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| 1 | User Manual Part 1 | Users Manual | 3.57 MiB | / October 10 2016 |
CONTINUOUS GLUCOSE MONITORING SYSTEM User Guide IMPORTANT CONTACTS AND NUMBERS Emergency Phone Number: ______________________________________________ Your Healthcare Professional: _____________________________________________ Your Receiver Serial Number: _____________________________________________ Your Transmitter Serial Number: ___________________________________________ ___________________________________________________________________ Dexcom Technical Support/Patient Care Team: _______________________________ 1.877.339.2664 Dexcom Website: ______________________________________________________ dexcom.com Nearest Hospital: ______________________________________________________ ___________________________________________________________________ Table of Contents 5 Part 1: Getting Started Glossary Chapter 1 - Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring 9
(CGM) System Journey 1.1 Introduction ............................... 9 1.2 Self-Paced Resources ................... 10 1.3 Your Dexcom Account .................... 12 Chapter 2 - Indications for Use and Safety Statement 15 2.1 Introduction .............................. 15 2.2 Important User Information .............. 15 2.3 Safety Statements ....................... 16 2.4 Overview of Safety Statements .......... 17 2.5 General CGM System Warnings .........20 2.6 Calibration Warning and Precautions ....20 2.7 System/Hardware/Software Warnings and Precautions ...............................22 Chapter 3 - Risks and Benefits 29 3.1 Risks ......................................29 3.2 Benefits ...................................30 Part 2: Lets G5! The Basics Chapter 4 - What Is the Dexcom G5 Mobile CGM System?
35 4.1 System Description ......................35 4.2 Safety Statement .........................35 4.3 The Dexcom G5 Mobile CGM System ...36 4.4 Whats New to the Dexcom G5 Mobile CGM System? ............................38 4.5 System Information ......................39 4.6 System Components .....................39 4.7 Smart Device Overview ..................48 Chapter 5 - Set up Your Display Devices ... 49 5.1 Introduction ..............................49 5.2 Safety Statement .........................49 5.3 Why Different Monitoring Methods? .....50 5.4 Dexcom G5 Mobile App ..................50 5.5 Dexcom G5 Mobile Receiver .............63 Chapter 6 - Starting a Sensor Session:
Inserting Sensor, Transmitter, and Starting Your Session 69 6.1 Overview .................................69 6.2 Safety Statements ....................... 70 6.3 Prepping for Sensor Insertion ............72 6.4 Choosing Your Insertion Site ............. 75 6.5 Inserting Your Sensor .................... 76 6.6 Attaching Your Transmitter ..............80 6.7 Loose Sensor Pod ........................ 81 6.8 Starting Your Sensor Session ............82 6.9 Receiver Bluetooth Tips ................86 6.10 Sensor Session Warmup .................90 Chapter 7 - Calibration 91 7.1 Introduction .............................. 91 7.2 Calibration Overview .....................92 7.3 Safety Statements .......................93 7.4 When to Calibrate ........................95 7.5 Calibration Prompts ......................96 7.6 Preparing for Calibration ............... 100 7.7 Ready? Set? Calibrate! ................. 100 7.8 Calibration Errors....................... 106 Chapter 8 - Ending Your Sensor Session and Transmitter Session 109 8.1 Introduction ............................ 109 8.2 Safety Statements ..................... 110 8.3 Ending Your Sensor Session ........... 110 8.4 Remove Sensor Pod and Transmitter .. 124 8.5 End of Transmitter Battery ............. 126 Part 3: Next Steps - Getting the Most out of Your Dexcom CGM Chapter 9 - Home Screen, Rate of Change Arrows, and Errors 133 1 Dexcom G5 Mobile System User GuideTable of Contents 9.1 Introduction to Home Screens ......... 133 9.2 Safety Statements ..................... 133 9.3 Overview of Home Screen ............. 134 9.4 Rate of Change Arrows ................ 146 9.5 Error Messages ........................ 147 Chapter 10 - Daily Events Affect Your Glucose Trends and Patterns 153 10.1 Introduction ............................ 153 10.2 What Is an Event? ...................... 153 10.3 Entering Events ......................... 162 10.4 Viewing Events ......................... 170 Chapter 11 - Sensor Glucose Alarm and Alerts 173 11.1 Introduction ............................ 173 11.2 Safety Statements ..................... 174 11.3 Alarm and Alerts ....................... 175 11.4 Alarm and Alerts Screens .............. 177 11.5 App: Alarm/Alert Recommended Settings ................................. 183 11.6 Receiver: Default Beeps and Vibrations ............................... 184 11.7 Clearing Alarm/Alerts .................. 188 Chapter 12 - On the Go With G5: Customizing Your Alarm and Alerts 191 12.1 Introduction ............................ 191 12.2 Safety Statement ....................... 192 12.3 Changing App Alarm and Alerts ....... 192 12.4 Changing Receiver Alarm and Alerts .. 204 Part 4: Everything Else G5 Chapter 13 - Warranty: The Fine Print 215 13.1 Introduction ............................ 215 13.2 Receiver Warranty Information ........ 215 13.3 Transmitter Warranty Information ..... 217 13.4 Dexcoms Obligations Under the Limited Warranty ................................ 219 Chapter 14 - How to Take Care of Your Dexcom G5 Mobile CGM System 221 14.1 Introduction ............................ 221 14.2 Basic Maintenance ..................... 222 14.3 Storage ................................. 226 14.4 Checking App and Receiver Information ............................. 227 14.5 System Disposal ....................... 228 Chapter 15 - On the Go With Dexcom G5 Mobile CGM System: Getting Through Security 229 15.1 Introduction ............................ 229 15.2 Going Through Security ................ 229 Chapter 16 - Need Help? Youre Not Alone!
233 16.1 Dexcom Technical Support ............ 233 16.2 Patient Care Team...................... 234 16.3 Sales Support Team .................... 235 16.4 Corporate ............................... 235 Chapter 17 - Technical Information 237 17.1 Device Performance Characteristics .. 237 17.2 Product Specifications ................. 275 17.3 FCC Requirements ..................... 283 Chapter 18 - Troubleshooting 285 18.1 Introduction ............................ 285 18.2 Safety Statements ..................... 285 18.3 Troubleshooting ........................ 287 Chapter 19 - Symbols on Package Labels 299 Part 5: Sharing Is Caring Chapter 20 - Dexcom Share 303 20.1 Learning About Dexcom Share ........ 303 20.2 Dexcom Share Overview ............... 307 20.3 Risks and Benefits ..................... 309 20.4 Safety Statement ....................... 310 20.5 Setting up Dexcom Share .............. 313 20.6 Using Dexcom Share ................... 323 20.7 Dexcom Follow App .................. 328 20.8 Troubleshooting ........................ 330 Index 333 2 Dexcom G5 Mobile System User GuideTable of Contents Glossary Getting Started Indications for Use and Safety Statement Risks and BenefitsGETTING STARTED Page intentionally left blank Glossary A1C Accessory Device Alternative Site Testing App Apple Watch Blood Glucose (BG) Value Blood Glucose Meter/Meter/BG Meter Blood test used to diagnose type 1 or 2 diabetes and to gauge how well youre managing your diabetes. The A1C test result reflects your average blood sugar level for the past two to three months. A device that connects with and extends a smart device. Such a device requires the smart device connection for full functionality. Examples are a smart watch or a Bluetooth headset. Also see the Apple Watch and Smart Watch entries in this glossary. Using a blood sample from non-fingertip (alternate) sites such as the palm, forearm or upper arm for meter readings. Do not use alternative site testing to calibrate the Dexcom G5 Mobile CGM System, only use fingerstick measurement. A self-contained program or piece of software designed to fulfill a particular purpose; an application, especially as downloaded by a user to a smart or mobile device. The Dexcom G5 Mobile App was developed as a display for continuous glucose monitoring. A specific smart watch that is compatible with iPhones only. The Apple Watch is considered an accessory device as it requires an active connection with the iPhone to have full functionality. Also see the Accessory Device and Smart Watch entries in this glossary. BG is an abbreviation of blood glucose. Blood glucose value is the amount of glucose in the blood measured by a BG meter. A blood glucose meter is a medical device used to measure how much glucose is in the blood.
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(Continued on next page) 5 GlossaryDexcom G5 Mobile System User Guide Calibration Continuous Glucose Monitoring (CGM) Contraindication Hyperglycemia
(Continued on next page) Calibration is a comparison or measurement between your meters fingerstick BG values, and the sensors 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. When you calibrate, you take a fingerstick measurement from your meter then enter the value into your receiver or smart device. The system uses that value to verify the sensor glucose reading is on track. Continuous glucose monitoring (CGM) systems use a sensor inserted under the skin to check glucose levels in interstitial fluid. A transmitter sends sensor glucose readings to a display device. Users must confirm glucose levels with a BG meter before making a change in treatment. A safety statement outlining specific situations where the Dexcom G5 Mobile should not be used because it may be harmful to you. The risk of use clearly outweighs any possible benefit. High blood glucose. Same as high or high blood sugar. Hyperglycemia is a characterized by an excess of glucose in the bloodstream. Its important to treat hyperglycemia. If left untreated, hyperglycemia can lead to serious complications. The default high alert in the Dexcom G5 Mobile CGM System is set to 200 mg/dL. Consult your healthcare professional to determine the appropriate hyperglycemic setting for you.
(Continued on next page) 6 GlossaryDexcom G5 Mobile System User Guide Hypoglycemia Indication IP Jailbroken Landscape
(Continued from previous page) Low blood glucose. Same as low or low blood sugar. Hypoglycemia is characterized by a low level of glucose in the bloodstream. Its important to treat hypoglycemia. If left untreated, hypoglycemia can lead to serious complications. The default low alert in the Dexcom G5 Mobile CGM System is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemic setting for you. A condition making a particular treatment or procedure advisable. How, for what purposes, and under what circumstances you should use the Dexcom G5 Mobile CGM System. Indications let you know who should use the Dexcom G5 Mobile CGM System and when. 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. An IP22 rating lets you know your electronic device wont allow you to stick your fingers in it and wont get damaged or be unsafe during specific testing with water dripping down. The removal of limitations and security measures set by the manufacturer on a smart device. The removal poses a security risk and data may become vulnerable. Do not use, install or run the Dexcom G5 Mobile App on a jailbroken smart device. The app may not work correctly on a jailbroken smart device. If your smart device is oriented sideways.
(Continued on next page) 7 GlossaryDexcom G5 Mobile System User Guide mg/dL Portrait Precaution RF Safety Statement Sensor Session Smart/Mobile Device Smart Watch Today View Warning
(Continued from previous page) Milligrams per deciliter. The standard unit of measure for glucose readings in the United States. If your smart device is oriented vertically. A safety statement regarding any special care to be exercised by you or your healthcare professional for the safe and effective use of the Dexcom G5 Mobile CGM System. Radio-frequency transmission used to send glucose information from the transmitter to the receiver or smart device. A statement of the intended uses of Dexcom G5 Mobile CGM System and relevant warnings, precautions, and contraindications. The seven day monitoring period after inserting a new sensor. During this time frame, your glucose is being monitored and reported every five minutes, with data being sent to your display device(s). A smart/mobile device is an electronic, mobile device that can wirelessly connect to networks over Wi-Fi or a cellular data connection (3G, 4G, etc.). Examples of smart/mobile devices are smartphones and tablets. A watch that communicates with and extends a smart device. These devices typically require a smart device connection for full functionality. An example is the Apple Watch. Also see the Apple Watch and Accessory Device entries in this glossary. A feature found on iOS smart devices used to quickly access information from any activity or from the lock screen. Access by swiping down from the top edge of your device. A safety statement letting you know the following feature has important hazard information. Describes serious and life threatening circumstances of using the Dexcom G5 Mobile CGM System, their consequences, and how to avoid the hazard. 8 GlossaryDexcom G5 Mobile System User Guide Chapter 1 Getting Started:
Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey 1.1 Introduction Welcome to the Dexcom G5 Mobile 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 Dexcom G5 Mobile CGM System allows you to break free from constant fingersticks. But how do you use the Dexcom G5 Mobile CGM System? What are its features? Do you need to avoid anything?
Where do you even begin?
This chapter is the first step to answering these and many other questions. After this chapter, you will be able to:
Describe different training resources Locate tutorials about using the Dexcom G5 Mobile CGM System in your diabetes management Find Dexcom G5 Mobile Systems step-by-step instructions Recall how to use the User Guide Explain why you need a Dexcom account We have numerous resources available to help you to get the most out of your Dexcom G5 Mobile CGM System. Between our self-paced training resources and our friendly and knowledgeable Dexcom customer support teams, help is always available. First Things First - Learning How to Learn Knowing about the Dexcom G5 Mobile CGM System is your first step in creating a successful CGM experience. Before using it, learn about it. You have numerous self-paced resources, helping you get to know the Dexcom G5 Mobile CGM System:
9 Dexcom G5 Mobile System User GuideBeginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey 1. Tutorials 2. Quick Start Guide 3. User Guide No matter which resource 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. This tutorial covers what to expect in your first week and includes links to step-by-step videos on how to insert your sensor, calibrations, ending a sensor session, etc. Next Steps With Your Dexcom CGM Just finished First Steps or already familiar with how a CGM can benefit you? This tutorial covers looking at trends and introduces some advanced features including our reporting tools. Accessing Online Tutorials:
From dexcom.com homepage, click Support, click Training. Once you have viewed the online tutorials you should be pretty comfortable with what CGMs do and how the Dexcom G5 Mobile CGM System can help you. Offline Tutorials You dont need to be tied to the Internet to view our instructional tutorials, theyre also available offline. Accessing Offline Tutorials:
USB Card in the receiver package. 10 Dexcom G5 Mobile System Users GuideBeginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey Written Mobile Resources Quick Start Guide (QSG) The Dexcom G5 Mobile Quick Start Guide compliments the tutorials by proving the same step-by-step instructions in a booklet form or within the app. One of the great things about the QSG is you can use it in conjunction with the videos, taking notes as you go!
Accessing the QSG:
Booklet in the receiver package. Both the tutorial and the QSG give you brief look at the Dexcom G5 Mobile CGM System. But what if you want more detailed information?
User Guide Your Dexcom G5 Mobile CGM System reference book!
This user guide gives you the most extensive overview of the system detailing features, important safety information and so much more. To download an ebook of the user guide or request a printed user guide, visit dexcom.com/guides. The Dexcom G5 Mobile User Guide is grouped into six separate parts:
Part 1: Getting Started 1. Glossary 2. Getting Started a. Learning how to learn about the Dexcom G5 Mobile CGM System b. Registering at dexcom.com 3. Indications for Use and Safety Statement 4. Risks and Benefits Part 2: Lets G5! The Basics 1. Introduction to the Dexcom G5 Mobile CGM System 2. Choose and Set up Your Display Device(s) 3. Initiating a Sensor Session: Inserting the Sensor & Transmitter 4. Calibration 5. End a Sensor Session 11 Dexcom G5 Mobile System User GuideBeginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey Part 3: Next Steps - Getting the Most out of Your Dexcom CGM Once you are up and running, how you can maximize the Dexcom G5 Mobile features:
1. Reading Trend Graph Screens and Recognizing Trends 2. Events 3. Alarm and Alerts 4. Sounds for Alarm, Alerts and System Messages Part 4: Everything Else G5 1. Warranty 2. Dexcom G5 Mobile CGM System Maintenance 3. Travel Tips 4. Customer Service Contacts 5. Technical Information 6. Troubleshooting 7. Package Label and Product Symbols At the end of your Dexcom G5 Mobile System User Guide, Part 5, is the user guide of a new Dexcom G5 Mobile System feature: Dexcom Share. Part 5: Sharing is Caring 1. Dexcom Share a. What Is Dexcom Share?
b. Setting Up Dexcom Share c. How to Use Dexcom Share d. Your Followers e. Troubleshooting Part 6 1. Index for Dexcom G5 Mobile System and Dexcom Share How to Use Your User Guide All chapters in the Dexcom G5 Mobile User Guide are laid out the same way:
The beginning of each chapter lists what youll be able to do after you have finished, after that, any applicable safety statements you need to know, followed by the chapters content. At the end, theres a recap of what was covered and whats in the next chapter. 1.3 Your Dexcom Account Youll need a username and password to set up the Dexcom G5 Mobile App and for reordering. 12 Dexcom G5 Mobile System Users GuideBeginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey If you havent already done so, go to dexcom.com and set up your own account. Or, if you prefer, the Dexcom G5 Mobile App walks you through creating your log in credentials as part of your initial app set up. Summary Now You Can:
Describe different training resources Locate tutorials about using a real-time CGM in your diabetes management Find Dexcom G5 Mobile Systems step-by-step instructions Recall how to use the user guide Explain why you need a Dexcom account Whats Next?
Now you are familiar with how to use this user guide and where to go for help. Throughout the user guide youll see color-coded boxes containing Safety Statements. The next chapter, Indications for Use and Safety Statement, lists all Safety Statements along with how to read and interpret them. Next youll learn about when and how to use the Dexcom G5 Mobile CGM System safely. 13 Dexcom G5 Mobile System User GuideBeginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey Page intentionally left blank 14 Dexcom G5 Mobile System Users GuideBeginning Your Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System Journey Chapter 2 Getting Started:
Indications for Use and Safety Statement 2.1 Introduction We want the Dexcom G5 Mobile CGM System to be a valuable tool in your diabetes management. Like any system, there are steps to take to get the most out of it. As excited as you are about getting started, did you know if you just took Tylenol, maybe you should wait?
Did you know taking Tylenol is contraindicated?
In this chapter, youll learn about some key areas that might prevent you from having the best CGM experience, or, if youre not careful, might even harm you or the system. Youll even learn what a contraindication is!
2.2 Important User Information Each part of your system has instructions including indications, contraindications, warnings, precautions, and other important user information. Please review the instructions for each part of the system in this user guide before using any of the Dexcom G5 Mobile CGM System. This chapter is important to read. It helps you use the Dexcom G5 Mobile CGM System safely and covers:
What is a Safety Statement?
