Oxygen Reserve Index Validation for RD Lite Sensors
Conditions: Healthy
Sponsor: Masimo Corporation

 
 
Official Title:  Oxygen Reserve Index Validation 
for RD Lite Sensors 
 
Date of Protocol: August 1, 2017 
 
NCT Number:   NCT03128892 

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Protocol/Test Procedure Title 
Oxygen Reserve Index (ORI) 
Lead Investigator 
Tala Harake, MS, BS  
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 
Based on IRB Approval Certification Approval Date 
Expected End Date 
Based on IRB Approval Certification Expiration Date 
IRB 
E&I West Coast Board – IRB00007807 
Date Submitted To IRB 
 
 
Protocol Test Abstract: 
This document describes a procedure to collect optical and invasive reference data for the development 
of Masimo’s devices and sensors.  Non-invasive data from devices and blood levels of oxygen reserve 
index (ORI) as well as other non-infectious blood solutes will be measured during hypoxic, normoxic, and 
hyperoxic conditions in order to evaluate and calibrate the system. This protocol may involve optical data 
collection, placement of arterial and venous line(s), and intermittent blood sampling for reference 
machines. 
 
 
 
APPROVALS 
 
Author 
Date
Engineering
Date 
 
 
 
 
Quality Assurance 
Date
Manufacturing
Date 
 
 
 
 

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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, the 
Declaration of Helsinki, ISO-14155, applicable regulatory requirements and International Conference on 
Harmonization Good Clinical Practice guidelines ICH GCP. 
1. 
PURPOSE 
 
 
The primary objective of this study is to collect data using noninvasive devices from healthy 
volunteers undergoing a desaturation procedure. Desaturation sub studies can be run on numerous 
parameters or devices while still following this same general procedure.   
Devices to be used in this study will use Masimo SET technology and Masimo Rainbow technology 
sensors.  Devices and sensors may be FDA-cleared or investigational.  Investigational devices and 
sensors are modified versions of the FDA-cleared products.  A listing of potential modifications to 
devices and sensors that are allowed to be conducted under this protocol is provided in Section 2.2  
All investigational devices and sensors undergo a risk assessment evaluation prior to use on 
human subjects to safeguard subjects.  No device or sensor that fall under a significant risk device 
classification as defined in 21 CFR 812.3(m) and determined by the IRB will be used under this 
protocol. 
 
The secondary objective of this study may include evaluating other non-invasive technologies that 
may also be affected by changes in hemoglobin concentration. These may include non-invasive 
hemoglobin, respiratory rate, cardiac output and carboxy-hemoglobin. In certain volunteers, 
additional sensors/devices may be used to better understand pulse and blood pressure correlation 
between the devices being tested in this study.  Pulse oximeters or similar non-invasive devices 
that are FDA approved or that are investigational may also be tested during this study if needed. 
This protocol describes procedures for multi-purpose testing that allows for evaluation of different 
investigational or FDA-cleared devices and sensors. Specific evaluations may require different 
testing conditions (i.e. warming and cooling), procedures, or testing on selected subject subsets 
(i.e. smokers).  Specific procedures and parameters for these evaluations are defined in Masimo 
Clinical Study Request Forms (CSRF). The procedures and parameters requested on the CSRF will 
at no time deviate from or exceed the procedures defined in this protocol.  CSRFs will be approved 
by the Principal Investigator to be within the limits of this protocol prior to enrollment of subjects for 
CSRF activities 
Modifications to devices and sensors that are not included in Section 2.2 fall outside this protocol 
and will require a separate IRB application and approval.  Procedures and parameters in CSRFs 
that fall outside of those identified in this protocol will likewise require a separate IRB application 
and approval.   
 
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 

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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: 
1. 
Oxyhemoglobin (oxygenated blood) and deoxyhemoglobin (non-oxygenated blood) 
differ in their absorption of red and infrared light (spectrophotometry).  
2. 
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.  
3. 
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.  
 
 
 
4. 
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 
rated at ≤ 25mW. The detector receives the light, converts it into an electronic signal 
and sends it to the Rad-57, or similar Masimo hardware platform, for calculation.  
5. 
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 and 
pulse rate, total hemoglobin, and/or other physiological parameters. 
 
2.2 STUDY DEVICES 
Devices used in this study may be either:  
x 
Masimo FDA cleared devices used according to the FDA-approved indication, or 
x 
Masimo investigational devices, which:  
x 
Are FDA-cleared devices used outside the FDA approved indication, or 
x 
Are novel prototypes or modified versions of the FDA-cleared products (with or 
without minor hardware and software adjustments) that do not pose increased risks 
to subjects. 
x 
Are non-significant risk devices. 
x 
Undergo a risk assessment evaluation prior to use in human subjects to safeguard 
subject safety. 

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x 
Competitor FDA-cleared devices used according to the FDA approved indication 
 
 
2.2.1 Current Masimo Predicate Devices 
Masimo rainbow SET® 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. Masimo rainbow and 
SET technology describes a line of sensors that all use the same pulse oximetry type 
technological concepts to read physiological parameters. Conventional pulse oximetry uses 
two LED (light emitting diodes) to emit light through one side of the finger and a detector on 
the other side that reads the amount of light that makes it through the digit.  With rainbow 
technology Masimo uses additional wavelength LEDs in order to calculate more complex 
blood solute concentrations like hemoglobin concentration. The same principles described 
above that govern Masimo SET technology (pulse oximetry) also govern Masimo Rainbow 
technology. These additional LEDs do not present any additional risk to the end user since 
they radiate light in the same wavelength and power ranges. 
Depending on the number and type of LED Emitters, the investigational device can provide 
non-invasive estimates of a number of physiological parameters. See Table 1.   
Oxygen Saturation (SpO2) 
Pleth Variability Index (PVI®) 
Pulse Rate (PR) 
Methemoglobin (SpMet®) 
Perfusion Index (PI) 
Carboxyhemoglobin (SpCO®) 
Total Hemoglobin (SpHb®) 
Acoustic Respiration Rate (RRa®)* 
Oxygen Content (SpOC™) 
Oxygen Reserve Index (ORI®) 
Table 1. List of currently FDA cleared Masimo non-invasive technology. 
 
