User's Guide
1
Introduction
The Simplera™ sensor (MMT‑5100J) with Bluetooth® wireless technology is a component of
the Medtronic personal continuous glucose monitoring (CGM) system.
The Simplera™ sensor converts small amounts of glucose from the interstitial fluid under the
skin into an electronic signal. The sensor uses that signal to provide sensor glucose values to
the Simplera™ app.
Indications for use
The Simplera™ sensor is intended to communicate with the Simplera™ app to provide
glucose information for diabetes management. The sensor is designed to replace fingerstick
blood glucose (BG) readings for diabetes treatment decisions.
The Simplera™ sensor is part of a personal continuous glucose monitoring (CGM) system. It is
intended for single‑patient, single‑use only.
All components of the Simplera™ sensor are disposable. The sensor is pre‑loaded into the
disposable inserter.
The Simplera™ sensor is indicated for use by persons ages 2years and older.
Contraindications
No contraindications are associated with Simplera™ sensor use. For contraindications related
to CGM, see the Simplera™ system user guide.
User Safety
Warnings and precautions
Read this entire user guide before attempting to insert the Simplera™ sensor. The inserter
portion of the sensor does not work the same way as other Medtronic insertion devices. The
sensor is not inserted the same way as other Medtronic sensors. Failure to follow directions
may result in improper insertion, pain, or injury.
Do not use the Simplera™ sensor adjacent to other electrical equipment that may cause
interference with normal system operation. For more information on electrical equipment
that may cause interference with normal system operation, see Exposure to magnetic fields
and radiation, page3.
Do not use continuous glucose monitoring if hydroxyurea, also known as hydroxycarbamide,
is taken. Hydroxyurea is used to treat certain diseases, such as cancer and sickle cell anemia.
Hydroxyurea use results in higher sensor glucose readings compared to blood glucose
readings. Taking hydroxyurea while using continuous glucose monitoring can result in