Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET Pulse Oximeters With Motion
Phase: NA
Conditions: Healthy, Hypoxia
Sponsor: Stryker Sustainability Solutions

NCT06149416 
Post-launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET 
Pulse Oximeters with Motion 
May 25, 2023 

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Post-Launch Hypoxia Clinical Study 
Protocol for Reprocessed Masimo RD 
SET Pulse Oximeters with Motion 
Document No: 
CRD10351 
Revision: 
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1.0 
Purpose 
1.1 The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability 
Solutions pulse oximetry sensors during motion conditions over the range of 70-100% SaO2 as 
compared to arterial blood samples assessed by CO-Oximetry during conditions in which the 
subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy 
validation of the reprocessed sensors with motion indications. 
In this study, the level of oxygen within the blood will be reduced in a controlled manner by 
reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive 
pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements 
from a laboratory blood gas analyzer. 
A machine will be used to induce motions of 20 mm during testing at a sine rate of 2Hz, 3Hz, and 
4Hz. A third motion moves the arm a random distance of 0 to 30mm at a random speed up to 5Hz. 
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse 
oximetry sensors will meet a specification of +/-3% with a target of +/-3% or better in motion 
conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air 
breathing and then at three or six levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or 95%, 85% 
and 75% saturation for about 30-60 seconds or 60-90 seconds at each level), thereby 
demonstrating an acceptable SpO2 accuracy performance specification. This study should utilize 
a three level structure (95%, 85% and 75%). 
1.2 This study is being conducted to support a modification to the regulatory body approval of pulse 
oximeter probes reprocessed by Stryker Sustainability Solutions. 
2.0 
Scope 
2.1 
This procedure applies to the following Stryker Sustainability Solutions location(s): 
 
 
☒ Tempe 
☐ Phoenix 
☐ Lakeland 
☒ Tijuana 
☐ Chandler 
 
 
2.2 This study has been designed to include the subject devices listed in Table 1. 
 
Study Device: 
OM 
SKU 
Minimum Quantity 
Cycle Count 
Masimo 
4000 Adt (Adult) 
10 
4x 
Masimo 
4003 Neo (Adult & Neonate) 
10 
4x 
Table 1: Subject devices 
3.0 
Associated References 
3.1 Pulse Oximeters – Premarket Notification Submissions [510(k)s] Guidance for Industry and Food 
and Drug Administration Staff Document issued on: March 4, 2013 
3.2 ISO 80601-2-61:2019 Medical Electrical Equipment — Part 2-61: Particular requirements for basic 
safety and essential performance of pulse oximeter equipment 
4.0 
Related Documents 
4.1 DWI-CDS-109, Division Engineering Study Templates 
General Information 

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SET Pulse Oximeters with Motion 
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4.2 DWI-CDS-112, Division Engineering Study Exceptions 
4.3 DWI109.650, New Product Development Training Form 
4.4 CRD10352, Post Launch Hypoxia Clinical Study Report for Reprocessed Masimo RD SET Pulse 
Oximeters with Motion 
4.5 TR22597, Post Launch Sample Preparation Report for Reprocessed Masimo RD SET Pulse 
Oximeters 
4.6 CQD-CCA-001 Conducting Clinical Research 
4.7 CQP-CCA-002 Approval of Clinical Research Proposals, Protocols, Study Design Documents and 
Publications 
4.8 DSOP587 Division Conducting Clinical Research 
4.9 D0000065949 Investigator Initiated Studies 
4.10 DP-MCF-001, Division Complaint Handling Process 
4.11 DP-CDS-013, Risk Management 
5.0 
Key Terms 
Refer to CQM-02, Stryker Corporation Quality and Regulatory Master Glossary, for definitions to the 
Key Terms used within this document. 
5.1 Allocation: A method used to assign participants to an arm of a clinical study. The types of 
allocation are randomized allocation and nonrandomized. 
5.2 Arm: A group or subgroup of participants in a clinical trial that receives a specific 
intervention/treatment, or no intervention, according to the trial's protocol. 
5.3 Eligibility criteria: The factors that allow someone to participate in a clinical study are called 
inclusion criteria, and the factors that disqualify someone from participating are called exclusion 
criteria. They are based on characteristics such as age, gender, the type and stage of a disease, 
previous treatment history, and other medical conditions. 
5.4 Intervention/treatment: A process or action that is the focus of a clinical study. Interventions 
include drugs, medical devices, procedures, vaccines, and other products that are either 
investigational or already available. Interventions can also include noninvasive approaches, such 
as education or modifying diet and exercise. 
5.5 Masking: A clinical trial design strategy in which one or more parties involved in the trial, such as 
the investigator or participants, do not know which participants have been assigned which 
interventions. Types of masking include: open label, single blind masking, and double-blind 
masking. 
5.6 Primary outcome measure: In a clinical study's protocol, the planned outcome measure that is 
the most important for evaluating the effect of an intervention/treatment. Most clinical studies have 
one primary outcome measure, but some have more than one. 
5.7 Study type: Describes the nature of a clinical study. Study types include interventional studies 
(also called clinical trials), observational studies (including patient registries), and expanded 
access. 
6.0 
Roles and Responsibilities 
6.1 Divisional 
R&D Engineering in collaboration with Advanced Quality Engineering and Regulatory 
Affairs is responsible for the preparation and execution of this protocol, analysis of the 
test results, and the preparation of the summary report. 
R&D Engineering, Advanced Quality Engineering, and Principal Investigators are 
responsible for ensuring adherence to the Clinical Trial Agreement associated with 
the study outlined in the protocol. 