Telling the difference between an indication and a contraindication Explaining why warnings are so important Defining precautions How to read a chapters Safety Statement Overview of Safety Statements Lets start with definitions, look at a Safety Statement example used throughout the User Guide, and then review the Safety Statements broken down into the systems components. Safety Statement A Safety Statement is a brief statement of the Dexcom G5 Mobile CGM Systems indications, relevant warnings, precautions, or its contraindications (when to avoid using it). The Safety 15 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Statements are meant to keep you and the system safe while using the Dexcom G5 Mobile CGM System:
1) Indications How, for what purposes, and under what circumstances you should use the Dexcom G5 Mobile CGM System. Indications let you know who should use the Dexcom G5 Mobile CGM System and when. Indications are the who, what, and why of the Dexcom G5 Mobile CGM System. 2) Contraindications Contraindications let you know when not to use the Dexcom G5 Mobile CGM System. If used during these situations, you may hurt yourself or the system, the risk of use clearly outweighs the benefit. 3) Warning Important hazard information: Describes serious or life threatening circumstances to stay away from while using the Dexcom G5 Mobile CGM System, their consequences, and how to avoid danger. 4) Precaution Special steps you need to take while using the Dexcom G5 Mobile CGM System, preventing minor or moderate injury to either you or the system. 2.3 Safety Statements This user guide presents Safety Statement two ways:
1. In this chapters Overview of Safety Statements Lists all Safety Statements Includes a section reviewing how the statements are formatted 2. Within a chapter Lists only those statements applicable to the chapter Chapters 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 towards the front so you can keep them in mind as you learn about that chapters topic. The same statement may be repeated throughout the user guide. Its important to recognize which factors could prevent the system from working correctly, or even harming you. 16 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Within chapters, each color coded Safety Statement is in a box, broken down into four sections:
1. Type of statement a. Bold and color-coded WARNING-Red PRECAUTION-Blue INDICATION-Green CONTRAINDICATION-Purple 2. Dos/Donts a. An action you should or should not take b. Italicized 3. Why 4. Consequences a. A statement of the potential harm a. What could happen if you dont follow the instructions The following is an example of a chapters Safety Statement and how to read it. WARNING Do: Calibrate at least once every 12 hours. Why: 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 WARNING, you know it covers important safety information. Italics are the Do/Dont steps to follow: Calibrate at least once every 12 hours. Below the italics is a statement explaining Why you need to follow the steps: Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings. And finally what happens, or the Consequences, if you dont: missing a severe low (hypoglycemia) or high (hyperglycemia) glucose event. 2.4 Overview of Safety Statements This section provides a review of Safety Statements containing the same elements described above (type of Safety Statement, an action, a statement of potential harm, and consequences) listed in a narrative, not boxed, format. Here youll learn what indications 17 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement and contraindications are and what to do to keep you safe and the system in proper working order. Safety Statements are broken down into two major categories. First, general CGM system Warningsreviews warnings and precautions you take with most CGM systemsand second, Hardware/Software Warnings and Precautions list warnings and precautions specific to the Dexcom G5 Mobile CGM System components. Indications and Contraindications Indications What are the Dexcom G5 Mobile CGM System indications? Well, in technical terms, the indications are:
The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System 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 Dexcom G5 Mobile CGM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Dexcom G5 Mobile CGM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G5 Mobile CGM System results should be based on the trends and patterns seen with several sequential readings over time. In Laymans Terms But what does that mean? Indications are the who, what, and why of the Dexcom G5 Mobile CGM System. Who The Dexcom G5 Mobile CGM System is a single patient use device (meaning you cant share the components with others) for people 2 years or older with diabetes. What The Dexcom G5 Mobile CGM System is a prescription-only glucose monitoring device. Dexcom G5 Mobile CGM System tracks your glucose patterns and detects trends. Working with your home blood glucose (BG) meter, the system is meant to complement, not replace, your BG meter. 18 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Why The CGM systems trend and pattern information, its glucose Alarm/Alerts, combined with your meters actual BG value, can help you manage your diabetes. By identifying low and high glucose level periods, the Dexcom G5 Mobile CGM System allows you to take action when needed and create long-term management strategies with your healthcare professional. Using trend information to see your highs and lows helps you stay inside your target range. The Dexcom G5 Mobile CGM Systems 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 Dexcom G5 Mobile CGM System; you may hurt yourself or damage the system. Remember, if used during certain situations, the risk of use may clearly outweigh any potential benefit. Within the chapters, contraindications are in purple boxes. MRI/CT/ Diathermy Remove the Dexcom G5 Mobile CGM System (sensor, transmitter, and receiver) before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The system hasnt been tested during MRI, CT scans, or with diathermy treatment. Magnetic fields and heat could damage the components, stopping sensor glucose readings or Alarm/Alert notifications. Without sensor glucose readings or Alarm/Alert notifications, you might miss a severe low or high glucose event. Medications 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 inaccuracy depends on the amount of acetaminophen active in your body and is different for each person. 19 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement 2.5 General CGM System Warnings Warnings 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 Dexcom G5 Mobile CGM System from harm. Review Training Materials Thoroughly review the training materials included with your Dexcom G5 Mobile CGM 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. Treatment Decisions The Dexcom G5 Mobile CGM System does not replace your BG meter. When making treatment decisions, such as the amount of insulin you need, only use your BG value. Dont use the Dexcom G5 Mobile CGM System sensor glucose readings because readings can be different from your BG value. If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event. Dont Ignore Low/High Symptoms If your sensor glucose readings dont match your symptoms, measure your BG with a fingerstick. You may miss a severe low or high glucose event. Who Shouldnt Use The Dexcom G5 Mobile CGM System was not evaluated for the following persons:
Pregnant women Persons on dialysis Do not use the Dexcom G5 Mobile 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. The systems accuracy hasnt been tested in people falling into these groups and sensor glucose readings may be inaccurate, resulting in missing a severe low or high event. 20 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement 2.6 Calibration Warning and Precautions Calibration is the process of making sure your sensor continues to be accurate. Your sensor doesnt automatically know what your glucose levels areyou 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. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, resulting in you missing a severe low or high glucose event. Precautions Be Accurate, Be Quick Enter the exact BG value displayed on your BG meter within five minutes of a fingerstick. Entering the wrong BG values, or waiting more than five minutes before entry, might affect sensor performance, resulting in you missing a severe low or high event. Significant Glucose Rate Changes Dont calibrate when your BG is changing at a significant rate: more than 2 mg/dL per minute. Look for rate of change arrows on your display device screen and dont calibrate when you see:
A single arrow, pointing up Rising 2-3 mg/dL each minute Two arrows pointing up Rising more than 3 mg/dL each minute Single arrow pointing down Falling 2-3 mg/dL each minute Two arrows pointing down 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. 21 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Alternative site BG values from your arms, palm of your hand, etc., may be different and less accurate than your fingerstick BG values. Using alternative for calibration might affect sensor performance, resulting in you missing a severe low or high glucose event. Prior to Initial Calibration: Data/Alarm/Alert After starting a new sensor session, until completing your initial calibrations you wont receive any sensor information such as readings, Alarm or Alerts. Without these, you may miss a severe low or high glucose event. Continue to take fingerstick measurements during a new sensor warmup period. Now that we have reviewed common CGM Safety Statements, lets focus the Dexcom G5 Mobile CGM System components. 2.7 System/Hardware/Software Warnings and Precautions In this section, you will learn how to safely use the Dexcom G5 Mobile CGM Systems hardware and software. Some sections have either Precautions or Warnings, others will have both. Sensor/Sensor Pod Warnings and Precautions Warnings Sensor Breaking Off On rare occasions, the sensor wire may break or detach from the sensor pod. Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department, toll free at 1.877.339.2664 or toll at 1.858.200.0200. If a sensor wire breaks under the skin with no portion of it visible, dont remove it. Contact your healthcare professional if you have redness, swelling, or pain at the insertion site. Placement Do not insert the sensor component of the Dexcom G5 Mobile System in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the Dexcom G5 Mobile System is not approved for other sites. If placed in other areas, the Dexcom G5 Mobile System may not function properly. 22 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Storage During a sensors shelf life, store it between 36 F-77 F. While you dont need to keep your sensor in a refrigerator, you can as long as the refrigerator is between 36 F-77 F. Never store sensors and/or sensor packages in a freezer. Storing the sensor incorrectly might cause the sensor glucose readings to be incorrect, resulting in you missing a severe low or high glucose event. Precautions Expiration Date Dont use expired sensors. Before inserting, always check the package label for the expiration date using the YYYY-MM-DD format. If past the expiration date, dont use because the sensor glucose readings might not be accurate, resulting in you missing a severe low or high glucose event. Sensor Package Dont 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. Dont insert the sensor until the cleaned insertion site is dry, and free from any lotions or perfumes. If your insertion site is not clean and completely dry, you run the risk of infection or the sensor pod not sticking and falling off. Sensor Placement Change the site where you place the sensor with each new insertion. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation. Sensor placement is important. Make sure the area you place your sensor wont:
Be bumped, pushed, or squeezed Have scars, tattoos, or irritation Insertion in these areas might affect sensor performance, resulting in you missing a severe low or high glucose event. 23 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Avoid injecting insulin or placing an insulin pump infusion set within three inches of the sensor. The insulin might affect sensor performance, resulting in you missing a severe low or high glucose event. Transmitter Warnings and Precautions Warnings Inspect Transmitter If your transmitter is damaged or cracked in any way, dont 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. Dont put it in your mouth or allow children to play with it. Precautions Reusable: Dont Throw Away When ending a session, dont throw away the transmitter. The transmitter is reusable and can be used in multiple sensor sessions. Keep using it until the system notifies you the transmitter battery is about to expire. Dont Share Your Transmitter Never share your transmitter with another person. The Dexcom G5 Mobile CGM System is a prescription-only medical device and is meant, or indicated, for your use only. Your transmitter is tied to your readings. If used by someone else, your reports, Alarm and Alerts, etc., would be wrong, resulting in you missing a severe low or high glucose event. System Precautions Next are precautions for the receiver, transmitter, sensor and the system. Precautions Use Correct Transmitter, Receiver, and Sensor Different generations transmitters and receivers arent interchangeable with each other. The Dexcom G5 Mobile CGM Systems transmitter and receiver are not compatible with the Dexcom G4 PLATINUM CGM Systems transmitter and receiver. The Dexcom G5 Mobile CGM System wont work if you mix receiver and transmitter components from different generations, resulting in you missing a severe low or high glucose event. 24 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement You can use a Dexcom G4 PLATINUM Sensor with the Dexcom G5 Mobile CGM System. Before using the sensor, make sure the sensor label says Dexcom G5 Mobile/G4 PLATINUM Sensor, or Dexcom G4 PLATINUM Sensor. System Accuracy 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 Receiver and Smart Device Precautions The Dexcom G5 Mobile Receiver and your smart device share some warnings and precautions. 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. If your transmitter and display device(s) are more than 20 feet from each other or are separated by an obstruction, they might not communicate, resulting in you missing a severe low or high glucose event. Water is often the biggest culprit in reducing the communication distance between the transmitter and display devices. Take special care when swimming, getting into a pool, bathtub, shower, etc. Setting Alarm/Alert Notifications When using both a receiver and a smart device, you must set your settings separately in each. If you set up one device and then use another, you might not get an Alarm or Alerts, causing you to miss a severe low or high glucose event. Using an accessory device (like a smart watch) might override your smart device sounds. Alarms or Alerts might vibrate or be heard on the accessory instead of your smart device. 25 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement After connecting any accessories, make sure that the smart device settings allow you to continue receiving Alarms or Alerts on the smart device. Is It On?
If the receiver or smart device is turned off (Shut Down), it will not display sensor data, information, Alarm or Alerts. Make sure they are turned on; otherwise you wont get sensor glucose readings or Alarm or Alerts, causing you to miss a severe low or high glucose event. Smart Device Warnings Next are warnings for just your smart device. Warnings Smart Device Settings The Dexcom G5 Mobile App cant override your smart devices internal settings. Also, accessory devices (like a smart watch or other wearable smart devices) might override your smart devices Alerts and Alarm. To receive Alarm or Alerts you must:
1. Make sure Dexcom G5 Mobile App Notifications are turned on in the Settings menu. 2. Verify app hasnt 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. Set Volume at a level you can hear. 7. Do not close app, always run app in the background. 8. Make sure accessory devices do not override your smart device settings. If your settings are incorrect, you might miss a severe low or high glucose event. Dexcom G5 Mobile CGM System Alarm/Alert vibrations arent any different from other vibrating apps on your smart device. Medical device apps, like the Dexcom G5 Mobile App, dont have any special priorities over your smart devices features. Dexcom G5 Mobile App notifications or alerts may sound or feel the same as notifications from another app. The only way to know is look at the screen. Cant Hear Your Alarm or Alert?
An Alarm or Alert cant be heard through your smart devices speakers if headphones are plugged in. Make sure you unplug your headphones when you are done using them, otherwise you might not hear an Alarm or Alert, causing you to miss a severe low or high glucose event. 26 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Receiver Warning and Precaution Warning Dont Use Damaged Goods If your receiver is damaged or cracked, dont use it. This could create an electrical safety hazard or malfunction, causing possible electrical shocks. Precaution Keep Receiver Dry Keep the USB port cover on the receiver closed whenever the USB cable is not attached and do not submerge in water. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts; you might miss a severe low or high glucose event. Caution U.S. law restricts the sale of the Dexcom G5 Mobile CGM System to sale by or on order of a physician. Summary Now You Can:
Define a Safety Statement Explain the difference between an indication and a contraindication Describe the importance of warnings Describe what a precaution is Correctly read a chapters Safety Statement Provide an overview of Safety Statements by category Whats Next?
In our next chapter, you will learn about the risks and benefits of using Dexcoms G5 Mobile CGM System. 27 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Page intentionally left blank 28 Dexcom G5 Mobile System User GuideIndications for Use and Safety Statement Chapter 3 Getting Started:
Risks and Benefits When using any medical device, there are risks and benefits. In this chapter, youll learn what they are, helping you decide if Dexcoms G5 Mobile CGM System is right for you. First, lets review some possible risks. 3.1 Risks There are some risks with using real-time CGM. Not Receiving Alarm/Alerts If you arent getting your CGM Alarm/Alerts, you run the risk of not knowing you are having a severe glucose low or high. Some hardware issues preventing Alarm/Alerts:
Alert function is turned off Transmitter and display device is out of range Receiver or smart device isnt showing sensor glucose readings Receiver or smart device battery is dead Unable to hear Alarm/Alerts or feel vibration App not running in the background Smart device is in Do Not Disturb See Troubleshooting or recommended settings in Chapter 11 for more information. Sensor Glucose Reading Different From Meters The sensor glucose reading can be different than your meters BG value. If the sensors glucose reading is higher than your meters BG value, you may miss a Low Alert. As an example, your last sensors glucose reading was 82 mg/dL, whereas your BG value shows 78 mg/dL. If your Low Alert is set at 80 mg/dL, you wont receive an Alert because the sensor glucose reading is 82 mg/dL. 29 Dexcom G5 Mobile System User GuideRisks and Benefits If youre not receiving an Alarm/Alert, and not taking fingerstick measurements, you may be unaware of low or high glucose levels. Sensor Insertion Risks Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (e.g., redness, swelling, bruising, itching, scarring or skin discoloration). The chance of this happening is low. The Dexcom G5 Mobile CGM System uses the same sensor as the previous CGM systemthe Dexcom G4 PLATINUM. The Dexcom G4 PLATINUM System clinical studies and compliant data showed slight redness and swelling occurring only in a few patients. During Dexcoms G4 PLATINUM Systems clinical study, no sensor wires broke however there is a remote chance sensor fragments could remain under your skin if the sensor breaks during normal wear. Sterile broken sensor wires dont pose a significant medical risk. If a sensor wire breaks off or detaches and remains under your skin, contact your healthcare professional and call Dexcoms Technical Support toll free, 24/7, at 1.877.339.2664 or toll at 1.858.200.0200 within 24 hours. Those are the risks, lets now review the benefits!
3.2 Benefits Daily habits impact your BG levels. With the Dexcom G5 Mobile CGM System, you can track how your exercise, carbs, stress levels, medication, or illness, influences your glucose levels. Knowing Your Trends Wearing the Dexcom G5 Mobile CGM System on a consistent and ongoing basis helps you manage your diabetes. Providing sensor glucose readings every five minutes, for up to seven days, the Dexcom G5 Mobile CGM System helps you detect trends and patterns. Trend information reveals where your glucose is now, where your glucose is heading, and how fast its changing. Understanding your trends allows you to take proactive action, helping you avoid dangerously low or high glucose values. Using Dexcom Share (see Part 5) allows friends and family, your Followers, to monitor your glucose activity, adding another layer of support and peace of mind. 30 Dexcom G5 Mobile System User GuideRisks and Benefits Helps in Your Diabetes Management The Alarm/Alerts features (see Chapter 11) keep you aware of your glucose levels. Alerts notify you when your glucose goes outside your target range or is rapidly falling or rising, letting you to take action before you get too low or too high. The Urgent Low Alarm lets you know when you are dangerously or urgently low, going below 55 mg/dL. By taking corrective measures, you lessen the time spent in your low/high range, while increasing time in your targeted range (Garg S. Z., 2006) (Battelino T, 2011). Real-time CGM can help improve your A1C as well as improve the quality of your glucose control. If you are at or below 7%, using a CGM such as Dexcoms G5 Mobile CGM System, helps reduce hypoglycemia (Tamborlane, W. V.,2008). 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) Whats Next?
Youve read the Safety Statements, reviewed the risks and benefits; now lets take a look at Dexcoms G5 Mobile CGM System!
References:
Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., & Bolinder, J. (2011). Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes. Diabetes Care, 34(4), 795-800. The Diabetes Control and Complications Trial Research Group. The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. The New England Journal of Medicine, Vol. 329, No. 14.
(September 1993), pp. 977-986. Garg, S., Zisser, H., Schwartz, S., Bailey, T., Kaplan, R., Ellis, S., & Jovanovic, L. (2005). Improvement in Glycemic Excursions With a Transcutaneous, Real-Time Continuous Glucose Sensor: A randomized controlled trial. Diabetes Care, 29(1), 44-50. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. (2009). The Effect of Continuous Glucose Monitoring in Well-Controlled Type 1 Diabetes, Diabetes Care, 32(8), 1378-1383. 31 Dexcom G5 Mobile System User GuideRisks and Benefits Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group.
(2009). Sustained Benefit of Continuous Glucose Monitoring on A1C, Glucose Profiles, and Hypoglycemia in Adults With Type 1 Diabetes. Diabetes Care, 32(11), 2047-2049. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2010). Quality-of-Life Measures in Children and Adults with Type 1 Diabetes. Diabetes Care, 33(10), 2175-2177. Ohkubo, Y., Kishikawa, H., Araki, E., Miyata, T., Isami, S., Motoyoshi, S., & Shichiri, M. (1995). Intensive Insulin Therapy Prevents the Progression of Diabetic Microvascular Complications in Japanese Patients with Non-insulin-dependent Diabetes Mellitus: A Randomized Prospective 6-year Study. Diabetes Research and Clinical Practice, 28(2), 103-117. Tamborlane, W. V., Beck, R. W., Bode, B. W., Buckingham, B., Chase, H. P., Clemons, R., ... &
Xing, D. (2008). Continuous Glucose Monitoring and Intensive Treatment Of Type 1 Diabetes. The New England Journal of Medicine, 359(14), 1464-1476. 32 Dexcom G5 Mobile System User GuideRisks and Benefits Introduction to the Dexcom G5 Mobile CGM System Initial Set-Up Starting a Sensor Session: Inserting the Sensor & Transmitter Calibration Ending a Sensor SessionLETS G5! THE BASICS Page intentionally left blank Chapter 4 Lets G5! The Basics:
What Is the Dexcom G5 Mobile CGM System?
