Stelo Glucose Biosensor Essentials Instructions

Stelo Glucose Biosensor Essentials
Instructions

Stelo Glucose Biosensor Essentials

These are the most important things you need to know to use your Stelo by Dexcom app.

Insertion Instructions

Stelo Glucose Biosensor basics

The applicator inserts the built-in biosensor (sensor) under your skin. Each sensor session lasts up to 15 days1, plus a 12-hour grace period at the end.

The sensor sends glucose sensor readings (readings) to your smartphone. You’ll get glucose updates every 15 minutes.

After you insert the sensor, you must apply an overpatch to keep the sensor on your skin.

¹A study was conducted to assess the sensor life where 77.9% of sensors lasted the full 15 days. In other words, when using the product per the package labeling, approximately 20% of sensors may not last for the full 15 days, 10% of these sensors may last less than 12 days.

Inserting your sensor

These instructions are also available in your app.

Open the app and follow the on-screen instructions to set up and use your Stelo Glucose Biosensor System.

1. Choose sensor site

Insert your sensor on the back of your upper arm

Don’t wear your sensor on other sites (such as your abdomen), as it may not work as expected.

Avoid areas:

• With loose skin or without enough fat to avoid muscles and bones
• That get bumped, pushed, or you lie on while sleeping
• Within 3 inches of injection site
• With irritations, scarring, tattoos, or lots of hair

To keep sensor attached see stelo.com/faqs.

2. Clean and dry site

a. Wash hands with soap and water. Dry.

b. Rub site with an alcohol wipe to get rid of all oils.

c. Let dry completely so sensor will stick.

3. Unscrew cap

The applicator uses a needle to insert a tiny sensor wire 3 under your skin. The needle stays in the applicator, not your skin.

• Don’t touch inside applicator
• Don’t use if damaged or previously opened

4. Use applicator to insert sensor

Relax any muscles near site.

1. Press and hold applicator firmly against skin until clear safety guard is pushed in.
2. Press the button while the guard is pushed in.
   Tip: Pressing applicator firmly against the skin unlocks the button.

5. Remove applicator

a. Move applicator away from your body. Sensor stays on skin.

b. Save applicator because you’ll need its pairing code.

c. Screw cap back on applicator.

6. Rub patch

To help keep the patch on your skin:

a. Rub firmly around patch 3 times

b. Gently press on top of sensor for 10 seconds

7. Apply overpatch

The overpatch keeps the sensor on your skin. It’s bundled with the instructions in the sensor box.

a. Carefully pull off both clear liners, one at a time. Don’t touch white adhesive area.

b. Use colored tab to place overpatch around sensor.

c. Rub around overpatch.

d. Use tab to peel off colored liner.

e. Rub around overpatch.

Go back to app to finish setup.

Adhesive patch care

• The longer you keep the patch dry and sweat-free in the first 12 hours, the longer it may stick to your skin.
• When it gets wet, gently pat it dry as soon as you can.
• If it peels off your skin, trim the peeled parts and put on medical tape.
• Go to stelo.com/faqs for more information.

Issue: Skin irritation around sensor site

Solution:
Some people are sensitive to the sensor adhesive. Extra care can help. Follow insertion instructions carefully. In addition to the site preparation tips above, consider these:

• New site: Don’t use the same sensor site twice in a row.
• Healthy skin: Consider moisturizing skin between sensor sessions to avoid dry skin. Don’t use moisturizer on the sensor site the day you insert the sensor.

If you have significant skin irritation (itching, burning and/or rashes at the site of the adhesive patch), contact your healthcare provider. Go to stelo.com/faqs for more tips.

Applicator disposal

After inserting and pairing the sensor, throw out applicator following local guidelines.

Issue: Applicator won’t detach after inserting sensor.

Solution:
1. Gently peel off adhesive patch with applicator attached.
2. Check insertion site to make sure the sensor isn’t left in the skin.
3. Don’t reuse applicator.
4. Contact technical support (in the app, go to Settings > Contact).

Shower, swim, or bathe wearing your sensor

Once inserted, the sensor is waterproof up to 8 feet. Swim, shower, and take a bath with the sensor.

If you’re in or near water, your smartphone may need to be closer than 20 feet to get readings. If you’re in water, you may not get readings until you get out.

The patch stays on longer if kept dry.

Glucose Tab Overview

The Glucose tab shows your current reading and trend information.

Trend graph

Images are representational.
Your display device screens may look different.

1. 3 Hours, 6, 12, 24: Change the number of hours shown on the trend graph.
2. : Information icon. It gives you more information about Target Range.
3. Target Range: This is where you want your glucose to be. It’s the green box in the trend graph.
   You can choose yours in Settings > Target Range.
4. Trend graph dots: The smaller black dots show past readings. The bigger white dot on the right is the most recent reading.