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The external facilities that may be used in the execution of this protocol are listed in 
Table 2. 
 
Service 
Name and Location 
Clinical Study 
UCSF (University of California San 
Francisco) 
490 Illinois Street, 5th Floor 
San Francisco, CA 94143-1209 
Table 2: Test laboratory name and address 
 
7.0 
Summary 
 
Study Design: 
Study Type: 
Interventional Non‐significant Risk Lab Test 
Enrollment: 
A typical study will include at least 10 subjects (up to 24 if needed to reach the 200 
necessary data points to meet the ISO 80601‐2‐61:2019). 
Allocation: 
Non‐randomized 
Intervention Model: 
Parallel Assignment 
Intervention Model Description: 
Subjects will recline for the study. Reference sensors will be placed on each subject 
to evaluate the SpO2 accuracy and performance. Shield material may be used 
between any adjacent finger sensors to prevent optical crosstalk. A machine will 
be used to induce motions of up to 20 mm during testing at a sine rate of 2Hz, 3Hz, 
and 4Hz. A third motion moves the arm a random distance of up to 30mm at a 
random speed up to 5Hz. Simultaneous data collection will be set up for devices 
under test. The data from the test devices will be collected by the sponsor or 
trained UCSF staff. Data will be collected for 1 second intervals data analysis. The 
SpO2 accuracy of the test devices will be evaluated over the oxygen saturation 
range between 70‐100%. 
Masking: 
None (Open Label) 
Primary Purpose: 
Device Validation 
Study Start Date: 
May 27‐28, 2023 
Arms and Interventions: 
Experimental: Masimo RD SET SpO2 Adhesive 
Sensors, Adult (4000 Adt), Adult & Neonate (4003 
Neo) 
Reference sensors from the reprocessed oximeter 
device will be placed on each subject to evaluate the 
SpO2 accuracy and performance. 
Device: Stryker Sustainability Solutions Reprocessed Masimo 
RD SET Pulse Oximetry Sensors 
An oximeter is a device used to transmit radiation at a known 
wavelength(s) through blood and to measure the blood oxygen 
saturation based on the amount of reflected or scattered 
radiation. Pulse oximetry monitoring is considered a standard 
physiological measurement and is used by clinicians in 
everyday situations to estimate arterial oxygen saturation. 
Because an arterial sample of blood is not required to make the 
measurement, the pulse oximeter can provide non‐invasive 
real time information. 
Procedure 

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Post-Launch Hypoxia Clinical Study 
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SET Pulse Oximeters with Motion 
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Sham Comparator: Radiometer ABL‐90 multi‐ 
wavelength oximeter 
A whole blood analyzer (CO‐Oximeter) is used as the 
reference standard device for obtaining the 
functional SaO2 value from arterial blood samples 
obtained during the study. 
Device: CO‐OXIMETRY SENSORS 
A whole blood analyzer (CO‐Oximeter) is used as the reference 
standard device for obtaining the functional SaO2 value from 
arterial blood samples obtained during the study. 
Primary Outcome Measures: 
1. 
Accuracy of Sensor by Arms 
Calculation [ Time Frame: 1‐5 
hours ] 
Percentage of SpO2 (oxygen saturation by pulse oximetry) measured by the 
Reprocessed Oximeter pulse oximetry sensors during motion conditions over the 
range of 70‐100% SaO2 as compared to arterial blood samples assessed by CO‐ 
Oximetry. 
The Accuracy root mean square (ARMS) between measured SpO2 and reference 
SaO2 (arterial oxygen saturation) must meet the 3% specification for each Stryker 
Sustainability Reprocessed pulse oximetry sensor style. 
Accuracy will be determined by comparing the noninvasive blood oxygen 
saturation measurement of the pulse oximeter to that obtained from a blood 
sample and calculating the arithmetic root mean square error (Arms) value. In 
order to obtain the Arms value, the blood oxygen saturation measurement is 
subtracted from the pulse oximeter oxygen saturation measurement for a number 
of samples, the average of this difference is computed as the bias. The standard 
deviation of the differences is computed as the precision. The square root of the 
sum of the squares of bias and precision is computed as the Arms Error value. 
For each range specified, SpO2 ACCURACY of the PULSE OXIMETER EQUIPMENT 
shall be stated in terms of the root‐mean‐square (rms) difference between 
measured values (SpO2i) and reference values (SRi), as given by the following 
formula. 
 
