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EndoTool SubQ is a software management system for use by trained healthcare professionals to calculate and recommend an individual patient's next dose of insulin to be administered subcutaneously to manage elevated blood glucose levels in both adult and pediatric patients (age 2 and above and 12 kg or more). The software is designed to recommend the insulin dose(s) (and on occasion a carbohydrate dose for the treatment of hypoglycemia) based on the prescribing healthcare provider's insulin regimen, target glucose level range, and nutritional regimen. The software provides an optional insulinon-board (IOB) calculation that estimates the sum of the remaining insulin activity from previously administered subcutaneous insulin(s). This IOB adjustment reduces the prescribed Bolus dose and, if appropriate, recommends a supplemental carbohydrate dose to the trained healthcare professional. EndoTool SubQ is not a substitute for clinical reasoning, but rather an aid for trained healthcare professionals based on timely, accurately obtained glucose readings and timely, accurately entered clinical data. Final dose recommendations for a patient must be accepted only after consideration of the full clinical status of the patient. No medical decision should be made based solely upon the recommendations provided by this software program.

Monarch Medical Technologies' EndoTool SubQ Glucose Management System is a software application for use by trained healthcare professionals to calculate a hospitalized patient's next dose of insulin (administered subcutaneously) or carbohydrates to manage blood glucose levels in both adult and pediatric patients (age 2 and above and 12kg and above) based on their individual glucose response to previously administered insulin. The subject device, EndoTool SubO with optional Insulin-on-Board (IOB) calculation, and the predicate device, EndoTool SubQ (K142918), both provide an insulin dose recommendation based on the patient's clinical data and the physician's current prescribed dosing regimen. EndoTool SubQ Glucose Management System is packaged in a user friendly, browser-based program using Microsoft .Net technologies. The application requires Windows. The application was developed for use on Personal Computers (PCs), network servers, and terminal server environments. EndoTool SubQ Glucose Management System can utilize barcode scanning for patient identification/verification. Other platform requirements of the system include installation of the following software: SQL Server 2005 or greater, Crystal Reports Basic for Visual Studio 2008, and Adobe Reader.