Dräger Medical JM-103, Руководство по эксплуатации

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DRAFT 20 June 2005
Page 2 - 4 Jaundice Meter (Model JM-103) User Manual (usr070)
Averaging of Measurements
Averaging measurements may allow for more precise results. Assess the
advantages of using average measurements at your facility. There was
no significant difference between the averaged measurements and the
single measurement approaches in the largest study for sternum
measurements. The mean of three measurements showed the highest
degree of correlation (r=0.965), however, the difference was minimal
with a single measurement (r=0.963).
Averaging was not evaluated in the physicians’ office study.
Action Levels
Each facility should determine their own action levels based on studies
of performance of the device on their population. Appropriate action
levels may vary depending on performance of the device, such as
precision or correlation with serum bilirubin, in the hands of the user.
Some factors that could affect performance of the device or appropriate
action levels include skin color, age, or measurement site. The bias
relative to serum bilirubin differs between hospital versus physicians’
office sites (see Appendixes A and B). Different action levels may be
appropriate for hospital versus physicians’ offices.
Careful selection of
action levels should be made so that false negatives do not prevent
appropriate follow up measures.
Calibration
There is no user calibration of this device. The system does include a
checker that measures the intensity of light from the device to ensure the
light output is acceptable for proper use.
Processing of Measured Values
The Jaundice Meter (JM-103) determines the yellowness of the
subcutaneous tissue by measuring the difference in the optical densities
for light in the blue and green wavelength regions. The optical density
difference has been shown to have a linear correlation with serum
bilirubin concentration. The device computes an estimated bilirubin
concentration based on this linear correlation and provides the value on
the display.