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calculating an insulin dose or carbohydrate intake
based on user entered data.
For an insulin dose based on amount of carbohydrates,
a healthcare professional must provide patient-
specific target blood glucose, insulin-to-carbohydrate
ratio, and insulin sensitivity parameters to be
programmed into the software prior to use.
For an insulin dose based on fixed/variable meal
sizes, a healthcare professional must provide patient-
specific fixed doses/meal sizes to be programmed into
the software prior to use.
3. Contraindications:
The InPen™ system is not intended for anyone unable
or unwilling to:
•
Test blood glucose (BG) levels as
recommended by a healthcare provider
•
Maintain sufficient diabetes self-care skills
•
Visit a healthcare provider regularly
Caution: US law restricts the sale of the InPen™
System to sale by or on the order of a physician.
Important Pediatric User Information:
The following recommendations are meant to
help younger patients and their caregivers manage
and care for the InPen™ system. Younger children may
inadvertently play with the pen injector or the app,
leading to unintentional logging or delivery of insulin. It
is the responsibility of the healthcare provider and the
caregiver to determine if the patient is appropriate for
treatment with the InPen™ system.
Do not allow small children to chew on or ingest parts,
such as the pen cap and cartridge components.
Small parts could pose a choking hazard. If ingested
or swallowed, these component pieces may cause
internal injury or infection.
For patients who do not self-manage their disease, the
smart device should always be under the supervision
of a caregiver. Inadvertent button presses may lead
to unintentional dose logging or changes to therapy
settings. These changes can potentially lead to
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