The Stelo by Dexcom app may compete with other apps for battery and storage capacity and may require certain phone settings to function.

Readings and trend arrows

Where your glucose is now

On the Glucose tab, your latest reading is the number at the top of the screen. It updates every 15 minutes. The app tells you how recent your reading is.

Sometimes you don’t get a number. Your readings may be above or below the trend graph, or your system may have an issue.

Where your glucose is heading

To know where your glucose is heading based on the last few readings.

Removing Your Sensor

After a sensor session ends, peel off the patch like a bandage. To make it easier, try these tips:

• Loosen edge and soak the patch in body oil, like baby oil or an adhesive remover for skin (see product instructions before using)
• Use adhesive removal wipes for skin to rub the skin that gets exposed as you peel back the patch
• Try different pulling techniques:
  • Pull off the patch slowly, folding it over itself, in the same direction of hair growth
  • Stretch loosened edge, and push your fingers under the patch to pull it off your skin

For more tips go to stelo.com/faqs.

Before inserting a new sensor, remove the old one. You can use only one sensor at a time with the Stelo Glucose Biosensor System.

Throw out the used sensor following local guidelines for blood contacting components.

Troubleshooting

For more troubleshooting information, find the frequently asked questions section on the Stelo website (stelo.com/faqs), or contact technical support (in the app, go to Settings > Contact).

Keep your Stelo by Dexcom app updated

You’ll get a notification when an app update is available while connected to the internet. Go to the App Store® or Google Play and download the updated Stelo by Dexcom app.

Stelo Glucose Biosensor Safety Statements

Indications for use

The Stelo Glucose Biosensor 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 Stelo Glucose Biosensor System helps to detect normal (euglycemic) and low or high (dysglycemic) glucose levels. The Stelo Glucose Biosensor 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.

Contraindications

No MRI/CT/diathermy — MR unsafe: Don’t wear any Stelo Glucose Biosensor System component during magnetic resonance imaging (MRI) or high-frequency electrical heat (diathermy) treatment. However, it’s safe to have a CT scan if you keep the sensor out of the scanned area and cover the sensor with a lead apron during the scan.

The Stelo Glucose Biosensor System hasn’t been tested in those situations when used during an MRI scan, diathermy, or in the scanned area of a CT scan. The magnetic fields and heat could damage Stelo Glucose Biosensor System components, which may cause inaccurate sensor readings.

Warnings

Choking hazard: The Stelo Glucose Biosensor System contains small parts and may pose a choking hazard if swallowed.

Don’t use if you have problematic hypoglycemia: The Stelo Glucose Biosensor System hasn’t been designed for these populations. Consult with your healthcare provider to discuss which Dexcom product is right for you.

Don’t use if you are on dialysis: The Stelo Glucose Biosensor System performance hasn’t been evaluated in this population and sensor readings may be inaccurate.

Don’t ignore low/high symptoms: Consult your healthcare provider when your sensor readings are not consistent with your symptoms of low or high glucose.

Don’t change medications: Consult your healthcare provider before making any medication adjustments based on your sensor readings.

Cautions

What to know before using the Stelo Glucose Biosensor System:

• Read product instructions before you use the Stelo Glucose Biosensor System.

What to know before applying the sensor:

• Don’t start a sensor past its Use By Date (YYYY MM DD) because it may give incorrect results. You can start a new sensor on or before its Use By Date. This gives you full wear.
• Do not use any damaged or cracked Stelo Glucose Biosensor System components because they may not work correctly and could cause injuries from electrical shocks. If the applicator and/or sterile cap has been damaged or opened, it might cause an infection. Don’t remove cap until ready for insertion.
• Clean and dry your hands prior to handling your sensor and clean your insertion site with alcohol wipes to prevent infections. If your insertion site and hands aren’t clean and dry, you run the risk of infection and the sensor not sticking well. Before insertion, don’t apply insect repellent, sunscreen, perfume, or lotion on your insertion site or sensor. This may cause the sensor to not stick well.
• Only insert your sensor on the back of your upper arm. Don’t wear your sensor on other sites (such as your abdomen), as it may not work as expected.
• The Stelo Glucose Biosensor System insertion safety guard is enabled until you press the Stelo Glucose Biosensor System applicator down against your skin. Only do this when ready to insert.
• Change your insertion site with each sensor to allow the skin to heal. Avoid areas:
  • With loose skin or without enough fat to avoid muscles and bones.
  • That get bumped, pushed, or you lie on when sleeping.
  • Within 3 inches of an injection site.
  • With irritations, scarring, tattoos, or lots of hair. If needed, trim site with electric clippers.

