Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and Fall Detection
Phase: NA
Conditions: Pressure Ulcer, Pressure Injury, Falls Injury
Sponsor: Masimo Corporation

 
 
Official Title: Calibration and Usability 
Validation of Patient Monitoring Device for 
Pressure Injury Prevention and Fall Detection 
 
Date of Protocol: 17 December 2018 
 
NCT Number:   
 
NCT03121144 

CLINICAL INVESTIGATION PLAN 
RAMS0006
Usability Validation of Patient Monitoring Device for Pressure Injury Prevention and 
Fall Detection 
Version 2.0
 
 
CONFIDENTIAL AND PROPRIETARY   
© 2020 Masimo Corporation (Unpublished) 
All Rights Reserved 
Page 1 of 13 
 
 
 
 
Calibration and Usability Validation of Patient Monitoring Device for Pressure 
Injury Prevention and Fall Detection 
 
 
 
Sponsor: 
Masimo 
52 Discovery 
Irvine, California 92618 
 
 
Principal Investigator: 
 
Sub-Investigator: 
Michael A.E. Ramsay, MD, FRCA  
 
Susan H. Smith, DNP, APRN, ACNS-BC   
 
 
Study Device: 
Masimo Centroid Sensor Monitoring Device 
Masimo Radical-7 Pulse CO-Oximeter 
Masimo LNCS® Pulse Oximeter Sensors  
Masimo Root Patient Monitoring System 
Masimo SedLine Brain Function Module and Sensors 
 
 
 
 
Sponsor Protocol Number: 
RAMS0006  
 
 
IRB: 
Baylor Research Institute  Institutional Review Board  
3310 Live Oak, Suite 501 
Dallas, TX 75204 
 
 
 
 
Principal Investigator 
 
Michael A.E. Ramsay, 
MD, FRCA 
Title 
 
Chairman, Department of 
Anesthesiology & Pain Management 
Signature 
Date 
Sponsor 
 
Vikram Ramakanth  
Title 
 
Director of Clinical Research  
Signature 
Date 
 
 

RAMS0006: Calibration and Usability Validation of Patient Monitoring Device for Pressure Injury 
Prevention and Fall Detection  
Version 2.0 
 
CONFIDENTIAL AND PROPRIETARY   
© 2020 Masimo Corporation (Unpublished) 
All Rights Reserved 
                                                                            Page 2 of 13 
 
 
1 
INTRODUCTION 
This document is a clinical investigational plan for a human research study. 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 IRB approval, federal and local regulatory requirements, 
21CFR 812, ISO-14155 and International Conference on Harmonization Good Clinical Practice guidance ICH GCP.  
This protocol describes a procedure to collect a subject’s position, movement and physiological data using Masimo’s 
Centroid system. The Centroid monitoring system consists of a noninvasive, coin-battery operated, wearable sensor that can 
be attached to a subject’s chest or back and is intended to send the subject’s position, movement and activity data to the Root 
monitoring station via a Bluetooth link. Device and usability data from the Centroid system as well as staff notes about the 
subject’s demographics, vital signs, health condition, and activity will be collected. Additionally, this protocol allows for the 
placement of Masimo’s pulse oximeter system and SedLine brain function monitoring system. The SedLine system will 
collect EEG data in this patient population. The pulse oximeter system will collect plethysmogram data. 
1.1 
Background and Rationale 
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), acoustic respiration rate monitoring (RAM), and cerebral and 
regional oximetry (rSO2, O3TM). These technologies are noninvasive and have a good patient safety record.  
Masimo has developed a new noninvasive sensor named Centroid as a device to aid in preventing hospital-acquired pressure 
injury or worsening of existing pressure injury by monitoring patient movement, position, and orientation. The sensor is also 
able to detect falls through the same monitoring features. This type of monitoring may be effective in reducing the 
debilitating conditions for patients and their extended stays in hospitals, especially in the patient population who are 
vulnerable to acquire pressure injuries and/or are prone to fall-related injuries.  
Each year over 2.5 million individuals in the U.S. develop a pressure injury.1 Pressure injuries are painful, debilitating and 
are usually avoidable. Routine repositioning relieves and redistributes pressure over bony prominences. It is a recommended 
procedure to help mitigate the risks for developing a pressure injury.2 The Centroid device, through detection of patient 
position, is a modality to ensure repositioning occurs routinely.  
As many as 1 million Americans fall in the hospital every year. Falls result in fractures, lacerations, bleeding and even death. 
Current practices to prevent falls include assessment of patient risk, scheduled rounding practices and patient specific 
interventions to prevent falls.3 The Centroid device is proposed to be an additional technology to assess risk for fall based on 
patient position and unique modality additive to these current practices. 
The Centroid system consists of a wearable, battery-operated, adhesive sensor and a back-end user interface and Root 
monitor display at the patient bedside as well as a central location (e.g., nursing station). The sensor contains sensing 
elements (accelerometers, gyroscopes), processor, and a blue-tooth communication chip (BTLE 2.4 GHz). An algorithm 
processes three-dimensional acceleration and rotation information and calculates the patient’s relative position and fall as 
parameters. These parameters are then combined over a given time period and computes past trend and future risk assessment 
for pressure injury. The system can generate alarms configured for adverse events related to patient posture, pressure injury 
risk and fall. 
In this study, subject position data and feedback about device usability will be collected. Data collection will also be 
conducted for Masimo’s SedLine brain function monitoring system. Secondary aims are to collect data for the pulse oximeter 
sensor and SedLine sensor for the purpose of correlating against Centroid sensor’s data and further investigation. 
1.2 
Investigational Devices  

