® X Dexcom G5x Mobile System User Guide 1 Table of Contents PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Table of Contents Glossary ..................................................................................................8 Chapter 1 .............................................................................................. 14 Beginning Your Dexcom G5®x Continuous Glucose Monitoring System (G5x) Journey........................................................................................ 14 1.1 Introduction .................................................................................... 14 1.
5.5 Dexcom Receiver............................................................................. 74 Chapter 6 .............................................................................................. 81 Starting a Sensor Session: Inserting Sensor, Attaching Transmitter, and Starting Your Session ............................................................................ 81 6.1 Overview ......................................................................................... 81 6.2 Safety Statements ..
Apple Today View Widget ................................................................... 171 9.4 Rate of Change Arrows ................................................................. 181 9.5 Error Messages.............................................................................. 182 Chapter 10 .......................................................................................... 189 Daily Events Affect Your Glucose Trends and Patterns ........................ 189 10.1 Introduction .............
14.3 Storage ........................................................................................ 268 14.4 Checking app and Receiver Information ..................................... 269 14.5 System Disposal .......................................................................... 270 Chapter 15 .......................................................................................... 272 On the Go With G5x: Getting Through Security ................................... 272 15.1 Introduction ............
20.8 Troubleshooting ..........................................................................
1 GETTING STARTED • Glossary • Getting Started • Indications for Use and Safety Statement • Risks and Benefits Dexcom G5x System User Guide 7 Glossary PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Glossary A1C Blood test used to diagnose type 1 or 2 diabetes and to gauge how well you’re managing your diabetes. The A1C test result reflects your average blood sugar level for the past two to three months. Accessory Device Hardware, connected to your smart device by Bluetooth, you use to get easy access to some of its features. For example, Bluetooth headset, Apple watch, or smart watch. Also called wearables.
(BG) value is the amount of glucose in the blood measured by a BG meter. Blood Glucose Meter/Meter/BG Meter A medical device used to measure how much glucose is in the blood. Calibration A comparison or measurement between your meter’s fingerstick BG values and the sensor’s interstitial fluid glucose readings. Although blood and interstitial fluids are similar, glucose concentration is higher in your blood. Calibration allows alignment between your sensor and meter readings.
Hyperglycemia High BG. Same as “high” or high blood sugar. Hyperglycemia is characterized by an excess of glucose in the bloodstream. It’s important to treat hyperglycemia. If left untreated, hyperglycemia can lead to serious complications. The default High Glucose Alert in the G5x is set to 200 mg/dL. Consult your healthcare professional to determine the appropriate hyperglycemic setting for you. Hypoglycemia Low BG. Same as “low” or low blood sugar.
IP The International Electrotechnical Commission (IEC) is a nonprofit, non-governmental, international organization created to produce safety standards for electronics. One of the safety standards it designed is the Ingress Protection (IP) Marking, which classifies and rates how protected an electronic device is against dust, water, accidental contact, etc. IP ratings are numerical, with the number based on the conditions the electronic device comes across.
Portrait When your smart device is oriented vertically. Precaution A safety statement regarding any special care to be exercised by you or your healthcare professional for the safe and effective use of the G5x. RF Radio-frequency (RF) transmission used to send glucose information from the transmitter to the receiver or smart device. Also used to send calibration data from the receiver or smart device to the transmitter.
Describes serious and life-threatening circumstances of using the G5x, their consequences, and how to avoid the hazard.
Chapter 1 Getting Started: Beginning Your Dexcom G5®x Continuous Glucose Monitoring System (G5x) Journey 1.1 Introduction Welcome to the G5x family! We are excited you chose us to partner with you in your journey to manage your diabetes. As a continuous glucose monitoring (CGM) device, the G5x allows you to break free from constant fingersticks.
3. User Guide No matter which resource(s) you select, make sure you review them prior to using your new CGM system. 1.2 Self-Paced Resources Tutorials Along with step-by-step instructions, our tutorials illustrate how real-time CGM can assist in your daily diabetes management. The following is a list of tutorials and how to access them. Online Tutorials First Steps With Your Dexcom CGM Designed for those who have never used a Dexcom CGM.
USB Card in the receiver package. Guides Getting Started Guide (GSG) The G5x GSG complements the tutorials by providing the same step-by-step instructions in a booklet form or within the app. One of the great things about the GSG is you can use it in conjunction with the videos, taking notes as you go! Accessing the GSG: Booklet in the receiver package. Both the tutorial and the GSG give you a brief look at the G5x.
• Introduction to the G5x • Initial Setup • Starting a Sensor Session: Inserting the Sensor and Attaching Transmitter • Calibration • Ending a Sensor Session and Transmitter Session Part 3: Next Steps - Getting the Most out of Your G5x Once you are up and running, how you can maximize the G5x features: • Reading Trend Graph Screens and Recognizing Trends • Events • Alarm and Alerts • Sounds for Alarm, Alerts, and System Messages Part 4: Everything Else G5x • Warranty • G5x Maintenance
o Your Followers o Troubleshooting Part 6 • Index for G5x System and Dexcom Share How to Use Your User Guide All chapters in the G5x user guide are laid out the same way: The beginning of each chapter lists what you’ll be able to do after you have finished, after that, any applicable safety statements you need to know, followed by the chapter’s content. At the end, there’s a recap of what was covered and what’s in the next chapter. 1.
Next you’ll learn about when and how to use the G5x safely.
Chapter 2 Getting Started: Indications for Use and Safety Statement 2.1 Introduction We want the G5x to be a valuable tool in your diabetes management. Like any system, there are steps to take to get the most out of it.
Let’s start with definitions, look at a Safety Statement example used throughout the User Guide, and then review the Safety Statements broken down into the system’s components. Safety Statement A Safety Statement is a brief statement of the G5x’s indications, relevant warnings, precautions, or its contraindications (when to avoid using it).
o Lists all Safety Statements o Includes a section reviewing how the statements are formatted 2. Within each chapter o Lists only those statements applicable to that specific chapter Chapter’s Safety Statements Each chapter will list all applicable indications, contraindications, warnings, and precautions. Some chapters will have multiple Safety Statements; others have none. Safety Statements are located toward the front so you can keep them in mind as you learn about that chapter’s topic.
The following is an example of a chapter’s Safety Statement and how to read it. W arning Do: Calibrate at least once every 12 hours W hy: Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings Consequences: Missing severe low (hypoglycemia ) or high (hyperglycemia) Alarm or Alerts Since this is a W arning, you know it covers important safety information. Italics are the Do/Don’t steps to follow: Calibrate at least once every 12 hours.
What are the G5x indications? Well, in technical terms, the indications are: The Dexcom G5x Continuous Glucose Monitoring (CGM) System (G5x) is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes. The system is intended for single patient use and requires a prescription. The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
The G5x’s trend and pattern information is based on a series of sensor glucose readings taken over a period of time. Work with your healthcare professional and create a game plan on how to best use your trend and pattern information in managing your diabetes. Contraindications Contraindications let you know when not to use the G5x; you may hurt yourself or damage the system. Remember, if used during certain situations, the risk of use may clearly outweigh any potential benefit.
Warnings outline important hazard information, describing any serious and/or life-threatening situations, their consequences, how to avoid danger while using the system and how to protect the G5x from harm. Review Training Materials Thoroughly review the training materials included with your system before using. Incorrect use could lead you to misunderstand system information or might affect its performance and you might miss a severe low or high glucose event.
2.6 Calibration Warning and Precautions Calibration is the process of making sure your sensor continues to be accurate. Your sensor doesn’t automatically know what your glucose levels are—you have to teach your system what a given BG value is by entering in a KNOWN glucose value from your BG meter. Warning Calibrate on Schedule Calibrate at least once every 12 hours.
• Two arrows pointing down o Falling more than 3 mg/dL each minute Calibrating during a significant rise/fall of your BG may affect accuracy of sensor glucose readings, resulting in you missing a severe low or high glucose event. Fingerstick Only Only use fingerstick measurements from your BG meter for calibration. Alternative site BG values from your arms, palm of your hand, etc., may be different and less accurate than your fingerstick BG values.
On rare occasions, the sensor wire may break or detach from the transmitter holder. Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department, toll free at 1.888.738.3646 If a sensor wire breaks under the skin with no portion of it visible, don’t remove it. Contact your healthcare professional if you have redness, swelling, or pain at the insertion site.
Don’t use sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection. Clean and Dry Before Using Before opening the sensor package, wash your hands with soap and water, then dry. If your hands are dirty while inserting the sensor, you may contaminate the insertion site and get an infection. Before sensor insertion, clean the skin with alcohol wipes to prevent infections.
If your transmitter is damaged or cracked in any way, don’t use it. Damaged components could create an electrical safety hazard or malfunction, which might cause electrical shocks. Choking The transmitter is small and may pose a choking hazard. Don’t put it in your mouth or allow children to play with it. Precautions Reusable: Don’t Throw Away When ending a session, don’t throw away the transmitter. The transmitter is reusable and can be used in multiple sensor sessions.
System accuracy may be affected when your glucose is changing at a significant rate such as during exercise or after a meal. Significant glucose rise/fall rates: • Rising 2-3 mg/dL each minute • Rising more than 3 mg/dL each minute • Falling 2-3 mg/dL each minute • Falling more than 3 mg/dL each minute Airport Scanners Be aware of airport body scanners and baggage x-rays when you travel. Do not place any part of the G5x system in the baggage x-ray machine or body scanner.
Precautions Communication Range Do not separate the transmitter from the receiver or smart device by more than 20 feet. The transmission range from the transmitter to receiver or smart device is up to 20 feet without obstruction. Types of obstruction differ and not all have been tested. Obstructions can include water, walls, metal, etc.
Warnings Smart Device Settings The app can’t override your smart device’s internal settings. Also, accessory devices (like a smart watch or other wearable smart devices) might override your smart device’s Alerts and Alarm. To receive Alarm or Alerts you must: 1. Make sure app Notifications are turned on in the Setting’s menu. 2. Verify app hasn’t been shut down. ® 3. Turn Bluetooth on. 4. Turn off Do Not Disturb (if available on your smart device). 5. Restart app after device is restarted. 6.
Warning Don’t Use Damaged Goods If your receiver is damaged or cracked, don’t use it. This could create an electrical safety hazard or malfunction, causing possible electrical shocks. Avoid Strangulation Use USB cable only as directed and store safely. Misuse of the USB cable can present a strangulation risk. Precaution Test Receiver If your receiver gets wet or dropped, make sure the speaker and vibrations still work. To check, either plug it in, turn it on, or go to the Profiles menu and select Try It.
• Explain the difference between an indication and a contraindication • Describe the importance of warnings • Describe what a precaution is • Correctly read a chapter’s Safety Statement • Provide an overview of Safety Statements by category W hat’s Next? In our next chapter, you will learn about the risks and benefits of using the G5x.
Chapter 3 Getting Started: Risks and Benefits When using any medical device, there are risks and benefits. In this chapter, you’ll learn what they are so you can better understand the pros and cons of CGM and the G5x. First, let’s review some possible risks. 3.1 Risks There are some risks with using real-time CGM. Not Receiving Alarm/Alerts If you aren’t getting your CGM Alarm/Alerts, you run the risk of not knowing you are having a severe glucose low or high.
The sensor glucose reading can be different from your meter’s BG value. If the sensor’s glucose reading is higher than your meter’s BG value, you may miss a Low Alert. As an example, your last sensor glucose reading was 82 mg/dL, whereas your meter BG value shows 78 mg/dL. If your Low Alert is set at 80 mg/dL, you won’t receive an alert because the sensor glucose reading is 82 mg/dL.
3.2 Benefits Daily habits impact your BG levels. With the G5x, you can track how your exercise, carbs, stress levels, medication, or illness influences your glucose levels. Knowing Your Trends Providing sensor glucose readings every five minutes, for up to seven days, the G5x helps you detect trends and patterns. Trend information reveals where your glucose is now, where it’s been, where it’s heading, and how fast it’s changing.
Lowering your A1C, increasing your time in your target range while decreasing time in low/high BG range is believed to reduce your risk of diabetes-related complications (Ohkubo, Y., 1995). In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM (Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, 2010).
2 LET’S G5x! THE BASICS • Introduction to the G5x • Initial Setup • Starting a Sensor Session: Inserting the Sensor and Transmitter • Calibration • Ending a Sensor Session and Transmitter Session Dexcom G5x System User Guide 41 PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 4 Let’s G5x! The Basics: What Is the G5x? 4.1 System Description Now it’s time to get an overview of the the Dexcom G5x. After this chapter, you’ll be able to: • Explain the G5x • Describe options to view trends • Locate your historical readings • Recognize system components • Explain each part’s function 4.2 Safety Statement While you can use the G5 Mobile receiver with the G5x, you can’t use the sensor or transmitter from previous generations.
W arning Don’t: The system was not evaluated for the following persons: • Pregnant women Persons on dialysis Don’t use the system in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients.
G5x-Compatible Components G5x System Components Components Not Compatible with G5x G5x Sensor G5 Mobile/G4 PLATINUM Sensor G5x Transmitter G5 Mobile Transmitter G5 Mobile Receiver G4 PLATINUM Transmitter G5 Mobile App G4 PLATINUM Receiver with Share G4 PLATINUM Receiver 4.3 The G5x The G5x is a medical device you use on yourself.
2. G5 Mobile app (app) on your smart device While the system works with different smart devices, they’re not interchangeable during a sensor session, so before starting one, select which smart device you want to use and stick with it throughout your session. You can’t use multiple smart devices at the same time, but you can combine the receiver with a smart device during a session. The G5x is the first CGM system where a smart device acts as a receiver.
Alarm/Alerts Being warned when your glucose value is too high or too low, falling or rising too quickly, or trending toward a severe low or high is very important. Warnings in the form of Alerts or an Alarm help you avoid getting too low or too high. Alarm and Alert notifications help keep you aware of your glucose trends and are made up of a combination of sounds, vibrations, and screens. There are a number of Alerts, but only one Alarm: when your glucose level dips below 55 mg/dL.
Redesigned G5x Transmitter Holder and Transmitter The redesigned transmitter and its holder enjoy a lower profile. The transmitter snaps into the newly designed holder and, with its new breakaway feature, snaps out for easy transmitter removal. For more information on how to attach the transmitter, go to Chapter 6. After a sensor session has ended, see Chapter 8 for its removal. 4.5 System Information The receiver and app also keep you informed on the system’s status.
Single use sensor(s) Sold separately. Comes in a sterile pack.
Receiver Receiver’s USB charging and download cable Receiver AC power adapter Welcome Card Dexcom G5x System User Guide 49 PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Getting Started Guide Training Checklist attached to Getting Started Guide Training Tutorial USB Card Overview of System Components This section is meant as a quick overview of each part; specifics for each are found in following chapters. For detailed product specifications and technical information, please go to Chapter 17. The G5x is comprised of four key parts: 1.
