulations. The 
Iinvestigator should not deviate from this protocol 
except for emergency use. I have read and 
understood and agree to abide by all the conditions 
and instructions contained in this protocol. 
Administrative changes. 
The changes do not have 
an impact on the study 
design or risk. 

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4 
Table of Contents 
Updated the table of contents based on the 
changes made. 
The change does not 
impact the study design or 
risk. 
5 
Document and Version 
Control 
Revision 
Date 
Revision 
Author 
Comments/Change
s 
1.0 
25/Apr/2017 Catherine 
Cadogan 
Clinical Writer – This 
is the initial version. 
2.0 
01/Mar/2019 Catherine 
Cadogan 
Clinical Writer – The 
purpose of this 
protocol amendment 
is to include the 
language required by 
the EU Data 
Protection 
Regulation 
2016/679. Details of 
the changes can be 
found in Appendix D.  
 
 
 
 
 
The addition of the revision 
does not impact the study 
design or risk. 
6 
List of Abbreviations and 
Terms 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
ALARP 
As Low as Reasonably Practical 
AMA 
American Medical Association  
ARMS 
Accuracy Root Mean Square 
 … 
EC 
Ethics Committee 
EC/IRB 
Institutional Review Board 
ISO 
International Standards Organization 
LDR 
Legally Designated Representative 
 … 
SpO2 
Peripheral Capillary Oxygen Saturation 
(also called as: pulse oximetry oxygen 
saturation 2 or an estimate of arterial 
oxygen saturation (SaO2) 
 … 
U.S. 
United States 
 
The corrections made does 
not impact the study design 
or risk. 
7 
Synopsis – Research Type This is a Clinicalclinical, open label, non-
randomized, prospective research study. 
The link for the field code 
was removed. This change 
does not impact the study 
design or risk. 
8 
Synopsis – Background 
and Rationale: 
Correction made in the last paragraph: 
A study with human subjects will provide the 
needed clinical evidence for assessing the accuracy 
of the pulse oximeter as recommended by the 
United States Food and Drug Administration (FDA) 
Guidance Document (entitled: “Pulse Oximeters – 
Premarketmarket Notification Submissions 
The changes made does 
not impact the study design 
or risk 

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[50510(k)s]: Guidance for Industry and Food and 
Drug Administration Staff”.). 
9 
Synopsis – 
Procedures/Methods: 
After providing consent, no preparation beyond the 
investigational site’s standard of care is required 
before study procedures begin. At the start of the 
procedure, one 1 to 2two sensors, upon the 
discretion of the Iinvestigator, shall be applied to the 
subject. Record site/location of the sensors on the 
case report form. Allow readings to stabilize. After 
at least 10 minutes of data collection, collect arterial 
blood and analyze blood per hospital’s standard 
procedure. Continue collection of data post blood 
draw for 2two minutes. Clinician shall monitor and 
record information as specified in this protocol, and 
obtain results of arterial blood draw. 
The duration of the subject’s participation in the 
study is dependent upon how long the arterial 
cannula is required for the subject. The period of 
data collection during the scheduled routine arterial 
blood draw (up to 3 independent arterial blood 
draws) is a minimum of 10 minutes and up to 
approximately 30 minutes from the application of 
the sensor to the subject. A and obtaining the 
maximum of 6 data pairs (3 data pairs per sensor) 
can be collected from each subject. 
Clarification was made on 
the duration of the subject’s 
participation and the length 
of data collection as well as 
administrative changes. The 
changes made do not 
impact the study design or 
risk. 
10 Synopsis – Objectives 
Formatting changes made. 
The change does not 
impact the study design or 
risk. 
11 Synopsis – Endpoints 
Formatting changes made. 
The change does not 
impact the study design or 
risk 
12 Synopsis – Eligibility Clear Inclusion Criteria: 
1) 
Parents or legally authorized designated 
representative (LARLDR) can understand 
and provide written informed consent; AND 
2) 
2) Subjects are < 29 days old, and requiring 
arterial blood samples per the site’s standard 
of care. 
The change does not 
impact the study design or 
risk. 
13 Synopsis – Sample Size 
ad Sites: 
This study is intended to collect blood samples from 
neonates under normal clinical conditions. The 
minimum number of subjects is seventeen (17) 
subjects. Maximum total enrollment for the study is 
one hundred forty (140) subjects. Subjects will be 
enrolled at 2two sites. 
The change does not 
impact the study design or 
risk. 
14 Synopsis – Study duration: The study is expected to last 2412 months. 
The expected duration of 
the study was increased. 

