ePoster Presentation

(EP-161) Comparative Performance of Pulse Oximeters in Chronic Disease Patients

Sunday, April 23
4:35 PM - 4:50 PM
Location: Experience Zone - ePosters

Clinimark Laboratories, an independent hypoxia lab, was asked to investigate the performance of two newer fingertip
pulse oximeters and the Nonin Medical fingertip pulse oximeter during dyspnea and low perfusion (conditions typical inpatients with a variety of Chronic Diseases). Multiple hypoxic events down to the 70–85% range were induced to
verify that the pulse oximeter was able to track saturation changes during these challenging conditions. In order to do
this in a repeatable, safe manner this study was conducted in a laboratory setting by creating dyspnea, low perfusion
and hypoxia in healthy volunteer subjects.

Prior to study start, Institutional Review Board approval was obtained.1 The study was registered at clinicaltrials.
gov (NCT00881829) and written informed consent was obtained from each subject prior to conducting the study.
Devices Under Test Fingertip pulse oximeters from three widely used manufacturers were studied. They were the Nonin 3230
(using the same PureLight® and PureSAT® technology as the Onyx® Vantage 9590 and Onyx® II 9550), the Beijing
Choice MD300 and the Contec Medical CMS50. The latter two manufacturers distribute under several different
names and are representative of many newer fingertip pulse oximeters. All devices are FDA-cleared.
Study Design
Dyspnea and low perfusion were simultaneously induced
in each volunteer test subject. During the dyspneic and low
perfusion periods, multiple hypoxic events down to the
70–85% SpO2 range were induced to verify that the
fingertip pulse oximeter was able to track saturation
changes during these challenging conditions.

In this study the Beijing Choice and Contec Medical fingertip pulse oximeters performed significantly worse
than the Nonin Medical fingertip pulse oximeter and the reference devices in
dyspneic, low perfusion conditions.
Warm reference 98%, Nonin Medical 97%, Cooled reference 92%, Beijing Choice 69%, Contec Medical 21%

In the last few years fingertip pulse oximeters have been available in the U.S. as “health and wellness” devices
Some clinicians are using these uncleared devices as well as similar inexpensive FDA cleared
devices in their practice.
Concerned clinicians often conduct impromptu evaluations of these devices by putting the oximeter on themselves
or on a stable patient under non-stressful conditions.

Performance in this type of evaluation is not representative of the dyspneic patient. Additionally, hypoxic events must be included in
the testing to verify that a device is not frozen and is able to track a saturation change.

This study indicated that when performance might be most needed—during labored breathing with low perfusion—the
two newer low cost oximeters tested in this study failed to track many of the hypoxic events and, instead froze the
readings, read >10% high or blanked the display when the saturation was critically low.

Mark K. Vanderwerf

Vice President
Nonin Medical

Mark VanderWerf is a long time leader in the telemedicine industry. He is a Fellow of the American Telemedicine Association, former ATA Board of Directors member, and has served as Chair of both the International SIG and the Industry Council. He is also a founding Board Member of the International Society for Telemedicine and eHealth. Mark is Vice President of OEM, eHealth and Strategic relationships at Nonin Medical.


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Paul Batchelder

Chief Clinical Officer, Clinimark
Clinimark, LLC

Mr. Batchelder attended the University Of Chicago Pritzker School Of Medicine Respiratory Therapy Program and is currently Chief Clinical Officer of Clinimark. For the last 14 years he has been the Head of Clinical Research for Datex-Ohmeda and GE Healthcare where he established and directed the Louisville laboratories and managed medical affairs.

He is a member of the University of Colorado Medical School, Division of Pulmonary Sciences and Critical Care Medicine Research Board. He is also a member of the ASTM Pulse Oximetry Working Group where he functioned as Designated United States Expert and representative to the International Standards Organization. He was actively involved in the development of the current International Standard for Pulse Oximetry (9919).

Mr. Batchelder formerly managed a clinical research grant that developed Non-invasive ventilatory support systems for use in the Critical Care arena. Prior to that, he instituted Pulmonary Function Laboratories and Respiratory Therapy Departments in several hospitals. He has a number of medical publications to his credit, and has lectured in clinical and collegiate settings throughout the US and Europe


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(EP-161) Comparative Performance of Pulse Oximeters in Chronic Disease Patients

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