Symbols And Important Safety Information - Abbott FreeStyle Aviator User Manual

Symbols and Important Safety Information

Symbols and Important Safety Information
Do not use near MRI
Read instructions for use
For sale by prescription only
Type BF Medical Equipment (patient
isolated, not defibrillator protected)
Water-Tight Equipment (protected
IPX8 against the effects of submersion;
tested to 12 feet (3.6 meters) for 24
hours)
Serial Number
Expiration date
Do not re-use
Reorder number
DOC15736_Rev-A-Man.indd 2-3
Lot number
Sterilized by Ethylene Oxide
Storage Temperature Range
CE Mark
Manufacturer
The European Battery Directive
requires separate collection of spent
batteries, aiming to facilitate recycling
and to protect the environment. The
batteries in this product should be
removed and disposed in accordance
with local regulations for separate col-
lection of spent batteries.
This product must not be disposed of
via general household waste collection.
Separate collection for electrical and
electronic equipment waste per Direc-
tive 2002/96/EC in the European Union
is required. Contact the manufacturer
for details.
Do not use if package is damaged
Consult instructions for use
II
Warnings, Cautions and Important Notes
•
Warnings – Possible hazards that, if NOT avoided, could result in serious injury or death.
•
Cautions – Hazard that can cause minor personal harm or damage your Aviator Companion and Aviator
Pump.
•
Important Notes – Important information you need to pay attention to. NOT hazard related.
1. Warnings
General
•
Read this entire User's Guide before you begin using your
start pump therapy only under the supervision of your healthcare professional. Incorrect usage or failure to fol-
low the instructions provided with the Freestyle Aviator Insulin Delivery and Glucose Monitoring System
may cause serious injury or death.
•
You should always be prepared to inject insulin in case your pump fails or you need to return it for service. If your
pump stops and you are NOT prepared to give yourself insulin injections, extreme hyperglycemia (high blood
glucose) and Diabetic Ketoacidosis (DKA) could develop within a few hours.
•
Before going to bed, make sure that the pump contains enough insulin to get you through the night. Failure to
do so could result in no insulin delivery and life threatening hyperglycemia.
• Aviator Companion and Aviator Pump are NOT intended to be used by a person who is hearing-impaired
The
or whose hearing makes it unlikely that the person will hear the companion and pump's sounds.
•
The Aviator Companion and Aviator Pump are NOT intended to be used by a person who is visually-impaired
or whose sight makes it unlikely that the person will see the companion and pump's screens.
•
Ensure that your healthcare professional has oriented you to the size and brightness of the screen.
•
The FreeStyle Aviator System must only be used with EN60950-1 rated PCs.
•
When using the USB features of the system, place the companion in its charger cradle and connect to the
cradle's USB port.
•
Use ONLY ADC supplied cables in order to avoid the risk of electrical shock.
•
The graphical output glucose range limitations are 20 to 500 mg/dL (1.1 to 27.8 mmol/L).
•
The accuracy of graphical output and statistics are dependent on the time being accurately set.
• NOT expose your companion or pump to MRI, X-ray, CAT scan, or ultrasound equipment. ALWAYS discon-
Do
nect your companion and pump and store it away from the machines. Do NOT bring the companion and/or
pump into the procedure room at any time.
•
You should have an alternate therapy plan for insulin delivery ready in the event that:
➢ An unexpected interruption in insulin delivery occurs.
➢ The companion and pump do NOT operate as described in the system's instructions and guide.
Symbols and Important Safety Information
Aviator Companion and Aviator Pump. You should
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2/9/09 11:29:31 AM