Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance During Hemodilution
Phase: NA
Conditions: Healthy
Sponsor: Masimo Corporation

 
 
Official Title: Comparison of Rainbow 
INVSENSOR00001 and Control SpHb Disposable 
Sensor Performance during Hemodilution 
 
Date of Protocol:  May 8, 2018 
 
NCT Number:   
NCT03273166 

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
CO-035572 
 
CONFIDENTIAL AND PROPRIETARY 
Page 1 of 15 
© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. E 
All Rights Reserved 
CO-024597 
 
Protocol/Test Procedure Title 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable 
Sensor Performance during Hemodilution 
Lead Investigator 
Tala Harake, MS, BS 
Senior Clinical Lab Manager 
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, BS 
Clinical Research Associate 
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
Expected Start Date 
 
Expected End Date 
 
IRB 
E&I West Coast Board – IRB00007807
Protocol Version Date 
TBD 
 
Protocol Test Abstract: 
This study involves comparison of the performance of two SpHb sensors in subjects that undergo a hemodilution 
procedure.  The sensors performance will be assessed by comparison of the measured hemoglobin values against 
reference values obtained by a laboratory hematology analyzer. Blood samples will be collected from healthy 
volunteers who undergo a hemodilution procedure wherein blood is repeatedly sampled as the concentration of 
hemoglobin is reduced by administering intravenous fluids to the volunteer in a controlled manner. 
 
APPROVALS 
Author 
Date
Engineering
Date
 
 
 
 
Quality Assurance 
Date
Manufacturing
Date
 
 
 
 
 
 
 

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
CO-035572 
 
CONFIDENTIAL AND PROPRIETARY 
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© 2020 Masimo Corporation (Unpublished) 
DOT-1037 Rev. E 
All Rights Reserved 
CO-024597 
 
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, 45 CFR Part 46, 21 CFR 
Part 50, 21 CFR Part 56, 21 CFR Part 812,  ISO-14155, and International Conference on Harmonisation 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.  In addition, all changes to the consent form will be IRB-
approved; a determination will be made regarding whether a new consent needs to be obtained from participants 
who provided consent, using a previously approved consent form. 
1. 
PURPOSE 
The objective of this study is to compare the noninvasive hemoglobin (SpHb) performance of the Masimo Rainbow 
INVSENSOR00001 sensor against a control sensor.  Data using the noninvasive devices will be collected from healthy 
volunteers undergoing a hemodilution procedure. 
This is a nonrandomized single arm study wherein all subjects are enrolled into the experimental arm and receive 
both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.  Hemodilution will be 
conducted by delivery of intravenous fluids in a controlled manner to reduce the subject’s blood concentration of 
hemoglobin to obtain noninvasive hemoglobin readings SpHb at various levels.  Reference blood samples will be 
repeatedly collected from the subject and analyzed using a standard laboratory hematology analyzer.  The 
performance of the sensors will be calculated using arithmetic root mean square (ARMS) analysis of the SpHb values 
and the reference blood values.   
Outcome Measure: Comparison of INVSENSOR00001 and control SpHb sensor by ARMS calculation   
Performance of the sensors will be determined by comparing the noninvasive hemoglobin measurement (SpHb) of 
the pulse oximeter sensors to the hemoglobin value obtained from a reference blood sample and calculating the 
ARMS value. 
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. 
A blood sample gives the best measure of hemoglobin as well as other blood solutes but is difficult to measure 
continuously and without skin puncture and risk of infection.  Masimo SET and Masimo Rainbow technology allows 
real-time, non-invasive monitoring of hemoglobin (and other blood solutes) in patients and has the potential to 
improve clinical outcomes while reducing the cost of care and risks to both patients and clinicians associated with 
venipuncture. 
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).  
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.  

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
CO-035572 
 
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x 
More generally, Masimo Pulse CO-Oximeters use a multi-wavelength sensor to distinguish between not only 
oxygenated blood and deoxygenated blood, but also blood with carbon monoxide, oxidized blood and blood 
plasma. 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 
detector receives the light, converts it into an electrical signal. Once the oximeter receives the signal from 
the sensor, it utilizes Masimo Rainbow signal extraction technology for calculation of the patient’s 
hemoglobin level. 
2.2. 
STUDY DEVICES 
Investigational sensor: INVSENSOR00001 
The noninvasive, investigational INVSENSOR00001 sensor is a modified version of the control SpHb 
disposable sensor.  It has been modified with minor hardware and software adjustments that do not pose 
increased risk to study subjects.  The sensor has undergone risk assessment prior to use in human subjects 
to safeguard subject safety and well-being. Refer to the Investigator’s Brochure for more details on the 
investigational device.   
Control sensor: Masimo FDA-cleared SpHb disposable sensor    
FDA-cleared Masimo Radical-7 pulse oximeter or equivalent 
 
