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The Genesis Health Record System is an accessory to the Genesis Health Technologies Blood Glucose Meter, Model TD-4123 to assist in the review and evaluation of blood glucose test results and related information to aid in diabetes management. It is indicated for use by adult diabetic patients for use in the home and by healthcare professionals in the professional setting. The System is not intended to provide automated treatment guidance or decisions. The System is not indicated for the diagnosis or screening of diabetes.

1. The Genesis Health Record System (GHRS) is an internet browser based data management system for use with the Genesis Health Technologies Blood Glucose Meter Cleared under K121224. 2. The GHRS data management system allows patients to wirelessly transmit the results of glucose testing including the test result, date and time from the blood glucose meter via a CDMA module in the blood glucose meter over the Verizon wireless network, to a secure central database. The results are then stored on a secure central database and can be accessed through the internet by patients and/ or authorized healthcare professionals, on a personal computer running any operating system with access to the internet. The user can review and evaluate results of blood glucose tests and related information to aid in the management of diabetic patients. Results can be displayed on the computer in the form of a Log Book report showing test results from a specified date range, a graphical display of the patient's results and a trending report showing within target and out of target percentages. 3. A current internet browser and internet access are required to reach the MyGHR website. No other programs or applications need to be installed on a computer terminal. No cables are required. The User goes to the MyGHR website and sets up their account.