4.1 System Description Now its time to get an overview of the Dexcoms G5 Mobile CGM System. After this chapter, youll be able to:
Explain the Dexcom G5 Mobile CGM System Describe options to view trends Locate your historical readings Recognize system components Explain each parts function 4.2 Safety Statement If youve used the Dexcom G4 PLATINUM CGM System, you might still have its transmitter or receiver. While you can use the sensors across the different generations (look for G5 Mobile or G4 PLATINUM on the sensors package), you cant mix the transmitter or receiver between the two systems. WARNING Dont: The Dexcom G5 Mobile CGM System was not evaluated for the following persons:
Pregnant women Persons on dialysis Do not use the Dexcom G5 Mobile 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. Consequences: The systems accuracy hasnt been tested in people falling into these groups and sensor glucose readings may be inaccurate, resulting in missing a severe low or high event. 35 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? PRECAUTION Dont: Never mix Dexcom G5 Mobiles Transmitter or Receiver with Dexcom G4 PLATINUMs Transmitter or Receiver. Why: The Dexcom G5 Mobile CGM Systems Transmitter and Receiver are not compatible with the Dexcom G4 PLATINUM CGM Systems Transmitter and Receiver. The Dexcom G5 Mobile CGM System wont work if you mix Receiver and Transmitter components from different generations. Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) event. 4.3 The Dexcom G5 Mobile CGM System CGM The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System is a medical device you use on yourself. It allows you to continually see your sensor glucose readings, updated every five minutes for up to 7 days, without the bother of taking constant fingerstick measurement. Your sensor glucose readings are measured by a single use sensor inserted under your skin. A reusable transmitter sends your data to your display device. The Dexcom G5 Mobile CGM System provides personalized trend alerts, prompting you to proactively react when your glucose levels are getting too low, or too high. Dexcom provides web-based reports reflecting your glucose trends and patterns. Share the reports with your healthcare professional when developing your diabetes management treatment plans. Options to View Your Trends The Dexcom G5 Mobile CGM System transmitter works with a number of display devices giving you flexibility to use whats best for you, your situation, or your lifestyle. 1. Dexcom G5 Mobile Receiver 2. Dexcom G5 Mobile App on your smart device While the system works with different smart devices, theyre not interchangeable during a sensor session. Before starting one, select which smart device you want to use and stick with it throughout your session. You cant use multiple smart devices at the same time, but you can combine the receiver with a smart device during a session. The Dexcom G5 Mobile CGM System is the first CGM system where a smart device acts as a receiver. For a list of current devices and operating systems go to:
dexcom.com/compatibility 36 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? Chapter 5 covers how to set up your smart device with the Dexcom G5 Mobile App. The primary difference between the receiver and app is not the information they give you, but how that information is presented. The following are some of the shared CGM data and system information features. Tracking Real Time CGM Data The receiver and app give you the ability to track your glucose trends in a number of different ways. Each devices home screen opens to your glucose trend screen. View Glucose Levels The receiver and app share many of the same glucose monitoring features. Your glucose values are color coded to highlight what zone you are in, allowing you, at a glance, to see what your levels are. Color coded glucose levels:
Red - Low Grey - Within your normal range Yellow - High Trend Arrows Glucose levels are not just about the numbers. The Dexcom G5 Mobile CGM System includes trend arrows so you know the speed and direction of your glucose, allowing you to proactively react before your glucose gets too high or too low. Alarm/Alerts Being warned when your glucose value is too high or too low, falling or rising too quickly, or if its trending towards a severe low or high is very important. Warnings in the form of Alerts or an Alarm help you avoid getting too low or 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. Some customization options are available and are part of the set up process for the receiver and smart device. In Chapter 11, you can learn more about the Alarm and Alerts feature. Viewing Your Glucose Values 37 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? The Dexcom G5 Mobile CGM System allows you to see your last 1-3-6-12-24 hours of your sensor glucose readings. On the receiver, from the home screen, press Up/Down Arrows to view. On a smart device, hold upright in portrait mode, and see the most recent three hours, turn sideways to landscape to view your glucose levels over the last 1-3-6-12-24 hours. Go to Chapter 9 to learn more about viewing your glucose trends. 4.4 Whats New to the Dexcom G5 Mobile CGM System?
Dexcoms G5 Mobile CGM System has features not found in our previous generations. These items are new to the Dexcom G5 Mobile App:
The Dexcom G5 Mobile widget in the Apple Today view Dexcom G5 Mobile on Apple Watch Share as a feature of the app The Dexcom G5 Mobile Widget in the Apple Today View Check your CGM information on your smart device without needing to open the app, even when the device is locked. Swipe down from the top of your screen to access the Dexcom G5 Mobile widget in the Apple Today view. This is where you might check the weather or stocks if using the default settings. For more information about the Dexcom G5 Mobile for Apple Watch, go to Chapter 9.3 under Additional Ways to View Your Apps CGM Information. Dexcom G5 Mobile for Apple Watch Check your CGM information on your wrist! The Dexcom G5 Mobile App supports Apple Watch* and can be used to discreetly view your glucose reading, trend arrow, and trend graph. For more information about Dexcom G5 Mobile for Apple Watch or the Dexcom G5 Mobile widget in the Apple Today View, go to Chapter 9.3 under Additional Ways to View Your Apps CGM Information.
*For compatibility information see dexcom.com/compatibility. Share Your Data Through secure wireless connections, Dexcom Share allows remote viewing of your sensor glucose readings, trends, and data by your loved ones from a smart device. Activate Dexcom 38 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? Share by tapping on the apps Share icon, follow a few simple steps, then invite up to five people to connect with you. After downloading the Dexcom Follow App, they become your Follower. As a Follower, they can watch your sensor glucose readings, trends, and receive Alarm/Alerts when your glucose is low or high. You determine what your Follower can see. Based on what you allow, your Followers can receive your Alarm or Alerts, and view your trends. Followers can pick and choose, or turn off, the data they receive, including the Alarm/Alerts, trends, and messages. The Share feature in the Dexcom G5 Mobile App is different than the Dexcom Share App used with other systems. More information about Dexcom Share and instructions for use, go to Part 5. NOTE: Review all Dexcom Share System indications, contraindications, warnings, precautions and detailed procedures in Part 5. 4.5 System Information The receiver and app also keep you informed on the systems status. Technical notifications provide information about your sensor session and about the systems hardware. Each chapter provides a table of the prompts, system, and error messages applicable to its subject. As an example, the calibration chapter will review all calibration messages you may see. Now you know what the Dexcom G5 Mobile CGM System does and whats new, lets open your Dexcom G5 Mobile packages, see whats inside, and review each item. 4.6 System Components Package The Dexcom G5 Mobile CGM System comes to you in a number of boxes; after opening keep the packaging until you are no longer using its contents. 39 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? Sensor Transmitter Sensor package Single use sensor(s) Insert Transmitter package Reusable transmitter
(Continued on next page) 40 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? Receiver
(Continued from previous page) Receiver package Receiver Receivers USB charging and download cable AC power adapter
(Continued on next page) 41 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? (Continued from previous page) Receiver Getting Started with Your Dexcom CGM Dexcom CARE is committed to making your CGM experience a positive one. We are here to ensure that you experience CGM the way it was designed to help you manage your diabetes. Refer to your enclosed Quick Start Guide or Tutorial. Get Started*
Call us at 877-339-2664 Ext. 4900 and speak with a Certified Diabetes Educator. Register for a live, no-charge training webinar at www.dexcom.com or open an online account to begin sharing at www.dexcom.com/register.
*Learn at your own pace with our Self-Guided Training Tutorial at www.dexcom.com/tutorial or review the disc and Quick Start materials inside your Dexcom G5 Mobile Receiver box; or receive remote training with Dexcoms Patient Care Specialist; or schedule an appointment for the Dexcom G5 Mobile device training in your physicians office or diabetes center. Expert Advice | Personalized Training | Customized Support | Guidance | Encouragement LBL013034 Rev 002 MT23142 Welcome Card Quick Start Guide Training Checklist attached to Quick Start 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. 42 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? The Dexcom G5 Mobile CGM System is comprised of four key parts:
1. Single use sensor 2. Reusable transmitter 3. Rechargeable receiver 4. Dexcom G5 Mobile App a. Downloaded to your smart device Dexcom G5 Mobile CGM System optional:
Dexcom Share Sensor Overview For your safety, the sensor is packaged in a sterile sealed pouch, containing an applicator, sensor pod, and sensor wire. When you first open the package, your sensor looks like one item, however its actually three: sensor applicator barrel, sensor pod, and sensor wire. The applicator barrel helps you insert the sensor wire inside the sensor pod under your skin. After inserting the sensor wire, remove the applicator barrel. The sensor wire stays in the sensor pod with the pod attached to your skin by adhesive. The sensor wire is made of silver and platinum with polymer membranes. Once inserted, the thin and flexible wire measures your glucose levels in the fluid between your cells (interstitial fluid) for up to seven days. This section is meant as a quick overview. More information on using and inserting the applicator, sensor, and sensor wire can be found in Chapter 6. Plunger Applicator Barrel
(contains small introducer needle and sensor) Transmitter Latch Release Tab Safety Lock Collar Sensor Pod Adhesive Patch Figure 1. Dexcom G5 Mobile Sensor Applicator and Pod 43 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? Applicator and Sensor Pod What its called What it does Applicator Applicator Barrel Safety Lock Collar Plunger Contains small insertion needle and sensor wire. Inserts sensor wire under the skin. Disposable, for single use only. Removed after insertion. Keeps all moving parts in place before insertion. Prevents accidental sensor insertion. Tool to remove transmitter after sensor session. Put in transmitter box after removal to use later. Collar removes insertion needle. Inserts sensor wire into your body. Transmitter Latch Securely snaps transmitter into sensor pod. Sensor Pod Sensor Pod Adhesive Patch Transmitter Cradle Sensor Wire Holds transmitter and sensor wire. Water resistant when transmitter is properly installed. Discarded after sensor session. Keeps sensor pod attached to your skin. Holds transmitter in place during sensor session. Wire measures glucose levels in fluid in between your cells. Attached to sensor pod. Discarded with pod after session. 44 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? Transmitter Overview Figure 2. Dexcom G5 Mobile Transmitter Front and Back Snapping into the sensor pod, the gray plastic transmitter wirelessly sends your glucose Snapping into the sensor pod, the gray plastic transmitter wirelessly sends your glucose information to your display devicesreceiver and/or smart device. If you have a new transmitter, open the package when you are ready to use it. The transmitter is:
1. Reusable a. Do not discard after sensor session. b. Only for you, dont share transmitter. 2. Water resistant 3. Can transmit data to your display devices for up to 20 feet a. Range is less if you are in or under water. 4. Battery lasts approximately three months a. Receiver or smart devices prompts you when battery is running low. 5. Transmitters serial number is on the back More transmitter features and insertion information is in Chapter 6. Now you are familiar with sensor and transmitter, lets review the Dexcom G5 Mobile Receiver. Dexcom G5 Mobile Receiver The receiver is a small hand-held device. Your receiver, along with your smart device, shows your sensor glucose readings, trend graphs, trend arrows and alerts you when your glucose is too high or too low or if there is something you should be aware of or need to do. The receiver is neither water resistant nor waterproof and can get damaged if moisture gets inside, so keep it away from any liquids and very high humidity. Keeping the micro USB port closed helps prevent damaging fluids and dust from getting inside the receiver. If your receiver does get wet, test it to make sure the speaker and vibrations still work (see Chapter 12). If your receiver isnt charged, see Chapter 14 for charging your receivers battery. 45 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? If you want to use the receiver along with a smart device, you need to set them up separately. Remember, you cant use a combination of smart devices during a sensor session; select just one. Receiver Overview What you see What its 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. Micro USB Cable Plug into receiver to charge battery. Dont plug into a computer port to charge. Battery can only be charged using the adapter/wall charger.
(Continued on next page) 46 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? What you see What its called What it does
(Continued from previous page) Wall Charger Display Screen Plug USB cable into adapter/wall charger. Plug wall charger into an electrical outlet to charge receivers battery. Dont block access to the charger. Shows sensor glucose readings, trend graphs and arrows, Alarm/Alerts, sensor session status. Change settings on Menu screen. Speaker Allows you to hear your Alarm/Alerts sounds. Navigation Wheel Arrows and button to help you navigate through the receivers menu options and choose features. Select Button Press to select menu option. Left Arrow Press to go back to last item/screen or home screen. Right Arrow Press to highlight next item.
(Continued on next page) 47 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? What you see What its called What it does
(Continued from previous page Up/Down Arrows Press to scroll up or down to select menu items or set values. Press to scroll back and forth beyond from the 3 hour trend graph to the 1-6-12-24 views. 4.7 Smart Device Overview The Dexcom G5 Mobile 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. This User Guide is not meant to show you how to use your smart device. Please contact your smart device support or read your smart devices user guide for assistance. Summary Now You Can:
Explain the Dexcom G5 Mobile CGM System Describe options to view trends Locate your historical readings Recognize system components Explain each parts function Next Steps Your next step in getting started with the Dexcom G5 Mobile CGM System is selecting how to continuously receive your sensor glucose readings: Dexcom G5 Mobile App, the Dexcom G5 Mobile Receiver or a combination. Our next chapter helps you set up both!
48 Dexcom G5 Mobile System User GuideWhat Is the Dexcom G5 Mobile CGM System? Chapter 5 Lets G5! The Basics:
Set up Your Display Devices 5.1 Introduction In the previous chapter, you received a high level overview of the Dexcom G5 Mobile CGM System and learned you can monitor your glucose levels with different display devices. Now its time to set up your Dexcom G5 Mobile App and your receiver. After this chapter, you will be able to:
Create a Dexcom username and password Download the Dexcom G5 Mobile App Set up the Dexcom G5 Mobile App with the recommended settings Successfully set up your Dexcom G5 Mobile Receiver 5.2 Safety Statement If youve used the Dexcom G4 PLATINUM CGM System, you might still have its transmitter or receiver. While you can use the sensors across the different generations (look for the Dexcom G5 Mobile/G4 PLATINUM Sensor package), you cant mix the transmitter or receiver between the two systems. PRECAUTION Dont: Never mix Dexcom G5 Mobiles Transmitter or Receiver with Dexcom G4 PLATINUMs Transmitter or Receiver. Why: The Dexcom G5 Mobile CGM Systems Transmitter and Receiver are not compatible with the Dexcom G4 PLATINUM CGM Systems Transmitter and Receiver. The Dexcom G5 Mobile CGM System wont work if you mix Receiver and Transmitter components from different generations. Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) event. 49 Dexcom G5 Mobile System User GuideSet up Your Display Devices 5.3 Why Different Monitoring Methods?
Your convenience!
By offering two separate monitoring systems, the app or receiver, you can choose to monitor your glucose levels in the handiest method at that moment. Smart device ran out of memory. If you forgot your receiver at home, use your smart device! Battery died on your smart device? Smart device memory full? Your receiver has you covered!
With the exception of Dexcom Share, the primary difference between the two monitoring systems is not the data itself, but how its presented. The next section walks you through the initial set up for the app. To set up the receiver, go to Section 5.5. If you want to use both the mobile app and the receiver, you need to set each up individually. Once you have completed the initial set up, youre one step closer to beginning your sensor session!
5.4 Dexcom G5 Mobile App Before starting your first sensor session, pick the smart device you want to use. As mentioned in the previous chapter, you can use the receiver with one smart device during a session; however, you cant use multiple smart devices during the same session. While your smart device can have the app installed, part of your initial set up is entering the transmitters serial number (SN). If by accident you enter the SN into more than one smart device, the system warns you and you wont be able to complete the set up process. Suggested Smart Device Settings Bluetooth is designed wireless communication between devices (unlike Wi-Fi, which wirelessly connects devices to the Internet). Your transmitter communicates to your app via Bluetooth Smart! Before beginning, make sure your smart devices Bluetooth is available and turned on. Refer to your smart devices user guide if you have questions on how to change your smart device settings. While checking your Bluetooth settings, check to see Silent and Do Not Disturb are off. Your app does not override these settings; if you have them on, you will miss Alarm/Alerts After verifying all your settings are correct, there is one more thing to check. Make sure your smart devices Volume is loud enough for you to hear any Alarm/Alerts 50 Dexcom G5 Mobile System User GuideSet up Your Display Devices Make sure your smart device settings allow your Dexcom Alarm/Alerts to always show on your lock screen For information on how to set the above settings, see your smart devices user guide. Once you have verified your smart devices settings are right, the next step is installing the Dexcom G5 Mobile App The app needs to be open and running in the background. This may drain your smart devices battery; make sure you check its battery is charged Dont change your smart devices time because it can make the time on the trend screen wrong and the app may stop displaying data If your smart device is broken or lost, use receiver until its fixed or replaced. Dexcom G5 Mobile App Installation Installing the app is easy! Simply download the Dexcom G5 Mobile App from your smart devices store. However, if your smart device has been jailbroken, do not install the app. For information on how to install an app, see your smart devices user guide. Initial Dexcom G5 Mobile App Setup Setting up your app is easy! Youll need your Dexcom account username and password, along with your transmitter box. Once inside, simply follow the set up wizard instructions. The set up wizard walks you through safety information, recommended settings, entering transmitter SN, setting your high/low glucose levels, and receiving CGM notifications. Your initial set up will require a Dexcom username and password. You can create them by tapping Sign Up within the app, or by going to dexcom.com. From Your Web Browser:
1. Go to dexcom.com. 2. Click green Get Started tab or the three green bars, then Get Started. 3. Click green Get Started button on the page. 4. Fill out User account screen. 5. Click the green Create New Account button towards the bottom of the screen. But what if you are unclear about a step?
The Dexcom App has prompts allowing you to get more information. If you are unsure of something during your initial set up process, look at the screen for additional information prompt. Informational prompts include, but arent limited to: I dont understand, Learn More, or Question Mark. Tap your informational prompt to get more information. To close out of the information prompt, tap the X in the upper right hand corner. 51 Dexcom G5 Mobile System User GuideSet up Your Display Devices Initial App Setup Step What you see What you do Introductory Screens 1 2 Tap Dexcom G5 Mobile App icon to open app. Swipe through introductory screens or tap Log In.
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(Continued from previous page) 3 4 Enter existing username and password OR Need a Dexcom username and password?
Tap Sign Up. Complete Username/Password fields. Tap Login once. Tap Lets Get Started.
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(Continued from previous page) 5 The next screens are the Terms of Use, safety warnings, contraindications, and the recommended settings. Once each screen is read, tap the appropriate answer to move forward. Tap Full Safety Statement or, when applicable, I dont understand to get more information.
