Insulet INT2-D001-MM-OUS2, User Manual

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Appendix
180
Appendix
Protection from Over-infusion or Under-infusion
The Pod software monitors the infusion rate. If an error that would result in over-
or under-infusion is detected and cannot be corrected, insulin delivery stops and
an alarm sounds.
Occlusion detection
An occlusion is a blockage or interruption in insulin delivery from the Pod. If the
Omnipod DASH™ System detects an occlusion, it sounds a hazard alarm and
prompts you to deactivate and change your Pod.
An occlusion hazard alarm sounds when an average of 3 units to 5 units of missed
insulin occurs. The following table depicts occlusion detection for three different
situations when using U-100 insulin. For example, if the Pod’s cannula becomes
occluded when delivering a 5 U bolus, 35 minutes may pass before the Pod sounds
a hazard alarm.
Time between occlusion and Pod alarm
Typical time
Maximum time
5.00 U bolus
33 minutes 35 minutes
1.00 U/hr basal
3.0 hr 5.5 hr
0.05 U/hr basal
51 hr 80 hr (Pod expiry)
If an occlusion spontaneously clears up, a volume of insulin could be released.
That volume would not exceed the volume of the programmed insulin intended
for delivery.
If an occlusion is detected during an immediate bolus, the Pod sounds a hazard
alarm at the conclusion of the immediate bolus.
Warning:
At very low basal flow rates, checking your blood glucose
frequently may give you an early indication of an occlusion. Occlusions can
result in hyperglycaemia.
Omnipod DASH™ System Label Symbols
Symbol Meaning Symbol Meaning
Single use only MR unsafe
Consult the
accompanying
documents
Do not use if the
package is damaged
Effective Date: 27SEP2019, ECO-000240