Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
Phase: NA
Conditions: Fever
Sponsor: Masimo Corporation

 
 
Official Title: Validation of the Masimo 
INVSENSOR00063 in Febrile and Afebrile 
Subjects 
 
Date of Protocol: 17Feb2023 
 
NCT Number:  NCT05787782 

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 1 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
 
Clinical Investigation Title: Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects 
 
Clinical Investigation Number, Version: R-CIP-1067, Version 1.1 
 
Other Study Identifier: KOEI0004 
 
Study Device(s): Masimo INVSENSOR00063 
 
 
Sponsor: 
 
Masimo Corporation 
52 Discovery 
Irvine, California 92618 USA 
 
 
 

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 2 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
Investigator Page 
Principal Investigator (s): Kevin Oei, DO 
 
Investigation Site(s): 
Address: 
Ascada Research 
301 W Bastanchury Road, Suite 175 
Fullerton, CA 92835 
 
 
IRB: 
Address: 
WCG IRB 
1019 39th Avenue SE, Suite 120 
Puyallup, Washington 98374 
 
 
 
Agreement between Investigator and Sponsor Regarding Responsibilities for Good Clinical Practice 
International Conference of Harmonization (ICH) E6 Good Clinical Practice guidance is an international ethical and scientific quality standard 
for designing, conducting, recording, and reporting trials that involve the participation of human subjects. 
It specifies general requirements intended to: 
x 
Protect the rights, safety and well-being of human subjects, 
x 
Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results, 
x 
Assist sponsors, monitors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity 
assessment of medical devices. 
The Principal Investigator of the clinical investigation shall: 
x 
Obtain and maintain IRB approval of the study. 
x 
Ensure all subjects are consented prior to enrollment, per FDA Code of Federal Regulations titled 21 CFR 50. 
x 
Ensure only appropriately trained personnel will be involved in clinical investigation. 
x 
Maintain study records mentioned in the Clinical Investigation Plan. 
x 
Maintain logs for study team delegation, site visit/monitoring, equipment disposition, study team training, subject recruitment and 
enrollment. 
x 
Evaluate all adverse events and adverse device effects and determining whether the study is safe to continue. 
x 
Allow the sponsor to conduct periodic monitoring of study activities to ensure GCP compliance. 
x 
Not promote device prior to clearance by FDA for commercial distribution, except for academic purposes and scientific presentations. 
The Sponsor shall ensure existence and record of all necessary compliance documents, and will conduct monitoring visits to ensure appropriate 
conduct of the study. 
 
The principal investigator’s signature on this page constitutes the investigator’s affirmation that he or she is qualified to conduct the clinical 
investigation, agreement to adhere to all stipulations of this clinical investigation plan, the conditions of the Institutional Review Board (IRB) or 
Research Ethics Committee approval, federal and local regulatory requirements, 21 CFR 812, ISO 14155, and International Conference on 
Harmonization Good Clinical Practice (ICH GCP) guidance. 
 
Principal Investigator: 
Title: 
Signature: 
Date: 
Kevin Oei, DO 
Principal Investigator 
 
 
Sponsor Representative: 
Title: 
Signature: 
Date: 
Chelsea Frank  
Director of External Sponsored Studies 
 
 
 
 

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 3 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
1. 
OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION 
Clinical investigation title: Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects 
 
Study objective(s): The objective of this study is to gather temperature data using the Masimo INVSENSOR00063 for 
validation purposes.  
Investigational device(s): INVSENSOR00063 
Number of subjects: Up to 150 subjects 
Inclusion criteria: 
x 
Participant DJH\HDUROG 
x 
Afebrile or febrile at time of enrollment: For febrile subjects, oF/37.5oC for sublingual 
WHPSHUDWXUHUHIHUHQFHoF/38oC for temporal artery temperature reference. 
x 
English- or Spanish-speaking patient or parent/Legal Guardian 
Exclusion criteria: x 
Participants deemed not suitable for the study at the discretion of the investigator 
Duration of the clinical 
investigation: 
The expected duration of study enrollment is 1 to 2 months. 
Study endpoint(s): Accuracy of temperature measurements using the Masimo INVSENSOR00063 will be compared 
to reference temperature measurements.  
 