3. 
REFERENCE 
FRM-3923 Consent Form 
FRM-3267 Post Care Instructions 
FRM-3939 Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance 
during Hemodilution Case Report Form (CRF) 
FRM-3948 Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance 
during Hemodilution Healthy Volunteers Needed Advertisement 
FRM-3949 Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance 
during Hemodilution Recruitment Script 
FRM-3947 Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor Performance  
 
during Hemodilution Health Assessment Questionnaire 
 
R-FRM- 2449 - Confidentiality Agreement 
DEO-6407 W-9 Request for Taxpayer Identification Number and Certification  

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
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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 
Competent adults between the ages of 18 and 50 years of age 
x 
Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall 
x 
BMI ≤ 35 unless the physician determines that a higher BMI is not due to morbid obesity, to 
safeguard subject safety during hemodilution  
x 
Must have a hemoglobin value ≥ 11 g/dL at time of screening, , to safeguard subject safety during 
hemodilution 
x 
Baseline heart rate between 45 bpm and 85 bpm 
x 
CO value < 2.0% FCOHb  
x 
Physical status of ASA I or II (American Society of Anesthesiology Class 1; Healthy subjects without 
any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic 
disease) The ASA definition strictly applies to the systemic disease portion of the classification 
x 
Systolic BP d 140 mmHg and Diastolic BP d 90 mmHg 
x 
Able to read and communicate in English 
5.2. 
Exclusion Criteria  
x 
Pregnancy or positive hCG test 
x 
Smokers (including e-cigarette users) 
x 
Subject has known drug or alcohol abuse. Subjects who uses recreational drugs 
x 
Subject has experienced a concussion or head injury with loss of consciousness within the last year 
x 
Any chronic bleeding disorders (i.e. hemophilia) 
x 
Any history of a stroke, myocardial infarction, or seizures 
x 
Any cancer or history of cancer (not including skin cancer) 

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
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x 
Chronic neurological diseases (i.e. multiple sclerosis, Huntington’s Disease) 
x 
Any cardiac dysrhythmias (i.e. atrial fibrillation)(without physicians clearance)  
x 
Subject has known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that 
interferes with the subject’s level of consciousness 
x 
Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome 
x 
Subjects who have/are currently taking anticoagulant medication 
x 
Subjects who have taken opioid pain medication within 24 hours of start of study  
x 
Subjects who do not understand the study and the risks 
x 
Subjects having either signs or history of peripheral ischemia 
x 
Subjects who have 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 
Subjects that have symptoms of congestion, head colds, flu, or other illnesses  
x 
Subjects with claustrophobia, or generalized anxiety disorder 
x 
Subjects who have been in severe car accident(s) or a similar type of accident(s) requiring 
hospitalization within the last 12 months 
x 
Subjects with chronic unresolved asthma, lung disease and respiratory disease 
x 
Subjects with allergies to lidocaine, latex, adhesives, or plastic 
x 
Subjects with heart conditions, insulin-dependent diabetes or uncontrolled hypertension 
x 
Subjects who have given vaginal delivery, had a pregnancy terminated, a miscarriage with 
hospitalization or had a c-section within the last 6 months 
x 
Subjects who intend on participating 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 following a study involving an 
arterial blood draw and/or arterial line placement 
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) 
5.3. 
Withdrawal and replacement 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: the investigator feels that the subject is too money 
motivated, the investigator feels that the subject does not fully comprehend and understand the 
consent form, the subject is ill-mannered and/or shows aggressive behavior towards study staff, 
malfunction of the device for greater than 30 minutes that prevents accurate collection of optical 
data. 
5.4. 
Replacement of subjects 

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
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In case a subject is withdrawn from the study, another subject may be recruited. 
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.  
Subject safety monitoring equipment and medical supplies 
x 
Non-invasive blood pressure arm cuff(s) – as required 
x 
ECG monitor – FDA approved product 
x 
Urine HCG pregnancy test 
x 
Standard medical, wound care equipment and biohazard waste containers necessary to carry out 
the test procedure 
x 
Standard Emergency equipment and medications will be available in the room during the study- 
Crash cart 
x 
0.5%-2% lidocaine - as required  
x 
Ethyl Chloride – as required 
x 
Pain Ease – as required 
x 
Heparin or saline flush solution (as required)- or equivalent 
Oxygen administration equipment  
x 
Medical grade O2  
x 
Oxygen mask 
x 
Mouthpiece 
x 
Nasal cannula 
 
