OmniPod 5 - Omnipod 5 Pump Important Safety Information

17
Omnipod 5 Pump Important Safety
Information
Pump Warnings
Omnipod 5 System Settings and
Training
Warning: DO NOT start to use your
system or change your settings without
adequate training and guidance from
your healthcare provider. Initiating
and adjusting settings incorrectly
can result in over-delivery or under-
delivery of insulin, which could lead
to hypoglycaemia or hyperglycaemia.
Settings that impact insulin delivery
mainly include: Pod Shutdown, basal
rate(s), Max Basal Rate, Max Bolus,
Correction Factor(s), Insulin to Carb
(IC) Ratio(s), Minimum Glucose for
Calculations, Target Glucose, Correct
Above and Duration of Insulin Action.
Insulin
Warning: ONLY use rapid-acting
U-100 NovoLog®/NovoRapid® (insulin
aspart), Humalog® (insulin lispro) and
Admelog® (insulin lispro) insulin in the
Omnipod 5 System as they have been
tested and found to be safe for use with
this system. NovoLog/NovoRapid,
Humalog and Admelog are compatible
with the Omnipod 5 System for use
up to 72 hours (3 days). Follow your
healthcare provider’s directions on how
oen to replace the Pod.
Warning: ALWAYS be prepared
to inject insulin with an alternative
method if insulin delivery from the
Pod is interrupted. You are at increased
risk for developing hyperglycaemia if
insulin delivery is interrupted because
the Pod only uses rapid-acting U-100
insulin. Failure to have an alternative
method of insulin delivery can lead
to very high glucose or diabetic
ketoacidosis (DKA). Ask your
healthcare provider for instructions on
handling interrupted insulin delivery.
Warning: NEVER use insulin that
is expired or cloudy in the Pod as it
may be damaged. Using damaged
or expired insulin could cause
hyperglycaemia and put your health
at risk.
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.
Omnipod 5 System
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