RAMS0006: Calibration and Usability Validation of Patient Monitoring Device for Pressure Injury 
Prevention and Fall Detection  
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The Centroid device is a non-invasive body-worn investigational device that is intended to detect the positional changes and 
physical movements of a subject. The device mainly consists of an inertial sensor, Bluetooth LE radio, and a coin-cell lithium 
battery. The Centroid device is a disposable sensor that is capable of adhering to a subject’s skin and continuously storing 
and transmitting positional data wirelessly, to a host instruments/devices to analyze the subject’s activities. The sensor’s skin-
contacting materials are biocompatible and are thermally non-conductive. The device is intended to be used in hospitals, 
hospital-type facilities, healthcare facilities, and home environments.  
Investigational SedLine sensors and patient cables may be used in this study. The SedLine brain function module is non-
invasive and uses sensors that adhere to the subject’s forehead. The SedLine brain function module uses a sophisticated 
multivariate algorithm to assess the patient’s electroencephalogram (EEG) data from all 4 channels of the SedLine EEG 
sensor. The SedLine V2 sensor is intended to monitor the state of the brain by real-time data acquisition and processing of 
EEG signals. The SedLine system includes patient cable that connects the sensor and module to the Root multi-function 
monitoring system, which monitors multiple physiological parameters in healthcare environments. 
2 
STUDY DEVICES 
2.1 
Description 
Investigational Devices: 
Centroid monitoring device 
SedLine V2 sensor and V2 patient cable 
FDA-cleared Devices: 
SedLine brain function module  
Root monitor*  
Radical-7 Pulse CO-Oximeter 
LNCS SpO2 sensors 
*NOTE: during the validation stage of the study, the FDA-cleared Root monitor will be updated with Centroid software. The 
Root monitor at this time will be considered an investigational device, although no new patient risks will be introduced by the 
addition of the Centroid software.  
2.2 
Device Accountability 
2.2.1 
Receipt of Study Device 
Masimo may ship or hand-carry devices and sensors to the investigative sites. Upon receipt of the study device supplies, an 
inventory must be performed and the Equipment Shipment Check Form (FRM-2713) and the device accountability log will 
be completed for each device and signed by the receiver. 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. 
2.2.2 
Use of Study Device 
Use of devices and sensors will be documented on case report forms (CRF) for each subject. Any unused devices must be 
returned to the Sponsor at the end of the study or before product expiration date. 
2.2.3 
Return or Destruction of Study Device 
At the completion of the study, there will be a final reconciliation of study devices. This reconciliation will be logged on the 
device accountability log. Any discrepancies noted will be investigated, resolved, and documented prior to return or 

