Self validating reduction
They are suitable for use in all clinical settings: NICU; SCBU; maternity; post-natal; and in the community.
The reduction in neonatal stress and parental anxiety add to the process of optimising developmental care.Each safe and dangerous failure mode is determined as Detectable or Un-detectable by the product’s diagnostics.The result is a list of all components, their failure modes, the failure mode classification as Safe-Detected (SD), Safe-Undetected (SU), Dangerous-Detected (DD) or Dangerous-Undetected (DU), and the failure rate of each classification using the Failure Rate Prediction results (l SD, l SU, l DD, l DU).The transcutaneous jaundice meter from Delta Medical International offers a reliable, non-invasive method for screening babies for jaundice.The product is convenient, effective and proven, reducing the need for blood sampling and thus contributing to developmental care practice.Within the product all failure rates of individual components contribute to the overall product failure rate. Failure rates of individual components of the BOM are calculated based on component type and in-circuit bias. Product failure rate is the sum of all component failure rates.
Step 2 Failure Mode Effects and Diagnostic Analysis (FMEDA) Failure Mode Effects and Diagnostic Analysis (FMEDA) is a technique that evaluates and quantifies the product’s self-diagnostic ability.
Once diagnosed jaundice can often be simply treated by using a phototherapy system to break down excess bilirubin levels.
Transcutaneous Bilirubin Measurement It is well established that the transcutaneous measurement of bilirubin level is well correlated with serum concentration.
The jaundice meter can facilitate routine screening and accelerate appropriate care and treatment of babies who may have an elevated bilirubin level.
For General Monitors, calculating the SIL suitability level for individual products is a combined effort between corporate quality, engineering, and a 3rd party for validating calculations.
Each component’s failure mode and its failure rate are listed.