Wireless Disposable SpO2 Sensor Hypoxia Testing
Phase: NA
Conditions: SpO2, Peripheral Oxygen Saturation Measurement
Sponsor: GE Healthcare



Study Title: Wireless Disposable SpO2 Sensor Hypoxia Testing 
 
 
Study Number: 2023-061-MS-GES 
 
 
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The Sponsor and Investigators have approved this protocol version, and I confirm hereby to conduct the study according 
to the protocol and per applicable principles of the World Medical Association Declaration of Helsinki and Good Clinical 
Practice (GCP) guidelines as per ISO 14155, any conditions of approval imposed by the reviewing ethics committee (EC) or 
governing regulatory body, and applicable local and federal 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 
 
 
 
Local Co-Investigator at study site: 
 
Co-Investigator Signature 
 
Date 
 
 
 
Print Name 
 
 
 
 
 
Site Name, Department, Address 
 
 
 

Study Title: Wireless Disposable SpO2 Sensor Hypoxia Testing 
 
 
Study Number: 2023-061-MS-GES 
 
 
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Table of Contents 
Document and Version Control ........................................................................... 6 
List of Abbreviations and Terms .......................................................................... 7 
Synopsis ............................................................................................................. 8 
1. 
Background and Justification ..................................................................... 15 
2. 
Device/Product Description ....................................................................... 15 
2.1 Identity, Mechanism, and Function ............................................................................. 15 
2.2 Intended Use ................................................................................................................ 15 
2.3 Packaging and Labeling ................................................................................................ 16 
2.4 Concomitant/Ancillary Administrations ...................................................................... 16 
2.4.1 Medications and Biologic Products ............................................................................. 16 
2.4.2 Laboratory Tests and Sample Processing .................................................................... 16 
2.5 Accountability .............................................................................................................. 16 
2.5.1 Issuance ....................................................................................................................... 16 
2.5.2 Disposition ................................................................................................................... 16 
2.6 Anticipated Risks and Benefits .................................................................................... 17 
2.6.1 Risk Category and Rationale ........................................................................................ 17 
2.6.2 Device/Product Classification and Rationale ............................................................... 17 
3 
Objectives and Endpoints .......................................................................... 18 
3.1 Purpose of the Study ................................................................................................... 18 
3.1.1 Primary Objective ........................................................................................................ 18 
3.1.2 Safety Objective(s): ...................................................................................................... 18 
3.1.3 Study Endpoints ........................................................................................................... 18 
4 
Study Design.............................................................................................. 18 
4.1 Summary of Study Design ............................................................................................ 18 
4.2 Study Population .......................................................................................................... 19 
4.3 Number of Participants ................................................................................................ 19 
4.4 Eligibility Criteria .......................................................................................................... 19 
4.5 Recruiting and Screening ............................................................................................. 21 
4.6 Skin Tone Diversity ...................................................................................................... 21 
4.7 Criteria for Withdrawal/Discontinuation..................................................................... 22 
5 
Study Procedures ...................................................................................... 23 
5.1 Procedure General Information .................................................................................. 23 
5.2 Desaturation Study Gas Delivery System .................................................................... 23 
5.3 Participant Preparation ............................................................................................... 24 
5.4 Description of Study Procedures ................................................................................. 24 
5.5 Follow-up ..................................................................................................................... 26 
6 
Study Data Collection and Assessments ..................................................... 27 
6.1 Primary Assessment..................................................................................................... 27 
6.2 Safety Assessments ...................................................................................................... 27 

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7 
QUALIFICATION AND TRAINING PLAN ....................................................... 27 
7.1 Staff Qualifications ....................................................................................................... 27 
7.2 Training Plan for the Protocol and Research Device/Product ..................................... 28 
8 
Safety ........................................................................................................ 28 
8.1 Anticipated Adverse Events ......................................................................................... 28 
8.2 Safety/Anticipated AE Risks ......................................................................................... 28 
8.3 Adverse Event Definitions............................................................................................ 29 
8.4 Documentation of Adverse Events .............................................................................. 30 
8.5 Reporting of Safety Events .......................................................................................... 32 
8.6 Reporting of Device Deficiencies/Complaints ............................................................. 32 
9 
Ethical Conduct of the Study ...................................................................... 32 
9.1 Ethics Committee ......................................................................................................... 32 
9.2 Regulatory Agencies and Competent Authority(ies) ................................................... 33 
9.3 Management of Protocol Modifications and Amendments ........................................ 33 
9.4 Management of Protocol Deviations ........................................................................... 33 
9.5 Participant Information and Informed Consent .......................................................... 33 
9.6 Suspension/Early Termination of the Study ................................................................ 34 
10 Statistical Methods .................................................................................... 34 
10.1 Statistical Hypothesis ................................................................................................... 34 
10.2 Sample Size Determination ......................................................................................... 34 
10.3 Statistical Analysis ........................................................................................................ 34 
10.3.1 General Statistical Methods ...................................................................................... 34 
10.3.2 Analysis of Primary Endpoint(s) ................................................................................. 35 
10.3.3 Safety Analysis ........................................................................................................... 35 
10.4 Handling of Missing Data ............................................................................................. 35 
10.5 Deviation(s) from the Original Statistical Plan............................................................. 35 
11 Quality Assurance and Control .................................................................. 35 
11.1 Data Management ....................................................................................................... 35 
11.2 Completion of Case Report Forms (CRFs) .................................................................... 35 
11.3 Data Handling and Record Keeping ............................................................................. 35 
11.4 Source Data and Documents ....................................................................................... 36 
11.5 Archiving ...................................................................................................................... 36 
12 Monitoring Plan ........................................................................................ 36 
12.1 Confidentiality and Data Protection ............................................................................ 36 
12.2 Storage of Images and Associated Health Data........................................................... 37 
13 Research Agreements ................................................................................ 37 
13.1 Clinical Study Report and Publication Policy ............................................................... 37 
Appendix A – Study Site and Investigator List ................................................... 39 
References ........................................................................................................ 40 