(Continued on next page) 54 Dexcom G5 Mobile System User GuideSet up Your Display Devices Setting up Your App Alarm/Alerts and Basic Settings
(Continued from previous page) 6 7 Set your Low Glucose Alert. Default is 80 mg/dL. Scroll to select another amount. Tap Save to move forward. Once set, youll receive an Alert notification if your glucose dips below your set amount. Set your High Glucose Alert. Default is 200 mg/dL. Scroll to select another amount. Tap Save to move forward. Once set, youll receive an Alert notification if your glucose rises above your set amount.
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(Continued from previous page) 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.
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(Continued from previous page) 9 The next screens provide suggestions for device volume, Do Not Disturb, and other basic settings. Tap appropriate answer to move forward.
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(Continued from previous page) 10 Tap Next. 11 Verify Bluetooth is on. The app will check to see if Bluetooth is turned on.
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(Continued from previous page) 12a 12b Get your Transmitter box. Tap Take Photo. Turn transmitter box upside down on a flat surface with barcodes facing up. Center longest barcode within green brackets.
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(Continued from previous page) 12c 13a Check mark confirms successful transmitter SN scan. If unable to use apps scanning device:
Tap Enter transmitter SN by hand.
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(Continued from previous page) 13b 14 Use keyboard to enter transmitter SN. Confirm correct SN . Tap Save. Insert sensor and attach transmitter following videos instructions. See Chapter 6 for more information.
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(Continued from previous page) 15 16 Wait up to 30 minutes for smart device and transmitter to connect. At prompt, Tap Pair to pair app with smart device.
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(Continued from previous page) 17 Tap the Sensor warmup circle to start your two hour sensor warmup. When you see the sensor warmup timer, your initial set up is complete. Congratulations!
If you have any issues setting up the Dexcom G5 Mobile App, call Technical Support toll free at 1.877.339.2664 or toll at 1.858.200.0200. We are here 24/7 to assist you. If you are having problems with your smart device, contact your smart devices support line. After completing your initial app setup, set up the receiver or go to Chapter 6 to start your initial sensor session. 5.5 Dexcom G5 Mobile Receiver In the previous chapter, you learned about the receivers components. The following is a refresher to help in your initial set up. Display Screen:
Trend screen Menu selection screen Navigation Wheel:
Select Button in the middle of the navigation wheel 63 Dexcom G5 Mobile System User GuideSet up Your Display Devices Press to Center button does not say Select Turn on receiver Select options/features Accept changes Move forward through menus/features Up/Down Scroll through trend screens Highlight menu items Change values Go back to last item or screen Go to next item or screen Left Right Initial Setup of the Dexcom G5 Mobile Receiver Press Select to turn receiver on. The first screen you see is the startup screen with ascending green bars. Once complete, a set up wizard guides you through the initial set ups steps. Dont be alarmed if your receiver buzzes or makes other sounds during this process. After your initial setup is complete, you wont see the setup wizard again. Your settings can always be adjusted using menu options. How you complete your initial set up differs between the receiver and your smart device;
however, the data is the same. Setup Wizard Prompts:
Time/Date Transmitter Serial Number Back of transmitter Back of transmitters box Setting Low Alert Setting High Alert Before starting a session, you may want to check the receivers battery level. If it is less than half, go to Chapter 4, for charging instructions. 64 Dexcom G5 Mobile System User GuideSet up Your Display Devices Initial Receiver Set up Step What you see What you do Initial Screens 1 2 Time/Date 3a Press Select to turn receiver on. Wait. Press Up/Down Arrow to change year. Press Right Arrow to move forward. Press Up/Down Arrow to change month. Press Right Arrow. Press Up/Down Arrow to change day. Press Right Arrow to move to time.
(Continued on next page) 65 Dexcom G5 Mobile System User GuideSet up Your Display Devices Time/Date 3b Transmitter 4a 4b 4c
(Continued from previous page) Press Up/Down Arrow to change hour. Press Right Arrow. Press Up/Down Arrow to change minutes. Press Right Arrow. Press Up/Down Arrow to select AM/PM. Press Select to save and close. NOTE: After initial set up, if battery is drained, receiver will vibrate once and you will need to reset date and time. Turn transmitter box upside down to locate SN number. If transmitter package isnt available:
SN is on transmitters 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.
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(Continued from previous page) 5a 5b Setting High Alert 6a 6b System default is at 80 mg/dL. Press Select to save at present levels and close. To change value:
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. Press Select to save at present levels and close. To change value:
Press Up/Down Arrows to change value at 10 mg/dL increments. Press Select to save and close. These steps are enough to get you going; now you can start your sensor session!
Summary Now You Can:
Create a Dexcom username and password Download the Dexcom G5 Mobile App 67 Dexcom G5 Mobile System User GuideSet up Your Display Devices Set app up with the recommended settings Successfully set up your Dexcom G5 Mobile Receiver Whats Next?
Now you have completed setting up your app and/or the receiver, your next step is starting a sensor session. No matter what monitoring method you choose, starting a sensor session is the same:
1. Inserting the sensor. 2. Inserting the transmitter. 3. Pairing the transmitter to your device. 4. Two hour sensor warmup. 5. Initial calibrations. 68 Dexcom G5 Mobile System User GuideSet up Your Display Devices Chapter 6 Lets G5! The Basics:
Starting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session 6.1 Overview Now that your display devices are set up, youre ready to begin a sensor session. If this is your first time inserting a sensor, you may want to watch the Dexcom G5 Mobile sensor insertion video to get a better understanding of the process. The Dexcom G5 Mobile sensor insertion video is available by three ways:
1. Through the App 2. USB card in your Dexcom G5 Mobile Receiver package 3. Online at dexcom.com:
a. Top of page, click Support Tab. b. Click Education. After inserting the sensor, start the sensor warmup on your smart device and receiver. The sensor warmup takes approximately two hours; during this time your body is getting used to the new sensor, allowing for more accurate sensor glucose readings. Once the two hour sensor warmup has passed, you enter two back-to-back fingerstick measurements to calibrate the sensors glucose readings with your fingerstick measurements (Calibration is covered in the next chapter). Make sure you give yourself enough time to finish the startup session. Remember your smart devices Bluetooth needs to pair with the transmitter, adding up to 30 minutes to your wait time. Good news is you dont need to sit around waiting: as long as you have your display device near, you can go about your day running errands, gardening, personalizing the Dexcom G5 Mobile settings, whatever you choose during that time frame. Keep your display device(s) handy during the warmup periodit shows how much time has passed, notifying you with beeps and an icon when your sensor session is ready for its initial calibrations. After this chapter you will be able to:
69 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session 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 sensor 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. WARNING Dont: If a sensor breaks under the skin with no portion visible above the skin, dont remove it. Do: Seek professional medical help if you have symptoms of infection or inflammation
(e.g., redness, swelling or pain) at the insertion site. Always report a broken sensor to our Technical Support, 24/7, team at as soon as possible:
Toll free: 1.877.339.2664 Toll call: 1.858.200.0200 Why: Sensors may fracture on rare occasions. Testing done in a controlled environment (in-vitro) didnt find any safety hazards during an MRI with a broken off sensor under the skin. The wire didnt heat up nor have any significant movement during the MRI, images were affected only in the area around the sensors wire. MRI with broken wire If you have experienced a broken sensor and are planning to take an MRI, please discuss the following with your doctor or technician. Laboratory (in vitro) MRI tests did not detect any safety hazards for a broken sensor that remains in the body. There was no significant movement or heating of the wire. Imaging artifacts were limited to the area around the wire. 70 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session WARNING Do: Store sensor between 36 F-77 F during its shelf life. Why: Storing the sensor incorrectly might cause the sensor glucose readings to be inaccurate. Never store sensors in the freezer. Consequences: If stored outside of 36 F-77 F, your sensor glucose readings may not be accurate, resulting in you missing a severe low or high glucose event. WARNING Dont: Never use the Dexcom G5 Mobile CGM System sensor glucose readings for treatment decisions. Do: Only use BG values from your BG meter for treatment decisions (e.g., how much insulin to take). Why: Since they measure your glucose from different body fluids, sensor glucose readings can be different from your meters blood glucose values. Consequences: Using sensor glucose readings for treatment decisions could result in you missing a severe low or high event. PRECAUTION Do: Select sensor insertion site with care. Avoid:
Areas likely to be bumped, pushed or squeezed Areas of skin with scarring, tattoos, or irritation Injecting insulin within 3 inches of sensor Placing an insulin pump infusion set within 3 inches of sensor Why: Inserting sensor in these areas may affect sensor glucose readings. Consequences: Inaccurate sensor glucose readings may result in you missing a severe low or high event. 71 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session PRECAUTION Do: Check sensor package before opening. Why: Make sure the sterilized package has not been damaged or previously opened. If opened or damaged, sensor may be unsterile. Consequences: Using an unsterile sensor may cause an infection. 6.3 Prepping for Sensor Insertion Before inserting a sensor, make sure you have everything you need. Some items are included in the Dexcom G5 Mobile CGM Systems packages, others are not. Items Included in Your Dexcom G5 Mobile Packages For sensor insertion, you need the sensor and transmitter. Sensor Applicator Inside Sensor Box What you see What it is Sterilized sensor pouch with important label information. Check expiration date. Single use sensor applicator. Knowing what each applicator piece does helps you successfully insert your sensor. Chapter 4, Section 4.6 gave you overview of the sensor applicator. 72 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session 4. Plunger 5. Applicator Barrel
(contains small introducer needle and sensor) 8. Transmitter Latch 9. Release Tab 3. Safety Lock 6. Collar 7. Sensor Pod 2. Adhesive Patch Figure 3. Dexcom G5 Mobile Sensor Applicator and Pod The following table reviews the sensor applicator components in order of use. Order of Use Name What it does 1 2 3 4 5 6 Sensor Pouch Adhesive Patch Safety Lock Plunger Applicator Barrel Collar Sterilized for your protection. Open to remove applicator and sensor. Holds the sensor/transmitter in place on your skin. Prevents plunger from inserting sensor until you are ready. Inserts sensor wire into your body. Contains small insertion needle and sensor wire. Disposable, for single use only. Collar removes insertion needle. Helps remove applicator barrel once sensor wire is inserted.
(Continued on next page) 73 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session Order of Use Name What it does
(Continued from previous page) 7 8 9 Sensor Pod Transmitter Latch Release Tab Holds sensor wire in place under skin. Holds transmitter. Locks transmitter into sensor pod. Allows you to remove applicator barrel from sensor pod. Transmitter Transmitter Box What you see What it is Bottom of box with important label information. Keep box until transmitter battery dies. Reusable transmitter. 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 wont be able to start a sensor session if your transmitter isnt paired with your receiver and/or smart device. Not included in packages:
1. Alcohol wipes 2. Your blood glucose meter 3. Your test strips Before starting, check your blood glucose meter; make sure its in good working order following manufacturers directions and the meters date and time match your display devices date and time. Make sure test strips havent expired and work with your meter. 74 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session Before removing the sensor applicator out of its sterile pouch, determine the best place to insert your sensor. 6.4 Choosing Your Insertion Site Choose a place on your belly (or if user is between the ages of 2 and 17, upper buttocks) to insert the sensor; the site should be either above or below your belt line. The best areas are usually flat, pinchable, and free from where rubbing can occur (along the waist band, seat belt strap or where you lay when sleeping). For more help on ideal sensor insertion sites, contact your healthcare professional. Insertion Sites Location Where it is Front of body (belly area) for ages 2 years and above. If user is between the ages of 2 years and 17:
Back of body (Upper buttocks) Do:
Remove the sensor and applicator from its sterile package only at time of use Place at least 3 inches from your insulin pump infusion set or injection site 75 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session If needed, shave the area so adhesive patch sticks securely Make sure area is clean and free of lotions, perfumes, medications Dont:
Never use same site repeatedly for sensor insertion Never use same site for 2 sensor sessions in a row If you have concerns about the sensor pod not sticking, before inserting your sensor, you can make the sensor site stickier to help ensure the sensor pod does not peel. Optional Site Preparation Use optional skin adhesives (Mastisol, SkinTac) as part of your insertion site preparation to help keep your sensor pod attached. Apply the skin adhesive after you selected and cleaned your insertion site. Use circular motions and create an O outline, making sure you dont get any skin adhesive inside the outline. Let the O dry based on skin adhesive manufacturers instructions. Once dry, your skin may feel slightly sticky. See Step 3 in the next table for directions. NOTE: Contact your healthcare professional for specific questions regarding the use of medical tape, barrier wipes and/or other adhesives as it relates to your use of Dexcom CGM. 6.5 Inserting Your Sensor Youve collected all of the needed items to begin a sensor session, viewed the tutorials, reviewed the sensor applicator and prepped the sensor pod site. Youre now ready to insert your sensor!
Step Picture Preparation What you do 1 Wash and dry your hands.
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(Continued from previous page) 2 3 4 Clean insertion site with alcohol wipe. Let dry. Optional Step: Skin Adhesive Create an oval on the skin Do not get any skin adhesive inside the circle Let skin adhesive dry Insert sensor on clean skin at the center of the circle Check pouch: Is it damaged or already opened?
Remove sensor applicator from sterile pouch. Closely inspect sensor, check it hasnt been damaged. Keep sensor packaging until sensor session is complete. Attaching Sensor Pod 5 Pull adhesive backing tabs. Dont touch sticky adhesive patch.
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(Continued from previous page) 6 7 8 9 Place sensor horizontally, not vertically, on skin. Move fingers around adhesive patchs top several times to secure tape. Hold applicator barrel. Pull safety lock out. Place fingers of one hand on edges of adhesive patch. Pinch up your skin at the tips of the white adhesive. Place two fingers directly above collar to steady applicator barrel. Place thumb on the white plunger. Push plunger completely down the applicator barrel. You should hear 2 clicks. NOTE: Finger placement is important for correct insertion.
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(Continued from previous page) 10 11 12a 12b Move two fingers from above collar to below collar. Keeping your thumb as a base on the white plunger. Pull collar all the way back towards your thumb. You should hear 2 clicks. NOTE: Finger placement is important for correct needle removal. Hold transmitter latch down against your body. Squeeze ribbed release tabs on the sides of sensor pod. Move applicator barrel forward and out, away from your body. Follow local ordinances when disposing the applicator. Whats left?
1. Sensor pod 2. Transmitter latch You have successfully inserted the sensor!
At this point, you should have two items attached:
1. The sensor pod 2. The transmitter latch Having problems?
If its the first time inserting a sensor, you may have questions or need help. If you do, please contact your Dexcom G5 Mobile CGM System Technical Support team, 24/7, at:
79 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session Toll free: 1.877.339.2664 Toll call: 1.858.200.0200 The next step is attaching your transmitter to the sensor pod. 6.6 Attaching Your Transmitter Now that you have inserted your sensor, you need to attach your transmitter. Since the transmitter is reusable, you dont need a new one every time you start a sensor session. Keep your current sessions transmitter box. The bottom label has important information you may need after youve inserted the transmitter. Once the transmitter has been attached, you cant remove it until your session is over. Chapter 8 reviews when and how to remove your transmitter. Before inserting your transmitter, check you entered the correct transmitter SN into your display device. Chapter 5 covers entering transmitters SN number. Step Picture What you do 1 2 3 Remove transmitter from box. Keep box. Save safety latch from sensor applicator (helps remove transmitter once sensor session is over). Get alcohol wipe. Wipe back of transmitter with alcohol wipe. Let dry for 2-3 minutes. Dont let the back of transmitter touch your skin. Dont scratch transmitters back, this can harm the waterproof seal. Flat side down. Slide transmitters small end under the sensor pod lip located in front of pods ribbed tabs, away from transmitter latch.
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(Continued from previous page) 4 5 6 Keep finger on transmitter holding it in place. Push transmitter latch up and forward over the transmitters wide end with your other hand. You should hear 2 clicks. Is transmitter secure?
Before removing transmitter latch, verify transmitter is securely in place. Make sure none of the transmitters sides popped out of the sensor pod. If not completely snapped in, you may have a bad connection and it wont be water tight. Hold sensor pod sides with one hand. Twist latch away from your body with other hand. Remove latch. Dont remove transmitter while sensor pod is attached to skin. Youre almost done starting your sensor session!
Inserting the sensor, attaching the transmitter, and the two hour sensor warmup are the same regardless 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 Sensor Pod The sensor pod should stay on your skin using its own adhesive. 81 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session If the patch peels up, use medical tape (such as Blenderm, Tegaderm, Smith & Nephew IV3000, 3M tape) for extra support. Tape over white adhesive patch on all sides for even support Dont tape over the transmitter or any plastic parts of the sensor pod Dont tape under sensor pod Dont leave any substance on the skin where you insert the sensor Figure 4. The Right Way to Use Tape for Extra Support 6.8 Starting Your Sensor Session If you choose to use both the receiver and the app, each system requires individual setups
(see Chapter 5). After pairing the transmitter to your device(s), inserting your sensor, and attaching the transmitter to the sensor pod, your next step is telling 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 initial two calibration BG values into either the smart device or the receiver. Well first review starting the sensor session for the app. 82 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session Dexcom App: Starting a Session Step What you see What you do 1 2 3 Wait for Successful Pairing notification. Tap green checkmark in black square. Tap Sensor Warmup circle to start your two hour sensor warmup. NOTE: You will NOT get any sensor glucose readings, Alarm/Alerts during your two hour sensor warmup period. Wait. Screen provides countdown to sensor warmup. The orange dashes darken as the countdown moves forward. Keep smart device within 20 feet of transmitter during the sensor warmup period.
(Continued on next page) 83 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session Step What you see What you do
(Continued from previous page) 4 5 Locked screen. Initial calibration prompt tells you when warmup is complete. Chapter 7 covers calibrating. Initial calibration prompt tells you when warmup is complete. Sensor warmup is complete. Youre ready to calibrate!
Receiver: Starting a Session Step What you see What you do 1 Press Select to turn on receiver.
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(Continued from previous page) 2 3 4 5 6 From Trend Graph. Press Select to go to Main Menu. Press Down Arrow to highlight Start Sensor. Press Select to start new sensor session. NOTE: After sensor starts, Start Sensor option disappears. Start Sensor progress bar confirms two hour sensor warmup. Keep your receiver within 20 feet during the warmup period. Receiver returns to the trend graph screen. Make sure receiver and transmitter are communicating. Check receiver 10 minutes after starting for Bluetooth icon. Solid: Connected Blinking: Searching for connection No Bluetooth Icon: No connection
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(Continued from previous page) 7 8 Wait. Screen provides countdown of the two hour sensor warmup. Sensor warmup is complete. Youre 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. If blinking, Bluetooth is looking for your transmitter Make sure your transmitter and receiver are within 20 feet of each other If the Bluetooth icon isnt on the receiver and the Signal Loss icon appears in the receivers upper right corner of the status bar, theyre not communicating. 86 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session No Communication Between Transmitter and Receiver Step What you see What you do 1 2 3 4 Check correct transmitter SN is in receiver. SN is on the label on bottom of transmitter box Press Select to go to Main Menu. Press Down Arrow to Settings. Press Select. Press Down Arrow to Transmitter. Press Select. Press Select.