Eligibility Criteria: 
Ages Eligible for Study: ≥18 and <50 (Adult) 
Sexes Eligible for Study: All 
Accepts Healthy Volunteers: Yes 
Inclusion and Exclusion Criteria 
Inclusions: 
• 
The subject is male or female, aged ≥18 and <50 
• 
The subject is in good general health with no evidence of any medical 
problems. 
• 
The subject is fluent in both written and spoken English 
• 
 The subject has provided informed consent and is willing to comply with the 
study procedures 

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Exclusions: 
• 
The subject is obese (BMI>30) 
• 
The subject has a known history of heart disease, lung disease, kidney or liver 
disease 
• 
Diagnosis of asthma, sleep apnea, or use of CPAP 
• 
Subject has diabetes 
• 
Subject has a clotting disorder 
• 
The subject a hemoglobinopathy or history of anemia, per subject report or 
the first blood sample, that in the opinion of the investigator, would make 
them unsuitable for study participation 
• 
The subject has any other serious systemic illness 
• 
The subject is a current smoker 
• 
Any injury, deformity, or abnormality at the sensor sites that in the opinion of 
the investigators would interfere with the sensors working correctly 
• 
The subject has a history of fainting or vasovagal response 
• 
The subject has a history of sensitivity to local anesthesia 
• 
The subject has a diagnosis of Raynaud’s disease 
• 
The subject has unacceptable collateral circulation based on exam by the 
investigator (Allen’s test) 
• 
The subject is pregnant, lactating or trying to get pregnant 
• 
The subject is unable or unwilling to provide informed consent, or is unable or 
unwilling to comply with study procedures 
• 
The subject has any other condition, which in the opinion of the investigators 
would make them unsuitable for the study 
Contacts and Locations: 
Locations 
United States, California 
University of California, San Francisco 
Sponsors and Collaborators 
Stryker Sustainability Solutions, Mike Bernstein (study monitor) 
Investigators 
Principal Investigator: 
Dr. Philip E. Bickler, MD, PhD, CA License # is G64031 Co‐
Principal Investigator: 
Dr. John R. Feiner, MD 
8.0 
Product Description 
8.1 Intended Use: Reprocessed Masimo RD SET Pulse Oximeter Sensors are indicated for single 
patient use for continuous noninvasive arterial oxygen saturation and pulse rate monitoring. 
8.2 Principle of Operation: The principle of operation of pulse oximetry is based upon the 
fundamental principle that hemoglobin bound to oxygen (oxyhemoglobin) and hemoglobin 
unbound to oxygen (deoxyhemoglobin) vary in the absorption of different wavelengths of the light 
and the absorptions can be used to estimate SpO2 and PR. The mechanism by which this 
process occurs is the use of red and infrared wavelengths of light delivered by an emitter and the 
detection of the signal from the light absorption of oxygenated blood and deoxygenated blood to 
determine functional oxygen saturation of hemoglobin (SpO2). 
8.3 Mechanism of Action for Achieving the Intended Effect: The Reprocessed Pulse Oximeter 
Sensor provides the intended effect equivalent to the previously cleared pulse oximeter sensor in 
that it utilizes an optical sensor that is applied to the patient’s finger or toe through which light is 
transmitted to the photodetector that detects the signal transmission. The signal transmission is 
processed by the Pulse Oximeter to provide SpO2 and PR. 

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SET Pulse Oximeters with Motion 
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9.0 
Worst Case Justification 
9.1 The pulse oximeter sensors which are identified in Table 1 as subject devices have received FDA 
clearance for a maximum of four (4) reprocessing cycles. Sensors used in this study were 
subjected to the maximum number of reprocessing cycles. Catalog number 4000 consists of a 
non-woven butterfly style tape and catalog number 4003 consists of a woven style tape. There is 
no worse case model in that the characteristics of both tape types are equivalent within the model 
family and do not present different challenges during the tape removal process when 
reprocessing. 
10.0 
Sample Size Designation 
10.1 A typical study will include at least 10 subjects (up to 24 if needed to reach the 200 necessary 
data points to meet the ISO 80601-2-61:2019). Per FDA guidance, at least 2 or 15% of the 
subjects will have dark skin pigmentation. Skin pigmentation will be assessed using the Fitzpatrick 
scale by UCSF study personnel. 
10.2 Each study subject will have two reprocessed sensors attached to their fingers. Two Reprocessed 
Masimo RD SET sensors should be placed on one side of the subject; however, sensors may be 
placed opposite sides. Digits selected should be two of the three middle fingers on each hand 
avoiding the thumb or pinky fingers as test sites. 
11.0 
Preliminary Investigations and Justification of the Study 
11.1 Stryker Sustainability Solutions has developed a process to reprocess pulse oximeters that cleans 
and disinfects the devices active element components and device cord and replaces all patient 
contacting tapes. The foam covering the cable is cleaned and disinfected but not replaced during 
reprocessing. 
11.2 The manufacturing process for reprocessing includes 100% visual inspection and functional 
assessment. 
11.3 As part of the product development and validation phases of this project, Stryker has performed 
the following studies: 
• 
Cleaning 
• 
Disinfection 
• 
Biocompatibility 
• 
Performance 
12.0 
Study Devices 
Reprocessed Masimo RD SET Pulse Oximeter 
Sensor 
4003 Neo 
Reprocessed Masimo RD SET Pulse Oximeter 
Sensor 
4000 Adt 

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Post-Launch Hypoxia Clinical Study 
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12.1 Device Accountability 
 
Devices will be transported to the test site by the study sponsor. 
 