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List of Figures  
Fig.1 
  ..……………………………………………………….18 
Fig.2 
  ..………………………………………………………………….20  
Fig.3 
 ....………………………………………………………………………………….22 
 
 

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LIST OF ABBREVIATIONS AND TERMS 
AE 
Adverse Event 
ADE 
Adverse Device Effect 
AFAP 
As far As Possible  
ASADE  
Anticipated Serious Adverse Device Effects  
BMI 
Body Mass Index 
CIP 
Clinical Investigation Plan 
CFR 
Code of Federal Regulations 
COHb 
Carboxyhemoglobin  
ECG 
Electrocardiogram 
eCRFs 
Electronic Case Report Forms 
EtCO2 
End-tidal carbon dioxide 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice (see ISO 14155:2020) 
GEHC   
GE HealthCare 
IRB 
Investigational Review Board 
ISO 
International Organization for Standardization 
ITA 
Individual Topology Angle 
MST 
Monk Skin Tone 
PI 
Principal Investigator 
SADE 
Serious Adverse Device Effect 
SAE 
Serios Adverse Event 
SaO2 
Arterial oxygen saturation 
SpO2 
Oxygen saturation as measured by pulse oximetry 
USADE 
Unexpected Serious Adverse Device Event 
 
      
               
 
      
 
      
                
                
               
             
 
 
 
            
                
             
 
 
 
 

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Procedures/ 
Methods: 
Procedures/Methods according to ISO 80601-2-61:2017 annex EE.3 (PROCEDURE for non-invasive 
laboratory testing on healthy adult volunteers) and FDA pulse oximetry guidance (Pulse Oximeters - 
Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug 
Administration Staff, March 2013). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
 
 
 
  
 
 
 
 
   
 
 
 
 
 
  
9. 
   

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10. 
 
 
 
 
 
 
 
 
   
 
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 

Study Title: Wireless Disposable SpO2 Sensor Hypoxia Testing Part 1, Non-
invasive Development Test for the New LED Platform 
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Eligibility Criteria: 
Inclusion criteria: 
Participants who meet the following 
criteria will be included:  
1. Participant is adult 18-50 years of 
age.  
2. Biological Male or female of any 
race 
3. Participant is a non-smoker or who 
has not smoked within 2 days prior. 
4. Participant must have the ability to 
understand and provide written 
informed consent. 
5. Participant is adult must be 
willing and able to comply with 
study procedures and duration. 
 
Exclusion criteria: 
Participants who meet any of the following criteria will be 
excluded from the study: 
1. Participant is considered as being morbidly obese 
(defined as BMI >39.5) 
2. Compromised circulation (i.e., Raynaud’s Syndrome), 
injury, or physical malformation of fingers, toes, hands, 
ears or forehead/skull or other sensor sites which would 
limit the ability to test sites needed for the study. (Note: 
Certain malformations may still allow participants to 
participate if the condition is noted and would not affect 
the particular sites utilized).  
3. Tattoo in the optical path which would limit the ability to 
test sites needed for the study.   
4. Females who are pregnant - confirmed by self-performed 
and self-reported positive urine pregnancy test 
performed on the day of the study unless the participant 
is known to be not of child-bearing potential  
5. Participants who have smoked in the last 2 days or 
participants who have refrained, for at least 48 hours, 
with COHb levels >3% as assessed per site standard 
operation procedure. 
6. Participants with self-reported respiratory conditions 
such as: 
o uncontrolled / severe asthma,  
o flu,  
o pneumonia / bronchitis,  
o shortness of breath / respiratory distress,  
o unresolved respiratory or lung surgery,  
o emphysema, COPD, lung disease 
o Recent COVID (last 2 months) 
7. Participants with self-reported heart or cardiovascular 
conditions such as:  
o have had cardiovascular surgery, except successful 
minor surgery without clinical symptoms (i.e., 
PFO, PDA) 
o chest pain (angina) 
o previous heart attack 
o blocked artery 
o unexplained shortness of breath 
o congestive heart failure (CHF) 
o history of stroke 
o transient ischemic attack 

Study Title: Wireless Disposable SpO2 Sensor Hypoxia Testing Part 1, Non-
invasive Development Test for the New LED Platform 
Study Number: 2023-061-MS-GES 
 
 
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o carotid artery disease 
o myocardial ischemia 
o myocardial infarction 
o cardiomyopathy 
o Cardiovascular implantable active medical device 
(such as pacemaker or automatic defibrillator) 
o Heart rhythms other than a normal sinus rhythm 
or with respiratory sinus arrhythmia 
o High blood pressure: systolic >140 mmHg or 
diastolic >90 mmHg on 3 consecutive readings 
8. Participants with self-reported health conditions such as:  
o diabetes,  
o uncontrolled thyroid disease,  
o kidney disease / chronic renal impairment,  
o history of seizures (except childhood febrile 
seizures),  
o epilepsy,  
o history of unexplained syncope,  
o recent history of frequent migraine headaches,  
o recent symptomatic head injury (within the last 2 
months),  
o Cancer requiring chemotherapy, radiation, or 
currently on treatment 
9. Participants with self-reported known clotting disorders  
o history of bleeding disorders or personal history of 
prolonged bleeding from injury 
o history of blood clots 
o hemophilia 
o current use of blood thinner: prescription or daily 
use of aspirin 
o Sickle Cell Trait or Disease 
10. Participants with severe contact allergies to standard 
adhesives, latex, silicone, or other materials found in 
pulse oximetry sensors, ECG electrodes, respiration 
monitor electrodes or other medical sensors (self-
reported) 
11. Unwillingness or inability to remove colored nail polish 
or non-clear artificial nails from test digits 
12. Surgical hardware in pathway which would limit the 
ability to test sites needed for the study 
13. Other known health condition, should be considered 
upon disclosure in health assessment form 

