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Dexcom stelo Manual
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Dexcom stelo Manual

Dexcom stelo Manual

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Susan Trulove
April 2, 2025

What are the circles and squares on the green trending graph

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Summary of Contents for Dexcom stelo

  • Page 1 Dexcom...

  • Page 3: Table Of Contents

    Table of Contents 1 • Welcome Contact information Compatible devices 2 • Safety Information Stelo Glucose Biosensor safety statements Risks and benefits Glossary 3 • Insertion Instructions 4 • App Screens Glucose tab overview Trend graph Readings and trend arrows...
  • Page 4 When to talk to your healthcare provider Understanding the connection between behavior and glucose The Stelo Glucose Biosensor System and blood glucose meters 6 • Notifications Signal Loss Brief Sensor Issue In-app notifications Responding to in-app notifications 7 • Smartphone Setup Smartwatch (Apple) 8 •...
  • Page 5 Travel with the Stelo Glucose Biosensor System Update Stelo  by  Dexcom app Water and the Stelo Glucose Biosensor System X-ray, CT scan, or radiation therapy 13 • Taking Care of the Stelo Glucose Biosensor System Stelo Glucose Biosensor System maintenance Storage System disposal 14 •...
  • Page 6 16 • Technical Information Device performance characteristics Product specifications Security measures Radio regulations compliance 17 • Packaging Symbols 18 • Index...

  • Page 7: Welcome

    You care about how your lifestyle choices affect your health, especially when it comes to your glucose, and you want to make the best choices possible. Wearing Stelo means you’ll get glucose levels delivered to your smartphone 24/7. No need to test your blood glucose any other way throughout the day.

  • Page 8: Contact Information

    Contact information Stelo has support teams to help you. Go to stelo.com/contact to connect with them. In the app, you can also go to Settings > Contact to get help. Corporate office Dexcom address: 6340 Sequence Drive, San Diego, CA 92121 Compatible devices ®...

  • Page 9: Safety Information

    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.
  • Page 10 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.
  • Page 11 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.
  • Page 12 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.
  • Page 13 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.

  • Page 14: Risks And Benefits

    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.

  • Page 15: Interfering Substances

    Interfering substances Acetaminophen With the Stelo Glucose Biosensor System you can take a standard or maximum acetaminophen dose of 1 gram (1,000mg) every 6 hours and still use the Stelo Glucose Biosensor System. Taking higher than the maximum dose of acetaminophen (e.g.
  • Page 16 Informing a medication regimen No fingersticks There's no need to take fingersticks to track your glucose levels as Stelo Glucose Biosensor System provides accurate and reliable glucose measurements. In addition, the Stelo Glucose Biosensor provides functions not feasible using traditional blood glucose monitoring.
  • Page 17 Making healthy lifestyle decisions The Stelo Glucose Biosensor System empowers you to make lifestyle decisions on your own. Clinical studies (Erhhardt et al., 2020 and Holzer et al., 2022) suggest that continuous glucose monitoring can be helpful for people with or without diabetes in connecting the dots of an individual's lifestyle choices and their glucose control.

  • Page 18: Glossary

    Android Operating system used for Android smartphones. App or Application Software installed on a smartphone. The Stelo by Dexcom app is a display for continuous glucose monitoring. ® App Store Internet stores for downloading applications to a smartphone.
  • Page 19 Compatible Works with the Stelo Glucose Biosensor System. A smartphone and operating system is compatible with the Stelo System when Dexcom has tested it to ensure it works as designed with the Stelo Glucose Biosensor System. Continuous A sensor inserted under the skin checks glucose levels in Glucose interstitial fluid and sends sensor readings to a smartphone.
  • Page 20 It's important to treat hypoglycemia. If left untreated, hypoglycemia can lead to serious complications. Indications How, for what purposes, and under what circumstances you should use the Stelo Glucose Biosensor System. Operating system used for Apple smartphones.
  • Page 21 The removal of limitations and security measures set by the Rooted manufacturer on a smartphone. The removal poses a security risk and your data may become vulnerable. Don't install the Stelo Glucose Biosensor app on a jailbroken (Apple) or rooted (Android) smartphone. It won't work correctly. mg/dL Milligrams per deciliter.
  • Page 22 Smartwatch A watch that communicates with and extends a smartphone. (watch) For example, an Apple Watch. The Stelo Glucose Biosensor System offers two target ranges. Target Range For people with diabetes, the international consensus for target range is 70–180 mg/dL.
  • Page 23 For people without diabetes (or with prediabetes), the target range is set to 70–140 mg/dL. Transmitter Sends sensor readings to the smartphone. The Stelo Glucose Biosensor transmitter is built into the sensor. Warning Describes serious and life-threatening circumstances, the consequences, and how to avoid the hazard while using the Stelo Glucose Biosensor system.
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  • Page 25: Insertion Instructions

