OmniPod 5 - Sensor Important Safety Information

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Sensor Important Safety
Information
Sensor Warnings
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 may 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: ALWAYS make sure
you are using the Sensor as per the
manufacturer's instructions. Do not
extend the Sensor wear beyond the
recommended duration and do not
start a Sensor past its Use-By date.
e Omnipod 5 System relies on
accurate, current sensor glucose values
to determine your insulin needs.
Incorrect use of the Sensor could
result in over-delivery or under-
delivery of insulin, which can lead to
hypoglycaemia or hyperglycaemia.
Warning: ALWAYS conrm that the
Dexcom G6 Transmitter serial number
(SN) 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,
mismatching Transmitter serial
numbers (SN) could result in over-
delivery or under-delivery of insulin,
which can lead to hypoglycaemia and
hyperglycaemia.
Warning: Device components
including the Pod, Sensor and
Transmitter may be aected by strong
radiation or magnetic elds. Device
components must be removed (and
the Pod and Sensor should be disposed
of) before X-ray, Magnetic Resonance
Imaging (MRI) or a Computed
Tomography (CT) scan (or any similar
test or procedure). In addition, the
Controller should be placed outside
of the procedure room. Exposure