2. 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
Masimo Corporation is the developer of noninvasive technologies for the measurement and monitoring of physiological variables, 
such as arterial oxygen saturation (SpO2), total hemoglobin concentration (SpHb), carboxyhemoglobin concentration (SpCO), 
methemoglobin concentration (SpMet), and other physiological variables to improve patient outcomes and reduce cost of care.  
The Masimo INVSENSOR00063 (see Figure 1) is a non-contact infrared thermometry device intended to ascertain body 
temperature from skin temperature measurements. Non-contact infrared thermometers utilize infrared sensors that detect thermal 
radiation from the body. The sensor then converts radiant energy to an electrical signal and provides a temperature reading 
without discomfort for the patient or associated hygiene concerns. Thus, non-contact thermometry is a particularly attractive 
solution due to its optimization of patient comfort, noninvasiveness, and minimization of cross contamination. The device is a 
non-invasive, non-contact, handheld pulse oximetry device with a rechargeable battery and LCD display. It uses Masimo 
Measure-through Motion and Low Perfusion™ SET® pulse oximetry technology to measure SpO2, respiration rate from the 
Pleth (RRp™), pulse rate (PR), perfusion index (PI), and temperature. The Masimo INVSENSOR00063 is not FDA cleared and is 
considered investigational. Though the Masimo INVSENSOR00063 may be used to measure the aforementioned parameters, the 
Masimo INVSENSOR00063 used in this study will only be used to measure body temperature. 
 
 
 
 
 
 
 
 
 

CLINICAL INVESTIGATION PLAN
R-CIP-1067
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects 
KOEI0004
Revision:  A
CONFIDENTIAL AND PROPRIETARY
Page 4 of 14
© 2023 Masimo Corporation (Unpublished)
DOT-1225 Rev. A
All Rights Reserved
CO-072624
3.
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION
This study is designed to be a validation study to obtain data for clinical performance of the Masimo INVSENSOR00063.  The 
study will be used to evaluate the accuracy of temperature measurements using the Masimo INVSENSOR00063.
4.
BENEFITS AND RISKS OF THE INVESTIGATIONAL DEVICE, CLINICAL PROCEDURE, AND CLINICAL 
INVESTIGATION
4.1.
Anticipated Benefits
There will be no direct benefits to the enrolled participants; however, this study hopes to learn more about the temperature device 
to potentially help other patients in the future. Other possible benefits would be to society as a whole.  
4.2.
Risks/Discomforts Associated with Participation in the Clinical Investigation
The Masimo INVSENSOR00063does not pose risks to the participant, because the device is non-contact and does not emit any 
energy. Reference measurements will be obtained using a sublingual thermometer or a temporal artery thermometer using normal 
practice.
The other mainrisk associated with the study is a potential breach of confidentiality which will be minimized by limiting the 
collection of protected health information (PHI) and through secure data storage practices. None of our measures are diagnostic in 
nature. There is no other foreseeable risk associated with this study.
4.3
Importance of Knowledge Gained
Development of new temperature technologies could enable users to monitor temperature vital signs remotely and lessen the need 
for hospital visits.
5.
OBJECTIVES OF THE CLINICAL INVESTIGATION
The objective of this study is to collect data for the validation of the Masimo INVSENSOR00063to evaluate the performance of 
the device in obtaining temperature measurements.Measurements from the Masimo INVSENSOR00063 will be compared to 
reference sublingual or temporal artery measurements. 
Figure 1: Masimo INVSENSOR00063 with 
integrated infrared temperature sensor at back 
of the device
Figure 2: Temperature measurement with 
Masimo INVSENSOR00063
Figure 2: Temperature measurement with
Masimo INVSENSOR00063

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 5 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
6. 
DESIGN OF THE CLINICAL INVESTIGATION 
6.1. 
General 
This is a prospective, nonrandomized, double- arm study. Temperature data will be obtained using the Masimo 
INVSENSOR00063 while obtaining sublingual or temporal artery temperatures as a reference. 
There will be up to 150 participants enrolled into this study.  
For the validation phase of the study, accuracy of temperature measurements using the Masimo INVSENSOR00063 will be 
compared to the reference sublingual or temporal artery measurements. 
The validation of the accuracy of the temperature measurement in the investigational device may be determined using data 
collected from this study, in addition to data from other Masimo sponsored studies.  
 
