Tandem t:slim X2, User Manual

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Customer Technical Support:
(877) 801-6901 28
Chapter 2 – Important Safety Information
2.6 Possible Risks From
Using the Pump
As with any medical device, there are
risks associated with using the t:slim
X2 Pump. Many of the risks are com-
mon to insulin therapy in general, but
there are additional risks associated
with continuous insulin infusion. Read-
ing your User Guide and following the
Instructions for Use are critical for the
safe operation of your pump. Consult
your health care provider about how
these risks may impact you.
Inserting and wearing an infusion set
might cause infection, bleeding, pain
or skin irritations (redness, swelling,
bruising, itching, scarring or skin discol-
oration).
There is a remote chance that an infu-
sion set cannula fragment could remain
under your skin if the cannula breaks
while you are wearing it. If you think a
cannula has broken under your skin,
contact your healthcare provider and
call Tandem Diabetes Care Customer
Technical Support at (877) 801-6901.
Other risks associated with infusion
sets include occlusions and air bubbles
in the tubing, which can affect insulin
delivery.
Risks that could result from pump
failure include the following:
•
possible hypoglycemia (low blood
glucose) from over-delivery of
insulin due to a hardware defect
•
hyperglycemia (high blood glucose)
and ketosis possibly leading to
Diabetic Ketoacidosis (DKA) due to
pump failure resulting in cessation
of insulin delivery due to either
a hardware defect or software
anomaly.
2.7 Working with your
Healthcare Provider
Any clinical language presented in this
User Guide is based on the assumption
that you have been educated by your
healthcare provider on certain terms
and how they apply to you in your
diabetes management. Your healthcare
provider can help you establish diabe-
tes management guidelines that best fit
your lifestyle and needs.
Monitor your blood glucose (BG) with
the guidance of your healthcare provid-
er. According to the American Associa-
tion of Diabetes Educators’ white paper
Insulin Pump Therapy: Guidelines for
Successful Outcomes
, patients should
routinely check their BG levels at least
4 times daily (optimally 6 to 8 times
daily) in order to detect hyperglycemia
(high blood glucose) and hypoglycemia
(low blood glucose) early. Undetected
hyperglycemia or hypoglycemia can
result without proper monitoring.
Consult your healthcare provider before
using the pump to determine which
features are most appropriate for you.
Only your healthcare provider can de-