2. Reusable transmitter 3. Rechargeable receiver 4. G5 Mobile app G5x optional: Dexcom Share Sensor Applicator Overview After removing the backing from the adhesive patch on the back of the sensor applicator, place the applicator on your skin and remove the safety guard. Push the orange button to insert the sensor wire and release the transmitter holder. The sensor wire is made of silver and platinum with polymer membranes.
Applicator and Transmitter Holder What it’s called What it does Applicator Contains small insertion needle and sensor wire. Inserts sensor wire under the skin. Applicator Disposable, for single use only. Removed after insertion. Keeps all moving parts in place before insertion. Safety Guard Prevents accidental sensor insertion. Fold and break to remove. Button Press to insert sensor wire and release transmitter holder.
Holds sensor wire and transmitter in place. Transmitter Holder Water resistant when transmitter is properly installed. Discarded after sensor session. Adhesive Patch Keeps transmitter holder attached to your skin. Measures glucose levels in the fluid between your cells (interstitial fluid). Sensor Wire Attached to transmitter holder once inserted under skin. Discarded with holder after session. Transmitter Overview Figure 2.
device. If you have a new transmitter, open the package when you are ready to use it. Transmitter features: • Reusable o Do not discard after sensor session. o Only for you, don’t share transmitter. Water resistant • • Can transmit data to your display devices for up to 20 feet o Range is less if you are in or under water. • Battery lasts approximately three months o Receiver or smart device notifies you when battery is running low.
Remember, you can’t use a combination of smart devices during a sensor session; select just one. Receiver Overview What you see What it’s called What it does Receiver Provides data about your glucose trends via screen display, sounds, and vibration. Micro USB Port Plug USB cable into port for recharging. USB Port Door Close USB port door after removing USB cable to keep receiver clean and dry. Plug into receiver to charge battery. Micro USB Cable Don’t plug into a computer port to charge.
What you see What it’s called What it does Plug USB cable into adapter/wall charger. Wall Charger Plug wall charger into an electrical outlet to charge receiver’s battery. Don’t block access to the charger. Display Screen Shows sensor glucose readings, trend graphs and arrows, Alarm/Alerts, sensor session status. Change settings on Menu screen. Speaker Dexcom G5x System User Guide Allows you to hear your Alarm/Alerts sounds.
What you see What it’s called What it does Left Arrow Press to go back to last item/screen or home screen. Right Arrow Press to highlight next item. Press to scroll up or down to select menu items or set values. Up/Down Arrows Press to scroll back and forth from the 3-hour trend graph to the 1-6-12-24 views. 4.7 Smart Device Overview The app was created to work with your smart device, giving you even more options in monitoring your glucose trends and patterns. The app is similar to all other apps.
• Describe options to view trends • Locate your historical readings • Recognize system components • Explain each part’s function Next Steps Your next step in getting started with the G5x is selecting how to continuously receive your sensor glucose readings: using the app, the receiver, or a combination.
Chapter 5 Let’s G5x! The Basics: Set Up Your Display Devices 5.1 Introduction In the previous chapter, you received a high level overview of the G5x and learned you can monitor your glucose levels with different display devices. Now it’s time to set up your app and your receiver. After this chapter, you will be able to: • Create a Dexcom username and password • Download the app • Set up the app with the recommended settings • Successfully set up your receiver 5.
Precaution Do : The G5x transmitter must be used with the G5x Sensor and is not interchangeable with the Dexcom G5® Mobile/G4® PLATINUM Sensor. The G5x transmitter is compatible with the G5 Mobile receiver. W hy: The G5x transmitter and G5 receiver are not compatible with the Dexcom G4 PLATINUM CGM System’s transmitter and receiver. Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) glucose event.
With the exception of Dexcom Share, the primary difference between the two monitoring systems is not the data itself, but how it’s presented. The next section walks you through the initial setup for the app. To set up the receiver, go to Section 5.5. If you want to use both the app and the receiver, you need to setup each individually. Once you have completed the initial setup, you’re one step closer to beginning your sensor session! 5.
• For information on how to set the above settings, see your smart device’s user guide. Once you have verified your smart device’s settings are right, the next step is installing the app • The app needs to be open and running in the background.
But what if you are unclear about a step? The app has notifications allowing you to get more information. If you are unsure of something during your initial setup process, look at the screen for additional information notifications. Informational notifications include, but aren’t limited to: I don’t understand, Learn More, or Question Mark. Tap your informational notification to get more information. To close out of the information notification, tap the X in the upper right-hand corner.
2 Swipe through introductory screens or tap Log In. Enter existing username and password OR 3 Need a Dexcom username and password? Tap Sign Up. Complete Username/Password fields. Tap Login once.
4 Tap Let’s Get Started. The next screens are the Terms of Use, safety warnings, contraindications, and the recommended settings. 5 Once each screen is read, tap the appropriate answer to move forward. Tap Full Safety Statement or, when applicable, I don’t understand to get more information.
Set your Low Glucose Alert. Default is 80 mg/dL. 6 Scroll to select another amount. Tap Save to move forward. Once your Low Glucose Alert is set, you’ll receive an Alert notification if your glucose dips below your set amount. Set your High Glucose Alert. Default is 200 mg/dL. 7 Scroll to select another amount. Tap Save to move forward. Once your High Glucose Alert is set, you’ll receive an Alert notification if your glucose rises above your set amount.
8a 8b Make sure you get your Alarm/Alerts notifications. Tap the appropriate response to move forward and set your notifications. Tap OK to receive Alarm/Alerts notifications.
9 The next screens provide suggestions for device volume, Do Not Disturb, and other basic settings. Tap appropriate answer to move forward.
10 Tap Next. Verify Bluetooth is on. 11 The app will check to see if Bluetooth is turned “on.
Turn transmitter box upside down on a flat surface with barcodes facing up. 12a Center longest barcode within green brackets. For information on how to pair transmitter after initial setup, see Chapter 8. 12b Center longest barcode within green brackets.
12c 13a Check mark confirms successful transmitter SN scan. If unable to use app’s scanning device: Tap Enter transmitter SN by hand.
Use keyboard to enter transmitter SN. 13b Confirm correct SN . Tap Save. 14 Insert sensor and attach transmitter following video’s instructions. See Chapter 6 for more information.
15 16 W ait up to 30 minutes for smart device and transmitter to connect. At notification, Tap Pair to pair app with smart device.
Tap the Sensor warmup circle to start your two-hour sensor warmup. 18 When you see the sensor warmup timer, your initial setup is complete. Congratulations! If you have any issues setting up the G5 Mobile app, always contact Technical Support (available 24/7) at: • TechSupport@dexcom.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 If you are having problems with your smart device, contact your smart device’s support line.
• Menu selection screen Navigation Wheel: • Select o Button in the middle of the navigation wheel o Press to: ! • Center button does not say “Select” ! Turn on receiver ! Select options/features ! Accept changes ! Move forward through menus/features Up/Down o Scroll through trend screens o Highlight menu items o Change values o Go back to last item or screen • Left • Right o Go to next item or screen Initial Setup of the Dexcom Receiver Press Select to turn receiver on.
How you complete your initial setup differs between the receiver and your smart device; however, the data is the same. Setup Wizard Notifications: • Time/Date • Transmitter Serial Number o Back of transmitter o Back of transmitter’s box • Setting Low Glucose Alert • Setting High Glucose Alert Before starting a session, you may want to check the receiver’s battery level. If it is less than half, go to Chapter 4 for charging instructions.
Press Up/Down Arrow to change year. Press Right Arrow to move forward. 3 Press Up/Down Arrow to change month. Press Right Arrow. Press Up/Down Arrow to change day. Press Right Arrow to move to time. Time/Date Press Up/Down Arrow to change hour. Press Right Arrow. Press Up/Down Arrow to change minutes. 3b Press Right Arrow. Press Up/Down Arrow to select AM/PM. Press Select to save and close.
If transmitter package isn’t available: 4b 4c • SN is on transmitter’s back Press Up/Down Arrows to select and enter transmitter SN. Press Right Arrow to move to next digit. Press Select to save and close. Setting Low Alert System default is at 80 mg/dL. 5a Press Select to save at present levels and close. To change value: 5b Press Up/Down Arrows to change value at 5 mg/dL increments. Press Select to save and close.
System default is at 200 mg/dL. 6a Press Select to save at present levels and close. To change value: Press Up/Down Arrows to change value at 10 mg/dL increments. 6b Press Select to save and close.
4. Two-hour sensor warmup. 5. Startup calibrations.
Chapter 6 Let’s G5x! The Basics: Starting a Sensor Session: Inserting Sensor, Attaching Transmitter, and Starting Your Session 6.1 Introduction Now that your display devices are set up, you’re ready to begin a sensor session. If this is your first time inserting a sensor, you may want to watch the G5x sensor insertion video to get a better understanding of the process. There are three ways to get the sensor insertion video: 1. Through the app 2. On the USB card in your receiver package 3. Online at dexcom.
• Identify sensor applicator features • Properly prepare for sensor insertion • Choose the best location to insert your sensor • Correctly insert your sensor • Prepare transmitter for placement • Correctly attach transmitter to transmitter holder • Outline what happens during the sensor warmup • Identify countdown icon 6.2 Safety Statements Following are some important Precautions and Warnings to review; we want to make sure you and the system are safe before starting a sensor session.
W ar nin g D on ’t: Insert the sensor component of the system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). W hy : The placement and insertion of the sensor component of the system is not approved for other sites. C on se qu e nc es : The system has not been tested in other areas and may not work properly if inserted in other areas. W arning Do: During a sensor’s shelf life, store it between 36° F-86° F.
W arning Don’t: Use the system sensor glucose readings for treatment decisions. Do: When making treatment decisions, such as the amount of insulin you need, only use your BG value from your BG meter. W hy: Since they measure your glucose from different body fluids, sensor glucose readings can be different from your meter’s BG values. Consequences: If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event.
Precaution Don’t: Use sensor if its sterile package has been damaged or opened. W hy: Make sure the sterile sensor pack has not been damaged or previously opened. If opened or damaged, sensor may be unsterile. Consequences: Using a non-sterile sensor might cause an infection. Precaution Don’t: Don’t remove the safety guard before placing the applicator on the skin. W hy: If you remove the safety guard first, you may accidentally deploy the needle and hurt yourself.
Sensor Applicator Inside Sensor Box What you see What it is Sterilized applicator and sensor tray with important label information. Check expiration date. Do not use if it is past the expiration date. Open when ready to use. Single use sensor applicator. Knowing what each applicator piece does helps you successfully insert your sensor. Chapter 4, Section 4.6 gave you an overview of the sensor applicator.
Figure 3. G5x Sensor Applicator and Transmitter Holder The following table reviews the sensor applicator components in order of use. Sensor Applicator Components Order of Use Name What it does 1 Adhesive Patch Keeps transmitter holder securely on your skin. 2 Safety Guard Prevents applicator from inserting sensor wire before you are ready. 3 Applicator Inserts sensor under your skin. 4 Transmitter Holder Holds sensor wire in place under skin. Holds transmitter.
Reusable transmitter. Please Note: Picture is representative only; your transmitter may look different. In the previous chapter, you entered your transmitter SN into your display devices and made sure your smart device and/or receiver connected with the transmitter. You won’t be able to start a sensor session if your transmitter isn’t paired with your receiver and/or smart device. Not included in packages: 1. Alcohol wipes 2. Your BG meter 3.
Front of body (belly area) for ages 2 years and older.
Optional Site Preparation Use optional skin adhesives (Mastisol™, SkinTac™) as part of your insertion site preparation to help keep your transmitter holder attached. Apply the skin adhesive after you selected and cleaned your insertion site. Create an empty sideways oval, making sure you don't get any skin adhesive inside the oval. . Let the oval dry based on skin adhesive manufacture’s instructions. Once dry, your skin may feel slightly sticky. See Step 3 in the next table for directions.
2 Clean insertion site with alcohol wipe. Let dry. Optional Step: Skin Adhesive Create a empty sideways oval on the skin 3 • Do not get any skin adhesive inside the oval • Let skin adhesive dry (see manufacturer’s instructions) • Insert sensor on clean skin at the center of the oval Preparation Check pack. Is it damaged or already opened? 4 • If yes, do not use Peel lid off of sensor pack Keep sensor packaging until sensor session is complete.
5 6 Place hand over pack’s opening Gently roll pack so applicator falls out and rests in the palm of your hand. Closely inspect sensor applicator, to check it has not been damaged. Remove Adhesive Backing 2-step process: 7 1. Remove large tab covering adhesive patch. 2. Remove small tab. Don’t touch adhesive after removing backing.
Inserting Sensor Wire and Transmitter Holder Place applicator horizontally, not vertically, on skin. 8 Firmly press down, sticking adhesive patch to your skin. Fold and break safety guard. 9 Throw safety guard away. 10 Dexcom G5x System User Guide Push button to insert sensor.
Release button and remove applicator. Throw out applicator following local guidelines for disposal of bloodcontacting components. 11 What’s left on your skin? • Sensor wire • Transmitter holder You have successfully inserted the sensor! Now the transmitter holder and sensor wire are attached to your body. Having problems? If it’s the first time inserting a sensor, you may have questions or need help. If you do, please contact Technical Support (available 24/7) at: • TechSupport@dexcom.
until your session is over. Chapter 8 reviews when and how to remove your transmitter. Before attaching your transmitter, check you’ve entered the correct transmitter SN into your display device. Chapter 5 covers entering transmitter’s SN number during initial setup. See Chapter 8 for pairing your transmitter after the startup wizard Attaching Transmitter Step Picture 1 What you do Remove transmitter from box only when you are ready to insert it. Keep box. Get alcohol wipe.
Hold transmitter’s round end. 3 Slide transmitter’s narrow tip into slot at the narrow end of transmitter holder. Step Picture 4 5 What you do Press down firmly on round end of the transmitter until it clicks into place. Move fingers around top of adhesive patch three times to secure tape. You’re almost done starting your sensor session! Inserting the sensor, attaching the transmitter, and the two-hour sensor warmup are the same, regardless of whether you use the receiver or app.
The remaining steps vary from app to receiver: 1. Letting your device know you need to start the sensor warmup. 2. Following your warmup countdown. 6.7 Loose Transmitter Holder The transmitter holder should be able to stay on your skin using its own adhesive. If the patch peels up, use medical tape (such as Blenderm™, Tegaderm™, ® Smith & Nephew IV3000 , 3M™ tape) for extra support.
your device(s) you want to start a sensor session. Transmitters are reusable; pairing is required only when using a new transmitter. During the warmup period, neither device will provide any sensor glucose readings. Your sensor glucose readings begin after the two-hour sensor warmup has passed and you entered the two startup calibration BG values into either the smart device or the receiver. We’ll first review starting the sensor session for the app.