6.2. 
Investigational device(s) and comparator(s) 
Equipment and materials are to be used as required. All study personnel will be trained on the use of relevant equipment.  
Investigational Device 
x 
Masimo INVSENSOR00063 
Reference Equipment (as needed) 
x 
Masimo Root with Noninvasive Blood Pressure and Temperature Monitoring 
x 
Hospital standard of care sublingual thermometer 
x 
Hospital grade temporal artery thermometer 
Research Equipment 
x 
Laptop with data collection software 
 
6.3. 
Subjects 
Inclusion Criteria: 
x 
6XEMHFWVDJH\HDUROG 
x 
Afebrile or Febrile at time of enrollment: For febrile subjects, oF/37.5o&IRUVXEOLQJXDOWHPSHUDWXUHUHIHUHQFH
100.4oF/38oC for temporal artery temperature reference. 
x 
English or Spanish speaking subject or parent/Legal Guardian 
Exclusion Criteria: 
x 
Subjects unable to provide written informed consent 
x 
Subjects deemed not suitable for the study at the discretion of the investigator.  
6.4. 
Procedures 
6.4.1. 
Data Collection Procedure 
6.4.1.1. Data collected by the Masimo INVSENSOR00063 is not intended to be used for clinical decisions, and research 
personnel should continue to use standard of care procedures for monitoring participants. 
6.4.1.2. Study duration will be approximately 15 to 30 minutes.  

CLINICAL INVESTIGATION PLAN
R-CIP-1067
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects 
KOEI0004
Revision:  A
CONFIDENTIAL AND PROPRIETARY
Page 6 of 14
© 2023 Masimo Corporation (Unpublished)
DOT-1225 Rev. A
All Rights Reserved
CO-072624
6.4.1.3. Record patient demographic information such as, but not only limited to, age, gender, weight, height, Massey scale, race 
or ethnicity on the case report form (CRF), as well as current medical conditions and recent medical history and the use 
of antipyretic medications, including medication, dosage and time of administration. Immunization within the prior 
seven (7) days of data collection will also be recorded on the CRF. 
6.4.1.4. Record room temperature on the CRF using an ambient thermometer. 
6.4.1.5. Record start and stop time of data collection procedures on the CRF.
6.4.1.6. Take the screening temperature measurement using the same thermometer to be used for the reference measurements, 
immediately before beginning the study measurements. 
Reference Measurements:
*Sublingual temperature measurements are preferred over temporal artery measurements.*
6.4.1.7 For participants suitable for sublingual measurement, reference temperature measurements will be obtained using the 
Root monitor’s (see Figure 3) integrated sublingual thermometer or the hospital’s standard of care sublingual 
thermometer.For younger participants who are unlikely to tolerate a sublingual thermometer measurement, perform 
temporal artery reference measurements using an Exergen TAT-5000 or equivalent thermometer. Multiple reference 
measurements may be obtained and should be taken at least 30 seconds apart when the temporal artery reference 
measurement is being utilized.
Masimo INVSENSOR00063 Device Measurements:
6.4.1.8   To obtain measurements using the Masimo INVSENSOR00063, start by locating the temperature button (Figure 4a) and 
sensor lens (Figure 4b). Make sure there are no obstructions to the sensor’s field of view (i.e., hair, glasses, fingers, 
clothing).
6.4.1.9
Press and hold the thermometer button on the Masimo INVSENSOR00063screen (Figure 4a) and align the sensor lens 
with the center of the subject’s forehead (Figure 4c) at a distance of approximately 1-2”. A first audible beep will 
indicate that the thermometer button has been pressed.
6.4.1.10 After aligning the sensor, with minimal movement, release the thermometer button on the Masimo INVSENSOR00063
screen (Figure 4a). A second audible beep will indicate the start of a measurement followed by a third beep at the end of 
the measurement. 
6.4.1.11 The three measurements need to be taken in quick succession of each other, with approximately 3 seconds between each 
measurement and keeping the same Masimo INVSENSOR00063 positioning for all three measurements.
6.4.1.12 Be sure to keep the Masimo INVSENSOR00063 steady during the measurement. 
Figure 3: Masimo Root with Noninvasive Blood Pressure and Temperature
Figure 3: Masimo Root with Noninvasive Blood Pressure and Temperature