    You must have secure internet access for the entire setup. For supported devices and operating systems, go to stelo.com/compatibility. Go to the app store on your phone and search for Stelo by Dexcom. You can also use the QR code below. Download and open the app, then follow on-screen instructions Stelo by Dexcom...

  • Page 26: Inserting Your Sensor

    These instructions are also available in your app. Open the app and follow the onscreen 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...
  • Page 27 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/support. 2. Clean and dry site a. Wash hands with soap and water. Dry.
  • Page 28 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.
  • Page 29 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. 3 • Insertion Instructions | Stelo Glucose Biosensor User Guide...
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  • Page 31: App Screens

    The bigger white dot on look different. 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. 4 • App Screens |...

  • Page 32: Readings And Trend Arrows

    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. You can tap the number for more information.
  • Page 33 Rising Rising or falling: Changing 60–90 mg/dL in 30 minutes Falling Rapidly Rapidly rising or falling (double arrows): Changing more than 90 mg/dL in 30 minutes Rising Rapidly Falling No arrow: Can't determine glucose trend. 4 • App Screens | Stelo Glucose Biosensor User Guide...

  • Page 34: Navigation

    Time in range is the percentage of time Yesterday your glucose is in target range. Time in Range 16% Above Target Range The Stelo Glucose Biosensor offers two target ranges. 62% In Target Range For people with diabetes, the international 12% Below Target Range consensus for target range is 70–...
  • Page 35 Stelo Basics help you understand how and why your glucose What’s Why Does What’s Glucose? Glucose Target changes throughout the day. Matter? Range? Requires internet connection. Glucose Deep Dive Nutrition Exercise 4 • App Screens | Stelo Glucose Biosensor User Guide...
  • Page 36 What you see What it means Settings: Here you can change settings and get Settings help. Sensor: Go here to get information on your Sensor 14 days left sensor, see your pairing code, and end your sensor session (go to the App Settings Next Sensor Session chapter).
  • Page 37 Answers to your questions Find Answers Instructions SENSOR INSTRUCTIONS Inserting and removing sensors Insertion Sensor readings Removal Links to product guides  Readings Safety information GUIDES Stelo Essentials User Guide CGM Safety Information 4 • App Screens | Stelo Glucose Biosensor User Guide...

  • Page 38: See Trend Graph History

    See trend graph history 3 Hours Tap the numbers above the trend graph to see your trend graph over 3, 6, 12, and 24 hours. 12PM To see your event history in your trend graph, turn 3 Hours mg/dL your phone to landscape and tap the numbers in the top left side of the screen to switch between 3, 6, 12, and 24 hours of data.

  • Page 39: Tips From Banners, Tooltips, And Icons

    Your phone settings are preventing your app from working as designed. Tap the icon at the Target Range top left corner to fix. I UNDERSTAND 75% Time in Range 4 • App Screens | Stelo Glucose Biosensor User Guide...
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  • Page 41: Behavior And Glucose

    Stelo Glucose Biosensor System. Reviewing your trends The Stelo Glucose Biosensor System can help you analyze your past glucose data. Your Glucose Summary shows your trends and patterns over the past month. If your readings are consistently outside the target range (for people with diabetes, this means lower than 70 mg/dL or above 180 mg/dL) you may need to consult your HCP for guidance.
  • Page 42 People without diabetes People with diabetes (or with prediabetes) Target range Between 70–180 mg/dL. Between 70–140 mg/dL. Time in range goal 70% of your day, or at least Set to 96% of the day. 17 hours in target range. Less than 1 hour of the day below target range (less than 70 mg/dL).

  • Page 43: When To Talk To Your Healthcare Provider

    When to talk to your healthcare provider The Stelo Glucose Biosensor System empowers you to make lifestyle decisions on your own. Consult your healthcare provider (HCP) if you have any questions around medication. Don't change medication based on sensor data.