W ait. Screen provides countdown to sensor warmup. The orange dashes darken as the countdown moves forward. 3 Keep smart device within 20 feet of transmitter during the sensor warmup period. Step What you see What you do Locked screen. 4 Startup calibration notification tells you when warmup is complete. Chapter 7 covers calibrating.
Startup calibration notification tells you when warmup is complete. 5 Sensor warmup is complete. You’re ready to calibrate! Receiver: Starting a Session Step What you see 1 Step What you do Press Select to turn on receiver.
Make sure receiver and transmitter are connected/paired before starting sensor session. Check receiver 10 minutes after starting for Bluetooth icon. 2 • Solid: Connected/paired • Blinking: Searching/not paired Don’t start a sensor session until they are paired. Once connected/paired: Press Select to go to the Main Menu Press Down Arrow to highlight Start Sensor. 3 Press Select to start new sensor session. NOTE: After sensor starts, Start Sensor option disappears.
Receiver returns to the trend graph screen. 5 Step What you see What you do W ait. 6 Screen provides countdown of the twohour sensor warmup. Sensor warmup is complete. 7 You’re ready to calibrate! 6.9 Receiver Bluetooth Tips Your transmitter and receiver begin communicating once you start a sensor session. After approximately 30 minutes, if the Bluetooth symbol is solid, and not blinking, your transmitter and receiver are talking to each other.
o Don’t start a sensor session until they are paired. If the Bluetooth icon isn’t on the receiver and the Signal Loss icon appears in the receiver’s upper right corner of the status bar, they’re not communicating. No Communication Between Transmitter and Receiver Step What you see What you do Check correct transmitter SN is in receiver. 1 • SN is on the label on bottom of transmitter box Press Select to go to Main Menu. 2 3 Dexcom G5x System User Guide Press Down Arrow to Settings.
Step What you see 4 What you do Press Select. Check correct transmitter SN is in receiver. • 5 SN is on the label on bottom of transmitter box Compare SN in receiver to SN on transmitter box. If correct, call our 24/7 Technical Support department, toll free at 1.888.738.3646 or toll at 1.858.200.0200 for help. Press Select to exit screen. Press Left Arrow twice to go to Main Menu. If Wrong SN Entered 6 Dexcom G5x System User Guide Press Left Arrow twice to go to Main Menu.
Step What you see 7 What you do If sensor session has started, to correct the transmitter SN, you must stop the sensor session. Press Down Arrow to Stop Sensor. Press Select. 8 Press Select to stop session. If Wrong SN Entered 9 W ait for sensor session to end. From Main Menu: 10 Press Down Arrow to Settings. Press Select.
Step What you see 11 12 What you do Press Down Arrow to Transmitter. Press Select. Highlight Transmitter SN. Press Select. Enter correct SN using Up/Down Arrow. Press Up/Down Arrow to select and enter transmitter SN. 13 Press Right Arrow to move to next digit. Press Select to save and close. Press Left Arrow twice to return to Main Menu. Start Sensor Session. 14 Press Up/Down Arrow to highlight Start Sensor. Press Select. 6.
The sensor takes about two hours to adjust to your body. While you are in the sensor warmup period, you can customize your settings. Chapter 12 steps you through how to personalize your G5x display devices. Once the sensor warmup is complete, you’re ready to enter your startup calibrations! The next chapter shows you how.
Chapter 7 Let’s G5x! The Basics: Calibration 7.1 Introduction In the previous chapter, you learned how to insert your sensor, transmitter, and start a new sensor session. You’re now ready to begin your last step before getting your sensor glucose readings: Calibration. This chapter reviews not just your startup calibration, but also update calibrations required throughout your sensor session.
• • Correctly enter your fingerstick measurement o In the app o In the receiver Identify calibration errors 7.2 Safety Statements Contraindication Don’t: Take medications containing acetaminophen while wearing the sensor. W hy: Taking medications with acetaminophen (such as Tylenol or Excedrin Extra Strength) while wearing the sensor may falsely raise your sensor glucose readings. The level of sensor inaccuracy: 1. Depends on amount of acetaminophen active in your body. 2.
W arning Do: Calibrate at least once every 12 hours. W hy: Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate. Consequences: Missing severe low (hypoglycemia ) or high (hyperglycemia) glucose event. Precaution Do: Look for rate of change arrows on your display device screen. Trend arrows help you determine if you can calibrate now or should wait. Don’t: Calibrate when your BG is changing at a significant rate: more than 2 mg/dL per minute.
Precaution Do: Enter the exact BG value displayed on your BG meter within five minutes of a fingerstick. W hy: Entering the wrong BG values, or waiting more than five minutes before entry, might affect sensor performance. Consequences: You may miss a severe low or high glucose event. Precaution Do: Only use fingerstick measurements from your BG meter for calibration. Don’t: Use alternative site BG values from your arms, palm of your hand, etc.
Why Is Calibrating Important? Calibrations are a must to make sure the CGM system is performing at its best. By calibrating when the system notifies you that a calibration is due, the G5x uses your meter’s BG value to make sure the sensor glucose readings remain accurate throughout your session. How Do I Calibrate? Take a fingerstick measurement from your meter, and simply enter the meter’s BG value into one of your display devices.
Now that you have an overview of calibration, let’s review some contraindications, warnings, and precautions you need to know and follow before you calibrate. 7.4 When to Calibrate Calibrating on a regular schedule aligns your sensor glucose readings with your meter’s BG values. Without calibrations, your sensor may be inaccurate, and as a result, so will your display device’s sensor glucose readings, Alerts, and notifications, etc. There are important times when you must calibrate: 1.
2. Entered update calibrations at 10 PM that night. 3. For the rest of the seven-day sensor period, you enter update calibrations at 10 AM and 10 PM. Figure 5. Example Minimum Calibration Schedule During Seven-Day Sensor Session Update calibrations are typically 12 hours since your last calibration; however, they can be sooner. As an example, if you know your next calibration is due at 10 PM, but you want to go to bed at 9 PM, you can do the calibration before bedtime, resetting the 12-hour count down. 1.
Once your two-hour sensor warmup is complete, your display device tells you it’s time to enter the first of your two back-to-back startup calibrations. Once the system has accepted your BG values, your glucose readings begin. If you don’t enter your BG values right away, the system reminds you every 15 minutes. Remember, use only your BG meter for calibrations, and never enter values from your CGM.
Receiver Device What you see What it means What you do Sensor accepted first calibration. Follow steps in Section 7.6 and 7.7. Ready for second BG meter value. Next calibration in 12 hours.
Receiver Your sensor glucose readings begin in approximately five minutes once the device(s) accepts your calibrations. Update Calibration Notifications Once your startup calibration is done, your update calibration schedule begins. The steps to enter your update calibrations are the same as your startup calibration, including only entering values in one display device. The only difference is, with update calibrations, enter your BG meter value just once.
Receiver • BG values are very different from sensor glucose readings Tap Message to clear notification on your smart device. To clear a notification on your receiver, press Select. Sound/Vibration Notifications In case you can’t look at your screen, both the smart device and receiver provide, with the exception of your regular 12-hour update calibration, beep/vibration notifications to let you know it’s time to calibrate or if there was a system calibration error.
1. Wash and dry your hands before staking a fingerstick measurement. 2. Always use the same meter you routinely use to measure your BG. a. BG meter and strip accuracy vary between meter brands. b. Switching within a session might cause sensor glucose readings to be less accurate. 3. Follow meter’s instructions exactly when taking your fingerstick measurement. 4. Verify test strips are current and, if required, coded correctly with meter. 5. Check: Is Bluetooth on? a. If off, can’t calibrate 6.
You don’t have to take a fingerstick measurement for each display device when calibrating. Once you enter the reading into one, data is pushed to the other within ten minutes. Next are steps to enter your calibrations using the app, followed by the steps for entering your calibrations into the receiver. Startup Calibration in the App Step What you see 1 What you do Additional Info Tap circle. Startup calibration: Enter two back-to-back meter BG values. Update calibration: Enter one meter BG value.
Step What you see 2 What you do Enter meter’s BG value using number pad. Tap Save. Additional Info Double-check your numbers. Entering wrong values, or values taken more than five minutes ago, can affect the sensor’s accuracy. Verify value is correct. Tap Save. 3 If not correct: Tap Cancel. Reenter correct value.
Step What you see 4 5 What you do Tap circle to enter your second BG value. Follow steps 2-3 and enter second reading. Meter icon has no calibration notification. Calibration accepted. Dexcom G5x System User Guide Additional Info Your calibration was successful.
Step What you see 6 What you do Additional Info W ait for next calibration notification in 12 hours. Default Home trend screen. Calibration accepted. Startup Calibration W ith Your Receiver Step What you see 1 Dexcom G5x System User Guide What you do Additional Info Press Select to turn on receiver. You won’t see calibration notifications when receiver screen is black. Press Select again for Main Menu.
Step What you see What you do Additional Info Press Up/Down Arrow. 2 Highlight Enter BG. Press Select. 3 Press Up/Down Arrow to change numbers. Stop at meter’s BG value. Press Select. 4a Verify BG value is correct. If correct: Press Select. Dexcom G5x System User Guide Sensor default reading is 120 mg/dL. If sensor glucose reading is within the last 15 minutes, screen will show sensor’s actual reading.
Step What you see What you do Verify BG value is correct. If incorrect: 4b Press Right Arrow to Cancel. Press Select. Additional Info Cancel and reenter BG value. Fingerstick measurement must be within the last five minutes. Reenter BG value. “Thinking” screen. 5 Wait. 6 Immediately take another meter reading. Enter meter’s BG value. Dexcom G5x System User Guide BG value is accepted. First calibration accepted. Time for second calibration.
Step What you see 7 What you do Additional Info W ait for next calibration notification in 12 hours. Default trend screen. Calibration(s) accepted. 7.8 Calibration Errors Before or during your calibration process, your display device may show error notifications. If the notifications don’t go away after 15 minutes, refer to Chapter 18, Troubleshooting. Calibration Error Notifications Device What you see What it means Smart Device: In App W ait 10-15 minutes. Sensor can’t calibrate now.
Device What you see What it means Smart Device: In App System didn’t accept recent calibration. Receive r What you do Additional calibration needed immediately. Calibrate. No sensor glucose readings. Approximately five minutes after entering your second BG meter value, your display device(s) will start providing sensor glucose readings and glucose level trends. While each display device may have different ways of presenting sensor glucose readings and trends, the meanings are the same.
o Recognize when you can enter BG meter values o Recognize when you should not enter BG meter values o Determine if you need to calibrate outside of the normal calibration guidelines • Initiate startup calibration • Perform update calibrations • Correctly enter your fingerstick measurement • o App o Receiver Identify calibration errors W hat’s Next? In the next chapter, you’ll learn how to end a typical seven-day sensor session, what to do if you need to end your sensor session early, alon
Chapter 8 Let’s G5x! The Basics: Ending Your Sensor Session and Transmitter Session 8.1 Introduction G5x sensor sessions last seven days. This chapter reviews what you should expect when your session is about to expire, and removing the sensor and transmitter. It also covers how to determine if you need to end your session early.
W arning Don’t: If a sensor breaks under the skin with no portion visible above the skin, don’t remove it. Do: Contact your healthcare professional if you have redness, swelling, or pain at the insertion site. Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department:: Email: TechSupport@dexcom.com Toll free: 1.888.738.3646 Toll call: 1.858.200.0200 W hy: Sensors may fracture on rare occasions.
The most common is your sensor’s typical seven-day time frame ended. The second is ending the sensor session early. You may end a session early based on a personal decision, or, on rare occasions, the receiver or app detects sensor issues and notifies you to end the session. Let’s review ending a normal session first; later in this chapter we’ll review the notifications for ending the session early.
Device What you see What it means Smart Device: Lock Screen Notifications begin when sensor session has only six hours left. Clock will count down until session has ended. Smart Device: In App Continue to get sensor glucose readings.
Device What you see What it means Smart Device: Lock Screen Two hours remain on your current sensor session. Smart Device: In App Continue to get sensor glucose readings.
Device What you see What it means At Thirty Minutes Smart Device: Lock Screen Smart Device: In App Thirty minutes remain. Continue to get sensor glucose readings.
Device What you see What it means Session Ended Smart Device: Lock Screen What see Session has ended. App Smart Device: In App Tap screen’s “?” for steps to: • • Remove sensor Insert new sensor Receiver Press Select to clear.
Device What you see What it means Session Stopped Smart Device: Lock Screen N/A Sensor session has stopped.
The receiver alerts you with an initial vibration notification. If not cleared, you receive a vibrate/beep twice, five minutes apart. Once a sensor session has expired, you are ready to start your new session! If you’re not sure what to do, the app will provide instructions, or you can refer to the Getting Started Guide, online tutorials, or Chapter 6 in this user guide.
Device What you see What it means Smart Device: Lock Screen Sensor issues detected. Smart Device: In App Session ends automatically. No: • • Sensor Glucose Readings Alarm/Alerts Replace sensor. Receiver Device What you see Smart Device: Lock Screen Dexcom G5x System User Guide What it means Wait up to three hours while the system autocorrects.
Device What you see Smart Device: In App What it means Check transmitter—is it properly inserted into transmitter holder? Make sure you haven’t taken acetaminophen. If not corrected after 3 hours: • Contact Dexcom Technical Support Receiver Smart Device: Lock Screen Smart Device: In App Wait up to three hours while the system autocorrects. Check transmitter—is it properly inserted into transmitter holder? Make sure you haven’t taken acetaminophen.
While the end result is the same (ending a sensor session), the steps differ between the app and receiver. If you’re using both, no need to stop the sensor session in each: the other display will see the session has stopped. Let’s first look at how to end a sensor session in the app, then the receiver. App: Ending a Sensor Session Early Step What you see 1 What it means What you do Access Main Menu. Tap Main Menu icon.
Step What you see What it means What you do Ends sensor session. During session: Stop Sensor option appears Not in active session: • 2 • Dexcom G5x System User Guide Tap Stop Sensor.
Step What you see 3 What it means What you do Blue ? icons provide additional information. Tap Stop Sensor. Confirms sensor session has ended. 4 Ready for new session. Remove sensor. Insert new sensor. Tap green circle when ready for new session. Receiver: Ending a Sensor Session Early Step What you see 1 What it means What you do Go to Main Menu. Press Select.
Step What you see What it means Ends sensor session. 2 3 4 5 During session, Stop Sensor option appears. Thinking screen. Confirms you want to stop sensor. Return to Main Menu. What you do Press Down Arrow to Stop Sensor. Press Select. W ait Press Select. Ready to start a new session. Remove sensor. Not in active session, Start Sensor option appears. Press Select to Start Sensor when ready for new session. Insert new sensor.
To save on its battery, you can temporarily shut down the receiver. When shut down, your receiver and transmitter no longer communicate and you will not get any Alarm or Alerts although your sensor session remains active. Shutting down the receiver does not extend your sensor session past the seven days; it only stops the receiver from communicating with the transmitter. Your sensor session will stop seven days after you started the session.
