Accuracy and Precision of Peripheral Capillary Oxygen Saturation of Reprocessed Pulse Oximetry Sensors Compared to Oxygen Saturation in Arterial Blood Samples Assessed by CO-oximetry in Neonates
Phase: NA
Conditions: Premature Birth
Sponsor: Medline Industries

Medline Industries, LP
Accuracy of SpO2 of reprocessed pulse oximetry sensors compared to SaO2 assessed by CO-oximetry in 
neonates 
MED-2020-DIV65-001 
May 9, 2022 
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Accuracy and precision of peripheral capillary oxygen saturation of reprocessed pulse oximetry 
sensors compared to oxygen saturation in arterial blood samples assessed by CO-oximetry in 
neonates.
Protocol Number MED-2020-DIV65-001
May 9, 2022
Version 3.0
Prepared by:
Medline Industries
Three Lakes Drive
Northfield, IL 60093 
Prepared by (Si
Reviewed by (Signature)
Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093

Medline Industries, LP
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Contents
INVESTIGATOR ACKNOWLEDGMENT SIGNATURE................................................................................4 
DOCUMENT HISTORY ................................................................................................................................5 
1. 
PROTOCOL SUMMARY .......................................................................................................................7 
1.1. 
Synopsis........................................................................................................................................7 
1.2           Schedule of activities ..................................................................................................................10 
2. 
INTRODUCTION .................................................................................................................................11 
2.1. 
Background & Rationale .............................................................................................................11 
2.2. 
Study Products............................................................................................................................11 
2.3. 
Risk/Benefit Profile......................................................................................................................11 
3. 
OBJECTIVES AND ENDPOINTS........................................................................................................12 
4. 
STUDY DESIGN..................................................................................................................................12 
4.1. 
Overall Design.............................................................................................................................12 
4.2. 
End of Study Definition................................................................................................................12 
5. 
STUDY POPULATION.........................................................................................................................13 
5.1. 
Inclusion Criteria .........................................................................................................................13 
5.2. 
Exclusion Criteria ........................................................................................................................13 
5.3. 
Strategies for Recruitment and Retention...................................................................................13 
6. 
STUDY PROCEDURES AND ASSESSMENTS .................................................................................14 
6.1 
Day 0 Screening Visit and Informed Consent ..........................................................................................14 
6.2.          Day 1 Study visit..........................................................................................................................14 
7 
ADVERSE DEVICE EVENTS..............................................................................................................16 
7.1 
Definition of Adverse Device Event (ADE)..................................................................................16 
7.2 
Definition of Serious Adverse Device Event (SADE) ..................................................................16 
7.3 
Definition of Unanticipated Adverse Device Effect (UADE) ........................................................16 
7.4 
Severity of Adverse Device Event...............................................................................................16 
7.5 
Relatedness of Adverse Event and Serious Adverse Device Event...........................................17 
7.6 
Expectedness..............................................................................................................................17 

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7.7 
Adverse Device Event Reporting ................................................................................................17 
7.8 
Serious Adverse Device Event and Unanticipated Adverse Device Effect Reporting................18 
8 
STATISTICAL CONSIDERATIONS.....................................................................................................19 
8.1 
Sample Size Determination.........................................................................................................19 
8.2 
Randomization ............................................................................................................................19 
8.3. Populations for Analysis.......................................................................................................................19 
8.4. 
Data Analysis ..............................................................................................................................19 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ...............................21 
9.1 
Clinical Monitoring.......................................................................................................................21 
9.2 
Regulatory and Ethical Considerations.......................................................................................22 
9.3 
Protocol Deviations .....................................................................................................................24 
9.4 
Abbreviations...............................................................................................................................24 
10 REFERENCES ....................................................................................................................................26 
11. APPENDIX...........................................................................................................................................26 

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INVESTIGATOR ACKNOWLEDGMENT SIGNATURE
I agree to conduct the study in accordance with the relevant, current protocol and 
will make changes in the protocol only after notifying the Sponsor, except when 
necessary to protect the safety, rights, or welfare of subjects.
I agree to personally conduct and supervise the investigation as described within.
I agree to inform all subjects that the study products are being used for the purposes 
of an investigational study. 
I will ensure that requirements relating to obtaining informed consent in the 
guidelines for Good Clinical Practices (GCP), and 21 Code of Federal Regulation 
(CFR) Part 50 and Institutional Review Board (IRB) review and approval in 21 
CFR Part 56 are met.
I agree to report to the Sponsor, IRB and/or Ethics Committee, according to the 
protocol, adverse experiences that occur during the course of the investigation in 
accordance with guidelines for GCP, and 21 CFR 812.
I have read and understand the information in the protocol, including the potential 
risks.
I agree to maintain adequate and accurate records in accordance with guidelines for 
GCP and 21 CFR 812.140 and to make those records available for inspection.
I will ensure that an IRB compliant with the requirements of guidelines for GCP
and 21 CFR Part 56 will be responsible for the initial and continuing review and 
approval of the clinical investigation. I also agree to promptly report to the IRB all 
changes in the research activity and all unanticipated problems involving risks to 
human subjects or others. 
I agree to comply with all other requirements regarding the obligations of clinical 
investigators and all other pertinent requirements in the guidelines for GCP, and the 
CFR.
I have received and reviewed this Investigational Plan. I will conduct the study as described.
Principal Investigator (Print):
Principal Investigator (Signature):
Date (DD-MMM-YYYY)

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DOCUMENT HISTORY
VERSION
DATE
DESCRIPTION
Version 1.0
July 30, 2021
Initial draft
Version 2.0
December 9, 2021
Following changes were made:
1. The Medline clinical designee or 
Medline 
Director 
of 
Clinical 
Operations name was changed from 
Kara Cassady to Julie A. Miller.
2. The Medline clinical designee or 
Medline 
Director 
of 
Clinical 
Operations phone number was also 
updated.
Version 3.0
May 9, 2022
Following changes were made:
1. Medline 
Industries, 
Inc. 
was 
changed to Medline Industries, LP 
throughout the document.
2. Section 1.1: i) An addition was 
made in the study population 
section to indicate that the same 
blood draw value can be used for 
multiple 
sensors 
placed 
simultaneously. ii) The description 
of the site was changed from
multiple 
centers 
to 
multiple 
neonatal intensive care centers in 
order to be more specific.
3.
The study staff was changed to PI 
or 
designee 
throughout 
the 
document where applicable.
4. Section 1.2: An addition was made 
in the required assessments and 
activities column to indicate that 
the pulse oximeter data will be 
collected to determine SpO2 from 
same or different hands and/or feet
using one or both of the provided 
sensor types. 
5. Section 4.1: Since the data were 
collected from a convenience 
sample of subjects, randomization 

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will 
not be required to be 
completed. An edit was made to 
indicate that this study is not a 
randomized clinical trial.
6.
The edits were
made (where 
applicable) to indicate that the 
maximum number of blood draws 
will be per the standard of care
(SOC) of that facility.
7. Section 4.2: An edit was made in 
the end of the study participation 
definition with regard to reaching 
the maximum duration of sensor 
wear time. It was updated to be per 
the SOC of the facility or the 
instructions for use (IFU) of the 
sensor, whichever occurs first.
8. Section 6.2.1: An edit was made in 
the collection of arterial blood 
sample and measurement by CO-
oximeter to indicate that the data 
pairs 
may 
be 
concurrently 
collected for each of the two sensor 
types if the sensors can be placed 
on separate extremities.
9. Section 6.2.6: More clarity was 
provided 
regarding 
removing 
and/or reusing the sensors.
10. Section 8.1: More clarity was 
provided for the sample size
determination. 
11. Section 9.4: The table was updated
to include all the abbreviations 
used in this protocol.
12. Minor changes were made in the 
protocol 
including 
naming 
conventions, abbreviations, and 
wording used in our current 
protocol template.