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1. 
BACKGROUND AND JUSTIFICATION 
 
 
 
   
 
 
 
 
  
 
 
 
 
 
 
 
   
Here we will collect SpO2 data with simultaneous transfer standard SpO2 
 
 Transfer standard is a validated pulse oximetry equipment with a calibration directly traceable to CO-oximetry. 
Test method and protocol is developed according to ISO 80601-2-61:2017 annex EE.3 (PROCEDURE for non-invasive 
laboratory testing on healthy adult volunteers). 
Funding for this study will be provided by GE HealthCare (GEHC). 
2. DEVICE/PRODUCT DESCRIPTION 
2.1 
Identity, Mechanism, and Function 
Name:  
Portrait Mobile Monitoring Solution 
 sensors 
Modality/Type: 
Life Care Solutions (LCS) – Monitoring Solutions 
Manufacturer:  
GE HealthCare (GEHC) 
Software version:      Portrait Mobile Patient monitor (Hub): 
 
     Sensor Battery:  
 
      SpO2 Sensor:
 
Regulatory Status:  
Pre-market  
 
The investigational devices will be exclusively used for research purposes and labeled in compliance with local regulations. 
2.2 
Intended Use 
The study plans to collect SpO2 data with simultaneous transfer standard SpO2 
 
 

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2.3 
Packaging and Labeling 
Research conducted for this study will utilize investigational devices and devices cleared through the 510k regulatory 
process. 
 
 
 
 
 
 
 
The Instructions for Use (IFUs) are provided as separate documents from this protocol. 
2.4 
Concomitant/Ancillary Administrations  
2.4.1 Medications and Biologic Products 
Medical grade oxygen and nitrogen are used in this study 
 
2.4.2 Laboratory Tests and Sample Processing 
 No sample 
processing is planned as part of the study procedures. 
2.5 
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 responsible for the security and integrity of research devices/products at the investigational 
site during the study. 
2.5.1 Issuance 
The devices will be provided by the Sponsor, GEHC and administered by the healthcare professional and site study 
coordinator. User training is provided before device administration. 
2.5.2 Disposition 
The devices will be dispositioned after the study by returning to the Sponsor, per applicable safety instruction, laws, and 
regulations. Unused investigational single-use accessories provided to the site during the study shall be returned to the 
Sponsor, GEHC. Used single-use medical devices/accessories, e.g., electrodes shall be disposed according to the 
hospital/investigational site policy. 

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2.6 
Anticipated Risks and Benefits 
The device/product under study has undergone risk assessment, per International Standards Organization (ISO) 14971, 
and risks have been mitigated to levels as far as possible (AFAP). 
 
 
 
 
 
  
The risks of investigational units have been analyzed. The risks will be mitigated by safety verification of each 
investigational unit and labeling before use in the study. Labeling mitigations are included in the investigational device 
Instructions for Use (IFU) and/or operating manuals, which will be provided to the site. 
The risks of study participation are not expected to be greater than those of similar procedures as described in ISO 80601-
2-61:2017 Annex EE.3 standard methods routinely conducted in earlier testing. There are no expected risks to 
participants, operators, or others in this study beyond those of routine/similar devices/products in clinical care post-study 
care or follow-up is not required by this study.   
The risks of study participation are not expected to be greater than those of similar patient monitoring procedures 
routinely conducted in clinical practice.   
Participants are not expected to benefit directly from study participation. The results may benefit future patients by 
helping to better understand the devices used in the study.   
2.6.1 Risk Category and Rationale 
Under the United States Food and Drug Administration (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 participant to the abbreviated requirements of 21 CFR 812.2(b).” 
Hence, it can be stated that the 
 sensors 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 participant. 
The application of risk management analysis to the investigational units conforms to EN ISO 14971:2007. For continued 
safe use of the investigational units, the instructions for use shall be followed. 
2.6.2 Device/Product Classification and Rationale 
 LED platform is intended for use in the measurement of oxygen saturation (SpO2) by non-invasive pulse 
oximetry. The FDA has classified such devices as Class II. 
 

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The study will be considered complete when the last visit of the final participant is completed.  
The maximum duration of participant participation is approximately 1 hour (typical data collection <1 hour) from the 
application of the sensors to the participant. 
This study is not intended to support a comparative claim, such as superiority or non-inferiority, so no control group is 
necessary. 
4.2 
Study Population 
Participant Population: Non-smoking, male, and female adults of varying skin tones, ages 18 to 50 years. 
Site information: 
 
4.3 
Number of Participants 
The study includes a minimum of 30 participants 
 
 
 
 
 
 
 