Use of Study Device 
12.1.2.1 
Use of devices will be documented electronically as case reports for each 
subject. 
12.2 Packaging and Labeling 
 
Research conducted for this study will utilize investigational devices. The Sponsor is 
responsible for packaging and labeling of the devices for delivery to the study site. 
Investigational devices or its immediate package shall bear a label with the following 
information: 
“CAUTION – Investigational device. Limited by Federal (or United States) law to 
investigational use”. 
13.0 
Procedure 
13.1 If the principal investigator deems it necessary, the subject may be asked to run hot water over 
hands and arms for 5 minutes to improve perfusion. After injection of a local anesthetic, a 22- 
gauge catheter is inserted in one radial artery. Pulse oximeters are attached to fingers with 
adequate spacing between fingers or shielding to minimize device cross-talk. Subjects are in a 
comfortable semi-recumbent position. Subjects then breathe air mixtures containing reduced 
amounts of oxygen to produce the desired level of hypoxemia. Stable, safe and controlled hypoxia 
is adjusted manually by an anesthesiologist that permits the inspired gas mixture to be adjusted to 
achieve a level of lung alveolar gas that will achieve the desired degree of saturation. 
13.2 Typically, saturation levels involve one period with air breathing and then at one of three or six 
levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or 95%, 85% and 75% saturation. Each level of 
saturation is held for 30-60 seconds or 60-90 seconds respectively. At appropriate intervals and 
when oxygen levels are stable, arterial blood samples are obtained from the radial arterial 
catheter. The operator then changes the inspired oxygen concentration to attain the next desired 
stead-state level of hypoxia. This study should utilize a three level structure (95%, 85% and 75%). 
A "run" consists of several stable steady-state hypoxia levels and together takes approximately 20 
minutes. Each run is terminated by a breath of 100% O2 followed by room air. Two runs together 
enable obtaining a total of 20-25 blood samples, 4 samples at each plateau. Saturation of each 
arterial blood sample is determined by direct oximetry in a Radiometer ABL-90 multi-wavelength 
oximeter. The precise target levels of saturation can be adjusted to suit the sponsor, but typical 
testing is done to satisfy ISO and FDA standards for testing, which is 70% to 100%. 
13.3 The study takes under 2 hours of each subject's time. Analysis of the data requires several days. 
Manufacturer’s representatives (Stryker) will be present for these tests, and to mount the probes. 
14.0 
Sponsor Pulse Oximeter Study Data 
14.1 Data from test pulse oximeters for comparison to blood values can be obtained in several ways. 
In every case, the goal is to obtain a reading from the oximeter that corresponds to the associated 
blood sample or a reference oximeter. Because of circulation delays and instrument averaging 
time, attempts will be made to create steady state conditions at each level of oxygenation. 
Therefore, a means should be provided to record the instrument reading at each blood sample. 
This instrument reading may be obtained with several different approaches. Some instruments 
have no digital or analog output and the instrument reading may be recorded manually or 
recorded by a video of the instrument display. Other instruments may have an analog output. 
The laboratory can record analog data by use of LabView. Digital recording of output can also be 

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obtained via LabView but this requires information from the sponsor concerning the structure of 
the digital signal. 
14.2 If a manufacturer prefers to collect and analyze the data, the continuous digital signal of each 
oximeter should be read, for comparison with the blood sample, 9 seconds before the record 
shows a sudden fall or rise in oxygen saturation, not at the time of blood sampling. This 
procedure accounts for the delays of finger circulation and uses the estimated delay from the lung 
to the sample site. There is no useful correlation between the actual time of blood sampling and 
the oximeter recording because of the variability of tissue blood flow lag. As mentioned, steady- 
state hypoxia avoids the concern that oximeter reading is not aligned with a blood sample reading. 
15.0 
Statistics 
15.1 The number of subjects and the number of comparisons (paired pulse oximeter readings and 
arterial saturation values) is determined by current FDA guidance requirements. This is a 
minimum of 200 data points and 10 subjects. In the course of this type of study, some subjects 
may drop out, some readings can be lost due to interference and occasionally some do not 
consent. 
15.2 The following demographic data will be collected on the subjects: 
 
Gender (male, female, other) 
 
Age 
 
Skin pigmentation (dark, medium, light) preferably 1-6 using the Fitzpatrick scale 
 
Height (cm) 
 
Weight (kg) 
 
Wrist circumference (cm) 
 
Dominant hand (left or right) 
16.0 
Data Analysis 
16.1 In all cases, the blood analysis data are provided, including the SaO2, MetHb, COHb and Hgb 
concentration. 
16.2 
The data analysis report will consist of the following: 
 
A Table of the oximeter readings versus corresponding blood SaO2 values. 
 
Graphic plots of the bias between the oximeter reading and the SaO2 measured by 
the hemoximeter (on the blood sample, i.e Modified Bland-Altman plots for each 
instrument or instrument probe combination). 
 
Regression equations for the bias of each instrument. 
 
Tables of the mean error or bias, its standard deviation, standard error, 95% 
confidence interval, maximum and minimum and root mean square error, all 
computed both overall and by several sub-ranges of desaturation. 
 
