Desaturation Validation of INVSENSOR00012
Phase: NA
Conditions: Healthy
Sponsor: Masimo Corporation

 
 
Official Title: Desaturation Validation of 
INVSENSOR00012 
 
Date of Protocol: 08 May2018 
 
NCT Number:   
 
NCT03435224 

PROTOCOL/TEST PROCEDURE 
R-TP-19088 
Desaturation Validation of INVSENSOR00012 
Revision: A 
CO-039801 
 
CONFIDENTIAL AND PROPRIETARY 
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© 2021 Masimo Corporation (Unpublished) 
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All Rights Reserved 
CO-024597 
 
Protocol/Test Procedure Title 
Desaturation Validation of INVSENSOR00012 
Lead Investigator 
Tala Harake, MS
Senior Manager, Clinical Research/Laboratory 
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
Other Investigators 
Stacy Lobato, BS
Assistant Clinical Lab Manager 
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
 
Chelsea Frank, MS 
Clinical Research Associate II 
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
Expected Start Date 
 
Expected End Date 
 
IRB 
E&I West Coast Board – IRB00007807
Protocol Version Date 
12/11/2017
 
Protocol Test Abstract: 
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to 
reference values obtained by a laboratory blood gas analyzer.  Arterial blood samples will be collected from 
healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is 
slowly reduced until the subject’s arterial oxygen concentration is approximately 70%.  During the desaturation, 
the subject’s hand and arm without the arterial line will be subjected to motion. After completing the 
desaturation, the gas mixture will be returned to room air concentrations. 
 
APPROVALS 
Author 
Date
Engineering
Date 
 
 
 
 
Quality Assurance 
Date
Manufacturing
Date 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
 
This document is a protocol for a clinical research study sponsored by Masimo Corporation.  The study will be 
conducted in compliance with all stipulations of this protocol, the conditions of IRB approval, 21 CFR Part 50, 21 CFR 
Part 56, 21 CFR Part 812, ISO-14155, and International Conference on Harmonisation E6 Good Clinical Practice (ICH 
GCP). 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the 
Institutional Review Board (IRB) for review and approval.  Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled.  Any amendment to the protocol will require review and approval by 
the IRB before the changes are implemented to the study.   
1. 
PURPOSE 
The objective of this study is to compare the noninvasive oxygen saturation (SpO2) performance of the Masimo 
noninvasive INVSENSOR00012 sensor against an arterial blood sample analyzed by a laboratory CO-oximeter 
reference instrument.  Data using the noninvasive devices will be collected from healthy volunteers undergoing a 
desaturation procedure. 
This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive 
the INVSENSOR00012 sensor on one or more fingers.  Desaturation will be conducted by reducing the concentration 
of oxygen the study subject breathes in a controlled manner to obtain noninvasive oxygen saturation readings, SpO2, 
at various levels.  Reference blood samples will be repeatedly collected from the subject and analyzed using a 
standard laboratory CO-oximeter.  During the desaturation, the subject’s hand and arm without the arterial line will 
be subjected to motion. 
Outcome Measure:  
Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement 
(SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood 
sample and calculating the ARMS value per ISO-80601-2-61. The acceptance criteria will be ARMS ≤ 3 %SpO2 across a 
saturation range of 70-100 %SpO2 under motion conditions. 
2. 
BACKGROUND 
Masimo Corporation develops non-invasive medical technologies.  These devices have applications in the operating 
room, critical care unit, emergency room, emergency transport vehicles, as well as physician’s offices. 
 
An invasive blood sample analyzed by a CO-oximeter reference instrument gives the best measure of arterial oxygen 
concentration as well as other blood solutes, but cannot  measure these parameters continuously and requires skin 
puncture, arterial line placement and subsequent risk of infection, hematoma, and other physiological damage.  
Masimo SET and Masimo Rainbow technologies allow real-time, non-invasive monitoring of oxygen saturation (and 
other blood solutes) and has the potential to improve clinical outcomes while reducing the cost of care and risks to 
both patients and clinicians associated with arterial and venous punctures. 
2.1. 
Technology Background 
 
Pulse oximetry is governed by the following principles: 
x 
Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) differ in their 
absorption of red and infrared light (spectrophotometry).  

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x 
The amount of arterial blood in tissue changes with arterial pulses (photoplethysmography).  Therefore, 
the amount of light absorbed by the varying quantities of arterial blood changes as well.  
x 
The CO-Oximeter utilizes a sensor with various light-emitting diodes (LEDs) that pass light through the 
site to a photodiode (detector).  See figure below.  
 
