OmniPod 5 - Automated Mode Important Safety Information

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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 2 years old. SmartAdjust
technology should also NOT be used
in people who require less than 5 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 or 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 sensor glucose 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 hypoglycaemia or
hyperglycaemia can still occur.
If your sensor glucose values do not
match your symptoms, ALWAYS
check your blood glucose using a BG
meter, and consider treatment and/
or Sensor calibration if necessary.
ALWAYS switch to Manual Mode if
you feel you are receiving inaccurate
sensor glucose values.
• Erroneously high sensor glucose
values can cause excessive
insulin delivery, leading to severe
hypoglycaemia, seizure, loss of
consciousness or death.
• Erroneously low sensor glucose
values can cause prolonged
insulin suspension, leading to
hyperglycaemia, 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
hypoglycaemia. 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 hypoglycaemia while
the Activity feature is enabled.
Hypoglycaemia can still occur when
using the Activity feature. Follow
your healthcare provider’s advice
on hypoglycaemia avoidance and