(Continued on next page) 87 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session Step What you see 5 If Wrong SN Entered
(Continued from previous page) What you do Check correct transmitter SN is in receiver. 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 1.877.339.2664 or toll at 1.858.200.0200 for help. Press Select to exit screen. Press Left Arrow twice to go to Main Menu. 6 7 8 Press Left Arrow twice to go to Main Menu. If sensor session has started, to correct transmitter SN, you must stop the sensor session. Press Down Arrow to Stop Sensor. Press Select. Press Select to stop session.
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(Continued from previous page) 9 10 11 12 13 Wait for sensor session to end. From Main Menu:
Press Down Arrow to Settings. Press Select. 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. Press Right Arrow to move to next digit. Press Select to save and close. Press Left Arrow twice to return to Main Menu.
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(Continued from previous page) Start Sensor Session. Press Up/Down Arrow to highlight Start Sensor. Press Select on Start Sensor. 6.10 Sensor Session Warmup 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 Dexcom G5 Mobile CGM Systems display devices. Once the sensor warmup is complete, youre ready to enter your initial calibrations! The next chapter shows you how. Summary Now You Can:
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 Properly attach transmitter to sensor Outline sensor warmup Identify countdown icon Whats Next?
The next chapter guides you through the calibration steps. 90 Dexcom G5 Mobile System User GuideStarting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session Chapter 7 Lets G5! The Basics:
Calibration 7.1 Introduction In the previous chapter, you learned how to insert your sensor, transmitter, and start a new sensor session. Youre now ready to begin your last step before getting your sensor glucose readings: Calibration. This chapter reviews not just your initial calibration, but also update calibrations required throughout your sensor session. After this chapter, you will be able to:
Calibration Overview Define calibration Explain the importance of calibration Identify steps to ensure a successful calibration Recognize steps in taking accurate blood glucose measurement Identify the correct blood glucose site for calibrations Prepare finger for fingerstick measurement Determine if you should/should not calibrate Recognize when you can enter fingerstick measurement for calibration Recognize when you shouldnt enter the fingerstick measurement for calibration Determine if you need to calibrate outside of the normal calibration requirements Initiate startup calibration Perform update calibrations Correctly enter your fingerstick measurement Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Identify calibration errors 91 Dexcom G5 Mobile System User GuideCalibration 7.2 Calibration Overview What Is a Calibration?
As you learned earlier, the sensor glucose readings come from measuring the glucose fluids found between your cells (interstitial fluids). Although blood and interstitial fluids are similar, sensor glucose readings can be different between your fingerstick and your CGM. Calibration provides a comparison, or measurement, between your meters fingerstick measurement and the sensors glucose readings, allowing alignment between the sensor and meter. Your BG meter teaches the sensor your glucose values through calibration. Just like a clock can need adjusting calibrations allow your CGM to adjust to your body. 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 Dexcom G5 Mobile CGM System uses your meters 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 meters BG value into your display device. This chapter lets you know what precautions you need to take before taking your BG meter value, then entering your data. Up to now, you needed to enter information such as Alerts, transmitter SN, etc., separately for the receiver and smart device. Calibration is different. Dont enter your BG values in both devices, enter into either your app or the receiver. If you enter your meters BG value into your receiver, it takes about five minutes for your sensor glucose readings to begin. In approximately ten minutes, you can view the readings in the other display device. How Often Do I Calibrate?
There are three primary must do calibration events, each with its own prompts:
1. Two initial calibrations once your warmup session is complete. 2. Update calibrations done twice daily, once every 12 hours. 3. When youre prompted. 92 Dexcom G5 Mobile System User GuideCalibration If you receive a calibration prompt outside of your scheduled calibration schedule, the system doesnt accept your most recent calibration or your meters BG value is very different from the sensors glucose reading. Dont worry about keeping track of the time between calibrations, the system will prompt you when you are ready for another. Now you have an overview of calibration, lets review some contraindications, warnings, and precautions you need to know and follow before you calibrate. 7.3 Safety Statements CONTRAINDICATION Dont: Never take any medications containing acetaminophen during your sensor session. Why: Taking medications with acetaminophen (such as Tylenol or Excedrin Extra Strength) while wearing sensor may falsely raise sensor glucose readings. Level of inaccuracy depends on:
1. Amount of acetaminophen active in your body. 2. May be different for each person. Consequences: Without correct readings you might miss a severe low event. WARNING Dont: Never use the Dexcom G5 Mobile CGM System sensor glucose readings for treatment decisions. Do: Only use BG values from your BG meter for treatment decisions (e.g., how much insulin to take). Why: Since they measure your glucose from different body fluids, sensor glucose readings can be different from your meters blood glucose values. Consequences: Using sensor glucose readings for treatment decisions could result in you missing a severe low or high event. 93 Dexcom G5 Mobile System User GuideCalibration WARNING Do: Calibrate at least once every 12 hours. Why: Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings. Consequences: Missing severe low (hypoglycemia ) or high (hyperglycemia) Alarm or Alerts. PRECAUTION Do: Look at trend arrows before calibrating. Trend arrows help you determine if you can calibrate now or should wait. Dont: Never calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Never calibrate when you see:
A single arrow, pointing up Rising 2-3 mg/dL each minute Two Arrows pointing up Rising more than 3 mg/dL each minute Single arrow pointing down Falling 2-3 mg/dL each minute Two arrows pointing down Falling more than 3 mg/dL each minute Why: Calibrating during significant rise/fall of blood glucose may affect accuracy of sensor glucose readings. Consequences: You may miss a severe low or high glucose event. PRECAUTION Do: Enter the exact BG value displayed on your BG meter within five minutes of a carefully performed fingerstick measurement. Why: Entering the wrong blood glucose values, or waiting more than five minutes before entry, might affect sensor accuracy. Consequences: You may miss a severe low or high glucose events. 94 Dexcom G5 Mobile System User GuideCalibration PRECAUTION Do: Only use fingerstick measurements from your BG meter for calibration. Dont: Never use alternative site blood glucose values such as blood from palms, forearms, etc. Why: Alternative site BG values are different from a fingerstick blood glucose value and may not reflect most recent blood glucose value. Consequences: You may miss a severe low or high glucose event. 7.4 When to Calibrate Calibrating on a regular schedule aligns your sensor glucose readings with your meters BG values. Without calibrations, your sensor may be inaccurate, and as a result, so will your display devices sensor glucose readings, Alerts, and prompts, etc. There are important times when you must calibrate:
1. Initial or Start-Up Calibration: two hours after you insert your sensor. 2. 12 Hour Update: every 12 hours after two hour startup calibration. 3. When system prompts you. With calibration prompts, your sensor and display device helps you keep your calibration schedule on track. If your BG values are not between 40-400 mg/dL, the system wont accept your calibration. Wait until you are within the 40-400 mg/dL range before entering your BG values. Initial Calibration: Sensor Start-Up Completed 1. At prompts (see next table) enter two back-to-back fingerstick measurements into just one device. 2. No need to do initial calibrations twice. a. Calibration data flows between the receiver and your app. b. Five minute reporting delay between devices. 3. First update calibration is 12 hours after your initial calibration. Update Calibration Update calibrations are typically 12 hours since your last calibration, however it can be sooner. As an example, if you know your next calibration is due at 4 AM, you can do the calibration before bedtime, resetting the 12hour count down. 95 Dexcom G5 Mobile System User GuideCalibration 1. Enter one fingerstick measurement at least every 12 hours. 2. Display devices provides calibration prompts. 3. You may be prompted to enter additional fingerstick measurements as needed. Figure 5. Example Minimum Calibration Schedule During Seven-Day Sensor Session 7.5 Calibration Prompts Sensor Session Start-Up Calibration Prompts Once your two hour sensor start-up is complete, your display device tells you its time to enter the first of your two back-to-back start-up calibrations. Once the system has accepted your BG values, your glucose readings begin. If you dont enter your BG values right away, the system reminds you every 15 minutes. Remember, only use your BG meter for calibrations, and never enter values from your CGM. 96 Dexcom G5 Mobile System User GuideCalibration Start-Up Calibration Prompts Device What you see What it means What you do First Calibration Smart Device:
Lock Screen Smart Device:
In App Receiver Sensor warmup is complete. Ready for first of two initial calibrations. Follow steps in Section 7.6 and 7.7. Immediately prepare for next calibration.
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(Continued from previous page) Second Calibration Smart Device:
Lock Screen Smart Device:
In App Receiver Sensor accepted first calibration. Ready for second BG meter value. Follow steps in Section 7.6 and 7.7. Next calibration in 12 hours. Your sensor glucose readings begin in approximately five minutes once the device(s) accepts your calibrations. Update Calibration Prompts Once your start-up calibration is done, your update calibration schedule begins. 98 Dexcom G5 Mobile System User GuideCalibration The steps to enter your update calibrations are the same as your initial calibration, including only entering values in one display device. The only difference is, with update calibrations, enter your BG meter value just once. Like the reminders you received with your initial calibration, if you dont enter your BG meter values right away, the system prompts you every 15 minutes. Update Calibration Prompts Device What you see What it means What you do Smart Device:
Lock Screen Smart Device:
In App Receiver Enter update calibration. If prompt doesnt go away:
System didnt accept calibration BG values are very different from sensor glucose readings Follow steps in Section 7.6 and 7.7. Immediately prepare for next calibration. Tap message to clear prompt on your smart device and to clear a prompt on your receiver, press Select. Sound/Vibration Prompts In case you cant look at your screen, both the smart device and receiver provide, with the exception of your regular 12 hour update calibration, beep/vibration prompts to let you know its time to calibrate or if there was a system calibration error. For more information on setting your sound/vibration prompts and how to clear them, please see Chapter 9. Smart Device Calibration prompts will alert you with a triple beep if your smart device is not on Silent or Do Not Disturb. 99 Dexcom G5 Mobile System User GuideCalibration Receiver The receiver alerts you with an initial vibration for calibration prompts. If not cleared, you receive a vibrate/beep every five minutes until confirmed. 7.6 Preparing for Calibration Your sensor depends on you to help make its sensor glucose readings accurate. If you dont prepare properly for the calibration, your sensor may not provide you with the most accurate sensor glucose readings. Eight Steps to Successful Calibration:
Do:
1. Wash and dry your hands before staking a fingerstick measurement. 2. Always use the same meter you routinely use to measure your blood glucose. a. Blood glucose meter and strip accuracy vary between meter brands. b. Switching within a session might cause sensor glucose readings to be less accurate. 3. Follow meters instructions exactly when taking your fingerstick measurement. 4. Verify test strips are current and, if required, coded correctly with meter. 5. Check: Is Bluetooth is active?
6. Use fingerstick BG values only. a. Other sites are not as accurate. b. Must enter within five minutes of taking BG meter value. c. Enter exact BG value from your meter for each calibration. Dont:
7. Dont take acetaminophen containing medication during your session (e.g., Tylenol). a. See your healthcare professional to better understand how long acetaminophen 8. Dont calibrate if your BG values are under 40 mg/dL or over 400 mg/dL. a. If BG value is outside of this range, receiver doesnt understand these values and is active in your body. wont calibrate. i. You must wait until your blood glucose is in the range to calibrate. Be safeif blood glucose is low, first treat low blood sugar, and then calibrate. 7.7 Ready? Set? Calibrate!
Youve followed the eight steps above, have a valid BG value from your meter, and your display device keeps alerting you: Calibrate! Calibrate! Calibrate!
100 Dexcom G5 Mobile System User GuideCalibration Remember:
You dont 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 five minutes. Next are steps to enter your calibrations using the app, followed by the steps for entering your calibrations into the receiver. Calibrate With Your Dexcom G5 Mobile App Step What you see What you do Additional info 1 Tap circle. Initial calibration: Enter two back-to-back meter BG value. Update calibration:
Enter one meter BG value.
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(Continued from previous page) 2 3 Enter meters BG value using number pad. Tap Save. Double check your numbers. Entering wrong values can affect the sensors accuracy. Verify value is correct. Tap Save. If not correct:
Tap Cancel. Reenter correct value.
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(Continued from previous page) 4 5 Tap circle to enter your second BG value. Follow steps 2-3 and enter second reading. Meter icon has no calibration prompt. Calibration accepted.
(Continued on next page) Your calibration was successful. 103 Dexcom G5 Mobile System User GuideCalibration Step What you see What you do Additional Info
(Continued from previous page) 6 Wait for next calibration prompt in 12 hours. Default Home Trend screen. Calibration accepted. Calibrate With Your Dexcom G5 Mobile Receiver Step What you see What you do Additional Info 1 Press Select to turn on receiver. Press Select again for Main Menu. You wont see calibration prompts when receiver screen is black.
(Continued on next page) 104 Dexcom G5 Mobile System User GuideCalibration Step What you see What you do Additional Info
(Continued from previous page) 2 3 4a 4b Press Up/Down Arrow. Highlight Enter BG. Press Select. Press Up/Down Arrow to change numbers. Stop at meters BG value. Press Select. Verify BG value is correct. If correct:
Press Select. Verify BG value is correct. If incorrect:
Press Right Arrow to Cancel. Press Select. Reenter BG value.
(Continued on next page) Sensor default reading is 120 mg/dL. If sensor glucose reading is within the last 15 minutes, screen will show sensors actual reading. If Select is not pressed:
Receiver times out BG level isnt recorded Cancel and re-enter BG value. Fingerstick measurement must be within five minute window. 105 Dexcom G5 Mobile System User GuideCalibration Step What you see What you do Additional Info
(Continued from previous page) 5 6 7 Wait. Thinking screen. BG value is accepted. Immediately take another meter reading. Enter meters BG Value. First calibration accepted. Time for second calibration. Wait for next calibration prompt 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 prompts. If the prompts dont go away after 15 minutes, refer to Chapter 18, Troubleshooting. 106 Dexcom G5 Mobile System User GuideCalibration Device What you see What it means What you do Smart Device:
In App Receiver Smart Device:
In App Receiver Sensor cant calibrate now. Wait 10-15 minutes. Retake fingerstick measurement at prompt. Enter BG value. System didnt accept recent calibration. 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. Fingerstick measurements entered into one device will be available in the other approximately ten minutes after entering data. 107 Dexcom G5 Mobile System User GuideCalibration Summary Now You Can:
Calibration Overview Define calibration Explain the importance of calibration Identify steps to ensure a successful calibration Recognize the steps required to take an accurate blood glucose levels Identify the best blood glucose site for calibrations Prepare finger for fingerstick measurement Determine if you should/should not calibrate Recognize when you can enter BG meter values Recognize when should not enter the BG meter values Determine if you need to calibrate outside of the normal calibration guides Initiate startup calibration Perform maintenance calibrations Correctly enter your fingerstick measurement Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Identify calibration errors Whats Next?
In the next chapter, youll learn how to end a typical seven day sensor session, what to do if you need to end your sensor session early, along with removing the transmitter and determining if you need to replace it. 108 Dexcom G5 Mobile System User GuideCalibration Chapter 8 Lets G5! The Basics:
Ending Your Sensor Session and Transmitter Session 8.1 Introduction Dexcom G5 Mobile Sensor Sessions last seven days. This chapter reviews what you should expect when your session is about to expire, removing the sensor and transmitter. It also covers how to determine if you need to end your session early. After this chapter, you will be able to:
Identify replace sensor prompts at the end of a seven day sensor session 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 sensor pod with transmitter attached Separate transmitter from sensor pod Determine if transmitter can be used for another sensor session To keep up with your glucose trends, its important to begin a new sensor session as quickly as possible. After a sensor session ends, the sensor stops taking your sensor glucose readings. You wont get your trends, nor will you get any Alarm or Alerts. Before stopping a session, and removing the sensor pod and transmitter, review the following safety statements to make sure you dont harm yourself. 109 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session 8.2 Safety Statements WARNING Dont: If a sensor breaks under the skin with no portion visible above the skin, dont remove it. Dont ignore sensor fractures. Do: Seek professional medical help if you have symptoms of infection or inflammation
(e.g., redness, swelling or pain) at the insertion site. Always report a broken sensor to our Technical Support, 24/7, team as soon as possible:
Toll free: 1.877.339.2664 Toll call: 1.858.200.0200 Why: Sensors may fracture on rare occasions. Testing done in a controlled environment (in-vitro) didnt find any safety hazards during an MRI with a broken off sensor under the skin. The wire didnt heat up nor have any significant movement during the MRI, images were affected only in the area around the sensors wire. MRI with broken wire If you have experienced a broken sensor and are planning to take an MRI, please discuss the following with your doctor or technician. Laboratory (in vitro) MRI tests did not detect any safety hazards for a broken sensor that remains in the body. There was no significant movement or heating of the wire. Imaging artifacts were limited to the area around the wire. PRECAUTION Do: Keep Transmitter until its battery life has ended. Why: Transmitter is reusable. Use for multiple sessions 8.3 Ending Your Sensor Session There are different ways your session might end. The most common is your sensors typical seven day timeframe ended. The second is ending the sensor session early. You may end a session early based on a personal decision, 110 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session or on rare occasions, the receiver or app detects sensor issues and prompts you to end the session. Lets review ending a normal session first, later in this chapter well review the prompts for ending the session early. Ending Your Seven Day Sensor Session Just like other prompts, your sensor session ending prompts need clearing:
App Tap screen Receiver Press Select 111 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session End of Seven Day Sensor Session Prompts Ending Sensor Session Prompts Device What you see What it means At Six Hours Smart Device:
Lock Screen Smart Device:
In App Receiver Prompts begin when sensor session has only six hours left. Clock will countdown until session has ended. Continue to get sensor glucose readings.
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(Continued from previous page) At Two Hours Smart Device:
Lock Screen Smart Device:
In App Receiver Two hours remain on your current sensor session. Continue to get sensor glucose readings.
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(Continued from previous page) At Thirty Minutes Smart Device:
Lock Screen Smart Device:
In App Thirty minutes remain. Continue to get sensor glucose readings. Receiver
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(Continued from previous page) Session Ended Smart Device:
Lock Screen Smart Device:
In App Receiver Session has ended. App Tap screens ? for steps to:
Remove sensor Insert new sensor Receiver Press Select to clear.
