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Device Profile

Masimo Rad-57 Pulse CO-Oximeter™ for noninvasive carboxyhemoglobin measurement

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Pages 125-130 | Published online: 09 Jan 2014
 

Abstract

Noninvasive methods of body fluid chemical measurement have been expanding. New technologies are enabling the quantification of different compounds in the blood and interstitial tissues. One example of this is the pulse oximeter, which has facilitated the measurement of oxyhemoglobin rapidly and reliably without the requirement of blood-draws. The Masimo Rad-57 Pulse CO-Oximeter™ expanded the capabilities of pulse-oximetry to include measurements of carboxyhemoglobin and methemoglobin. This innovation has revolutionized the paradigm for detection of patients with CO poisoning. Previously, clinicians relied on historical information and patient signs and symptoms pointing to the possibility of CO exposure or toxicity. Only then would a blood test be ordered to measure carboxyhemoglobin levels. Since the presentation of CO poisoning is nonspecific and overlaps with many other conditions, and since the presence of environmental CO is often unknown, the detection of this condition was only possible in cases where the presence of CO was obvious or where the symptoms were severe. We now know, from studies conducted using the Rad-57, the only US FDA-approved device for noninvasive measurement of SpCO, that there are a significant number of patients who experience CO exposure but are nonsymptomatic. The Rad-57 provides a clinical justification for screening in the healthcare setting to identify patients with significant CO exposure who would otherwise be undetected.

Financial & competing interests disclosure

Both authors are founders and shareholders of Corum Medical Inc., which is a company involved in the development of noninvasive hemoglobin monitors. Suner is a patent holder for a method of determining hemoglobin noninvasively. Neither the patent nor the product developed by Corum Medical Inc. are directly related to the Masimo device and utilize different methods of estimating hemoglobin. Some data in the studies conducted by Brown University were obtained through loaned equipment from Masimo. Also Masimo funded a portion of the research assistants to collect the data. The investigators did not receive any funds from Masimo. The data remain the sole property of the investigators in the Brown University studies. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

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