CLINICAL INVESTIGATION PLAN
R-CIP-1067
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects 
KOEI0004
Revision:  A
CONFIDENTIAL AND PROPRIETARY
Page 7 of 14
© 2023 Masimo Corporation (Unpublished)
DOT-1225 Rev. A
All Rights Reserved
CO-072624
                       
Figure 4A: Temperature 
Button on screen
     
6.4.1.13 Multiple rounds of measurements may be obtained per subject. 
6.4.1.14 Data from the Masimo INVSENSOR00063 device will be downloaded using Masimo Trace software on the data 
collection laptop at the end of each day. Reference data from the Root monitorwill also be downloaded to a separatedata 
collection laptop using Masimo Trace software. Both sets of data will be uploaded to OneDrive. 
6.5
Monitoring plan
As the sponsor of this clinical investigation, Masimo Corporation is required by 21 CFR Part 812, of the Food and Drug 
Administration regulations to monitor and oversee the progress of the investigation.  The monitor(s) assigned by Masimo 
Corporation to this task will be trained on departmental SOPs on conduct and monitoring of sponsored studies.
In accordance with good clinical practices guidelines, there will be at least three scheduled monitoring visits to ensure overall 
regulatory compliance of the study:
x
An initiation visit, prior to any participantenrollment to confirm site readiness, and to document training on the study 
protocol and procedures, and use of equipment.
x
At least one monitoring visit during initial enrollment, and/or every 2-4 weeks until completion of the study. 
x
A final close out visit after the last patient had finished the study. 
The monitor will contact and visit the investigator and will be allowed, on request, to have access to all source documents needed 
to verify the entries in the CRFs and other GCP-related documents (IRB approvals, IRB correspondences, and ICFs) provided that 
participant confidentiality is maintained in agreement with HIPAA regulations. 
It will be the monitor’s responsibility to inspect the CRFs at regular intervals throughout the study, to verify the adherence to the 
Figure 4B: Sensor lens on 
back of device
Figure 4C: Sensor lens to 
forehead alignment
Figure 4C: Sensor lens to 
forehead alignment
Figure 4A: Temperature
Button on screen
Figure 4B: Sensor lens on
back of device

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 8 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
CIP and the completeness, consistency and accuracy of the data being entered on them.  
During each visit, the monitor will also verify adherence to the inclusion/exclusion criteria, and documentation of SAEs/SADEs 
and protocol deviations/violations, and check CRF against source documentation. 
After each visit, the monitor will provide a monitoring letter to the investigator within 4 weeks of visit completion. The 
monitoring letter will detail findings and open action items observed during the visit. It is the responsibility of the Principal 
Investigator and Study Coordinator(s) to respond to the findings of the monitoring letter and complete any open action items as 
soon as possible but no later than 60 days of receiving the monitoring letter. Any open action items not completed within the time 
allowed may be sufficient grounds for study site suspension or termination; it will be up to the sponsor to determine whether any 
incomplete action items are sufficient grounds for suspension or termination. Depending on the quality of the data and/or changes 
to factors affecting patient safety, additional monitoring visits may be necessary according at the sponsor’s discretion. 
 
