OmniPod DASH Guide De L'utilisateur page 41

Cannula insertion depth: 4-7 mm (0.16-0.28")
Depth of insulin infusion: ≥ 4 mm (0.16")
Waterproof rating: IP28 (7.6 m (25 ft) for up to 60 minutes)
Insulin concentration: U-100
Alarm type: Audible. Output: ≥ 45 db(A) at 1 m
Operating relative humidity range: 20 to 85%, non-condensing
Storage relative humidity range: 20 to 85%, non-condensing
Operating atmospheric pressure: 700 hPA to 1,060 hPA
Storage atmospheric pressure: 700 hPA to 1,060 hPA
Non-pyrogenic: Fluid pathway only
Type BF applied part: Protection from electrical shock
Maximum infusion pressure: 35 psi
Maximum volume infused under single-fault conditions: 0.5 U
Flow Capability:
Prime rate: 0.05 units per second
Basal: Programmable by the user in 0.05 U increments 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
Note: The user should consider bolus dose accuracy when setting a bolus dose.
When using the lowest bolus dose allowable (0.05 units), the actual bolus delivered
may be as low as 0.00 units or
as high as 0.10 units.
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)
XXXXX
Appendix
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41