User's Guide

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inaccurate or missed alerts, and substantially higher sensor glucose readings in reports than
actual blood glucose readings.
Always check the label of any medication being taken to confirm if hydroxyurea or
hydroxycarbamide is an active ingredient. If hydroxyurea is taken, consult a healthcare
professional. Use additional blood glucose meter readings to verify glucose levels.
Always consult a healthcare professional before using sensor glucose values to make
treatment decisions if a medication that contains acetaminophen or paracetamol is taken
while wearing the sensor. Medications that contain acetaminophen or paracetamol can
falsely raise sensor glucose readings. The level of inaccuracy depends on the amount of
acetaminophen active in the body and can differ for each person. Falsely elevated sensor
readings can result in over‑administration of insulin, which can cause hypoglycemia.
Medications that contain acetaminophen or paracetamol include, but are not limited to,
cold medicines and fever reducers. Check the label of any medications being taken to see if
acetaminophen or paracetamol is an active ingredient. Use additional blood glucose meter
readings to confirm blood glucose levels.
Always examine the Simplera™ sensor box for damage. If the sensor box is open or
damaged, examine the sensor for damage. If the sensor is visibly damaged, discard the
device to avoid possible contamination.
Do not use the Simplera™ sensor if any part of the device is damaged. If the device is
damaged, discard the device to avoid possible contamination.
Do not use the Simplera™ sensor if the tamper band is broken, damaged, or missing from
the device. The sensor is sterile and non‑pyrogenic unless the device is damaged. If the
tamper band is broken, damaged, or missing from the device, the sensor and the needle can
be exposed to contamination. A sensor and needle exposed to contamination can cause site
infection if inserted into the body.
Do not use the Simplera™ sensor if the cap label is broken, damaged, or missing from the
device. The sensor is sterile and non‑pyrogenic unless the device is damaged. If the cap label
is broken, damaged, or missing from the device, the sensor and the needle can be exposed
to contamination. A sensor and needle exposed to contamination can cause site infection if
inserted into the body.
Do not unscrew or remove the Simplera™ sensor cap until the device is ready to be used. Do
not remove the cap and place it back on the device. Do not remove the cap and store the
device for future use. The sensor is sterile and non‑pyrogenic unless the cap is removed from
the device or the tamper band is broken. If the cap is not on the device or the tamper band