RAMS0006: Calibration and Usability Validation of Patient Monitoring Device for Pressure Injury 
Prevention and Fall Detection  
Version 2.0 
 
CONFIDENTIAL AND PROPRIETARY   
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All Rights Reserved 
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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. 
2.2.4 
Device Deficiencies 
Device deficiencies are defined as the inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance. Record all device deficiencies on the case report form and report to the Sponsor. 
2.3 
Risk/Benefits 
Benefits: There will be no direct benefits to the enrolled subjects.  Future benefits to subjects include effective pressure 
injury prevention (i.e., reduction in their occurrence and/or severity) and detection of hospital falls.  
Centroid device risks: As with all wearable sensors, the Centroid sensor has a risk of thermal burn as there is a coin battery 
in the sensor. The coin battery used in the Centroid device is widely used in other commercially available medical devices for 
wearable monitoring applications. Masimo’s design includes safeguards against thermal burn, and this risk is believed to be 
low. Sensors will be attached with a medical-grade, biocompatible adhesive. Marks may appear on the skin beneath the 
sensor due to adhesion for a long period (from several hours to days). The risk is believed to be low. The sensor transmits 
that data, after on-sensor processing, via a radio link to the host device. 
SEDLine V2 sensor and V2 patient cable risks: All patient-contact materials, including the adhesive used in the design of 
the Masimo sensors, have been subjected to biocompatibility tests per ISO 10993-1 and results demonstrate that the materials 
are non-toxic, non-irritating, and non-sensitizing. The sensors have been evaluated for mechanical and electrical safety and 
the risks have been determined to be minimal. The modifications to the sensor are specifically designed so as not to introduce 
any new risks to the subject. 
Pulse oximeter risks: The Radical-7 pulse CO-oximeter device and LNCS® pulse oximeter sensors used in this study are 
FDA-cleared.  
Root patient monitoring system risks: The Masimo Root Monitoring System and SedLine brain function module used 
during this study are FDA-cleared devices. 
3 
STUDY OBJECTIVES 
The primary aim of this study is to collect data for calibration and usability validation of the new Centroid monitoring 
system which Masimo has developed for monitoring a patient’s position and movement to prevent pressure injury and 
detecting falls in the hospital. This protocol describes data collection from patient volunteers during their routine hospital stay 
lasting usually for more than one day. During the calibration phase, positional data will be collected for the purpose of 
evaluating the Centroid design and technology. Usability validation data will be collected and analyzed from a questionnaire 
regarding the Centroid system, with regards to ease of use, sensor application and adhesive quality, subject comfort, device 
display and user selection, and feedback from the study staff about clarity of parameters display, etc. 
Secondary aims are to collect data for the pulse oximeter sensor and SedLine sensor for the purpose of correlating against 
Centroid sensor’s data and further investigation. 
4 
STUDY DESIGN 
4.1 
General Design 
This is a prospective clinical study of Masimo’s Centroid sensor in patients to collect movement, position, and other 
physiological data from a sensor placed on the subject’s chest or back. LNCS pulse oximeter sensors will be placed on 
subjects according to their tolerance of the sensors. SedLine sensors may be placed on subjects while they are asleep. 
4.2 
Study Endpoint 

RAMS0006: Calibration and Usability Validation of Patient Monitoring Device for Pressure Injury 
Prevention and Fall Detection  
Version 2.0 
 