 
4.4 
Eligibility Criteria   
4.4.1 Inclusion Criteria  
Participants who meet the following criteria will be included:  
1. Participant is adult 18-50 years of age  
2. Biological Male or female of any race 
3. Participant is a non-smoker or who has not smoked within 2 days prior. 
4. Participant must have the ability to understand and provide written informed consent. 
5. Participant must be willing and able to comply with study procedures and duration. 
4.4.2 Exclusion Criteria 
Participants who meet any of the following criteria will be excluded from the study: 
1. Participant is considered as being morbidly obese (defined as BMI >39.5) 
2. Compromised circulation (i.e., Raynaud’s Syndrome), injury, or physical malformation of fingers, toes, hands, ears 
or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Note: 
Certain malformations may still allow participants to participate if the condition is noted and would not affect the 
particular sites utilized. 
3. Tattoo in the optical path which would limit the ability to test sites needed for the study.   
4. Females who are pregnant - confirmed by self-performed and self-reported positive urine pregnancy test 
performed on the day of the study unless the participant is known to be not of child-bearing potential  

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5. Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with 
COHb levels >3% as assessed per site standard operation procedure. 
6. Participants with self-reported respiratory conditions such as: 
o uncontrolled / severe asthma,  
o flu,  
o pneumonia / bronchitis,  
o shortness of breath / respiratory distress,  
o unresolved respiratory or lung surgery,  
o emphysema, COPD, lung disease 
o Recent COVID (last 2 months) 
7. Participants with self-reported heart or cardiovascular conditions such as:  
o have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA) 
o chest pain (angina) 
o previous heart attack 
o blocked artery 
o unexplained shortness of breath 
o congestive heart failure (CHF) 
o history of stroke 
o transient ischemic attack 
o carotid artery disease 
o myocardial ischemia 
o myocardial infarction 
o cardiomyopathy 
o Cardiovascular implantable active medical device (such as pacemaker or automatic defibrillator) 
o Heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia 
o High blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings 
8. Participants with self-reported health conditions such as:  
o diabetes,  
o uncontrolled thyroid disease,  
o kidney disease / chronic renal impairment,  
o history of seizures (except childhood febrile seizures),  
o epilepsy,  
o history of unexplained syncope,  
o recent history of frequent migraine headaches,  
o recent symptomatic head injury (within the last 2 months),  
o Cancer requiring chemotherapy, radiation, or currently on treatment 
9. Participants with self-reported known clotting disorders  
o history of bleeding disorders or personal history of prolonged bleeding from injury 
o history of blood clots 
o hemophilia 
o current use of blood thinner: prescription or daily use of aspirin 
o Sickle Cell Trait or Disease 
10. Participants with severe contact allergies to standard adhesives, latex, silicone, or other materials found in pulse 
oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported) 

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5.2.1 Control Oximetry System 
The Control Pulse Oximeter, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout 
the study for participant safety and to target stable plateaus. This device is used to assess the stability of the data. 
• 
 
 
 
 
 
 
5.2.2 Safety Equipment  
Multi-parameter monitor used during the study to observe a participant’s vital signs including ECG tracing, heart rate, 
respiratory rate, end-tidal CO2 with capnograph, secondary monitor for the oxygen concentration being delivered to the 
participant. This device will also serve as the pulse rate reference. 
• 
 
 
 
 
 
5.2.3 Breathing Apparatus for Participant 
 
  
 
 
 
 
 
 
 
 
 
. 
5.2.4 Transfer Standard / Control Oximetry System 
 
The Transfer Standards have been previously compared to Arterial blood draws as measured by CO-Oximetry. 
• 
 
 
 
5.3 
Participant Preparation  
Study staff will confirm that the participant is eligible and complies with applicable site requirements prior to starting 
study procedures. No preparation beyond that required by the investigational site is required before procedures. 
5.4 
Description of Study Procedures 
1. Perform health assessment and same day health screening. Take the participant’s blood pressure and record 
values. 
2. Once participant has met all inclusion criteria, written informed consent shall be performed by a member of the 
study team.  Each participant will be given a signed copy of the consent form prior to release.   

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Any data, including images, collected for the participant, up until the time of withdrawal or discontinuation, may still be 
included in the study results and provided to the Sponsor, unless the participant requests that their data not be used. The 
site shall document all requests by participants regarding their data use.    
6 
 STUDY DATA COLLECTION AND ASSESSMENTS 
Only data relevant to the conduct of the study shall be collected by the Sponsor. 
 
  
During the study procedures, electronic data collection shall take place. 
 
 
 
 
 
 
 
 
 
  
6.1 
Primary Assessment 
During the study period, the following participant information shall be collected if available: 
1) Demographics to include age, biological sex race, and ethnicity. 
2) Vitals to include height (cm), weight (kg/g), BMI, blood pressure, SpO2 readings. 
3) Skin tone 
 assessed from 
 with a Monk Skin Tone Scale.  
4) 
 
5) 
 
 
6) Location of sensors 
7) Date and time of study procedures 
8) Test set-up information 
6.2 
Safety Assessments 
The description, severity, and device relatedness of any AE or SAE during the study will be recorded. Participants 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 
7.1 
Staff Qualifications 
All members of the study staff participating in the conduct of the investigation shall be qualified by education, training 
and/or experience to perform their tasks, and this shall be documented appropriately, per ISO 14155:2020 for clinical 
studies. Study staff and the PI’s qualification for the study will be verified by collecting their CV’s and GCP certifications. 
Study staff and the PI will be trained for the study processes and devices during Site Initiation Visit prior to study 
initiation. All the training will be recorded on training logs. If study staff or PI qualification lapses, the Sponsor will work 
with the site to requalify the respective role or ensure the duties are reassigned appropriately by the site. The Sponsor 