2.2.2 Masimo Rainbow Pulse CO-Oximeter and Other Non-Invasive Sensors 
The Masimo Rainbow SET CO-Oximeter platform is FDA 510(k) cleared for the noninvasive 
and continuous monitoring of total hemoglobin concentration in adults. The devices under 
test may be investigational versions of the Masimo or Cercacor (Masimo Labs) approved 
pulse oximeters, sensors or other monitoring devices. 
 
Investigational devices are modifications of FDA-cleared products. They may differ from 
FDA-cleared products listed in Table 2 below. Each aspect of the investigational device’s 
modification is considered for impact on subject safety, and all investigational devices 
undergo a risk analysis assessment to identify required safety tests or risk mitigation 
strategies prior to use on any study subject. For investigational devices to be allowed to be 
tested under this protocol, the acceptable modification types are listed in Table 2. 
Modifications not listed in Table 2 will require a protocol amendment and approval by the 
IRB.   
 
 
 
 
 

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Type of modifications that can be 
assessed under this protocol without 
separate IRB approval 
 
Associated risks to be 
mitigated for subject safety 
Applicable US or 
international testing 
standards 
Devices:  
Power source, internal circuits, software, 
features/functionality, internal components, 
connected cables, materials, dimensional, 
active skin-contacting components, LEDs 
 
 
Electromagnetic compatibility,  
electric shock, fire, 
mechanical, unwanted 
energies (i.e. thermal), ingress 
of liquid/particulates, 
environment 
IEC 60601-1-2
ANSI/AAMI ES 
60601-1 
ISO 10993 
ISO 80601-2-61 
Sensors:  
Power source, enclosure, software, 
instrument hardware, shielding, 
dimensional, materials, patient contacting 
materials, internal components, LEDs, 
internal circuits 
Electromagnetic compatibility,  
electric shock, fire, 
mechanical, unwanted 
energies (i.e. thermal), ingress 
of liquid/particulates, 
environment, biocompatibility
IEC 60601-1-2
ANSI/AAMI ES 
60601-1 
ISO 10993 
ISO 80601-2-61 
Table 2: List of the type of modification that can be assessed under this protocol without separate IRB 
approval.  NOTE: Each aspect of an investigational device’s modification will be considered for impact on 
subject safety. All investigational devices’ modifications shall undergo a risk assessment to identify required 
safety tests or risk mitigation strategies prior to use on any study subject.  Depending on the investigational 
device, not all listed tests or standards may be applicable. 
 
2.2.3 Masimo 4- Board Engineering Device  
Masimo Rainbow 4-Board System is a multi-input platform designed to duplicate the 
functionality of four Masimo Rainbow Technology Pulse CO-Oximeters.  The instrument, 
approximately 6 inches x 8 inches x 12 inches (HxWxL) contains four Masimo MX circuit 
boards inside it (see Appendix 2) that are identical to the circuit boards in the commercial 
device. The circuit board is the component of the device that performs the functions of the 
pulse oximeter including the LED and photodiodes on the sensor and signal processing in 
the main unit.  The instrument receives input from four Masimo sensors and sends output to 
a specific data acquisition program on a computer.  The MX circuit boards are FDA 
approved and are the primary component on the three currently marketed Masimo devices, 
including the Radical-7, Rad-87, and Rad-57.   
The Rainbow 4-Board System is a non-significant risk device that has no additional risks 
compared to the commercially available pulse oximeter devices.   
2.2.4 Cercacor  Pronto Device and Sensors 
The Cercacor (Masimo Labs) Pronto System is a device that is functionally very similar (For 
example, change in LEDs to qualify a new lot of LEDs, or change in software; none of these 
changes would present any additional risk to the subject and none would be used outside 
the parameters of what the approved device would be used for. The devices would be used 
as indicated)to the Masimo Rainbow SET technology. Data is collected by means of a 
noninvasive optical sensor and digitally stored for later post processing and analysis. The 
measurements are taken by placing a sensor on a patient, usually on the fingertip.  The 
sensor connects directly to the data collection instrument with a patient cable. The sensor 
collects optical signal data from the patient and sends it to the instrument to be stored. 
 
 

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3. 
REFERENCE 
Below is a full list of documents relevant to this protocol and study conduct under this protocol. 
Please reference this list if additional information is needed on any specifics of this study. 
Documents Related To This Study: 
R-FRM-3759 Consent to Act as Human Research Subject 
FRM-3514 Subject Gender & Ethnicity Questionnaire 
FRM-3267 Post Care Instructions 
FRM-3758 Oxygen Reserve Index (ORI) Case Report Form (CRF) 
FRM-3760 Oxygen Reserve Index (ORI) Advertisement 
FRM-3756 Oxygen Reserve Index (ORI) Recruitment Script 
FRM-3757 Oxygen Reserve Index (ORI) Health Questionnaire 
 
R-FRM- 2449 - Confidentiality Agreement 
DEO-6407 W-9 Request for Taxpayer Identification Number and Certification  
FRM- 1084 Volunteer payment form 
 
Administrative Documents: 
FRM- 3451 Informed Consent Process 
FRM-3336 Device Accountability Log  
FRM-2336 Clinical Study Request Form (CSRF)  
 
Regulations/ Guidance: 
LAB-7666 Operator’s Manual, English ISA™ CO2 Sidestream Analyzer 
CSD-1008 PHYSIOLOG User’s Guide 
CP-10098 Oxigraf Calibration Procedure 
CP-10028 Desaturation Test System Calibration Procedure 
CSD-1071 PHYSIOLOG User’s Manual 
DEO-7038 Microcap Handheld Capnograph User Manual 
LAB-5475 Radical 7 Operator’s Manual 
DEO-1006 21 CFR Part 812 Investigational Device Exemptions 
DEO-1006  21 CFR Part 812 - Investigational Device Exemptions 
DEO-6398  21 CFR Part 56 - Institutional Review Board 
 
DEO-6397  21 CFR Part 54 – Financial Disclosure by Clinical Investigators 
DEO-1369  Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 
DEO-1427  The Declaration of Helsinki 
DEO-5550  ISO 14155:2011 Clinical investigation of medical devices for human subjects – Good 
clinical practice 
DEO-2873  MEDDEV 2.7.1, December 2009: Evaluation of Clinical Data: A Guide for 
Manufacturers and Notified Bodies 
DEO-6373  The Belmont Report 
DEO-6395  21 CFR Part 11 – Electronic Records and Electronic Signatures 
DEO-6396  21 CFR Part 50 – Protection of Human Subjects 
DEO-6399  21 CFR Part 801 – Labeling 
DEO-6401  45 CFR Part 46 – Protection of Human Subjects 
DEO-6402  Guidance for Adverse Event Reporting to IRB’s 
DEO-6403  ICH Clinical Safety Data Management 
DEO-6361  ICH Guidelines for Good Clinical Practice  
DEO-6406  The Nuremburg Code 
DEO-6404  Title 24 Chapter 9 360c – Classification of Devices Intended for Human Use 

