Users Manual Part 6

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Automated Mode Important Safety
Information
Automated Mode
Warnings
Warning: SmartAdjust technology
should NOT be used by anyone under
the age of 6 years old. SmartAdjust
technology should also NOT be used
in people who require less than 6 units
of insulin per day as the safety of the
technology has not been evaluated in
this population.
Warning: DO NOT use SmartAdjust
technology in pregnant women,
critically ill patients, and those on
dialysis. e safety of SmartAdjust
technology has not been evaluated in
these populations. Consult with your
healthcare provider if any of these
conditions apply to you before using
SmartAdjust technology.
Warning: ALWAYS be aware of
your current CGM value, trust how
your body feels, and do not ignore
symptoms of high and low glucose.
Even though insulin delivery adjusts
automatically in Automated Mode
with the goal of bringing your glucose
level to your dened Target Glucose,
severe hypoglycemia or hyperglycemia
can still occur.
If your CGM values do not match your
symptoms, ALWAYS check your blood
glucose using a BG meter, consider
treatment and/or CGM sensor
calibration if necessary. ALWAYS
switch to Manual Mode if you feel you
are receiving inaccurate CGM values.
• Erroneously high CGM values can
cause excessive insulin delivery,
leading to severe hypoglycemia,
seizure, loss of consciousness or
death.
• Erroneously low CGM
values can cause prolonged
insulin suspension leading to
hyperglycemia, DKA, or death.
If you are having symptoms that are
not consistent with your blood glucose
readings and you have followed all
instructions described in this User
Guide, contact your healthcare
provider.
Warning: AVOID administering
insulin, such as by injection or
inhalation, while wearing an active Pod
as this could result in hypoglycemia.
e Omnipod 5 System cannot track
insulin that is administered outside of
the system. Consult your healthcare
provider about how long to wait aer
manually administering insulin before
you start Automated Mode.
Warning: ALWAYS monitor for
symptoms of hypoglycemia while
the Activity feature is enabled.
Hypoglycemia can still occur when
using the Activity feature. Follow
your healthcare provider’s advice
on hypoglycemia avoidance and
treatment. If untreated, hypoglycemia
Automated Mode Important Safety
Information