User`s guide

II
III
Symbols and Important Safety Information
Do not use near MRI
Lot number
Read instructions for use Sterilized by Ethylene Oxide
For sale by prescription only Storage Temperature Range
Type BF Medical Equipment (patient
isolated, not debrillator protected)
CE Mark
IPX8
Water-Tight Equipment (protected
against the eects of submersion;
tested to 12 feet (3.6 meters) for 24
hours)
Manufacturer
Serial Number
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.
Expiration date Do not use if package is damaged
Do not re-use Consult instructions for use
Reorder number
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 • Aviator Companion and Aviator Pump. You should
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.
The
• Aviator Companion and Aviator Pump are NOT intended to be used by a person who is hearing-impaired
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.•
Do • NOT expose your companion or pump to MRI, X-ray, CAT scan, or ultrasound equipment. A LWAYS discon-
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 Symbols and Important Safety Information
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