Sensor failures can happen when your display device doesn’t receive your sensor’s glucose readings. While it is rare to have a sensor failure, there are preventative steps you can take. Help prevent sensor failures by checking: 1. Sensor hasn’t expired. 2. Transmitter is snapped securely into its holder. 3. Transmitter holder isn’t dislodged or adhesive isn’t peeling. 4. Nothing is rubbing against transmitter holder (for example, seat belts). 5. You selected a good insertion site (see Chapter 6). 6.
Before reusing the transmitter in your new sensor session, remove it from the old transmitter holder. Removing Sensor, Transmitter, and Transmitter Holder Step Picture What you do Grasp end of adhesive patch. 1 Peel adhesive patch up and away from your body like a bandage, removing sensor, transmitter, and its holder. NOTE: Do not remove the transmitter while the adhesive patch is on your skin. Hold transmitter holder in your hand. 2 Bend and break latch, releasing the transmitter.
Step Picture What you do Hold ridged side 3 Pull transmitter straight out Keep transmitter to use with next sensor. 4 5 Throw away adhesive patch, transmitter holder, and sensor following your local guidelines for disposal of blood-contacting components. After removing your sensor and taking the transmitter out of the transmitter holder, you’re ready to begin a new sensor session. The transmitter’s battery is good for up to three months.
2. Never use same site for 2 sensor sessions in a row. 8.5 End of Transmitter Battery How do you know if your transmitter’s battery will last through your next session? System messages help you determine if your transmitter’s battery will last through your next seven-day session. Starting at three weeks prior to the end of its battery life, the messages count down the transmitter’s battery until it has only seven days.
Device What you see What it means What you see What it means Receiver Device Smart Device: Lock Screen Smart Device: In App Transmitter battery will expire in two weeks. Order a new transmitter.
Device What you see What it means Smart Device: Lock Screen Smart Device: In App Transmitter battery will expire in one week. Order a new transmitter. Receiver To make sure you have a transmitter that’s ready for a new sensor session, you may want to reorder a new one at.dexcom.com/order, by calling Customer Service (see Section 16.1), or through the channels you used before, at your first low battery notification.
For more information on setting your sound/vibration notifications and how to clear them, please see Chapter 9. Smart Device Your smart device notifies you with a triple beep. If not cleared, you receive the triple beep twice, five minutes apart. Receiver The receiver alerts you with an initial vibration notification. If not cleared, you receive a vibrate/beep twice, five minutes apart. 8.
Step Picture What you do 2 Tap Settings 3 Tap Transmitter Dexcom G5x System User Guide 152 Ending Your Sensor Session and Transmitter Session PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Step Picture 4 What you do Tap Pair New If you still have transmitter package: 5a Turn transmitter box upside down on a flat surface with barcodes facing up.
Step Picture 5b What you do Center longest barcode within green brackets. Tap Take Photo 5c Check mark confirms successful transmitter SN scan.
Step Picture 6a What you do If unable to use app’s scanning device: Tap Enter transmitter SN by hand. Use keyboard to enter transmitter SN. 6b Confirm correct SN . Tap Save.
Step Picture What you do 7 W ait up to 30 minutes for smart device and transmitter to connect. 8 At notification, Tap Pair to pair app with smart device.
Receiver Step Picture 1 2 3 4 5a What you do Press Left Arrow twice to go to Main Menu. Press Down Arrow to Settings. Press Select. Press Down Arrow to Transmitter. Press Select. Highlight Transmitter SN. Press Select. Turn transmitter box upside down to locate SN number.
Step Picture What you do If transmitter package isn’t available: 5b • SN is on transmitter’s back Enter correct SN using Up/Down Arrow. Press Up/Down Arrow to select and enter transmitter SN. Press Right Arrow to move to next digit. 6 Press Select to save and close. Press Left Arrow twice to return to Main Menu. Make sure receiver and transmitter are connected/paired. Check receiver 10 minutes after starting for Bluetooth icon.
• Recognize when you have to end a sensor session early • Successfully end a sensor session early • Identify how you can prevent sensor session failures • Remove your transmitter holder with transmitter attached • Separate transmitter from transmitter holder • Determine if transmitter can be used for another sensor session • Pair new transmitter W hat’s Next? Congratulations, you have the basics down! You can set up your app and receiver, start a sensor session, calibrate, as well as end your
3 NEXT STEPS - GETTING THE MOST OUT OF YOUR G5x • Reading Trend Graph Screens and Recognizing Trends • Events • Alarm and Alerts • Sounds for Alarm, Alerts, and System Messages Dexcom G5x System User Guide 160 Home Screen, Rate of Change Arrows, and Errors PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 9 Next Steps: Home Screen, Rate of Change Arrows, and Errors 9.1 Introduction to Home Screens In the previous chapter, you learned about calibrations: why they are important and how to do them. Within five minutes of your final startup calibration your sensor glucose readings begin! In this chapter, you’ll learn three things.
Take a moment and read the safety statements. If not followed, your sensor glucose readings and trends may be less accurate, and you may miss important High or Low Glucose Alerts. Contraindication Don’t: Take medications with acetaminophen while wearing the sensor. W hy: Taking medications with acetaminophen (such as Tylenol or Excedrin Extra Strength) while wearing the sensor may falsely raise your sensor glucose readings.
W arning Don’t: Ignore symptoms of high and low glucose. Do: If your sensor glucose readings don’t match your symptoms, measure your BG with a fingerstick. W hy: Your sensor glucose readings may not be accurately reading your glucose. Consequences: You may miss a severe low (hypoglycemia) or high (hyperglycemia) glucose event. Precaution Do: When using both a receiver and a smart device, you must set your settings separately in each.
status. While the screen does look different between the receiver, smart devices, along with the Apple Today View, and Apple Watch the information and color-coding are the same. No matter how you hold it, the receiver’s view does not change. The app, however, has two ways to view data based on how you hold your smart device: 1. Vertically in portrait: 3-hour trend information with task bar. 2. Horizontally in landscape: 1, 3, 6, 12, or 24-hour trend information without task bar.
Figure 6. Example App Home Screen on Smart Device App Task Bar App Name What it means What you do Displays signal strength, time, Bluetooth, and battery level. Time: Status Bar: Information Only Status Bar Changes are made using smart device settings, not in the app. May look different depending on your smart device/carrier. Check smart device and receiver show same time. Bluetooth: Check Bluetooth is on. Battery: App can use up battery—Check you are charged.
App Name What it means What you do Tap Main Menu icon to access: • • • • Alerts Settings Help Start/Stop Sensor Main Menu Goes to other options. BG Meter with red circle and number Calibration Notification. Tap icon and enter fingerstick BG value (see Chapter 7). BG Meter without red circle No need to calibrate. Do nothing. Tap icon to enter data for: Event Enter different events capturing activities affecting your glucose. • Carbs • Insulin • Exercise • Health (See Chapter 10).
App Name Dexcom Share Dexcom Share What it means Dexcom Share is available only on the app. Gray icon means Share is not active. Once activated, Dexcom Share icon is colored. What you do Tap icon to activate (see Part 5). Do nothing. Tap icon to access Dexcom Share. Glucose Information App: Portrait App: Landscape What it means Home Screen In Landscape mode, Tap the trend view you want to see at the top of the screen: 1, 3, 6, 12, or 24-hour historical trend views.
App: Portrait App: Landscape What it means Number: Most recent sensor glucose reading. Shown in milligrams per deciliter (mg/dL). • Yellow: At or above target • Gray: Within range • Red: At or below target Historical Readings Turn smart device to Landscape mode. N/A Tap time shows time frame’s sensor glucose reading. Slide finger across screen to view rest of day’s sensor glucose readings.
App: Portrait App: Landscape What it means Rate of Change Arrow N/A Direction and number of arrows show sensor glucose change rate. Sensor Glucose Reading Range Shows between 40400 mg/dL.
App: Portrait App: Landscape What it means W ithin Glucose Range and Alert Levels • Yellow: High Alert level • Gray: Within range • Red: Low Alert level Trend Graph Time Frame Default is most recent 3 hours. Turn smart device to Landscape mode for most recent 1, 3, 6, 12, and 24-hour readings.
Apple Today View Widget Check your CGM on your smart device without opening the app, even when the smart device is locked. Swipe down from the top edge of your smart device to find the Dexcom widget in your Today view; the widget installs when you install the app. (See your smart device instructions for customizing your Today view.
Apple Today View Name What it does What you do Shows most recent sensor glucose reading. Color of circle changes: Sensor Glucose Reading • Yellow: At or above target Take appropriate action. • Gray: Within target range • Red: At or below target Trend Arrow Dexcom G5x System User Guide Shows direction and speed your glucose is changing. Review and take appropriate action based on fingerstick BG value.
Apple Today View Name What it does What you do Graph of your recent glucose readings between 40 and 400 mg/dL. Glucose target range Alert settings: Historical Readings • Yellow Line: High Alert setting • Gray: Target range • Review and take appropriate action based on fingerstick BG value. (See Chapter 9) Red Line: Low Alert setting or, if that’s disabled, 55 mg/dL (Urgent Low Glucose Alarm) Receiver Home Screen This section gets you familiar with the receiver’s home screen.
Receiver Home Screen Unlike your smart device screens, the receiver’s screen is not interactive; all notifications are for information only. To make changes or enter data in the receiver, press Select and go to the Main Menu. The receiver’s home screen has two main sections: 1. Status Bar a. Reflects glucose trends, readings, status of receiver’s system (e.g., battery level). 2. Glucose Information Trend Graph a. Reflects sensor glucose readings and trends.
Status Bar Receiver Name Status Bar What it does What you do Provides at-aglance information about the receiver, system, or you. Review and take appropriate action. Icons will change based on current data. Battery Shows battery level. Bluetooth Shows Bluetooth connection is working. Dexcom G5x System User Guide When low, plug micro USB cable into receiver. Plug USB into the adapter and then into electrical outlet. Do nothing. Receiver’s Bluetooth is always on.
Receiver Name Sensor Glucose Reading Trend Arrow What it does Shows most recent sensor glucose reading. Color of status bar changes: • Yellow: At or above target • Gray: Within target range • Red: At or below target Shows direction and speed your glucose is changing. Far right. Status Area Dexcom G5x System User Guide Error icons and calibration notifications. What you do Take appropriate action. Review and take appropriate action based on fingerstick BG value. Take appropriate action.
Glucose Information Receiver What it does Home screen. Number: Most recent sensor glucose reading. Shown in milligrams per deciliter (mg/dL). Color of status bar changes: • • • Yellow: At or above target Gray: Within target range Red: At or below target Historical Readings Default is most recent 3 hours. Press Up/Down Arrows to access 1, 3, 6, 12, or 24hour trend views. Rate of Change Arrow Direction and speed of your glucose changes.
Receiver What it does Sensor Glucose Reading Range Shows between 40-400 mg/dL. Glucose target range Alert settings. • • • Yellow: High Alert setting Gray: Target range Red: Low Alert setting Now that you’re familiar with the basic layout of the trend graph screen, can locate readings, identify color-coding, and view time frames, let’s take a closer look at the rate of change arrows. Apple Watch Home Screen This section gets you familiar with the Apple Watch home screen.
Apple Watch Receiver Name What it does What you do Displays your glucose information: Apple Watch Home Screen Sensor Glucose Reading Dexcom G5x System User Guide • Current glucose number • Direction your glucose is heading • Graph of glucose trend Shows most recent sensor glucose reading. Review and take appropriate action. Take appropriate action.
Receiver Name Trend Arrow What it does What you do Shows direction and speed your glucose is changing. Review and take appropriate action based on fingerstick BG value. (See Chapter 9) Graph of your recent glucose readings between 40 and 400 mg/dL.
9.4 Rate of Change Arrows Not sure of how your sensor glucose readings are trending? Rate of change arrows show the speed and direction of your glucose trends based on the last several sensor glucose readings. Arrows and the trend graph help you know when to take action before you are too high or too low. However, before doing anything, think about your most recent insulin dosing, food intake, overall trend graph, and current BG value. Don’t overreact to the arrows.
Rapidly Rising or Falling Changing: • More than 3 mg/dL each minute More than 45 mg/dL in 15 minutes System can’t calculate the speed and direction of your glucose change. There are a number of reasons why you may not get rate of change arrows: • You just started your sensor session • No sensor glucose readings over the last few minutes 9.
What you see What you do Bluetooth Is Out of Range Smart Device: Lock Screen Make sure there are no obstructions, such as a wall or water between your transmitter and your display device. Smart Device: In App Move within 20 feet of display device. Wait up to 30 minutes while transmitter restores communication. Receiver Bluetooth Off Smart Device: Lock Screen Smart device: 1. Exit app. Smart Device: In App 2. Tap Settings. 3. Tap Bluetooth. 4. Turn Bluetooth on.
What you see What you do Not Getting Sensor Glucose Reading Smart Device: N/A Lock Screen Smart Device: In App Check—Are you: • N/A • • Receiver • Within 20 feet of your display device? In your two-hour warmup period? Outside of your calibration schedule? In a sensor session? System Found Temporary Sensor Issue Smart Device: N/A Don’t calibrate. Lock Screen System may correct problem on its own and display sensor glucose readings again.
What you see What you do Receiver Transmitter and Sensor Not Communicating Smart Device: N/A Wait three hours while the transmitter tries to fix the error. Lock Screen Do not enter calibrations during this time. Smart Device: In App Make sure your transmitter is properly inserted into the transmitter holder. If not corrected: • Receiver • • Contact Technical Support (see Section 16.
What you see What you do mg/dL. Enter another BG meter value. Smart Device: In App Receiver Calibration Error Smart Device: N/A Lock Screen Smart Device: In App Wait 15 minutes. Enter a BG meter value. If error screen still appears, enter one more BG meter value. Wait 15 minutes. If no sensor glucose readings appear on the display, the sensor needs to be replaced. Contact Technical Support (available 24/7) at: • TechSupport@dexcom.co m • Toll free: 1.888.738.3646 • Toll call: 1.858.200.
What you see What you do Display Devices and Transmitter Not Communicating Smart Device: App/Receiver Lock Screen Wait 10 minutes. Smart Device: In App Move display device and transmitter within 20 feet of each other without obstruction (walls or water). Wait up to 30 minutes. In app (if not resolved): Receiver • Tap Settings. • Tap Bluetooth. • Turn Bluetooth Off and On.
• Recognize error messages W hat’s Next? By now you have a pretty good understanding of how your trends look on the different display devices, but did you know what you do can affect your trends and patterns? It’s important to track actions or well-being to better understand that what you do or how you feel can change your trends. In the next chapter, you will learn how to enter Events into your G5x.
Chapter 10 Next Steps: Daily Events Affect Your Glucose Trends and Patterns 10.1 Introduction Your daily activities can impact your glucose trends and patterns. In the previous chapter, you learned how to read your glucose trend screens; in this chapter, you learn how to enter situations, or “Events.” By tracking Events, you can determine how certain actions or circumstances affect your glucose levels.