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reserves the right to disqualify PI with appropriate justification, such as repeated issues that impact participant safety and 
data integrity.   
7.2 
Training Plan for the Protocol and Research Device/Product 
The Sponsor will provide training for all participants involved in the study. This includes any individual that will operate 
any equipment involved in the study, collect any data that is a part of the study, analyze any data associated with the 
study, or is in any other way involved with the study. Training to the site personnel will be conducted prior to the first 
subject enrolled. 
The following training information will be collected in the training log prior to study enrollment: 
• 
Title of Training 
• 
Training objectives 
• 
Training logistics (who conducts training and training method) 
• 
Target audience (who will be trained) 
• 
Training content (including device operation, protocol review, ICF, other documentation needed) 
 
Study staff directly operating or maintaining the research device or product will be trained based on the training plan and 
qualified based on experience, and the hospital/clinical site policy. 
The PI will be ultimately responsible for execution of this study per the protocol and for device/product use in this study 
by members of the study staff. 
8 
SAFETY 
8.1 
Anticipated Adverse Events 
Being in this study involves some foreseeable risks.  
There is always a chance of unexpected risks. Throughout the study, the Sponsor will evaluate and update safety 
information in study documents. In case of unexpected risks appearing, FDA will be informed by the Sponsor. 
Participants will be closely monitored by study staff, and testing will be discontinued if more than minor discomfort or any 
signs or symptoms that could indicate medically important adverse effects related to testing are observed.  
8.2 
Safety/Anticipated AE Risks 
Laboratory Testing  
The risk determination is based on the use of the device in an investigation in addition to the device itself. Generally, the 
FDA believes pulse oximeters as addressed in the FDA Guidance Document for Pulse Oximeters7 are non-significant risk 
devices. Further, the recommendation is to conduct the study in accordance with Clause 201.12.1.101.2 and Annex EE.2 
of ISO 80601-2-61:2017, where Annex EE.2 describes the procedure for invasive laboratory testing on healthy volunteers. 
Controlled Desaturation Study 
Desaturation of the participant involves the administration of oxygen/nitrogen mixtures that are less than that of normal 
air, i.e., less than 21% oxygen.
 
 
 
During the test, the participant is 

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closely monitored and constant communication regarding the participant’s comfort and sense of well-being is assessed. 
The ECG, pulse oximetry saturation, oxygen saturation levels, and EtCO2 are monitored. Since 1983 we have performed 
these types of tests in this and other laboratories where we conducted approximately 8,900 desaturation tests with no 
significant negative events. 
The mask allows gas for maximum delivery. The mask is made of soft flexible plastic so as to minimize the discomfort level 
as much as is reasonably possible. Materials may cause some skin irritations.  
Pulse Oximetry Sensor 
Pulse Oximetry Sensor placement involves positioning pulse oximetry sensors on the volunteer participant in the same 
manner that is used on hospitalized patients.  The sensors may be warm to the touch. Under normal operating conditions, 
(no fault conditions), the sensors are not expected to overheat. If the sensors are too warm, they will be removed 
immediately.  If the sensors are too uncomfortable, they will be removed immediately.  Adhesive sensors or tape may 
cause some irritations to the skin in some participants. Every effort will be made to minimize products with natural rubber 
or latex. Products containing natural rubber or latex will be identified.  The risk in the use of pulse oximetry sensors is 
believed to be minimal. 
ECG Electrodes  
Materials (such as the adhesive and/or gel contact) used in the electrodes may cause some skin irritations in some 
participants. Typical skin irritations present with redness of skin and in some cases of sensitivity is an allergic reaction. 
Because the adhesive is aggressive on the ECG pads, it may cause pulling of the skin or hair upon removal. 
Biocompatibility testing for surface contact electrodes is a requirement of the International Standards Organization (ISO) 
10993 – Biological Evaluation of Medical Devices. The risk in the use of ECG electrodes is believed to be minimal. 
 
Blood Pressure Cuff 
The reported risks associated with NIBP include A) slight discomfort upon inflation of the cuff, B) possible bruising, C) 
petechial rash, and D) discoloration of the skin beneath the cuff. In rare instances the reported risks associated with NIBP 
include A) peripheral nerve injuries, B) skin tear, and C) compartment syndrome (swelling of muscles in the limb causing 
the reduction of the blood supply to the muscle). Through literature searches of other studies, we found the 
complications of taking repeated blood pressures were temporary and involved either bruising/rash; for example, 
petechiae rash (less than 2.2%), skin redness/lines (0.8%), or tingling/discoloration in the extremity wearing the cuff while 
the cuff is inflated (0.1%).  
It is possible that the test participant may experience an allergic reaction to the material in the cuff.   
 
Heating Pad / Hot Water Bottles 
A heating pad or hot water bottles may be used 
Mild discomfort 
can be expected if it is too warm. To minimize the discomfort, the participant will be asked about comfort level. If the 
heating is too warm, it will be turned on the lowest level possible, removed or additional separation will be used between 
the heater and the site for comfort. 
8.3 
Adverse Event Definitions 
Adverse Event Definitions  
The definitions for adverse event, adverse device effect, serious adverse event, serious adverse device effect, 
unanticipated adverse device effect, and their classifications are provided below (ISO 14155, 21 CFR 812.3).  
 
Adverse Device Effect (ADE): Adverse event related to the use of an investigational medical device resulting from 
insufficiencies or inadequacies in the instructions for use, the deployment, installation, the operation, or any 
malfunction of the investigational medical device or from error use.  

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Adverse Event (AE): Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs 
(including an abnormal laboratory finding) in participants, users or other persons whether or not related to the 
investigational medical device or investigational procedure.  
 