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For the data collection and calibration phase of the study, there are no study endpoints. For the centroid usability validation 
phase of the study, user feedback will be collected from a questionnaire and analyzed based on the variability of scores 
aggregated from questions regarding ease of application and use with respect to Centroid comfort and durability, Centroid 
pairing/connection with Root monitor, and Root display.   
5 
CLINICAL SITE 
Baylor University Medical Center 
Webb Roberts Hospital  
3500 Gaston Avenue 
Dallas, TX 75246 
6 
SUBJECT SELECTION AND WITHDRAWAL 
6.1 
Population Base 
Subjects will be at least 18 years of age. Subjects will be recruited from Baylor University Medical Center. A total enrollment 
of at least 60 unique subjects is targeted. 
6.2 
Inclusion Criteria 
x 
At least 18 years of age  
x 
ICU patient 
x 
Primarily bedbound subjects 
x 
Able to be monitored for a minimum of approximately 8 hours  
6.3 
Exclusion Criteria 
x 
Pregnancy 
x 
Prisoner status 
x 
Pressure injury stage 2, 3, or ungroupable 
x 
Has a pacemaker or internal defibrillator  
x 
Has a history of complications with a similar study 
x 
Has any medical condition which in the judgment of the Investigator, renders them inappropriate for participation in 
this study 
6.4 
Study Timelines 
Each individual subject may participate in this study from approximately 8 hours to 16 hours. Data collection may start only 
after the informed consent has been signed by the participant. The subject will be considered to have completed the study 
after at least 8 hours of Centroid data have been collected. The study is expected to be completed within 12 months of 
initiation.    
6.5 
Subject Recruitment and Screening 
Following identification of a potential subject, the patient will be approached by the principal investigator or a designated 
research staff member, who will explain the purpose and procedures of the study. If the patient expresses interest in 
participating in the study, they will be asked to read the written Informed Consent Form in English or Spanish depending on 
the patient’s language preference.  
All items of the Informed Consent will be explained in a way that is easily understandable, for either English or Spanish 
speaking subjects. The patient will be given adequate time to read through the Informed Consent, and they will be given 
adequate time and privacy to consider the decision of whether or not to sign the Informed Consent Form. Once all of the 
patient’s questions have been answered and the Informed Consent Form signed, the patient is now adequately consented. 

RAMS0006: Calibration and Usability Validation of Patient Monitoring Device for Pressure Injury 
Prevention and Fall Detection  
Version 2.0 
 
CONFIDENTIAL AND PROPRIETARY   
© 2020 Masimo Corporation (Unpublished) 
All Rights Reserved 
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Now the patient will be enrolled as a study subject, at which time the subject will be assigned a study identification number 
or enrollment number.  
All subjects will have their medical history reviewed at the time of screening by either the PI or the study staff who is 
delegated for this task. Subjects will be evaluated based on the inclusion and exclusion criteria to determine eligibility to be 
enrolled into the study. If a subject is deemed ineligible after screening, the subject will be withdrawn from the study.  
Information regarding the subject’s demographic (including, but not limited to age, weight, race, ethnicity, etc.), preexisting 
allergies, skin abnormalities, and other preexisting diseases/conditions that may be relevant to the study will be recorded 
within a paper-based Case Report Form (CRF).  
HIPAA 
The pre-screening of patients will require the investigators to access personal health information to identify prospective 
subjects without HIPAA authorization prior to obtaining written informed consent for the study. Informed consent and 
HIPAA authorization will be obtained during recruitment and screening procedures as described in previous sections of this 
clinical investigation plan; however, pre-screening process would require a waiver of HIPAA authorization, as the research 
study could not be practicably carried out without this implied waiver of consent. The participants’ rights and welfare will not 
be adversely affected by waiving consent. Patients’ protected health information (PHI) will not be inappropriately reused or 
disclosed to any other person or entity. To further safeguard all protected health information, the data collected during the 
study will not be labeled with any personal identifying information, or with a code that this research team can link to personal 
identifying information. The data will not be stored with any protected health information identifiers.   
6.6 
Early Withdrawal of Subjects 
6.6.1 
Withdrawal of Individual Subjects 
Subjects can leave the study at any time for any reason if they wish to do so without any consequences or loss of benefits to 
which they are otherwise entitled.  Subjects may be withdrawn from the study prior to expected completion for reasons such 
as safety concerns, failure to adhere to protocol requirements, subject consent withdrawal, etc.   
Any data collected until the time of subject withdrawal may be included in the final data analysis. Information on the 
subject’s withdrawal should be documented in the case report form and should include clear documentation of the reason for 
withdrawal to the Sponsor. 
6.6.2 
Follow-up for subjects withdrawn from study 
None. There are no long term effects anticipated from participating in this study. 
6.6.3 
Replacement of individual subjects after withdrawal 
In case a subject leaves the study prematurely, another volunteer may be recruited. 
7 
STUDY PROCEDURES 
7.1 
Subject’s demographic information, vital signs, Braden Scale score, risk for fall using the Johns Hopkins Fall Risk 
Assessment tool, Richmond Agitation and Sedation Scale (RASS) and all specified parameters will be noted in the 
subject’s Case Report Form.  
7.2 
Centroid sensor placement 
Up to two Centroid sensors may be attached to the subject’s chest and/or back. The sensors will then be turned on. Study staff 
will note down time, subject’s current position and head-of-bed angle information, heart rate, respiration rate, and parameters 
on the Root display on the case report forms approximately every 30 minutes. The duration of the study for each subject will 
be at least 8 hours each day of monitoring up to 16 hours. Sensors may be replaced after 8 hours of use on a subject. If the 