A table of the demographics of the subject population is provided. 
17.0 
Subject Safety 
17.1 Pulse oximeter sensors are typically considered non-significant risk medical devices. The LED 
light energy utilized in typical test measurements is within the same range as other cleared 
marketed devices and introduces no further risks. An LED light emits light that passes through the 

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tissue. A light detector then measures how much light was absorbed by the tissue. Based on the 
ratio of absorbance of different wavelengths of light, the device calculates the oxygen saturation. 
18.0 
Risks and Benefits of the Investigational Device and Clinical Investigation 
18.1 Breathing a very low oxygen mixture may cause dizziness and might cause loss of consciousness 
for a few seconds. It may make one feel very short of breath during the test and for a few seconds 
afterwards. There is a remote possibility that if the subject loses consciousness, he/she might 
have muscular twitching or convulsions. This study will not seek to reach saturations below 70%. 
Hypoxia may cause tachycardia and increased blood pressure during the test and might cause 
headache. In all the years of the lab conducting the study no subject has mentioned headache. 
Much more severe and prolonged lack of oxygen could cause brain injury or death, but the 
duration and depth of hypoxia is limited by the test protocol to short intervals. The needle catheter 
used to take blood may hurt when it is inserted despite the use of local anesthesia, and there may 
be a black and blue spot afterward. It is remotely possible the artery might be damaged or clot, or 
a tendon sheath near it be injured by the needle, resulting in some soreness. These risks are 
unlikely because none of the enrolled 2000+ subjects has ever had a serious complication. 
Hyperventilating during the part of the study requiring reduced PCO2 may make subjects 
lightheaded or dizzy. Breathing air with added CO2 may make subjects feel short of breath and 
cause a headache. Some subjects feel faint when they arrive for the study, apparently related to 
the thought of having an arterial line. These subjects will likely be excluded from the study. 
18.2 Currently the FDA defines pulse oximeters as Class II devices which transmit radiation at a known 
wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of 
reflected or scattered radiation and may be used alone or in conjunction with a fiberoptic oximeter 
catheter. All oximeters being used in this study work by transmittance of radiation at known 
wavelength(s) through tissue to measure blood oxygen saturation based on the amount of 
reflected and scattered radiation. The devices under test and this study procedure are considered 
Non-Significant Risk (NSR). 
Non-significant risk letter and checklist were sent to test lab and accepted per a previously 
approved UCSF IRB for an identical test which can be obtained from UCSF with reference 
number 330726. 
The device and use of the device under test does not meet the definition of a significant risk 
device. Under 21 CFR 812.3(m), an SR device means an investigational device that: 
• 
Is intended as an implant and presents a potential for serious risk to the health, safety, or 
welfare of a subject; 
• 
Is purported or represented to be for use supporting or sustaining human life and presents a 
potential for serious risk to the health, safety, or welfare of a subject; 
• 
Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or 
otherwise preventing impairment of human health and presents a potential for serious risk to 
the health, safety, or welfare of a subject; or 
• 
Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. 
19.0 
Invasive Laboratory Testing on Healthy Volunteers 
19.1 The risk determination is based on the use of the device in an investigation in addition to the 
device itself. Generally, the FDA believes pulse oximeters as addressed in the FDA Guidance 
Document for Pulse Oximeters (March 4, 2013) are non-significant risk devices. Further, the 
recommendation is to conduct the study in accordance with Clause 201.12.1.101.2 and Annex 
EE.2 of ISO 80601-2-61:2019, where Annex EE.2 describes the procedure for invasive laboratory 
testing on healthy volunteers. 

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20.0 
Risk Mitigations 
Subjects are all monitored with accurate reference oximeters and continuous end-tidal gas 
analysis to prevent the risk of more profound hypoxia than desired. Investigators are experienced 
anesthesiologists adept at assessing breathing and in maintaining appropriate airway conditions. 
The study room is set up like an OR with all resuscitation equipment immediately available. 
21.0 
Informed Consent 
21.1 Written informed consent is obtained before any study interventions. In discussions with the study 
coordinator before the day of the study, potential subjects will be offered the consent form to 
review. On the day of the study subjects are given the consent form which they read and sign if 
they wish to participate. A study doctor is present to answer questions. 
21.2 Only subjects clearly able to understand and read English will be enrolled. Subjects will be asked 
if they have any questions and are told they can withdraw at any time. 
22.0 
Investigational Review Board (IRB)/Independent Ethics Committee (IEC) 
22.1 Prior to the start of subject enrollment, the investigator will be responsible for obtaining approval 
from the authorized IRB/IEC for the institution at which the proposed clinical investigation is to be 
conducted. Written approval from the IRB/IEC should specifically refer to the investigator, the 
protocol title and date, and subject informed consent date. 
22.2 Written IRB/IEC approval and any conditions of approval imposed by the IRB/IEC was obtained by 
the sponsor/investigator. 
22.3 Protocol amendments must also undergo IRB/IEC review and approval at each clinical site. The 
written approval from the IRB/IEC for the amendment should specifically refer to the investigator, 
the protocol version number and title, and any amendment numbers that are applicable. 
22.4 The IRB approval for this study was obtained May 16th 2023 and is valid through December 19th 
2023. Approval reference number 375731. 
23.0 
Monitoring Arrangements 
23.1 A representative from the sponsor and study monitor will provide all monitoring. The Monitor shall 
be responsible for maintaining a record of the findings, conclusions, and actions taken for the 
results of monitoring the study ensuring that: 
23.2 The monitoring requirements for an NSR device study is identified in 21 CFR 812.2(b) 
Abbreviated requirements. For monitoring an NSR device investigation, the requirement is to 
comply with 21 CFR 812.46 with respect to monitoring investigations: (a) Securing Compliance, 
(b) Unanticipated adverse device effects, (c) Resumption of terminated studies 
• 
Compliance to the signed agreement between the Investigator and sponsor 
• 
The study follows the protocol and any amendments that apply 
• 
Compliance to any conditions of the approval imposed by the IRB or FDA 
23.3 Sponsor will assess any new hazards/harms identified during a clinical investigation (i.e., pre- or 
post-market study) as part of the risk management process per DPCDS-013, Risk Management 
and the complaint handling process per DP-MCF-001, Division Complaint Handling Process, as 
applicable. 
24.0 
Data Storage 
24.1 Identifiable subject information is always stored securely following all applicable rules and 
regulations. Consent forms and other study related documents are retained following UCSF data 
retentions policy. 

