All of this information is from the CCSI Information Page listed on the introduction post for this board.
Message 3447686
510(k) SUMMARY from the FDA:
techstocks.com
Indications for use:
The Colormate III is to be used as an aid to the physician in monitoring the status of newborn babies for the development of hyperbilirubinemia.
Following the physician's examination within the first hours of birth, newborn babies are initially measured and periodically monitored by the Colormate III for incremental changes in the yellow content of the skin color as compared to the baseline Colormate III measurements. Babies with Colormate III test results indicative of hyperbilirubinemia are to be re-evaluated by the attending physician for appropriate patient management.
4.0 Device Description
The Colormate III (Colormate III or CM III) is a computer assisted noninvasive transcutaneous bilirubinometer which, through colorimetric technology, illuminates the skin of newborn babies and measures the yellow content of the skin color.
The incremental changes of these color readings measured over time are compared to the newborn's baseline readings. These data are then automatically processed to provide a numerical index of estimated bilirubin count in mg/dl that has been shown to correlate with total serum bilirubin within a clinically useful range. The Colormate III like other colorimeters, generates a set of tristimulus color coordinates for each measurement. It then performs a series of algorithms to produce final measurement results.
About Jaundice
pathfinder.com@@gJSqeAYAIIimRc2v/ParentTime/Health/jaundce.html
.....Babies are born with more red blood cells than they need. These excess cells, resembling tiny wafers packed with a yellow pigment called bilirubin, are broken down by the body's disposal system. During this process the yellow pigment, bilirubin, is released. This happens every day in our bodies. We don't get yellow because our liver - the master filter - disposes of the excess bilirubin.
A newborn's immature liver can't handle the extra bilirubin, resulting in this yellow pigment's settling in the skin and reflecting a yellow color by the third or fourth day after birth. This is normal jaundice.
As soon as your baby's bilirubin-disposal system matures and the excess blood cells diminish, the jaundice disappears - usually within a week or two, and without any harm.
Abnormal jaundice usually develops within the first 24 hours after birth. This type of jaundice is caused by too many red blood cells being broken down too fast. If too much bilirubin is released into the system (in medical terms, "if the bilirubin level is too high"), the excess bilirubin could cause brain damage (which, with modern prevention and treatment, rarely occurs). Even the abnormal type of jaundice almost never harms a full-term healthy baby. It is much more worrisome in premature or sick newborns......
Jane |