RAMS0006: Calibration and Usability Validation of Patient Monitoring Device for Pressure Injury 
Prevention and Fall Detection  
Version 2.0 
 
CONFIDENTIAL AND PROPRIETARY   
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All Rights Reserved 
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sensor is removed for a procedure, surgery, x-ray, or other reasons, the sensor may be placed back on the subject depending 
on the subject’s comfort or at the PI’s discretion.  
During the calibration phase, data will be stored within the Centroid device. During the validation stage, the Centroid sensor 
will pair with the Root monitor and Centroid data will be stored and displayed on the Root. Study staff will also record the 
Root’s displayed patient position. 
7.3 
LNCS Pulse oximeter sensor placement 
The LNCS pulse oximeter sensor may be placed on the subject’s finger. The data collection will be initiated on the Root 
monitor. The sensor may be removed at any time, depending on the subject’s tolerance of the sensor. 
7.4 
SedLine sensor placement 
The SedLine sensor will only be placed when subjects have a RASS of -5. The SedLine sensor will be applied to the 
subject’s forehead and data collection will be initiated on the Root monitor. The sensor may be removed at any time, 
depending on the subject’s tolerance of the sensor. 
7.5 
The study will be terminated at the discretion of the PI if any significant adverse event is observed. 
7.6 
At the conclusion of the study, devices and data recording will be stopped and all sensors will be removed from the 
subject.  
7.7 
The skin will be inspected for any signs of redness or irritation. 
8 
SAMPLE SIZE AND STATISTICAL CONSIDERATIONS 
8.1 
Calibration and Validation stage 
The calibration stage will continue until a sufficient number of cases have been obtained with quality data (e.g. no data drop-
outs).  Initial data sets may be considered training sets and may not be used for device calibration. Documentation will be 
included in the study records of when the calibration stage has concluded and when the validation stage commenced. 
8.2 
Usability validation 
In the validation stage, since this is a usability validation only, there is no statistical justification needed for the sample size. 
The study will enroll at least 30 subjects for this stage. 
 
9 
SAFETY AND ADVERSE EVENTS 
9.1 
Definitions 
The definitions for adverse event, adverse device effect, serious adverse event, serious adverse device effect, and 
unanticipated adverse device effect are provided below (ISO 14155:2011, 21 CFR 812.3(s)). 
x 
Adverse Event (AE): an adverse event is any untoward medical occurrence in a subject which need not be related to the 
device under investigation. 
x 
Adverse Device Effect (ADE): an adverse device effect is any untoward or unintended response to a medical device 
which may result from insufficiencies in the instructions for use or deployment of the device, or from use error.  
x 
Serious Adverse Event (SAE): a serious adverse event is an adverse event that results in death, inpatient hospitalization, 
severe or permanent disability, a life threatening illness or injury, fetal distress, fetal death, a congenital abnormality, a 
birth defect, or medical or surgical intervention to prevent permanent impairment to body or structure. 
x 
Serious Adverse Device Effect (SADE): a serious adverse device effect is an adverse device effect that results in death, 
inpatient hospitalization, severe or permanent disability or is life threatening. 
x 
Unanticipated Adverse Device Effect (UADE): any serious adverse effect on health or safety or any life threatening 
problem or death cause by or associated with, a device, if the effect, problem, or death was not previously identified in 

