OmniPod UST400, User Manual

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Appendix Appendix
Storage relative humidity range
: 20 to 85%, non-condensing
Operating atmospheric pressure
: 696 hPA to 1060 hPA
Storage atmospheric pressure : 696 hPA to 1060 hPA
Non-pyrogenic
: Fluid pathway only
Type BF applied part
: Protection from electrical shock
Maximum infusion pressure
: 10 psi
Maximum volume infused under single fault conditions
: 0.0 U
Flow Capability
:
Basal: Programmable by the user in 0.05U increments up to 30.0 U per hour
Bolus: Rate: 1.5 U per minute. Dose range from 0.05 to 30.0 U
Delivery accuracy (tested per IEC 60601-2-24):
Basal: ± 5% at rates ≥ 0.05 U/hr
Bolus: ± 5% for all set values ≥ 0.05 U
One Pod was tested at each configuration.
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 0.05 U/h at high operating temperature. The overall mean percentage
flow error was 1.40%.