 
 
x 
Signal data is obtained by passing various visible and infrared lights through a capillary bed (for example, 
a fingertip, a hand, a foot) and measuring changes in light absorption during the blood pulsatile cycle.  
The maximum radiant power of the strongest light is limited to ≤ 25mW.  The detector receives the light, 
converts it into an electronic signal and sends it to the Masimo hardware (e.g. Rad-57, Radical-7) for 
calculation.  Once the oximeter receives the signal from the sensor, it utilizes Masimo SET signal 
extraction technology for calculation of the patient’s functional oxygen saturation, pulse rate and other 
blood parameters. 
2.2. 
Study Devices 
Investigational sensor: INVSENSOR00012 
The INVSENSOR00012 sensor is a modification to Masimo’s SpO2 Reusable line of sensors.  These sensors 
use red and infrared LEDs to calculate SpO2 values. INVSENSOR00012 is similar to existing Masimo FDA-
cleared reusable sensors. INVSENSOR00012 is a smaller form factor sensor that utilizes the same optical 
components as the FDA cleared sensors.  This study will validate that the new sensor design meets the 
accuracy requirements for SpO2 under motion conditions when compared to laboratory reference CO-
oximeter SaO2 values(ARMS ≤ 3 %SpO2). 
 
FDA Cleared Sensors and Devices: 
Masimo Root Patient Monitoring Platform: Root is a patient monitoring and connectivity platform that 
offers rainbow® and Masimo SET® measurements with other parameters in an integrated platform. With 
docking capabilities for the Radical-7® handheld monitor and multiple networking/connectivity options, Root 
integrates multiple streams of data into one display monitor.  
Masimo Radical-7 Pulse Oximeter: The Masimo Radical-7 pulse oximeter is a noninvasive monitoring 
platform featuring Masimo SET Measure-through Motion and Low Perfusion™ pulse oximetry with the 
option to measure multiple additional blood constituents and physiologic parameters.  
 
3. 
REFERENCE 
 
R-FRM-4154 Consent To Be A Research Subject Desaturation Validation of INVSENSOR00012 
FRM-4150 Health Assessment Questionnaire Desaturation Validation of INVSENSOR00012 
FRM-4153 Desaturation Validation of INVSENSOR00012 Recruitment Script 
FRM-4151 Desaturation Validation of INVSENSOR00012 Healthy Volunteers Needed Advertisement 
R-FRM-2449 Confidentiality 
FRM-4152 Desaturation Validation of INVSENSOR00012 Case Report Form (CRF) 

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FRM-3267 Post Care Instructions 
DEO-6407 W-9 Request for Taxpayer Identification Number and Certification  
FRM-1084 Volunteer Payment Form 
 
4. 
LOCATION 
Masimo Corporation 
Clinical Laboratory 
52 Discovery 
Irvine, CA 92618 
The Masimo Clinical Laboratory facility is designed as a Phase 1 clinical study research center.  The laboratory is 
staffed by physicians, anesthesiologists, certified registered nurse anesthetists, registered nurses, medical assistants, 
and clinical research staff.  All personnel undergo routine required training on GCP and human research subject 
protections.  The laboratory is equipped with standard FDA-approved medical monitoring equipment including ECG 
monitors, blood pressure monitors, pulse oximeters, standard hematology analyzers, and has emergency crash carts 
available.  Hospitals and urgent care facilities are within three miles of the Masimo Clinical Laboratory. 
5. 
STUDY POPULATION  
5.1. 
Inclusion Criteria  
x 
Subject is 18-50 years of age. 
x 
Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.  
x 
Hemoglobin value is greater than or equal to 11 g/dL. 
x 
Baseline heart rate ≥ 45 bpm and ≤ 85 bpm. 
x 
CO value d 2.0% FCOHb  
x 
Subject has a physical status of ASA I or II (American Society of Anesthesiology Class I; Healthy 
subjects without any systemic disease at all.  American Society of Anesthesiology Class II; subjects 
with mild systemic disease) as it applies to the systemic disease portion of the classification. 
x 
Systolic Blood Pressure d 140 mmHg and Diastolic Blood Pressure d 90 mmHg. 
x 
Subject is able to read and communicate in English and understands the study and risks involved. 
5.2. 
Exclusion Criteria  
x 
Subject is pregnant. 
x 
Subject smokes (smoking includes e-cigarette use). 
x 
Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for 
participation by a medical professional. 
x 
Subject has open wounds, inflamed tattoos or piercings, visible healing wounds. 
x 
Subject experiences frequent or severe headaches and/or migraine headaches.  
x 
Subject has known drug or alcohol abuse and/or use of recreational drugs. 
x 
Subject has experienced a concussion or head injury with loss of consciousness within the last year. 
x 
Subject has any chronic bleeding disorders (i.e. hemophilia). 
x 
Subject has any history of a stroke, myocardial infarction, seizures or heart attack. 
x 
Subject has any cancer or history of cancer (not including skin cancer). 
x 
Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington’s Disease). 
x 
Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance by their 
physician to participate. 

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x 
Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) 
that interferes with the subject’s level of consciousness. 
x 
Subject has any medical condition which in the judgment of the investigator and/or medical staff, 
renders them ineligible for participation in this study (Discretion of investigator). 
x 
Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome. 
x 
Subject who has taken anticoagulant medication within the last 30 days.  
x 
Subject has taken opioid pain medication within 24 hours of start of study.  
x 
Subject has either signs or history of peripheral ischemia/carpal tunnel syndrome. 
x 
Subject has had invasive surgery within the past year- including but not limited to major dental 
surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, 
urinary tract surgery, plastic surgery, major ENT surgery, joint replacement or gynecological 
surgeries, heart surgery or thoracic surgery.  
x 
Subject has donated blood within the past 30 days. 
x 
Subject has symptoms of congestion, head colds, flu or other illnesses. 
x 
Subject experiences claustrophobia or has generalized anxiety disorder. 
x 
Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization 
within the last 12 months.  
x 
Subject has chronic unresolved asthma, lung disease or respiratory disease. 
x 
Subject is allergic to lidocaine, latex, adhesives, or plastic. 
x 
Subject has heart conditions, insulin-dependent Diabetes or uncontrolled hypertension. 
x 
Subject has given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization, 
or had a C-section within the last 6 months. 
x 
Subject intends to participate in any heavy lifting, repetitive movement of their wrist (including 
riding a motorcycle) or exercise (working out, riding a bike, riding a skate board etc.), or any activity 
that will put additional stress on the wrist within 24 hours of the study. 
x 
Discretion of investigator/study staff. 
 
5.3. 
Withdrawal of subjects  
Subjects must be withdrawn under the following circumstances: 
5.3.1 
The subject withdraws consent. 
 
5.3.2 
Discretion of investigator, for example:  
x 
The investigator feels that the subject is too money motivated. 
x 
The investigator feels that the subject does not fully comprehend and understand the 
consent form. 
x 
The subject is ill-mannered and/or shows aggressive behavior towards study staff. 
x 
Malfunction of the device for greater than 30 minutes that prevents accurate collection 
of optical data. 
x 
Subject displays or communicates signs of discomfort or distress so that the study may 
not be continued. 
5.4. 
Replacement of subjects 
In case a subject is withdrawn from the study, another subject may be recruited. 

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6. 
EQUIPMENT AND MATERIALS  
Equipment and Materials: All lab analyzers and equipment will be maintained per manufacturer specifications and 
all study personnel will be trained on the use of relevant equipment.  Equivalent equipment and materials to those 
listed below may be used.  
Safety Equipment (FDA-Cleared) 
x 
Blood pressure monitoring system 
x 
Electrocardiogram (ECG) 
x 
Masimo Pulse Oximeters (Radical-7) 
x 
Masimo Patient Monitoring Platform (Root®) 
x 
Pulse oximeter sensors and cables (Masimo SET, Masimo rainbow, or comparable)  
x 
Medical-grade oxygen tank and mask 
x 
Crash cart  
 
Test Devices 
x 
Masimo INVSENSOR00012 pulse oximeter sensor - Investigational 
 
Research Equipment 
x 
Passive Data Collection Research Equipment (automated data collection software (ADC), multi-input pulse 
oximeter technology board)   
x 
Gas Blender: electro-pneumatic system intended to assist the clinical operator in setting and delivering a 
prescribed concentration of O2, CO2 and N2 gases.   
x 
Motion Generator 
x 
Warming blanket 
x 
Laboratory co-oximeters/blood analyzers  
x 
Laboratory hematology analyzers 
7. 
PROCEDURE 
7.1        SCHEDULE OF ACTIVITIES 
Procedures 
Phone  
Pre-Screen 
Baseline 
Visit 1 
Procedure 
Visit 1 
Brief Study Procedure Description 
X 
 
 
Informed consent 
X 
 
Demographics (including skin tone) 
X 
X 
 
Medical history (subject-reported) 
X 
X 
 
Concomitant medication review  
X 
X 
 
Vital Signs (ECG, Blood Pressure Cuff, Pulse Ox) 
X 
X 
Height  
X 
X 
 
Weight  
X 
X 
 
ASA Status Assessment  
 
X 
 
Pregnancy test1 
 
X 
 
Allen’s Test 
 
X 
 
Venous sample (via needle stick or IV placement)  
 
X 
Local anesthetics (lidocaine, ethyl chloride spray, or pain ease skin 
refrigerant) as needed2 
 
X 
X 
Peripheral Venous Line (IV)2 
 
X 
X 
Intra-arterial catheter (A-line)  
 
 
X 

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Procedures 
Phone  
Pre-Screen 
Baseline 
Visit 1 
Procedure 
Visit 1 
Placement of test sensors  
 
 
X 
Data collection 
 
 
X 
Desaturation 
 
 
X 
Continuous A-line sampling 
 
 
X 
Line Removal 
 
 
X 
Post Care Instructions Given 
 
X 
X 
Discharge 
 
X 
X 
Adverse Event Review and Evaluation3 
X 
X 
1 hCG (urine) pregnancy test (all female subjects) 
2 IV may be placed during screening/baseline to obtain qualifying venous sample at discretion of medical staff.  If 
the IV is placed during screening/baseline, medical staff will offer to use local anesthetics. 
3 Adverse events may be reported by the subject after their visit.  See section 10 for additional details. 
 
7.2. 
RECRUITMENT AND PRESCREENING 
Subjects will be recruited using IRB-approved advertisements.  Subjects may be referred to the 
study by previous subjects.  Subjects are contacted via phone call to conduct a prescreening 
interview to determine their initial eligibility for the study.  Potential eligible subjects are scheduled 
for a study visit to the clinical laboratory. 
7.3         CONSENTING AND SCREENING 
7.3.1. Study staff will discuss the informed consent process and the study with the potential 
subjects.  The subjects will be provided with enough time to read and understand the 
informed consent document and their questions will be answered by study staff prior to the 
subject signing the informed consent form.  No study related activities will be conducted 
until consent is signed. 
7.3.2. The subject’s weight and height are self-reported, however the subject may be weighed on 
a scale for verification. 
7.3.3. Subjects will be asked to provide a copy of their valid government photo ID and/or Social 
Security Number (SSN) card to verify subject identity.  The copies of these forms of 
identification will be stored along with the subject’s consent.  The confidentiality and 
retention of these documents will be protected to the extent provided and required by law.  
7.3.4. Subjects will be asked a brief series of health questions to ensure their eligibility for this 
study.  Subjects who do not meet the inclusion and exclusion criteria will not be eligible to 
participate in the study.   
7.3.5. Subject demographic information including age, sex, skin tone, ethnicity, height and weight 
will be collected.  These may be recorded for data analysis and/or subject safety monitoring 
purposes. 
7.3.6. In addition, a medical history will be recorded after the initial screening questionnaire. 

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7.3.7. Pre-procedure vital signs will be recorded for subject safety monitoring.  Spikes in blood 
pressure and heart rate can be expected during line placement, needle sticks, blood draws 
etc. and may also be attributed to anxiety/nervousness relating to a new environment.  Only 
the initial recorded blood pressure and/or heart rate determines a subject’s qualification for 
the study. 
7.3.8. Female subjects will be required to take a pregnancy test.  Results will be noted in study 
documentation.  If the pregnancy test is positive, the subject will be notified and removed 
from the study.  
7.3.9. A venous sample will be obtained via needle stick or by placement of an IV and analyzed to 
verify that the subject meets the inclusion criteria for hemoglobin level and HbCO.  The 
subject will be excluded from the study if the values from the blood draw fall outside the 
ranges stated in the inclusion criteria. 
7.3.10. Subjects may have a blanket placed on them for their comfort.  
7.3.11. Subjects may be offered a snack (e.g., granola bar) and/or beverage (e.g., water, juice) due 
to the amount of time their involvement in this study may take.  
7.4. 
PROCEDURES 
7.4.1. Standard hospital-type monitors will be placed on the subject, including ECG, blood 
pressure, and a reference pulse oximeter for safety monitoring by medical staff. 
7.4.2 
Proprietary Masimo data collection software will be used to verify all oximeters are reading.  
If not, proper sensor positioning will be checked and sensors may be repositioned, as 
needed.  
7.4.2.1 Pulse oximeter output values (e.g., SpO2, Pulse rate) will be recorded using the 
proprietary Masimo data collection software.  These values match the values 
calculated by the instrument at runtime. 
7.4.2.2 Raw absorbance data from the noninvasive device(s) will also be recorded using the 
data collection software. 
7.4.3 
A peripheral venous line will be placed in the subject’s hand or arm.  This line may be used 
for the qualifying venous blood draw and for safety or clinical intervention required during 
the study. 
7.4.4 
Local anesthetics such as lidocaine, ethyl chloride spray, or Pain Ease skin refrigerant spray 
may be used in the event that an IV is placed to numb the site.  Subjects will be given the 
option to have lidocaine or numbing spray be used during IV placement for the purpose of 
making catheter placement more comfortable for the subjects. 
7.4.5 
After intravenous access is established, one or more intra-arterial catheter(s) (arterial line or 
A-line) will be placed in the radial artery of the subject’s wrist.  The A-line is placed to 
facilitate continuous blood pressure measurement for subject safety monitoring, and/or to 
enable repeated removal of blood aliquots for reference arterial blood gases (ABG), Hgb, 
Hct, as well as other non-infectious blood solutes. 
7.4.6 
After arterial access is established, sensors will be placed on the required sensor sites.  
Depending on the sensor design, these may include the subject’s fingers, toes, ears, nose, 
and/or forehead.   