7 
STATISTICAL DESIGN AND ANALYSIS 
7.1 
Acceptance Criteria 
For validation studies, acceptance criteria are determined by Masimo specifications. 
7.2 
Sample Size  
The sample size of up to 150 participants includes a minimum of 32 febrile patients for the validation phase per ISO 80601-2-
56:2017, section 201.102. 
7.3 
Statistical Analysis 
The statistical analysis will follow the procedure outlined in ISO 80601-2-56:2017 section 201.102. 
7.4 
Exclusion 
Data from the following participants will be excluded from data analysis: 
x 
Any subject administered antipyretic medications during study participation 
x 
Any subject who does not complete at least one full round of measurements. 
x 
Any subject whose data suggests a defective device. 
x 
Any subject whose data suggests existence of external conditions that interfere with Masimo INVSENSOR00063 or 
reference measurements. 
7.5 
Expected Dropout Rates 
Participants may not complete the study for various reasons, at the investigator’s or study staff’s discretion, or because the 
participant or participant’s parent/Legal Guardian does not want to continue the study. Due to the short duration and simple, 
noninvasive procedures of this study, there are limited expected dropouts. 
 
8 
DATA MANAGEMENT 
8.1 
Data Management and Confidentiality 
All documents associated with this protocol will be securely stored in a physical location or on password-protected computers.  
The confidentiality and retention of these documents will be protected to the extent provided and required by the law. All data 
will be de-identified before any statistical analysis. Only de-identified data will be shared with Masimo for research purposes 
stated in this protocol.  Data collected by data capture software and data entered in case report form will be shared with Masimo 
via a secure, password-protected server that only study staff and Masimo study team members will have access to. Data will be 
retained for a minimum to 2 years following completion of the final analysis. 

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 9 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
8.2 
Source Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a clinical trial necessary for 
the reconstruction and evaluation of the trial.  Source data are contained in source documents.  Examples of these original 
documents and data records include: hospital records, clinical and office charts, laboratory notes, memoranda, recorded data from 
automated instruments, and copies or transcriptions certified after verification as being accurate and complete. 
8.3 
Case Report Forms 
The site shall capture study data in case report forms (CRFs) for each subject enrolled, to be provided to the sponsor. CRFs may 
be in paper or electronic format through electronic data capture (EDC) software. Masimo shall ensure that systems used for 
electronic CRFs are compliant with the requirements of 21 CFR Part 11 and ISO / IEC 27001 Certification. The CRFs will be 
completed and signed by the principal investigator or delegate. This also applies to those subjects who fail to complete the study. 
If a subject withdraws from the study, the reason must be noted on the CRF. Case report forms are to be completed on an ongoing 
basis. CRF entries and corrections will only be performed by study site staff, authorized by the investigator. For paper CRFs, 
entries and corrections to the CRF will be made following Good Documentation Practices.  
The CRF may include the following information, including but not limited to: inclusion / exclusion criteria, whether subject 
consent was obtained before start of study, demographic information, device readings, and if occurrence of any adverse event, 
protocol deviation, and device deficiencies, etc. The CRFs will be signed by the PI or delegate to attest that the data are complete 
and accurate.  
CRF entries will be checked by the study monitor and any errors or inconsistencies will be queried to the site on an ongoing basis. 
Any changes made within an electronic CRF will be tracked by audit trail. Any changes on a paper CRF will be made directly on 
the CRF and will be initialed and dated by the person making the change. Query resolution will be assessed and confirmed by 
study monitor during site visit.  
8.4 
Data Transfer and Storage 
8.4.1 
Original paper CRFs will be stored in a secure location at the site. Copy of the original paper CRFs may be 
scanned and sent to sponsor. If using electronic CRFs, the site staff will be assigned unique usernames and 
passwords for data security. Final copies of the electronic CRFs in EDC are stored on a secure server. 
8.4.2 
Only authorized sponsor personnel will have access to study data, and will move it to a secure and backed-up 
drive at Masimo.  
8.4.3 
CRFs will be checked for completeness and if there are inconsistent or missing data points, queries will be 
generated. If delegated study staff are to correct the paper CRF, they shall follow GDP practices to strike 
through old entry, add in new entry, and initial and date it, and provide the corrected information to sponsor. 
Corrections made to electronic CRFs will be tracked by audit trail and require PI or delegate sign-off.   
 
