UNITED STATES OF AMERICA

Indications for Use

The Lingo Glucose System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze and display glucose values in people 18 years and older not on insulin. The Lingo Glucose System helps to detect euglycemic and dysglycemic glucose levels. The Lingo Glucose System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.  

The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional. 

Compatible Devices

For a list of compatible devices that can be used with the Lingo Biosensor, please go to: http://www.hellolingo.com.

Important Safety Information

Warnings

This System must NOT be used for diagnosis of disease including diabetes.  

Do not take medical action based on your data without health care professional (HCP) oversight. Medical action is defined as activities undertaken in consultation with or under the guidance of a licensed health care professional to screen, diagnose, treat, cure, mitigate, prevent or monitor a disease or other medical condition.  

Consult your HCP before making changes to your diet or exercise regime or if you have an eating disorder or a history of eating disorders.  

Don't use if you have problematic hypoglycemia. The Lingo Glucose System hasn't been designed for these populations. Consult with your health care provider to discuss which Abbott product is right for you.  

If you have a medical appointment that includes strong magnetic or electromagnetic radiation, for example an X-ray, MRI (Magnetic Resonance Imaging), diathermy, or CT (Computed Tomography) scan, remove the Lingo Biosensor you are wearing and apply a new one after the appointment.  

Cautions and Limitations

What to know about using the System:

Before using the System, review all product information and take standard precautions to avoid contamination through transmission of blood borne pathogens.  

Make sure that your devices and Lingo Biosensor Kits are kept in a safe place, and maintain your devices under your control during use. This is important to help prevent anyone from accessing or tampering with the System.  

Choking hazard: The System contains small parts that may be dangerous if swallowed.  

Who should not use the System:

You can only use the system if you are 18 years of age and older and not on insulin.  

Do not use the System if you are on dialysis or critically ill. It is not known how different conditions or medications common to these populations may affect performance of the System.  

Performance of the System when used with other implanted medical devices, such as pacemakers, has not been evaluated.  

What should you know about wearing a Lingo Biosensor:

The Lingo Biosensor can be worn for up to the wear duration specified within your Lingo Biosensor instructions. Remember to always have your next Lingo Biosensor available before your current one ends so you can keep getting your glucose readings.  

The System is designed to detect certain conditions which may occur where the Lingo Biosensor is not working as intended and shut it off, telling you to replace your Lingo Biosensor. This may occur if the Lingo Biosensor gets knocked off from the skin or if the System detects that the Lingo Biosensor may not be performing as intended. Contact Customer Service if you receive a Replace biosensor message before the end of the wear duration specified by your Lingo Biosensor instructions.  

Some individuals may be sensitive to the adhesive that keeps the Lingo Biosensor attached to the skin. If you notice significant skin irritation around or under your Lingo Biosensor, remove the biosensor and stop using the System. Consult your HCP before applying a new Lingo Biosensor.  

Your Lingo Biosensor may become loose if you bump it, play contact sports, or sweat a lot. If the Lingo Biosensor is becoming loose or if the Lingo Biosensor tip is coming out of your skin, you may get no readings or unreliable readings; the Lingo Biosensor may self-terminate in this instance. Remove and replace your Lingo Biosensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Lingo Biosensor. Contact Customer Service if your Lingo Biosensor becomes loose or falls off before the end of the wear period.  

Do not reuse Lingo Biosensors. The Lingo Biosensor and Lingo Biosensor Applicator are designed for single use. Reuse may result in no glucose readings and infection. Not suitable for re-sterilization.  

Your Lingo Biosensor is water-resistant and can be worn while bathing, showering, or swimming. Your Lingo Biosensor has been tested to withstand immersion into 3 feet (1 meter) of water for up to 30 minutes. It is also protected against insertion of objects > 12 mm diameter. (IP27)  

If a Lingo Biosensor breaks inside your body, call your HCP.  

How to Store the Biosensor Kit:

Store the Lingo Biosensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate biosensor glucose readings.  

If you suspect that the temperature may exceed 82°F (for example, in an unairconditioned home in summer), you should refrigerate your Lingo Biosensor Kit. Do not freeze your Lingo Biosensor Kit.  

Store your Lingo Biosensor Kit in a cool, dry place. Do not store your Lingo Biosensor Kit in a parked car on a hot day.  

Store the Lingo Biosensor Kit between 10-90% non-condensing humidity.  

When not to use the System:  

Do NOT use if the Lingo Biosensor Kit package, Lingo Biosensor Pack, or Lingo Biosensor Applicator appear to be damaged or already opened due to risk of no results and/or infection.  

Do NOT use if Lingo Biosensor Kit contents are past expiration date.  

The Lingo Biosensor Pack is sterile and non-pyrogenic unless opened or damaged. Using a non-sterile or pyrogenic Lingo Biosensor might cause infection. 

