Indications For Use; General Warnings; General Precautions - Medtronic ENLITE Guia Del Usuario

MP6025427-2AF1 / A
Introduction
The Enlite insertion device (Serter) is used as an aid for the insertion of a Medtronic Diabetes glucose sensor.
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Potential risks related to Serter use
General risks with Serter use may include skin infection around the area where the Serter is used.

Indications for use

The Enlite Serter is indicated for use for a single patient as an aid to insert the Enlite glucose sensor (sensor).
Contraindications
Do not use the Enlite Serter on products other than the Enlite sensor. Medtronic cannot guarantee this
product's safety or efficacy if used on other products.

General warnings

Read this entire user guide before attempting to insert the sensor. The Enlite 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. Failure to follow directions may result in pain or injury.
Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood
glucose values may differ. If your sensor glucose reading is low or high, or if you feel symptoms of low or high
glucose, confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe low
or high glucose conditions.
Keep an arm's length between you and the patient when removing the needle. A retractable needle is attached
to the sensor and minimal blood splatter may occur.
Keep the needle housing within sight at all times to avoid accidental needle stick injury.
Always inspect the sensor packaging for damage prior to use. Sensors are sterile and nonpyrogenic, unless
the package has been opened or damaged. Do not use any of the sensors if the sterile package has been
opened or damaged. Use of an unsterile sensor can cause site infection.
Watch for bleeding at the insertion site (under, around, or on top of the sensor). Apply steady pressure using
sterile gauze or a clean cloth placed on top of the sensor for up to three minutes, if bleeding occurs. The use
of unsterile gauze can cause an infection.
Do not attach the transmitter to the sensor, if bleeding does not stop. Blood can get into the transmitter
connector, which may damage the device. Remove the sensor and continue to apply steady pressure until the
bleeding stops.
1. Remove the sensor and discard in a sharps container.
2. Check the site for redness, bleeding, irritation, pain, tenderness, or inflammation and treat accordingly.
3. Insert a new sensor in a different location.
Make sure the sensor is securely placed in the Serter to avoid pain or minor injury.
Keep the Serter away from children. This product contains small parts and may pose a choking hazard.
Refer to the Enlite Glucose Sensor User Guide for additional sensor related warnings.

General precautions

Wash your hands with soap and water before inserting the sensor to help prevent site infection.
Wear gloves when inserting the sensor into someone other than yourself to avoid contact with patient blood.
Do not insert the sensor through tape to ensure proper sensor function and insertion.
Only use alcohol to prepare the insertion site to ensure that residue is not left on the skin.
Rotate the sensor insertion site so that sites do not become overused.
Discard used sensors and needle housings in a sharps container after each use to avoid accidental needle
stick injury.
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