8.5 
Record Retention 
Study data will be retained for the necessary period of time as required by the institution’s regulations.  Study records shall be 
retained for a minimum of two years after study closure. The Institution’s own retention policies and regulations may apply in 
addition to the minimal requirement. 
 
9 
AMENDMENTS TO THE CLINICAL INVESTIGATION PLAN 
Any changes made to the clinical investigational plan/study protocol will be documented by way of an amendment. Before 
submitting a protocol amendment to the IRB, the protocol amendment must be agreed upon and signed by both the principal 
investigator and the sponsor. The protocol amendment will be submitted to the IRB for approval. At a minimum, a redline version 
and a clean version of the new protocol amendment will be kept on file by the PI and the sponsor. Protocol amendments will need 

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 10 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
to be version controlled. Both PI and sponsor will retain the IRB approval letter as confirmation that the protocol amendment was 
approved. 
10 DEVIATIONS FROM CLINICAL INVESTIGATION PLAN 
Deviations from the protocol must receive both Sponsor and the investigator’s IRB/ethics committee approval before they are 
initiated, with the exception that under emergency circumstances, deviations from the Clinical Investigation Plan to protect the 
rights, safety and well-being of human subjects may proceed without prior approval of the sponsor or the IRB/ethics committee.  
Any protocol deviations initiated without Sponsor and the investigator’s IRB/ethics committee approval that may affect the 
scientific soundness of the study, or affect the rights, safety, or welfare of study subjects, must be documented and reported to the 
Sponsor and to the investigator’s IRB/ethics committee as soon as a possible, but no later than 5 working days after the 
occurrence of the protocol deviation. In addition to documenting deviations on the CRF, the Protocol Deviation Form may also be 
used.  If protocol deviations continue to occur frequently at a study site, a corrective and preventive action (CAPA) may be 
opened by the Sponsor.  
Withdrawal of IRB approval: An investigator shall report to the sponsor a withdrawal of approval by the investigator’s 
reviewing IRB as soon as possible, but no later than 5 working days of the IRB notification of withdrawal of approval. 
11 DEVICE ACCOUNTABILITY 
11.1Receipt of Study Device 
Upon receipt of the of the study device supplies, an inventory must be performed and the device accountability log filled out and 
signed by the person accepting the shipment.  It is important that the designated study staff counts and verifies that the shipment 
contains all the items noted in the shipment inventory.  Any damaged or unusable study devices in a given shipment will be 
documented in the study files.  The investigator must notify the study sponsor of any damaged or unusable study devices that 
were supplied to the investigator’s site. 
11.2Use of Study Device 
Use of device will be documented on case report forms for each subject. Any unused devices must be returned to the Sponsor at 
the end of the study or before product expiration date. 
11.3Return or Destruction of Study Device 
At the completion of the study, there will be a final reconciliation of study devices shipped, devices used, and devices remaining.  
This reconciliation will be logged on the device accountability log.  Any discrepancies noted will be investigated, resolved, and 
documented prior to return or destruction of unused study devices.  Devices destroyed on site will only be upon written 
instruction from the sponsor and will be documented in the study files. When a Masimo device deficiency is observed, every 
effort should be made to return the device and its packaging to the Sponsor in a timely manner. 
12 STATEMENTS OF COMPLIANCE 
This document is a clinical investigational plan for a human research study sponsored by Masimo Corporation. The study will be 
conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki. By participating in the 
study, the Investigator agrees to adhere to all stipulations of this protocol, the conditions of the Institutional Review Board (IRB) 
or Research Ethics Committee approval, federal and local regulatory requirements, 21 CFR 812, ISO-14155, International 
Conference on Harmonization Good Clinical Practice (ICH GCP) guidance. 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional 
Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any 
participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study. 

