What the System has not been evaluated for: The System has not been evaluated for use with other implanted medical devices such as pacemakers.
The System has not been evaluated for use in persons on dialysis or people less than 2 years of age.
When is Sensor Glucose different from Blood Glucose: Glucose levels in the interstitial fluid can be different from blood glucose levels and may mean that Sensor glucose readings are different from blood glucose. The patient may notice this difference during times when the blood glucose is changing quickly, for example after eating, taking insulin, or exercising.
When to remove the Sensor: On rare occasions, the patient may get inaccurate Sensor glucose readings. If the patient believes the glucose readings are not correct or do not match how the patient feels, perform a blood glucose test on the finger to confirm the glucose. If the problem continues, remove the Sensor and apply a new one.
Some individuals may be sensitive to the adhesive that keeps the Sensor attached to the skin. If the patient notices significant skin irritation around or under the Sensor, remove the Sensor and stop using the System. Contact a health care professional before continuing to use the System.
If the patient has a medical appointment that includes strong magnetic or electromagnetic radiation, for example an X-ray, MRI (Magnetic Resonance Imaging), or CT (Computed Tomography) scan, remove the Sensor the patient is wearing and apply a new one after the appointment. The effect of these types of procedures on the performance of the system has not been evaluated.
What to know about wearing the Sensor: 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.
What to know about Glucose Alarms: For the patient to receive alarms, they must be turned ON and the patient should ensure that the Reader is within 6 meters (20 ft) of the patient at all times. The transmission range is 6 meters (20 ft) unobstructed. If the patient is out of range, patient may not receive glucose alarms.
To prevent missed alarms, make sure the Reader has sufficient charge and that sound and/or vibration are turned on.
What to know about the Reader's Built-in Meter: The Reader is designed to be used only with FreeStyle Optium blood glucose and blood ketone test strips and MediSense control solution.
The Reader is for use by a single person. It must not be used on more than one person including other family members due to the risk of spreading infection. All parts of the Reader are considered biohazardous and can potentially transmit infectious diseases, even after cleaning the Reader.
Avoid getting dust, dirt, blood, control solution, water or other substances in the Reader's USB and test strip ports.
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