Information About The Lab:

Study Protocols:

1.  Standard pulse oximeter accuracy testing

Our testing protocols are designed to generate data suitable for submission to the US Food and Drug Administration needed for device approval.

We are approved by the UCSF Committee on Human Research for desaturation testing toSaO2 levels  as low as 50% on healthy non-smoking volunteers; however standard testing is to a minimum of 70% SaO2 is typical.

Testing is done at stable steady state levels of inspired oxygen to achieve target saturations evenly distributed between 70 and 100%.  To achieve steady state levels of saturation, continuous airway gas analysis by mass spectrometer and computer is utilized.  Pulse oximeter readings are compared to multiwavelength oximetry (Radiometer OSM-3 Hemeoximeter). A typical test involves 12 saturation plateaus, with a total of 24 arterial blood samples for each subject.  Six subjects can be studied in one day, 12 subjects over 2 days.  Variations on this theme include simultaneous testing of different probe types and body locations , testing of remanufactured probes, testing of probes in selected subject populations (skin pigment, gender), etc.

2. Motion and low perfusion testing

Motion fixtures to simulate patient motion can be incorporated into the testing (provided by manufacturer)

Low perfusion conditions can be created by external clamps, cuffs, etc.  Arterial blood pressure monitoring can be done as well.  Different body positions are also possible (e.g. Trendelenburg) during testing.

3. Testing of special sensors

-Met-hemoglobin detection by pulse oximetry with or without simultaneous oxyhemoglobin desaturation.

-Carboxy-hemoglobin detection by pulse oximetry with or without simultaneous oxyhemoglobin desaturation.

-Transcutaneous carbon dioxide sensors can be tested alone or in combination with pulse oximetry andoxyhemoglobin  desaturations

4. Other human testing in human subjects:

Profound hemodiltuion studies

Hypoxic ventilatory response testing  (isocapnic and poikilocapnic)

Drug-induced apnea testing