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(Continued from previous page) Session Stopped Smart Device:
Lock Screen N/A Smart Device:
In App Receiver Sensor session has stopped. App No sensor glucose readings Prompts for new session Receiver Straight line No sensor glucose readings Sound/Vibration Prompts In case you cant look at your screen, both the smart device and receiver provide beep/vibration prompts to remind you your sensor session will end in 30 minutes, it has just ended, or if your sensor failed and you need to start a new session. Remember, if your smart device is on Silent or Do Not Disturb, you wont get any sound prompts. For more information on setting your sound/vibration prompts, please see Chapter 9. Smart Device Your smart device prompts 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 prompts. 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 youre not sure what to do, the app will provide instructions, or you can refer to the Quick Start Guide, online tutorials, or go to Chapter 6 in the User Guide. 116 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Ending Your Sensor Session Early For personal reasons, you may want to force quit a sensor session early (e.g., youre getting an MRI and need to remove sensor pod). Or, occasionally, the app or receiver may detect something is wrong with your sensor and let you know its stopping the current session. This may be caused by a number of reasons:
1. Unresolved calibration issues. 2. Error symbol does not go away. 3. Wait symbol does not go away. 4. Sensor is coming out of the body (for example, the adhesive is peeling off). Youll receive error prompts leading to a new sensor session. If you see error prompts, always contact Technical Support before stopping a sensor session early. Technical Support, 24/7, at:
Toll free: 1.877.339.2664 Toll call: 1.858.200.0200 When your display device has system errors, you may not receive any sensor glucose readings and you should not calibrate. 117 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Prompts to End Sensor Session Early System Prompts Device What you see What it means Smart Device:
Lock Screen Smart Device:
In App Receiver Sensor issues detected. Session ends automatically. No:
Sensor Glucose Readings Alarm/Alerts Replace sensor.
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(Continued from previous page) Smart Device:
Lock Screen Smart Device:
In App Receiver Smart Device:
Lock Screen Smart Device:
In App Receiver Wait up to three hours while the system autocorrects. Check transmitteris it properly inserted into sensor pod?
Make sure you havent taken acetaminophen. If not corrected after 3 hours:
Contact Dexcom Technical Support Wait up to three hours while the system autocorrects. Check transmitteris it properly inserted into sensor pod?
Make sure you havent taken acetaminophen. If not corrected after 3 hours:
Contact Dexcom Technical Support 119 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session The Dexcom G5 Mobile CGM System knows when a typical seven day sensor session is over, automatically ending the session in each display device. However, if you need to end the session early, you need to let the system know by manually stopping the sensor session. While the end result is the same (ending a sensor session), the steps differ between the app and receiver. If youre using both, no need to stop the sensor session in each: the other display will see the session has stopped. Lets 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 What it means What you do 1 1 Access Main Menu. Tap Main Menu icon. Ends sensor session. During session:
Stop Sensor option appears Not in active session:
Start Sensor option appears Tap Stop Sensor.
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(Continued from previous page) 3 4 Blue ? icons provide additional information. Tap Stop Sensor. Confirms sensor session has ended. 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 What it means What you do 1 Go to Main Menu. Press Select.
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(Continued from previous page) 2 3 4 5 Ends sensor session. During session, Stop Sensor option appears. Press Down Arrow to Stop Sensor. Press Select. Thinking screen. Wait. Confirms you want to stop sensor. Return to Main Menu. Press Select. Ready to start a new session. Not in active session, Start Sensor option appears. Remove sensor. Insert new sensor. Press Start Sensor when ready for new session. Temporary Shutdown Receiver 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. 122 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Step What you see What it means What you do 1 2 3 Go to Main Menu. Press Select. Shutdown confirmation screen appears. Press Down Arrow to Shutdown. Press Select. Confirms you want to shut down. Shuts down receiver. Press Select. Press Select to turn the receiver back on. It may take up to 20 seconds for the receiver to turn on. Preventing Sensor Failures Sensor failures can happen when your display device doesnt receive your sensors 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 hasnt expired. 2. Transmitter is snapped securely in sensor pod. 3. Sensor pod isnt dislodged or adhesive isnt peeling. 4. Nothing is rubbing against sensor pod (e.g., seat belts, etc.). 5. You selected a good insertion site (see Chapter 6). 6. Insertion site is clean and dry before sensor insertion. 123 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session The app and receiver are ready for a new session! However before you can start a new sensor session, you need to end the current sensor session, and remove the old sensor and transmitter. 8.4 Remove Sensor Pod and Transmitter Remove Sensor Pod Think of the transmitter as being part of the sensor pod. Do not remove the transmitter before removing the sensor pod from your body. To remove the sensor pod:
1. Gently peel sensor pod adhesive patch from skin. a. Sensor wire comes out with sensor pod. 2. Separate the transmitter from the sensor pod. 3. Discard the sensor pod following your local waste management regulations for disposing blood contacting parts (sensor and applicator). Remove Transmitter from Sensor Pod Remember your transmitter is reusable. With a battery life of 90 days, use the same transmitter over a number of sensor sessions. Youll receive prompts as you near the end of its battery life. Before reusing the transmitter in your new sensor session, separate it from the old sensor pod. You can detach transmitter two ways:
1. Use safety lock (see With Safety Lock table). You removed this from the applicator barrel at the beginning of the session. 2. Manually spread out tabs holding transmitter in sensor pod (see Without Safety Lock table). 124 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session With Safety Lock Step Picture What you do 1 2 3 4 Grasp end of adhesive patch. Peel adhesive patch up and away from your body to remove sensor pod and transmitter. Put sensor pod on flat surface. Place safety latchs jagged edge:
Over transmitters wide edge In between open slots on sensor pods sides Lift up safety latch. If you no longer have the safety lock, dont worry! You can use your fingers to remove the transmitter from the old sensor pod. After removing your sensor, and taking the transmitter out of the sensor pod, youre ready to begin a new sensor session. The transmitters battery is good up to three months. If you havent received your final seven day transmitter battery life warning, you can reuse the transmitter for your next session. Remember:
1. Never use same spot repeatedly for sensor insertion. 2. Never use same site for 2 sensor sessions in a row. 125 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Without Safety Lock Step Picture What you do 1 2 3 4 Grasp end of adhesive patch. Peel adhesive patch up and away from your body to remove sensor pod and transmitter. Put sensor pod on flat surface. Grasp sensor pods wide end with two hands and place fingers in sides open slots. Pull tabs away from transmitter. 8.5 End of Transmitter Battery How do you know if your transmitters battery will last through your next session?
System messages help you determine if your transmitters battery will last through your next seven day session. Starting at three weeks to the end of its battery life, the messages countdown the transmitters battery until it has only seven days. If the transmitter battery has seven days or less remaining, you wont be able to start a new session. 126 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Transmitter Battery Messages Device What you see What it means Smart Device:
Lock Screen Smart Device:
In App Receiver Battery will expire in three weeks. Order a new transmitter.
(Continued on next page) 127 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Device What you see What it means
(Continued from previous page) Smart Device:
Lock Screen Smart Device:
In App Receiver Battery will expire in two weeks. Order a new transmitter.
(Continued on next page) 128 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Device What you see What it means
(Continued from previous page) Smart Device:
Lock Screen Smart Device:
In App Receiver Battery will expire in one week. Order a new transmitter. To make sure you have a transmitter thats ready for a new sensor session, you may want to reorder a new one at store.dexcom.com, by calling Customer Service (see Section 16.1), or through the channels you used before, at your first low battery prompt. Sound/Vibration Prompts In case you cant look at your screen, both the smart device and receiver provide beep/vibration prompts to tell you your transmitters battery is low or the transmitter failed. Remember, if your smart device is turned on to Silent or Do Not Disturb, you wont get any sound prompts. For more information on setting your sound/vibration prompts and how to clear them, please see Chapter 9. 129 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Smart Device Your smart device prompts 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 prompts. If not cleared, you receive a vibrate/beep twice, five minutes apart. Summary Now You Can!
Identify replace sensor prompts at the end of a seven day sensor session 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 sensor pod with transmitter attached Separate transmitter from sensor pod Determine if transmitter can be used for another sensor session Whats Next?
Congratulations, you have the basics down!
You can set up your app and receiver, start a sensor session, calibrate, along with ending your sensor session and when to replace your transmitter. But the Dexcom G5 Mobile CGM System can do much more. In the next part, Part 3: Next Steps, you will learn how to get the most out of your Dexcom G5 Mobile CGM System. 130 Dexcom G5 Mobile System User GuideEnding Your Sensor Session and Transmitter Session Reading Trend Graph Screens and Recognizing Trends Events Alarm and Alerts Sounds for Alarm, Alerts and System Messages NEXT STEPS - GETTING THE MOST OUT OF YOUR DEXCOM CGM Page intentionally left blank 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 complete them. Within five minutes of your final calibration your sensor glucose readings begin!
In this chapter, youll learn three things. First, reading the home screen, second, identifying your sensor glucose readings and trends: What do they mean? Whats the best way to use trend information? And third, what you do if you arent getting your sensor glucose readings. The purpose of this chapter isnt to tell you how to react to your trends, but to help you recognize where your glucose was and where its going. Your healthcare professional can help you with your questions on what actions to take based on your glucose trends. After this chapter, youll be able to:
Recognize home screen icons Locate sensor glucose reading Explain sensor glucose target range Recognize the importance of gray, yellow, and red colors Identify low/high glucose alert levels on your trend graph Describe when you receive a High or Low sensor glucose reading Change trend graph views Cite differences between rate of change arrows Recognize error messages 9.2 Safety Statements Take a moment and read the safety statements. If not followed, your sensor glucose readings and trends may be less accurate, plus and you may miss important high or low glucose alerts. 133 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors CONTRAINDICATION Dont: Never take any medications containing acetaminophen during your sensor session. Why: Taking medications with acetaminophen (such as Tylenol or Excedrin Extra Strength) while wearing sensor may falsely raise sensor glucose readings. Level of inaccuracy depends on:
1. Amount of acetaminophen active in your body. 2. May be different for each person. Consequences: Without correct readings you might miss a severe low event. WARNING Dont: Never use the Dexcom G5 Mobile CGM System sensor glucose readings for treatment decisions. Do: Only use BG values from your BG meter for treatment decisions (e.g., how much insulin to take). Why: Since they measure your glucose from different body fluids, sensor glucose readings can be different from your meters blood glucose values. Consequences: Using sensor glucose readings for treatment decisions could result in you missing a severe low or high event. WARNING Dont: Never ignore symptoms of high and low glucose. Do: Measure your blood glucose with fingerstick measurement if sensor glucose readings dont match your symptoms. Why: Your sensor glucose readings may not be accurately reading your glucose. Consequences: Using sensor glucose readings for treatment decisions could result having severe low (hypoglycemia) or high (hyperglycemia) events. 9.3 Overview of Home Screen Regardless of your display device, the home screen shows your current sensor glucose value, glucose trend, rate of change arrow and CGM system status. While the screen does look different between the receiver and smart devices, their information and color coding are the same. 134 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors No matter how you hold it the receivers view does not change; the Dexcom G5 Mobile App 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. This section first familiarizes you with the apps home screen, then with the receivers home screen. The app also supports two additional, and optional, ways that you can see your apps CGM information: the Today view widget and the Apple Watch. See Additional Ways to View Your Apps CGM Information in this chapter for more detail. In other chapters, youll see how to use the icons or use the navigation wheel to enter data or make system changes. App Home Screen The apps home screen has two main sections:
1. The Task Bar. This is where you go to do tasks such as changing settings and entering 2. The Glucose Information area. This area displays your sensor glucose readings and data. trends. Task Bar Glucose Information Figure 6. App Home Screen on Mobile Device 135 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors Task Bar App Name What it means What you do Task Bar: Complete Tasks Tap Main Menu icon to access:
Alerts Settings Help Start/Stop Sensor Tap icon and enter fingerstick BG value (see Chapter 7). Main Menu Goes to other options. BG Meter with red circle and number BG Meter without red circle Event Dexcom Share Dexcom Share Calibration Prompt. No need to calibrate. Do nothing. Enter different events capturing activities affecting your glucose. Tap icon to enter data for:
Carbs Insulin Exercise Health
(See Chapter 10). Dexcom Share is only available on the app. Gray icon means Share is not active. Once activated, Dexcom Share icon is colored. Tap icon to activate
(see Part 5). Do nothing. Tap icon to access Dexcom Share. 136 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors Glucose Information App: Portrait App: Landscape What it means Home Screen In Landscape mode, tap on the trend view you want to see at the top of the screen: 1, 3, 6, 12, or 24 historical trend views. Number: Most recent sensor glucose reading. Shown in milligrams per deciliter(mg/dL). 1. Yellow: At or above target 2. Gray: Within 3. Red: At or below range target
(Continued on next page) 137 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors App: Portrait App: Landscape
(Continued from previous page) N/A N/A
(Continued on next page) What it means Historical Readings Turn smart device to Landscape mode. Tap time, shows timeframes sensor glucose reading. Slide finger across screen to view rest of days sensor glucose readings. Rate of Change Arrow Direction and number of arrows show sensor glucose change rate. 138 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors App: Portrait App: Landscape What it means
(Continued from previous page) Sensor Glucose Reading Range Shows between 40-400 mg/dL. Within Glucose Range and Alert Levels 1. Yellow Bar: High Alert level 2. Gray Background:
Within range 3. Red Bar: Low Alert level
(Continued on next page) 139 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors App: Portrait App: Landscape What it means
(Continued from previous page) Trend Graph Timeframe Default is most recent 3 hours. Turn smart device to Landscape mode for most recent 1, 3, 6, 12, and 24 hour readings. Additional Ways to View Your Apps CGM Information The Dexcom G5 Mobile App offers more ways to check on your CGM information apart from opening the app. If you choose, you can expand the flexibility of your app by using either of the following features:
Dexcom G5 Mobile widget in the Apple Today view Dexcom G5 Mobile for Apple Watch Safety Statements PRECAUTION Using an accessory device (like a smart watch) might override your smart device sounds. Alarms or Alerts might vibrate or be heard on the accessory instead of your smart device. After connecting any accessories, make sure that the smart device settings allow you to continue receiving Alarms or Alerts on the smart device. 140 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors The Dexcom G5 Mobile Widget in the Apple Today View Check your CGM information on your smart device without needing to open the app, even when the device is locked. Your Dexcom G5 Mobile App provides a widget for your Today view thats accessed by swiping down from the top edge of the screen. Sensor Glucose Reading Trend Graph Trend Arrow Figure 7. The Dexcom G5 Mobile App widget in the Today view. You can edit your widgets by clicking on the Edit button at the bottom of the Today view. See your smart device instructions for the latest information on customizing your Today view. The Dexcom G5 Mobile for Apple Watch Check your CGM information on your wrist! The Dexcom G5 Mobile App supports Apple Watch* and can be used to view your glucose reading, trend arrow, and trend graph. Trend Arrow Sensor Glucose Reading Trend Graph Figure 8. The Dexcom G5 Mobile for Apple Watch 141 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors To set up Dexcom G5 Mobile on your Apple Watch youll need to use the Watch app located on your smart device. See your Apple Watch instructions for more detail on setting up an app on the watch. Your Apple Watch will only communicate with your smart device, not the Dexcom G5 Transmitter. You will not receive alerts, alarms, and other notifications on the watch unless it is connected with your smart device. For example, if you have your watch on and you go out, but leave your smart device at home, you will not receive any CGM updates. When you wake your Apple Watch, it gets your current CGM data from your smart device. There may be a brief delay before your watch app shows current information.
*For compatibility information see dexcom.com/compatibility. Now that youve learned about the apps home screen, lets move our focus to the Dexcom G5 Receiver. Receiver Home Screen Unlike your smart device screens, the receivers screen is not interactive; all prompts are for information only. To make changes or enter data in the receiver, press Select and go to the Main Menu. The receivers home screen has two main sections:
1. Status Bar a. Status Bar reflects glucose trends, readings, status of receivers system (e.g., battery level). 2. Glucose Information Trend Graph a. Reflects sensor glucose readings and trends. This section will get you familiar with the receivers home screen. In other chapters, youll see how to use the navigation wheel to enter data or make system changes. 142 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors Status Bar Glucose Information Figure 9. Home Screen on Receiver Status Bar Receiver Name What it does What you do Status Bar Provides at a glance information about the receiver, system, or you. Icons will change based on current data. Battery Shows battery level. Bluetooth Shows Bluetooth connection is working.
(Continued on next page) Review and take appropriate action. When low, plug micro USB cable into receiver. Plug USB into the adapter and then into electrical outlet. Do nothing. Receivers Bluetooth is always on. 143 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors Receiver Name What it does What you do
(Continued from previous page) Shows most recent sensor glucose reading. Color of status bar changes:
Sensor Glucose Reading Yellow: At or above target Gray: Normal range Red: At or below target Trend Arrow Status Area Shows direction and speed your glucose is changing. Far right. Error icons and calibration prompts. Take appropriate action. Review and take appropriate action based on fingerstick BG value. Take appropriate action. 144 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors 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: Normal Within 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 24 hour trend views. Rate of Change Arrow Direction and speed of your glucose changes. Sensor Glucose Reading Range Shows between 40-400 mg/dL.
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(Continued from previous page) Glucose target range Alert settings. Yellow Bar: High Alert setting Gray Fill: Normal range Red Bar: Low Alert setting Now youre familiar with the basic layout of the trend graph screen, can locate readings, identify color coding, and view time frames. Lets take a closer look at the rate of change arrows. 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 your current BG value. Dont overreact to the arrows. Remember the arrows dont reflect your latest reading: they reflect a combination of recent readings. Rate of Change Arrows App Receiver What your glucose is doing Glucose is steady. Not increasing/decreasing more than 1 mg/dL per minute or up to 15 mg/dL in 15 minutes. Glucose slowly rising 1-2 mg/dL each minute or up to 30 mg/dL in 15 minutes.
(Continued on next page) 146 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors App Receiver What your glucose is doing
(Continued from previous page) Glucose rising 2-3 mg/dL each minute or up to 45 mg/dL in 15 minutes. Glucose rapidly rising more than 3 mg/dL each minute or more than 45 mg/dL in 15 minutes. Glucose is slowly falling 1-2 mg/dL each minute or up to 30 mg/dL in 15 minutes. Glucose is falling 2-3 mg/dL each minute or up to 45 mg/dL in 15 minutes. Glucose is rapidly falling more than 3 mg/dL each minute or more than 45 mg/dL in 15 minutes. N/A No arrow System cant 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 9.5 Error Messages Sometimes the transmitter, or sensor, or display devices arent communicating, causing you not to get your sensor glucose readings or rate of change arrows. Each device notifies you when there is an issue; however, the notifications look different. Before the system can move forward, you need to address the error. 147 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors App 1. If screen is locked:
a. Swipe message to go to app. 2. Within app:
a. Read message. i. Tap Question Marks for more information and follow steps as appropriate. Receiver 1. Press Select to clear message. You will not get any sensor glucose readings or rate of change arrows on either display device until the error is resolved. Check with your BG meter to monitor your glucose during these error periods. Error Messages What you see Bluetooth is Out of Range What you do Smart Device:
Lock Screen Smart Device:
In App Receiver Make sure there are no obstructions, such as a wall or water between your transmitter and your display device. Move within 20 feet of display device. Wait up to 30 minutes while transmitter restores communication.