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DEO-5595  Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; 
Approved Standard – Sixth Edition (H3-A6, Vol. 27 No. 26) 
DEO-6521 Arterial Blood Gas Sampling 
DEO-6631 Body Mass Index Table 
 
4. 
LOCATION 
Masimo Corporation 
52 Discovery 
Irvine, CA 92618 
 
(Any other locations will be added by modification) 
5. 
EQUIPMENT, MATERIALS AND SAMPLE SIZE JUSTIFICATION  
5.1. 
Safety equipment and Blood Analyzers Maintenance:  
5.1.1. All blood analyzers, ECG monitors, Blood pressure monitors and safety equipment 
will be maintained per manufacturer specifications and all study personnel will be 
trained on the use of relevant equipment.  
5.1.2. The blood pressure cuff, ECG monitors, and FDA cleared oximeter will be used for 
monitoring of the participants for their safety.  
5.1.3. The blood analyzers will be used to run blood samples collected throughout these 
studies for analyzing blood solutes that are relevant to specific noninvasive 
technology readings being tested. e.g. Blood  will be run for purposes of reading 
hemoglobin from sample compared to non-invasive hemoglobin reading from 
Masimo Hemoglobin sensor. 
5.2. 
Equipment and Materials: to be used as required. Similar devices would not present any 
additional risk to the subject and none would be used outside the parameters of what the 
approved device would be used for. Standard safety monitors will be used for this study 
(e.g. ECG, FDA-cleared pulse oximeter, BP cuff) 
Equivalent equipment and materials to those listed below may be used: All lab analyzers 
and equipment will be maintained per manufacturer specifications and all study personnel 
will be trained on the use of relevant equipment. 
 
Subject safety monitoring equipment and medical supplies 
x Non-invasive blood pressure arm cuff(s)  
x ECG monitor – FDA approved product 
x Urine HCG pregnancy test -female subjects only 
x Standard band aids, needles, syringes, sharps container or other 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 on-site during the 
study 
x 0.5%-2% lidocaine  
x Ethyl Chloride/Pain Ease  
x Heparin or saline flush solution (as required)- or equivalent 
x Arterial blood pressure transducer 

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FDA-Cleared devices and sensors  
x Other companies Sensors/Devices  
x Other companies Blood Pressure Devices  
x Rainbow Sensors 
x Conventional Pulse Oximeters 
x Conventional Pulse Oximeter Sensors  
x Conventional Pulse Oximeter Patient Cables (Cleared, investigational and/ or similar to 
cleared device. (The similar device would not present any additional risk to the subject 
and none would be used outside the parameters of what the approved device would be 
used for. The devices would be used as indicated)  
x Masimo 4-board system 
x Masimo Radical or comparable data collection unit (The comparable data collection unit 
would not present any additional risk to the subject and none would be used outside the 
parameters of what the approved device would be used for. The devices would be used 
as indicated) – as required 
 
Investigational devices and sensors  
x Other companies Sensors 
x Masimo Sensors 
x Pulse Oximeters 
x Pulse Oximeter Sensors  
x Pulse Oximeter Patient Cables  
x Masimo 4-board system 
x Masimo Radical or comparable data collection unit (The comparable data collection unit 
would not present any additional risk to the subject and none would be used outside the 
parameters of what the approved device would be used for. The devices would be used 
as indicated) – as required 
 
Oxygen administration equipment  
x Medical grade O2  
x Oxygen mask 
x Mouthpiece 
x Nasal Cannula 
 
Desaturation equipment and safety equipment 
x Gas flow meters 
x Gas tanks, regulators 
x Gas hoses 
x ISA OR+ 
x IRMA 
x EMMA (associated tubing etc.) 
x Capnography 
x Oxigraf (or equivalent) 
x Motion Generator  
x Mouthpiece 
x Nose clip 

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General lab supplies 
x Ambient sensor shielding bags 
x Data Collection Software 
x Stopwatch  
x Icy Hot topical gel (or equivalent) 
5.3. 
Sample size justification  
5.3.1. Sample size justification is not applicable for this protocol. This is a protocol for an 
IRB study with annual renewal therefore the total number of participants will be within 
the allowance approved by the IRB and submitted annually for renewal while the 
study remains active.   
5.4. 
Standard Precautions  
5.4.1. Subjects will have continuous ECG monitoring throughout the study (may not be 
recorded/ for monitoring by medical staff).  
5.4.2. ACLS certified physician will be in attendance (in the study space) throughout the 
entire procedure, and the study will be completed under their general supervision.  
5.4.3. Any emergency drug deliveries in the case that a subject loses consciousness or has 
another emergency arise (standard crash cart medications- atropine, ephedrine 
etc.) shall be recorded. This individual will be monitored and this information will be 
recorded and submitted to the IRB if necessary (unanticipated adverse event) and 
the subject will be given the option to follow up with a local urgent care facility. 
5.4.4. The volunteer will be monitored (through observation by clinical study staff) 
throughout the study procedure.  
5.4.4.1. An additional pulse oximeter will occasionally be used for the duration of the 
study to monitor subjects’ vital parameters to ensure their safety. 
5.4.5. All adverse events will be recorded.  
6. 
PROCEDURE 
Overview: During this study we will recruit human subjects; this will include members of the general 
public and Masimo employees, to participate in a study. The study may contain any subset of the 
procedures listed below. During this study we will be testing the sensors in order to make a 
desaturation assessment of our noninvasive devices (listed above). Participants in this study will 
come in and be seated, review the consent information, agree or not. One or more clinician(s) will 
place venous line(s) and arterial line(s), and sensors will be placed. The clinician will collect arterial 
blood samples which will be run on our internal blood analysis equipment (coulter counter, arterial 
blood gas analyzer etc.). This blood sampling will serve the purposes of a comparison tool for the 
readings that were recorded from the noninvasive devices and sensors. 
Pulse oximetry monitoring will take place throughout the study. During this study subjects may have 
any of the following done: continuous reference blood sampling from an established arterial or 
venous line and oxygen administration. Please refer to Appendix A for an example of a typical ORI 
study schematic. 
6.1 
RECRUITMENT 
6.1.1 Advertisement  
Recruitment materials are posted publically in local newspapers, Craigslist, 
schools/universities etc. 