DF-CDS-109-11 
Rev. L 
Sustainability Document Template 
UNCONTROLLED WHEN PRINTED 
STRYKER CONFIDENTIAL – This document contains confidential and proprietary 
information that is the property of Stryker Corporation. Neither this document nor the 
information herein may be reproduced, used or disclosed to any third party without the prior 
written consent of Stryker Corporation. 
 
 
Post-Launch Hypoxia Clinical Study 
Protocol for Reprocessed Masimo RD 
SET Pulse Oximeters with Motion 
Document No: 
CRD10351 
Revision: 
A 
Page: 
11 of 11 
 
25.0 
Acceptance Criteria 
25.1 The statistical results of the data will be reviewed for the following pass/fail criteria: 
 
At least 200 data points with SpO2 Accuracy for the range of 70-100%, 3% (ARMS) is 
considered a Pass per FDA guidance. 
 
At least 10 participants where at least two participants or 15% of participant 
population will have dark skin pigmentation per the Fitzpatrick scale. 
26.0 
Protocol Revision History 
 
Revision 
Change Order 
Number 
Description 
A 
ECO153475 
Establishment of a new protocol. 
27.0 
Attachments 
27.1 Attachment 1: Non-significant Risk Determination 
27.2 Attachment 2: IRB Approval 
27.3 Attachment 3: Informed Consent Forms 
27.4 Attachment 4: Executed Contract 

 
UNCONTROLLED WHEN PRINTED 
STRYKER CONFIDENTIAL – This document contains confidential and proprietary 
information that is the property of Stryker Corporation. Neither this document nor the 
information herein may be reproduced, used or disclosed to any third party without the prior 
written consent of Stryker Corporation. 
DF-CDS-109-11 
Rev. L 
Sustainability Document Template 
 
 
 
 
 
 
 
 
 
CRD10351 
 
Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET 
Pulse Oximeters with motion 
Attachment 3 
Informed Consent Form 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

IRB NUMBER: 10-00437 
IRB APPROVAL DATE: 02/16/2021 
IRB EXPIRATION DATE: 02/15/2022 
1/29/21 
 
 
 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
CONSENT TO PARTICIPATE IN A RESEARCH STUDY 
Study Title: Accuracy of pulse oximeters with profound hypoxia 
This is a medical research study. Your study doctors, Philip Bickler, MD, John Feiner, 
MD, Jeffrey Sall, MD, Helge Eilers, MD, Matthew Dudley, MD, Andrew Schober, MD, or 
Michael Lipnick, MD, from the UCSF Department of Anesthesia and their associates will 
explain this study to you. 
Medical research studies include only people who choose to take part. Take your time 
to make your decision about participating. You may discuss your decision with your 
family and friends and with your health care team. If you have any questions, you may 
ask your study doctor. 
You are being asked to participate in this study because you are healthy, between 18 
and 50 years of age and willing to participate in breathing studies with or without blood 
samples in San Francisco. 
Why is this study being done? 
The aim of this study is to determine the accuracy of devices called pulse oximeters, 
which measure blood oxygen by shining light through fingers, ears or other skin, without 
requiring blood sampling. 
How many people will take part in this study? 
About 150 volunteer subjects will participate in this study each year. 
What will happen if I take part in this research study? 
For studies requiring arterial blood sampling by the sponsor, you will have a small 
plastic tube placed in a wrist artery under local anesthesia. Most studies will require 
arterial blood sampling, however, some sponsors may choose not to collect blood 
samples; in these instances, no anesthesia will be used and no arterial catheter will be 
placed. The study staff will notify you whether this does or does not apply to your 
particular study date. Standard and test pulse oximeters will be attached to your 
fingers, forehead, chest, or ears. You will be asked to rapidly breathe in and out of a 
tube through a mouthpiece, with a nose clip on your nose. The gas you will breathe will 
be adjusted to lower your blood oxygen saturation from its normal value of 95% - 98% 
to as low as 70%. The time it will take to desaturate you from your normal blood 
saturation range to a saturation in the 70s will take about 20 minutes. At most you will 
be at blood oxygen saturation in the 70s for about 2 minutes. 
During studies requiring arterial blood sampling, 20-25 small blood samples (each less 
than 2 ml or 1 teaspoon) will be taken from the wrist arterial catheter, for a total of less 
than two ounces of blood. Some sponsors may add additional blood samples for their 
particular study date; up to 35 samples total may be drawn. 
 
