Insulet Omnipod Dash - Protection from Over-Infusion or Under-Infusion; Omnipod DASH System Label Symbols

Appendix
180
Appendix
Protection from Over-infusion or Under-infusion
e Pod soware 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. e following table depicts occlusion detection for three dierent
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.
at 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 ow 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