COMPANION InPen, Инструкция по эксплуатации

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System Description
The InPen™ system includes the InPen™ smart
insulin pen and the InPen™ App. The InPen™ system
automatically records dose size and timing of insulin
doses, provides reminders if insulin is not taken,
includes an insulin dose calculator with personalized
settings, tracks insulin on board, and has the ability to
integrate with other diabetes technologies, including a
continuous glucose monitor (CGM).
Key Features:
•
View simple, graphical visuals of your diabetes
therapy and active insulin.
•
Calculate insulin doses using current glucose
and carbohydrates or meal type and/or size.
•
Set reminders so you don’t forget to take
your insulin
•
Import glucose data automatically from
supported CGMs and BGMs
•
View and share integrated diabetes therapy
reports with your healthcare provider
Support:
•
Setup wizard within the app.
•
User Guide links within the app
•
Instructional videos within the app.
2. Indications for Use
The InPen™ is a home-use reusable pen injector for
single-patient use by people with diabetes under the
supervision of an adult caregiver, or by a patient age
7 and older for the self-injection of a desired dose of
insulin. The pen injector is compatible with Lilly
Humalog® U-100 3.0 mL cartridges, Novo Nordisk
Novolog® U-100 3.0 mL cartridges, and Novo Nordisk
Fiasp® U-100 3.0 mL cartridges and single-use
detachable and disposable pen needles (not
included). The pen injector allows the user to dial the
desired dose from 0.5 to 30 units in one-half (1/2) unit
increments.
The InPen™ dose calculator, a component of the InPen™
App, is indicated for the management of diabetes
by people with diabetes under the supervision of an
adult caregiver, or by a patient age 7 and older for