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15 Administrative Structure of 
Investigation 
Clinical Affairs Project Manager (Sponsor Contact: 
Cynthia Hines-Sabol Stephanie Karwedsky 
Tel: 
+1-262-422-1306 +1262-443-7008 
E-mail: Cynthia.A.hinessabol@ge.com 
Stephanie.Karwedsky@ge.com 
 
Research Manager: 
Petra Peltola Jaana Vedenjuoksu 
Tel: 
+358-40-354-848240-524-3886 
Email: Jaana.Vedenjuoksu@ge.com 
Petra.Peltola@ge.com 
 
Biostatistician: 
Shanggen Zhou Bin Xing 
Tel: 
+262-548-2906 420-8926 
Email: Bin.Xing@ge.com 
Shanggen.zhou@ge.com 
Changes made in Sponsor’s 
personnel. The changes 
made do not impact the 
study design or risk. 
16 Section 1 – Background 
and Justification 
In general, pulse oximeters use 2two wavelength 
absorption spectrophotometries to measure oxygen 
saturation. The wavelengths are selected to provide 
the best separation of absorbencies of oxy-
hemoglobin (O2Hb) and deoxyhemoglobin-
hemoglobin (RHb) states. The ratio of the 2two 
absorbencies is used to calculate the oxygen 
saturation (SpO2) value. The pulse oximeter can 
provide continuous non-invasive real time 
information, because an arterial sample of blood is 
not required to make the measurement. 
At a NICUneonatal intensive care unit (NICU), 
continuous health monitoring for the neonates 
provides crucial parameters for urgent diagnoses so 
that adequate medical treatment can be instituted. 4 
The goal of SpO2 monitoring for neonates is to 
ensure adequate oxygen delivery to the tissue 
without causing oxygen toxicity. Often, the SpO2 
readings from neonates are labile and difficult to 
keep within a narrow range. The caregiver should 
aim to maintain the SpO2 levels within the narrow 
range. 6 
The purpose of this study is to collect blood 
samples from neonates under normal clinical 
conditions to ensure proper function (clinical 
performance) with the U-TruSignal device per 
FDAood and Drug Administration (FDA) Guidance 
Document: Pulse Oximeters – Pre-marketmarket 
Notification Submissions [510(k)s]: Guidance for 
Industry and Food and Drug Administration Staff). 5 
Testing will follow ISO 80601-2-61 Annex EE.4.12. 
7 The study will include both the TruSignal AllFit 
Sensor and TruSignal Sensitive Sensor. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 

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A study with human subjects will provide the 
needed clinical evidence for assessing the accuracy 
of the pulse oximeter as recommended by the 
FDAood and Drug Administration (FDA) Guidance 
Document: Pulse Oximeters – Pre-marketmarket 
Notification Submissions [510(k)s]: Guidance for 
Industry and Food and Drug Administration Staff). 5 
17 Section 2.2. – Intended 
Use 
The investigational device is intended to be used for 
continuous monitoring and measuring of arterial 
oxygen saturation (SpO2) and peripheral pulse rate 
by non-invasiveinvasive pulse oximetry. 
The sensors and accessories are biocompatible. 
TS-AF and TS-SE sensors that will be used in the 
study are cleared by the FDAood and Drug 
Administration (FDA) for commercial use. The 
products can be traced through their respective 
(manufacturing) LOT numbers. 
The procedures conducted in this study are 
intended for research purposes and are not 
intended as a substitute for required medical care. 
The study staff will be trained in the use of the 
devices and will be provided with the instructions for 
use. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
18 Section 2.3 – Reference 
Standard 
Last sentence corrected: 
If more than one CO-Ooximeter is used, the 
pairwise comparisons are separately performed for 
each CO-Ooximeter, and the data pairs are pooled 
together for the final accuracy assessment. 7 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
19 Section 2.5 – 
Accountability 
Last sentence corrected: 
The Principal Investigator will be ultimately 
responsible for the security and integrity of research 
devices at the investigational site during the course 
of the study. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
20 Section 2.6.1 – Risk 
Category and Rationale 
First sentence corrected: 
Under the United States FDAood and Drug 
Administration (USFDA) Guidance Document on 
Pulse Oximeters for Premarket Notification 
Submissions [510(k)], 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
21 Section 3.1 – Purpose of 
the Study 
Last sentence corrected: 
For the purposes of this study, proper function will 
be defined by accuracy (i.e. ARMS ARMS value), 
substantially continuous measurement abilities, and 
safety profile. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
22 Section 3.2.1 – Primary 
Endpoint 
The primary endpoint will be Accuracy Root Mean 
Square (ARMSARMS), comparing the accuracy of 
SpO2 values from the investigational device to 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 

