Average occlusion
volume before
error
Delivery
Basal rate
Bolus
Temporary
basal rate
Safety system
Maximum infusion
pressure before error
Flow (delivery rate)
Maximum quantity
delivered at first
error
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Precision of flow rate
The trumpet curve shows the precision of the delivery rate in relation to the
observation window duration according to the standard IEC 60601-2-24:1998.
The measurements were made at a medium basal rate 1.0 U/h.
Infusion set: Classic PC 16/110
Trumpet curve plotted from data after the end of the stabilization
period of 24 h (stabilization diagram see next page)
Percentage error of flow (%)
Observation window duration (min)
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Approx. 2 to 5 units with Classic Infusion Set PC 16/110 (worst
case max. 8 units), calculated with a delivery rate of 1 U/h this
corresponds to about 2–5 hours (worst case max. 8 hours).
1/20 hourly basal rate in 3 minute intervals.
Min. 0.0 U/h, max. 25 U/h. There are 24 hourly basal rates
adjustable in 0.1 unit increments.
The max. bolus amount per delivery is 25 units. The bolus amount
for the standard bolus is adjustable in increments of 0.1, 0.2, 0.5
and 1.0 units. For the scroll and/or extended bolus, the amount
is adjustable in increments of 0.1 units, the duration in intervals of
15 minutes (0–4 hr).
Adjustable in 10% increments, 0–90% for decreases, 110–200%
for increases. The duration is adjustable in 1 hour intervals, up to
a maximum of 24 hours. The last programmed duration is given by
default for the next temporary basal rate change programmed.
Alert system, beeps, display, vibrations, dual microprocessors. Your
insulin pump is controlled by two microprocessors. The safety con-
cept is based on one processor (supervisor processor) supervising
the other (main processor). Whenever a defect or fault occurs in the
main processor, it is located by the supervisor processor. The motor
is immediately switched off and an “Error E7: Electronic Error”
occurs. Conversely, the main processor can also determine at any
time whether the supervisor is working correctly. The motor also
constitutes an important safety component, as the combination of
main and supervisor processor and step motor provides the best
possible reliability and precision in insulin delivery.
3.9 bar
During infusion set filling and bolus 0.2 units/sec.
2 units
minimum measured variation maximum measured variation overall mean flow error
Medium basal rate (1.0 U/h; Figure 1):
The percentage error of flow is within ± 10%
(observation window duration
≥
1 hour).
Figure 1