  • Page 44: Understanding The Connection Between Behavior And Glucose

    Understanding the connection between behavior and glucose The Stelo by Dexcom app shows you readings and glucose trends over time. You can use this information to help you uncover what causes your glucose to change. For example: Does your glucose go down after a walk around the neighborhood?
  • Page 45 Consider: Physical activity can down. help bring your glucose into target range. Watch the arrow to see how your glucose changes during activity. 5 • Behavior and Glucose | Stelo Glucose Biosensor User Guide...

  • Page 46: The Stelo Glucose Biosensor System And Blood Glucose Meters

    The Stelo Glucose Biosensor System and blood glucose meters If you need to track your glucose levels when your 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.

  • Page 47: Notifications

    6 • Notifications You'll get a notification if the Stelo by Dexcom app isn't working as intended. Three of these messages are shown next. What you see What it means Signal Loss Lets you know when your smartphone temporarily stops getting readings because there's an issue with the...
  • Page 48 Android's Digital Wellbeing and Apple’s Screen Time may prevent notifications if enabled. Allow the Stelo by Dexcom app's notifications to show on your lock screen. This will ensure you receive Stelo notifications and allow you to see notifications without unlocking your phone.

  • Page 49: Responding To In-App Notifications

    Tips Notification vibrations feel the same as notifications you get from other apps on your smartphone. The only way to know if it's from the Stelo by Dexcom app is to look at your smartphone. In the app, you see notifications on your lock screen and Apple Watch. If you're not seeing any data, open your app.
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  • Page 51: Smartphone Setup

    7 • Smartphone Setup With the Stelo Glucose Biosensor System, you get your glucose information in a smartphone app. You can set up the Stelo by Dexcom app on only one smartphone. Download the Stelo by Dexcom app from your app store and follow the instructions on the screen.

  • Page 52: Internet Requirements

    Smartwatch (Apple) Check your Stelo Glucose Biosensor on your Apple smartwatch. Suggested use Using a smartwatch with your Stelo Glucose Biosensor may change how you get notifications. Your smartwatch communicates with your smartphone, not the sensor. You won't get notifications or readings on your watch unless it's connected to your smartphone and your smartphone is connected to your sensor.
  • Page 53 Waking up your watch updates your Stelo Glucose Biosensor data from your phone. There may be a brief delay before your watch app shows current information. Go to stelo.com/compatibility to make sure your smartwatch works with the Stelo Glucose Biosensor.
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  • Page 55: App Connections

    8 • App Connections The Stelo by Dexcom app lets you add additional features and services to help you manage your glucose. From Settings, you can: Settings Get information about your sensor session Sensor Replace your sensor 14 days left Active connections — like your sensor — appear App Settings in Settings >...

  • Page 56: Sensor

    Sensor Settings Sensor Sensor Not Active Sensor Start - - - In Settings > Sensor, you can do all this and Sensor Expires - - - more: Start New Sensor Check how much time is left in your sensor session Stop Sensor Session Replace a sensor (go to the Next Sensor...

  • Page 57: Health Apps

    Stelo Glucose Biosensor System. Activate your smartphone's health app, and the Stelo Glucose Biosensor System will send data to the health app with a 3-hour delay. Stelo sends glucose data between 70–250 mg/dL. 8 • App Connections | Stelo Glucose Biosensor User Guide...
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  • Page 59: Events

    9 • Events Using events to manage glucose The Stelo by Dexcom app gives you a graph showing where your glucose has been. Events can help you understand why your glucose changed. For example, what happened to your glucose level when you took a walk after breakfast? You can use these reflections to find even more ways to manage your glucose.

  • Page 60: Adding Bg Meter Values

    To edit or delete an event you logged: Events Meal FEB 22, 2021 Meal Chicken with pasta 3 : 45PM Go to the Events tab. Select the event you want to edit or delete and follow the instructions on the screen. Edit Event Delete Event Adding BG meter values...
  • Page 61 Your readings come from different fluids than your BG meter values, so they won't usually match. Neither number is as accurate as the lab test your doctor does. For more information about the Stelo Glucose Biosensor System's accuracy, go to the Accuracy section of the Troubleshooting chapter.
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  • Page 63: Reports And Insights

    10 • Reports and Insights Reports on your smartphone are an important part of the Stelo Glucose Biosensor System as they highlight glucose patterns, trends, and statistics. They can help you identify glucose patterns and determine the potential causes of those patterns.