Anticipated Serious Adverse Device Effects (ASADE): ASADE is an effect which by its nature, incidence, severity or 
outcome has been identified in the risk analysis report.  
 
Mild: a mild adverse event is one in which the participant is aware of the event, but it is easily tolerated without 
intervention.  
 
Moderate: a moderate adverse event is one that causes sufficient discomfort to interfere with usual activities. 
  
Serious Adverse Device Effect (SADE): adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
  
Serious Adverse Event (SAE): a serious adverse event is an adverse event that results in death, inpatient 
hospitalization, severe or permanent disability, a life-threatening illness or injury, fetal distress, fetal death, a 
congenital abnormality, a birth defect, or medical or surgical intervention to prevent permanent impairment to body 
or structure.   
 
Severe: a severe adverse event is one that results in the inability to perform usual activities.  
 
Unanticipated serious adverse device effect (USADE): a serious adverse device effect, 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. 
8.4 
Documentation of Adverse Events 
All adverse events (AE), including all serious adverse events (SAE), are required to be collected, investigated, and 
documented. AEs will be collected from [describe the reporting period, e.g., from the time they enter the scan room to 
the time they leave the scan room]. All AEs will be followed through to their resolution. Documentation will include: 
• 
Description of Event 
• 
Date of onset  
• 
Date of resolution unless resolution does not occur during study reporting period. In the instance that resolution 
does not occur, the status of the AE will be documented (not resolved/recovered or resolving/recovering) 
• 
Severity (mild, moderate, or severe) 
 
Mild: Symptom(s) barely noticeable to the participant or does not make the participant uncomfortable. 
The AE does not influence performance or functioning. Prescription drugs are not ordinarily needed for 
relief of symptom(s). 
 
Moderate: Symptom(s) of sufficient severity to make the participant uncomfortable. Performance of 
daily activities is influenced. Treatment of symptom(s) may be needed. 
 
Severe: Symptom(s) of a sufficient severity to cause the participant severe discomfort. Treatment for 
symptom(s) may be given. 
• 
Serious (yes/no) 

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• 
Causal relationship to investigational or comparator medical device? (not related, possible, probable, or causal 
relationship) 
 
Not related: Relationship to the device, comparator or procedures can be excluded when:  
• 
the event has no temporal relationship with the use of the investigational device, or the 
procedures related to application of the investigational device;  
• 
the serious adverse event does not follow a known response pattern to the medical device (if 
the response pattern is previously known) and is biologically implausible;  
• 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible - and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious adverse event;  
• 
the event involves a body-site or an organ that cannot be affected by the device or procedure;  
• 
the serious adverse event can be attributed to another cause (e.g., an underlying or concurrent 
illness/clinical condition, an effect of another device, drug, treatment or other risk factors);  
• 
the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable;  
In order to establish the non-relatedness, not all the criteria listed above might be met at the same 
time, depending on the type of device/procedures and the serious adverse event. 
 
Possible:  The relationship with the use of the investigational device or comparator, or the relationship 
with procedures, is weak but cannot be ruled out completely. Alternative causes are also possible (e.g., 
an underlying or concurrent illness/ clinical condition or/and an effect of another device, drug or 
treatment). Cases where relatedness cannot be assessed, or no information has been obtained should 
also be classified as possible.  
 
Probable:  The relationship with the use of the investigational device or comparator, or the relationship 
with procedures, seems relevant and/or the event cannot be reasonably explained by another cause. 
 
Causal relationship:  the serious adverse event is associated with the investigational device, comparator 
or with procedures beyond reasonable doubt when: 
• 
the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures;  
• 
the event has a temporal relationship with investigational device use/application or procedures;  
• 
the event involves a body-site or organ that  
 
the investigational device or procedures are applied to;  
 
the investigational device or procedures have an effect on;  
• 
the serious adverse event follows a known response pattern to the medical device (if the 
response pattern is previously known);  
• 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious adverse event (when clinically feasible);  
• 
other possible causes (e.g., an underlying or concurrent illness/clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out;  
• 
harm to the participant is due to error in use; 
• 
the event depends on a false result given by the investigational device used for diagnosis, when 
applicable;  
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious adverse event. 
• 
Causal relationship to investigational procedure? (not related, possibly related, probably related, or causal 
relationship) 

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• 
Treatment given and/or action taken (procedure stopped, withdrawn from study, or no action) 
• 
Anticipated (yes/no) 
• 
Signals from AE that might indicate a serious health threat. 
8.5 
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 
• 
Any signal from an AE that might indicate a serious health threat 
• 
Unanticipated AE and unanticipated ADEs 
Additional follow-up information 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. 
The Sponsor contact for reporting safety events:    
Research Program Integrator (see Appendix C) 
e-mail: 
 
8.6 
Reporting of Device Deficiencies/Complaints 
Device deficiency: an inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, 
safety, or performance, such as malfunctions, use errors, and inadequacy in the information supplied by the manufacturer 
including labelling. 
Device deficiencies/complaints should be reported to the study Sponsor contact identified on the cover page of this 
protocol. All device deficiencies/complaints will be collected, fully investigated, and documented in the source document 
during the study reporting period. The Principal Investigator is responsible for notifying the Sponsor in the event that 
there is any device issue that could potentially lead to a SAE. 
9 
ETHICAL CONDUCT OF THE STUDY 
The study will be carried out per the protocol and with principles enunciated in the current version of the Declaration of 
Helsinki; the guidelines of Good Clinical Practice (GCP) for medical devices, as set forth by ISO 14155 and ISO 14971; The 
study will be conducted in accordance with the Declaration of Helsinki, 21 CFR 50, and 21 CFR 812 for non-significant risk 
device study investigations. The study will not commence until the approval has been received from the IRB. 
The study will be conducted and reported per applicable policies of the Ethics Committee (EC) and governing regulatory 
authorities. 
If national or regional EC requirements are less strict than the requirements of GCP, such as ISO 14155: 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. 
9.1 
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 participants, and the PI will ensure that documentation of approval is 
maintained for the duration of the study. 