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SaO2 values from CO-Oximeter analysis of 
simultaneously drawn arterial blood. 
23 Section 3.3 – Summary of 
Study Design 
This is a pre-market, clinical, open label, 
prospective, non-randomized research study 
conducted at 2two sites. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
24 Section 4.2 – Number of 
Subjects 
This study is intended to collect blood samples from 
neonates under normal clinical conditions. The 
minimum number of subjects is seventeen (17) 
subjects. Maximum total enrollment for the study is 
one hundred forty (140) subjects. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
25 Section 4.3 – Protection of 
Vulnerable Subjects 
Second to the last paragraphs were corrected: 
The Sponsor shall avoid improper influence on, or 
inducement of, the subject, monitor, any 
Iinvestigator(s), or other parties participating in, or 
contributing to, the clinical investigation. 
All investigators shall avoid improper influence on, 
or inducement of, the subject, Sponsor, monitor, 
other Iinvestigator(s), or other parties participating 
in, or contributing to, the clinical investigation. 
The study activities cannot otherwise be performed 
without the use of vulnerable populations. 
Neonates: Neonates will be subjects in this study. 
The purpose of this study involves meeting the 
health needs of these populations. These subjects 
are considered a vulnerable research population 
since neonates cannot provide valid informed 
consent to which their parent or LADRlegally 
authorized representative (LAR) must provide 
written informed consent for their child’s 
participation. 
Studying subject populations as specified in the 
inclusion and exclusion criteria set forth in this 
protocol is necessary, because SpO2 monitoring is 
a routine part of these population’s clinical 
assessment. The study staff will be present during 
all study procedures and no subject will be left 
alone during any part of the study procedure. 
This research is approved by the Ethics Committee 
(EC) and/or Institutional Review Board (IRB) prior to 
the start of the clinical study. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
26 Section 4.4.1 – Inclusion 
Criteria 
1) 
Parents or legally authorized representative 
(LARLDR) can understand and provide 
written informed consent; AND 
2) 
Subjects are < 29 days old, and requiring 
arterial blood samples per the site’s standard 
of care. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 

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27 Section 4.5 – Recruiting 
and Screening 
Subjects, who are neonates, will be recruited for 
potential enrollment in this study per the standard 
procedures of the investigational site, unless 
otherwise specified by the Sponsor in this study 
protocol. The parent(s) or LARLDR(s) of the 
neonate patient will be asked to volunteer their child 
to participate in this research study and provide 
written informed consent. All participation will be 
voluntary. 
Subjects will be screened for enrollment in this 
study against the inclusion and exclusion criteria 
per the standard procedures of the investigational 
site. 
Following recruitment, a subject will be considered 
enrolled (the point of enrollment) once the 
parent/LARLDR signs and dates the informed 
consent form (ICF). Once enrolled, the subject will 
be assigned a unique subject number, which will not 
contain information that could identify the subject 
(such as subject name or date of birth). The unique 
subject number will be used to label case report 
form (CRF) data for the subject throughout his/her 
participation in the study. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
28 Section 4.6 – Criteria for 
Withdrawal/Discontinuation 
The parent(s) or LARLDR(s) may withdraw their 
child from study participation at any time, for any 
reason. The Iinvestigator may withdraw a subject at 
any time, for any reason. The reasons for 
withdrawal and discontinuation for any subject shall 
be recorded. These will be reported to the Sponsor. 
The EC/IRB should be notified per their notification 
of subject withdrawal policy. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
29 Section 5.1 – Diagram of 
Procedures 
Notes under Figure 2—Diagram of Study 
Procedures corrected: 
Notes: 
1 
Subject is considered enrolled once the 
informed consent has been signed. 
2 
After the parent/LARLDR signed the informed 
consent form, subjects that did not completely 
fulfill the inclusion/exclusion criteria will be 
considered withdrawn. 
3 
Adverse Event monitoring and reporting 
begins when the subject’s parent/LARLDR 
signed the informed consent form through 
study completion. 
Study Completion or Subject’s End of 
Study is defined as the last data 
collection as determined by the 
Iinvestigator and /or study staff by 
Clarification was made on 
the duration of the subject’s 
participation and the length 
of data collection as well as 
administrative changes. The 
changes made do not 
impact the study design or 
risk. 