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1. PROTOCOL SUMMARY
1.1. Synopsis
Title:
Accuracy and precision of peripheral capillary oxygen saturation of 
reprocessed pulse oximetry sensors compared to oxygen saturation 
in arterial blood samples assessed by CO-oximetry in neonates.
Study Description:
Pulse oximetry helps in measuring peripheral capillary oxygen
saturation (SpO2) continuously and non-invasively, and provides an 
indirect measurement of arterial oxygenation (SaO2) based on the 
red and infrared light-absorption characteristics of oxygenated and 
deoxygenated hemoglobin. Uses of pulse oximetry include
detection of hypoxia, avoidance of hyperoxia, titration of fractional 
inspired oxygen, and enabling weaning from mechanical 
ventilation. Arterial blood gas (ABG) analysis, such as by the use 
of CO-oximeter, provides a direct measurement of SaO2. However, 
ABG analysis requires time, expense, and arterial access. 
Therefore, this study aims to validate the SpO2 accuracy of pulse 
oximetry sensors (manufactured by Nellcor and Masimo, and 
reprocessed by Medline Industries, LP) in neonates as compared to
ABG measurements as part of their clinical standard of care (SOC),
as assessed by CO-oximetry. 
Objective:
To validate the SpO2 accuracy, bias, and precision
reprocessed pulse oximetry sensors as compared to SaO2 in arterial 
blood samples as assessed by CO-oximetry in neonates.
Endpoint:
Pulse oximeter and co-oximeter reading pair used to determine the 
accuracy of each pulse oximeter by evaluating accuracy root mean 
square (ARMS), bias, and precision.

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Study Population:
A total of at least 80 total data pairs per sensor will be collected. 
These should be collected from a minimum of 27 subjects such that 
there are no more than three pairs per subject (maximum of 3 blood 
draws). The same blood draw value can be used for multiple sensors
placed simultaneously.
Inclusion Criteria
Subjects who are postnatal 28 days or younger (neonates)
Subjects who are likely to receive one or more ABG
measurements as part of their clinical SOC.
Subjects who weigh less than 5 Kg (weight range for the
sensors)
Exclusion Criteria
Subjects with current signs and symptoms of a clinically 
significant Patent Ductus Arteriosus (PDA) combined with 
a current or planned arterial line placement which will affect 
the validity of the co-oximetry measurement
Subjects with physical malformation of hands, fingers, feet,
or toes that would limit the ability to place sensors for this 
study
Subjects judged by the Principal Investigator (PI) to be 
inappropriate for participation in this study
Subjects for whom placing a pulse oximeter will cause 
dermatological issues (e.g. allergic to foam rubber or 
adhesive tape)
Phase:
Post-Market
Description of 
Sites/Facilities 
Enrolling subjects:
Multiple neonatal intensive care centers
Description of 
Study:
Data collection will take place at the sites. The PI or designee will 
place one or both of the pulse oximeter sensors (Medline 
) on hands and/or feet of 
the subjects according to the IFU and record the readings. The 
arterial blood sample used in this study will be taken in the normal 
course of care and will be measured in the reference CO-oximeter 

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for SaO2. This arterial sample will be obtained from a systemic 
artery. 
Anticipated 
Enrollment period:
Six months to one year
Subject Duration:
Approximately 15 episodic minutes at the time of the blood draw
(the sensor, disconnected from the monitor, may stay on the subject 
for the maximum allowable duration of sensor use) or per the
facility SOC.

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2. INTRODUCTION 
2.1. Background & Rationale
Pulse oximetry helps in measuring SpO2 continuously and non-invasively, and also 
provides an indirect measurement of SaO2 based on the red and infrared light-absorption 
characteristics of oxygenated and deoxygenated hemoglobin. The ABG analysis, such as 
by the use of CO-oximeter, provides a direct measurement of SaO2.1,2 However, ABG 
analysis requires time, expense, and arterial puncture; therefore non-invasive techniques
that give similar results are being investigated.
This study aims to validate the SpO2 accuracy and precision of pulse oximetry sensors 
(manufactured by Nellcor and Masimo, and reprocessed by Medline Industries, LP) in 
neonates as compared to ABG measurements as part of their clinical SOC, as assessed by 
CO-oximetry. 
2.2. Study Products
2.2.1. Medline
Sensors, Neo (2329)
The Masimo sensors are indicated for monitoring SpO2 and pulse rate for use with 
neonatal patients in hospitals, hospital-type facilities, mobile, and home environments. 
Further information on these sensors can be found in Appendix 11.1.1.
2.2.2. Medline
N
The Nellcor sensors are used for monitoring SpO2 and pulse rate on neonates. Further 
information on the products can be found in Appendix 11.1.2.
2.3. Risk/Benefit Profile
2.3.1. Potential Study Risks
Masimo and Nellcor sensors are contraindicated for use on patients who exhibit allergic 
reactions to foam rubber products and/or adhesive tape. While we are screening to not 
include subjects with dermatological issues, some subjects with unidentified issues may be 
enrolled. Subjects will be under the care of a physician who will be able to appropriately 
address any potential reaction from these products. Although protective measures are taken 
by the sponsor and site, there is a risk of potential disclosure of Protected Health 
Information (PHI) by being enrolled in this study. 