  • Page 64: Insights

    When you're no longer getting readings, you'll get a summary of your time in range and average glucose for the entire sensor session. If you've used the Stelo by Dexcom app before, you'll also get a comparison of each sensor's time in range percentage.
  • Page 65 This Insight is to help people with type 2 diabetes be aware of any patterns of low glucose they might previously not be aware of. Most insights require an active internet connection. 10 • Reports and Insights | Stelo Glucose Biosensor User Guide...
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  • Page 67: Next Sensor Session

    You must end the sensor session or grace period before you start a new sensor. You can end it two ways: Automatically, when the grace period ends (A notification lets you know) Manually, before the grace period ends 11 • Next Sensor Session | Stelo Glucose Biosensor User Guide...
  • Page 68 Automatically: End sensor when grace period ends At the end of the grace period, you'll get a Start New Sensor notification: What you see What it means Tap OK and follow instructions on the screen. Replace Sensor Now Grace period expired. No sensor readings until you start a new sensor.

  • Page 69: Remove Your Sensor

    Before inserting a new sensor, remove the old one. You can use only one sensor at a time with the Stelo Glucose Biosensor System. After your sensor session ends, peel off the patch like a bandage. To make it easier and to avoid irritating your skin, try...

  • Page 70: Remove Old Sensors From Bluetooth Connections (Optional)

    Bluetooth connections list. Apple 1. Go to Phone Settings > Bluetooth. 2. Find a used sensor in My Devices list. Stelo names start with DXCM. 3. Tap i to see details about this sensor. 4. Tap Forget This Device.
  • Page 71 To remove old sensors from the Bluetooth connections list while you're wearing a sensor, follow the above steps and keep these tips in mind: All Stelo sensors are listed as not connected, even the current one. The current sensor's status changes to connected during the few seconds every 5 minutes when it's sending your sensor reading to your smartphone.
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  • Page 73 Appendix...
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  • Page 75: Troubleshooting

    Water and the Stelo Glucose Biosensor System X-ray, CT scan, or radiation therapy For more troubleshooting information, see the frequently asked questions section on the Stelo website (stelo.com/support), or contact technical support (in the app, go to Settings > Contact) . 12 • Troubleshooting |...

  • Page 76: Accuracy

    The lab test is considered the most accurate number. Other reasons there could be a difference between your BG meter and the Stelo Glucose Biosensor System are: Hand cleanliness: Wash your hands with soap and water (not hand sanitizer) and dry them.

  • Page 77: Adhesive Patch

    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 an overpatch or medical tape 12 • Troubleshooting | Stelo Glucose Biosensor User Guide...
  • Page 78 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/support for more tips.

  • Page 79: Common Notifications

    Check your sensor. Tap Help in app for more information on troubleshooting. If Brief Sensor Issue continues for more than 3 hours, contact technical support (in the app, go to Settings > Contact) . Brief Sensor Issue may lead to Sensor Failed. 12 • Troubleshooting | Stelo Glucose Biosensor User Guide...
  • Page 80 Issue Sensor Failed Sensor Failed Replace Sensor Now Sensors can only be used for one session. No readings until you start a new sensor. Solution This issue may happen anytime during a sensor session. If you get this notification, go to its Help screen for more information.
  • Page 81 Searching for sensor Pairing usually takes less than 5 minutes. Troubleshooting tips: Keep phone close Insert sensor to pair Check pairing code Move away from others wearing sensors Cancel Search Restart Pairing Process 12 • Troubleshooting | Stelo Glucose Biosensor User Guide...
  • Page 82 Solution If you get this notification, go to its Help screen for more information. Pairing usually takes less than 5 minutes. If it takes longer, use these troubleshooting tips. Keep phone close: Always keep smartphone within 20 feet of sensor. Insert sensor to pair: Make sure your sensor is inserted.

  • Page 83: Troubleshooting Tips

    Use recommended phone settings listed in the app at Settings > Phone Settings. Keep your smartphone battery charged to at least 20% If Signal Loss continues for more than 30 minutes, contact technical support (in the app, go to Settings > Contact). 12 • Troubleshooting | Stelo Glucose Biosensor User Guide...

  • Page 84: Gap In Trend Graph

    Gap in trend graph Issue When you aren't getting readings, your trend graph may show a gap in the trend dots. In the following example, you can see the gap where your current dot should be. Signal Loss Always keep phone within 20 feet of your sensor.