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6.1.2 Phone Screening 
Potential subjects can contact Masimo to inquire more details about the study. The 
recruitment process is managed by the designated person(s) who is trained for 
phone screening/scheduling.  Appointments are made once the phone screening 
process is completed and the person screening the subject determines if they qualify 
or not for the study based on inclusion and exclusion criteria. 
Information from the screening will be kept in a database located within the firewall 
Masimo internal network with user level access control enforced domain log in.  
Additionally the database is encrypted and password protected. The information is 
kept to contact subjects for other studies they may qualify for or instances to track 
subjects who call in and provide false information only to qualify.  
 
6.2 
PRE-ENROLLMENT SCREENING AND EXAM 
6.2.1 Subjects will be asked to provide a copy of their valid government photo ID and/or 
Social Security (SSN) to verify subject information in our scheduling database and/or 
to verify the subjects’ identity. Foreign persons (A foreign person includes a 
nonresident alien individual and certain foreign entities that are not U.S. persons) will 
be asked to provide a copy of U.S. immigration documents/Tax ID Number (TIN) or 
equivalent, and to complete a W-8BEN form to report earnings to the Internal 
Revenue Service (IRS). 
The copies of these forms of identification will be stored along with the subjects 
consent documents. The confidentiality and retention of these documents will be 
protected to the extent provided and required by the law.  
The SSN number and ID card is kept to verify subject’s identities or instances to 
track subjects who provide false identification. 
6.2.2 Subjects will be informed of the procedure prior to participating in the study. Subjects 
must read and sign the consent document, using our informed consent process. The 
consent form must be stamped with a current IRB approval. No study related 
activities will be conducted until consent is signed.  
6.2.3 Weight is self-reported by the subject, but if the subject appears to be outside the 
weight range based on the inclusion/exclusion criteria, subjects will be weighed on a 
scale.  
6.2.4 After consenting, 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. 
6.2.5 Subject demographic information including age, sex, skin tone, ethnicity, height and 
weight will be collected.  
6.2.6 In addition, a medical history will be recorded after initial screening questionnaire. 
Pre-procedural vital signs will be recorded for subject safety monitoring.  
6.2.7 Female subjects will be required to take a pregnancy test. Results will be noted. If 
the pregnancy test is positive the subject will be removed from the study and notified 
of their pregnancy test results.  

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6.2.8 A venous blood sample will be obtained and analyzed to verify that the starting 
hemoglobin level is greater than or equal to 11 g/dL and HbCO<2.0%.  If less than 
11 g/dL and/ or HbCO>2.0%, the subject will be excluded from the study. 
6.2.9 Blood samples will be discarded after testing. These samples will be discarded in the 
appropriate biohazard waste bins and the samples are de-identified 
6.2.10 Subjects may have a blanket placed on them (per request of subject or staff). 
6.2.11 Subjects may be offered a snack (ie. Granola bar) and/or beverage (ie. Water, juice) 
due to the amount of time their involvement in this study may take.  
 
6.3 
PRE DESATURATION PROCEDURE 
6.3.1 The subject will be seated and/or lying in supine position and should refrain from 
excessive movement during the study. 
6.3.2 Safety monitors will be placed on the subject, which may include FDA-cleared pulse 
oximetry, ECG, and blood pressure (may not be recorded automatically depending 
on the protocol, this may be recorded manually by medical staff). 
6.3.2.1 
Post Qualification: Spikes in blood pressure and heart rate can be 
expected during (but is not limited to) line placement, needle sticks, blood 
draws etc. and may also be attributed to anxiety/nervousness relating to a 
new environment. For most participants, only the initial recorded blood 
pressure and/or heart rate determines a subject’s qualification for the 
continuation of the screening procedure.  In the case where heart rate and 
blood pressure changes suggest participant discomfort or a potential 
safety concern, the participant will be removed from the study after 
qualifying.  This will be left to the discretion of medical and study staff. 
6.3.3 A peripheral venous line will be placed in the volunteer’s hand or arm. One or more 
venous sampling catheters may be used during the study for removal of samples of 
blood to allow for determination of hemoglobin concentration, Hct, as well as other 
non-infectious blood solutes. This is a necessary study parameter. 
6.3.3.1 
In the event that an IV is placed we will offer to use lidocaine (lidocaine 
injection, Ethyl Chloride and/or Pain Ease) to numb the site. Lidocaine is 
not a required study parameter and is presented to subjects as a choice 
for comfortability and/or preference. Subjects will be given the option to 
have Lidocaine or numbing spray used during IV placement. Lidocaine 
and/ or numbing spray will be administered by medical personnel who are 
IV certified for the purpose of making catheter (venous and/or arterial) 
placement more comfortable for the subjects. Although the subject would 
be receiving two “pokes” if they choose the lidocaine injection prior to the 
IV placement, the IV may be a smaller gauge (larger size) than the needle 
used for lidocaine injection causing more discomfort to the subject. If the 
subject chooses to have Lidocaine used then it will be administered 
through a smaller-sized needle (28 gauge). Subjects may prefer the 
smaller size needle for the lidocaine knowing it may help the IV insertion to 
be less uncomfortable. 
6.3.4 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 volunteers wrist. This study is 
being done with an arterial line to facilitate continuous blood sampling to allow for 
determination of arterial blood gases (ABG), hemoglobin (Hgb), hematocrit (Hct), as 
well as other non-infectious blood solutes. 

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6.3.5 Upon successful placement of the IV, Arterial line and the volunteers’ indication that 
they are comfortable, optical sensors for noninvasive measurement(s) will be placed 
on the subjects fingers. 
6.3.6 Because this is a general procedure for desaturation testing sensor placement on 
digits or other parts listed is not specified. The configuration for any particular study 
will be determined at test time. 
6.3.7 Other non-invasive sensors may also be placed on the skin, toes, feet, neck, clavicle, 
face, chest, forehead, wrist, arms, legs, nose, nostrils, back, abdomen and/or ears. 
These sensors may be placed and removed by several operators several times 
during the study.  
6.3.8 The subjects will be informed of the type of procedure that they will be participating in 
before enrollment in the study. 
 