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2.3.2. Potential Study Benefits
There are no direct benefits to the neonates enrolled in this study or to their families. The 
societal benefit is knowing if the reprocessed sensors are accurate and precise.
2.3.3. Assessment of Potential Risk/Benefit Profile
The use of these products presents minimal risk for subjects enrolled in this study, while 
offering the potential for societal benefit. Therefore, the risk-benefit profile for the study 
is favorable. 
3. OBJECTIVES AND ENDPOINTS
OBJECTIVE
ENDPOINT
JUSTIFICATION FOR 
ENDPOINT
To validate the SpO2 accuracy, 
reprocessed 
pulse 
oximetry 
sensors as compared to SaO2 in 
arterial 
blood 
samples 
as 
assessed by CO-oximetry in 
neonates.
Pulse oximeter and co-
oximeter reading pair used 
to determine the accuracy 
of each pulse oximeter by 
evaluating accuracy root 
mean square (ARMS), bias, 
and precision.
CO-oximetry is an invasive
technique 
requiring 
blood 
draw(s), 
whereas 
pulse 
oximetry does not involve any 
blood draw.
4. STUDY DESIGN
4.1. Overall Design
This study is a multi-site, open-label clinical trial validating the SpO2 accuracy and precision
2 in arterial blood samples 
as assessed by CO-oximetry in neonates. The data collection will take place at the sites. The 
PI or designee will place the Masimo and Nellcor sensors on hands and/or feet of the subject
according to the IFU and record the reading. The arterial blood sample used in this study will 
be taken in the normal course of care and will be measured in the reference CO-oximeter for 
SaO2. This arterial sample will be obtained from a systemic artery. 
4.2. End of Study Definition 
When the maximum number of blood draws, as per SOC (three), has been reached

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The maximum duration of sensor wear time has been reached, as per SOC or IFU, 
whichever occurs first.
The PI or patient care team 
discontinue in 
the study.
Parent or legal guardian of the subject withdraws the subject from the study for any 
reason.
If the subject withdraws from the study, they will be replaced by another subject.
The study will be considered complete upon issuance of a Clinical Study Report that has been 
approved by the Clinical Affairs Director.
5. STUDY POPULATION 
5.1. Inclusion Criteria
Subjects, who satisfy ALL of the inclusion criteria below, will be eligible to participate in the 
study:
Subjects who are postnatal 28 days or younger (neonates).
Subjects who are likely to receive one or more arterial blood gas measurements as part 
of their clinical standard of care
Subjects who weigh less than 5 Kg (weight range for the sensors).
5.2. Exclusion Criteria
Subjects, who meet ANY of the criteria below, will be ineligible for the study:
Subjects with current signs and symptoms of a clinically significant PDA, combined 
with a current or planned arterial line placement which will affect the validity of the 
co-oximetry measurement.
Subjects with physical malformation of hands, fingers, feet, or toes that would limit the 
ability to place sensors for this study.
Subjects judged by the PI to be inappropriate for participation in this study.
Subjects for whom placing a pulse oximeter will cause dermatological issues (e.g.,
allergic to foam rubber or adhesive tape).
5.3. Strategies for Recruitment and Retention 
The site PIs and their staff regularly care for neonates and will recruit eligible subjects from 
their practice. Each site will clearly and adequately convey that participation is voluntary, and 
that refusal by the parent or legal guardian of the subject will not impact the care and/or medical 
treatment provided to the subject.

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6. STUDY PROCEDURES AND ASSESSMENTS
6.1 Day 0 Screening Visit and Informed Consent
6.1.1
Informed Consent
Prior to conducting study activities, written consent will be obtained from the parent(s) or 
legal guardian(s) of all participating subjects and documented on an informed consent form 
(ICF) that has been approved by an IRB/Ethics Committee. The ICF must be written in 
adherence to Good Clinical Practice (GCP) and comply with all elements required by FDA 
CFR 50.25 and ICH 4.8, state and local regulations, and additional elements relevant to 
specific study situations, (including a statement that Medline Industries, LP and authorities 
have access to subject records). A copy of the ICF will be given to the parent(s) or legal 
guardian(s) of the subject.
6.1.2
Eligibility Screening
Potential subjects will be screened for eligibility by the site PI, via a combination of the 
screening form provided by Medline Industries, LP, and by a review of the potential 
subject
6.2. Day 1
Study visit
6.2.1. Collection of arterial blood sample and measurement by CO-oximeter
The arterial blood sample will be collected in the normal course of care and will be 
measured in the reference CO-oximeter for SaO2. The time of the arterial blood sample 
will be recorded on the CRF by the PI or designee
using a calibrated
clock as the reference time. No more than three blood draws, resulting in three data pairs 
per sensor in a subject, will be used for this study. Data pairs may be concurrently 
collected for each of the two sensors type if sensors can be placed on separate extremities. 
6.2.2. Data collection using pulse oximeter
At or near the time the first blood sample is collected, the PI or designee will place one or 
both sensors (Masimo and/or Nellcor sensors) on the subject. If the subject is currently 
receiving biliruben light therapy, then the biliruben light must be turned off when the pulse 
oximeter sensor reading is taken. The PI or designee will record the SpO2 measurement, 
heart rate, and the time and location of the measurement on the CRF using a 
calibrated clock as the reference time. 
6.2.3 Timing of Data Collection
The ideal time to collect SpO2 values is <1 minute of the arterial blood sample collection. 
However, the PI or designee may collect the SpO2 values up-to 10 minutes before or 10

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minutes after the arterial blood sample is collected. It is also ideal to collect both SpO2
values at the same time. If this is not possible, it is acceptable to collect the SpO2 values 
at different times, but still within the ±10-minute timeframe of when the arterial blood 
sample was collected.
6.2.4 Placement of Study Pulse Oximeters
The ideal placement of the sensors is to be on the same location (e.g., same foot, hand, 
finger, or toe). If this placement is not possible, it is permissible to place the sensors onto
different locations.
6.2.5 Conflicting Choice of Same Location versus Same Time
If the preference of measurements at the same time and at the same location cannot both 
be accommodated, the PI or designeewill be advised to use personal judgement and 
preferentially pick the solution that will give the most similar measurement (that is
selecting the same location (if the patient has a stable SpO2 over time), or selecting the 
same time (if the patient has markedly different SpO2 or perfusion suspected between 
measurement locations)).
6.2.6 Moving and Removing Sensors
The sensors may remain on the subject up-to the same duration as would be used for a 
SOC pulse oximeter. Thus, the duration the sensors remains on the subject is variable but
limited by the SOC for each subject.
Subject specific sensors that are removed in between samplings will be secured by the 
study team until the next time point use.  Sensors may be reused on the same subject but 
will not be used on another subject. Once a subject has completed participation, their 
sensor will be collected and returned to Medline Industries, LP.
The study or clinical team may move a sensor from location to location on the subject's 
body to facilitate care and measurement quality.
If the subject has multiple arterial blood samples collected, 6.2.1-6.2.6 can be repeated up 
to three times using the same sensor. If a new sensor is used, it shall be noted in the CRF. 
6.2.7 Additional Data Collected
life, weight, length, reason for admission, and skin tone. The skin tone will be evaluated 
using the Munsell System Soil Color Chart, Hue 7.5YR. The value score that best matched 

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7
ADVERSE DEVICE EVENTS 
7.1 Definition of Adverse Device Event (ADE)
The ADE is the adverse event (AE) related to the use of an investigational medical device 
resulting from insufficiencies or inadequacies in the IFU, the deployment, installation, the 
operation, or any malfunction of the investigational medical device or from error use.
7.2 Definition of Serious Adverse Device Event (SADE)
The SADE is the adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event (SAE).
The FDA definition of SAE will be used in this study: An AE or suspected adverse reaction is 
considered serious if, in the view of either the PI or sponsor, it results in any of the following 
outcomes: 
Death
A life-threatening adverse event
Inpatient hospitalization or prolongation of existing hospitalization 
A persistent or significant incapacity or substantial disruption of the ability to conduct 
normal life functions or,
A congenital anomaly/birth defect. 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical judgment, 
intervention to prevent one of the outcomes listed in this definition. All SADEs will be reported 
to Medline, regardless of potential relationship to the investigational device. SADEs will be 
reported to the reviewing IRB as necessary according to their rules. 
7.3 Definition of Unanticipated Adverse Device Effect (UADE)
Any serious adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously identified 
in 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 relates to the rights, safety, or welfare of subjects.
7.4 Severity of Adverse Device Event
Mild (1 = Grade 1): Awareness of signs or symptoms, but easily tolerated; are of 
minor irritant type, causing no loss of time from normal activities; symptoms would 
not require medication or a medical evaluation; signs and symptoms are transient.