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Prevention and Fall Detection  
Version 2.0 
 
CONFIDENTIAL AND PROPRIETARY   
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All Rights Reserved 
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nature, severity or degree of incidence in the investigational plan, or application (including a supplementary plan or 
application) or any other unanticipated serious problem associated with a device that related to the rights, safety or 
welfare of subjects. Refer to the Device Risk Analysis and Risk Assessment section for details on anticipated adverse 
device effects. 
9.2 
Anticipated Adverse Events: 
Sensor may cause slight, temporary redness, which should fade away shortly after sensor removal. 
Sensor may cause thermal burn; however, the design includes safeguards and this risk is believed to be minimal. There may 
be mild allergic reaction to sensor material and adhesives. 
9.3 
Adverse 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. 
9.4 
Deviations from the study protocol 
Deviations from the protocol must receive both Sponsor and the investigator’s IRB approval before they are initiated with the 
exception that under emergency circumstances, deviations from the CIP to protect the rights, safety and well-being of human 
subjects may proceed without prior approval of the sponsor or the EC. Any protocol deviations initiated without Sponsor and 
the investigator’s IRB 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 as soon as a possible, but no 
later than 5 working days of the protocol deviation. If protocol deviations continue to occur frequently at a study site, a 
corrective and preventive action (CAPA) may be opened by the Sponsor.   
9.5 
Withdrawal of IRB approval 
An investigator shall report to the sponsor a withdrawal of approval by the investigator’s reviewing IRB as soon as a 
possible, but no later than 5 working days of the IRB notification of withdrawal of approval. 
10 
VULNERABLE POPULATIONS 
10.1 
Definition 
10.1.1 
Vulnerable populations are defined as disadvantaged sub-segment of the community requiring utmost care, special 
considerations and protections in research. This study will recruit subjects from the following: economically 
disadvantaged or unemployed, educationally disadvantaged, and limited English skills and/or Non-US citizens.  
10.2 
Protection of vulnerable subjects  
x 
There is no compensation 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.  

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Prevention and Fall Detection  
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x 
Subjects with limited English skills and/or Non-US Citizens will be provided translated documents in native 
language, staff/independent interpreter, and have ample time to ask questions and understand 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.  
10.3 
Responsible Parties  
x 
The IRB will review research with vulnerable populations and evaluate consent, level of risk, coercion, and the 
reason for choosing this particular subject population. The 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. 
11 
DATA MANAGEMENT 
11.1 
Confidentiality of Records 
Information about the patients will be kept confidential. The data will be stored on a password protected database on a secure 
server, accessible only to the Investigators.  Study data that will be released to Masimo and other regulatory authorities will 
be de-identified and will only pertain to study data collection, demographics, finger location of the sensor, and the recordings 
from the pulse oximeter.  
11.2 
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. For this study, the case report forms may also be used as source worksheets.  
11.3 
Case Report Forms 
The Site shall capture study data in the CRFs for each subject enrolled. The CRFs will be completed and initial and dated by 
the PI or delegated personnel. 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. Entries and corrections to the CRF will 
be made following Good Documentation Practices.  
The CRF will include the following information, including but not limited to: inclusion/exclusion criteria, whether patient 
consent 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 to attest that the data is complete and 
accurate and forward a copy to Masimo.  
CRF entries will be verified by study monitor and any errors or inconsistencies will be queried to the site on an ongoing 
basis. Any changes will be made directly on the paper CRFs and re-verified. Query resolution will be assessed and confirmed 
by study monitor during site visit. The monitor or study manager will collect original completed and signed CRFs at the end 
of the study. A copy of the completed and signed CRFs will remain on site 
11.4 
Data Transfer and Storage 
Training on CRF completion will be provided to study personnel prior to data collection. Original CRFs will be stored in a 
secure location at site. Original CRFs will be scanned and sent to sponsor. During Calibration stage, centroid device will be 