6.4 
ORI PROCEDURE 
6.4.1 Upon successful placement of the safety monitors and the volunteer’s indication that 
they are comfortable, a baseline set of blood samples will be obtained. 
6.4.2 A qualified person will complete blood draws. These blood draws may occur at 
various points during the length of the study. This is a necessary study parameter. 
6.4.3 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.  Up to 50 samples of blood may be 
collected and analyzed. The blood sample will be collected in vacutainer tubes or 
syringes for analysis by standard laboratory methods which may include CO-
Oximetry, Coulter Counter, spun hematocrit, Cyanomethemoglobin method and 
analysis by other Point of Care devices.  
6.4.4 The total amount of blood drawn will not exceed 550mL  
6.4.5 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. 
6.4.5.1 It is normal for subjects to feel as though they have to concentrate on 
their breathing more than they would normally.  This is due to the fact 
their nose is plugged and most subjects are not used to breathing with 
a mouthpiece.  The gas flow rate may be increased to help subjects to 
feel less like their breathing is restricted. 
6.4.5.2 Subjects will be instructed to spit out the mouthpiece at any time if 
they wish to stop the study, feel uncomfortable, or feel as though they 
are getting light headed, dizzy, or nasuseous. 
6.4.6 If the subject is not a Masimo Corporation employee, a de-identified blood sample 
may also be tested for hemoglobinopathies.   
6.4.7 The process will be stopped if there is any evidence of volunteer stress or distress. 
x 
These signs include but are not limited to a rise or fall in mean arterial 
blood pressure of more than 30% from baseline, complaints of feeling 
faint, chest discomfort, GI distress, urinary discomfort or feelings of a 
bloated bladder, altered mental status, or significant elevation in heart 
rate (per physician’s discretion).  
6.4.8 The sensors/devices used in this study may be placed and removed by several 
operators multiple times during the study. 
6.4.9 Any blood not used for analysis will be discarded.  

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6.4.10 Raw absorbance data from the noninvasive device(s) may be collected from the 
sensors/ devices and stored on a computer.   
6.4.11 Other standard output parameters may also be recorded from the device(s) (SpO2, 
SpMet, SpCO, PVI, PI, pulse rate are some examples of these).   
6.5 
DESATURATION PROCEDURE 
6.5.1 Subjects may also be taken to different saturation levels below room air. The lowest 
targeted value will be 85% oxygen saturation. Subjects will not be below 85% for 
longer than 240 seconds as verified by the reference pulse oximeter or reference 
blood analyzer. 
6.5.2 Note: There will be a medical grade oxygen tank next to the subject, equipped with 
an oxygen mask, ready for a scenario where a subject needs 100% oxygen 
immediately. At any point in the study, if the subject feels uncomfortable, the subject 
will be given 100% oxygen. The subject’s mouthpiece and nose clip will be removed 
and oxygen will be administered until medical personnel determine the subject is 
asymptomatic and the subject acknowledges they are feeling better. 
6.5.3 Continuous pulse oximeter readings, using on-line computer data collection, will be 
done for all parts of the study. The points of the blood samples will be noted into the 
data collection software. 
6.5.4 During the study, subjects may be recorded using photography and/or videography.  
The recordings may include sound.  These recordings will not capture any identifying 
features.  These recordings may be used for training or quality control purposes.  
6.5.5 In studies with photography and/or videography, subjects will give consent for the 
recordings prior to the start of any study-related activities. 
 
6.6 
ENDING PROCEDURE 
6.6.1 The total time will be approximately 180 minutes with or without the oxygen 
administration procedures. In the event that the total procedure time exceeds 180 
minutes, subjects will be compensated for the extra time.  
6.6.2 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. 
6.6.3 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 study. All subjects including subjects that are employees of 
Masimo will be advised to take as much time as they need after the study before 
returning to work. 
6.6.4 Volunteers will be given instructions on wound care. All volunteers will be instructed 
to contact the principal investigator and/or study staff in the event of any potential 
complication. 
6.6.5 Volunteers will be paid according to the compensation breakdown on the consent 
form. 
6.6.6 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. 
 
6.7 
TIMING REQUIREMENTS FOR SUBJECT PARTICIPATION 
 

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There are waiting periods associated with different studies and protocols. Below is a 
list of waiting periods for participating in this study. 
 
  
Circumstances 
Wait Period Before Participating 
If the subject does not participate in the 
study for reasons other than being 
disqualified. 
The subject may return and participate 
in a study immediately. 
Participated in a study that includes 
blood draws from a vein  
There is no waiting period after 
After having participated in a study 
where an IV is attempted but not placed 
There is a 48-hour waiting period from 
participating in studies involving venous 
lines or venous sticks after having 
participated in a study where an IV is 
attempted but not placed. This also 
applies if the IV is placed and used only 
for a qualifying draw or placed for safety 
during a study. 
Once an arterial catheter (arterial line) is 
successfully placed and used to draw 
blood. 
Subjects must wait 8 weeks to 
participate in a study 
In the event of an unsuccessful arterial 
line placement 
Subjects must wait 4 weeks to 
participate in a study. 
 
7. 
ACCEPTANCE CRITERIA (IF APPLICABLE) 
7.1. 
Acceptance criteria not applicable as this protocol is for data collection purposes for product 
research and development.  
8. 
DATA ANALYSIS PROCEDURE TO BE USED 
8.1. 
As this protocol is to collect data for the purposes of product development and/or validation, 
data analysis procedures will vary depending on the nature of the testing required. For 
validation studies, a full description of the statistical analysis plan will be provided in the 
CSRF prior to subject enrollment for the CSRF. 
8.2. 
Sample size and level of significance and power   
 
Sample size is non-deterministic and will be determined per CSRF testing set. 
Any of the parameters listed in Table 1 may be tested. In many cases, a number of 
parameters can be evaluated simultaneously. For example this can be done by 
placing multiple types of sensors on the same subject but on different fingers. 
8.2.1. 
Study variables 
8.2.1.1. 
Devices (see section 2 for descriptions and limits) 
8.2.1.2. 
Procedures (see section 6 for descriptions and limits) 