(Continued on next page) 148 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors Bluetooth Off Smart Device:
Lock Screen Smart Device:
In App
(Continued from previous page) Smart device:
1. Exit app. 2. Tap Settings. 3. Tap Bluetooth. 4. Turn Bluetooth on. Receiver N/A; Bluetooth is always on. Not Getting Sensor Glucose Reading Smart Device:
Lock Screen Smart Device:
In App N/A N/A Receiver CheckAre you:
Within 20 feet of your display device?
In your two hour warmup period?
Outside of your calibration schedule?
In a sensor session?
(Continued on next page) 149 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors (Continued from previous page) System Found Temporary Sensor Issue Smart Device:
Lock Screen N/A Smart Device:
In App Receiver Dont calibrate. System may correct problem on its own and display sensor glucose readings again. If prompt stays for three hours:
Contact Technical Support (see Section 16.1). Transmitter and Sensor not Communicating Smart Device:
Lock Screen N/A Smart Device:
In App Receiver Wait three hours while the transmitter tries to fix the error. Do not enter calibrations during this time. Make sure your transmitter is properly inserted into the sensor pod. If not corrected:
Contact Technical Support (Section 16.1) Remove sensor Insert new sensor
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(Continued from previous page) Smart Device:
Lock Screen Smart Device:
In App Receiver Calibration Error Smart Device:
Lock Screen N/A Smart Device:
In App Receiver Error in calibrating. Enter another BG meter value. Wait 15 minutes. Enter a BG meter value.
(Continued on next page) 151 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors Display Devices and Transmitter not Communicating
(Continued from previous page) Smart Device:
Lock Screen Smart Device:
In App Receiver Wait 10 minutes. 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):
1. Tap Settings. 2. Tap Bluetooth. 3. Turn Bluetooth Off and On. If error messages dont go away after you followed necessary steps, and you arent getting sensor glucose readings, contact Technical Support (see Section 16.1). Now You Can:
Recognize home screen icons Locate sensor glucose reading Explain glucose target range Recognize the importance of gray, yellow, and red colors Identify low/high alert glucose setting lines Describe when you receive a High or Low sensor glucose reading Change Trend Graph Hours view Cite differences between rate of change arrows Recognize error messages Whats Next?
By now you have a pretty good understanding how your trends look on the different display devices, but did you know what you do can affect your trends and patterns? Its important to track actions or well-being, to better understand what you do or how you feel can change your trends. In the next chapter, you will learn how to enter Events in the Dexcom G5 Mobile System. 152 Dexcom G5 Mobile System User GuideHome Screen, Rate of Change Arrows, and Errors 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. After this chapter, youll be able to:
Define Event Describe each Event Create Events Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Recognize Event markers on the Dexcom G5 Mobile App Describe how Event markers are different in portrait and landscape view Describe how to view Events entered via your receiver View Event markers on your smart device 10.2 What Is an Event?
Did you take a walk after lunch today? Did you go to happy hour with your co-workers and have a beer? Are you feeling stressed? Did you catch your kids sniffles? How much insulin did you take for your dinner meal? These are all Events that can raise or lower your blood sugars. An Event is an action or situation affecting your glucose levels. With the Dexcom G5 Mobile CGM System, 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. 153 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns You can use the reports with your healthcare professional to create a game plan in managing your diabetes. Even though they differ on how to enter an Event and time, the app and receiver have the same Event categories and subcategories. Later in this chapter, youll learn how to enter Events in each device. Event Categories There are four main Event categories:
1. Carbs 2. Insulin 3. Exercise 4. Health The fourth category, Health, has more options:
Illness Stress Feel High Feel Low Cycle Alcohol The following table provides more detail on each type of Event. 154 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Events Menu Device Carbs Smart Device:
In App Receiver What you see What it means What you do How many grams did you just eat?
Receivers screen reflects last number entered. Enter Carb grams per snack or meal, up to 250 grams.
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In App Receiver
(Continued from previous page) What you see What it means What you do Receivers screen reflects last number entered. Enter insulin units for each dose, up to 250 units. Cant enter type of insulin, only dosage.
(Continued on next page) 156 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Device Exercise Smart Device:
In App Receiver
(Continued from previous page) What you see What it means What you do Defaulted at 30 minutes. Select each exercises intensity level and duration. Enter intensity and duration. Type of exercise isnt an option.
(Continued on next page) 157 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Device Health Smart Device:
In App Receiver
(Continued from previous page) What you see What it means What you do General well being. Enter different health Events (see following Health Events Menu table).
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(Continued from previous page) Event Time Smart Device:
In App Receiver Event time. For each separate Event, enter date/time Event began. 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 youre having low or high BG symptoms, etc. You select the Event: no amounts are entered, just date and time. 159 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Health Events Menu Device What you see What it means Health Main Menu Smart Device:
In App Receiver Use Health Main Menu to access selections.
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(Continued from previous page) Health Events Smart Device:
In App Receiver Illness Have a cold, flu, or any other temporary illness affecting your well-being?
Stress Are you under stress? Feeling anxious?
High Symptoms Feel high BG symptoms?
Low Symptoms Feel low BG symptoms?
Cycle 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. As an example, youre running late because of traffic (Stress) and quickly swing by a drive-thru to get lunch (Carbs of 85 grams). 161 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns 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 meant to be entered as individual occurrences: dont enter daily totals, enter each Event separately. In the next section, you will learn how to enter Events, first in your smart device, then into the receiver. 10.3 Entering Events You probably will enter Events in your in the display device you use most often; however, you should know how to enter Events into each. First, lets look at how to enter Events in a smart device, then in the receiver. When using Dexcom Share, you can allow your Followers see your Event entries. For more Dexcom Share information, please see Part 5. Enter Events: Smart Device In the Dexcom G5 Mobile App, Events are just a tap away! The Event icon, a running man, is on the apps home screens task bar in portrait mode (remember, you dont have the task bar in landscape). Entering Events for Carbs, Insulin, Exercise, and Healths categories follow the same steps. If you can enter a Carb Event, you can enter an Insulin Event. To enter Events, well use the above scenario. The following table shows how to enter Carb (drive-thru lunch) and Stress
(traffic jam) Events. Entering Events: Dexcom G5 Mobile App Step What you see What you do Enter Carb Event 1 Tap Running Man.
(Continued on next page) 162 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Enter Carb Event
(Continued from previous page) 2 3 Tap Carbs. Add up all carb grams from lunch. Enter 85 using keypad. Tap Done.
(Continued on next page) 163 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Enter Carb Event
(Continued from previous page) 4 5 Tap Event Time. Scroll and select date and time. Tap Done.
(Continued on next page) 164 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Enter Carb Event
(Continued from previous page) 6 Tap Save or Cancel. Enter Stress Event 7 8 Tap Running Man. Tap Health.
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(Continued from previous page) 9 10 Tap Stress. Tap Done. Tap Event Time.
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(Continued from previous page) 11 12 Scroll and select date and time. Tap Done. Tap Save or Cancel.
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| 1 | User Manual Part 2 | Users Manual | 3.84 MiB | / October 10 2016 |
Enter Stress Event
(Continued from previous page) 14 Turn to landscape. The receiver and app dont talk to one another. If you enter an Event only into the receiver, while the information will appear on Dexcom reports, you wont get an Event marker on your apps Trend screen. The app has Event markers on its screen, the receiver doesnt. There may be times when you want or need to enter Events on the Dexcom G5 Mobile Receiver. Enter Events: Dexcom G5 Mobile Receiver While the Event data is the same between display devices, the flow is not the same, including how to enter the Events date and time. The following table reviews how to enter the same Carb/Stress Event data from the previous scenario: Carbs at 85, and a Stress Event. Entering Events: Receiver Step What you see What you do Enter Carbs Event 1 Default screen Press Select to go to Main Menu.
(Continued on next page) 168 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Enter Carbs Event
(Continued from previous page) 2 3 4 5 6 Press Down Arrow until Events is highlighted. Press Select. Highlight Carbs. Press Select. Add up all carb grams from lunch. Arrow up to 85. Press Select. Press Left/Right Arrows to change time and date. Left: Backwards Right: Forward Press Select. Confirmation screen. Press Select.
(Continued on next page) 169 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Enter Health Event
(Continued from previous page) 7 8 9 10 Press Down Arrow until Health. Press Down Arrow to Stress. Press Select. Press Left/Right Arrows to change time and date. Left: Backwards Right: Forward Press Select. Verify information is correct. Press Left/Right Arrows to highlight field. Press Up/Down Arrows to change numbers. Press Select to save. 10.4 Viewing Events Events entered into your receiver can only be viewed on a Dexcom report; there are no markers on your receivers screen. On your smart device, turn to landscape to view your Event markers. A single small square marks all Events. Slide your finger across the screen or tap the square to get your Events information. 170 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Landscape What it does What you do Landscape Only Show Event details. Landscape Only Tap square Slide finger across screen Once you have allowed your Share Followers access to your Trend screen, they too will be able to view your Events. See Part 5 for more information. Summary Now You Can:
Define Event Describe each Event Create an Event Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Recognize Event Markers on the Dexcom G5 Mobile App Describe how Event Markers are different in portrait and landscape view Describe how to view Events entered via your receiver Whats Next?
In the next chapter, you will learn about your trends Alarm and Alerts helping you monitor you glucose levels. Youll also learn how you know when your system loses its signal and stops communicating. 171 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns Page intentionally left blank 172 Dexcom G5 Mobile System User GuideDaily Events Affect Your Glucose Trends and Patterns 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 youre driving, in a meeting, at the movies, and cant or, dont want to, keep looking at your display device?
Dexcoms G5 Mobile CGM System understands there are times when you cant look at your receiver or smart device; however you still need to know of actionable glucose trends or if youre not getting your sensor glucose readings. This chapter reviews the sensor glucose Alarm and Alerts based on your sensor glucose readings, allowing you to proactively manage your glucose trend levels and make sure your transmitter is communicating with your display device. In the next chapter, youll learn how to customize the Alarm and Alerts. After this chapter you will be able to:
Define an Alarm Define an Alert Identify the different types of Alerts Describe the difference between an Alarm and an Alert Recognize different Alarm/Alert prompts and sounds Determine signal loss is preventing you from getting an Alarm or Alert Describe recommended app settings Successfully clear an Alert notification Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Your trending information is one of the greatest benefits of the Dexcom G5 Mobile System. Its important to focus on your trends and rate of change arrows, rather than the exact number of your glucose reading 173 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts 11.2 Safety Statements The Alarm and Alerts were designed to keep you safe, helping you avoid severe lows and highs or from missing your readings. The following safety statements help ensure you get your Alerts and Alarm. WARNING Do: Verify your smart device settings let you get Alarm and Alerts. To receive Alarm/Alerts you must:
1. Make sure Dexcom G5 Mobile App Notifications are turned on in Settings menu 2. Verify app hasnt been shut down. 3. Adjust volume so you can hear sounds. 4. Turn Bluetooth on. 5. Turn off Do Not Disturb. 6. Keep Dexcom G5 Mobile App running in the background. 7. Restart app after device is restarted. Why: Your apps settings do not override phone settings. Consequences: Missing severe low or high Alarm or Alerts. WARNING Dont: Never assume the Dexcom G5 Mobile CGM Systems Alarm/Alert vibrations are different from other vibrating apps. Do: Look at your smart device and check if vibration is a Dexcom G5 Mobile CGM System Alarm or Alert. Why: Medical device apps dont have special priority over your smart devices features. You cant determine if the vibration is coming from your Dexcom G5 Mobile App or another app. Consequences: Missing severe low or high Alarm or Alerts. WARNING Do: Unplug headphones from your smart device when not in use. Why: If headphones are plugged in while not being used, you wont hear an Alarm or Alert. Consequences: Missing severe low or high Alarm or Alerts. 174 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts PRECAUTION Dont: Never prevent communication between transmitter and display devices. Do: Keep smart device and receiver within 20 feet of transmitter and away from obstructions. Why: If your transmitter display device(s) are more than 20 feet apart or are separated by an obstruction, they might not communicate. Types of obstruction differ and not all types have been tested. Obstructions can include water, walls, metal, etc. Water (e.g., swimming, surfing, bathing, etc.) can severely limit communication range. Consequences: Missing severe low or high Alarm or Alerts. PRECAUTION Do: Set smart device and receiver settings separately. Why: Settings are specific to each display device and dont carry over to other devices. If you set up one device and then use another, you wont get an Alarm or Alert. Consequences: Missing severe low or high Alarm or Alerts. PRECAUTION Do: Verify smart device and receiver are turned on. Why: Neither the receiver nor smart device will generate sensor glucose readings, Alarm or Alerts if turned off. Consequences: Missing severe low or high Alarm or Alerts. 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, youll learn how Alarm and Alerts can keep you safe from severe lows or highs. Depending on your display device, you can customize how you receive your Alarm or Alerts. 175 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts What Is an Alarm?
While there are a variety of Alerts, there is just one Alarm, the Urgent Low Alarm (Alarm) is set at 55 mg/dL. The Alarm will repeat every 5 minutes until you clear the Alarm (see Chapter 12 on how to customize the sounds). If you clear the Alarm and your sensor glucose readings do not go over 55 mg/dL in the next 30 minutes, you get another Alarm. Unlike Alerts, the Urgent Low Alarm setting cant be changed or turned off. Think of it as a safety net: your glucose level is dangerously lowpay attention now!
What Are Alerts?
An Alert is a message telling you your glucose trend levels need attention. Low/High glucose Alerts tell you when your sensor glucose readings are outside your target glucose ranges. Think of them as an FYI: You need to know whats happening, Rising/Falling Alerts tell you your glucose levels are changing quickly. Their default settings are Off (see Chapter 12 on how to turn them on). Alerts message you with vibrations (vibrations not available on all smart devices), visual prompts, sounds, or a combination of all three. Unlike the Alarm, you can customize your different Alerts target range (Chapter 12). During your initial set up, you establish your low and high alert levels. As mentioned before, this chapter is a review of the Alarm and Alerts, recommended smart device settings and the receivers default Alert settings. Chapter 12 will show you how to change their settings: customize glucose levels prompts, how you are notified, and in some cases, how often you get notified. The following are the defaults. Default Alerts Low/High Alerts Your Low/High Alerts have the same color coding as your Trend Graph screen:
1. Red: Glucose levels are below your low threshold. a. Default setting of 80 mg/dL. 2. Gray: Glucose levels are within your high/low Alert levels. a. No Alerts. 3. Yellow: Glucose levels are above your high threshold. a. Default setting of 200 mg/dL. 176 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Rise Rate/Fall Rate/Repeat/Signal Loss Alerts Rise Rate and Fall Rate Alerts warn you when your glucose levels are changing rapidly, either down or up, and look similar to the rate of change arrows. Repeat Alerts let you know if your sensor glucose readings continue to be above or below your Alert levels. Glucose Level Alerts 1. Rise Rate 2. Fall Rate 3. Repeat a. Default setting is OffNo Alert. b. Need to change settings to receive Rising Alert. a. Default setting is OffNo Alert. b. Need to change settings to receive Falling Alert. a. Default setting is OffNo 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. Now you have the basics for Dexcoms G5 Mobiles Alarm/Alerts feature. Next, you will learn about each Alarm/Alert in more detail. 11.4 Alarm and Alerts Screens When you fall within an Alarm or Alert target range, your display device tells you. As mentioned in previous chapters you wont get any Alarm or Alerts within five minutes of calibration. Lets first review how the information is presented visually across the devices. While the Alarm/Alerts prompts look different on the display devices, they reflect the same information. After prompts well separately review the vibration and audible Alarm/Alerts for app and receiver. Alarm and Alerts look different based on your display device, but reflect the same information. 177 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Urgent Low Glucose Alarm Device What you see What it means Smart Device:
Lock Screen Smart Device:
In App Receiver Sensor glucose reading at or below 55 mg/dL. Shows last glucose value. Arrows reflect rate of change. Check BG meter to make treatment decisions. 178 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Low/High Glucose Alerts Device What you see What it means Smart Device:
Lock Screen Smart Device:
In App Receiver Sensor glucose reading at or below your low Alert level. Shows most current sensor glucose reading. Arrows reflect rate of change. Can be set to repeat between 15 minutes to 4 hours. Check your BG meter to make any treatment decisions.
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(Continued from previous page) Smart Device:
Lock Screen Smart Device:
In App Receiver Sensor glucose reading at or above your high Alert level. Shows most current sensor glucose reading. Arrows reflect rate of change. Can be set to repeat between 15 minutes to 4 hours. Check BG meter to make treatment decisions. 180 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Rise Rate/Fall Rate Alerts Device What you see What it means Smart Device:
Lock Screen Smart Device:
In App Sensor glucose readings rising quickly. Number of arrows shows how fast (2 mg/dL/min;
3+ mg/dL/min). Check BG meter to make any treatment decisions. Receiver
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(Continued from previous page) Smart Device:
Lock Screen Smart Device:
In App Receiver Sensor glucose readings falling quickly. Number of arrows shows how fast (2 mg/dL/min;
3+ mg/dL/min). Check BG meter to make any treatment decisions. 182 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Signal Loss Alert Device What you see What it means Smart Device:
Lock Screen Smart Device:
In App Receiver Your receiver and transmitter are not communicating. You will not receive Alarm/Alerts. Check BG meter to check your glucose and make any treatment decisions. 11.5 App: Alarm/Alert Recommended Settings The receiver is a stand-alone medical device and used solely to monitor your glucose trends. The app cannot override the smart devices general settings. The app cant override your smart device settings:
When your smart device is on Silent, youll still receive Alarms and Alerts visual prompts and messages, but not vibrations if you havent adjusted your smart device settings Some smart devices dont have a Vibration feature, so you wont get any vibration notifications When your ringers volume is low, you may not hear an Alarm or Alert When your smart device is in Do Not Disturb mode, you wont receive any Alarm/Alerts. The Dexcom G5 Mobile App cant override the Do Not Disturb setting If you dont enable your Dexcom G5 Mobile push Notifications settings during set up, you wont get any Alarm/Alerts Check in Settings under Notifications on how your Alarm/Alerts are prioritized For information on smart device settings, see your smart devices instructions. 183 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts If you are concerned about missing an Alarm or Alert (e.g., 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 Dexcom G5 Mobile Receivers 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 cant be changed. In Chapter 12 youll learn how to adjust the volume and intensity of your Alarm/Alerts. The following is a table of the receivers default beep and vibration patterns. If you clear the Alerts initial vibration, you wont get any beeps or sounds unless youve turned on the Repeat Alert. In the next section, youll learn how to clear the Alarm/Alerts. Urgent Low Glucose Alarm What you see Beeps and vibration Initial Default Alert:
Vibrates 4xs. After 5 Minutes:
Vibrates/beeps 4xs every 5 minutes until cleared or sensor glucose readings go above Alarm level. After 30 Minutes:
After clearing Alarm, continues to notify if sensor glucose readings remain at or below Alarm level. 184 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Low/High Glucose Alerts What you see Beeps and vibration Initial Default Alert:
Vibrates 3xs. After 5 Minutes:
Vibrates/beeps 3xs every 5 minutes until cleared. Trend screen will continue to reflect Alert until sensor glucose readings go above Alert level. Initial Default Alert:
Vibrates 2xs. After 5 Minutes:
Vibrates/beeps 2xs every 5 minutes until cleared. Trend screen will continue to reflect Alert until sensor glucose readings go below Alert level. 185 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Rise Rate/Fall Rate Alerts What you see Beeps and vibration Initial Default Alert:
None/Off. After Setting Change:
Vibrates 2xs, 2 sounds. After 5 Minutes:
Vibrates/beeps 2xs every 5 minutes until cleared. Initial Default Alert:
None/Off. After Setting Change:
Vibrates 3xs. After 5 Minutes:
Vibrates/beeps 3xs every 5 minutes until cleared or sensor glucose reading drops below Alert level. 186 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Low Repeat/High Repeat What you see Signal Loss Alert What you see Beeps and vibration Initial Default Alert:
None/Off. After Setting Change:
Vibrates 3xs. After 5 Minutes:
Vibrates/beeps 3xs 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 2xs. After 5 Minutes:
Vibrates/beeps 2xs every 5 minutes until cleared. Beeps and vibration Initial Default Alert:
On. After Setting Change:
Vibrates 1x. After 5 Minutes:
Vibrates/beeps 1x every 5 minutes for a total of 6 times if not cleared. After 6 times it will not alert again. 187 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts 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, youll need to clear each separately. Due to their medical importance, the Alarm is more persistent. Even after acknowledging and clearing an Alarm, if your sensors glucose readings remain at or below 55 mg/dL, an Alarm will sound every 30 minutes until readings are above 55 mg/dL. Clearing Your Smart Device Device What you see What you do Smart Device:
Lock Screen Smart Device:
In App Slide Alarm or Alert to access app. Tap OK to accept Alarm or Alert. 188 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Clearing Your Receiver What you see What you do Press Select. Once cleared, you wont receive the same Alert unless you hit the Alerts target range again. Your Alarm will repeat even after clearing if your glucose levels do not return to your target range. Summary Now You Can:
Define an Alarm Define an Alert Identify the different types of Alerts Describe the difference between an Alarm and an Alert Recognize different Alarm/Alert prompts and sounds Determine if signal loss is preventing you from getting an Alarm/Alert Describe recommended app settings Successfully clear an Alert notification Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Whats Next?
