User's Guide

Dose accuracy
308
309
Trumpet Curve of analysis Period
Percentage error (%)
Observation Window (min)
Average Error = 4.7%
0
-5
0
5
10
15
100 200 300 400 500
IDD flow accuracy after initial stabilization period (per IEC
60601-2-24)
The Trumpet curve shows the accuracy of the flow rate as a function
of an averaging window. The reported percent deviation is calculated
from the overall weight increase across the full T2 time period.
IDD flow accuracy
after initial stabilization
period (per IEC 60601-
2-24)The average basal
insulin and food dose
delivered are expected
to be within 10% of the
requested dose. However,
dose accuracy may be
aected by the presence of residual air in the IDD. Occasionally, the
dose accuracy of 10% may not be maintained for the minimum food
dose of 1U. The maximum food dose of 30U is expected to be within
10% of the requested dose. The Essential Performance of BD Strive™
system can be stated as “The BD Strive™ Insulin Management System
maintains Insulin delivery accuracy of ±10% under specified operating
conditions.” The measurements were taken for two IDD samples.
Bolus accuracy:
Set Bolus
Average
Bolus
(Actual)
Percentage
average deviation
from set Bolus
Maximum
positive deviation
from set bolus
Maximum
negative deviation
from set bolus
(Units) (uL) (Units) (%) (Units) (uL) (Units) (uL)
Maximum 30 U 300uL 30.86U 2.87% 1.44U 14.4uL -0.52U -5.2uL
Minimum 1 U 10uL 1.03U 3.00% 0.06U 0.6uL -0.14U -1.4uL
92038.01_IFUCanada.indd 308-309 10/18/18 8:54 AM