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8.2.1.3. 
Subjects (see section 9 for descriptions and limits) 
8.2.1.4. 
Other: None allowed unless named. 
8.2.2. 
Measures taken to minimize/avoid bias: 
8.2.2.1. 
Subjects are selected from the population surrounding the test site 
(including employees). Where applicable, subjects with required 
demographics (skin color, age, gender, etc.) may be preferentially recruited. 
8.2.2.2. 
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.   
8.2.2.3. 
Operators will not make any decisions based on results from other 
operators or any parameters obtained from blood samples. 
8.3. 
Statistical Design 
8.3.1. Data will be analyzed using statistical software or Matlab code (or similar programs) 
to perform a multi-factor analysis.  Estimates of variance components from these 
procedures will be used to calculate the reproducibility and repeatability. 
8.3.2. When applicable, Clinical Summary Reports for each CSRF run under this protocol 
will describe any reasons for terminating the study early. 
8.3.3. Depending on the specific study, values may be calculated for subgroups (e.g. 
gender, device types, subject demographics, etc.). These will be addressed in the 
CSRF, as required. 
8.4. 
Data Quality Assurance 
8.4.1. The investigator/study staff shall prepare and maintain accurate case histories 
designed to record all observations and other data pertinent to the study for each 
study participant. All information shall be recorded on the case report forms. 
8.5. 
Case Report Forms 
8.5.1. Data shall be entered into a Case Report Form. The relevant data on the Case 
Report Forms will be transferred into a database for analysis.  No subject identifiers 
will be collected on the Case Report form. Access to the completed Case Report 
Forms will be locked and the Study Database will be password protected, both 
limited to study personnel. 
8.5.2. Case report forms will capture protocol deviations and will prompt any notifications to 
the IRB.  
8.6. 
Expected Dropout Rates 
There are two possible dropout causes: 

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8.6.1. The first is if the sensor/device fails to provide a valid reading on a Subject. 
Depending on desired endpoints and parameter statistics, individual CSRF may 
address how many valid measurements are required to include a subject in the 
analysis. The second is if the Subject does not wish to complete the study. All 
subjects have the right to terminate the study at any time. Depending on the number 
of valid measurements taken prior to termination, the sponsor may elect to keep the 
collected data. 
8.6.2. If required due to a significant amount of missing data from specific subjects, 
advanced statistical techniques using Mixed Effects analysis will be used. These 
techniques are more immune to missing data. 
9. 
SUBJECTS 
Potential subjects may be recruited and enrolled according to the criteria below.  CSRFs may 
include all or just some of these criteria based on the nature of the testing required.  At no time shall 
CSRFs enroll subjects outside the limits defined inclusion and exclusion criteria below.  For 
example, a CSRF may define a CSRF inclusion criteria of 18-25 years of age as this subset meets 
this umbrella protocol’s inclusion and criteria for subject age. 
 
Inclusion Criteria (Eligible Subjects) 
x 
Competent non-smoking (smokers including e-cigarette users) adults between the ages of 
18 and 50 years of age. 
x 
We may also be interested in specifically recruiting smokers for some portions of this 
study as well as non-smokers for other portions of this study.   
x 
Must weigh a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet 
tall.  
x 
Must have a hemoglobin value greater than or equal to 11 g/dL. 
x 
Baseline heart rate > 45 bpm and < 85 bpm. 
x 
CO value d 2.0% FCOHb (unless we are specifically interested in recruiting smokers) 
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) 
x 
The ASA definition strictly applies to the systemic disease portion of the classification 
x 
Blood Pressure (Systolic BPd 140 mmHg and Diastolic BP d 90 mmHg). 
x 
Able to read and communicate in English 
x 
Has signed written informed consent 
x 
Female, non-pregnant.  
x 
Female subjects will be provided with a pregnancy test free of charge.  
 
Exclusion Criteria (Ineligible subjects) 
x 
Subjects who do not understand the study and the risks involved.  
x 
Subjects with BMI > 35 that a medical professional classifies as morbid obesity or has an 
increased risk for participation 
x 
Subjects with open wounds, lacerations, inflamed tattoos or piercings, visible healing 
wounds. 
x 
Subjects with frequent or severe headaches and/or migraine headaches.  
x 
Subject has known drug or alcohol abuse. Subjects who uses recreational drugs. 
x 
Subject has experienced a head injury with loss of consciousness within the last year. 
x 
Any chronic bleeding disorders (i.e. hemophilia) 

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x 
Any history of a stroke, myocardial infarction, seizures or heart attack. 
x 
Any cancer or history of cancer (not including skin cancer). 
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 subjects’ level of consciousness. 
x 
Known or concurrent chronic usage of psychoactive or anticonvulsive drugs. Subjects with 
psychiatric conditions or are on psychiatric medications 
(i.e. tricyclic antidepressants, MAO inhibitors, Lithium, neuroleptics, anxiolytics or 
antipsychotics, except SSRIs). 
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, such as Reynauds Syndrome. 
x 
Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome 
x 
Inability to tolerate sitting still or maintain minimal movement for up to 90 minutes. 
x 
For studies involving finger sensors: subjects with polished, gel or acrylic nails, skin 
abnormalities affecting the fingers or arms (such as psoriasis, eczema, angioma, scar 
tissue, burn, fungal infection), distinct finger edema, substantial skin breakdown damaged 
and/or finger nail deformities (specific finger will not be used, unless we are specifically 
testing sensors in use with nail polish, gel, and /or acrylic nails). 
x 
Subjects who have/are currently taking anticoagulant medication.  
x 
Subjects who have had caffeine consumption the day of the study. 
x 
Subjects who have taken pain medication within 24 hours of start of study. Unless minimal 
preventative dose recommended for adults (discretion of physician). 
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 who have had minor surgery or conditions in the past two months including but not 
limited to minor foot surgery (bunion), arthroscopic procedure, blood donation, plasma 
donation, skin biopsy/ procedures, root canal, fractures,  eye surgery, and other minor 
procedures. 
x 
Subjects that have been on antibiotics had congestion, head colds, flu, ear infection, chest 
congestion will have a 2 week waiting period from the time of finishing medications and must 
have no more symptoms. 
x 
Subjects with claustrophobia, or anxiety. 
x 
Subjects who have been in severe car accidents or a similar type of accidents will have a 12 
month waiting period, from the time of the accident; unless upon further medical history 
questions the physician determines it does not place the subject in any additional harm, 
increase their risk, or compromise the subjects’ safety. 
x 
Subjects who have had a concussion will have a 12 month waiting period, from the time of 
the concussion.  
x 
Subjects with chronic unresolved asthma, lung disease or respiratory disease. 
x 
Subjects with allergies to lidocaine, latex, adhesives, or plastic. 
x 
Subjects with heart conditions, Diabetes or hypertension. 
x 
Subjects who have given vaginal delivery will have a 6 month waiting period. Subjects who 
had a pregnancy terminated, a miscarriage or had a C-section will have a 12 month waiting 
period. 