What to know while using your sensor:

• Make sure your smartphone’s Bluetooth is on and keep your smartphone battery charged to prevent missed readings.
• Keep your sensor and smartphone within 20 feet with no obstacles between them. Otherwise, they might not be able to communicate.
• Don’t use the Stelo Glucose Biosensor System to diagnose or indicate your risk of developing diabetes.
• If you need to track your glucose levels when the Stelo Glucose Biosensor System readings don’t match how you feel, don’t show a number, or during the 30 minute sensor warmup period, a blood glucose meter may be an option as needed.
• Don’t ignore broken or detached sensor wires. If this happens, please contact 24/7 technical support (in the app, go to Settings > Contact).
• If a sensor wire breaks off or detaches under your skin and you can’t see it, don’t try to remove it. Contact your healthcare provider if you have symptoms of infection or inflammation — redness, swelling, or pain — at the insertion site.
• During your sensor session, don’t apply insect repellent, sunscreen, perfume, or lotion on your insertion site or sensor. This may cause the sensor to not stick well or could damage the Stelo Glucose Biosensor System.
• When going through a security check point, you can wear the Stelo Glucose Biosensor System sensor for the walkthrough metal detector and Advanced Imaging Technology (AIT) body scanner. If you do, don’t use the Stelo Glucose Biosensor System until you leave the security area. This is because the Stelo Glucose Biosensor System hasn’t been tested with every x-ray and security scanner and you may not be able to bring a smartphone. You can also ask for hand-wanding or full-body pat-down and visual inspection instead of going through any walk-through body scanners or putting any part of the Stelo Glucose Biosensor System in the baggage scanning machine.

What to know about the Stelo Glucose Biosensor System:

• No modifications to the Stelo Glucose Biosensor System are allowed.
• Stelo Glucose Biosensor components aren’t compatible with any other Dexcom products. Don’t mix with any other Dexcom products.
• Only use a cellular internet connection, a trusted Wi-Fi network (like your home or office), or use a secure internet connection such as a VPN service when using the Stelo Glucose Biosensor System. Don’t use unsecured public Wi-Fi such as guest networks in other’s homes, restaurants, schools, libraries, hotels, airports, airplanes, etc. Those could expose the Stelo Glucose Biosensor to viruses or hacking.
• Before upgrading your smartphone or its operating system, check for compatibility at stelo.com/compatibility. Automatic updates of the app or your smartphone operating system can change settings or shut down the app. Always update manually and verify correct device settings afterward.
• While connected to the internet, the app periodically checks compatibility and will display a message if it’s not compatible (or no longer compatible) with your smartphone or your smartphone’s operating system (OS). The message may include a timeframe for updates.
• Portable radio frequency communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 12 inches to any part of the Stelo Glucose Biosensor System. Otherwise, degradation of the performance of this equipment could result in improper operation. Use of this equipment adjacent to, or stacked with, other equipment should be avoided because it could result in improper operation.

How to store the sensor:

• You can store your sensors at room temperature or in your refrigerator, between 36° F and 86° F, but not in the freezer.

Interfering substance risks

Hydroxyurea

Hydroxyurea is a medication used in the treatment of diseases including cancer and blood disorders; it is known to interfere with sensor readings.

If you are taking hydroxyurea, your sensor readings will be higher than your actual glucose. The level of inaccuracy depends on the amount of hydroxyurea in your body. Talk to your physician about alternative glucose monitoring approaches.

Acetaminophen

With the Stelo Glucose Biosensor System, you can take a standard or maximum acetaminophen dose of 1 gram (1,000 mg) every 6 hours and still use the Stelo Glucose Biosensor System. Taking higher than the maximum dose of acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the sensor readings and make them look higher than they really are.

Open source software code

This product may include open source software code. Third Party notices, terms, and conditions pertaining to third party software included in this product can be found at stelo.com/notices.

Contact Information

In the app, go to Settings > Contact to get help.

You can also see the Stelo Glucose Biosensor User Guide at:

• App: Settings > Help
• Online: stelo.com/guides
• Free printed copy: Order at stelo.com

Warranty

Dexcom sensor limited warranty

To the extent allowed by law, the Stelo Glucose Biosensor is provided to you without any warranty by Dexcom. Dexcom hereby disclaims all warranties (express, implied, and statutory) with respect to the sensor, including, but not limited to, the implied warranties of merchantability and fitness for a particular purpose. There are no warranties which extend beyond the description herein.

Dexcom, Inc.
6340 Sequence Drive
San Diego, CA 92121 USA
stelo.com

© 2024 Dexcom, Inc. All rights reserved..

Dexcom, Stelo, and any related logos and design marks are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. Bluetooth is a registered trademark owned by Bluetooth SIG. App Store is a registered trademark of Apple Inc. Google Play is a trademark of Google LLC.

AW-1000419-10 Rev 001 MT-1000419-10

Rev Date: 02/2024