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Moderate (2 = Grade 2): Discomfort severe enough to cause interference with usual 
activities; requiring treatment but not extended hospitalization or intensive care for 
the subject.
Severe (3 = Grade 3): Incapacitating with inability to do work or usual activities; 
signs and symptoms may be systemic in nature or require medical evaluation and/or 
treatment; requiring additional hospitalization or intensive care (prolonged 
hospitalization).
Life-threatening (4 = Grade 4): At immediate risk of death in view of the 
investigator, or it is suspected that the use or continued use of the product would 
result in subject
Death (5 = Grade 5): Death related to adverse event.
7.5 Relatedness of ADE and SADE
Unrelated: This category applies to those adverse events which, after careful 
consideration, are clearly and incontrovertibly due to extraneous causes (disease, 
environment, etc.)
Possible: This category applies to those adverse events for which, after careful medical 
consideration at the time they are evaluated, a connection with the Investigational 
Product administration appears unlikely but cannot be ruled out with certainty.
Probable: This category applies to those adverse events which, after careful medical 
consideration at the time they are evaluated, are felt with a high degree of certainty to 
be related to the Investigational Product.
Definite: This category applies to those adverse events which, after careful 
consideration, are clearly and incontrovertibly due to the Investigational Product.
7.6 Expectedness
The site PI will be responsible for determining whether an ADE or SADE is expected or 
unexpected. An ADE will be considered unexpected if the nature, severity, or frequency of the 
event is not consistent with the risk information previously described for the medical device. 
Expected ADEs include a reaction or irritation at the study site following application of the 
sensors or the site from where blood is drawn.
7.7 Adverse Device Event Reporting
The ADEs will be recorded on the Adverse Event form, provided by Medline Industries, LP,
by the site PI. Changes in the severity of an ADE will be documented to allow an assessment 
of the duration of the event at each level of severity. Changes in severity will necessitate a new 
CRF to document the new level of severity. ADEs characterized as intermittent require 
documentation of onset and duration of each episode.

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Non-serious ADEs are to be reported to the study sponsor for review and reported to the IRB 
per IRB reporting requirements. 
7.8 Serious Adverse Device Event and Unanticipated Adverse Device Effect Reporting
The site PI shall complete a SAE Form provided by Medline Industries, LP and submit to the 
study sponsor, but in no event later than 48 hours after the investigator first learns of the effect. 
The site PI shall report the SADE to the reviewing IRB, if applicable, according to their 
reporting requirements. The study sponsor is responsible for conducting an evaluation of the 
SADE and shall report the results of such evaluation to the FDA and to all reviewing IRBs if 
applicable within 10 working days after the sponsor first receives notice of the effect. 
Thereafter, the sponsor shall submit such additional reports concerning the effect as FDA 
requests.
For questions regarding this process or the event, you may contact your Medline clinical 
designee or the Medline Director of Clinical Operations:
Name: Julie A. Miller RN, BSN, CCRA
Phone:  630-418-6891
E-mail: clinicaloperations@medline.com

Medline Industries, LP
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8
STATISTICAL CONSIDERATIONS
8.1 Sample Size Determination 
Data from a study assessing the accuracy of both pulse oximeters on an adult population (Study 
ID # 2018-268) were used as parameters for sample size estimation for this protocol. Sample 
size estimation was conducted separately for each product using both the Confidence Intervals 
for One Standard Deviation Using Standard Deviation (as an estimate for the accuracy root 
mean square
statistic in equation 1.1 below) and Bland-Altman procedures in PASS 
2020 Power Analysis and Sample Size Software (2020). NCSS, LLC. Kaysville, Utah, USA, 
ncss.com/software/pass. The most conservative estimate between the two products for the 
sample size (18) and the Bland-Altman statistic (40) was used as the minimum number 
of data pairs, n. A data pair will consist of a pulse oximeter sensor reading paired with an ABG 
reading collected by a CO-oximeter. We selected a sample size of at least 80 total data pairs
for each of the two product sensors, consisting of at least 40 data pairs per site per product 
sensor. We doubled this estimate and selected a sample size of at least 80 total data pairs per 
product sensor, such that no subject contributes more than three data pairs for each of the two 
product sensors, for a minimum of 27 subjects. The same blood gas value can be used for 
multiple sensors applied simultaneously.
8.2
Randomization 
Randomization will not be completed as the data are collected from a convenience sample of 
subjects.
8.3. Populations for Analysis
All data pairs will be included for analysis, unless at the time of data acquisition any one or 
more of the following is true
OR (3) the heart rate measurement derived from the pulse oximeter is 0 beats per minute; OR 
(4) the research personnel collecting the data notes an anomaly in the measurement on the CRF 
at the time of data collection before data analysis begins. Any such designated outliers and/or 
anomalous data will be explained and any data that is excluded from the analysis will be 
justified in the final report. 
8.4 Data Analysis
Accuracy of each pulse oximeter will be assessed per ISO 80601-2-61:2017, the FDA
Oximeters - Premarket Notification Submissions [510(k)s] Guidance for Industry and Food 
paper by Bland et al.,  
2007.3,4,5