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recording the study completion date and 
time. 
4 
The maximum duration of the subject’s 
participation in the study is dependent upon 
how long the arterial cannula is required for 
the subject. Data collection for a data pair (3 
data pairs per sensor) is a minimum of 10 
minutes and approximately up to 
approximately 30 minutes from the 
application of the sensor to the subject. 
5 
Investigator or designee can determine when 
a longer data collection is needed. 
6 
Removal of the investigational device may or 
may not be the end of the study and the end 
of AE monitoring and reporting – see 
definition Study Completion/Subject’s End of 
Study under Note#3 above. 
7 
Procedure may be repeated at the time of 
arterial blood draw to collect a maximum of 6 
data pair, (3 data pairs per sensor). 
30 Section 5.3 – Description 
of Study Procedures 
a. 
To document the case, photographs of the 
position of the measurement sensors and 
other equipment may be taken at the request 
of the Ssponsor at any point of the procedure, 
when necessary. 
7) 
After arterial blood draw, continue collecting 
data using the data collection tool for a 
minimum of 2 minutes. Record possible 
accidental annotations in CRF. Stop data 
collection. 
9) 
Monitor and record the following information 
using the data collection tool or recording on 
CRF during steps 4-7): 
a. 
clinical status notes; i.e., frequent apnea, 
hemodynamic instability, abnormal heart 
rhythm, or other status; 
b. 
environmental conditions such as 
changes in lightning conditions, ongoing 
care moving the neonate outside blood 
sampling, excessive clinical signs such 
as agitation, readjustment of a sensor; 
AND 
c. 
notes regarding data collection such as 
accidental annotations . 
NOTE: Study Completion or Subject’s End of 
Study is defined as the last data collection 
determined by the Iinvestigator and /or study staff 
by recording the study completion date and time. 
GE Healthcare engineering representatives may be 
present during study procedures, depending upon 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 

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their need to observe the functioning of the 
investigational device (their need to observe will 
depend upon the study staff indicating there is an 
issue for the engineers to look at). These 
representatives will always be accompanied by 
study staff at all times. These visits will be agreed 
upon and arranged by the Research Manager and 
the Iinvestigator on a case-by-case basis. 
31 Section 6.1 – Primary 
Assessment 
The following data will be collected on the CRFcase 
report form (CRF): 
1) 
Demographics:  date of birth, gender, length, 
and weight, skin tone (see Appendix C – 
Modified Fitzpatrick Scale 8); 
2) 
U-TruSignal Serial Number, Sensor Type, 
LOT Number, and Attachment Location of the 
Sensor; 
3) 
Notes regarding data collection e.g. incorrect 
annotation of data file or several data files; 
4) 
Relevant information on the clinical status 
affecting hemodynamic stability such as 
frequent apnea, hemodynamic instability, 
abnormal heart rhythm; 
5) 
Environmental conditions e.g. open bed, 
changing lightning conditions, on 
goingongoing care causing movements, 
readjustment of a senso.r. 
The laboratory results will include and to be 
collected from the hospital’s medical record: 
1) 
Co-Ooximeter information, 
2) 
Functional SaO2 (%), 
3) 
Fractional oxyhemoglobin (FO2Hb) [%], 
4) 
Fractional carboxyhemoglobin (FCOHb) [%], 
5) 
Fractional methemoglobin (MetHb) [FMetHb] 
[%], 
6) 
Total hemoglobin (tHb) (ctHb) [g/L or g/dL], 
and 
7) 
Fetal hemoglobin (Hb) [g/L or g/dL] (, if 
availablecalculated),and. 
7)8) Fractional fetal hemoglobin [%]. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
32 Section 7.1 – Staff 
Qualification 
All members of the study staff participating in the 
conduct of the clinical investigation shall be 
qualified by education, training and/or experience to 
perform their tasks, and this shall be documented 
appropriately, as per ISO 14155:2011 for clinical 
studies. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
33 Section 8.1 – Anticipated 
Adverse Events 
Pulse Oximetry Sensor placement involves 
positioning pulse oximetry sensors on the volunteer 
subject in the same manner used with released 
SpO2 cables. The U- TruSignal investigational 
device is not in direct contact with the patient. The 
 