Please initial here to indicate you have been informed that your study will 
require additional blood samples (up to 35). 
CF-BIOMED-0205 
PAGE 1 OF 5 

PAGE 2 OF 5 
CF-BIOMED-0205 
 
 
1/29/21 
IRB NUMBER: 10-00437 
IRB APPROVAL DATE: 02/16/2021 
IRB EXPIRATION DATE: 02/15/2022 
During some of the testing you may lay flat, or with your head up or down to measure 
low perfusion. During some of the studies, Testing may also be done with your hand 
fixed to a motion machine, which rhythmically moves your hand up or down a few 
inches. 
 
Please initial here to indicate you have been informed that your study will be 
examining low perfusion ☐ or motion testing ☐. 
During some parts of the testing you may be asked to hyperventilate for a few minutes 
of to breathe air with slightly increased or decreased amounts of carbon dioxide (CO2). 
 
 
Please initial here to indicate you have been informed that your study will 
require measurements of high or low CO2. 
 
During some of the studies, you may be asked to complete non-invasive experimental 
‘eye-tracking’ tests. Small cameras will track the movement of your eyes throughout the 
duration of the test. 
 
 
Please initial here to indicate you have been informed that your study will be 
measuring eye-movements during your tests. 
 
During some studies, blood samples may be stored for future analysis. The purpose of 
this analysis is to investigate the biochemical changes in your blood during hypoxia. 
 
 
Please initial here to indicate you have been informed that your study will 
involve storing your blood samples. 
 
 
Please initial here to indicate the sponsor is going to video record your 
hands and wrist through the study, your face will not be recorded. This video 
recording will be the property of the sponsor and will usually be kept for one year 
after the completion of the study. 
 
 
Please initial here to indicate that the sponsor will be recording your face 
through the study. The purpose of recording your face is to determine if blood 
oxygen saturation can be calculated through minor changes in skin hue at 
different blood oxygen saturation levels. These recordings will be the property of 
the sponsor and will be kept for a period of at most 2 years after the completion 
of the study. 
 
Before you begin the main part of the study… 
 
The following will be done: 
• 
You will answer a few brief questions regarding your general medical 
history and any smoking habits. 
• 
A partial physical examination may be done of your heart, lungs, heart rate 
and blood pressure, height and weight. 
• 
We may also test if you have good blood flow in your wrist artery by 
observing the color of your fingers after making a fist. 

IRB NUMBER: 10-00437 
IRB APPROVAL DATE: 02/16/2021 
IRB EXPIRATION DATE: 02/15/2022 
1/29/21 
PAGE 3 OF 5 
CF-BIOMED-0205 
 
 
• 
We will screen you for COVID-19 symptoms. This will include a few brief 
questions along with a temperature check. 
How long will I be in the study? 
The study will require you to participate for about 1 hour, on a single day. 
Study location: All study procedures will be done at the UCSF Dept of Anesthesiology, 
on the Parnassus Campus. 
 
Can I stop being in the study? 
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about 
stopping or decide to stop. He or she will tell you how to stop your participation safely. 
The study doctor may stop you from taking part in this study at any time if he believes it 
is in your best interest, if you do not follow the study rules, or if the study is stopped. 
 
What side effects or risks can I expect from being in the study? 
a. Risks of arterial cannulation include bleeding, infection, nerve injury and bruising at 
the site of catheter insertion. There are also remote risks of an allergic reaction from 
the lidocaine used for local anesthesia, or the development of arterial spasm, dissection 
or thrombosis. If the sponsor for your study is not collecting arterial blood samples, this 
risk does not apply to your participation. You should wait 2 to 3 weeks after arterial 
cannulation to allow the site to heal before having another arterial line placed in the 
wrist. 
b. The risks of the brief exposures to low oxygen levels include feeling short of breath, 
headache, and dizziness. Brief loss of consciousness may occur, but is not expected at 
the levels of oxygen targeted for these tests. If you lose consciousness you may 
experience slight myoclonic twitching or jerking, this will resolve when you gain 
consciousness. 
c. The risks of hyperventilating include feeling light-headed or dizzy. The risks of 
breathing air with increased amounts of carbon dioxide include feeling short of breath 
and developing a headache. 
d. For studies requiring eye-tracking, you may experience some watering of your eyes 
from keeping your eyes open during the test. This can be relieved by blinking. 
 
Unknown Risks: The experimental treatments may have side effects that no 
one knows about yet. The researchers will let you know if they learn anything that 
might make you change your mind about participating in the study. 
 
For more information about risks and side effects, ask your study doctor. 
Are there benefits to taking part in the study? 
There will be no direct benefit to you from participating in this study. However, this 
study will help develop a medical device that may help others who have low oxygen 
levels in their blood. 
 
What other choices do I have if I do not take part in this study? 
None 

IRB NUMBER: 10-00437 
IRB APPROVAL DATE: 02/16/2021 
IRB EXPIRATION DATE: 02/15/2022 
1/29/21 
PAGE 4 OF 5 
CF-BIOMED-0205 
 
 
Will my medical information be kept private? 
We will do our best to make sure that the personal information in your medical record is 
kept private. However, we cannot guarantee total privacy. Your personal information 
may be given out if required by law. If information from this study is published or 
presented at scientific meetings, your name and other personal information will not be 
used. 
Organizations that may look at and/or copy your medical records for research, quality 
assurance, and data analysis include the UCSF Committee on Human Research, the 
study sponsor and the FDA. The information on your responses to questions about your 
health will be kept for 6 months and then destroyed. 
 
What are the costs of taking part in this study? 
You will not be charged for any of the study activities. 
 