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The PI 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 notify the Sponsor and provide a written 
explanation. 
9.2 
Regulatory Agencies and Competent Authority(ies) 
GEHC 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 followed, if applicable. 
9.3 
Management of Protocol Modifications and Amendments 
Substantial amendments will only be implemented after approval of the EC. 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 competent authority (CA) as soon as possible, if applicable, and to the EC per their policy. 
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 wellbeing of human participants 
may proceed without prior approval of the Sponsor and the EC/CA. Such deviations shall be documented and reported to 
the Sponsor and the EC/CA 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 study. These deviations must be documented on the CRF Protocol Deviation page and will be 
reviewed by the study monitor. 
The Sponsor will assess and implement any corrective or preventative actions necessary, such as retraining the study staff 
and PI.  
9.5 
 Participant Information and Informed Consent   
The investigators will explain to each participant 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 will be informed that participation in the study is voluntary, that he/she may withdraw 
his/her from the study at any time, and that withdrawal of consent will not affect his/her subsequent medical assistance 
and treatment. The participant must be informed that his/her study records may be examined by authorized individuals 
other than the study investigator. 
All participant for the study will be provided an informed consent form (ICF), describing the study and providing sufficient 
information, to allow the participant (i) to make an informed decision about his/her 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 
IRB prior to enrolling subjects in the study. 
The participant 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. 

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9.6 
 Suspension/Early Termination of the Study 
Participation in the study is voluntary. The participant may choose to withdraw the participant from the study at any 
point. If a participant officially withdraws from the study, the laboratory staff will document the reason for withdrawal in 
the case report.  
   
Participation in the study may also be stopped at any time by the principal investigator or by the sub-investigators or 
sponsor.  
The Sponsor may suspend or terminate the study prematurely for various significant and documented reasons. Reasons 
for suspension or termination may include but are not limited to insufficient participant recruitment, updated risk profile 
impacting participant safety, alterations in accepted clinical practice impacting study procedures, early evidence of 
benefit or harm of the research product, or serious or repeated deviations by the investigator.  
Suspension or termination can occur at individual sites or across the study, as applicable. The decision to suspend or 
terminate the study should be shared in writing with all parties described above.  
If the reason for study suspension is resolved, the deciding party shall inform all appropriate parties of the decision and 
actions to resume study procedures.  
 
All the data collected prior to study suspension or early termination will be stored and can be used by the Sponsor.  
 
Withdrawal of IRB approval shall be reported to the sponsor by the investigator within 2 working days.  
 
In case of early termination of the study, all study participants should be followed until the resolution of any pending 
adverse event(s).  
 
10 STATISTICAL METHODS 
10.1 Statistical Hypothesis 
No statistical hypothesis is being tested in this study. 
10.2 Sample Size Determination 
Per ISO 80601-2-61:2017, at least 200 data pairs from at least 10 subjects are required for adult desaturation test, with 
SaO2 values distributed on several saturation plateaus spanning the range of 70-100%.   
10.3 Statistical Analysis 
Data collected will be analyzed by the GEHC Engineering Team. 
10.3.1 General Statistical Methods 
Data analysis will follow ISO 80601-2-61, 2017, and the FDA Guidance Document for Pulse Oximeters (FDA Guidance, 
March 4, 2013). The reference guidance documents clearly define the study, number of subjects, data points needed for 
the analysis and handling of missing data or data that is removed from the analysis. This is achieved through a minimum 
of 200 paired observations of Test and Reference values equally distributed over the specified SpO2 accuracy range (70-
100%) of the device under test. The data will be collected on a minimum of 10 healthy adult volunteer subjects who range 

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in age, gender and skin tone. The controls of the study will be provided in the following manner. A control oximeter will 
be used to assess the stability of the plateaus for data collection. 
10.3.2 Analysis of Primary Endpoint(s) 
Data analysis will follow ISO80601-2-61, 2017 and the FDA Guidance Document for Pulse Oximeters (FDA Guidance, 
March 4, 2013).8  
10.3.3 Safety Analysis 
Safety events will be presented as a listing, and frequency of instances will be calculated. This will be conducted for all 
participants.  
10.4 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.    
10.5 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 
study final report per ISO 14155:2020.   
11 QUALITY ASSURANCE AND CONTROL 
11.1 Data Management 
Data management processes for handling study data will be maintained by the Sponsor. 
11.2 Completion of Case Report Forms (CRFs) 
The data reported on the eCRFs shall be derived from source documents and be consistent with these source documents. 
Electronic CRFs (eCRFs) will be used to collect data. The Sponsor will provide eCRFs and train study staff on completion of 
eCRFs using Good Documentation Practices (GDP). eCRF Completion Guidelines (CCG) may be provided by the Sponsor to 
help facilitate training. 
eCRFs are to be completed as information becomes available at the site. eCRFs should be signed by indicated parties, in 
indicated area(s), to certify the contents of the form. The PI is ultimately responsible for ensuring completion of eCRFs. 
If 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.  
11.3 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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 Only authorized users, as determined by GEHC, 
are allowed to login and view data in Medidata. Access is controlled through study level, role-based security.
 