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sensors that will be in contact with the subject are 
cleared for commercial use. The sensors may be 
warm to the touch. Under normal operating 
conditions (no fault conditions), the sensors are not 
expected to overheat. If the Iinvestigator or delegate 
conducting the study senses the sensor is too warm 
or the subject is experiencing discomfort the sensor 
will be removed immediately and the area of 
concern will be massaged, and the sensor will be 
replaced at the discretion of the study staff, the 
sensor may be removed, and the study procedures 
discontinued at any time. Sensors may cause 
irritations to the skin in some subjects. The risk in 
the use of pulse oximetry sensors is considered 
minimal. 
34 Sections: 
8.2 – Adverse Event 
Definitions 
8.3 – Documentation of 
Saftey Events 
 
Throughout this section full-term words were 
replaced by its abbreviation because it has been 
defined in previous section. 
▪ 
“adverse event” was corrected to “AE” 
▪ 
“adverse device effect” was corrected to 
“ADE” 
▪ 
“serious adverse device effect” was corrected 
to “SADE” 
▪ 
“serious adverse events (SAE)” was 
corrected to “SAEs” 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
35 Section 8.4 – Reporting of 
Safety Events 
The following events are to be reported to the 
Sponsor within 72 hours of the event occurrence 
and to the EC/IRB per their policy: 
• 
All SAEs and USADEs 
• 
All device issues that could possible possibly 
lead to an SAE 
The following information is the Sponsor contact for 
SAEs and/or UADEs: 
Helena Haukilehto, MD 
Fax: 
+1- 262-364-2544 (24 hours) 800-888-
3983 
E-mail: SAE@ge.com 
Additional follow-up information including the 
medical records of the subject may be requested by 
the Sponsor. In addition, safety information may be 
shared with regulatory agencies and other 
participating sites, as required by applicable law 
and regulation. 
Administrative changes and 
corrected the phone number 
to report any SAEs and/or 
UADEs. The changes made 
do not impact the study 
design or risk. 
36 Section 8.5 – Device 
Deficiencies/Complaints 
Device deficiencies related to the investigational 
device should be reported directly to the 
engineering team, after each case by the 
Iinvestigator or study staff, who finishes the case. 
Device deficiencies related to the approved or 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 

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cleared device should be reported to the study 
Sponsor. 
Sponsor contact for device complaints: 
Cynthia Hines-SabolStephanie Karwedsky, 
Clinical Affairs Project Manager 
Tel: +1 262-422-1306 +1-262-443-7008 
E-mail: 
cynthia.A.hinessabol@ge.com 
Stephanie.Karwedsky@ge.com 
All device deficiencies will be collected, fully 
investigated, and documented in the source 
document and appropriate CRFcase report form 
(CRF) during the study reporting period. The 
Principal Investigator is responsible for notifying the 
Sponsor in the event thatif there is any device issue 
that could potentially lead to a SAE. 
37 Section 9 – Ethical 
Conduct of the Study 
The study will be carried out in accordance with the 
protocol and with principles enunciated in the 
current version of the Declaration of Helsinki; the 
guidelines of GCPood Clinical Practice (GCP) for 
medical devices, as set forth by ISO 14155:2011 
and ISO 14971:2012; European Directive on 
medical devices 93/42/EEC for studies conducted in 
Europe; applicable regulatory authority’s 
requirements of the United States – USFDA 21 
Code of Federal Regulations (CFR); and applicable 
local regulatory authority’s requirements of Finland 
– Valvira. 
The study will be conducted and reported in 
accordance with applicable policies of the local 
EthicEthics Committee Institutional Review Board 
(EC/IRB) and governing regulatory authorities in 
Finland and India (when India's law comes into 
effect). 
If national or regional EC/IRB requirements are less 
strict than the requirements of GCP, such as ISO 
14155:2011 for medical devices, the Sponsor shall 
apply the requirements of this International 
Standard to the greatest extent possible, 
irrespective of any lesser requirements, and shall 
record such efforts. 
Administrative changes and 
removed the reference to 
the USFDA 21 CFR since 
the study is conducted in 
Finland and India. The 
changes made do not 
impact the study design or 
risk. 
 
