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The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is comprised of the Accu-Chek Guide Solo diabetes manager blood glucose meter, Accu-Chek Bolus Advisor and the Accu-Chek Guide test strips. The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip. The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use), by individuals with diabetes at home as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is intended to be used by a single person and should not be shared. This Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Guide Solo diabetes manager, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data. Before its use, a physician or healthcare professional must activate the bolus calculator and provide the patient-specific target blood glucose, insulin-to-carbohydrate ratio, and insulin sensitivity parameters to be programmed into the software. The Accu-Chek bolus advisor is intended for home use. The Accu-Chek Guide Solo diabetes manager steers the Accu-Chek Solo micropump.

The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system consists of the following components: - Accu-Chek Guide Solo diabetes manager - Accu-Chek Bolus Advisor - Accu-Chek Guide Test Strips The Accu-Chek Guide Solo diabetes manager blood glucose monitoring system is a handheld device that incorporates features to aid in self-monitoring of blood glucose. The blood glucose results are displayed on the screen and stored in the meter's memory, and may also be transmitted via USB wireless communication. Our blood glucose monitoring system creates a glucose result from an amperometric reaction. Capillary whole blood from the user's fingertip reacts with the chemicals in the test strip to create a harmless electrical current in the test strip. The blood glucose meter reads the current and gives a blood glucose result. The Accu-Chek Guide Solo diabetes manager is a remote control for the Accu-Chek Solo micropump.

The Accu-Chek Solo micropump system with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Accu-Chek Solo micropump system is able to communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Accu-Chek Solo micropump system is intended for single patient, home use and requires a prescription. The Accu-Chek Solo micropump system is indicated for use in individuals 2 years of age and greater.

The Accu-Chek Solo micropump is a portable programmable insulin pump, which adheres to the patient's skin. The patch is comprised of two connected parts: a disposable reservoir, in which the insulin is stored and a reusable pump, which includes the pumping mechanism and electronic components. The patch is controlled via a connected Device. The Accu-Chek Solo micropump is designed to deliver basal and bolus insulin doses at various rates, volumes and patterns, as prescribed by the user's physician.