The Pivot™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 18 years of age and greater.

The Pivot™ Insulin Delivery System is contraindicated for use in diagnosing diabetes mellitus. It should not be used by patients who do not have adequate hearing and/or vision to recognize all system functions, including status indicators and alarms. Pivot™ is also contraindicated for patients who are unable to manage their diabetes therapy; who are unwilling to perform a minimum of four (4) blood glucose measurements per day; or who are unable or unwilling to use the system as described in the User Guide. Additionally, Pivot™ should not be used by patients who require basal insulin rates greater than 4 U/hr or less than 0.5 U/hr, or with insulin brands or concentrations other than Humalog® U100 insulin or Lispro U-100 (Generic Humalog®).

WARNING: Do not start using the Pivot™ Insulin Delivery System or change any settings unless a healthcare provider has trained you. Always follow your healthcare provider’s instructions. Using the system the wrong way may deliver too much or too little insulin. This can cause low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia).

The Pivot™ App is currently compatible with iOS version 26.0+ and the following phone models: iPhones 12, 12 Pro, 12 Pro Max, 13, 13 Pro, 13 Pro Max, 14, 14 Plus, 14 Pro, 14 Pro Max, 16e, 16, 16 Plus, 16 Pro, and 16 Pro Max.

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