  • Page 85: Travel With The Stelo Glucose Biosensor System

    Travel with the Stelo Glucose Biosensor System Issue You want to use the Stelo Glucose Biosensor System when going through security or flying. Solution TSA Security check point You can wear your Stelo Glucose Biosensor when going through walk-through metal detectors and Advanced Imaging Technology (AIT) body scanners.

  • Page 86: Update Stelo  By  Dexcom App

    You want to know how and when to update your app. Solution Keep app updated You'll get a notification when a Stelo by Dexcom 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.

  • Page 87: X-Ray, Ct Scan, Or Radiation Therapy

    You need an x-ray, CT scan, or radiation therapy while wearing the sensor. Solution Discuss these safeguards with your healthcare provider: Avoid including the sensor in the scanned area during the procedure Cover the sensor with a lead apron 12 • Troubleshooting | Stelo Glucose Biosensor User Guide...
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  • Page 89: Taking Care Of The Stelo Glucose Biosensor System

    Stelo components work together. Don't mix with any other Dexcom products. Don't use damaged components. Storage Storing the Stelo Glucose Biosensor System correctly helps prevent system failures. Sensor Keep in its sterile packaging until you're ready to use it Store at temperatures between 36°F and 86°F...
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  • Page 91: Warranty

    14 • 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.
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  • Page 93: App Terms Of Use And Open Source Software Code

    By using the Stelo Glucose Biosensor System, you are acknowledging that you have read and agreed to the Dexcom App Terms of Use and the included provisions for binding individual arbitration, as well as the Privacy Policy, including what personal information Dexcom collects from you and how Dexcom uses your personal information.
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  • Page 95: Technical Information

    Clinical study overview To demonstrate the safety and effectiveness of the Stelo Glucose Biosensor System, a prospective clinical study was conducted at six (6) centers across the United States with a total of 130 participants. The study included adult (18 years and older) participants with Type 1 or Type 2 diabetes.
  • Page 96 Accuracy The Stelo Glucose Biosensor System accuracy was assessed with paired sensor readings to YSI blood glucose values. For YSI blood glucose values less than 70 mg/dL, the absolute difference in mg/dL between the two glucose results was calculated. For values greater than or equal to 70 mg/dL, the absolute difference (%) relative to the YSI value was calculated.
  • Page 97 <70 2,008 93.5 99.9 10.5 93.8 99.7 70–180 10,463 86.2 -0.3 88.0 180–250 2,988 94.9 99.9 -6.5 86.1 92.5 >250 4,871 99.9 -15.8 Biosensor readings are within 40-400 mg/dL, inclusive. 16 • Technical Information | Stelo Glucose Biosensor User Guide...
  • Page 98 Concurrence of Stelo Glucose Biosensor and comparator method Table 2 describes (column percent), for each range of YSI values, what percentage of paired Biosensor readings was in the same glucose range (shaded) or in glucose ranges above and below the paired YSI values. For example, Table 2 shows that when YSI values are within 70 to 120 mg/dL, you can expect your Biosensor readings to be within 70 to 120 mg/dL 85.1% of the time.
  • Page 99 Trend accuracy Trend accuracy explains how well Stelo Glucose Biosensor System captures the time- dependent characteristics of glucose fluctuation. The following examples quantify the trend accuracy: 1. When the Biosensor rate of change is rapidly rising (> 2 mg/dL/min), how often is reference glucose also trending up (>0 mg/dL/min)? The answer is...
  • Page 100 Stelo Glucose Biosensor System is capable of recording up to 288 valid sensor readings per day. For a variety of reasons, Stelo Glucose Biosensor System may be unable to provide a valid sensor reading. The percentage of valid sensor readings you can expect from Stelo Glucose Biosensor System over the sensor life is 99.3% (data...
  • Page 101 Table 4. Data availability rate by wear day — adults (n=130) Wear day Number of sensors Data availability rate (%) 99.4 99.7 99.7 99.6 99.8 99.7 99.8 99.6 99.5 99.2 98.9 98.6 98.9 97.8 97.1 16 • Technical Information | Stelo Glucose Biosensor User Guide...

  • Page 102: Adverse Events

    Sensor insertion experience Enrolled subjects in the clinical study were asked to complete questionnaires on comfort and ease of use of sensor insertion. The questionnaires were completed by the subjects. Ninety-six percent (96%) of subjects responded that the sensor insertion was painless.