What to know about the System:

The System is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information.

What to know before you apply the Lingo Biosensor:

Biosensor insertion under the skin may cause bruising or bleeding.  

Clean hands prior to biosensor handling/insertion to help prevent infection.  

Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove any oily residue that may prevent the Lingo Biosensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site according to these instructions will help the Lingo Biosensor stay on your body for the full wear period and help prevent it from falling off early.  

The Lingo Biosensor Pack and Lingo Biosensor Applicator are packaged as a set and have the same biosensor serial number. All digits must match. Check that the biosensor serial numbers match before using your Lingo Biosensor Pack and Lingo Biosensor Applicator. Do not use Lingo Biosensor Packs and Lingo Biosensor Applicators with different biosensor serial numbers together as this will result in incorrect glucose readings.  

Change the application site for the next Lingo Biosensor application to prevent discomfort or skin irritation.  

Only apply the Lingo Biosensor to the back of the upper arm. If placed in other areas, the Lingo Biosensor may not function properly.  

Select an appropriate Lingo Biosensor site to help the biosensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding).  

What to know about X-Rays:

Your Lingo Biosensor may become loose if you bump it, play contact sports, or sweat a lot. If the Lingo Biosensor is becoming loose or if the Lingo Biosensor tip is coming out of your skin, you may get no readings or unreliable readings; the Lingo Biosensor may self-terminate in this instance. Remove and replace your Lingo Biosensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Lingo Biosensor.  

If you believe your glucose readings are not correct or are inconsistent with how you feel, contact your HCP. If the problem continues, remove the current biosensor, apply a new one, and contact Customer Service.  

Security Information

You are responsible for properly securing and managing your phone. If you suspect an adverse cybersecurity event related to the Lingo app, please contact customer service. The Lingo app is not intended for use on a phone that has been altered or customized to remove, replace, or circumvent the manufacturer’s approved configuration, use restrictions, or otherwise violates the manufacturer’s warranty. The Lingo app should only be downloaded and/or updated through the official Apple App Store. Please contact customer service if you suspect your biosensor or its packaging have been tampered with. 

Interfering Substances

Taking more than 1000 mg of Vitamin C per day may falsely raise your biosensor readings. Vitamin C can be found in supplements including multivitamins and cold remedies such as Airborne^® and Emergen-C^®. See your health care professional to understand how long Vitamin C is active in your body.

UNITED KINGDOM

Intended Use

The Lingo Glucose Biosensor for wellness helps users to correlate their daily activities, general wellbeing and health to their glucose levels by providing continuous glucose measurements for up to 14 days and is intended for use by persons aged 18 and older. The Biosensor is NOT intended for the screening, diagnosis, treatment, cure, mitigation, prevention or monitoring of disease. 

Safety Information

Not a medical device.  

The Biosensor is not a medical device and should not be used as a substitute for professional medical judgement. It is not designed or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of any condition or disease. Please consult your doctor prior to making any decisions related to your health. 

Consult your healthcare professional before making changes to your diet and exercise regime, or if you have an eating disorder or history of eating disorders.  

The Biosensor is not a toy. The Biosensor contains small components that could be a choking hazard, and are not intended for use by small children.  

The Biosensor adhesive may cause skin irritation. If you experience skin irritation around or under your Biosensor, remove the Biosensor. If symptoms persist longer than 2-3 days after removing the Biosensor, consult your doctor.  

The Biosensor contains components and radios that emit electromagnetic fields. These electromagnetic fields may interfere with medical devices, such as pacemakers and defibrillators. Consult your doctor if you are using a medical device or require a medical procedure such as imaging (for example an X-ray, MRI or CT scan) or dialysis. Stop using the Biosensor if you suspect it is interfering with your medical device.  

Your Biosensor may become loose if you bump it, play contact sports or sweat a lot. If the Biosensor is becoming loose, you may get no readings or unreliable readings; the Biosensor may self-terminate in this instance. Remove and replace your Biosensor if it starts to loosen and follow the instructions to select an appropriate application site. Do not attempt to reinsert the Biosensor.  

The Biosensor Pack is sterilised by irradiation and remains sterile unless opened or damaged. Do not reuse Biosensors. The Biosensor has been designed so that it cannot be reused. Not suitable for re-sterilisation.  

Store the Biosensor package within the temperature limits of 4°C and 25°C. While you don’t need to keep your Biosensor package in a refrigerator, you can as long as the refrigerator is between 4°C and 25°C. Do not freeze.  

Your Biosensor is water-resistant and can be worn while bathing, showering or swimming. Your Biosensor has been tested to withstand immersion into one metre (3 ft) of water for up to 30 minutes. It is also protected against insertion of objects > 12 mm diameter. (IP27). 

Do not use if expiry date has passed.