Tandem T:Slim, User Manual

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Chapter 19 – Technical Specifications
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Specification Type Specification Details
Statement of Meaning of the Claimed
Ingress Protection (IP) Classification
IPX7: watertight to a depth of 3 feet for up to 30 minutes
Internal System Battery Life 4 years minimum under normal use conditions
Typical Operating Time when System
is Operating at Intermediate Rate During normal use, the intermediate rate is 2 units/hr; battery charge can be reasonably expected to last up to
7 days from a fully charged state to a totally discharged state
Handling of Over-Infusion or
Under-Infusion
The method of delivery isolates the insulin chamber from the patient and the software performs frequent
monitoring of system status. Multiple software monitors provide redundant protection against unsafe
conditions.
Over-infusion is mitigated by continuous self-tests, layering of redundancies and confirmations, and numerous
other safeguard alarms. Users are required to review and confirm the details of all bolus deliveries, basal rates,
and temp rates to ensure certainty before initiating a delivery. In addition, once bolus deliveries are confirmed,
the user is given 5 seconds to cancel the delivery before it is started. An optional Auto-Off alarm triggers when
the user has not interacted with the pump’s user interface for a pre-defined period of time.
Under-infusion is mitigated by occlusion detection and blood glucose monitoring as blood glucose entries are
recorded. Users are prompted to treat high blood glucose conditions with a correction bolus.
Bolus Volume at Release of Occlusion
0.4–0.6 units at 2 units per hour with Unomedical Comfort ™ (110cm) infusion set.
Alarm Signal Sound Pressure Range Minimum sound pressure level of 45 dBA at 1 meter