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 11 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
13 INFORMED CONSENT PROCESS 
x 
The investigator shall not enroll any subject to participate in the study or consent any subject prior to receiving IRB 
approval of the informed consent form.  
x 
No study-related activities will be conducted until the assent/consent is signed and dated from the subject (if age-
applicable), and the parental consent form is signed and dated by the subjects parent or Legal Guardian. 
x 
Following identification of a potential eligible subject as defined by the inclusion and exclusion criteria, the subject will 
be approached by the study staff. Study staff will explain the purpose and procedures of the study with respect to 
potential risks and benefits, and clarification of the subjects’ rights and privacy information. The research team will 
emphasize that participation is voluntary and declining participation in the study will not result in any penalty or loss of 
benefits that the subject is otherwise entitled.  
x 
Individuals will be given ample time to review the assent, consent, and/or parental consent form and the opportunity to 
ask the person obtaining consent any questions.  
x 
Once the subject or parent(s)/Legal Guardian questions have been answered and the informed consent is signed and 
dated, the Principal Investigator or delegate will also sign the informed consent document, approving that the subject will 
be enrolled in the study. The investigator shall retain the original copy of the informed consent document in each 
subjects records and provide a copy to the subject.  
x 
The point of enrollment is defined as the time at which the assent, consent and/or parental consent is signed and dated. 
The subject may withdraw from the study at any time.  
14 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS, AND DEVICE DEFICIENCIES 
14.1Definitions 
The definitions for adverse event, adverse device effect, serious adverse event, serious health threat, serious adverse device effect, 
and unanticipated adverse device effect, device deficiencies are provided below (ISO 14155, 21 CFR 812.3(s)). 
x 
adverse event: untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical 
device and whether anticipated or unanticipated (ISO 14155) 
x 
adverse device effect: adverse event related to the use of an investigational medical device 
x 
serious adverse event: adverse event that led to any of the following:  
o a) death 
o b) serious deterioration in the health of the subject, users, or other persons as defined by one or more of the 
following: 
 
1) a life-threatening illness or injury, or 
 
2) a permanent impairment of a body structure or a body function including chronic diseases, or 
 
3) in-patient or prolonged hospitalization, or 
 
4) medical or surgical intervention to prevent life-threatening illness or injury, or permanent 
impairment to a body structure or a body function, 
o c) foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by the Clinical Investigation Plan, 
without serious deterioration in health, is not considered a serious adverse event. 

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 12 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
x 
serious health threat: signal from any adverse event or device deficiency that indicates an imminent risk of death or a 
serious deterioration in the health in subjects, users or other persons, and that requires prompt remedial action for other 
subjects, users or other persons. 
Note: This would include events that are of significant and unexpected nature such that they become alarming as a 
potential serious health hazard or possibility of multiple deaths occurring at short intervals. 
x 
serious adverse device effect: adverse device effect that has resulted in any of the consequences characteristic of a 
serious adverse event 
x 
unanticipated serious adverse device effect: serious adverse device effect which by its nature, incidence, severity or 
outcome has not been identified in the current risk assessment 
Note: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, severity or outcome 
has been identified in the risk assessment. 
x 
device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, 
safety or performance 
Note 1: Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by the 
manufacturer including labelling. 
Note 2: This definition includes device deficiencies related to the investigational medical device or the comparator. 
14.2List of non-reportable adverse events 
All adverse events will be reported and documented as described below.  
14.3Adverse Event Reporting  
x 
All Adverse Events, both Anticipated and Unanticipated, must be recorded in the within the CRF and in the Adverse 
Event Report Form. 
x 
All Adverse Events must be promptly reported to the Sponsor.  
x 
All Unanticipated Adverse Device Effects will be also reported to both the Sponsor and the IRB.   
x 
Both Serious Adverse Events and Unanticipated Adverse Device Effects must be reported to the Sponsor within 48 
hours. All other Adverse Events should be reported to the Sponsor within 5 business days.  
x 
All Serious Adverse Events will be also reported to the IRB per IRB reporting requirements.  These reports may include, 
but will not be limited to: date of onset; brief description of the events; their treatment; whether they resulted in death, 
inpatient hospitalization, severe or permanent disability or were life threatening; their relationship to the study device; 
and resolution. 
14.4Device Deficiencies Reporting 
All Masimo device related deficiencies should be reported to the Sponsor and must be recorded in the CRF in a timely manner. 
When a Masimo device deficiency is observed, every effort should be made to return the device and its packaging to the Sponsor 
in a timely manner. 
15 VULNERABLE POPULATION 
15.1Definition 
Vulnerable population are research participants, such as children, prisoners, pregnant women, handicapped, or mentally disable 
persons, or economically or educationally disadvantaged persons,  who are likely to be vulnerable to coercion and undue 
influence.  

