IV
V
The companion and/or pump’s screen are missing segments or some of the screen is blank. Discontinue use
➢
immediately. Use of the system may result in incorrectly displayed information and may cause you to mis-
use the companion or pump, resulting in possible adverse medical events or serious injury. Call Customer
Care and/or your healthcare professional.
The
•
Aviator Companion and Aviator Pump are intended only for continuous subcutaneous (under the skin)
infusion of insulin and should NOT be used for any other type of therapy.
Discontinue use of the pump and switch to an alternate insulin therapy method in the event that
•
one or both of
the pump’s speakers fail to sound as part of the change from idle mode to basal delivery mode, or following
the replacement of a battery.
It is very important that the time and date are correctly set. Your pump will be programmed to deliver specific
•
basal rates of insulin at specific times of the day. If you set the incorrect time, you may get incorrect insulin
amounts, resulting in high or low glucose, and possible adverse medical events including serious injury due to
delivery errors.
If your companion or pump is cracked or a button is torn, this may result in water getting into the internal parts
•
of the pump causing malfunction. Discontinue use and switch to an alternate insulin therapy method immedi-
ately AND contact your healthcare professional and/or Customer Care. ONLY Abbott Diabetes Care should take
care of a damaged companion or pump.
Using your pump and/or companion inappropriately will void the warranty.
•
If the pump’s status cannot be obtained using the companion, use the pump’s screen. If you still cannot obtain
•
the pump status, reposition the companion closer to the pump.
Do
•
NOT use the sterile supplies (reservoir, infusion set, insulin, etc.) after their expiration date. Do NOT reuse any
disposable supplies.
Be sure to follow your healthcare professional’s instructions for the specific settings described in
•
Section 6.1 Set
Additional Options.
Do
•
NOT attempt to sterilize your pump.
Do
•
NOT use the pump near flammable or explosive materials.
Parts of the pump and infusion sets may be a choking hazard. Keep the pump and all accessories out of the
•
reach of small children.
Discontinue use of the companion’s radio link to the pump when on board a commercial aircraft (
•
Section 6.9).
The trainer Mode feature on your pump should only be used for training and should never be used when deliv-
•
ering actual therapy.
User notification of alarms may be delayed when using Trainer Mode on the pump because notification of Pump
•
alarms is held off whenever the Pump screen is on and displaying a screen other than the Home screen and the
Trainer Mode prevents the Pump screen from timing out.
Although the pump is water resistant, avoid getting it wet because it is
•
not waterproof. The pump should not be
submerged under water or other fluids as this may damage the battery or internal components.
If your pump has been dropped, the water resistance capability of your pump may be compromised. If you sus-
•
pect that your pump is damaged, contact your healthcare professional and/or Customer Care.
Insulin Delivery and Calculations
If you receive an occlusion alarm, you
•
MUST disconnect from the pump using the quick disconnect feature of
the Infusion Set before investigating the cause of the occlusion. Bolus delivery may occur when the cause of the
occlusion is removed. When an occlusion alarm sounds, it is recommended to change the infusion set, tubing,
and reservoir.
Rapid or short-acting U-100 Insulin is the only substance that should be delivered via your pump. Do
•
NOT infuse
blood, cellular blood products or other medications. Use of any other product may result in adverse medical
events or serious injury.
Ask your healthcare professional which type of insulin you will be using and what action time should be set. If
•
you do NOT set these values correctly, you may receive the wrong amount of insulin, which may result in ad-
verse medical events like extreme hyperglycemia and DKA.
Insulin that has been degraded by environmental conditions (extreme heat over 104ºF (40º C), extreme cold
•
below 30ºF (-1º C), has clots, etc.) may cause adverse medical events or serious injury. Discard any insulin that
has been exposed to extreme temperatures.
Accurate determination and programming of the insulin to blood glucose ratios (insulin sensitivity) are neces-
•
sary to avoid possible delivery errors that may result in adverse medical events or serious injury.
Accurate determination and programming of the insulin to carbohydrate ratios are necessary to avoid possible
•
delivery errors that may result in adverse medical events or serious injury.
Accurate calculation and programming of blood glucose targets and insulin sensitivity are necessary to avoid
•
possible delivery errors that may result in adverse medical events or serious injury.
The stability of insulin following six days of storage in a pump Reservoir has been verified. Storage of insulin in
•
the Reservoir beyond six days might result in adverse medical events (including serious injury).
Blood Glucose Testing
Test
•
ONLY on your fingers if you are testing for hypoglycemia (low blood glucose) or if you have hypoglycemia
unawareness.
Do
•
NOT insert any foreign materials in the test strip port.
FreeStyle Lite Test Strips
•
and lancets are small parts that may be dangerous if swallowed. Refer to package
insert for further information.
Peritoneal dialysis solutions containing icodextrin or compounds of Galactose ≥ 13 mg/dL (≥ 0.7 mmol/L), Malt-
•
ose ≥ 20 mg/dL (≥0.6 mmol/L) or Lactose ≥ 10 mg/dL (≥ 0.3 mmol/L) cause the integrated FreeStyle Lite Blood
Glucose Meter to overestimate blood glucose test results. If you are receiving such treatment, do NOT use the
blood glucose meter and discuss this issue with your healthcare professional to ensure proper treatment.
Blood glucose levels
•
MUST be tested when the pump’s operation is stopped. When the pump is stopped, and
Symbols and Important Safety Information
Symbols and Important Safety Information
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