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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 
Discretion of investigator/study staff 
 
10. 
WITHDRAWAL OF SUBJECTS  
Subjects must be withdrawn under the following circumstances: 
10.1. The subject withdraws consent 
10.2. Discretion of investigator/study staff 
10.2.1. For example (not limited to these examples): 
10.2.1.1. The investigator/study staff feels that the subject is too money motivated 
10.2.1.2. The investigator/study staff feels that the subject does not fully comprehend 
and understand the consent form 
10.2.1.3. The subject is ill-mannered and/or shows aggressive behavior towards 
study staff 
10.2.1.4. Malfunction of the device for greater than 30 minutes that prevents accurate 
collection of optical data. 
10.3. There is set criteria that will be used to determine if the subject qualifies to participate in this 
study. Based on the discretion of the investigator/study staff and/or the evaluation of the 
qualifying criteria they may be excluded from this study. 
• If the investigator/study staff notices a trend with (not limited to these examples) the 
subjects’ blood pressure fluctuating outside the parameters, their heart rate fluctuating 
outside the parameters, their need to repetitively void early and/or their inability to remain 
still for the majority of the study they will be removed from the study and may not be used 
as a participant in that particular study in the future. We don’t want to put the subject in 
any situation that makes them uncomfortable or may compromise their safety (ie. 
fidgeting, bladder tolerance, hypertension, inability to stay awake, discomfort with 
mouthpiece, etc.). 
11. 
ADVERSE EVENTS 
Definitions (SQP-1125): 
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. 
x 
Device deficiencies will be reported according to department procedures. 

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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. 
11.1. Adverse Events 
11.1.1 All adverse events that occur during the study shall be recorded on the Case Report 
Form even if the investigator/study staff assesses the adverse event as unlikely to be 
causally related to the test device or study procedures. 
11.2. Serious Adverse Events 
11.2.1 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. 
11.2.2 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/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. 
 
 
12. 
MEASURES TAKEN TO PROTECT THE RIGHTS AND WELFARE OF SUBJECTS 
12.1. 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. 
12.2. The following measures will be taken to insure the confidentiality of the subjects: 
12.2.1. A code (identification) number for each subject will be kept on file. 
12.2.2. Only their corresponding identification number will identify subjects. 
12.2.3. Access to identifying documents (IC, SSN, Photo ID) and data will only be made to 
the principal investigators in the study and study staff. 
12.2.4. The confidentiality and retention of these documents will be protected to the extent 
provided and required by the law. 
12.3. Documents and Database  

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12.3.1. 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 
12.3.2. Documents and information stored electronically will be protected using a multi-
faceted procedure including, but not limited to the following steps: 
x    Endpoint: 2 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. 
 
12.4. Vulnerable Populations 
12.4.1. Employees are considered to be a vulnerable population 
12.4.1.1. 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. 
12.4.1.2. Neither supervisors nor superiors will be involved in the recruitment of 
employees for participation in the study. 
12.4.2. Economically disadvantaged or unemployed and educationally disadvantaged 
12.4.2.1. Reasonable compensation will be provided for economically disadvantaged 
subjects to eliminate possibility of undue influence due to financial 
incentive. 
12.4.2.2. Educationally disadvantaged subjects will be provided ample time to ask 
questions and comprehend information 
 
13. 
RISKS/DISCOMFORTS  
The studies will be conducted per IRB approved procedures. The study subjects will consist entirely 
of healthy volunteers.  The readings obtained during the study will be recorded but will not be used 
in patient care, monitoring, or diagnosis. 
13.1. Risks 

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13.1.1. Risks can be categorized into the following categories: 
x 
Those associated with the device 
x 
Those associated with the placement of venous access (venous cannulation) 
x 
Those associated with placement of the arterial line (arterial cannulation) 
x 
Those associated with blood draws 
x 
Those associated with inflicted knowledge 
x 
Those associated with the Lidocaine injection 
x 
Those associated with the Lidocaine spray 
x 
Those associated with low oxygen concentration 
x 
Those associated with oxygen administration 
x 
Those associated with the nose clip 
x 
Those associated with loss of confidentiality/privacy 
x 
Those associated with Additional testing 
Note: In the very unlikely, worst case, complications from the study may result in death. The 
study shall be stopped by the subject or study staff long before this would occur. 
 
13.1.2. Device Risk 
13.1.2.1. 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.   
13.1.2.2. 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). 
13.1.2.2.1. If there are any cuts and/or abrasions near the finger nail certain 
types of sensors may not be placed on the particular finger to 
avoid any discomfort for the subject. 
13.1.3. Venous Cannulation Risks: 
13.1.3.1. Risks associated with venipuncture include bleeding, swelling, infection, 
infiltration of fluids/ blood into area surrounding IV, bruising, hematoma, 
damage to the blood vessel and surrounding nerves or tissue. 
13.1.4. Arterial Cannulation Risks: 
13.1.4.1. The radial artery is the most common site for invasive blood pressure 
monitoring in anesthesia and critical care medicine because it is technically 
easy to cannulate and complications are uncommon, in part owing to the good 
collateral circulation of the hand.  The widespread application of invasive 

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arterial pressure monitoring in anesthesia and intensive care is related to the 
extremely good safety record of this technique.   
13.1.4.2. Other risks include 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. 
 