RAMS0006: Calibration and Usability Validation of Patient Monitoring Device for Pressure Injury 
Prevention and Fall Detection  
Version 2.0 
 
CONFIDENTIAL AND PROPRIETARY   
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All Rights Reserved 
                                                                            Page 10 of 13 
 
 
shipped back. During validation stage, centroid device data will downloaded from a host device, the Root® monitoring 
system. For the pulse oximeter and SedLine systems, device data will be downloaded from the devices and transferred to 
Masimo using secure file transfer protocols. 
CRFs will be checked for accuracy and completeness of data. If there are inconsistent or missing data points, a data query list 
will be generated and submitted to the PI or designee, who shall both follow GDP practices for data correction by striking 
through the old entry, adding in new entry with initial and date, and resend to Masimo the corrected CRF. Once all queries 
have been resolved, Masimo engineers are notified that data is ready for analysis. To ensure data integrity, Masimo engineers 
will only have read access to study data, therefore are unable to unintentionally tamper with the original data files.  
11.5 
Record Retention 
All study information, including but not limited to study correspondence, study logs, device accountability records, consent 
forms, subject records, and copies of CRFs should be maintained in the Investigator site files.   
Study records shall be retained during the study and for a minimum of two years after date of study closure or date when 
records are not required to support 510(k) clearance. The Institution’s own retention policies and regulations may apply in 
addition to the minimal requirement.  
The Sponsor is responsible for verifying study data, retaining records, analyzing data, and authoring study reports. 
12 
MONITORING PLAN 
12.1 
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 a direct employee from the Clinical Research department trained on 
departmental SOPs on conduct and monitoring of Sponsored studies. 
12.2 
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 subject enrollment 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 enrollment, preferably when enrollment has reached 10-20% of subjects, and 
then at least once every year thereafter. 
x 
A final close out visit after the last patient had finished the study.  
12.3 
The Investigator shall allow 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 subject confidentiality is 
maintained in agreement with HIPAA regulations.  
12.4 
It will be the monitor's responsibility to inspect the CRFs at regular intervals throughout the study, to verify the 
adherence to the CIP and the completeness, consistency and accuracy of the data being entered on them.  
12.5 
During each visit, the monitor will also verify presence of informed consent, adherence to the inclusion/exclusion 
criteria, and documentation of SAEs/SADEs and protocol deviations/violations, and check CRF against medical 
records as necessary. 
12.6 
After each visit, the monitor will provide a monitoring follow-up letter to the investigator within 4 weeks of visit 
completion. The follow-up 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 
report, and complete any open action items as soon as possible but no later than 30 days of receiving the monitoring 
report. Any open action items not completed within the time allowed may be sufficient grounds for study site 

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suspension or termination; it will be up to the sponsor to determine whether any incomplete action items are 
sufficient grounds for suspension or termination. See Section 13 for details on suspension and termination.  
12.7 
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. 
13 
ADMINISTRATIVE ASPECTS 
13.1 
Protection of Human Subjects 
Per 21 CRF 50, written consent must be obtained from each subject or from their legal guardian prior to any study procedures 
in accordance with applicable federal, state, and study site regulations. The Investigator must keep a copy of the signed 
consent form in each subject’s record and provide a copy to the subject as well. The Investigator shall not allow a subject to 
participate in a study or sign consent prior to IRB approval.  
Prior to the start of data collection or subject enrollment, the Investigator must provide documentation of IRB approval of the 
study protocol and a copy of the approved informed consent form (21 CFR 50).  
All subjects will be monitored closely throughout the study. The following measures will be taken to ensure the privacy of 
subjects: 
x 
A code (unique identification) number for each subject will be kept on file. 
x 
Only their correspondence identification number will identify subjects. 
x 
Access to the documents and data will only be made to the Investigators and study staff in the study.  
x 
The confidentiality of these documents will be protected to the extent provided by the law.  
13.2 
Institutional Review Boards 
The Sponsor and/or Investigator must submit the protocol to the appropriate IRB and obtain a copy of the written and dated 
approval letter.  
The approval letter should state the name of the documents reviewed, date of review, date of approval, and reference the 
study name (protocol title, study number, and version). 
The informed consent used by the Investigator must be reviewed and approved by the Sponsor prior to submission to the 
IRB. The Investigator cannot enroll subjects until a copy of the approved informed consent is obtained from the IRB.  
Any amendments to the protocol or informed consent should be submitted to the IRB for review and approval per 21 CFR 56. 
The IRB should be notified of any changes that may affect conduct of the study or pose safety risks to the subjects. 
13.3 
Confidentiality 
All data collected will be kept confidential and de-identified. It can only be accessed by researchers and will be used for 
research purposes only.  
13.4 
Protocol Amendments 
Any changes made to the clinical investigational plan/study protocol will be documented by way of an amendment. Before 
submitting protocol amendment to the IRB for approval, the protocol amendment must be agreed upon and signed by both 
the Investigator and the Sponsor. The Investigator shall not make any changes to the protocol without Sponsor approval and 
documented approval from the IRB. Both PI and Sponsor will retain the IRB approval letter and approved protocol as 
confirmation that the protocol amendment was approved.  
13.5 
Suspension 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 

