User's Manual

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D. Device Specications – Pump
Dimensions: 3.3 X 1.8 X 0.75” (84 X 46 X 19 mm)
Display Type: Dot graphic•
Display Viewable Dimensions: 0.97” X 0.76” (24.7 X 19.4 mm )
Display Backlight: Yes
Audio/Vibe Alert: Yes
Weight: Without battery and reservoir/hub, weight is approximately 2.7 oz (76.5 g). Add battery and
empty reservoir, weight is approximately 3.3 oz (93.6 g).
Reservoir: Single use plastic reservoir
Reservoir Connection: Proprietary secure connector
Basal Increment: 0.05 units
Total Basal Rates: 48/day
Basal Prole Conguration: Numerical display
Basal Proles: 4
Basal Interval: 30 minutes
Basal Frequency: Every 3 minutes
Basal Rate Range: 0.05 to 30U/h
Temporary Basal: +/- 10% increment between 0-200% for 0.05 to 30U/h* OR +/- 0.05 unit increment, single
rate for 0.05 to 30U/h.
You may set a temporary basal for up to 72 hours.
*• The minimum allowable percentage is equal to the minimum basal rate (0.05)
divided by the lowest basal rate over the specied duration of the temporary basal that is
greater than 0. (e.g. if the lowest basal rate greater than 0.0U over the duration is 0.20U, the
minimum percentage is 25% — 0.05/0.2 = 0.25)
The maximum allowable percentage is equal to the maximum basal limit (Setup: Basal
Limits: Maximum) divided by the highest basal rate over the specied duration of the
temporary basal, truncated to the nearest 10%. (e.g. if the highest basal rate over the
duration is 1.35 U/h, and the maximum basal limit is 2.00 U/h, the maximum percentage is
140% — 2.00/1.35 = 1.48)
Bolus Dose Range: 0.05 to 50U
Bolus Increments: 0.05U, 0.1, 0.5 or 1.0 using One-Button Bolus (audio/vibrate)
Normal Bolus Delivery Rate: At least 0.1U per second
Prime Deliver Rate: At least 0.1U per second
Extended Bolus: Yes
1 U Bolus Duration: 10 seconds typical
Inactivity Alarm: Always on, 1 – 24 hours.
Maximum Time to Assert Occlusion
Alarm:
Occlusion Alarm set to High
Sensitivity
1 U/hr Approximately 3 hrs Approximately 6 hrs
0.05U/hr Approximately 60 hrs Approximately 120 hrs
Occlusion Alarm Threshold/Pressure
(Maximum Infusion Pressure)
25 psig (pounds per square inch gauge)
Bolus Volume upon Release of an
Occlusion
Approximately 2.0 units
Pump Battery:
One AAA battery (Energizer E92 or Duracell MN2400 recommended). Other models from
these companies have not been tested.
Battery Life: 30 days (in typical use cases)
The expected life of the battery is dependent upon the following usage:
Basal: 1 U/h (U100) 24 hr/day, 7 days/week
Bolus: 5 boluses per day with a total daily bolus delivery of 24 Units (U100)
Prime: 20 Units (U100) occurs three times a week
Memory: 90 days worth of events; display shows last 30, remainder can be seen if downloaded to a PC
Water Resistance: Water resistant to IPX8
Moisture Protection: IPX8 (Water resistant to 8 feet [2.4 meters] for 30 minutes and 12 feet [3.6 meters] for 3
minutes)
IEC Classication:
Internally powered equipment, Type BF applied part (protection against electric shock)
Reservoir Volume: 250U or 2.5 mL
Operational Conditions (Temperature
and Humidity):
41°F – 104°F (5°C to 40°C) with 10% to 90% relative humidity
Storage Range: Shipping container for 1 year at -4°F – 113°F, average temperature at 72.5°F (-20°C to 45°C,
average temperature at 22.5°C) with 10% to 90% relative humidity.
Accuracy: Bolus Accuracy : +0.1U / -0.2U (or +0.001ml/-0.002ml); for doses from 0.05U to 2U inclusive
+5% / -10%; for doses greater than 2U up to and including 6U
+5% / -5% for doses greater than 6U
Basal Accuracy: +/-5%
Data Storage: The Pump has the ability to store a minimum of 2700 patient events in non-volatile memory
for the expected life of the pump.
Section 12: Appendices
Appendix E: FCC Compliance Information
Section 12: Appendices
Appendix F: Electromagnetic Information
DOC15736_Rev-A-Man.indd 255-256 2/9/09 11:29:56 AM