OmniPod DASH Guide De L'utilisateur page 195

Appendix
Type BF applied part: Protection from electrical shock
Maximum infusion pressure: 35 psi
Maximum volume infused under single fault conditions: 0.0 U
Flow Capability:
Basal: Programmable by the user in 0.05 U increments of up to
30.0 U per hour
Bolus Rate: 1.5 units per minute. Dose range from 0.05 to 30.0 units
Delivery accuracy (tested per IEC 60601-2-24):
Basal: ± 5% at rates ≥ 0.05 U/hr
Bolus: ± 5% for amounts ≥ 1.0 unit
± 0.05 units for amounts < 1.0 unit
Accuracy test results: The following graph shows the flow accuracy of the Pod
against given time periods. The measurements were made using a Pod with a
basal rate of 0.5 μl/h (which delivers 0.05 U/h of U-100 insulin) at a high operating
temperature. The overall mean percentage flow error was 1.40%.
EpMax
EpMin
Observation Interval (min)
178
Effective Date: 18OCT2020, PCO-000235