Users Manual Part 6

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CGM Important Safety Information
CGM Warnings
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
may 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: ALWAYS make sure you
are using the CGM per manufacturer's
instructions. Do not extend the sensor
wear beyond the recommended
duration and do not wear a sensor that
is past the labeled expiration date. e
Omnipod 5 System relies on accurate,
current CGM values to determine
your insulin needs. Incorrect use
of the CGM could result in over-
delivery or under-delivery of insulin,
which can lead to hypoglycemia or
hyperglycemia.
Warning: ALWAYS conrm the
Dexcom G6 Transmitter serial number
you save in the Omnipod 5 App
matches the one you are wearing. In
cases where more than one person
in the household uses the Dexcom
G6 CGM, mis-matching transmitter
serial numbers could result in over-
delivery or under-delivery of insulin,
which can lead to hypoglycemia and
hyperglycemia.
Warning: Device components
including the Pod, CGM transmitter,
and CGM sensor may be aected by
strong radiation or magnetic elds.
Device components must be removed
(and the Pod and CGM sensor
should be disposed of) before X-ray,
Magnetic Resonance Imaging (MRI),
or Computed Tomography (CT) scan
(or any similar test or procedure).
In addition, the Controller and
smartphone should be placed outside