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Prevention and Fall Detection  
Version 2.0 
 
CONFIDENTIAL AND PROPRIETARY   
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All Rights Reserved 
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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 GCP and federal regulations 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 patient enrollment upon receiving written notification of reinstatement from the 
Sponsor and/or IRB.  
13.6 
Termination 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.  
14 
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 
Conduct the clinical investigation in accordance with the protocol, all applicable laws and federal regulations, and 
conditions or restrictions implemented by the governing IRB. 
x 
Ensure only appropriately trained personnel will be involved in clinical investigation. 
x 
Maintain study records mentioned in the CIP. 
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. 

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Prevention and Fall Detection  
Version 2.0 
 
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15 
REVISION HISTORY: 
Version Number 
Version Date 
Summary of Revisions Made: 
1.0 
05-Jan-2017 
Original version  
2.0 
18-Jan-2018 
Study Title: Amended title to specify usability validation.  
Section 1: Changed from Centroid device to Centroid system. 
Section 1.1: Added clarification to background rationale that 
positional data and user feedback about device usability will be 
collected. 
Section 3: Added clarification around study objectives. During 
calibration, positional data will be collected. During validation, 
usability data will be collected from a questionnaire.  
Section 4.2: Added that user feedback will be analyzed based on 
variability of scores collected from a questionnaire for the usability 
validation phase of the study. Removed study endpoints for 
validation phase as fall detection rate, error rate, and positional 
accuracy of the sensor against staff notes will no longer be analyzed.  
Section 6.3: Removed “based on Braden Scale Score” from 
exclusion #3 and added “pressure injury stage 2, 3, or ungroupable.” 
Section 7.2: Added clarification around Centroid placement 
procedures and the data points (time, subject’s current position, 
head-of-bed angle, heart rate, respiration rate, and parameters on 
Root display) to be collected. Added clarification that Centroid 
sensor can be placed back on subject after procedure, x-ray, or other 
reasons in the procedural section.  
Section 8.2: Removed sample size justification for position detection 
rates. Added statement that no sample size justification is required 
for usability validation.  
Section 8.3: Removed sample size justification for fall detection 
rates.  
 
 
16 
REFERENCES 
1. Berlowitz, et al. (2014). Preventing pressure ulcers in hospitals: A toolkit for improving quality of care. 
Retrieved http://www.ahrq.gov/sites/default/files/publications/files/putoolkit.pdf 
2. National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure 
Ulcer Injury Alliance. Prevention and treatment of pressure ulcers: Quick reference guide. Emily Haesler (Ed.). 
Cambridge Media: Perth, Australia; 2014 
3. Ganz, DA, Huang, C, Saliba D, et al. Preventing falls in hospitals: A toolkit for improving quality of care. 
(Prepared by RAND corporation, Boston University School of Public Health, and ECRI Institute under Contract 
No. HHSA2902010000171 TO#1). Rockville, MD: Agency for Healthcare Research and Quality; January 2013. 
AHRQ Publication No. 13-0015-EF.