Will I be paid for taking part in this study? 
In return for your time, effort and expenses, you will be reimbursed $150 for a 20- 
sample test, and $200 for a 25-sample test. 
If you are participating in a non-blood study, you will be reimbursed $100 for study 
completion. 
For studies requiring additional blood samples, motion evaluations, low perfusion, or 
high or low carbon dioxide for specific sponsor requests, you may receive an additional 
$25. The study staff will notify you if this applies to your particular study participation 
date. 
If you do not complete the study, you will be reimbursed $25 per breathing test. A check 
will be mailed to you approximately 4 weeks after your participation in the study has 
ended. 
 
What happens if I am injured because I took part in this study? 
It is important that you tell your study doctors (Bickler or Feiner) if you feel that you have 
been injured because of taking part in this study. You can tell the doctor in person or 
call him/her at (415) 476-1411. 
 
Treatment and Compensation for Injury: 
If you are injured as a result of being in this study, the University of California will 
provide necessary medical treatment. The costs of the treatment may be billed to you 
or your insurer just like any other medical costs, or covered by the University of 
California or the study sponsor depending on a number of factors. The University and 
the study sponsor do not normally provide any other form of compensation for injury. 
For further information about this, you may call the office of the Committee on Human 
Research at 415- 476-1814. 
 
What are my rights if I take part in this study? 
Taking part in this study is your choice. You may choose either to take part or not to 
take part in the study. If you decide to take part in this study, you may leave the study 

IRB NUMBER: 10-00437 
IRB APPROVAL DATE: 02/16/2021 
IRB EXPIRATION DATE: 02/15/2022 
1/29/21 
PAGE 5 OF 5 
CF-BIOMED-0205 
 
 
at any time. No matter what decision you make, there will be no penalty to you and you 
will not lose any of your regular benefits. Leaving the study will not affect your medical 
care. You can still get your medical care from our institution. 
 
We will tell you about new information or changes in the study that may affect your 
health or your willingness to continue in the study. 
In the case of injury resulting from this study, you do not lose any of your legal rights to 
seek payment by signing this form. 
 
Who can answer my questions about the study? 
You can talk to your study doctor about any questions or concerns you have about this 
study. Contact your study doctor(s) Philip Bickler, M.D. or John Feiner, M.D. at (415) 
476-1411 
 
For questions about your rights while taking part in this study, call the office of the 
Committee on Human Research, UCSF's Institutional Review Board (a group of 
people who review the research to protect your rights) at 415-476-1814. 

IRB NUMBER: 10-00437 
IRB APPROVAL DATE: 02/16/2021 
IRB EXPIRATION DATE: 02/15/2022 
1/29/21 
PAGE 6 OF 5 
CF-BIOMED-0205 
 
 
 
*********************************************************** 
CONSENT 
 
You have been given copies of this consent form and the Experimental Subject's Bill of 
Rights to keep. 
 
Please initial here to indicate you have reviewed the Experimental Subject’s 
Bill of Rights. 
 
This study has multiple sponsors. The sponsor for this study date has been 
provided to you. Please initial to acknowledge. 
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to 
participate or to withdraw at any point in this study without penalty or loss of benefits to 
which you are otherwise entitled. 
If you wish to participate in this study, you should sign below. 
 
 
Participant (Print name) 
 
 
Participant's Signature for Consent 
Date (mm-dd-yyyy) 
Time (hh:mm) 
 
 
Person Obtaining Consent (Print name) 
 
 
Person Obtaining Consent Signature 
Date (mm-dd-yyyy) 
Time (hh:mm) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO 
EXPERIMENTAL SUBJECT'S 

IRB NUMBER: 10-00437 
IRB APPROVAL DATE: 02/16/2021 
IRB EXPIRATION DATE: 02/15/2022 
1/29/21 
PAGE 7 OF 5 
CF-BIOMED-0205 
 
 
BILL OF RIGHTS 
 
The rights below are the rights of every person who is asked to be in a research study. As 
an experimental subject I have the following rights: 
1) To be told what the study is trying to find out, 
2) To be told what will happen to me and whether any of the 
procedures, drugs, or devices is different from what would be used 
in standard practice, 
3) To be told about the frequent and/or important risks, side 
effects, or discomforts of the things that will happen to me for 
research purposes, 
4) To be told if I can expect any benefit from participating, and, if so, 
what the benefit might be, 
5) To be told of the other choices I have and how they may be 
better or worse than being in the study, 
6) To be allowed to ask any questions concerning the study both 
before agreeing to be involved and during the course of the 
study, 
7) To be told what sort of medical treatment is available if any 
complications arise, 
8) To refuse to participate at all or to change my mind about 
participation after the study is started. This decision will not affect 
my right to receive the care I would receive if I were not in the 
study, 
9) To receive a copy of the signed and dated consent form, 
10) To be free of pressure when considering whether I wish to agree to be 
in the study. 
 
 
 
If I have other questions I should ask the researcher or the research assistant. In 
addition, I may contact the Committee on Human Research, which is concerned with 
protection of volunteers in research projects. I may reach the committee office by 
calling: (415) 476-1814 from 8:00 AM to 5:00 PM, Monday to Friday, or by writing to 
the Committee on Human Research, Box 0962, University of California, San 
Francisco, CA 94143. 
Call 476-1814 for information on translations.