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7.4.7 
Subjects may be warmed using equipment such as blankets or heating pads, according to 
ISO 80601 EE.2.3.3. 
7.4.8 
Upon successful placement of the sensors and the subject’s indication that they are 
comfortable, a baseline set of blood samples will be obtained. 
7.4.9 
Arterial blood samples may be drawn consecutively during the procedure at different 
saturation levels.  No more than 100 samples of approximately 1-4 cc each may be drawn 
including blood drawn to flush the line and prepare for new samples. A maximum total of 
250 cc of blood may be taken per subject. 
7.4.10 Subjects will wear a nose clip or nose plugs during the desaturation procedure.  A 
mouthpiece will be placed in the subject’s mouth.  Upon indication the subject is 
comfortable, a gas mixture will be administered through the mouthpiece.  The proportion of 
oxygen in this mixture will be decreased in a controlled manner to lower the subject’s blood 
oxygen saturation.  The lowest targeted value will be 70% oxygen saturation.  Readings near 
70% will be immediately verified by the reference CO-oximeter to ensure that levels are 
within the targeted oxygen saturation range and to minimize time that the subject may drop 
below the targeted range. Note: At any point in the study, if the subject feels 
uncomfortable, the subject will be given 100% oxygen through either the mouthpiece or a 
supplemental mask.  
7.4.11 Subjects may undergo the desaturation procedure up to 2 times.  
7.4.12 The timing of the blood samples will be entered into the data collection software. 
7.4.13 To allow for pulse oximeter instrument response times, the subject should be at the desired 
saturation level for at least 30 seconds before and after a blood sample is taken. 
7.4.14 Motion is to be done with the volunteer’s test hand; their control hand (arterial line side) is 
to remain steady. There will be several types of motion. The motion will be on for 
approximately 2 minutes at a time.  
Subjects will experience a variety of motions, for example tapping, rubbing, waving and/or 
scratching random motion, or a combination of the previously listed type motions.  
The motion generator will be turned on to simulate motion at a rate between 3 to 4 Hz and 
an amplitude of approximately 3 cm. 
No motion periods should be a minimum of 60 seconds, or enough time to allow all pulse 
oximeters to settle to their non-motion values. 
Blood samples may be taken during motion and non-motion. 
7.4.15 The study will end with several minutes at a FiO2 greater than room air (>21%) to help the 
subject re-saturate after the procedures.  
7.4.16 If at any point the subject is uncomfortable with the study, the study will be stopped. 
7.4.17 At the conclusion of the procedure, the sensors/devices, IV(s), and arterial line(s) will be 
removed and the subject will be allowed to leave after medical personnel determine it is 
safe to do so.  
7.4.18 The total procedure time will be approximately 180 minutes. 

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7.4.19 All subjects will be encouraged to remain in the study area until they feel fit to leave; 
subjects should feel safe and able before returning to work directly after participation in the 
study.  
7.4.20 Subjects will be given instructions on wound care.  All subjects will be instructed to contact 
the principal investigator or study staff in the event of any potential complication. 
7.4.21 Subjects will be paid for their time. 
7.4.22 Subjects will be provided with information related to any significant new findings that 
develop at any time during the study which may relate to their willingness to continue their 
participation. 
8. 
ACCEPTANCE CRITERIA 
For validation studies, acceptance criteria is determined by Masimo specifications for each design.  
9. 
SAMPLE SIZE JUSTIFICATION AND DATA ANALYSIS PROCEDURE TO BE USED 
9.1. 
Sample size determination 
ISO 80601 only requires 10 Subjects and approximately 200 points for a standard validation 
desaturation study.  However, if greater precision in the RMS estimate is required, additional 
subjects are needed. A previous study collected data on 35 subjects using Red Diamond disposable 
sensors during an observational study.  Monte Carlo analysis established that the estimated RMS 
variation reduced to below 0.25 %SpO2 when clinical trials using 25, or more, subjects were 
simulated. 
Therefore, this study will use a minimum of 25 subjects with up to 5 additional subjects may be 
added to meet reference range and subject demographics requirements.  
It is not possible to predict which subjects will be able to complete full desaturations to 70% SpO2. 
Therefore, the number of samples for each subject will vary depending on the subject’s ability to 
reach and maintain the targeted SaO2 level.  The final analysis will utilize statistical methods to 
ensure accuracy statistics are calculated with comparable density over the range 70-100 %SaO2. 
9.2. 
Statistical Analysis 
Accuracy will be reported as the ARMS using the following equation: 
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9.3. 
The ARMS and precision values will be adjusted to account for repeated measurements on each 
subject. 
9.4. 
Measures taken to minimize/avoid bias: 