An Event is an action or situation affecting your glucose levels. With the G5x, you have the ability to enter your daily Events, helping you track their effect on your glucose trends. Once entered into the smart device or receiver, Events can be viewed in Dexcom reports. The reports help you review how each Event influenced your glucose trends. You can use the reports with your healthcare professional to create a game plan in managing your diabetes.
Events Menu Device What you see What it means What you do Carbs Smart Device: In App How many grams did you just eat? Receiver’s screen reflects last number entered. Enter Carb grams per snack or meal, up to 250 grams.
Device What you see What it means What you do Insulin Smart Device: In App Receiver’s screen reflects last number entered. Enter insulin units for each dose, up to 250 units. Can’t enter type of insulin, only dosage.
Device What you see What it means What you do Exercise Smart Device: In App Default is 30 minutes. Select each exercise’s intensity level and duration. Enter intensity and duration. Type of exercise isn’t an option.
Device What you see What it means What you do General wellbeing. Enter different health Events (see following Health Events Menu table).
Device What you see What it means What you do Event time. For each separate Event, enter date/time Event began. Event Time Smart Device: In App ice Receiver As mentioned in the last table, Health has a series of Events. Tell the system how you are feeling, if you had a drink, if you’re having low or high BG symptoms, etc. You select the Event: no amounts are entered, just date and time.
Health Events Menu Device What you see What it means Health Main Menu Smart Device: In App Use Health Main Menu to access selections.
Device What you see What it means Health Main Menu Illness Smart Device: In App Have a cold, flu, or any other temporary illness affecting your wellbeing? Stress Are you under stress? Feeling anxious? High Symptoms Feel high BG symptoms? Low Symptoms Feel low BG symptoms? Cycle Receiver Have you started your menstrual cycle? Alcohol Had a glass of wine, beer, or cocktail? You can have multiple Events in a single day, or even during the same time frame and enter them all in at the same time.
For your convenience (and safety!), no need to stop everything and enter your Events as they are happening. When you have a moment, you can enter your Events retroactively in your app or receiver. Events are entered as individual occurrences: don’t enter daily totals, enter each Event separately. In the next section, you will learn how to enter Events, first in your smart device, then in your receiver. 10.
Step What you see 2 What you do Tap Carbs. Enter Carbs Event 3 Using the above example, add up all carb grams from lunch. Enter “85” using keypad. Tap Done.
4 Tap Event Time. Enter Carbs Event 5 Dexcom G5x System User Guide Scroll and select date and time. Tap Done.
6 Tap Save or Cancel. Enter Health Event - Stress 7 Dexcom G5x System User Guide Tap Events icon.
8 Dexcom G5x System User Guide Tap Health.
Enter Health Event - Stress 9 10 Tap Stress. Tap Done. Tap Event Time.
11 12 Scroll and select date and time. Tap Done. Tap Save or Cancel. View Events 13 Dexcom G5x System User Guide Trend graph shows events.
The receiver and app don’t talk to one another. If you enter an Event only into the receiver, while the information will appear on Dexcom reports, you won’t get an Event marker on your app’s trend screen. The app has Event markers on its screen, but the receiver doesn’t. However, there may be times when you want or need to enter Events on the receiver.
3 Highlight Carbs. Press Select. Add up all carb grams from lunch. 4 Arrow up to “85.” Press Select. Enter Carbs Event Press Left/Right Arrows to change time and date. 5 • Left: Backwards • Right: Forward Press Select. 6 Confirmation screen. Press Select.
7 Press Down Arrow until Health is highlighted. Press Select. 8 Press Down Arrow to Stress. Press Select. Enter Health Event - Stress Press Left/Right Arrows to change time and date. 9 • • Left: Backward Right: Forward Press Select. Verify information is correct. 10 Press Left/Right Arrows to highlight field. Press Up/Down Arrows to change numbers. Press Select to save. 10.
Events entered into your receiver can only be viewed on a Dexcom report; there are no markers on your receiver’s screen. On your smart device, turn to landscape to view your Event markers. A single small square marks all Events entered on your smart device. Slide your finger across the screen or tap the square to get your Event’s information. App: Viewing Events Landscape What it does Landscape Only Show Event details. What you do Landscape Only Slide finger across screen.
Chapter 11 Next Steps: Sensor Glucose Alarm and Alerts 11.1 Introduction Monitoring your glucose trends is critical in managing your diabetes. But what happens if you’re driving, in a meeting, at the movies, and can’t, or don’t want to, keep looking at your display device? The G5x understands there are times when you can’t look at your receiver or smart device; however, you still need to know critical glucose trends or if you’re not getting your sensor glucose readings.
11.2 Safety Statements The Alarm and Alerts were designed to keep you safe, helping you avoid severe lows and highs or missing your readings. The following safety statements help ensure you get your Alerts and Alarm. W arning Do: Verify that your smart device’s internal settings let you receive Alarm and Alerts. To receive Alarm/Alerts you must: 1. Make sure Dexcom G5 Mobile app Notifications are turned on in your smart device settings 2. Verify app hasn’t been shut down 3. Turn Bluetooth on 4.
W arning Don’t: Assume the app Alarm/Alert vibrations are different from other vibrating apps on your smart device. Do: Look at the screen of your smart device and check to see if the sound or vibration is from the G5 Mobile app. W hy: Medical device apps, like this app, don’t have any special priorities over your smart device’s features. App notifications or alerts may sound or feel the same as notifications from another app. Consequences: You might miss a severe low or high glucose event.
As with any wireless device, water is often the biggest culprit in reducing communication distance. This applies to the transmitter and display devices. Take special care when swimming, taking a bath, or getting into a hot tub. Consequences: Missing a severe low or high glucose event. Precaution Do: When using both a receiver and a smart device, you must set your settings separately in each. W hy: Settings are specific to each display device and don’t carry over to other devices.
Precaution Do: Make sure the receiver and smart device are turned on. W hy: If the receiver or smart device is turned off (Shut Down), it will not display sensor information, Alarm or Alerts. Consequences: You may miss a severe low or high glucose event. 11.3 Alarm and Alerts As part of managing your diabetes, you learned how to read your trend screen and how to enter Events. In this chapter, you’ll learn how Alarm and Alerts can keep you safe from severe lows or highs.
Alerts message you with vibrations (vibrations not available on all smart devices), visual notifications, sounds, or a combination of all three. Unlike the Alarm, you can customize your different Alert’s target range (see Chapter 12). During your initial setup, you establish your Low/High Glucose Alert levels. As mentioned before, this chapter is a review of the Alarm and Alerts, recommended smart device settings, and the receiver’s default Alert settings.
b. Need to change settings to receive Rising Alert. 2. Fall Rate a. Default setting is Off—No Alert. b. Need to change settings to receive Falling Alert. 3. Repeat a. Default setting is Off—No Alert. b. Need to change settings to receive Repeat Alert. Signal Loss Alert Signal Loss tells you when you and the transmitter are too far from your display device or something is blocking your transmitter signal, causing you not to get sensor glucose readings. The default setting for Signal Loss is On.
Smart Device: Lock Screen Sensor glucose reading at or below 55 mg/dL. Smart Device: In App Shows last glucose value. Arrows reflect rate of change. Check BG meter to make treatment decisions. Receiver Low/High Glucose Alerts Device What you see Smart Device: Lock Screen Dexcom G5x System User Guide What it means Sensor glucose reading at or below your Low Glucose Alert level.
Shows most current sensor glucose reading. Arrows reflect rate of change. Can be set to repeat between 15 minutes to 4 hours. Smart Device: In App Check your BG meter to make any treatment decisions. Receiver Device What you see Smart Device: Lock Screen Dexcom G5x System User Guide What it means Sensor glucose reading at or above your High Glucose Alert level.
Shows most current sensor glucose reading. Arrows reflect rate of change. Can be set to repeat between 15 minutes to 4 hours. Smart Device: In App Check BG meter to make treatment decisions. Receiver Rise Rate/Fall Rate Alerts Device What you see Smart Device: Lock Screen Dexcom G5x System User Guide What it means Sensor glucose readings rising quickly.
Number of arrows shows how fast (2 mg/dL/min; 3+ mg/dL/min) glucose is rising. Check BG meter to make any treatment decisions. Smart Device: In App Receiver Device What you see Smart Device: Lock Screen Dexcom G5x System User Guide What it means Sensor glucose readings falling quickly.
Number of arrows shows how fast (2 mg/dL/min; 3+ mg/dL/min) glucose is falling. Check BG meter to make any treatment decisions. Smart Device: In App Receiver Signal Loss Alert Device What you see Smart Device: Lock Screen Dexcom G5x System User Guide What it means Your display device and transmitter are not communicating.
Smart Device: In App You will not receive glucose readings or Alarm/Alerts. Check BG meter to check your glucose and make any treatment decisions. Receiver 11.5 App: Alarm/Alert Recommended Settings The receiver is a standalone medical device and used solely to monitor your glucose trends.
If you are concerned about missing an Alarm or Alert (for example, due to smart device settings, app shutting off due to lack of storage, low smart device battery, etc.), bring your receiver with you. 11.6 Receiver: Default Beeps and Vibrations The receiver’s Alarm/Alerts are vibrations and a beep, or a series of beeps, based on the Alarm or Alert. Beeps and vibrations are preprogrammed into the receiver, and unlike the smart device, the volume can’t be changed.
Initial Default Alert: Vibrates 3 times. After 5 Minutes: Vibrates/beeps 3 times every 5 minutes until cleared. Trend screen will continue to reflect Alert until sensor glucose readings go above Alert level. Initial Default Alert: Vibrates 2 times. After 5 Minutes: Vibrates/beeps 2 times every 5 minutes until cleared. Trend screen will continue to reflect Alert until sensor glucose readings go below Alert level.
Initial Default Alert: None/Off. After Setting Change: Vibrates 2 times, 2 sounds. After 5 Minutes: Vibrates/beeps 2 times every 5 minutes until cleared or sensor glucose reading drops below Alert level. Initial Default Alert: None/Off. After Setting Change: Vibrates 3 times. After 5 Minutes: Vibrates/beeps 3 times every 5 minutes until cleared or sensor glucose reading rises above Alert level.
Initial Default Alert: None/Off. After Setting Change: Vibrates 3 times. After 5 Minutes: Vibrates/beeps 3 times every 5 minutes until cleared. Will re-Alert if sensor glucose readings drop at or below 55 mg/dL. Initial Default Alert: None/Off. After Setting Change: Vibrates 2 times. After 5 Minutes: Vibrates/beeps 2 times every 5 minutes until cleared.
Initial Default Alert: On. After Setting Change: Vibrates 1 time. After 5 Minutes: Vibrates/beeps 1 time every 5 minutes for a total of 6 times if not cleared. After 6 times it will not Alert again. 11.7 Clearing Alarm/Alerts Alerts require you to acknowledge and clear them. How this is done depends on your display device. If using both display devices, you’ll need to clear each separately. Due to its medical importance, the Alarm is more persistent than an Alert.
Smart Device: In App Tap OK to accept Alarm or Alert. Clearing Your Receiver What you see What you do Press Select. Once an Alert is cleared, you won’t receive the same Alert unless you hit the Alert’s target range again. Your Alarm will repeat even after clearing if your glucose levels do not return to your target range.
• • • Determine if signal loss is preventing you from getting an Alarm/Alert Describe recommended app settings Successfully clear an Alert on o App o Receiver W hat’s Next? Up to now, you have learned about the Alarm or Alert default settings.
Chapter 12 Next Steps: On the Go With G5x: Customizing Your Alarm and Alerts 12.1 Introduction The receiver and app come with default glucose Alert level settings, but perhaps they don’t reflect the glucose level that works best for you. Perhaps you’re in a meeting and can only clear an Alert, yet want to make sure your Alert repeats, or continues, until you’re able to take corrective measures. Maybe you’d like to get a Rising/Falling glucose Alert, but their settings are off by default.
Precaution Do: When using both a receiver and a smart device, you must set your settings separately in each. W hy: Settings are specific to each display device and don’t carry over to other devices. If you set up one device and then use another device with different settings, you might not get an Alarm or Alerts. Consequences: You may miss a severe low or high glucose event.
Customizing Alerts: App Alarm/Alerts Screen Overview Step What you see 1 Step What you see What it means What you do Access Main Menu. Tap Main Menu icon.
Step What you see 2 What it means What you do Access Alerts Main Menu. Tap Alerts. All customizable Alarm and Alerts. Current Alert settings. 3 All Alerts have: • • • Tap Alarm/Alert you want to change.
Step What you see What it means What you do “?” explains: • 4 • • Each Alarm/Alert Message options Recommended settings Tap “?” for Alarm/Alert information. Urgent Low Glucose Alarm: • 5 • • Preset at 55 mg/dL and cannot be changed Repeat preset at 30 minutes and can’t be changed Sound is the only change option Tap Sound to change sound.
Although the results will vary depending on the Alarm or Alert you are customizing, the steps to change your Alerts are the same: From app’s Main Menu: 1. Tap Alerts. 2. Tap the Alert you want. a. Tap On or Off switch to turn on desired Alerts. 3. Tap Notify me. a. Change the Alert glucose level (mg/dL). i. Scroll selection wheel, find your desired Alert level. ii. Tap to highlight. iii. Tap Save. 4. Tap Repeat. a.
Step What you see 2 What it means What you do Access Alerts Main Menu. Tap Alerts.
3 Access High Alert settings (mg/dL). 4 Shows High Alert options and current settings. Tap High mg/dL. Check High Alert is On.
If Off: 5 6 Won’t get Alerts if Off. Change High Alert (mg/dL). Slide to On. • On - Orange • Off - Gray Tap Notify Me Above.
7 Change glucose level from current level (mg/dL). Scroll selection wheel. Stop at 190 mg/dL. Saves new High Alert glucose level (mg/dL). 8 Returns to High Glucose Alert screen options. Tap Save. Notify Me Above set at 190 mg/dL.
9 Changes how often your High Alert repeats after initial Alert and confirmation. Tap Repeat. Repeats only if you are above your high glucose level. 10 Change the current repeat setting. Can select in 5minute steps (range 15 minutes-4 hours). Scroll selection wheel. Stop at 1 hour.
Saves your new repeat timing. 11 Returns to High Glucose Alert screen options. Tap Save. Repeat shows how often you’ll get notified. 12 Customize Alert sound. Tap Sound.
13 14 Change current sound setting. Saves your new Alert sound. Returns to High Glucose Alert Menu. Tap Door Bell. Tap Sound again to hear sound sample. Tap back arrow.
15 Return to Main Menu. 16 Return to trend screen. Tap “X”. Tap Menu icon Or Swipe right. Any changes to the app will not carry over to the receiver. If using both, make the same changes in the receiver you made in your smart device. If you don’t, you may miss an Alarm or Alert.
