Simplera™ Sensor User Guide M013391C003_2
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.
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.
is broken, 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 change or modify the Simplera™ sensor. Changing or modifying the sensor can result in improper insertion, pain, or injury. Do not let children hold the Simplera™ sensor without adult supervision. Do not let children put any part of the sensor in their mouth.
radio frequency energy and, if not installed and used in accordance with the provided instructions, may cause harmful interference to radio communications. • Portable and mobile RF communications equipment can affect medical electrical equipment. If you encounter RF interference from a mobile or stationary RF transmitter, move away from the RF transmitter that is causing the interference.
Reagents The Simplera™ sensor contains two biological reagents: glucose oxidase, and human serum albumin (HSA). Glucose oxidase is derived from Aspergillus niger and manufactured to meet industry requirements for extraction and purification of enzymes for use in diagnostic, immunodiagnostic, and biotechnical applications. The HSA used in the Simplera™ sensor consists of purified and dried albumin fraction V, derived from pasteurized human serum which is cross‑linked via glutaraldehyde.
Ages 2-17 years Back of upper arm Upper buttock Insertion on abdomen for ages 2‑17 years has not been evaluated for accuracy. Note: Insertion into the upper buttocks should target the top‑third of the buttocks area. Assistance from another person may be needed for sensor insertion into the back of the upper arm or the upper buttock. If assistance is not needed, a mirror may be helpful for self‑insertion.
Inserting the Simplera™ sensor The inserter label is on the top of the inserter. 1. Before insertion, perform the following steps: 1 YYYY MM DD XXXX XXX XXX CODE: XXXXXX a. Inspect the expiration date. Do not use an expired Simplera™ sensor. b. Make note of the serial number (SN) and the CODE. Both numbers will be used later to pair the sensor with the Simplera™ app. Note: The SN and CODE label is also on the inside of the Simplera™ sensor box lid. 2 3 2.
5 5. Choose an insertion site that has a sufficient amount of fat. For insertion sites see Where to insert the Simplera™ sensor, page 5. For the best sensor performance, and to avoid accidental sensor removal, do not insert the Simplera™ sensor into the following areas: • muscle, tough skin, or scar tissue • areas that are constrained by clothing or accessories • areas subjected to rigorous movement during exercise 6 6. Clean the insertion site with alcohol. Allow the insertion site to air dry. 7 7.
8 9 10 11 8. Place the inserter on top of the prepared insertion site. 9. Press the inserter firmly against the body until there is a click. 10. Gently pull the inserter straight out of the body. 11. Smooth down the sensor adhesive with a finger to ensure the sensor stays on the body for the entire duration of wear. Note: Use over-the-counter tape if needed for additional adhesion.
12. Pair the Simplera™ sensor with a compatible display device. Note: The SN and CODE are required to pair the sensor with a compatible display device. For details on how to pair the sensor with a compatible display device and the Simplera™ app, see the Simplera™ system user guide. Removing the Simplera™ sensor To remove the Simplera™ sensor: 1. Gently peel the sensor adhesive away from the body. 2. Dispose of the Simplera™ sensor in accordance with all local laws and regulations.
FCC notice The Simplera™ sensor complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Medtronic could void the user’s authority to operate the equipment.
Guidance and manufacturer’s Declaration-Electromagnetic Immunity Immunity Test IEC 60601-12:2014 Test Level IEC 60601-12:2014 Compliance Level Electromagnetic Environment Guidance Electrostatic discharge (ESD) ±8 kV contact ±2, ±4, ±8, ±15 kV air ±8 kV contact ±2, ±4, ±8, ±15 kV air For use in a typical domestic, commercial, or hospital environment. Conducted disturbances induced by RF fields 3 Vrms Not applicable Requirement does not apply to this battery powered device.
Guidance and manufacturer’s Declaration-Electromagnetic Immunity Immunity Test Voltage dips, short interruptions, and voltage variations on power supply lines IEC 60601-12:2014 Test Level IEC 60601-12:2014 Compliance Level 0% UT; 0.5 cycles (at 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°) Electromagnetic Environment Guidance Not applicable Requirement does not apply to this battery powered device.
Guidance and manufacturer’s Declaration-Electromagnetic Immunity Radiated RF 10 V/m 10 V/m 80 MHz to 2.7 GHz 80 MHz to 6 GHz 80% AM at 1 kHz 80% AM at 1 kHz Portable and mobile RF communications equipment should be used no closer to any part of the transmitter than the recommended separation distance of 30 cm (12 in). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Storage CAUTION: Do not freeze the Simplera™ sensor, or store it in direct sunlight, extreme temperatures, or high humidity. These conditions may damage the device. Room temperature storage range 36°F to 86°F (2°C to 30°C) Relative humidity (RH) storage range up to 95% relative humidity Simplera™ sensor life of use The Simplera™ sensor can be used one time and has a maximum life of 170 hours (seven days). The 170‑hour life span of the sensor begins within 30 minutes after insertion.
Assistance Department Telephone Number 24-Hour Technical Support (calls within the United States) +1 800 646 4633 24-Hour Technical Support (calls outside the United States) +1 818 576 5400 Website www.medtronicdiabetes.com For definitions of the symbols displayed in the Simplera™ sensor and package labels, see www.medtronicdiabetes.com/symbols-definitions. © 2021 Medtronic. Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners.
M013391C003_2 MMT-5100J FCC ID: OH2BLEGST1 M013391C003_2