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9.3.1 
Sensors and devices will be provided to operators in a way that minimizes the operator bias. 
Sensors and devices will be provided at random when deemed necessary.   
9.5. 
Expected drop out rates 
Subjects may not complete the study for various reasons, such as screen failure, unable to complete 
desaturation criteria, unable to have intravenous or arterial line placed.  Expected drop out rate for 
this study is approximately 50% of the total number of subjects enrolled. 
10. 
ADVERSE EVENTS 
Definitions: 
Adverse event:  Any untoward medical occurrence in a subjects, users or other persons, whether or not 
related to the medical device under study. 
Device-related adverse event:  Adverse event related to, associated with, or caused by, the use of a medical 
device under study, including but not limited to events that may have been attributed to the device because 
of device failure or malfunction, improper or inadequate design, manufacture or user error. 
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance.  Device deficiencies include malfunctions, use errors and inadequate labeling. 
Device deficiencies will be reported according to department procedures. 
Serious adverse event:  Adverse event that: a) led to death, b) led to serious deterioration in the health of 
the subject, that resulted in: (i) a life-threatening illness or injury,  (ii) a persistent or significant impairment 
of a body structure or a body function, (iii) in-patient or prolonged hospitalization, or (iv) medical or surgical 
intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a 
body function, or c) led to fetal distress, fetal death or a congenital abnormality or birth defect.  NOTE:  
Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational 
plan, without serious deterioration in health, is not considered a serious adverse event. 
All adverse events, including inter-current illnesses will be reported and documented as described below. 
10.1. 
Adverse Events 
All adverse events that occur during the study shall be recorded on the Case Report Form even if the 
investigator/study staff assess the adverse event as unlikely to be causally related to the test device 
or study procedures. 
10.2. 
Serious Adverse Events 
The investigator/study staff shall promptly report both serious adverse events and unanticipated 
adverse device effects to the sponsor within 48 hours.  All serious adverse events will also be 
reported to the IRB per IRB reporting requirements. 
At the time of discharge from the study, any unresolved serious adverse event(s) will be followed up 
by the investigator/study staff until the event(s) are resolved, stabilized or the patient is lost to 
follow-up or the adverse event is otherwise explained.  The investigator and/or study staff  will also 
instruct the subject to report any subsequent events occurring in the next 30 days, which the 
subject or the subject’s physician believes might reasonably be regarded as caused by or have a 
reasonable possibility of being caused by the test device or procedures involved in the study. 
10.3. 
Unanticipated Problems 

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Any unanticipated problem involving subjects will be reported to the IRB, such as protocol violations 
or deviations as required by the IRB reporting procedures. 
11. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
11.1 
Measures Taken to Protect the Rights and Welfare of Subjects 
11.1.1 All subjects will be monitored closely throughout the study.  There will be an ACLS certified 
medical doctor present in the study area throughout the study. 
11.1.2 The following measures will be taken to ensure the confidentiality of the subjects: 
11.1.2.1 A code (identification) number for each subject will be kept on file. 
11.1.2.2 Only their corresponding identification number will identify subjects. 
11.1.2.3 Access to identifying documents (IC, SSN, photo ID) and data will only be made to 
the principal investigators in the study and study staff. 
11.1.2.4 The confidentiality and retention of these documents will be protected to the 
extent provided and required by the law. 
11.2 
Vulnerable Populations 
11.2.1 Masimo Employees are considered to be a vulnerable population. 
Participation is not a condition of employment.  There will be no repercussions in the 
workplace in the case that the employee refuses to participate in the study or withdraws at 
any point during the study.  Neither supervisors nor superiors will be involved in the 
recruitment of employees for participation in the study. 
11.2.2 Economically disadvantaged or unemployed and educationally disadvantaged. 
Reasonable compensation will be provided for economically disadvantaged subjects to 
eliminate possibility of undue influence due to financial incentive.  Educationally 
disadvantaged subjects will be provided ample time to ask questions and comprehend 
information.  
11.3 
Documents and Database 
11.3.1 Documents will be kept a minimum of 5 years after the specific product/tested for is no 
longer being made.  If destroyed, these documents will be shredded and done by a certified 
company used for destroying medical and clinical data. 
11.3.2 Documents and information stored electronically will be protected using a multi-faceted 
procedure including, but not limited to the following steps: 
x 
Two layers of endpoint security and one layer of DLP (Data loss prevention) running on 
all company machines. 
x 
Premier firewalls/Network monitoring appliances and log collection systems (SIEM) 
protecting the network.  
x 
4 layers of email security systems for protecting against phishing attacks. 
x 
Security policies to limit access to specific folders. 
12. 
DEVICE ACCOUNTABILITY 
12.1 
Receipt of Study Device 