12.4 Changing Receiver Alarm and Alerts You’ll notice a flow difference between the app and the receiver when personalizing your Alarm/Alerts. With the app, all Alert adjustments are made from one screen, whereas in the receiver, you make changes in different screens. Unlike the app, you change your receiver’s tones (known as Profiles) through a number of different screens in the Profiles menu. Profiles Profiles determine the sound and volume of your Alarm and Alerts.
Alarm/Alert Sound Profiles: Receiver Icon Profile name Notification description Vibration only. Vibrate Soft Normal Only sound is your receiver vibrating. Vibrate is not available for the Urgent Low Glucose Alarm. Lower volume beeps. Medium volume beeps. Default Profile. No beeps. Attentive Rising melody for High and Rising Alerts Dropping melody for Low and Falling Alerts Medium volume beeps. Urgent Low Glucose Alarm only.
After choosing your sound Profile, changing it is just a few steps away! Change your Profile throughout the day depending on what lies ahead: In a meeting? Select Vibrate. Going to a ball game after work? Select Attentive. The next table shows how to change a sound Profile, then sample how it sounds. Customizing Sound Profile: Receiver Step What you see What it means What you do 1 Go to Main Menu. Press Select. 2 Access second Main Menu screen. 3 Profiles adjusts volume of Alarm/Alerts.
Step What you see What it means What you do To sample sound: Press Down Arrow. Stop at Try It. 5 Hear selected Profile. Press Select to play the sound. To exit Profiles: Press Left Arrow to Main Menu. Repeat steps 2-5 to change Profile. 6 N/A Repeat as needed. To exit Profiles: Press Left Arrow to Main Menu. Profiles allow you to change your Alarm and Alerts tones.
Your trend screen provides visual cues letting you know your sensor glucose readings are falling or rising rapidly. Constantly looking at your screen may not be practical. You can customize your Rise/Fall Alert with vibrations or beeps letting you know when your glucose is rising or falling (2 mg/dL/min or 30 mg/dL up or down in 15 minutes) or rising or falling rapidly (3 or more mg/dL/min or 45 mg/dL or more up or down in 15 minutes). The default setting for Repeat and Rise/Fall Rate is Off.
Step What you see 1 2 What it means What you do Go to Main Menu. Press Select. Alerts option from the Main Menu. Press Down Arrow. Enter Alerts menu option. Alerts option menu. 3 Lists different Alerts: High/Low/Advanced (Repeat, Rise/Fall, Signal Loss) Alerts. Stop at Alerts. Press Select. Press Up/Down Arrow. Stop at High Alert. Press Select. Change High Alert Level 4 Alert’s current settings. Change your current High Alert level. G5x System User Guide Press Down Arrow. Stop at Level.
Current setting. 5 6 Use Up/Down arrows to change your High Alert level (mg/dL). Stop at 190 mg/dL. Saves new High Alert level. Press Select. Return to Alerts Menu. Press Down Arrow. To exit: Press Left Arrow. Turn On Repeat 7 Alerts Menu. Press Down Arrow. Choose Advanced to get to Repeat Alert. Stop at Advanced. Enter Advanced Alert options. Press Select on Advanced.
Main Advanced screen. 9 Set Repeat Alerts. Turn on Rise/Fall Rate Alerts. 10 Initial screen shows current repeat minutes. Change time frame in 5-minute increments. 11 12 Changed Repeat time for High Alert. Change completed. Return to Alerts Menu. Arrow to High Repeat. Press Select. Press Up/Down Arrow. Stop at 60 minutes. Press Select. To exit: Press Left Arrow.
• Customize your glucose trend Low/High Alerts in o App o Receiver • Adjust Alarm Profiles • Set up receiver’s Advanced Alerts o Low/High Repeat o Rise/Fall Rate o Signal Loss W hat’s Next? Believe it or not, you are becoming a pro at using your G5x! You’ve set up the app and receiver, started a session, calibrated, followed your glucose trends, paid attention to your Alarm/Alerts notifications, and ended a session! The next chapters begin our fourth part of the user guide: information you need to
4 EVERYTHING ELSE G5x • Warranty • G5x Maintenance • Travel Tips • Customer Service Contacts • Technical Information • Troubleshooting • Symbols on Package Labels Dexcom G5x System User Guide 252 Warranty: The Fine Print PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 13 Everything Else G5x: Warranty: The Fine Print 13.1 Introduction Sometimes stuff happens. Dexcom has you covered! The following is our warranty information outlining what we do cover, what we don’t, and for how long. First the receiver’s limited warranty information, then the transmitter’s limited warranty information. 13.2 Receiver Warranty Information G5x’s Limited Warranty What’s Covered and for How Long? Dexcom, Inc.
processes and transmits, “jailbreaking” your CGM system or cell phone, and taking other unauthorized actions may put you at risk, cause the CGM system to malfunction, is not permitted and voids your Limited Warranty. This Limited Warranty does not cover: 1. Defects or damage resulting from accident, misuse, abuse, neglect, unusual physical, electrical or electromechanical stress, modification of any part of the product, or cosmetic damage. 2. Equipment with the ID number removed or made illegible. 3.
The return package needs to include: 1. Receiver 2. Sales receipt or comparable substitute proof of sale showing the date of purchase 3. Receiver’s serial number 4. Seller’s name and address Call Dexcom Technical Support Department for delivery information help: • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 Upon receipt, Dexcom will replace the defective receiver.
This Limited Warranty is only provided to the original Purchaser and can’t be transferred to anyone else, and states Purchaser’s exclusive remedy. If any portion of this Limited Warranty is illegal or unenforceable by reason of any law, such partial illegality or enforceability shall not affect the enforceability of the remainder of this Limited Warranty. This Limited Warranty will be enforced to the maximum extent permitted by law. 13.
1. Defects or damage resulting from accident, misuse, abuse, neglect, unusual physical, electrical or electromechanical stress, modification of any part of the product, or cosmetic damage. 2. Equipment with the ID number removed or made illegible. 3. All surfaces and other externally exposed parts that are scratched or damaged due to normal use. 4.
To return, you must send the transmitter to an authorized Dexcom Technical Support Department. Make sure you package the transmitter adequately for shipping. The return package needs to include: 1. Transmitter 2. Sales receipt or comparable substitute proof of sale showing the date of purchase 3. Transmitter’s serial number 4. Seller’s name and address Call Dexcom Technical Support Department for delivery information or help: • • Toll free: 1.888.738.3646 Toll call: 1.858.200.
This Limited Warranty is only provided to the original Purchaser and can’t be transferred to anyone else, and states Purchaser’s exclusive remedy. If any portion of this Limited Warranty is illegal or unenforceable by reason of any law, such partial illegality or enforceability shall not affect the enforceability of the remainder of this Limited Warranty. This Limited Warranty will be enforced to the maximum extent permitted by law.
Chapter 14 Everything Else G5x: How to Take Care of Your G5x 14.1 Introduction There are not a lot of moving parts in the G5x, so maintenance is relatively simple: • Keep it clean • Keep display device(s) dry and protected • Use accessory parts, like the USB cable, etc., included with the system • Store according to each piece’s instructions This chapter covers only Dexcom parts (sensor, transmitter, and receiver). Follow the manufacturer’s instructions when caring for your smart device.
14.2 Safety Statements Following are some important Warnings and Precautions to review. This information helps you take care of your system so it can take care of you. Warning Do: Inspect your transmitter. Don’t: Use your transmitter if it is damaged or cracked in any way. W hy: Damaged components could create an electrical safety hazard or malfunction. Consequences: Electrical safety hazard or malfunction could cause electrical shocks. Warning .
Precaution Don’t: Use expired sensors. Before inserting, always check the package label for the expiration date using the YYYY-MM-DD format. W hy; If past the expiration date, the sensor glucose readings might not be accurate. Consequences: Missing severe low or high glucose event. Precaution Don’t: Share your transmitter with another person. W hy: The system is a prescription-only medical device and is meant, or indicated, for your use only. Consequences: Your transmitter is tied to your readings.
Precaution Do: If your receiver gets wet or dropped, make sure the speaker and vibrations still work. To check, either plug it in, turn it on, or go to the Profiles menu and select Try It. If it doesn’t vibrate and beep, contact Technical Support. W hy: If your receiver gets wet or dropped, the speaker and vibrations may not work. Consequences: If the vibration motor and/or speaker on your receiver aren’t functioning properly you may miss a severe low or high Alarm/Alert.
a. Check transmitter and don’t use if damaged. 2. Transmitter is reusable, but only by the same person. a. Never share transmitter with anyone. 3. Between uses, clean outside of the transmitter with damp cloth or alcohol wipes. Let dry before use or storage. 4. When not in use: a. Protect transmitter by returning it to its packaging or another safe place. b. Store between 32° F-113° F. Receiver 1. Check receiver casing; if it’s cracked or damaged, don’t use. Do not open it.
Charging Receiver Battery Step What you see 1 2 What it means What you do Low Battery Charge your battery. Open USB port door. Micro USB Port Dexcom G5x System User Guide Plug USB cable into port for recharging.
Step What you see What it means What you do Plug into receiver to charge battery. Don’t plug into a computer port to charge. 3 Micro USB Cable Don’t use an external USB hub; it doesn’t provide enough power to charge battery. Battery can only be charged using the adapter/wall charger. Charge battery before each new sensor session. Plug USB cable into adapter/wall charger. 4 Wall Charger Plug wall charger into an electrical outlet to charge receiver’s battery. Don’t block access to the charger.
Step What you see What it means What you do 5 Battery Charging Keep charging until battery icon is solid. 6 Battery Charged Disconnect wall charger from outlet when fully charged. Remove USB cable from receiver. 7 USB Port Door Close USB port door after removing USB cable to keep receiver clean and dry. Accessories 1. Only use Dexcom-supplied parts (including cable and charger). a. Use of non-Dexcom supplied parts may affect safety and performance. 2. Insert cable only as directed. a.
3. Look at cable for signs of wear and tear. Do not use if worn or damaged. There is no repair service available for any G5x parts. If you experience problems, report the issue to Technical Support (available 24/7) at: • TechSupport@dexcom.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 14.4 Storage Storing your G5x correctly helps prevent system failures. Sensor Applicator 1. Keep the sensor applicator in its sterile packaging until you are ready to use it. 2.
14.5 Checking app and Receiver Information You can check your app or receiver for information about your CGM system at any time.
CHECKING YOUR APP & RECEIVER SOFTW ARE VERSION You can check your app or receiver for information about your CGM system at any time. Receiver 1. From the Settings menu, press Up or Down arrows to scroll to “Device Info.” 2. Press Select. Information about your sensor session and system will show App 1. From Main Menu, tap Settings. 2. Tap Device Info.
Different municipalities have different requirements when throwing away electronics (receiver and transmitter) and parts that have come in contact with blood or other bodily fluids (sensor). Consult your area’s local waste management authorities for proper disposal instructions. Taking care of your G5x is pretty easy.
Chapter 15 Everything Else G5x: On the Go With G5x: Getting Through Security 15.1 Introduction G5x can be a great travel companion; you can go through metal detectors, be handwanded, and even keep your receiver on during your flight. This chapter covers only the G5x. It doesn’t cover steps you need to take when traveling with your smart device. See your smart device’s instructions for use to learn how to travel with it.
Precaution Don’t: Place any part of the G5x in the baggage x-ray machine or body scanner. Do: Ask for visual inspection instead: • • Baggage x-ray machine: Instead of putting any part of your G5 Mobile through the baggage x-ray, ask the TSA officer to visually inspect it. Body scanner: When you are wearing your G5 Mobile, request handwanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner. (AIT is also called millimeter wave scanner.
If you’re concerned or uncomfortable about walking through the metal detector, the Transportation Security Administration (TSA) requests you tell the Security Officer that you’re wearing a continuous glucose monitor and want a full-body pat-down with a visual inspection of your sensor and transmitter. Let the Security Officer know the sensor can’t be removed because it’s inserted under the skin. X-Ray Machines Receiver, Extra Sensors Don’t put your components through x-ray machines.
The G5x System is an M-PED (Medical-Portable Electronic Device) which meets the FAA RTCA/DO-160 edition G section 21, Category M. It can be used on aircraft according to the directions provided by the operator of the aircraft.. Any M-PED that meets this standard in all modes may be used onboard the aircraft without any further testing by the operator. This device can withstand exposure to common electrostatic discharge (ESD) and electromagnetic interference (EMI).
Chapter 16 Everything Else G5x: Need Help? You’re Not Alone! Dexcom has three support teams to help you, each with their own specialty: • • • Dexcom Technical Support Team Dexcom Patient Care Team Dexcom Sales Support Team 16.1 Dexcom Technical Support Team The Dexcom Technical Support Team helps you with all CGM system-related issues as well as software-related issues. They provide replacement units, resolve technical issues and take product complaints.
you if needed. For example: by phone 555-555-5555 after 5 PM Pacific Time By Phone Available 24 hours a day, 7 days a week Dexcom Technical Support phone numbers: • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 16.2 Dexcom Patient Care Team The Dexcom Patient Care Team is a group of Certified ® Diabetes Educators (CDE ) and Registered Nurses (RNs) offering you customer care and individualized education services around Dexcom CGM.
If you prefer to email, to help us help you best, include the following information in your email: • • • • Name of patient Patient’s date of birth Contact phone number Reason for inquiry or education needed For additional Dexcom CGM education, check the Dexcom website: dexcom.com/web-based-education By Phone Available Monday-Friday 5:30 AM-8:00 PM PST (subject to change) Toll Free: 1.888.738.3646 Toll Call: 1.858.200.0200 16.
By Phone Dexcom Inside Sales Support phone numbers: Toll Free: 1.888.738.3646 Toll Call: 1.858.200.0200 By Fax 1.877.633.9266 16.4 Corporate Dexcom Website: dexcom.
Chapter 17 Everything Else G5x: Technical Information 17.1 Device Performance Characteristics NOTE: We recommend that you review the information in this chapter with your healthcare professional to understand how well the G5 Mobile performs. The G5 Mobile (the System) uses a glucose sensor to continuously measure and monitor your glucose levels. The sensor is “calibrated” using a commercially available BG meter. Once calibrated, the System reports glucose readings up to every 5 minutes.
Original Pediatric Study: the receiver included software version SW10050 Software 505 Pediatric Study: the receiver included software version SW10505 The G5 Mobile incorporates the algorithm from software version SW10505 and has a new software number. Overview of Adult Studies The System performance for adults was evaluated in two separate prospective clinical studies: Original Adult Study (software SW10050) and the Software 505 Adult Study (software SW10505).
