Guardian™ Sensor 3.
Manage your glucose levels with a smarter CGM (Continuous Glucose Monitoring) system, powered by Guardian™ Sensor 3. Always read the Instructions for Use.
BENEFITS OF CGM POWERED BY
Guardian™ Sensor 3.
Medtronic is the only company that offers standalone CGM and sensor-integrated pump therapy, which streamlines the process for optimal customer experience. Other CGM companies do not offer an integrated system, requiring an insulin pump from a different company.
Guardian™ Sensor 3, our most advanced sensor, provides an option that fits every lifestyle. For ages 2 and up.
SMART AND RELIABLE
Diagnostic chip that automatically monitors sensor health every 5 minutes to improve sensor performance and reduce variability.
ACCURATE
Our most accurate sensor to date.
COMFORTABLE AND SMALL
80% volume reduction compared to EnliteTM sensor. Updated sensor adhesive patch to enhance application and reduce irritation.
CONVENIENT
Up to seven days of sensor life and a shorter start-up time.
Why Guardian™ Sensor 3?
SmartGuard® TECHNOLOGY
Integrated with our latest advancement in insulin pump therapy, the Guardian™ Sensor 3 enables different levels of automation that fit your lifestyle.
| The MiniMed® 670G System | The MiniMed® 640G System |
|---|---|
| Self adjusting insulin delivery* and predictive low glucose suspend | Predictive low glucose management |
| Available age 7 and up | Available age 2 and up |
Medtronic’s (real-time) continuous glucose monitoring (CGM) products are indicated for use by people living with type one diabetes. Guardian™ Sensor 3 may be used as part of the Guardian™ Connect and MiniMed® 640G systems for ages 2 and up. Sensor is indicated for use on arm and abdomen. Guardian™ Sensor 3 may also be used as part of the MiniMed® 670G system for people living with type 1 diabetes age 7 and up. Sensor is indicated for use on abdomen only.
EXCLUSIVE CareLink™ SOFTWARE
A web-based program that collects information directly from your Medtronic diabetes management system. It allows you to generate reports that can be used during your doctor’s visits and to monitor your own progress.
MORE TIME TO BE
Sage^ is a professional athlete who is striving to represent the USA at the 2020 Olympics. Sage is constantly traveling around the world competing in two specific water sports: kayaking and canoeing.†† With Sage’s hectic work, travel, and competition schedule, it is critical that she uses a continuous glucose monitor that helps her stay in range. Sage transitioned to the Guardian™ Sensor 3 earlier this year and has been amazed by the experience and results.
Sage D.
Former Dexcom user and current Guardian™ Sensor 3 user
The intelligent diagnostics of the transmitter are continuously and proactively monitoring the health of the sensor. Guardian™ Sensor 3 can be worn for up to 7 days, however if your sensor is not performing well, you may receive a Change Sensor alert. Each monthly box of sensors includes 30 days of sensor wear to ensure you are only provided with safe, reliable and accurate sensor glucose values.
Guardian™ Sensor 3 can be worn on the abdomen‡.
Choose an insertion site that has an adequate amount of subcutaneous fat.
Guardian™ Sensor 3 is compatible with MiniMed® 670G insulin pump and the MiniMed® 640G insulin pump
Extra tape can be purchased on our online store.
If you are experiencing a problem with your Guardian™ Sensor 3, please contact the 24-hour helpline at 1800 777 808.
Guardian™ Sensor 3 is the newest sensor from Medtronic. It is the only sensor on the market that is approved to power a hybrid closed loop system. It is more accurate1 and comfortable** than previous sensors.
* Refers to Auto Mode. Some user interaction required. Individual results may vary.
†† At the time of manufacture and when the reservoir and tubing are properly inserted, the pump is waterproof. It is protected against the effects of being underwater to a depth of up to 12 feet (3.6 meters) for up to 24 hours.
Indications
The sensor is a component of Medtronic Continuous Glucose Monitoring Systems and is indicated for continuously monitoring glucose levels in persons with type 1 diabetes. The sensor is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices.
The sensor is indicated for:
Ages 2 or older when used as part of a system with Guardian Connect
Ages 2 or older when used as a part of a system with the MiniMed 640G insulin pump
Ages 7 or older when used as part of a system with the MiniMed 670G insulin pump
The indication for children under the age of 18 is limited to those who are supervised by a caregiver. The caregiver must be at least 18 years of age.
Warnings
Important Safety Information: Guardian® Sensor 3
The Guardian™ Sensor (3) is only intended to be used by patients (aged 2 years and older) with type 1 diabetes.
Health care professionals and consumers should be aware about the limitations of available scientific evidence for use of this device in any other groups of patients who require diabetes management.
Nevertheless it would not be unreasonable to allow the clinical data derived from type 1 diabetes to be adduced to other forms of diabetes which are truly insulin dependent or deficient, including severe insulin deficient secondary diabetes, and some with cystic fibrosis related diabetes, where the achievement of adequate glycaemic control may benefit from continuous glucose monitoring or continuous subcutaneous insulin infusion.
During times of rapidly changing glucose (more than 0.1 mmol/L (2 mg/dL) per minute), interstitial fluid glucose levels as measured by the Guardian™ Sensor (3) may not accurately reflect blood
glucose levels. Under these circumstances, check the Sensor glucose readings by conducting a fingerstick test using a blood glucose meter.
In order to confirm hypoglycaemia or impending hypoglycaemia as reported by the Guardian™ Sensor (3), conduct a fingerstick test using a blood glucose meter.
Do not ignore symptoms that may be due to low or high blood glucose. If you have symptoms that do not match the Guardian™ Sensor (3) reading or suspect that your reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter. If you are
experiencing symptoms that are not consistent with your glucose readings, consult your health care professional.
Read this entire user guide before attempting to insert the sensor. The one-press serter (MMT-7512) does not work the same as other Medtronic insertion devices. Failure to follow directions or using a different serter may result in improper insertion, pain, or injury.
The sensor is designed to work with approved transmitters only. It prevents connection with transmitters and recorders that are not compatible with the sensor. Connecting your sensor to a transmitter or recorder that is not approved for use with the sensor may cause damage to the components. Refer to your system user guide for a list of compatible products.
Do not make therapy decisions based on sensor glucose values because sensor glucose and blood glucose (BG) values may differ. If your sensor glucose is low or high, or if you feel symptoms of low or high blood glucose, do the following prior to making therapy decisions. Confirm your blood glucose with your meter using a fingerstick blood sample.
Taking medications with acetaminophen or paracetamol, including, but not limited to Panadol™*, fever reducers, or cold medicine, while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen or paracetamol active in your body and may be different for each person. Always use BG meter readings to verify your glucose level before making therapy decisions, including when you could have acetaminophen or paracetamol active in your body. Always check the label of any medications to confirm whether acetaminophen or paracetamol is an active ingredient.
Do not expose your sensor to MRI equipment, diathermy devices, or other devices that generate strong magnetic fields as the performance of the sensor has not been evaluated under those conditions and may be unsafe. If your sensor is inadvertently exposed to a strong magnetic field, discontinue use and contact your local representative for further assistance.