NOTE: INFUSION SET MUST BE DISCONNECTED FROM PUMP USER BEFORE PERFORMING CARTRIDGE REPLACEMENT AND MANUAL PRIMING PROCEDURE. PLEASE REFER TO PUMP USER MANUAL FOR COMPLETE PROCEDURE.

The Medtronic/Minimed Paradigm 511 pump uses a proprietary plastic insulin cartridge with a maximum installed capacity of 176 Units (of U-100 insulin). One notable difference of this particular cartridge is that it does not accept standard Luer lock type infusion sets. Infusion sets with a specialized connector are required to allow for the water resistant design of the pump to function properly. The cost of these specialized infusion sets are comparable to the standard Luer lock types of infusion sets. The insulin cartridges come with a "Transfer Guard" and "Plunger Rod" attached, which makes filling the cartridge relatively easy.

The Paradigm 511 tracks the amount of remaining insulin and alerts the user with a "LOW RESERVOIR" alarm at approximately 30, 20, and 10 units remaining. Once the empty cartridge is removed, the captive actuator within the pump must be reset using the "Rewind" option under the "Prime" menu. Rewinding the pump retracts the actuator fully into the pump so a filled cartridge can be installed. A new cartridge is filled and attached to the infusion set tubing, then inserted into the pump. The cartridge/tubing assembly is seated into place by turning the tubing connector about 1/2 turn counter-clockwise. Once the cartridge is in place, the pump walks you through a manual priming step which seats the actuator into the cartridge plunger and can be continued to prime the tubing if it was not manually primed prior to insertion into pump.

When the manual priming procedure is completed, the tubing can be connected to a newly inserted infusion set and at this point the "Fixed Prime" feature can be used to prime the infusion set by a pre-programmed amount as recommended by the infusion set documentation.

One nice feature of the Paradigm 511 pump is that it uses a single standard AAA alkaline battery. The user guide does contain guidelines on the recommended brand to use for maximum battery life. The battery door is a round slotted cap that can be opened with the use of a coin or similar tool. Replacing the battery is as simple as removing the old one and sliding the new one in and replacing the cap.

3.0 x 2.0 x 0.77 inches (flares out to 0.8 inches along battery compartment)

< 100 grams.

Proprietary stepper motor design with captive lead screw. Delivers insulin in discrete 0.05 unit increments (U-100 insulin) per cycle. Motor does not audibly "click" as in previous Medtronic/Minimed models such as the 508.

Automated using pump motor. A mandatory "manual" priming step is presented as part of the insulin cartridge replacement procedure. This manual priming step seats the plunger and can also be continued to prime the tubing if desired. A "fixed" priming option is provided under the "Prime" menu to prime the infusion set with a pre-programmed amount of insulin.

One "AAA" alkaline battery.

Proprietary plastic insulin cartridge with an installed capacity of 1.76 ml - 176 units of U-100 insulin

Medtronic issued a notice in September of 2003 instructing users to avoid immersion of any model Paradigm pump in water. Medtronic should be contacted for additional details.

Four year warranty.

Supports three basal programs which can be activated as the user desires. A basal rate can be set from 0.0 units to 35.0 units per hour, in 0.1 unit increments. A "Max Basal Rate" setting can be adjusted anywhere from 0.1 up to 35.0 units. Each basal program can contain up to 48 segments which can be between 30 minutes to 24 hours long in 30 minute increments.

A temporary basal setting is available under the "Basal" menu. This feature allows the user to set a temporary basal rate to override the current basal program. A fixed rate is set (which could be lower or higher than the current basal rate) for a specified time duration from 30 minutes to 24 hours, in 30 minutes increments.

The Paradigm 511 allows 3 different bolus delivery options: Normal, Square Wave, Dual Wave. Also an Easy Bolus is provided as an audible method to deliver a "Normal" bolus ("Easy Bolus" can also be programmed via remote). A Normal bolus starts delivery immediately after it is entered, and can range from 0.1 units to 25.0 units (depending in user adjustable "Max Bolus" parameter).

The Easy Bolus must be enabled from within the "Bolus" menu before it can be used and a step size from 0.1 to 2.0 units (in 0.1 unit increments) selected. To deliver an audio bolus, the "Up" scroll button is pressed multiple times until the desired dosage is reached, followed by a press of the ACT button (for example, with a step size of 0.5 you would press the button 4 times to get a 2.0 unit bolus). Each time the button is pressed, a beep is sounded. Once the ACT button is pressed, the pump sounds a series of beeps to verify the dosage, and a second press of the ACT button is required to verify and activate delivery.

The Square Wave bolus program is an extended bolus which requires programming in the bolus amount as for a Normal bolus, plus a duration which can vary between 30 minutes to 8 hours in 30 minute increments. The "Dual/Square Bolus" setting must be turned on under the "Bolus" menu before this feature can be used.

The Dual Wave bolus program is a variation of a Square Wave bolus, and is basically a combination of a Normal bolus and a Square Wave bolus. First, the user is prompted to enter a bolus of insulin for immediate delivery (the Normal portion). Then, the user is prompted to enter an extended bolus amount with time duration (the Square Wave portion). As with the Square Wave bolus, the "Dual/Square Bolus" setting must be turned on under the "Bolus" menu before this feature can be used.

It should be noted that a Normal or Easy Bolus may be programmed concurrently with (on top of) a Square Wave bolus or the extended portion of a Dual Wave bolus.

The Paradigm 511 supports up to 3 different remotes. Each remote "RF ID" must be programmed into the pump using the "RF Options" item under the "Utilities" menu. "RF" must also be turned on to be able to use the remote. A remote may be used to control Easy Bolus, Suspend, and Resume pump features.

The Paradigm 511 user interface utilizes Medtronic E-Z Path™ Programming. Four primary buttons on the front of the pump are used for most of the programming ("Up" and "Down" arrow keys, "ACT", and "ESC"). There is also a fifth button which is a shortcut to go directly to the bolus screen. Most commonly used features can be accessed within a few button presses.

The main LCD screen displays simply the "Minimed" logo under normal operation. Small outlined circles appear if the pump is in a special mode (for example temp basal or low battery). If these circles appear filled in, insulin delivery has stopped (such as an alarm or suspend mode) which usually indicates that user intervention is required.

Current time and pump status summary can be displayed by hitting the "ESC" button once. The main menu is activated by pressing "ACT", and contains menu entries labeled "Bolus", "Suspend", "Basal", "Prime", and "Utilities" which can be highlighted by scrolling with the up/down buttons and then pressing the "ACT" key. Each of these menus either provides direct access to specific features, or to additional submenus.

Yes

Yes

Yes

Boluses with time and date, alarms with time and date, daily totals, priming.

This feature, accessed through the "Utilities" menu, will alarm and suspend the pump if no buttons have been pressed for the programmed time limit. That limit can be set from 1 hour to 24 hours in 1 hour increments.