General lab supplies and equipment 
x 
Masimo proprietary multi-input data collection system 
x 
Computer with data collection software 
x 
Ambient sensor shielding bags 
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 
 

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
CO-035572 
 
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Procedures 
Phone  
Pre-Screen 
Baseline 
Visit 1 
Procedure 
Visit 1 
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 
Placement of test and control sensors  
 
 
X 
Noninvasive data collection 
 
 
X 
Removal of Blood (if necessary) 
 
 
X 
Supplemental O2 (mask or equivalent) 
 
 
X 
IV Fluid Administration 
 
 
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 volunteers.  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 if the subject appears to be 
outside the weight range based on the inclusion/exclusion criteria, the subject will 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 card (SSN) 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.   

PROTOCOL/TEST PROCEDURE 
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Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
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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. 
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.  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 or hot water bottles placed under their hands.  
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 and blood 
pressure, for safety monitoring by medical staff.  The procedure will be stopped if there is 
any evidence of volunteer stress or distress.  These signs include but are not limited to a rise 
or fall in mean arterial blood pressure of more than 30% from baseline, a rise in heart rate 
to more than 130 BPM, complaints of feeling faint, chest discomfort, GI distress, urinary 
discomfort or feelings of a bloated bladder, or alternation of mental status. Blood samples 
are also monitored for hemoglobin and/or blood oxygenation levels for subject safety.  
7.4.2. A peripheral venous line will be placed in the volunteer’s hand or arm. One or more venous 
sampling catheters will be used during the study for the removal of blood and 
administration of fluids. 
7.4.3. 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. 
7.4.4. 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 volunteer’s wrist. The A-line is placed to 
facilitate continuous blood pressure measurement for subject safety monitoring, to enable 
repeated removal of blood aliquots for reference hemoglobin values, to allow for 
determination of arterial blood gases (ABG), Hgb, Hct, as well as other non-infectious blood 
solutes. 

PROTOCOL/TEST PROCEDURE 
R-TP – 18788 
Comparison of Rainbow INVSENSOR00001 and Control SpHb Disposable Sensor 
Performance during Hemodilution 
Revision:  A 
CO-035572 
 
CONFIDENTIAL AND PROPRIETARY 
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CO-024597 
 
7.4.5. After arterial access is established, optical sensors for the noninvasive measurement(s) will 
be placed on the subject’s fingers.  Up to three test and three control sensors will be placed 
on the subject’s fingers and connected to the data collection system.   
7.4.6. Upon successful placement of the sensors and the volunteer’s indication that they are 
comfortable, a baseline set of blood samples will be obtained. 
7.4.7. One unit of blood, up to approximately 500cc (if required), will be drawn from the volunteer 
through the arterial line or through the venous site. This blood will not be re-infused and 
will be discarded. 
7.4.8. Following removal of blood, the volunteer will rapidly receive intravenous fluid (such as 
Ringers Lactate or Isolyte), to compensate for the decrease in intravascular volume and 
further reduce the hemoglobin concentration.   
7.4.9. Volunteers will receive a maximum of 40 mL/kg of intravenous fluid with no more than a 
maximum volume of 5 liters given.   
7.4.10. A set of blood samples of approximately 5cc each will be drawn at selected time intervals 
throughout the study while intravenous fluid is being administered for laboratory analysis of 
hemoglobin concentration.  The blood sample will be collected in vacutainer tubes or 
syringes for analysis by standard laboratory methods which may include CO-Oximetry, 
Coulter Counter, cyanomethemoglobin method. Any blood not used for analysis will be 
discarded.  
7.4.11. The total amount of blood removed from the subject may be up to approximately 620cc.  
This amount includes the unit of blood from section 7.4.7 (if required) and the blood 
samples from section 7.4.10.  
7.4.12. Subjects will be given supplemental oxygen through a nasal cannula, mouth piece or mask 
during some portion of the study. This is to simulate the high oxygen environments during 
surgeries and test our sensors performance during oxygen administration.  
7.4.13. Subjects may be warmed for their comfort with the use of a blanket, heating pads, or hot 
water bottles. 
7.4.14. The hemodilution procedure will continue until the subject’s fluid limits have been reached 
based on their weight, or the target hemoglobin value has been reached. 
7.4.15. The sensors/devices used in this study may be placed and removed by several operators 
multiple times during the study. 
7.4.16. At the conclusion of the procedure, the sensors/devices, IV(s) and the arterial line(s) will be 
removed and the volunteer will be allowed to leave after medical personnel determine it is 
safe to do so. 
7.4.17. At the end of the hemodilution procedure, if the last arterial blood draw hemoglobin value 
is below 8.0 g/dL, then the subject’s hemoglobin level will be monitored using an FDA 
cleared pulse oximeter. Subjects who have a hemoglobin level below 8.0 g/dL must remain 
in the study area for observation and meet a minimum rise in hemoglobin of 0.5 g/dL prior 
to leaving the study area, or until medical staff determines it is safe to do so. If medical staff 
finds it is not safe to do so, the subject will be referred to an urgent care facility.  
7.4.18. All volunteers 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 