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 13 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
The federal regulations that govern the protection of human subjects require additional protection for the vulnerable population. 
15.2Protection of vulnerable subjects 
x 
Reasonable compensation will be provided for economically disadvantaged subjects to eliminate possibility of undue 
influence due to financial incentive. 
x 
Educationally disadvantaged subjects will be provided ample time to ask questions and comprehend information.  
x 
Medical care will be provided to these subjects after the clinical investigation has been completed if they are injured as a 
direct result of participating in this research study. The cost of treatment for any research related injury will be covered 
by Masimo. 
x 
For children, the Investigator will ensure that the parent/legal guardian does not unduly influence subjects to participate 
(21 CFR Part 50). Parents/legal guardian of the participant will have ample time to ask question and understand the 
information being presented.  
15.3Responsible Parties  
x 
The EC/IRB will review research with vulnerable populations and evaluate consent, level of risk, coercion, and the 
reason for choosing this particular subject population. The EC/IRB will be responsible for determining what practices 
will include continuing review for compliance while monitoring these studies.  
x 
The Investigator holds the ultimate responsibility for protecting the rights, safety, and welfare of research subjects by 
ensuring that all regulations and proper documentation of consent is handled in a compliant and timely manner. 
16 SUSPENSION OR PREMATURE TERMINATION OF THE CLINICAL INVESTIGATION 
16.1Suspension or Termination of Study Site 
The sponsor can suspend or prematurely terminate the PI’s and study site’s participation in the study, particularly if sponsor finds 
serious non-compliance by the PI or site, and if such non-compliance was not resolved in a timely manner. The sponsor will 
document the decision to suspend or terminate the investigation in writing. A suspended study site cannot enroll new subjects.  
If the sponsor determine that the study site’s compliance to be inadequate at any point during the study, and sponsor move to 
suspend or terminate the study site, the sponsor will provide notification in writing to the principal investigator and IRB as 
necessary. The study site is eligible for reinstatement upon correction of any findings and any open action items prior to the 
suspension, and provides a written guarantee that the same non-compliance will not reoccur in the future. Site can only resume 
subject enrollment upon receiving written notification of reinstatement from the sponsor.  
If for any GCP and Regulatory non-compliance reasons the study site is prematurely terminated by the sponsor, then the study site 
is not eligible for reinstatement under the same Clinical Investigational Plan/Study Protocol. 
16.2Termination of Clinical Investigation/Study due to UADE 
The clinical investigation may be terminated if sponsor determines that an unanticipated adverse device effect presents an 
unreasonable risk to the subjects. Termination shall occur not later than 5 working days after the sponsor makes this 
determination, and not later than 15 working days after the sponsor first received notice of the effect.  
The sponsor may resume the terminated clinical investigation with prior IRB approval if the device is non-significant risk. 
17 PUBLICATION POLICY 
In compliance with 42 CRF Part 11, a study that meets the definition of an Applicable Clinical Trial (ACT) and that is initiated 
after September 27, 2007 must be registered on ClinicalTrials.gov. Results of the clinical investigation will be made publicly 
available.  
This study meets the definition of an ACT, and thus registration and results are required on ClinicalTrials.gov.  

 
CLINICAL INVESTIGATION PLAN 
R-CIP-1067 
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subjects  
KOEI0004 
Revision:  A 
 
 
CONFIDENTIAL AND PROPRIETARY 
Page 14 of 14 
© 2023 Masimo Corporation (Unpublished) 
DOT-1225 Rev. A 
All Rights Reserved 
CO-072624 
 
18 BIBLIOGRAPHY 
N/A 
19 REVISION HISTORY 
 
Version Number 
Version Date 
Summary of Revisions Made 
1.0 
31Jan2023 
Original version 
1.1 
16Feb2023 
Updated title in header 
Updated to remove LAR and add 
Legal Guardian.