  • Page 103: Product Specifications

    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 including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result in improper operation.
  • Page 104 Sensor with built-in transmitter product specifications Stelo Glucose Biosensor Model System sensor/transmitter Glucose Range 40–400 mg/dL Useful Life Up to 15.5 days Sterilization Ethylene Oxide gas Memory Storage Minimum 24 hours of glucose data Data Backfill for 24 hours User Display Power Source...
  • Page 105 8 feet for 24 hours Applied Part Type BF applied part Alert Audible Output TX/RX 2.402–2.480 GHz Frequencies Bandwidth 1.07 MHz Maximum Output 1.0 mW EIRP Power 16 • Technical Information | Stelo Glucose Biosensor User Guide...

  • Page 106: Essential Performance

    5-minute intervals. If connection is lost between the transmitter and display device, upon re-connection any missed packets (up to 24 hours) will be transmitted from the transmitter to the display device. The Stelo Glucose Biosensor System is designed to only accept radio frequency (RF) communications from...

  • Page 107: Security Measures

    Transmitter: BLE. App: BLE to transmitter. TLS to Dexcom data platform using cellular data or Wi-Fi. The Stelo Glucose Biosensor System is designed to transmit data between the transmitter and designated display devices in accordance to the industry standard Bluetooth Low Energy (BLE) protocols.

  • Page 108: Backup And Restore

    Use these tips to help secure a smart device: Secure network: Only connect to a trusted/secure network Secure smart device: Don't use the Stelo by Dexcom app on a jailbroken (Apple) or rooted (Android) smart device App sources: Only install apps from trusted sources, such as Google Play or the...

  • Page 109: Security Events

    SBOM Request Form at account.stelo.com. Security events The Stelo by Dexcom app will notify the user when a security issue is detected, such as attempting to use the app on a jailbroken (Apple) or rooted (Android) smart device, or when the transmitter is not reachable.
  • Page 110 Securely deleting the app Deleting the app will remove all Stelo by Dexcom app information from your smart device. Touch and hold the app icon on the Home Screen Tap Remove App Tap Delete App to confirm Android Touch and hold the app icon on the home screen...
  • Page 111 Radiated Fields Disturbance 10 V/m IEC 61000-4-3 at 80 MHz to 2700 MHz (AM Modulation) Radiated and Conducted Meets RTCA /DO-160 edition G Section 20, Fields Category T Aircraft use 16 • Technical Information | Stelo Glucose Biosensor User Guide...
  • Page 112 Electromagnetic interference can still occur in the home health care environment as control over the EMC environment cannot be guaranteed. An interference event can be recognized by gaps in sensor readings or gross inaccuracies. The user is encouraged to try to mitigate these effects by one of the following measures: If your symptoms do not match your sensor readings, consider using a BG meter as needed.

  • Page 113: Radio Regulations Compliance

    Radio regulations compliance FCC information The Stelo Glucose Biosensor System is classified as a Class B medical digital device and complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operation.
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  • Page 115: Packaging Symbols

    17 • Packaging Symbols Symbols are on the Stelo Glucose Biosensor packaging. They show proper and safe use of the device. You may also reference the symbols glossary at stelo.com/symbols. Below is a list of each symbol and its meaning.
  • Page 116 Humidity Limitation Use By Date (YYYY MM DD) Do Not Reuse Sterilized Using Ethylene Oxide Single sterile barrier system with protective packaging outside Consult Instructions for Use Caution Indicates the item is a Medical Device MR (Magnetic Resonance) Unsafe Type BF Applied Part IPXX Degree of Ingress Protection, see Technical Information IPXX for product detail...
  • Page 117 Unique device identifier 17 • Packaging Symbols | Stelo Glucose Biosensor User Guide...
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  • Page 119: Index

    Missing Readings, 78 Reading, 26-27 Home Screen, 25 Maintenance, 83 Notifications, 41 Resources, 69 Safety Statements, 3 Sensor Session Definition, 16 Smart Watch, 46 Symbols, 109 Technical Information, 89 Trend Arrow, 25-27 18 • Index | Stelo Glucose Biosensor User Guide...
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  • Page 121 © 2024 Dexcom, Inc. All rights reserved. Covered by patents stelo.com/patents. 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.
  • Page 122 Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA Web: stelo.com AW-1000421-10 Rev 001 MT-1000421-10 Rev Date: 05/2024...
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