Reason for deletion of 
USFDA 21 CFR reference: 
The FDA Guidance on 
Acceptance of Clinical 
Data to Support Medical 
Device Applications and 
Submissions FAQs states: 
“Under the new rule, FDA 
is requiring that data 
submitted from clinical 
investigations OUS 
intended to support an 
IDE, 510(k), De Novo, 
PMA, HDE, or PDP 
applications, be from 
investigations conducted 
in accordance with GDP, 
which includes review and 
approval by an IEC and 
informed consent from 
subjects. The GCP 
requirements in the final 
rule encompass both data 
quality and intertiy and 
ethical standards for 
device clinical 
investigations.” 

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38 Section 9.1 – Ethics 
Committee 
The responsible Principal Investigator at each site 
will ensure that approval from an appropriately 
constituted EC/IRB is attained for the clinical study 
prior to enrolling subjects, and Principal Investigator 
will ensure that documentation of approval is 
maintained for the duration of the study. 
The Principal Investigator will ensure that the 
Sponsor is notified of any withdrawal of EC/IRB 
approval within 5 working days of such occurrence. 
If approval is terminated or suspended, the Principal 
Investigator will promptly notify the Sponsor and 
provide written explanation. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
39 Section 9.2 – Regulatory 
Agencies and Competent 
Authority(ies) 
The Sponsor will obtain approval from the local 
regulatory agency or competent authority before the 
start of the clinical trial, if necessary, per applicable 
local laws and regulations. Any additional 
requirements imposed by the EC/IRB or regulatory 
authority shall be followed, if applicable. 
Documentation of notification will be maintained in 
the Site Regulatory Binder. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
40 Section 9.3 – Management 
of Protocol Modifications 
and Amendments 
Substantial amendments will only be implemented 
after approval of the EC/IRB. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
41 Section 9.4 – Management 
of Protocol Deviations 
A deviation is any instance(s) of failure to follow, 
intentionally or unintentionally, the requirements of 
the protocol. Under emergency circumstances, 
deviations from the protocol to protect the rights, 
safety, and well-beingbeing of human subjects may 
proceed without prior approval of the Sponsor and 
the EC/IRB. Such deviations shall be documented 
and reported to the Sponsor and the EC/IRB as 
soon as possible. Deviations will be reported as: 
• 
Critical Deviations: Deviations that 
significantly affect the safety, efficacy, 
integrity, or conduct of the study. These 
deviations must be reported to the Sponsor 
no later than 5 working days from awareness 
of occurrence and reported to the EC/IRB per 
the deviation reporting policy. 
• 
Non-Critical Deviations: Protocol deviations 
that do not significantly affect the safety, 
efficacy, integrity, or conduct of the trial. 
These deviations must be documented on the 
CRF Protocol Deviation page and will be 
reviewed by the study monitor. 
Non-substantial modifications may be made during 
the normal course of device optimization, 
maintenance, and feasibility testing. Non-substantial 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 