 
 
 
 
11.4 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 participant 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 participant screening and eCRF corroboration. 
Questionnaires may be directly entered into the eCRF and therefore considered source. 
• 
Participant records containing the completed ICFs and (e)CRFs. 
• 
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 PI or institution shall provide direct access to source data during and after the clinical investigation for monitoring, 
audits, EC review, and regulatory authority inspections. 
11.5 Archiving 
All study data must be archived for a minimum of ten (10) years after study termination or premature termination of the 
clinical study.  
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 per the protocol, written procedures, Good Clinical Practice (GCP) ISO 14155:2020, 
and the applicable regulatory requirements. 
12.1 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, data privacy will be ensured when presenting the data at scientific meetings or 
publishing data in scientific journals. 
Individual participant medical information obtained because of this study will be considered confidential, and disclosure 
to third parties will be prohibited. Participant confidentiality will be further ensured by utilizing participant identification 
code numbers. For data verification purposes, authorized representatives of the Sponsor, a competent authority (CA), or 
an ethics committee (EC) may require direct access to parts of the medical records relevant to the study, including 
participant medical history. 
A checklist will be maintained identifying the contents of the Trial Master File / Project folder 
  

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The participant’s name will be recorded on the Informed Consent, Health Assessment Form, and a participant 
participation list. The data collection form will only use a participant number for the day of the test along with participant 
demographics. A name will not be recorded on the case report form.   
 
Records identifying the participant’s name will be kept in a secured location with either a locked file or locked 
door.  Access to these files will be on a limited basis. Potential reviewers of this information include: Element 
representatives collecting the information and conducting the study, Medical Director for Element, Regulatory 
Authorities, Department of Health and Human Services (DHHS) agencies, Governmental agencies in other countries, Salus 
Independent Review Board and representatives of the Sponsor. This group may use the information to conduct 
independent audits and reviews to verify compliance of the regulatory requirements for these studies but not copy the 
information.   
 
Data files stored electronically will be associated with a participant based off of participant #, date and by filename 
recorded on the data collection forms. The original device electronic data files will be preserved in its original form.    
 
Data files, data collection records with participant demographics and participant number may be additionally copied, 
(after de-identification, if applicable) reviewed and supplied to the commercial sponsor for the study or Contractors 
associated with Element for data analysis purposes.  
 
All study records will be stored for at least 10 years post the release of the product or project cancellation. The 
investigator will notify sponsor prior to destruction of study records.  Other storage arrangements may be executed per 
contractual agreement between the sponsor and the investigator.   
12.2 Storage of Images and Associated Health Data 
All electronic data collected from the participant and associated data will be collected and disclosed to the Sponsor as 
part of this study.  
 
 
 
13 RESEARCH AGREEMENTS 
GE HealthCare will fund this clinical investigation, which will be conducted under contractual agreements between the 
investigational sites and the Sponsor, GE HealthCare. Agreement details for each participating site will be stored by the 
Sponsor. 
13.1 Clinical Study Report and Publication Policy 
Prior to recruitment, a description of this clinical investigation will be registered in a publicly accessible database. This 
database will be updated per regional or national requirements throughout the conduct of the clinical investigation and 
results will be entered upon completion. 
This study may not qualify as an Applicable Clinical Trial (ACT) and information about this trial may not be made publicly 
available. However, the sponsor may voluntarily register the clinical trial and submit summary results information to the 
databank. If so, it’s possible the results may not be published until after a product is cleared or approved by the FDA. The 
conditions of publication are described in a separate contractual agreement. 
 

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REFERENCES 
      
1. 
Fouzas S, Priftis KN, Anthracopoulos MB. Pulse oximetry in pediatric practice. Pediatrics. Oct 
2011;128(4):740-52. doi:10.1542/peds.2011-0271 
2. 
Batchelder PB, Raley DM. Maximizing the laboratory setting for testing devices and understanding 
statistical output in pulse oximetry. Anesth Analg. Dec 2007;105(6 Suppl):S85-S94. 
doi:10.1213/01.ane.0000268495.35207.ab 
3. 
Gehring H, Duembgen L, Peterlein M, Hagelberg S, Dibbelt L. Hemoximetry as the "gold standard"? 
Error assessment based on differences among identical blood gas analyzer devices of five manufacturers. 
Anesth Analg. Dec 2007;105(6 Suppl):S24-S30. doi:10.1213/01.ane.0000268713.58174.cc 
4. 
Tin W, Lal M. Principles of pulse oximetry and its clinical application in neonatal medicine. Semin Fetal 
Neonatal Med. Jun 2015;20(3):192-7. doi:10.1016/j.siny.2015.01.006 
5. 
HealthCare G. TruSignal SpO2 Clinical Accessories. GE Pulse Oximetry Technology.  
6. 
Foglia EE, Whyte RK, Chaudhary A, et al. The Effect of Skin Pigmentation on the Accuracy of Pulse 
Oximetry in Infants with Hypoxemia. J Pediatr. Mar 2017;182:375-377 e2. doi:10.1016/j.jpeds.2016.11.043 
7. 
FDA -- U.S. Food and Drug Administration. Pulse Oximeters -- Premarket Notification Submissions 
[510(k)s] - Guidance for Industry and Food and Drug Administration Staff. March 4, 2013. 
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm0813
52.pdf. Accessed December 02, 2019.  
8. 
FDA -- U.S. Food and Drug Administration. Pulse Oximeters -- Premarket Notification Submissions 
[510(k)s] - Guidance for Industry and Food and Drug Administration Staff. 2013. Accessed March 4. 
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm0813
52.pdf 
 
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