SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions

Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET Pulse Oximeters With Motion

The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.

In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.

A machine will be used to induce motions of 20 mm during testing at a sine rate of 2Hz, 3Hz, and 4Hz. A third motion moves the arm a random distance of 0 to 30mm at a random speed up to 5Hz.

It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% with a target of +/-3% or better in motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at three or six levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or 95%, 85% and 75% saturation for about 30-60 seconds or 60-90 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. This study should utilize a three level structure (95%, 85% and 75%).

Inclusion Criteria:

• The subject is male or female, aged ≥18 and <50
• The subject is in good general health with no evidence of any medical problems.
• The subject is fluent in both written and spoken English
• The subject has provided informed consent and is willing to comply with the study procedures

Exclusion Criteria:

The subject is obese (BMI>30)

• The subject has a known history of heart disease, lung disease, kidney or liver disease
• Diagnosis of asthma, sleep apnea, or use of CPAP
• Subject has diabetes
• Subject has a clotting disorder
• The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation
• The subject has any other serious systemic illness
• The subject is a current smoker
• Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly
• The subject has a history of fainting or vasovagal response
• The subject has a history of sensitivity to local anesthesia
• The subject has a diagnosis of Raynaud's disease
• The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test)
• The subject is pregnant, lactating or trying to get pregnant
• The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures
• The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study