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study. Subjects who are employees of Masimo will be advised to take as much time as they 
need after the study before returning to work. 
7.4.19. Volunteers will be given instructions on wound care. All volunteers will be instructed to 
contact the principal investigator in the event of any potential complication. 
7.4.20. The total time for the study procedures will be up to approximately 210 minutes. In the 
event that the total procedure time exceeds 210 minutes, subjects will be compensated for 
the extra time. Volunteers will be paid according to the compensation breakdown on the 
consent form. 
7.4.21. 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, their health and/or medical care. 
8. 
ACCEPTANCE CRITERIA  
The sensors will be determined to have equivalent performance based on the agreement of their ARMS 
values.  
9. 
SAMPLE SIZE JUSTIFICATION AND DATA ANALYSIS PROCEDURE TO BE USED 
9.1. 
Sample size determination 
Sample size for this study has been determined to be at least 20 subjects, based on previous experience with 
similar devices and Masimo internal procedures for sample size calculation and justification (DN-10165A).  
9.2. 
Statistical Analysis 
Accuracy will be reported as the ARMS using the following equation: 
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ሺሺܵ݌ܪܾെݐܪܾሻെܤ݅ܽݏሻଶ
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9.3. 
Measures taken to minimize/avoid bias: 
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.   
9.3.2. Operators will not make any decisions based on results from other operators or any 
parameters obtained from blood samples. 
9.4. 
Expected drop out rates 
Subjects may not complete the study for various reasons, such as screen failure, unable to complete 
hemodilution 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. 

PROTOCOL/TEST PROCEDURE 
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Performance during Hemodilution 
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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. 
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 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 assesses the adverse event as unlikely to be causally related to the test device or study 
procedures.  The investigator will inform the sponsor and IRB as required by IRB reporting guidelines. 
10.2. 
Serious Adverse Events 
10.2.1 The investigator/study staff shall promptly report both serious adverse events (e.g., subject 
death, subject hospitalization for several days) 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. 
10.2.2 At the time of discharge from the study, any unresolved serious adverse event(s) will be 
followed up by the investigator until the event(s) are resolved, stabilized or the patient is 
lost to follow-up or the adverse event is otherwise explained.  The investigator 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 
Any unanticipated problem involving subjects or others 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. 

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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. 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 
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 
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 
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. 

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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 would be no other 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: bleeding, swelling, infection, infiltration of fluids/ blood into area 
surrounding IV, bruising, hematoma, damage to the blood vessel and surrounding nerves or tissue. 
13.4. 
Arterial Cannulation risks: bleeding, 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. 
Risks Associated with Removal of Blood: Removal of blood is generally considered to be safe in most 
patients and exceptionally safe in healthy volunteers (i.e. blood donation).  The risk of removing 
blood includes the risks obtaining venous access.  Additionally, there is the risk of hypotension, 
tachycardia, anemia, dizziness and loss of consciousness.  All subjects will be maintained in a 
reclined position throughout the study and a physician will be available to continually monitor the 
vital signs.  
13.6. 
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: Vaso vagal (passing 
out), infiltrated IV, 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. 
13.7. 
Risk From Hemodilution: Hemodilution has been used successfully as a technique to reduce 
perioperative blood loss during surgery.  Hemodilution is generally considered to be safe in most 
patients and exceptionally safe in healthy volunteers.  In surgery, the chief benefit of hemodilution 
is the reduction of blood losses when whole blood is shed perioperatively at lower hematocrit levels 
after hemodilution is completed.  In our controlled clinical lab, withdrawal and blood loss will be 
limited to samples required for laboratory analysis; hemodilution will be used principally to lower 

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the subject’s hematocrit and hemoglobin.  The risks of hemodilution include heart failure, 
respiratory failure, hypertension, edema, infection and electrolyte abnormalities.  Isotonic fluids will 
be administered.  A physician will be immediately available thorough out the procedure and vital 
signs will be continually monitored.   
13.8. 
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. 
13.9. 
Risk from Inflicted Knowledge: The risk of inflicted medical knowledge to volunteers 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. 
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, 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 

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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 volunteer 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.