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Important Safety Information
What to know about Alarms/Alerts:
•
There are NO alarms or alerts unless you scan the Sensor.
What to know before using the System:
•
Review all product information before use.
•
Take standard precautions for transmission of blood borne pathogens to avoid contamination.
Who should not use the System:
•
Do not use the System in people less than 18 years of age. The System is not approved for use in people under 18 years of age and Sensor readings
in this population may be inaccurate. In general, continuous glucose monitoring systems are recognized to be less accurate in children than in adults.
•
Do not use the System in critically ill patients. The System is not approved for use in these patients. It is not known how different conditions or
medications common to the critically ill population may affect performance of the System. Sensor glucose readings may be inaccurate in
critically ill patients.
•
Do not use the System in pregnant women or persons on dialysis. The System is not approved for use in pregnant women or persons on dialysis
and has not been evaluated in these populations.
•
Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.
What should you know about wearing a Sensor:
•
After the start-up period, the Sensor can be worn for up to the wear duration specified in your Sensor Kit's product insert.
•
Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If you notice significant skin irritation around or under
your Sensor, remove the Sensor and stop using the System. Contact your health care professional before continuing to use the System.
•
Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor. Remove and replace your Sensor if it starts to loosen
and follow the instructions to select an appropriate application site.
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The System uses all available glucose data to give you readings so you should scan your Sensor at least once every 8 hours for the most accurate
performance. Scanning less frequently may result in decreased performance. If you are using both the App and Reader with the same Sensor,
be sure to scan frequently with both devices.
•
Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and infection.
Not suitable for re-sterilization. Further exposure to irradiation may cause inaccurate results.
•
If a Sensor breaks inside your body, call your health care professional.
How to Store the Sensor Kit:
•
Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings. While you don't need to keep
your Sensor Kit in a refrigerator, you can as long as the refrigerator is between 39°F and 77°F. Do not freeze.
•
Store the Sensor Kit between 10-90% non-condensing humidity.
When not to use the System:
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Do NOT use if the Sensor Kit package, Sensor Pack or Sensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.
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Do NOT use if Sensor Kit contents are past expiration date.
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Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.
Important Safety
Information
- Quick Links:
- Getting to Know Your System
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