The Modular Medical Pivot™ Insulin Delivery System is intended for the treatment of diabetes mellitus inpersons requiring insulin. Your Pivot™ System consists of an Inserter, Pump, Cartridge, Patch, and the Pivot™Diabetes App. The Pivot™ Diabetes App operates on your smartphone device and connects to the Pump viaBluetooth® connection to support basal rate programming and viewing activity information. The Pivot™System can be filled with up to 3.0mL (300 units) of Humalog® U-100 rapid acting insulin and can be worncontinuously for three days. Your Healthcare Provider will help you to manage your insulin dosing regimenand prescribe insulin. The Pivot™ System can be used by persons with diabetes to manage insulin therapyindependently. The Pivot™ System is capable of delivering insulin at set and variable rates via a selectablebasal rate between 0.5 – 4 units per hour (in 0.1-unit increments) and user-selected bolus doses of between 2and 20 units (in 2-unit increments)

The Modular Medical 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 compatible with Humalog® U-100 rapid acting insulin only. Insulin Lispro U-100 (Generic Humalog®) may be used in place of Humalog® U-100 rapid acting insulin.

The Insulin Pump STARTER KIT contains: Pump (90-day use life), Inserter (2-year use life), Quick Start Guide, User Guide, Patient Medical Device card, 10 Cartridges and 10 patches in sealed trays, and 10 needles and syringes.The supply kit contains the disposable components and accessories with a 3-day use life, this includes 5 cartridges, 5 Patches, and 5 syringes & needles.

The Pump has a single button to initiate priming, control insulin delivery, and check the Pivot™ System status. The Pivot™ System uses lights and tones to make users aware of the Pivot™ System status, delivery mode, and Alarms. The user can check the Pivot™ System status during use with a quick press of the Control Button.

The System should not be used outside of the altitude limits of -1,300ft - 10,000ft. (1060 hPa - 700hPa). If the system is being used outside of the altitude limits the system will deliver an Extreme Altitude Alarm