®	Animas R1000

Summary

The Animas R1000 has features that allow flexibility in adjusting both basal and bolus insulin delivery. It has four basal programs and both normal and extended boluses. The large backlit LCD screen allows for detailed display of information and a menu based user interface which non-technical people should find easy to use. Programming is performed through the use of three front buttons. A fourth button on the front activates the backlight, and a recessed button on the edge is used to program the audio bolus feature. The R1000 is waterproof (IPX8 - 12 feet for 24 hours) and can be worn swimming or bathing without any additional adapters or covers.

Common Procedure Descriptions

(Please note... these are descriptions only! Please see pump manual for complete official procedure instructions)

• Replacing Insulin Cartridge
  As with most pumps, the Animas R1000 pump uses specially designed proprietary plastic insulin cartridges incorporating a seal for the waterproof case design. The cartridge is usually filled with 3.0 ml of insulin (300 units U-100), but can be filled at any level below this if desired. The Luer lock connection does not protrude far from the case, and different fill levels do not change this (full or half fills). The pump automatically tracks the amount of insulin remaining in the cartridge, which is conveniently displayed on the main screen. As described in the Alarms section, the pump has a "Low Insulin Remaining" alarm which can be set to either 20 or 40 units left in the cartridge, so you will be notified when your current cartridge is low.

  The insulin cartridges come with a disposable filling needle, protective cap, and a optional "C" shaped clip to make gripping the cartridge plunger easier. The cartridge is keyed to fit into the pump in only one way (the plunger has a "U" shaped handle and there is a notch on the cartridge to ensure correct orientation). The pump is held upright (screen facing forward, up arrow pointing towards the ceiling) while inserting the new cartridge to ensure proper seating of the lead screw mechanism to the cartridge plunger. Once the cartridge is inserted and before the cartridge door is latched closed, the enclosed pump lead screw mechanism is seated to the cartridge plunger by gently tapping the top edge of the pump. The infusion tubing is attached after closing the cartridge door and removing the protective cap, and is then primed using the Prime menu option.

• Changing the batteries
  The R1000 uses four 357 sized alkaline watch batteries. The battery compartment door is located under the latched pump door. Once the pump door is opened, the battery compartment door is then removed and batteries are replaced. The battery door has a rubber "O" ring which Animas recommends replacing before the battery door is reseated.

Technical Specification Details

• Size
  3.5 x 2.2 x 0.7 inches

• Weight
  3.5 ounces

• Physical Delivery Mechanism
  DC motor with enclosed lead screw.

• Priming
  Automated using pump motor. Under the priming menu, the user presses and holds down the enter button to prime the infusion set. The priming continues until the enter button is released.

• Battery Type
  Four standard 357 alkaline watch batteries.

• Cartridge Type and Capacity
  Proprietary plastic insulin cartridge with a capacity of 3 ml - 300 units of U-100 insulin

• Water Resistance
  IPX8 - Can be safely submerged in water per manufacturer. Animas specifies that the R1000 is tested at a water submersion depth of 12 feet for 24 hours. This means that the pump can worn while bathing, showering, or swimming (at depths less than 12 feet) with the pump attached.

• Warranty
  Four year warranty.

Feature Details

• Basal Programming Options
  Supports four basal programs which can be activated as the user desires (for instance one profile for a weekday and another for a weekend day). A basal rate can be set from 0.05 units to 1.5 units per hour, in 0.05 unit increments. Each profile can contain up to 12 segments which can be between 30 minutes to 24 hours long in 30 minute increments.

• Temporary Basal Rate
  A temporary basal setting is also available under the "Basal" menu. The temporary basal setting can be programmed as a percentage of the current basal rate, from negative 50% (decrease) to positive 90% (increase) in 10% increments. The temporary basal rate can be programmed from 30 minutes to 12 hours in duration, in half-hour increments. The temporary basal feature also allows the user to turn the basal OFF if desired for a specified time period.

• Bolus Programming Options
  Normal, Extended, and Audio bolus options are available. Both the Normal and Extended bolus options are available from the Bolus menu off of the Menu screen. The Audio and Extended bolus features must be activated via the "Setup" menu ("Advanced" submenu) prior to use. A Normal bolus begins delivery immediately upon confirmation, and can be from 0.10 Units to 25 Units in 0.10 Unit increments.

  The Audio bolus is activated by pressing the side button. The audio bolus step size can be set to either 0.5 units or 1.0 units per button press. The 0.5 unit step size allows for 0.5 to 10.0 units per bolus, and the 1.0 step size allows for 1.0 to 20.0 units per bolus. Once the button is pressed the desired number of times (for instance, pressed 4 times for a bolus of 2.0 units with 0.5 unit step size), the pump beeps once for each button press and then emits a double-beep for confirmation. You confirm by pressing the button one more time and then the insulin is delivered.

  An Extended bolus requires programming in a bolus amount from 0.1 units to 25 units in 0.1 unit increments, and a duration of 30 minutes to 4 hours in 30 minute increments. A normal or audio bolus can be programmed and delivered even while an Extended bolus is active.

• Remote Control
  No

• User Interface and Display
  The R1000 graphical menu driven interface (ATM type interface as the Animas literature describes it) helps to guide the user in accesses the desired pump functions. Three primary buttons on the front of the pump are used for most of the programming. Most commonly used features can be accessed within a few button presses.

  The main screen displays the current time, active basal program name, current basal rate, units of insulin remaining, and an option to go to the main menu by simply pressing the Enter key. The main menu has submenus titled "BOLUS", "SUSPEND", "HISTORY", "BASAL", "SETUP", "PRIME", and "STATUS" which can be highlighted by scrolling with the up/down buttons and then pressing the Enter key. Each of these submenus either provides direct access to specific features, or to additional submenus.

• Backlight
  Yes

• Vibrating Mode
  No

• Child Lock Mode
  No

• Warnings and Alarms
  • Warning: Low Battery
  • Warning: Low Insulin Remaining
    Can be set to warn at either 20 or 40 units of insulin remaining.
  • Warning: Insulin Limits Exceeded
  • Warning: No Delivery - Cartridge Low
  • Warning: Not Primed
  • Warning: Pump Suspended
  • Warning: Bolus Delivery Canceled by User
  • Warning: Bolus Delivery Canceled by Low Battery
  • Warning: Archive Clear
  • Warning: Active Basal Program Clear
  • Alarm: Dead Battery
  • Alarm: Pump Malfunction
  • Alarm: Empty Cartridge
  • Alarm: Occlusion
    Can be set to L(ow) or H(igh) sensitivity level.

• History
  Last 255 boluses with time and date, last 255 alarms with time and date, last 255 days total daily insulin delivery with total basal per day.

• Automatic OFF
  This feature 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 16 hours in 1 hour increments.