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modifications will be communicated to the CA as 
soon as possible, if applicable, and to the EC/IRB 
per their policy. 
42 Section 9.5 – Participant 
Information and Informed 
Consent 
The investigators will explain to each participant’s 
parent(s) or LARLDR(s) the nature of the study, its 
purpose, the procedures involved, the expected 
duration of exposure to the investigational device, 
the potential risks and benefits, and any potential 
discomforts. Each participant’s parent(s) or 
LARLDR(s) will be informed that participation in the 
study is voluntary, that he/she/they may withdraw 
his/her/their child from the study at any time, and 
that withdrawal of consent will not affect 
his/her/their child’s subsequent medical assistance 
and treatment. The participant’s parent(s) or 
LARLDR(s) must be informed that his/her/their 
child’s medical records may be examined by 
authorized individuals other than their treating 
physician. 
All participant’s parent(s) or LARLDR(s) for the 
study will be provided an informed consent form, 
describing the study and providing sufficient 
information, to allow the participant’s parent(s) or 
LARLDR(s): (i) to make an informed decision about 
his/her/their child’s participation in the study, and (ii) 
to be fully aware of his/her rights under the 
applicable law. Informed consent documents will be 
subject to approval by the Ethics Committee 
(EC)/Institutional Review Board (IRB) prior to 
enrolling subjects in the study. 
The participant’s parent(s) or LARLDR(s) should 
read and consider the statement before signing and 
dating the ICF, and shall be given a copy of the 
signed document. The ICF must also be signed and 
dated by the Iinvestigator (or his/her designee), and 
it shall be retained as part of the study records. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
43 Section 9.7 – Incidental 
Findings 
Incidental findings observed during the study 
conduct shall be processed under the purview of 
the Principal Investigator through the investigational 
site’s standard of practice. 
This section was added to 
communicate with the PI’s 
and study staff’s 
responsibility in handling 
incidental findings. This 
addition does not impact the 
study design or risk. 
44 Section 10.3.3 – Analysis 
of Primary Endpoint 
Data analysis for the data collection interval, which 
is defined as the 5five (5) second period starting 
after a twelve (12) second technical delay from the 
time sampling occurs, will follow ISO80601-2-61, 
2011, Annex EE and the FDA Guidance Document 
for Pulse Oximeters (FDA Guidance, March 4, 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 

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2013). Separate analysis will be performed for each 
sensor type. 
The ARMS ccuracy Root Mean Square (ARMS) 
calculation is used as a means to define the SpO2 
Accuracy. Arms will be calculated as 
 , where 
Refi = Reference CO-Oximeter Functional SaO2 of 
data pair i 
DUTi = Device Under Test SpO2 of data pair i 
The difference between SpO2 and SaO2 will be 
summarized using mean, minimum and maximum. 
Number of subjects and number of data pairs will 
also be presented. 
A least squares regression of SpO2 on SaO2 will be 
performed and results be presented with a 
regression plot and table. 
Bland-Altman graphical plots, error (SpO2 – SaO2) 
versus average SaO2 will be generated with mean, 
and upper 95% and lower 95% limits of agreement 
according to Section 3 of “Agreement Between 
Methods Of Measurement With Multiple 
Observations Per Individual“ by Bland and Altman 
in 2007 Journal of Biopharmaceutical Statistics.  
Individual test subjects will be color coded in the 
Bland-Altman graphical plot. 
Data listed below will be excluded from analysis: 
▪ Data with SaO2 < 70%, tHb < 10g/Ll, MetHb 
> 2%, COHb > 3%; 
▪ Draws with values smaller than -0.5% in any 
of the Hb values; 
▪ Artefacts/other external error sources 
indicated by clinical documentation or derived 
from the collected data around sampling 
including but not limited to: 
o changes in sensor fit; 
o excessive movement during draw; 
o low perfusion (mod% < 0.5%); 
o irregular plethysmographic waveform 
or artefacts in the waveform; 
▪ Data with error conditions on CO-Ooximeter 
analysis indicated by clinical documentation 
e.g. air bubbles in syringe, clots, violation of 
hospital’s standard procedure; 
▪ Data with error conditions on pulse oximeter; 
▪ Unstable SpO2 readings from the respective 
device under test: 