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For each pulse oximeter, a Bland-Altman plot (mean vs. difference of SaO2 and SpO2) and an error 
plot (SaO2 vs. difference of SaO2 and SpO2) will be generated. Between and within subject 
variance and upper and lower 95% limits of agreement will be presented. Subject demographic 
data will be presented with summary statistics and site-level effects will be assessed as appropriate.
Outliers will be explained and any data that is excluded from the data analysis or any deviations 
from this statistical analysis plan will be justified in the final report.
9
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
9.1
Clinical Monitoring
The Clinical Research Associate (CRA) will confirm that the rights and well-being of 
subjects are protected, and that the reported trial data are accurate, complete, and verifiable 
from source documents. Moreover, the CRA will confirm the conduct of the trial by the PI, 
PI or designee, and sites are in compliance with the protocol, GCP, and regulatory 
requirements as well as any applicable institution or IRB and federal or local processes. 
Monitoring will occur every two months, depending on the enrollment during the study 
duration. It will occur more frequently if:
The volume or quantity of data is large or there is a backlog of review due to 
unexpected issues
This would also include any large volume of CRFs to be reviewed 
The site compliance with the protocol or compliance with expected ICH/GCP 
and regulatory requirements is lacking or there are continuing unresolved 
compliance issues
There are unexpected AE/SAE or subject safety concerns noted 
There are any unexpected inconsistencies with study product management
There is a request for more frequent monitoring by the site
Any mutually agreeable situation as determined by the sites and Medline 
The frequency of routine monitoring may be increased to a longer interval based off of 
enrollment. CRA will discuss this with Medline Director or Clinical Manager and will 
inform the PI prior to implementation. 
Monitoring activities will include subject eligibility, source data review, CRF completion 
verification, product accountability, site continued suitability, PI study oversight, 
compliance, and all general monitoring activities as outlined in FDAs Code of Federal 
Regulations and ICH/GCP guidelines that guide that activity.  
Medline Industries LP may, on occasion, contract with external Clinical Research 
Organizations to provide CRA services and those CRAs are authorized to act on behalf of 
Medline Industries, LP.

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It is expected that the site will be compliant with any institutional Standard Operating 
Procedures during the execution of the protocol and evidence of that compliance should be 
readily documented and verifiable by the CRA. 
The CRA will generate an internal Medline Industries, LP visit report that will be filed with 
the Medline Industries, LP trial master file and will provide the PI a detailed follow-up letter 
after each monitoring visit that will outline the completed monitoring activities as well as 
any identified areas of concern and the expected/applicable corrections needed. Medline 
Industries, LP reserves the right to perform audit of the study activities 
either routine or 
for-cause as needed, and may also perform clinical monitoring audit as well.
9.2 Regulatory and Ethical Considerations
9.2.1
Confidentiality and Privacy
Subject confidentiality and privacy is strictly held in trust by the investigators, their staff,
and the Sponsor. Therefore, documentation, data, and all other information generated will 
be held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the Sponsor. All 
HIPAA compliant policies on data storage and security. All electronic transmission of data 
will adhere to HIPAA Security Rules.
The study monitor, other authorized representatives of the Sponsor, representatives of the 
IRB and regulatory agencies may inspect all documents and records required to be 
maintained by the investigators, including but not limited to, medical records (office, clinic, 
or hospital) and pharmacy records for the subjects in this study. The clinical study sites 
will permit access to such records.
A master list linking subject numbers to subject name and medical record number will be 
maintained in a secure database (paper or electronic) by the site PI. The study subject
contact information will be securely stored at each clinical site for internal use during the 
study. At the end of the study, all records will continue to be kept in a secure location for 
at least a period of two years, or longer if dictated by the reviewing IRB, Institutional 
policies, Sponsor requirements, or ICH/GCP and FDA requirements.  The PI will agree to 
notify Sponsor of any intent to move or destroy these documents. 
research data, which is for purposes of statistical analysis and scientific 
reporting, will be maintained at the research sites on the CRFs. Copies of the CRFs, which 
will not contain any identifiable information, will be provided to the Sponsor for the 
purposes of data analysis.  The study data entry and study management systems used by 
clinical sites and by Medline Industries, LP research staff will be secured and stored in an 
access controlled locked area (any paper forms) and password protected (electronic 

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records). At the end of the study, all study databases that are not already de-identified will 
be de-identified and archived at Medline Industries, LP.
9.2.2
Safety Oversight
The design of this study is such that the ethical issues/special protections, related to 
children (neonates) as study subjects, have been considered.6 In addition, given that this is
a post-market study on the sensors used in accordance with their IFU and the ISO standard,
there is minimal safety risk to participating subjects.3 The subjects are in care of the site PI 
who are qualified to provide adequate safety oversight for the study. In the event there any
AEs or SAEs, the site PI will review them and make any necessary safety determinations 
as needed. 
9.2.3
Data Handling and Record Keeping
Data collection is the responsibility of the clinical trial staff at the site under the supervision
of the PI. The PI is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported.
All source documents of any kind (electronic, paper, etc.) should be completed in 
accordance with Good Documentation Practices (GDP) to ensure accurate interpretation of 
data.  CRFs will be created for each subject. The CRA will verify the data entered into the 
CRF with the site source regardless of the type of source. The site will be responsible for 
developing a written process that ensures the CRA is able view the source data.   
Data from the CRFs will be entered by Medline into an electronic spreadsheet via dual-
entry to assure no errors. Data will be transferred to and analyzed with Statistical Analysis 
System (SAS), SAS® 9.4, for statistical analysis. SAS® allows for internal quality checks, 
such as automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate. Medline Industries, Inc. will be responsible for performing final data analysis 
and confirmation of results. 
9.2.4
Study Records Retention
Study documents should be retained until at least two years have elapsed since the formal 
discontinuation of the study intervention or as required by any applicable FDA guidelines 
or for a longer period if required by local regulations. No records will be destroyed without 
the written consent of the Sponsor, if applicable. It is the responsibility of the Sponsor to 
inform the PI when these documents no longer need to be retained. The PI is required to 
notify Medline if the location of the stored documents is changed after it is defined at the 
time of the Close Out Visit at study end. 

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9.2.5
Study Discontinuation 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by the suspending or terminating party to the PI, Sponsor, 
and IRB.  If the study is prematurely terminated or suspended, the PI will promptly inform 
the IRB and Sponsor and will provide the reason(s) for the termination or suspension.  
Circumstances that may warrant termination or suspension include, but are not limited to:
Determination of unexpected, significant, or unacceptable risk to participating 
subjects as determined by AE review
Insufficient compliance to protocol requirements
Data that are not sufficiently complete and/or evaluable
The study may resume once concerns about safety, protocol compliance, and data quality 
are addressed, and satisfy the Sponsor and/or IRB.
9.2.6 Study Closeout
Upon completion of the study, Medline and/or its designees will notify the sites of closeout 
related procedures and will coordinate with the site the return of equipment and/or any unused 
product.  Medline CRA will communicate closely with the PI and co-investigators at that time 
point and will review all close out steps and materials. All study data, related study documents, 
and unused study product, will be returned to the Sponsor.  Sponsor will provide the facility with 
a summary of the activities and findings after the final analysis of the data has been completed. 
The site will also notify the IRB that the study has completed.
9.2.7 Conflict of Interest Policy
The independence of this study from any actual or perceived influence is critical. Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, publication 
or any aspect of this trial will be disclosed and managed.
9.3
Protocol Deviations
It is the responsibility of the PI or designee to use continuous vigilance to identify and report 
deviations on a routine basis. All deviations must be addressed in study source documents, and 
reported to Medline Industries, Inc. Protocol deviations must be sent to the reviewing IRB per 
their policies. The site investigator is responsible for knowing and adhering to the reviewing IRB 
requirements.
9.4
Abbreviations
ABG
Arterial Blood Gas
ADE
Adverse Device Event