13.1.5. Blood Draw Risks 
13.1.5.1. Discomfort is generally associated with needle puncture. The most common 
complications associated with blood draws are hematomas or bruising. 
13.1.5.2. There is also a possible risk of infection, tendon or tissue damage, damage 
to the blood vessel and surrounding nerves, loss of feeling in hand and/or 
arm and even the loss of hand due to rare complications of the study.  
13.1.5.3. Other anticipated adverse events that may occur, include but are not limited 
to: 
x 
Vasovagal (fainting) 
x 
Infiltrated IV 
x 
Lightheadedness 
x 
Feeling flush/ warm 
x 
Feeling nauseated 
x 
Throwing up 
x 
Seizures 
x 
Sudden drop in blood pressure/ sudden increase in blood pressure 
x 
Sudden drop in heart rate/ sudden increase in heart rate 
x 
Tingling sensation of face, arms and/or legs 
x 
Sweating 
x 
Mouth dryness  
These anticipated adverse events are expected to be temporary. 
The listed discomforts and complications associated with blood draws can be 
expected and are not an act of neglect, failure to follow standards or related to the 
sensors or devices used in the study.   
13.1.6. Risk from Inflicted Knowledge 
13.1.6.1. The risk of inflicted medical knowledge to volunteers is negligible since we 
de-identify 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. We 
will reduce the risk of inflicted knowledge by assuring the subjects that 
device readings and blood measurements are for research use only. In the 
case that a subject becomes aware of a condition (anemia, hypertension, 
arrhythmia etc.) they have during the course of our study our study staff will 
recommend that they contact their primary care physician and we will 
document this recommendation. As part of that process we will follow up 
with these individuals prior to enrollment if their condition meets exclusion 
for that particular study. 

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13.1.7. Lidocaine (injection) risks 
13.1.7.1. Insertion of the Lidocaine may be discomforting and can feel like a slight 
pinch along with a warm/burning sensation. 
13.1.7.2. Other anticipated adverse events that may occur, include but are not limited 
to: 
x 
Flushing or redness of the skin 
x 
Itching skin 
x 
Small red or purple spots on the skin 
x 
Unusually warm skin 
x 
Bruising 
x 
Bleeding at the application site 
x 
Swelling 
These adverse events are expected to be temporary. 
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 called 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. 
13.1.8. Ethyl Chloride (Lidocaine Spray) 
13.1.8.1. Ethyl Chloride is a topical anesthetic which is used to prevent pain by 
cooling the skin. 
13.1.8.2. Although unlikely, the anticipated adverse events that may occur, include 
but are not limited to: 
13.1.8.2.1.  Changes in skin color (ie. Flushing or redness of the skin) 
13.1.8.2.2. Delayed wound healing 
13.1.8.2.3. Rash 
13.1.8.2.4. Itching 
13.1.8.2.5. Swelling 
 These adverse events are expected to be temporary. 
 
13.1.9. Low Oxygen Concentration 
13.1.9.1. Risks associated with hypoxia include dizziness, shortness of breath, 
drowsiness, or headache. If or when this occurs, the study can be stopped. 
13.1.9.2. There is an extremely small risk of loss of consciousness or death from lack 
of oxygen. The study shall be stopped by the subject or clinical staff long 
before this could occur. 

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13.1.9.3. Other anticipated adverse events that may occur, include but are not limited 
to: 
x 
Vaso vagal (passing out) 
x 
Lightheadedness 
x 
Feeling nauseated 
x 
Throwing up 
x 
Seizures 
x 
Sudden drop in blood pressure/ sudden increase in blood pressure 
x 
Sudden drop in heart rate/ sudden increase in heart rate 
x 
Tingling sensation of face, arms and/or legs 
x 
Sweating 
x 
Mouth dryness  
13.1.9.3.1. These anticipated adverse events are expected to be temporary. 
13.1.10. Risk from Oxygen Administration  
13.1.10.1. 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. 
13.1.10.2. 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. 
13.1.11. Nose Clip Risks 
13.1.11.1. It is expected that some people will have discomfort/ pinching/ scratches 
from wearing a nose clip. If or when this occurs, adjustments can be made 
and/or the study can be stopped. 
13.1.12. Risk from Loss of Confidentiality 
13.1.12.1. Masimo upholds the highest standards to protect hard and electronic data 
however a complete promise for confidentiality cannot be guaranteed due 
to unforeseeable events.   
 
13.1.13. Risk from Additional Testing 
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. 
 
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 

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as confidential and will only be used by healthcare professionals for the 
diagnosis and treatment of the exposed individual as appropriate.  
 
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.  
 
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. 
 
14. 
EMERGENCY RESPONSE PLAN FOR MEDICAL EMERGENCIES  
14.1. 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. 
BENEFITS 
15.1. There are no other benefits to the subject. 
15.2. Other possible benefits would be to society as a whole. Validation of the accuracy of this 
new device could enable healthcare workers to more appropriately treat potentially life 
threatening conditions. 
16. 
ALTERNATIVES 
16.1. The alternative is to not participate in the study. 
17. 
ADDITIONAL  
17.1. Device Accountability 
17.1.1. Device accountability procedure, consistent with SQP-1122 Device Accountability for 
Clinical Investigations 
17.2. Bibliography 
17.2.1. Masimo Corporation maintains a current list of publications for all of its products and 
technologies.  In order to view the most current clinical information, please visit the 
Clinical Evidence portion of the Masimo website at 
http://www.masimo.com/cpub/clinical-evidence.htm 
18. 
PROTOCOL DEVIATION AND PROCEDURE TO AMEND PROTOCOL  
18.1. Modifications to the protocol, informed consent materials, recruitment materials, or any other 
materials provided to subjects must be reviewed and approved by the IRB in accordance 
with SQP-1002 Institutional Review Board Procedure prior to implementation. 
18.2. Deviations from the protocol will be reported in a test report for validation studies and in a 
Summary Case Report for others. 

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APPENDIX A 
The study likely will not start by giving a subject 100% oxygen and we will never drop to 0% oxygen. A 
typical ORI study goes as follows. Please refer to the schematic and study outline below for an example of 
a typical ORI study schematic (please keep in mind this is an example and not all ORI studies will follow 
this same schematic, oxygen percentages and sequence of these events may vary): 
x 
We will start taking samples at a baseline of 21% and continue sampling as the oxygen percentage 
gradually increases to 100% (ie. 21%, 24%, 27%, 30%, 33%, 36%, 100%). 
x 
We will then start to decrease the oxygen percentage back to 21% and continue to take blood 
samples (ie. 100%, 36%, 33%, 30%, 27%, 24%, 21%).  
x 
Once we have brought the subject back to 21% oxygen, we will desaturate them by reducing the 
oxygen given to approximately 13% (or slightly lower depending on the subjects ability to adapt to 
the desaturation) until their oxygen saturation reaches the desired saturation level and continue 
obtaining blood samples. 
x 
The subject will receive 21% oxygen or breathe room air again at the end of the study; this brings 
the subjects oxygen saturation back to a normal range. 
Example 1:  
Example 2: