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The Bigfoot Unity
™
Diabetes Management System User Guide | Chapter 3
3.4 Who Should Not Use Bigfoot Unity
CAUTIONS and LIMITATIONS
• Do NOT use in people less than 12 years of age. Bigfoot Unity is
not cleared for use in people under 12 years of age.
• Do NOT use if you are pregnant, on dialysis or critically ill. Bigfoot
Unity is not cleared for use in these groups and it is not known how
different conditions or medications common to these populations
may affect performance.
• Performance of Bigfoot Unity when used with other implanted
medical devices, such as pacemakers, has not been evaluated.
• Bigfoot Unity does not support insulin doses in half-unit increments.
You should not use Bigfoot Unity if you take half-unit doses of insulin.
• Bigfoot Unity supports once daily dosing of long-acting insulin. You
should not use Bigfoot Unity if you take more than one daily dose of
long-acting insulin.
3.5 Bigfoot Unity Components
WARNINGS
• Use your blood glucose meter to make diabetes treatment
decisions when you see “Use Meter” on the White Cap during the
first 12 hours of wearing a Sensor, if your Sensor glucose reading
does not match how you feel, or if the reading does not include a
number.
• Choking Hazard: Bigfoot Unity contains small parts that may be
dangerous if swallowed.
CAUTIONS and LIMITATIONS
• Make sure Bigfoot Unity is kept in a safe place under your control. This
is important to help prevent anyone from accessing or tampering with
your Bigfoot Unity components and supplies.
• Bigfoot Unity must not be used by more than one person due to the risk
of providing incorrect glucose and insulin information.
• Do NOT use if the Caps appear damaged due to risk of electric
shock and/or no results.
• Make sure to select a location for charging the Caps that allows the
power adapter to be easily unplugged. Do NOT block access to the
charger due to the potential risk of electrical shock.
• Use USB charging cable only as directed, and store safely. Misuse
of the USB charging cable can be a strangulation risk.