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AE
Adverse Event
CFR
Code of Federal Regulations
CRA
Clinical Research Associate
CRF
Case Report Form
FDA
Food and Drug Administration 
GCP
Good Clinical Practice
GDP
Good Documentation Practice
HEOR
Health Economics and Outcomes Research
HIPAA
Health Insurance Portability and Accountability Act
ICF
Informed Consent Form
ICH
International Conference on Harmonization
IFU
Instructions for Use
IRB
Institutional Review Board
ISO
International Organization for Standards
PDA
Patent Ductus Arteriosus
PHI
Protected Health Information
PI
Principal Investigator
SADE
Serious Adverse Device Event
SAE
Serious Adverse Event 
SaO2
Arterial Oxygenation
SOC
Standard of Care
SpO2
Peripheral Capillary Oxygen Saturation
UADE
Unanticipated Adverse Device Event

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10 REFERENCES
1. Ascha M, Bhattacharyya A, Ramos JA, Tonelli AR. Pulse Oximetry and Arterial Oxygen 
Saturation during Cardiopulmonary Exercise Testing. Med Sci Sports Exerc. 2018 Oct; 
50(10):1992-1997.
2. Dawson JA, Davis PG, O'Donnell CP, Kamlin CO, Morley CJ. Pulse oximetry for 
monitoring infants in the delivery room: a review. Arch Dis Child Fetal Neonatal Ed. 2007 
Jan; 92(1):F4-7.
3. International standard ISO 80601-2-61, Second edition 2017-12. Medical electrical 
equipment Part 2-61: Particular requirements for basic safety and essential performance 
of pulse oximeter equipment.
https://www.iso.org/standard/67963.html
4. Pulse Oximeters 
Premarket Notification Submissions [510(k)s] Guidance for Industry 
and Food and Drug Administration Staff. March 4, 2013.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulse-
oximeters-premarket-notification-submissions-510ks-guidance-industry-and-food-and-
drug
5. Bland JM, Altman DG. Agreement between methods of measurement with multiple 
observations 
per 
individual. 
J 
Biopharm 
Stat. 
2007; 
17(4):571-82. 
doi: 
10.1080/10543400701329422. PMID: 17613642.
6. U.S. Department of Health and Human Services. Office of Human Research Protections.
https://www.hhs.gov/ohrp/regulations-and-policy/guidance/special-protections-for-
children/index.html
11.
APPENDIX
11.1 Study Products
11.1.1
Sensors, Neo (2329)
This Masimo sensor is indicated for monitoring SpO2 and pulse rate for use with  
neonatal patients during no-motion conditions, and for patients who are well perfused 
in hospitals, hospital-type facilities, mobile, and home environments. This sensor is 
manufactured by Masimo and reprocessed by Medline Industries, Inc. The preferred 
site for use of this sensor is the foot, but across the palm and back of the hand can also 
be used. Sensor placement will be chosen at the discretion of the PI. 

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Medline ReNewal Reprocessed Masimo LNCS Series 
Adult, Pediatric, Infant, and Neonatal  
SpO2 Adhesive Sensors  
Models Adtx/Adtx-3, Pdtx/Pdtx-3, Inf-L/Inf-3/Inf, and 
Neo-L/Neo-3/Neo
Instructions for Use
*Read the Instructions for Use in their entirety before using 
Medline ReNewal Reprocessed Masimo SpO2 Adhesive Sensors. 
Failure to comply may result in patient and/or healthcare-staff injury.
Description: Reprocessed device for single use. Reprocessed by Medline ReNewal.
Non Sterile: The device is supplied non sterile. 
Caution:
Federal (USA) law restricts this device to sale by or on the order of a 
physician. 
Contact:  
For more information, please call Medline ReNewal Customer Service: 
1-866-866-7477. 
Description:  Medline ReNewal Reprocessed Masimo LNCS Series Adult Pediatric, 
Infant and Neonatal SpO2 Adhesive Sensors models Adtx/Adtx-3, Pdtx/Pdtx-3, Inf-
L/Inf-3/Inf, and Neo-L/Neo-3/Neo. Following clinical use, each sensor is returned to 
Medline ReNewal where it is cleaned, disinfected, and packaged for an additional clinical 
use. Each sensor is tracked through the reprocessing cycle to monitor the number of times 
the sensor has been reprocessed. If sensors are to be used again, they must be returned to 
Medline ReNewal for reprocessing. Please see Medline ReNewal instructions to 
healthcare facilities before returning.
The sensor site must be inspected at least every eight hours; and if the circulatory
condition or skin integrity has changed, the sensor should be applied to a different site. 
INDICATIONS
The Medline ReNewal Reprocessed Masimo LNCS Adult, Pediatric, Infant, and Neonatal 
adhesive sensors are indicated for single patient use for continuous noninvasive 
monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate
(measured by an SpO2 sensor) for use with adult, pediatric, infant, and neonatal patients
during no motion conditions, and for patients who are well perfused in hospitals, hospital-
type facilities, mobile, and home environments (see Table 1).  
Consult Instructions for Use
Do not re-use. Single patient use only
Non-sterile
Not made with natural rubber latex
Do not use if package is damaged

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If using pulse oximetry during full body irradiation, keep the sensor out of the 
radiation field. If sensor is exposed to the radiation, the reading might be inaccurate 
or the unit might read zero for the duration of the active radiation period. 
Do not use the sensor during MRI scanning or in a MRI environment. 
High ambient light sources such as surgical lights (especially those with a xenon light 
source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight 
can interfere with the performance of the sensor.
To prevent interference from ambient light, ensure that the sensor is properly applied, 
and cover the sensor site with opaque material, if required. Failure to take this 
precaution in high ambient light conditions may result in inaccurate measurements. 
High levels of COHb or MetHb may occur with a seemingly normal SpO2. When 
elevated levels of COHb or MetHb are suspected, laboratory analysis (CO-Oximetry) 
of a blood sample should be performed. 
Elevated levels of Carboxyhemoglobin (COHb) may lead to inaccurate SpO2
measurements.
Elevated levels of Methemoglobin (MetHb) will lead to inaccurate SpO2
measurements. 
Elevated Total Bilirubin levels may lead to inaccurate SpO2 measurements.
Intravascular dyes such as indocyanine green or methylene blue or externally applied 
coloring and texture such as nail polish, acrylic nails, glitter, etc. may lead to 
inaccurate SpO2 measurements.
Inaccurate SpO2 readings may be caused by severe anemia, low arterial perfusion or 
motion artifact.
To prevent damage, do not soak or immerse the sensor in any liquid solution. 
Do not modify or alter the sensor in any way. Alteration or modification may affect 
performance and/or accuracy.
Do not attempt to reuse on multiple patients, reprocess, recondition or recycle sensors 
or Masimo patient cables as these processes may damage the electrical components, 
potentially leading to patient harm. 
High oxygen concentrations may predispose a premature infant to retinopathy. 
Therefore, the upper alarm limit for the oxygen saturation must be carefully selected 
in accordance with accepted clinical standards.
Caution: Replace the sensor when a replace sensor message is displayed, or when a 
low SIQ message is consistently displayed after completing the low SIQ 
troubleshooting steps identified in the monitoring device operator’s manual. 
Note: The sensor is provided with X-Cal™ technology to minimize the risk of 
inaccurate readings and unanticipated loss of patient monitoring. The sensor will 
provide up to 168 hours of patient monitoring time. After single-patient use, discard 
sensor.

