Pulse Oximetry
Product Development Testing
Accuracy Test
- Non-Blood Hypoxia study:
Non-Blood Hypoxia Performance comparison to a Transfer
Standard
Pulse
Oximeter
Human
Desaturation Study (non-blood):
Steady state accuracy testing over the specified range (usually
70-100%
SaO2) in comparison to a Transfer Standard Pulse
Oximeter.
Can be used to develop or improve the Pulse Oximeter
Calibration Curve.
Quick -
Low-cost - used to verify performance of a Pulse Oximeter - Usually
conducted during Product Development or
Technology
Assessment - Also used to verify that the more costly Regulatory
Accuracy test can be met
This test is the same
as the Accuracy Validation Blood Study (see Pulse Ox Tests
Regulatory) but does not compare the test
pulse oximeter to blood samples. Instead, it compares
the test system to a Pulse Oximeter Reference Transfer Standard.
This
test is less expensive and quicker because it does not
involve blood samples. It is used to find out whether the test
pulse
oximeter or sensor is accurate enough to pass the more
expensive final Blood Study. The information from this study
can be
used to modify and improve the test device so that it will
pass the final Blood Study.
It provides confidence that the pulse oximeter will perform
well over the specified range (usually 70-100% saturation) and that
the
calibration curve is correct. If needed, the
calibration curve can be corrected based on the data from this test.
Motion Performance:
Non-Blood Hypoxia Performance
Human
Desaturation study during motion conditions:
Steady state accuracy testing with motion during
saturation plateaus over the specified range in comparison to
Transfer Standard Pulse Oximeter
Low Perfusion
Performance:
Non-Blood Hypoxia Performance
Human
Desaturation study during low perfusion
conditions:
Steady state
accuracy testing with low
signal
conditions during saturation plateaus over the specified range in
comparison to Transfer Standard
Pulse
Oximeter.
Performance in Response to Rapid Saturation Change:
Non-Blood Hypoxia Performance
Human
Desaturation Study during rapid saturation changes:
Continuous data collected during rapid
changes
in
saturation (approximately 7-15% SpO2 change during a 6
second period) in comparison to
Transfer Standard
Pulse
Oximeter.
Neonatal Performance:
Non-Blood Performance
on Neonates / Infants
Data
collection
on hospitalized and non-hospitalized infants:
Evaluation of performance issues in
comparison to
Transfer Standard Pulse Oximeter (not accuracy verification).
Pulse Rate Performance: Comparison to ECG
Data collection on infants to adults: Evaluation
pulse rate performance under various conditions.
Custom Performance Study:
Studies can be designed to answer specific performance questions.
These
can include a modification or combination of the above tests.
New test types are also available to
evaluate
specific issues.
