Table 5. Limitations of Pulse Oximeters

Patient factors Device factors Environmental factors
Chronic respiratory disease
 Battery level/charge Extremes of temperature
Nail thickness and nail paint or polish Device condition such as being dusty, dirty, or damaged Movement or vibration such as transportation
Heart rhythm and cardiac output Size and orientation of light and sensor Moisture and humidity
Skin thickness, perfusion, pigmentation, and temperature

Device accuracy and calibration (FDA categories):

  1. Consumer product
  2. Home-use medical devices
  3. Medical device
 Interference from direct external light sources, including sunlight

FDA indicates US Food and Drug Administration