19
before sale, so there is no need to calibrate it
during its life cycle. Any SpO
2
simulators should
not be used to validate the accuracy of the
Oximeter, they can only be used as functional
testers to verify its precision. The SpO
2
accuracy claimed in this manual is supported
by the clinical study conducted by inducing
hypoxia on healthy, non-smoking, light-to-dark
skinned subjects in an independent research
laboratory
.
If it is necessary to verify the precision of the
Oximeter routinely, the user can do the
verification by means of SpO
2
simulator, or it
can be done by the local third party test house.
Please note that the specific calibration curve
(so called R-curve) should be selected when
use of SpO
2
simulator, e.g. for Index 2 series
SpO
2
simulator
from
Fluke
Biomedical
Corporation,
please
set
"Make"
to
"DownLoadMake: KRK", then the user can use
this particular R-curve to test the Oximeter. If
the SpO
2
simulator does not contain "KRK"
R-curve, please ask the manufacturer for