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Instructions: Sensor and Cable
A. Site Selection
Always choose a site that is well perfused and will completely cover the sensor’s 
detector window.
Site should be cleaned of debris and dry prior to sensor placement.
LNCS Adtx and Adtx-3 Adult Sensors
30 kg: The preferred site is the middle or ring finger of non-dominant hand. 
LNCS Pdtx and Pdtx-3 Pediatric Sensors
10 - 50 kg: The preferred site is middle or ring finger of non-dominant hand. 
LNCS Inf, Inf-L and Inf-3 Infant Sensors
3 - 20 kg: The preferred site is the great toe. Alternatively, the toe next to the 
great toe or the thumb can be used. 
LNCS Neo, Neo-L and Neo-3 Neonatal/Adult Sensors
< 5 kg: The preferred site is the foot. Alternatively, across the palm and back
of the hand can be used. 
> 40 kg: The preferred site is the middle or ring finger of non-dominant hand. 
B. Attaching the Sensor to the Patient
1.  
Open the pouch and remove the sensor. Remove the backing from the sensor, if
present.
Adult (> 30 kg) and Pediatric (10 - 50 kg)  
Figure 1: 
Adtx 1859, Adtx-3 2317, Pdtx 1860, and Pdtx 2318  
2.
Refer to Fig. 1a: Orient the sensor cable so that the detector can be placed first.
Place the tip of the finger on the dashed line with the fleshy part of the finger 
covering the detector window.  
3.
Refer to Fig. 1b: Press the adhesive wings one at a time onto the finger. Complete
coverage of the detector window is needed to ensure accurate data.
4.
Refer to Fig. 1c: Fold the sensor over the finger with the emitter window (star)
positioned over the fingernail. Secure the wings down one at a time around the 
finger. 

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5.
Refer to Fig. 1d: When properly applied, the emitter and detector should be
vertically aligned. 
6.
Verify correct positioning and reposition if necessary (the black lines should align).
Infants (3 - 20 kg) 
Figure 2: 
Inf 2328, Inf-L 1861, and Inf-3 2319
7.
Refer to Fig. 2a: Direct the sensor cable so that it either points away from the 
patient or runs along the bottom of the foot. Position the detector onto the fleshy
part of the great toe. Complete coverage of the detector window is needed to
ensure accurate data.
8.
Refer to Fig. 2b: Wrap the adhesive wrap around the toe and ensure that the emitter
window (star) aligns on the top of the toe directly opposite the detector.
9.
Refer to Fig. 2c: Verify correct positioning and reposition if necessary.
Neonates (< 5 kg) 
Figure 3: 
Neo 2329, Neo-L 1862, and Neo-3 2320
10.
Refer to Fig. 3a: For fragile skin, the stickiness of the medical grade adhesive can
be diminished or eliminated by daubing the adhesive areas with a cotton ball or 
with gauze. 
11.
Refer to Fig. 3b: Direct the sensor cable so that it either points away from the 
patient or runs along the bottom of the foot. Apply the detector onto the fleshy part 
of the lateral aspect of the sole of the foot aligned with the fourth toe. Alternatively,

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the detector may be applied to the top of the foot (not shown). Complete coverage
of the detector window is needed to ensure accurate data.
12.
Refer to Fig. 3c: Wrap the adhesive/foam wrap around the foot and ensure that the 
emitter window (star) aligns directly opposite of the detector. Be careful to
maintain proper alignment of the detector and emitter windows while attaching
adhesive/foam wrap to secure the sensor. 
13.
Refer to Fig. 3d: Verify correct positioning and reposition if necessary. 
C. Attaching the Sensor to the Patient Cable
Refer to Fig. 4: Insert the connector completely 
into the patient cable connector (1). Completely 
close the protective cover (2).
D. Disconnecting the Sensor from the Patient Cable
Refer to Fig. 5. Lift the protective cover to gain 
access to the sensor connector (1). Pull firmly 
on the sensor connector to remove from the 
patient cable (2).
CAUTION
To prevent damage, do not soak or immerse the sensor in any liquid solution. 
ACCURACY SPECIFICATIONS
The Medline ReNewal Reprocessed Masimo LNCS SpO2 sensors are indicated for the 
following conditions: 
SpO2 range: 70 – 100% 
Pulse rate: 25 – 240 bpm  
Operating temperature: 5 – 40ºC 
Storage temperature: -40 – 70ºC 
Humidity: 5 – 95% 

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Fig. 6:
Bland-Altman plot of all sampled data points by subject for the adult clinical 
study for the Medline ReNewal Reprocessed Masimo Adtx 1859 sensor with 
linear regression fit and upper and lower 95% limits of agreement.
Fig.7:  
Bland-Altman plot of all sampled data points by subject for the adult clinical 
study for the Medline ReNewal Reprocessed Masimo Neo 2329 with linear 
regression fit and upper and lower 95% limits of agreement.

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WARNINGS
Single use devices cannot be reused. If devices are to be used again, they must be 
returned to Medline ReNewal for reprocessing. Please see Medline ReNewal instructions 
to healthcare facilities before returning. 
The names of actual companies and products mentioned herein may be the trademarks of their 
respective owners.

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Medline ReNewal Reprocessed  
Nellcor™ OxiMax SpO2 Sensors  
Models MAXA, MAXAL, MAXP, MAXI, and MAXN 
Instructions for Use
*Read the Instructions for Use in their entirety before using 
Medline ReNewal Reprocessed Nellcor™ OxiMax SpO2Sensors. 
Failure to comply may result in patient and/or healthcare-staff injury. 
Description: Reprocessed device for single use. Reprocessed by Medline ReNewal.
Non Sterile: The device is supplied non sterile. 
Caution: 
Federal (USA) law restricts this device to sale by or on the order of a 
physician. 
Contact:  
For more information, please call Medline ReNewal Customer Service: 
1-866-866-7477. 
 
