User's Manual

CHAPTER 1. Understanding Your New Analyzer
1. Indication for Use; Purpose of the analyzer
The SD MultiCare™ analyzer work to measure the quantitative measurement of blood
parameter: HbA1c, CRP, u-ALB, CRT. The analyzer is indicated for monitoring the blood
parameter in fresh capillary whole blood samples or venous blood. The SD MultiCare™
analyzer should be used with the SD MultiCare™ test strip. Testing is done outside the
body (in vitro diagnostic use). This analyzer is indicated in clinical settings by healthcare
professionals. The SD MultiCare™ analyzer be only used the SD MultiCare™ test strip
for the appropriate parameter.
2. Test principle
By means of a code chip, the analyzer reads the lot-specific characteristics of the test
strips currently in use. Then an unused test strip is inserted into the analyzer. While
inserted, the application area of the test strip is illuminated by an LED (light-emitting diode)
from below while scanning. Before the actual measurement is performed, the reflection
behaviour of the test strip is determined by means of the light which is reflected (from the
application area).
The blood sample is then applied to the application area. The constituent to be
determined in the applied sample undergoes an enzymatic reaction with formation of a
dye. The amount of dye formed increases with the concentration of the substance to be
determined.
After a certain period of time, the colour intensity is measured by illuminating the
application area again from below using motor and LED. The intensity of the reflected
light is measured with a detector (reflectance photometry). The measured value is
determined from the signal strength of the reflected light, with the previously measured
blank value and the read lot-specific information (code chip) also being considered.
Finally, the result is displayed and simultaneously stored in the memory.