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Upon receipt of the study device supplies, an inventory must be performed and the device 
accountability log filled out and signed by the person accepting the shipment.  It is important that 
the designated study staff counts and verifies that the shipment contains all the items noted in the 
shipment inventory.  Any damaged or unusable study devices in a given shipment will be 
documented in the study files.   
12.2 
Use of Study Device 
Use of devices and sensors will be documented on Case Report Forms for each subject. 
12.3 
Return or Destruction of Study Device 
At the completion of the study, there will be a final reconciliation of study devices and sensors 
shipped, devices/sensors used, and devices/sensors remaining.  This reconciliation will be logged on 
the device accountability log.  Any discrepancies noted will be investigated, resolved, and 
documented prior to return or destruction of unused study devices.  Devices destroyed on site will 
only be upon written instruction from the sponsor and will be documented in the study files. 
13. 
RISKS AND BENEFITS 
13.1. 
Benefits: There will be no benefit to the subject.  Other possible benefits would be to society as a 
whole.  Evaluation of the accuracy of this new device could enable healthcare workers to more 
appropriately treat potentially life threatening conditions. 
13.2. 
Device Risks: The noninvasive devices used in this study are similar in technology and design to 
some commercially available pulse oximeters and other non-invasive devices and hence have the 
same risks.  Pulse oximeters and other non-invasive devices are commonly used and are considered 
to be minimal risk.  There is an extremely small risk of damage to the subject’s fingers, or other 
locations where sensors are placed, from the device including temporary skin irritation or 
discomfort associated with exposure to the sensor as well as potential temporary mechanical 
irritation or discomfort.  There is a remote, yet possible, risk of a burn from the sensor. In the case of 
a sensor burn there is the potential for permanent skin damage (scar/discoloration). 
13.3. 
Venous Cannulation Risks: swelling, infection, infiltration of fluids/ blood into area surrounding IV, 
bruising, hematoma, lightheadedness, fainting, feeling flush/warm, feeling nauseated, throwing up, 
sudden drop in blood pressure/sudden increase in blood pressure, sudden drop in heart 
rate/sudden increase in heart rate, tingling sensation of face, arms and/or legs, sweating, mouth 
dryness, damage to the blood vessel and surrounding nerves or tissue. 
13.4. 
Arterial Cannulation risks: decreased blood supply, blood clot, embolization, infection, hematoma, 
damage to the blood vessel and surrounding nerves, tendons or tissue; loss of feeling in hand and/or 
arm and even the loss of hand due to rare complications of the study. 
13.5. 
Blood Draw risks: discomfort is generally associated with needle puncture.  The most common 
complications associated with blood draws and capillary sticks are hematomas or bruising.  All blood 
draws will be performed by qualified personnel.  An ACLS certified physician will be in attendance 
throughout the entire procedure, and the study will be completed under their general supervision.  
Other anticipated adverse events that may occur, include but are not limited to: vasovagal (passing 
out/fainting), infection to the skin or area right below the skin, lightheadedness, feeling flush/ warm, 
feeling nauseated, throwing up, seizures, sudden drop in blood pressure/ sudden increase in blood 
pressure, sudden drop in heart rate/ sudden increase in heart rate, tingling sensation of face/arms 
and/or sweating, and mouth dryness.  These anticipated adverse events are expected to be 
temporary. 