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o 
SpO2 max-min ≥ 4% in time window 
during 30 sec prior/after the blood 
sample; 
o 
SpO2 max-min ≥ 8% in time window 
during 10 minutes prior to the blood 
sampling time; 
A rationale will be provided for any data that is 
excluded from the data analysis. 
45 Section 10.4 – Handling of 
Missing Data 
Last sentence corrected: 
The Iinvestigator is obligated to provide written 
documentation of any missing data to the Sponsor 
and to provide clarification upon Sponsor request if 
possible. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
46 Section 11.1.3 – Source 
Data and Documents 
Source data includes information in original records, 
certified copies of original records of clinical 
findings, observations, or other activities for the 
study. Source documents for each subject must be 
retained throughout the investigation, including 
printed or electronic documents containing source 
data. Elements should include: 
• 
Source data and documentation relevant to 
data recorded for subject screening and CRF 
corroboration. 
• 
Subject records containing the completed 
ICFs, CRFs, and electronic data copied from 
the data collection tool. 
• 
Regulatory binder containing the protocol and 
any subsequent amendments, EC/IRB 
submissions and approvals, blank ICF(s), and 
site logs. 
• 
Reference manuals containing Iinvestigator 
responsibilities, Sponsor, AE/SAE and 
informed consent guidelines, applicable study 
aids and training materials, and operator’s 
manuals. 
The Principal Investigator or institution shall provide 
direct access to source data during and after the 
clinical investigation for monitoring, audits, EC/IRB 
review, and regulatory authority inspections. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
47 Section 11.1.4 -- Archiving All study data must be archived for the period 
defined by local law a minimum of 3 years or 
according to the site’s standard procedure, after 
study termination or premature termination of the 
clinical trial. No source documents or study records 
will be destroyed without Sponsor notification and 
approval. 
The period of archiving was 
changed to reflect the new 
Medical Device Regulation 
requirement. This change 
does not impact the study 
design or risk. 
48 Section 12 – Monitoring 
Plan 
In collaboration with the site, the Sponsor will 
ensure proper monitoring of the study to confirm 
that all the research requirements are met. 
Administrative changes. 
The changes made do not 

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Monitoring visits will oversee the progress of a 
clinical investigation and ensure that it is conducted, 
recorded, and reported in accordance with the 
protocol, written procedures, GCPood Clinical 
Practice (GCP) ISO 14155:2011, and the applicable 
regulatory requirements. 
impact the study design or 
risk. 
49 Section 12.1 – 
Confidentiality and Data 
Protection 
The Iinvestigator affirms and upholds the principle 
of the participant's right to privacy, and the 
Iinvestigator shall comply with applicable privacy 
laws. Especially, anonymity of the participants shall 
be guaranteed when presenting the data at 
scientific meetings or publishing data in scientific 
journals. 
Individual subject medical information obtained as a 
result of this study will be considered confidential, 
and disclosure to third parties will be prohibited. 
Subject confidentiality will be further ensured by 
utilizing subject identification code numbers. For 
data verification purposes, authorized 
representatives of the Sponsor, a competent 
authority (CA), or an institutional review board 
(EC/IRB) may require direct access to parts of the 
medical records relevant to the study, including 
subject medical history. 
Administrative changes. 
The changes made do not 
impact the study design or 
risk. 
50 Appendix A – Study 
Schedule 
Table A.1 - Schedule of Study Procedures 
Evaluation 
Visits* 
Screening 
(enrollment) 
Study 
Procedure 
Written Informed 
Consent 
X 
 
Patient 
Demographics 
X 
 
Inclusion criteria 
X 
 
Exclusion 
criteria 
X 
 
Blood draw 
 
X 
*Subjects will be followed for AE reporting 
purposes from the time the parent(s) or 
LARLDR(s) provided written consent to end of 
study procedures. There will be no follow-up 
after the completion of the study. 
Administrative change. The 
change made does not 
impact the study design or 
risk. 

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51 Appendix B – Study Site 
and Investigator List 
Investigator(s): 
Rajiv Agarwal Russel 
Hirsch, MD 
Director & Senior 
Consultant Associate 
Professor of Pediatrics and 
Neonatology 
MBBS (AIIIMS), Pediatrics 
(AIIMS) 
Principal Investigator 
Tel:  
+91 80 7122 2360 
1-515-636-7072 
E-mail: 
russel.hirsch@cchm
c.org 
rajiv.aggarwal.dr@n
arayanahealth.org 
NH Narayana Multispecialty 
Hospital 
Unit of Narayana Health, 
Mazumdar Shaw Medical 
Center Cincinnati Children’s 
Hospital Medical Center 
Address:  258/A 
Bommasandra 
Industrial Area, 
Anekal Taluk, 
Hosur Road, 
Bangalore 560099 
Karnaktaka3333 
Burnet Avenue 
Cincinnati, OH 
45229 
 
A different site was selected 
for the study. This change 
does not affect the study 
design or risk.