Intended Use

The Animas^® Vibe™ Insulin Pump and CGM System (Animas^® Vibe™ System) is indicated for continuous subcutaneous infusion of insulin for the management of insulin-requiring diabetes. The Animas^® Vibe™ System is also a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The Animas^® Vibe™ System is intended for use by patients at home and in health care facilities. The Animas^® Vibe™ System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Animas^® Vibe™ System aids in the detection of episodes of hyperglycæmia and hypoglycæmia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom^® CGM results should be based on the trends and patterns seen with several sequential readings over time.

CONTRAINDICATIONS:

The CGM Sensor and Transmitter must be removed prior to Magnetic Resonance Imaging (MRI). Use of acetaminophen-containing medications while the CGM Sensor is inserted may affect the performance of the CGM.

WARNINGS:

The CGM is not designed to replace a blood glucose meter. The CGM must be used with a blood glucose meter. You must take a fingerstick test with your BG meter and use that BG value to make any insulin or treatment decisions. Insulin dosing decisions should not be based solely on results from the CGM. Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use your blood glucose meter to check the CGM results. You should update the CGM's calibration every 12 hours at a minimum. CGM Sensors may fracture on rare occasions. If a CGM Sensor breaks and no portion of it is visible above the skin, DO NOT attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the injection site. If you experience a broken CGM Sensor, report this to Customer Support or your local Animas distributor. CGM is NOT APPROVED For Use in children or adolescents, pregnant women or persons on dialysis. The safety and effectiveness of the CGM has not been evaluated for Sensor Probe insertion sites other than the abdomen. For important safety information about pump therapy and use of the Animas^® Vibe™ insulin pump, please consult with your healthcare provider and the Animas^® Vibe™ Owner's Booklet.
Contact Animas at (877) YES-PUMP or www.animas.com for detailed indications for use and safety information