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The GlucoStabilizer Insulin Dosing Calculator 3.0 is designed for use by order of a physician for hospitalized patients. It is intended to evaluate the current as well as cumulative patient blood glucose values, and based on those measurements, calculate and recommend a dose of insulin or dextrose to drive the either up or down towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend dosing of insulin or dextrose for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing calculations of insulin and dextrose for both adult and pediatric (ages 2 to <18 years) patients with no known insulin allergies. The GlucoStabilizer Insulin Dosing Calculator's programmed logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated by the GlucoStabilizer Insulin Dosing Calculator are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decisions should be based solely on the recommended guidance provided by this software program.

The GlucoStabilizer Insulin Dosing Calculator 3.0 is a Web-based software solution that automates calculations used by healthcare professionals to determine the appropriate intravenous insulin drip rate necessary to manage blood glucose levels across a variety of patient populations. GlucoStabilizer also provides alerts for subsequent blood glucose testing and monitoring. The GlucoStabilizer software release described in this 510(k) submission contains a modification that allows its use for pediatric patients. The pediatric protocol considers patient weight in insulin calculations for patients under the age of 18 years and provides a 3-digit multiplier for more granular calculation results. In addition, this release of GlucoStabilizer provides an optional 'multi-view'screen that allows healthcare personnel to more easily manage multiple, on-going patient treatment programs. Other features and technological characteristics of GlucoStabilizer are unchanged.

HERO is intended to acquire, store, analyze, and report on ECG data collected from infants. HERO is intended to be used under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment. HERO is intended to be used for the analysis of the variability in RR intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by HERO are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate. HERO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation of those measurements or any kind of diagnosis. The specialized HRV measurements produced by HERO have not been approved by the FDA for any specific clinical diagnosis. HERO acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.

HERO is comprised of several off-the-shelf Personal Computers (PC's) capable of acquiring, storing, analyzing, and reporting ECG data from the cardiac monitoring real-time network. Data is acquired, stored, analyzed, and displayed on a Bedside Monitoring Station (BMS) located near each patient. Demographic data is entered on a Central Monitoring Station (CMS). Results of the analyses are reported by both the CMS and the BMS. The analysis algorithms identify Heart Rate Variability (HRV) patterns that reflect transient decelerations and/or reduced baseline variability.