User's Manual

Page 30 of 38
6 TECHNICAL SPECIFICATIONS
6.1 Pump Accuracy
The dose accuracy of the Wearable Infusion per ISO 11608-1 under normal conditions is ±10% for dose of 0.1mL
and ±5% for doses of up to 3mL.
The rated accuracy of the Wearable Infusion per IEC 60601-2-24 under normal conditions is ±5%.
Testing was performed under normal conditions at room temperature (25
o
C, 72
o
F).
Normal conditions to ensure optimal accuracy
 Barometric pressure of sea level altitude (101kPa)
 Subcutaneous medication with water like fluid characteristics
In the Wearable Infusion Pump, as in all infusion systems, external factors may cause fluctuations in rate
accuracy. Conditions that can cause flow fluctuations include:
 Fluid characteristics that deviate from water-like characteristics, such as density, viscosity and
homogeneity
 Barometric pressure below 101kPa
6.1.1 Start-up and Trumpet Graphs
The following graphs and curves were derived from the pump accuracy testing procedures described in the
IEC60601-2-24 standard.
The start-up graphs represent startup flow versus operating time for the first half of the 3 mL cartridge (filled
with 3 mL water) from the start of the infusion ("Stabilization period"), while the trumpet curve represents the
percent flow rate deviation from the programmed rate over time of the second half of the cartridge ("Analysis
period"). The horizontal axis represents the observation time intervals, which were adapted to represent the
time of the delivery.
Over long observation windows, short-term fluctuation has little effect on accuracy, as represented by the flat
part of the curve. As the observation window is reduced, short-term fluctuations have a greater effect, as
represented by the "mouth" of the trumpet.