Springs Instrument 2300 STAT Plus™ Glucose Analyzer. This instrument is referred to as the “YSI.” Readings from the System were reported every 5 minutes and paired with YSI values in order to characterize how well the System readings agreed with laboratory standard BG results. The remainder of the study took place at home, and the System performance was also paired with the comparative meter results, referred to as the “SMBG.
subjects ages 6-17 also provided venous blood for comparison to a laboratory method, the Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer. This instrument is referred to as the “YSI.” In the Original Pediatric Study, subjects’ glucose levels were not intentionally manipulated during this study; in the Software 505 Pediatric Study, subjects ages 13-17 had their glucose levels intentionally manipulated during the clinic session.
Table 1-A.
Table 1-B.
Agreement Relative to YSI Agreement between the System and BG values is characterized using paired System and YSI values. The System and YSI results were compared by pairing the YSI BG value to a System glucose reading that occurred immediately after the YSI was collected. The agreement of the System to BG value was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and greater than 40% of the YSI values.
Table 2-A.
Table 2-B.
Because the System does not display glucose values below 40 mg/dL or above 400 mg/dL, the comparisons to the actual BG levels (as determined by the YSI analyzer) when CGM is classified as “LOW” or “HIGH” are included separately in Table 2-A and 2-B. The tables include the numbers and the cumulative percentages when YSI values were less than certain glucose levels (for “LOW”), and when YSI values were greater than certain glucose levels (for “HIGH”).
Table 3-A.
Table 3-B.
Table 3-C.
Table 3-D.
Adult Study, when CGM readings are within 81 to 120 mg/dL, you can expect your BG levels are within 81 to 120 mg/dL 72% of time. Table 4-A. System Difference to YSI W ithin CGM Glucose Ranges (Adult) CGM Glucose 1 Range (mg/dL) Overall *40-60 Study 2 Number of Mean Median Paired Percent Percent CGM-YSI Difference Difference Mean Median Absolute Absolute Percent Percent Difference Difference Original 9152 2.9% 1.7% 13.3% 9.8% Software 505 2263 2.5% 2.4% 9.0% 7.0% Original 512 -10.0 -8.
*For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent differences (%).
Table 4-B. System Difference to YSI W ithin CGM Glucose Ranges (Pediatric) CGM Glucose 1 Range (mg/dL) Study 2 Number of Mean Median Paired Percent Percent CGM-YSI Difference Difference Mean Median Absolute Absolute Percent Percent Difference Difference Original 2922 13.5% 11.6% 17.4% 13.5% Software 505 2262 1.8% 1.2% 10.4% 7.9% Original 19 -18.1 -9.1 19.2 9.1 Software 505 86 -15.3 -13.2 16.1 13.2 Original 76 -3.7 -2.3 13.4 10.6 Software 505 142 -4.8 -1.0 11.8 7.
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Accuracy Relative to YSI Accuracy between matched pairs was also estimated by calculating the percent difference between the System reading and the YSI value. For example, if the YSI value is 100 mg/dL and the System reading is 90 mg/dL, a 10% difference between the System and the YSI is reported. The System and YSI values were compared by pairing the System reading that fell immediately after the YSI value was collected.
Table 5-A.
Table 5-B.
Table 5-C.
The ability of the System to detect high and low glucose levels is assessed by comparing System results to YSI results at low and high BG levels and determining if the Alert may have sounded. The System and YSI values were compared by pairing the System reading that occurred immediately after the YSI value was collected. We suggest that you ask your doctor what Alert settings would be best for you.
Hypoglycemia Detection Rate The Detection Rate shows how often the device recognizes and Alerts you to an episode of hypoglycemia or how often it misses such an event. The Hypoglycemia Detection Rate is the % of time the BG level was at or below the Alert setting and device alarmed within 15 or 30 minutes before or after the BG was at or below the Alert settings.
Table 6-A.
Table 6-B.
Table 6-C.
The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Table 6-A, 6-B and 6-C. Table 6-A represents the hyperglycemia Alert evaluation within 15 minutes of the YSI value in the adult studies. Table 6-B represents the Alert evaluation within 15 minutes of the YSI value for a subset of the pediatric population—subjects age 6 to 17 years who had YSI measurements every 15 minutes.
For example, if you set your High Glucose Alert to 200 mg/dL, how often will your Alarm Alert you if your BG goes at or above 200 mg/dL? In the Software 505 Adult Study (Table 6-A), when your blood sugar goes above 200 mg/dL, you can expect your Alarm to sound 98% of the time and not to sound approximately 2% of time within the 15 minute period before or after your blood sugar goes above 200 mg/dL.
1 Table 7-A.
1 Table 7-B.
Calibration Stability The System must be calibrated every 12 hours. To demonstrate performance of the System over a 12-hour calibration period, Systems were evaluated to verify that performance remains consistent over the 12-hour calibration period. Systems were evaluated in 2-hour increments after calibration.
1 Table 8-B. Sensor Stability Relative to YSI (Accuracy Over Time ) - (Pediatric, Ages 6-17 Years) Day of Wear Day 1 Day 4 Day 7 Study 2 Percen Number Mean Median Percen Percen Percen t of Absolute Absolute t t t Greater Paired Percent Percent Within Within Within than CGM- Differenc Differenc 15/15% 20/20% 30/30% 40/40% YSI es es YSI YSI YSI YSI Original 1016 21.2% 15.8% 48% 61% 78% 15% Software 505 740 12.7% 8.5% 75% 83% 91% 4% Original 810 16.0% 13.
Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over 1 Time ) - (Pediatric, Ages 2-17 Years) Day of Wear Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 1 Study 2 Percen Number Mean Median Percen Percen Percen t of Absolute Absolute t t t Greater Paired Percent Percent Within Within Within than CGM- Differenc Differenc 15/15% 20/20% 30/30% 40/40% SMBG es es SMBG SMBG SMBG SMBG Original 3216 18.8% 14.2% 53% 65% 81% 10% Software 505 893 14.8% 10.
2 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505).
Sensor Stability Relative to YSI Sensors can be worn for up to 7 days. Performance was estimated by calculating the percentage of System readings within 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30% , 40 mg/dL or 40% and greater than 40 mg/dL or 40% of the YSI values at the beginning (Day 1), middle (Day 4) and end (Day 7) of the System lifecycle.
Sensors may be worn for up to 7 days (168 hours). To estimate how long a sensor will work over 7 days, all sensors worn were evaluated to determine how many days/hours of readings each sensor provided. In the Original Adult Study, 108 sensors were evaluated. Ninety-four percent (94%) of the sensors lasted until Day 7 (145-168 hours). There were 6 (6%) sensors that ended early, four of which lasted more than 3 days. In the Software 505 Adult Study, 51 sensors were evaluated.
Table 9-B.
Table 10-A.
Table 10-B.
Table 11-A.
Table 11-B.
Table 12-A. System Difference to SMBG Within CGM Glucose Ranges (Adult) CGM Glucose 1 Range (mg/dL) Study 2 Number of Paired CGMSMBG Mean Median Percent Percent Difference Difference Mean Median Absolute Absolute Percent Percent Difference Difference Original 7508 -0.4% -1.4% 14.0% 11.0% Overall Software 505 2992 -2.6% -2.7% 11.3% 8.6% Original 731 -9.3 -8.0 11.7 8.0 *40-60 Software 505 221 -10.3 -6.0 13.0 8.0 Original 968 -1.0 1.0 10.7 8.
Table 12-B. System Difference to SMBG Within CGM Glucose Ranges (Pediatric) CGM Glucose 1 Range (mg/dL) Study 2 Number of Paired CGMSMBG Mean Median Percent Percent Difference Difference Mean Median Absolute Absolute Percent Percent Difference Difference Original 16,318 2.2% 0.9% 15.3% 11.1% Overall Software 505 4264 -0.7% -1.1% 12.5% 9.5% Original 487 -22.1 -17.0 23.9 18.0 *40-60 Software 505 240 -15.9 -14.0 16.9 14.0 Original 1340 -11.8 -8.0 17.0 11.
Agreement and Accuracy Relative to SMBG Agreement between the System and BG values is also characterized using paired System and SMBG results (Table 11 to 12). The System and SMBG values were compared by pairing the comparative SMBG value to a System glucose reading that occurred immediately after the SMBG was collected.
17.2 Product Specifications The G5x is intended for single patient use in the home environment and requires a prescription. Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
Part Number 9445-01 Power Supply Lithium manganese dioxide/Organic electrolyte battery (not replaceable) Operational Conditions Ambient temperature is 10° C-42° C (50° F-107.6° F) Equilibrium temperature of less than 0.5° C (0.
Transmitter Performance Characteristics Parameter Performance Characteristic TX/RX Frequencies 2.402-2.480 GHz Bandwidth 1.02 MHz Maximum Output Power 1.0 mW EIRP Modulation Gaussian Frequency-Shift Keying Data Rate 1 Mbps Data Communication Range 20 feet The Dexcom G5x CGM System is safe for use on U.S. commercial airlines. The G5x System is an M-PED (Medical-Portable Electronic Device), which meets the FAA RTCA /DO-160 edition G section 21, Category M.
Transmitter Electromagnetic Immunity Specifications Immunity Test IEC 60601 Test Level Electrostatic Discharge (ESD) IEC 61000-4-2 Transmitter Compliance Level Electromagnetic Environment Guidance ± 8 kV Contact ± 15 kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Weight 2.
The receiver (MT22719) is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the receiver should ensure that it is used in such an environment. Receiver Electromagnetic Immunity Specifications Immunity Test IEC 60601 Test Level Transmitter Compliance Level Electromagnetic Environment Guidance ± 8 kV Contact ± 15 kV Air ± 8 kV Contact ± 15 kV Air Floors should be wood, concrete or ceramic tile.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Dexcom G5 Mobile System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the Dexcom G5 Mobile System should ensure that it is used in such an environment.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Receiver The receiver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
propagation is affected by absorption and reflection from structures, objects and people. USB Charging/Download Cable* Specifications Part Number MT20655 Input/Output 5V DC, 1A Type USB A to USB micro B Length 3 feet *The power supply/charger can be connected to the USB charging/download cable for charging using an AC power outlet. Misuse of the USB cable can present a strangulation risk. Isolation of system is by disconnecting charger from wall.
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. Warning (Part 15.21) Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. No modification of the equipment is allowed as it could create an unsafe condition. FCC Interference Statement (Part 15.
Chapter 18 Everything Else G5x: Troubleshooting 18.1 Introduction Transmitter holder not sticking? Notification won’t go away? Not getting your sensor glucose readings? Don’t know when to replace your transmitter? This chapter will help you figure it out! Troubleshooting sections are categorized by function or system component. The solutions here are meant to be brief and not all-inclusive; some have audible notifications, and others don’t.
W arning Do: Calibrate at least once every 12 hours. W hy: Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate. Consequences: Missing severe low (hypoglycemia) or high (hyperglycemia) glucose event. Precaution Do: Enter the exact BG value displayed on your BG meter within five minutes of a carefully performed fingerstick. W hy: Entering the wrong BG values, or waiting more than five minutes before entry, might affect sensor performance.
No Alarm/Alerts Device What you see Problem What you do See Chapter 11. Smart Device: In app Not receiving Alarm/Alerts Check Alarm/Alerts, sound and/or vibrations notifications are turned on. Check your smart device is not on Silent or Do Not Disturb (if applicable). Receiver Sensor Glucose Readings Device What you see BG Meter Dexcom G5x System User Guide Problem What you do Sensor readings and BG meter glucose values often don’t show the same numbers. See Chapter 7.
Device What you see Problem What you do Meter - from blood Sensor - from interstitial fluid Smart Device: In app 20/20 Rule: If the meter shows 80 or less, CGM should read within ± 20 points. If the meter shows 80 or above, the CGM should read ± 20%. Example: a 202 mg/dL sensor reading and a 188 mg/dL glucose meter value = a 7% difference (this is still considered accurate). Receiver Outside of 20/20 rule: Calibrate again. Device What you see Problem What you do See Chapter 9.
Device What you see Problem What you do the transmitter holder? Make sure you haven’t taken acetaminophen. Don’t calibrate. Use BG meter for BG reading. Receiver If this continues for more than 3 hours, contact Technical Support (see Chapter 16.: See Chapter 9. W ait Smart Device: In app System will often resolve itself. Not getting sensor glucose readings.
Device What you see Problem What you do See Chapter 9. Don’t calibrate. Smart Device: In app Verify display device and transmitter are within 20 feet of each other without obstruction. System display device and transmitter not connecting. Receiver No sensor readings, Alarm/Alerts or notifications until error is fixed. Wait up to 30 minutes. Don’t calibrate. Use BG meter for BG reading. More than 30 minutes? App (if not resolved): • Go to Settings. • Tap Bluetooth. • Turn Bluetooth Off and On.
Device What you see Problem What you do Receiver Applicator Picture Problem What you do Can’t push in orange button. After placing on body, make sure safety guard is removed. Hurts when the needle fires. Smaller adhesive patch won’t come off. Dexcom G5x System User Guide Fold and break away guard. Make sure your application site is not directly over a bone. Use an area of your belly with less scar tissue or irritation. Lift up the tab of the label.
Picture Problem What you do See Chapter 6. Transmitter holder won’t stick. Put medical tape over transmitter holder’s white adhesive patch (e.g., Blenderm). Don’t place tape over the transmitter.
Picture Problem What you do Don’t panic! Remove applicator and adhesive patch: 1. Gently pull applicator up until you see adhesive patch 2. Using your finger or thumb, hold front edge of patch and peel from skin Applicator doesn’t come off after pushing button 3. While holding adhesive patch’s front edge, gently rock back applicator, away from your body. Check insertion site to make sure the sensor isn’t left on the skin. Don’t try to reuse applicator. Call Customer Service.
Hardware Error Device What you see Problem What you do See Chapter 4. Receiver Won’t turn on: Battery dead. Charge receiver using electrical outlet, not computer/laptop. Full charge may take up to five hours. See Chapter 4. Reset receiver. Connect receiver to charger. Receiver After full charge session: Won’t turn on. Insert end of paper clip into small circular hole on receiver’s back. Push down on paper clip. Receiver will vibrate. Processing screen appears. Charge receiver.
Device What you see Problem What you do See Chapter 16. W rite down error code. (Screen may show other codes.) Call Technical Support: Receiver Corrupted database. • Toll free: 1.888.738.36 46 • Toll call: 1.858.200.02 00 Notification: Vibrates one time for four seconds and four beeps. See Chapter 16. Do nothing. Receiver System recovery. Receiver is able to continue to work and recover from an error. app: Tap OK to clear Alert. Receiver: Press Select to clear Alert.
Device What you see Problem What you do No Bluetooth. See Chapter 5. No sensor readings, Alarm/Alerts or notifications until error is fixed. Smart Device: In app Go to smart device’s Settings. Make sure Bluetooth is On. If problem persists, please contact device’s manufacturer. Calibration Error Device What you see Problem What you do See Chapter 7. BG Meter System will not accept calibration if outside of the 40-400 mg/dL range.
