SpO2 Accuracy Comparison of Medline ReNewal Sensors to Arterial Blood CO-Oximetry

An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and
to measure the blood oxygen saturation based on the amount of reflected or scattered
radiation. Pulse oximetry monitoring is considered a standard physiological measurement and
is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because
an arterial sample of blood is not required to make the measurement, the pulse oximeter can
provide non-invasive real time information. The clinical use of pulse oximeters has reduced
the frequency and necessity of invasive arterial blood sampling and has helped to improve
patient safety by providing continuous information to clinicians about patients' oxygenation
status.

The Medline ReNewal Reprocessed pulse oximeter sensors are indicated for single patient use
when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are
required. 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. The purpose of this study will be to test the accuracy of the SpO2 component of
the devices.

The SpO2 accuracy performance of ReNewal pulse oximetry sensors will be evaluated during
non-motion conditions over the range of 70-100% SaO2 and compared to arterial blood samples
assessed by CO-Oximetry. A minimum of 10 healthy adult subjects, ranging in pigmentation from
light to dark, will be enrolled in the study to meet the study design requirements defined by
ISO 80601-2-61:2011 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). The
subjects will have an arterial catheter placed in the radial artery to allow for simultaneous
blood samples during stable plateaus of induced hypoxic levels. The investigational devices
will be placed on the fingers of both hands for the test sites per the instructions for use.
Simultaneous data collection will be set up for each of the systems under test. For the data
analysis, the control oximeter will be used to assess the stability of each data point. Data
that is found to be unstable will be removed prior to the comparative analysis. Next the
CO-Oximeter data will be reviewed to make sure it does not contain any anomalous values such
as elevated, low or inconsistent COHb, MetHb, or tHb data. Anomalous values will be removed
from the analysis prior to pairing of the SpO2 and SaO2 data. The Accuracy Root Mean Square
(ARMS) calculation is used to determine the SpO2 accuracy performance. Success will be
achieved with an ARMS of 3 or better showing equivalence to the Gold Standard Reference
CO-Oximetry providing documentation to support SpO2 accuracy claims for the investigational
device(s).

The study population will include 10-15 healthy non-smoking (or has refrained from smoking
for 2 days) competent adults 18-50 years of age. The subject selection will be an equitable
distribution of males and females of any race with varying skin tones including at least 2
darkly pigmented subjects or 15% of the subject pool, whichever is larger. Data collection
will occur over a 2-5 day period for this study population. Follow-up with each subject will
be conducted within 5 days following participation in the study and will be conducted via
telephone, text or email.

Inclusion Criteria:

- 10-15 Adults with a minimum of 3 males and a minimum of 3 females, with the balance
made up of either

- Subject must have the ability to understand and provide written informed consent

- Subject is 18 to 50 years of age

- Subject must be willing and able to comply with study procedures and duration

- Subject is a non-smoker or who has not smoked within 2 days prior to the study

Exclusion Criteria:

- Subject is considered as being morbidly obese (defined as BMI >39.5)

- Compromised circulation, injury, or physical malformation of fingers, toes, hands,
ears or forehead/skull or other sensor sites which would limit the ability to test
sites needed for the study. (Note: Certain malformations may still allow subjects to
participate if the condition is noted and would not affect the particular sites
utilized.)

- Females who are pregnant, who are trying to get pregnant, or have a urine test
positive for pregnancy on the day of the study

- Smoker Subjects who have refrained will be screened for COHb levels >3% as assessed
with a Masimo Radical 7 (Rainbow)

- Subjects with known respiratory conditions such as: (self-reported)

- uncontrolled / severe asthma,

- flu,

- pneumonia / bronchitis,

- shortness of breath / respiratory distress,

- respiratory or lung surgery,

- emphysema, COPD, lung disease

- Subjects with known heart or cardiovascular conditions such as: (self-reported, except
for blood pressure and ECG review)

- hypertension: systolic >140mmHg, Diastolic >90mmHg on 3 consecutive readings
(reviewed during health screen).

- have had cardiovascular surgery

- Chest pain (angina)

- heart rhythms other than a normal sinus rhythm or with respiratory sinus
arrhythmia (reviewed during health screen)

- previous heart attack

- blocked artery

- unexplained shortness of breath

- congestive heart failure (CHF)

- history of stroke

- transient ischemic attack

- carotid artery disease

- myocardial ischemia

- myocardial infarction

- cardiomyopathy

- Self-reported health conditions as identified in the Health Assessment Form
(self-reported)

- diabetes,

- uncontrolled thyroid disease,

- kidney disease / chronic renal impairment,

- history of seizures (except childhood febrile seizures),

- epilepsy,

- history of unexplained syncope,

- recent history of frequent migraine headaches,

- recent head injury

- cancer / chemotherapy

- Subjects with known clotting disorders (self-reported)

- history of bleeding disorders or personal history of prolonged bleeding from
injury

- history of blood clots

- hemophilia

- current use of blood thinner: prescription or daily use of aspirin

- Subjects with severe contact allergies to standard adhesives, latex or other materials
found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or
other medical sensors (self-reported)

- Subjects with prior or known allergies to iodine or lidocaine (or similar
pharmacological agents, e.g. Novocaine)

- Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test

- Unwillingness or inability to remove colored nail polish from test digits.

- Other known health condition, should be considered upon disclosure in health
assessment form