DESCRIPTION 
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors. Following clinical use, 
each sensor is returned to Medline ReNewal where it is cleaned, disinfected, and 
packaged for an additional clinical use. Each sensor is tracked through the reprocessing 
cycle to monitor the number of times the sensor has been reprocessed.  
This product cannot be adequately cleaned and/or sterilized by the user to facilitate safe 
reuse and is, therefore, intended for single use. Attempts to clean or sterilize these 
devices may result in a bio- incompatibility, infection or product failure risks to the 
patient. If sensors are to be used again, they must be returned to Medline ReNewal for 
reprocessing. Please see Medline ReNewal Instructions to Healthcare Facilities – Pulse 
Oximeters before returning. 
This product contains DEHP. The intended use limits exposure to transient contact, 
minimizing the risk of DEHP release from the device. In order to avoid undue risk of 
DEHP exposure in children and nursing or pregnant women, product should only be 
used as directed. 
Devices have been determined to be biocompatible following validated reprocessing 
methods. Inspection and pre-release testing are used to ensure appropriate device 
integrity and function of each device prior to release of product for use. 
INDICATIONS 
Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors are indicated for single 
patient use when continuous noninvasive arterial oxygen saturation and pulse rate 
monitoring are required for patients in the sizes indicated in the respective sensor 
directions for use. 

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Note: When selecting a sensor site, priority should be given to an extremity free of an 
arterial catheter, blood pressure cuff, or intravascular infusion line.
2. Orient the MAXA(L) or MAXP so the dashed line in the middle of the sensor is 
centered on the tip of the digit. Wrap adhesive flaps on non-cable end around the digit.
Note that the cable must be positioned on the top of the hand. (2)
3. Fold cable end over top of digit so that windows are directly opposite each other. 
Wrap adhesive securely around sides of digit.  (3)
4. Plug the MAXA(L) or MAXP into the oximeter and verify proper operation as 
describedin the oximeter operator’s manual.
Note: If the sensor does not track the pulse reliably, it may be incorrectly positioned-or 
the sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored 
(for example, as a result of externally applied coloring such as nail polish, dye, or 
pigmented cream) to permit appropriate light transmission. If any of these situations 
occurs, reposition the sensor or choose an alternate Nellcor sensor for use on a different 
site.
Model MAXI
1.
Remove plastic backing from the MAXI and locate transparent windows (b) on 
the adhesive side. Windows cover optical components. Note corresponding 
alignment marks (a) on the non-adhesive side and dashed line (c) midway between
the marks. (1) 
A great toe is the preferred MAXI location. Alternatively, apply the sensor to 
another digit of similar size, for example a thumb. 
Note: When selecting a sensor site, priority should be given to an extremity free of an 
arterial catheter, blood pressure cuff, or intravascular infusion line.
2.
Orient the MAXI so the window next to the cable is aligned on the bottom of the 
great toe as shown. The cable should extend towards the heel. (2)
3.
Wrap the MAXI firmly, but not too tightly around the toe. Windows must oppose 
each other. (3)
4.
Wrap any excess tape loosely around toe. Use additional tape provided to secure 
cable across bottom of foot, loosely enough to maintain good circulation. (4)

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5.
Plug the MAXI into the oximeter and verify proper operation as described in the 
oximeter operator’s manual.
Note: If the sensor does not track the pulse reliably, it may be incorrectly positioned—or 
the sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored 
(for example, as a result of externally applied coloring such as nail polish, dye, or 
pigmented cream) to permit appropriate light transmission. If any of these situations 
occurs, reposition the sensor or choose an alternate sensor for use on a different site.
Model MAXN
1.
Remove plastic backing from the MAX-N and locate transparent windows (a) on 
the adhesive side. Windows cover optical components. Note corresponding 
alignment marks (a) on the non-adhesive side and dashed line (b) midway between
the marks. (1) 
2.
Orient the MAXN so the dashed line is on the lateral edge of the site.
Neonates: The preferred site is a foot. Alternatively, use a hand. The window next 
to the cable goes on the sole of the foot as shown. (2) 
Adults: The preferred site is an index finger. Alternatively, other fingers may be 
used. The window next to the cable goes on the nail side, distal to the first joint. 
Do not place on a joint. Note that the cable must be positioned on the top of the 
hand. (3) 
Note: When selecting a sensor site, priority should be given to an extremity free 
of an arterial catheter, blood pressure cuff, or intravascular infusion line. 
3.
Wrap the MAXN firmly, but not too tightly around the foot or finger. Windows 
must oppose each other.
4.
Plug the MAXN into the oximeter and verify proper operation as described in the 
oximeter operator’s manual.

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Note: If the sensor does not track the pulse reliably, it may be incorrectly positioned—or 
the sensor site may be too thick, thin, or deeply pigmented, or otherwise deeply colored 
(for example, as a result of externally applied coloring such as nail polish, dye, or 
pigmented cream) to permit appropriate light transmission. If any of these situations 
occurs, reposition the sensor or choose an alternate sensor for use on a different site. 
WARNINGS 
 Do not use the any oximetry sensors during MRI scanning. Conducted current 
may cause burns. Also, the sensors may affect the MRI image, and the MRI unit 
may affect the accuracy of oximetry measurements. 
CAUTIONS 
1. 
Do not use if package is damaged. 
2. 
Failure to apply the sensor properly may cause incorrect measurements.
3. 
While the sensor is designed to reduce the effects of ambient light, excessive light 
may cause inaccurate measurements. In such cases, cover the sensor with opaque 
material. 
4. 
Circulation distal to the sensor site should be checked routinely. The site must be 
inspected every 8 hours to ensure adhesion, skin integrity, and correct optical 
alignment. If skin integrity changes, move the sensor to another site.
5. 
Intravascular dyes or externally applied coloring such as nail polish, dye, or 
pigmented cream may lead to inaccurate measurements. 
6. 
Motion may compromise performance. In such cases, try to keep the patient still, 
or change the sensor site to one with less motion. 
7. 
Do not immerse in water or cleaning solutions. Do not sterilize. Immersion or 
sterilization could damage the sensor. 
8. 
If the sensor is wrapped too tightly or supplemental tape is applied, venous 
pulsations may lead to inaccurate saturation measurements. 
9. 
Do not alter or modify the sensor. Alterations or modifications may affect 
performance or accuracy. 
10. 
The operator must verify the compatibility of the monitor, sensor, and cable 
before use, otherwise patient injury can result. 
11. 
Misapplication of a pulse oximeter sensor with excessive pressure for prolonged 
periods can induce pressure injury. 
12. 
For additional warnings, cautions or contraindications with Nellcor pulse 
oximeters, refer to the instrument operator’s manual or contact the manufacturer 
of the instrument. 
ACCURACY SPECIFICATIONS 
The Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensors are indicated for the 
following conditions: 
 SpO2 range: 70 – 100% 
 Pulse rate: 20 – 250 bpm  

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Figure 2: Bland-Altman plot of all sampled data points by subject for the adult clinical 
study for the Medline ReNewal Reprocessed Nellcor MAXN sensor with linear 
regression fit and upper and lower 95% limits of agreement.
WARNINGS
Single use devices cannot be reused. If devices are to be used again, they must be 
returned to Medline ReNewal for reprocessing. Please see Medline ReNewal Instructions 
to Healthcare Facilities – Pulse Oximeters before returning. 
The names of actual companies and products mentioned herein may be the trademarks of their 
respective owners.
Consult Instructions for Use
Do not re-use. Single patient use only
Non-sterile
Not made with natural rubber latex
Do not use if package is damaged
Contains DEHP