Device What you see Problem What you do for a possible reason). below. No sensor readings, Alarm/Alerts or notifications until error is fixed. W ait 15 minutes. app/Receiver: Enter 1 calibration. If error screen still appears enter 1 more BG meter value. W ait 15 minutes. Receiver If no sensor glucose readings display on the smart device or receiver, the sensor needs to be replaced. Contact Technical Support (see Section 16.
Device What you see Problem What you do See Chapter 7. W ait 15 minutes. Enter 1 BG meter value. W ait 15 more minutes. Smart Device: In app If error screen still appears enter 1 more BG meter value. W ait 15 minutes. System didn’t accept recent calibration. If no sensor glucose readings appear on the display, the sensor needs to be replaced. Call Technical Support (see Section 16.1) to report error: Receiver • TechSupport@dex com.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.
Device What you see Problem What you do See Chapter 16. Smart Device: In App Transmitter not working. Sensor session automatically stopped. No sensor readings, Alarm/Alerts or notifications until transmitter is replaced Receiver Make sure transmitter is snapped into sensor pod Contact Technical Support: • TechSupport@dex com.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 Use BG meter for BG reading. You won’t get additional Alerts after clearing.
Device What you see No sensor readings, Alarm/Alerts or notifications until transmitter is paired. Receiver Device Problem What you see Problem What you do contact Tech Support at: • TechSupport@dex com.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 What you do See Chapter 16. Contact Technical Support: Smart Device: In App Dexcom G5x System User Guide Transmitter Low Battery • TechSupport@dex com.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.
Device What you see Problem What you do Receiver Dexcom G5x System User Guide 352 Troubleshooting PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 19 Everything Else G5x: Symbols on Package Labels The following symbols may be found on the sensor, transmitter, and receiver package labels. These symbols tell you about the proper and safe use of the Dexcom G5x System. Some of these symbols may not have meaning in your region, and are listed for informational purposes only. This table shows what each symbol means.
Humidity Limitation Input IP22: Protection Against Insertion of Large Objects and Dripping Water IP28: Protection Against Insertion of Large Objects and Immersion in Water Keep Dry Manufacturer Marking Certifies Device Meets European Council Directive 93/42/EEC MR Unsafe Non-Ionizing Radiation Prescription Required Refer to Instruction Manual/Booklet Ship By Date Temperature Limitation SN STERILE R Serial Number Sterile by Radiation Type BF Applied Part Use By Date Dexcom G5x System User Guid
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5 SHARING IS CARING • Dexcom Share G5x System User Guide ® 356 Sharing is Caring PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
Chapter 20 Sharing is Caring: Dexcom Share® 20.1 Learning About Dexcom Share Glossary Airplane Mode A setting on a smart device where wireless features are disabled in order to comply with airline regulations. Application or App A software program, such as the Dexcom G5 Mobile app and the Dexcom Follow app, designed to run on a smart device. App Store Internet store for downloading applications to a smart device. Blood Glucose Meter A device used to measure how much glucose is in the blood.
Dexcom Follow App Gets the Sharer’s glucose information and notification data from the Dexcom Share Cloud. Dexcom G5 Mobile App Receives glucose information from the G5x transmitter. Sends glucose information to the Dexcom Cloud using an Internet connection. Dexcom G5x Sensor The Dexcom G5x System part that includes an applicator and sensor wire. Dexcom G5x System CGM system made of a sensor, transmitter, and smart device/receiver.
Do Not Disturb A setting on a smart device where all incoming calls, Alerts, and notifications are silenced. Do Not Disturb can be set to specific times and can be set to allow exceptions (people who can disturb you). Follower A person that gets the Sharer’s shared information in the Dexcom Follow app. Follow Dashboard® On the Dexcom Follow app, the Follow Dashboard shows the glucose information of up to five (5) Sharers. Follower’s Smart Device Runs the Dexcom Follow app.
Hyperglycemia High BG. Same as “high.” The default High Glucose Alert in the G5x is set to 200 mg/dL. Consult your healthcare professional to determine the appropriate hyperglycemia setting for you. Hypoglycemia Low BG. Same as “low.” The default Low Glucose Alert in the G5x is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemic setting for you.
Notification A visual message that appears on the screen of the Follower’s smart device. Notifications may also include a sound, depending on the smart device’s settings. Not Sharing When the Sharer chooses to temporarily not share glucose data with the Follower. Obstruction An object that stops the wireless communication between devices, such as wall thickness or radio waves. Profile Located in Follow Dashboard and displays the Sharer’s glucose information, trend arrow, and profile picture.
Sharer The person who uses the Dexcom Share app.. Sharing The act of electronically transmitting glucose information from the Sharer’s smart device to the Follower’s smart device. Simultaneous Voice and Data The ability to make a phone call and access the Internet on the same cellular connection at the same time. Smart Device A cordless (unless charging), mobile (easily transportable), connected (via Wi-Fi, 3G, 4G, etc.) electronic device that can operate the G5 Mobile app or the Dexcom Follow app.
Trend Graph Displays the pattern of the Sharer’s glucose information. W i-Fi or Wireless Internet A technology that allows electronic devices to wirelessly access the Internet. These networks can include your home Internet or one found at a public location. 20.2 Dexcom Share Overview Dexcom Share is a feature within the G5 Mobile app. It allows for remote monitoring of G5x data from one person, the Sharer, to another person, the Follower.
Figure 8. Sharing The Sharer must be within 20 feet of his/her smart device in order to send data to the Follower or it will not work.
Dexcom Share Parts Sharer’s smart device* 1 Follower’s smart device* 1 G5 Mobile app Dexcom Follow app G5x transmitter* G5x sensor* Internet/Wi-Fi or mobile data service/3G/4G/LTE* Bluetooth *Must be purchased separately. 1 A list of compatible devices can be found at dexcom.com/compatibility.
Conditions Affecting Use Once sharing is active, make sure the Sharer’s and Follower’s smart device settings are not altered. Make sure the Sharer’s and Follower’s smart devices have: • • • Enough battery power to maintain sharing An active Internet connection Notifications turned on. If turned off, Follower won’t receive any notifications Dexcom recommends charging the smart device while sharing. 20.3 Risks and Benefits Risks Dexcom Share is a feature of the G5x.
Followers who are concerned by notifications on the Dexcom Follow app should contact Sharers and remind them to check their BG with a BG meter before driving a car or making any treatment decisions, such as taking insulin or eating fast-acting carbohydrates. Sharers should not rely on Followers to notify them about low or high glucose.
continuous glucose monitoring (G5x) or standard home BG monitoring. The Dexcom Share Direct Secondary Displays is not intended to modify or analyze data received from the continuous glucose monitoring system, nor is it intended to instruct, or to transmit information to the continuous glucose monitoring system. The Dexcom Share Direct Secondary Displays is not intended to serve as a replacement for a primary display device for a continuous glucose monitoring system.
replace G5x and requires Share to be turned “On” to communicate glucose information to the Follower. You cannot use Dexcom Share to make treatment decisions, such as how much insulin to take. Dexcom Share does not replace a BG meter. Always use the values from a BG meter for treatment decisions. BG values may differ from the sensor glucose information. Using the sensor glucose information for treatment decisions could lead to low or high BG values.
low battery, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high BG values. If the patient’s smart device is powered off or restarted, make sure the app is reopened after the smart device is turned back on in order to resume sharing. If the app is not reopened, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high BG values.
20.
Step What you see What you do Download the G5 Mobile app from your app store. 1 See your smart device’s user manual for instructions. Download the app to use Dexcom Share. Launch the app. Set up your smart device (see Chapter 5) before sharing. 2 Once your app has been set up, activate Dexcom Share. A series of screens walk you through the Dexcom Share features, highlighting important information.
Step What you see What it means Activates Dexcom Share. 1 2 G5x System User Guide If Dexcom Share icon is gray, your Share feature has not been turned on. Dexcom Share Welcome Screen. What you do Tap Dexcom Share icon in the upper right corner of your smart device’s home screen. Read screen. Tap Next when done.
Step What you see What it means What you do 3 Message about Internet access. Tap Next. 4 How to know you are sharing your data. Tap Next.
Step What you see 5 What it means What you do How to know your Follower is not getting your sensor data. Tap Let’s Get Started to move on and invite your Followers. Inviting Followers Step What you see 1 G5x System User Guide What you do Tap Invite Followers to set up your Followers.
Step What you see What you do Enter the Follower’s nickname and email address. Confirm Follower’s email address. 2 The Follower will get a Follow Invitation email. Make sure the Follower can access this email account from their smart device. Tap Next.
Step What you see What you do Slide Allow Trend Graph View’s On/Off switch if you want Follower to see your trend graph. Tap Next. 3 Turned Off: Follower sees only your sensor glucose reading and trend arrow. Turned On: Follower sees your sensor glucose reading, trend arrow, and trend graph.
Step What you see What you do Choose if your Follower gets your Urgent Low, Low, and High Glucose Alarm/Alerts. Choose if you want your Follower to get notifications if they are not receiving your sensor glucose readings. 4 Select what Alarms/Alerts your follower gets and how long you are low/high or not sharing data (for example, if you want your Follower to know when your glucose is above 200 mg/dL for more than 2 hours, you can set up notifications in the Follower’s Settings menu).
Step What you see What you do Before Follower invitation is sent, review the Summary screen. 5 Tap Send Invitation. After sending invitation, you cannot adjust the Follower’s settings. To add more Followers: 6 Tap Followers on the Share Status screen. Invite up to a total of five (5) Followers.
20.6 Using Dexcom Share Dexcom Share Status You can look at the Dexcom Share icon on your home screen to see if Dexcom Share is working. After turning Dexcom Share on, check its status. Share icon Figure 9. Share Status Dexcom Share Status Icons Status tab What it is The Share icon is in color when Dexcom Share is sending sensor glucose readings and information.
Status tab 1 What it is The Share icon is dark gray with a red circle when Dexcom Share is not working. The Sharer should tap on the dark gray Share icon when Share is not working to get further information about the error. The Share icon is light gray when Dexcom Share has not been activated. The Sharer should tap the light gray icon to get started using Dexcom Share. When a device or connection is not working, Dexcom Share will not work.
On/Off Switch Turns sharing on or off Sharing Status Bar - Status of sharing your sensor glucose readings with your Followers Follower List - Add Followers and lists status of Followers. Figure 10. Dexcom Share Screen NOTE: Whether or not Dexcom Share is working and the Followers are receiving glucose Alarm/Alerts, you must always refer to your G5x display device for your sensor glucose readings and Alerts. All treatment decisions must be based on your BG value from your BG meter.
What you see What it means What you do The Sharer should: Issue with: • Sharer’s CGM data • Sharer’s smart device • Verify there is a glucose value on the smart device • Be sure the transmitter is in range of the smart device • Tap on blue “?” to learn more about how to troubleshoot this issue • Allow up to 10 minutes for their status to turn green and a green check mark to appear If the Sharer continues to see this, the Sharer should turn off Share and then turn it back on.
What you see What it means What you do The Sharer should: • Verify their Wi-Fi or cellular connection is ON • Be sure they are in an area that has cellular reception • Not be on a voice call • Be sure they can access the web via a browser • Check later or follow up with their Internet connectivity provider • Tap on blue “?” to learn more about how to troubleshoot this issue Issue with: • Sharer’s Internet connection • Dexcom Share Cloud Followers List The Followers list allows the Sharer
Icon/Status What you see What it means Invite a new Follower. Follower is set to get notifications from Sharer. Follower is able to view Sharer’s trend graph. Follower did not accept Sharer’s Follow Invitation email within 7 days. Sharer can invite Follower again by tapping on the + icon in the top right corner of the screen. Follower has been sent a Follow Invitation email but has not accepted it yet. Sharer stopped sharing with Follower.
Stop Sharing The Sharer can swipe the On/Off switch to temporarily stop glucose information and Alarm/Alerts from being sent to Followers. Sharing stops until the Sharer turns the On/Off Switch back on. For reasons of safety and intended use, the Follower will get a message telling them the Sharer’s data was set to Not Sharing. The Follower’s dashboard will show the Sharer has stopped sharing glucose information. 20.
• • • Low Sensor Glucose Reading Urgent Low Glucose Alarm (< 55 mg/dL) High Sensor Glucose Reading Followers can change some of the initial settings to fit their needs. Followers cannot change the Sharer’s permission settings to see the trend graph.
The Follower Dashboard If the Sharer doesn’t allow the Follower to see the trend graph, he/she will only see the glucose reading and trend arrow. Sharer’s picture Sharer’s glucose reading and trend arrow How long ago the Sharer’s glucose reading and trend arrow were last updated Figure 12.
If you choose to have your Followers see your trend graph, they see: Sharer’s name Notification settings Home icon Sharer’s glucose reading Trend arrow Time duration setting of 3, 6, 12 or 24 hours Trend graph Glucose range (between high and low alerts) 20.8 Troubleshooting Dexcom Share Troubleshooting Troubleshooting Status—See the Troubleshooting Status Issues portion of Section 20.6. Figure 14.
Sharing Checklist To share, make sure: • Your smart device works with the G5 Mobile app o To see a list of supported smart devices and operating systems, go to: dexcom.
| Sample Index (note, pagination is wrong) A Warning and Precautions 6 Change Low/High Alerts 44 Choose Display Device 18 Components Applicator and Sensor 17 Display Devices 17 Transmitter 17 A Adhesive Adhesive won’t stick 51 Optional use 30 Customer Service 60 E Alarm or Alerts Change Low/High Alerts 44 Rise Rate, Fall Rate, and Signal Loss Alerts 44 Urgent Low Glucose Alarm 44 Ending Sensor Session Early 42 End Sensor Session 40 Enter Initial BG Meter Values 36 Enter Initial BG Meter Values 22 E
P Receiver Warning and Precaution 11 System Precautions 10 Transmitter Warnings and Precautions 9 Precautions 7, 8, 10, 11, 13 Sensor Q Ending Sensor Session Early 43 End Sensor Session 40 Insert Sensor 29 Question Marks 46 R Receiver Confirm Transmitter and Receiver Communication 35 Ending Sensor Session Early 43 Enter BG Meter Values Every 12 Hours 37 Enter Initial BG Meter Values 36 Receiver Setup 27 Set Up Alert Sounds 34 Start Sensor 33 Trend Arrows 39 View Receiver Trend Screen 38 Rise Rate 44
Applicator 52 Calibration Errors 48 Sensor Glucose Readings 45 Transmitter Errors 49 U Urgent Low Glucose Alarm 44 W Warnings 6, 8, 9, 12, 13 Warranty Receiver Warranty Information 53 Transmitter Warranty Information 55 G5x System User Guide 393 Sharing is Caring PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor
© 2016 Dexcom, Inc. All rights reserved. Covered by patents: dexcom.com/patents. Dexcom, Dexcom G4 PLATINUM, G5, Dexcom G5, Dexcom G5 Mobile, Dexcom G5x, G5x, Dexcom G5x CGM System, Dexcom Share, Dexcom Care 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.
