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Indications for use
The Enlite glucose sensor (sensor) is intended for use with
Medtronic Diabetes (Medtronic) glucose sensing systems to
continuously monitor glucose levels in persons with diabetes.
Refer to the Enlite Serter User Guide for instructions on inserting
the sensor. The sensor has a maximum life of 144 hours (six days).
The 144-hour life span of the sensor begins when the insulin pump
or monitor receives the first METER BG NOW alert.
Contraindications
None known.
Warnings
The Enlite Serter (Serter) does not work the same as other
Medtronic insertion devices. The Serter injects the sensor into
the insertion site when the button is released, not when the
button is pressed. Be sure to read the entire Enlite Serter User
Guide before attempting to insert the sensor. Failure to follow
directions may result in pain or injury.
The sensor may create special needs regarding your medical
conditions or medications. Bleeding, swelling, irritation or infection
at the insertion site are possible risks associated with inserting the
sensor and sometimes result from improper insertion and
maintenance of insertion site. Discuss these conditions and
medications with your doctor before using the sensor.
Remove the sensor if you experience unexplained fevers, or
develop inflammation, redness, soreness or tenderness at the
insertion site. Check the insertion site often for these conditions
and to ensure that the sensor is still in place. Consult your
healthcare professional if these conditions persist.
This device contains an automatically retracting needle which may
cause minimal blood splatter when the needle is removed from the
sensor. When removing the needle from someone other than
yourself, do so at arms length and pointed away from self and
others. Keep device within sight at all times to avoid accidental
needle stick injury.
Sensors are sterile and nonpyrogenic, unless the package has
been opened or damaged. Always inspect the packaging for
damage prior to use. Do not use any of the sensors if the sterile
package has been opened or damaged.
Watch for bleeding at the insertion site. If bleeding occurs, do
not attach the transmitter or recorder to the sensor. Apply steady
pressure using a sterile gauze or clean cloth for up to 3 minutes.
If bleeding stops, attach the transmitter or recorder to the sensor.
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