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13.6. 
Risk From Oxygen Administration:  There are no risks associated with high oxygen/oxygen 
administration for less than 24 hours as long as subjects do not have any cardiac conditions, COPD 
or any other lung diseases.  Subjects’ answers on the health questionnaire will help the medical staff 
decide if they can safely participate in this study; subjects are encouraged to let the study staff know 
if they have any concerns. 
13.7. 
Low Oxygen Concentration Risks: Risks associated with hypoxia include dizziness, shortness of 
breath, drowsiness, or headache. If or when this occurs, the study can be stopped. There is an 
extremely small risk of loss of consciousness, damage to vital organs, or death from lack of oxygen. 
The study shall be stopped by the subject or clinical staff long before this could occur.  Other 
anticipated adverse events that may occur, include but are not limited to:  vasovagal (passing 
out/fainting), lightheadedness, feeling nauseated, throwing up, seizures, sudden drop in blood 
pressure/sudden increase in blood pressure, sudden drop in heart rate/sudden increase in heart 
rate, tingling sensation of face, arms and/or legs, sweating, mouth dryness.  These anticipated 
adverse events are expected to be temporary. 
13.8. 
Nose Clip Risks: It is expected that some people will have discomfort/ pinching/ scratches from 
wearing a nose clip. If this occurs, adjustments can be made and/or the study can be stopped. 
13.9. 
Risk from Inflicted Knowledge: The risk of inflicted medical knowledge to subjects is negligible since 
we deidentify all associated sample information including those relevant to our clinical and 
engineering parameter studies.  The monitoring and test results are not examined for diagnostic 
purposes and do not reflect an attempt to ascertain any subject's medical condition.  The attending 
physician's role during this study is to ensure the safety of the subject during the study. Subjects are 
informed that these are not diagnostic tools, if observations are made using FDA cleared devices we 
will refer them to their primary care physician. 
13.10. Risk From Loss of Confidentiality: Masimo upholds the highest standards to protect hard and 
electronic data however, a complete promise for confidentiality cannot be guaranteed due to 
unforeseeable events. 
13.11. Risk From Additional Testing: 
13.11.1. During the conduct of the study, it is possible, but not likely, that someone could become 
exposed to the sample of blood drawn from the subject through an inadvertent needle 
stick or by contact with an open cut. In such circumstances, it will be important to the 
exposed individual to know whether the blood to which he or she was exposed contained 
Hepatitis B virus (HBV), Human immunodeficiency virus (HIV), or Hepatitis C virus (HCV) 
and additional testing of the sample will be performed. 
13.11.2. Within the consent, subjects will agree to permit the company to test the blood sample 
(or samples) by signing the consent.  The test results will be maintained as confidential 
and will only be used by healthcare professionals for the diagnosis and treatment of the 
exposed individual as appropriate.  
13.11.3. In the case that Masimo needs to contact a subject regarding additional testing they will be 
contacted by a Masimo employee and medical personnel can be available for further 
counsel if requested.  
13.11.4. The cost for the initial testing and compensation for their time/travel to the testing facility 
will be the only things paid for by Masimo. 

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13.12. Lidocaine (injection) Risks:  Insertion of the Lidocaine may be discomforting and can feel like a slight 
pinch along with a warm/burning sensation.  Other anticipated adverse events that may occur, 
include but are not limited to: Flushing or redness of the skin, itching skin, small red or purple spots 
on the skin, unusually warm skin, bruising, bleeding at the application site, and swelling. These 
adverse events are expected to be temporary. 
13.13. Although not common, it is also possible to have an allergic reaction to injectable lidocaine.  
Subjects should not take part in this study if they are allergic to lidocaine injection or other types of 
numbing medicine, or if they have a heart rhythm disorder such as Wolff-Parkinson-White 
Syndrome or Stokes-Adams syndrome.  Subjects are instructed to tell the study staff right away if 
they experience hives; difficulty breathing; swelling of your face, lips, tongue or throat. 
13.14. Ethyl Chloride (Lidocaine Spray): Ethyl Chloride is a topical anesthetic which is used to prevent pain 
by cooling the skin. Although unlikely, the anticipated adverse events that may occur, include but 
are not limited to: changes in skin color (i.e. Flushing or redness of the skin), delayed wound healing, 
rash, itching and swelling.  These adverse events are expected to be temporary. 
14. 
EMERGENCY RESPONSE PLAN FOR MEDICAL EMERGENCIES  
The physician and nurse present during the study will be ACLS certified and will respond to any medical 
emergency involving a subject with the ACLS approved protocol for intervention.  A crash cart is on site and 
full emergency services are within 3 miles. 
15. 
MONITORING PLAN 
A separate document for the study monitoring plan will be developed and followed to ensure subject safety 
and GCP compliance.   
16. 
PROTOCOL DEVIATIONS AND AMENDMENTS 
Deviations to the protocol will be documented on the Case Report Form or a separate document.  Protocol 
deviations will be reported to the sponsor and IRB per IRB reporting guidelines. 
Modifications to the protocol, informed consent materials, recruitment materials, or any other materials 
provided to subjects must be reviewed and approved by the IRB.