Up to now, you have learned about the Alarm or Alert default settings. But what do you do if you want to decrease the High Alert glucose level threshold, or you want to continue getting a Low Alert notification if your glucose levels dont improve, even though you cleared the message?
How do you make your Alarm/Alerts fit your needs?
189 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Page intentionally left blank 190 Dexcom G5 Mobile System User GuideSensor Glucose Alarm and Alerts Chapter 12 Next Steps:
On the Go With G5: Customizing Your Alarm and Alerts 12.1 Introduction The receiver and app come with default glucose Alert level settings, but perhaps they dont reflect the glucose level that works best for you. Perhaps youre in a meeting and can only clear an Alert, yet want to make sure your Alert repeats, or continues, until youre able to take corrective measures. Maybe youd like to get a Rising/Falling glucose Alert, but their settings are off by default. How do you turn them on?
In this chapter, youll learn how to personalize your Alarm and Alerts tones and glucose levels. Afterwards, you will be able to:
Customize your Low/High Alerts Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Adjust Alarm sound notification Use receivers Advanced Alerts Low/High Repeat Rise/Fall Alerts Signal Loss Each display device has customization options; however the setup flow is different. Before making any changes to your Alert levels, talk with your healthcare professional. First, lets take a look at personalizing your app Alarm and Alerts, and then well review the same process for the receiver. 191 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts 12.2 Safety Statement WARNING Do: If using both receiver and app for to get an Alarm or Alert, change settings in each display device. Why: Any changes to the G5 Mobile app will not carry over to the receiver. Consequences: Missing severe low or high Alarm or Alerts. 12.3 Changing App Alarm and Alerts App Screen Overview The Alerts Main Menu lists all customizable Alerts and Alarm and their current settings. Part of your initial set up included setting your Low/High Alerts. In this chapter, youll learn how to change them. Before learning how to change your settings, lets review the apps Alerts Main Menu screen. Customizing Alerts: App Alarm/Alerts Screen Overview Step What you see What it means What you do 1 Access Main Menu. Tap Main Menu icon.
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(Continued from previous page) 2 3 Access Alerts Main Menu. Tap Alerts. Tap Alarm/Alert you want to change. All customizable Alarm and Alerts. Current Alert settings. All alerts have:
On/Off switch Notify me options Sound options
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(Continued from previous page) 4 5
? explains:
Each Alarm/Alert Message options Recommended settings Tap ? for Alarm/Alert information. Urgent Low Glucose Alarm:
Preset at 55 mg/dL and cannot be changed Repeat preset at 30 minutes and cant be changed Sound is the only change option Tap Sound to change sound. 194 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts Steps to Customize App Alarm/Alerts Although the results will vary depending on what Alarm or Alert you are customizing, the steps to change your Alarm or Alert are the same:
From apps Main Menu:
1. Tap Alerts. 2. Tap the Alert you want. 3. Tap Notify me. a. Tap On or Off switch to turn on desired Alerts. 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. sensor glucose readings continue to be low or high. i. Scroll selection wheel, find your desired Alert level. ii. Tap to highlight. iii. Tap Save. 5. Tap Sound. a. Assign a different sound to each Alarm or Alert. i. Scroll selection wheel, find your desired sound. ii. Tap to highlight. iii. Tap back arrow. a. Change the amount of time you want between your High/Low Alerts if your In this following example, well change the High Alert level from 200 mg/dL to 190 mg/dL, repeating every hour if you continue to stay high, with a Door Bell sound. Customizing Alerts: App Step What you see What it means What you do Access Alerts Main Menu 1 Access Main Menu. Tap Main Menu icon.
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(Continued from previous page) 2 Access Alerts Main Menu. Tap Alerts.
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(Continued from previous page) 3 4 Access High Alert settings (mg/dL). Tap High mg/dL. Shows High Alert options and current settings. Check High Alerts is On. On - Orange Off - Gray
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(Continued from previous page) 5 6 Wont get Alerts if Off. If Off:
On Slide to On. On - Orange Off - Gray Change High Alert
(mg/dL). Tap Notify Me Above.
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(Continued from previous page) 7 8 Change glucose level from current level
(mg/dL). Scroll selection wheel. Stop at 190. Saves new High Alert glucose level (mg/dL). Returns to High Glucose Alert screen options. Notify Me Above set at 190 mg/dL. Tap Save.
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(Continued from previous page) 9 10 Changes how often your High Alert repeats after initial Alert and confirmation. Repeats only if you are above your high glucose level. Tap Repeat. Changing the current repeat setting. Can select in five minute steps (range 15 minutes-4 hours). Scroll selection wheel. Stop at 1 hour.
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(Continued from previous page) 11 12 Saves your new repeat timing. Returns to High Glucose Alert screen options. Repeat shows how often youll get notified. Tap Save. Customize Alert sound. Tap Sound.
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(Continued from previous page) 13 14 Changes current sound setting. Tap Doorbell. Tap Sound again to hear sound sample. Saves your new Alert sound. Return to High Glucose Alert Menu. Tap Back Arrow.
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(Continued from previous page) 15 Return to Main Menu. Tap X. 16 Return to trend screen. Tap Menu icon Or Swipe right. 203 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts 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 dont, you may miss an Alarm or Alert. 12.4 Changing Receiver Alarm and Alerts Youll 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 receivers 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. As mentioned in the previous chapter, the receiver uses a series of beeps/vibrations for an Alarm or Alert. The receiver doesnt have the same variety of tones as the app; however you can adjust their volume. While the receiver doesnt have a silent mode, selecting Vibrate will replace audible beeps with quiet vibrations. The only exception is the Alarm: the urgent low Alarm cant be turned off. Changes made in Profiles are applied to all of the receivers Alarm/Alerts. If you choose Soft
(see next table), all Alerts are in Soft mode. In Chapter 10, you learned how many beeps each Alarm/Alert has. Normal is the default setting for your receiver sound Profiles. Attentive uses a rising or falling melody instead of beeps. The receiver first vibrates when sending you an Alarm or Alert. If you clear the alert at the first vibration by pressing the Select button on your navigation wheel, you wont get any Alarm/Alert tones. If you would like to continue to get your Alarm or Alert after clearing, later in this chapter youll learn about setting up Repeat Alerts. HypoRepeat is very similar to the Normal Profile, but keeps repeating the fixed low alarm every 5 seconds until your sensor glucose value rises above 55 mg/dL or you confirm by pressing the Select button. The next table lists the different sound Profiles, starting with the quietest, working its way up to the loudest. 204 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts Alarm/Alert Sound Profiles Icon Profile name Notification description Vibrate Vibration only. Only sound is your receiver vibrating. Vibrate is not available for the Alarm. Soft Lower volume beeps. Normal Attentive HypoRepeat Medium volume beeps. Default Profile. No beeps. Rising melody for High and Rising Alerts Dropping melody for Low and Falling Alerts Medium volume beeps. Urgent low Alarm only. Repeats fixed low alarm every 5 seconds until sensor glucose reading rises above 55 mg/dL or is confirmed. Try It Sample Profile setting before selecting. After choosing your sound profile, changing it is just a few steps away! Change your Profile throughout the day depending on what lays 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. 205 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts Customizing Sound Profiles: Receiver Step What you see What it means What you do 1 2 3 4 Go to Main Menu. Press Select. Second Main Menu screen. Press Down Arrow. Profiles on second screen. Profiles adjusts volume of Alarm/Alerts. Press Up/Down Arrow. Stop at Profiles. Press Select. Press Up/Down Arrow. Stop at desired Profile. Press Select. Choose sound Profile.
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(Continued from previous page) 5 6 Selected Profile check marked. N/A Repeat as needed. Sample sound:
Press Down Arrow. Stop at Try It. Press Select to have the sound play. Exit Profiles:
Press Left Arrow. Repeat steps 2-5 to change Profile. To Exit:
Press Left Arrow to Main Menu. Profiles allow you to change your Alarm and Alerts tones. The Alerts menu gives you options for personalizing your glucose level Alerts, repeating Alerts, turning your Rising/Falling Alerts on and turning on your Signal Loss Alert. Alerts Main Menu Low/High Alert option lets you adjust your low/high glucose Alert level (mg/dL). Advanced gives you options to turn on Low/High Repeat, Rise/Fall Alerts and Signal Loss Alert. Low/High Repeat In the previous chapter, you learned clearing an Alert stops it from repeating. If you want to continue to be re-alerted until your glucose levels are back in your target range, turn on the Repeat option. Rise/Fall Rate Your trend screen provides visual cues letting you know your sensor glucose readings are falling or rising rapidly. 207 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts 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. Its important you discuss your alert settings with your healthcare professional. Signal Loss Signal Loss Alert tells you when your transmitter and receiver arent communicating. Set the Signal Loss and get alerted if your sensor glucose readings have stopped due to a signal loss anywhere from 20 to 200 minutes. The default setting for Signal Loss is On. Steps to Customize Receiver Alarm/Alerts Using the same example from changing your app Alerts, lets change the receivers High Alert notification level from 200 mg/dL to 190 mg/dL, repeating every 60 minutes. Follow the same steps turning on the Rise/Fall Alerts, and adjusting your Low Alerts. Customizing Alerts: Receiver Step What you see What it means What you do Change High Alert Level 1 Go to Main Menu. Press Select.
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(Continued from previous page) 2 3 4 5 6 Alerts option from the Main Menu. Press Down Arrow. Stop at Alerts. Enter Alerts menu option. Press Select. Alerts option menu. Lists different Alerts:
High/Low/Advanced
(Repeat, Rise/Fall, Signal Loss) Alerts. Press Up/Down Arrow. Stop at High Alert. Press Select. Alerts current settings. Change your current High Alert level. Press Down Arrow. Stop at Level. Press Select. Current setting. Use Up/Down arrows to change your High Alert level (mg/dL). Press Down Arrow. Stop at 190 mg/dL.
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(Continued from previous page) 7 Turn Repeart On 8 9 10 11 Saves new High Alert level. Return to Alerts Menu. Press Select. To exit:
Press Left Arrow. Alerts Menu. Choose Advanced to get to Repeat Alert. Press Down Arrow. Stop at Advanced. Enter Advanced Alert options. Press Select on Advanced. Main Advanced screen. Set Repeat Alerts. Turn On Rise/Fall Rate Alerts. Initial screen shows current repeat minutes. Change time frame in 5 minute increments.
(Continued on next page) Arrow to High Repeat. Press Select. Press Up/Down Arrow. Stop at 60 minutes. 210 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts Turn Repeat On
(Continued from previous page) 12 13 Changed Repeat time for High Alert. Press Select. Changed completed. Return to Alerts Menu. To exit:
Press Left Arrow. It doesnt matter which device you first use to customize your Alarm/Alert settings, key is making sure you make the same changes in both or you may miss an Alarm or Alert. Summary Now You Can:
Customize your glucose trend Low/High level notifications Dexcom G5 Mobile App Dexcom G5 Mobile Receiver Adjust Alarm tones Set up receivers Advanced Alerts Low/High Repeat Rise/Fall Rate Signal Loss Whats Next?
Believe it or not, you are becoming a pro at using your Dexcom G5 Mobile CGM System!
Youve set up the app and receiver, started a session, calibrated, followed your glucose trends, paid attention to your Alarm/Alerts, prompts, and ended a session!
The next chapters begin our fourth part of the user guide: information you need to know, but unlike the previous chapters, typically not part of your day-to-day Dexcom G5 Mobile CGM System experience. 211 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts The next part, Part 4: Everything Else G5, reviews the technical specifications, the warranty, how to take care of the Dexcom G5 Mobile components, going through security when traveling, contacting the Help Desk, Troubleshooting information, and symbols on system components and packages. 212 Dexcom G5 Mobile System User GuideOn the Go With G5: Customizing Your Alarm and Alerts Warranty Maintenance Travel Tips Customer Service Contacts Technical Information Troubleshooting Package SymbolsEVERYTHING ELSE G5 Page intentionally left blank Chapter 13 Everything Else G5:
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 dont and for how long. First the receivers limited warranty information, then the transmitters limited warranty information. 13.2 Receiver Warranty Information Dexcom G5 Mobile CGM Systems Limited Warranty Whats Covered and for How Long?
Dexcom, Inc. (Dexcom) provides a limited warranty to the original purchaser (you or Purchaser) that the Dexcom G5 Mobile Receiver (the Receiver) is free from defects in material and workmanship under normal use (Limited Warranty) for the period starting from the shipment date and continuing for a year following the shipment date
(Warranty Period):
Dexcom G5 Mobile Receiver: 1 year from shipment date NOTE: If you received this Receiver as a replacement for an in-warranty Receiver, the Limited Warranty for the original Receiver shall continue for the Warranty Period on the original Receiver, but the replacement is not subject to any other warranty. Whats Not Covered?
This Limited Warranty is based on the Purchaser properly using the CGM system in accordance with the documentation provided by Dexcom. You are not permitted to use the CGM system otherwise. You understand that misusing the CGM system, improperly accessing it or the information it 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. 215 Dexcom G5 Mobile System User GuideWarranty: The Fine Print 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. All surfaces and other externally exposed parts that are scratched or damaged due to 4. Malfunctions resulting from the use of the Receiver in conjunction with accessories, ancillary products, and peripheral equipment, whether hardware or software, not furnished or approved by Dexcom. 5. Defects or damage from improper testing, operation, maintenance, installation, normal use. or adjustment. 6. Installation, maintenance, and service of products or services other than the CGM system (which may be subject to a separate limited warranty), whether provided by Dexcom or any other party; this includes your cell phone or smart device and your connection to the Internet. 7. Equipment which has been taken apart physically or which has had any of its software accessed in any unauthorized manner. 8. Water damage to the Receiver. a. Receiver is not water resistant. b. Do not get the receiver wet at any time. Dexcoms Obligations Under the Limited Warranty During the Warranty Period, Dexcom will replace, without charge to purchaser, any defective Dexcom G5 Mobile Receiver. To return, you must send the Receiver to an authorized Dexcom Technical Support Department. Make sure you package the Receiver adequately for shipping. The return package needs to include:
1. Receiver 2. Sales receipt or comparable substitute proof of sale showing the date of purchase 3. Receivers Serial Number 4. Sellers name and address Call Dexcom Technical Support Department for delivery information help:
Toll free: 1.877.339.2664 Charges may apply: 1.858.200.0200 Upon receipt, Dexcom will promptly replace the defective Receiver. 216 Dexcom G5 Mobile System User GuideWarranty: The Fine Print If Dexcom determines the Receiver isnt covered by this Limited Warranty, Purchaser must pay all shipping charges for the Receivers return by Dexcom. Limits on Dexcoms Warranty and Liability Obligations The Limited Warranty described above is the exclusive warranty for the Receiver, and in lieu of all other warranties, expressed or implied, either in fact or by operation of law, statutory or otherwise. Dexcom expressly excludes and disclaims all other warranties, including without limitation any warranty of merchantability, fitness for a particular purpose, or non-infringement, except to the extent prohibited by applicable law. Dexcom shall not be liable for any special, incidental, consequential, or indirect damages, however caused, and on any theory of liability, arising in any way out of the sale, use, misuse, or inability to use, any Dexcom G5 Mobile CGM System or any feature or service provided by Dexcom for use with the Dexcom G5 Mobile CGM System. These limits on Dexcoms warranty and liability obligations apply even if Dexcom, or its agent, has been advised of such damages and notwithstanding any failure of essential purpose of this Limited Warranty and the limited remedy provided by Dexcom. This Limited Warranty is only provided to the original Purchaser and cant be transferred to anyone else, and states Purchasers 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. 13.3 Transmitter Warranty Information Dexcom G5 Mobile Transmitter Limited Warranty Whats Covered and for How Long?
Dexcom, Inc. (Dexcom) provides a limited warranty to the original purchaser that the Dexcom G5 Mobile Transmitter is free from defects in material and workmanship under normal use for the period commencing on the date of first use by the original purchaser (the Date of First Use) and expiring three (3) months thereafter; provided, that, the Date of First use occurs within five (5) months of the date of shipment (or disbursement) of the transmitter to the original purchaser. 217 Dexcom G5 Mobile System User GuideWarranty: The Fine Print NOTE: If you received this Transmitter as a replacement for an in-warranty Transmitter, the Limited Warranty for the original Transmitter shall continue for the Warranty Period on the original Transmitter, but the replacement is not subject to any other warranty. Whats Not Covered?
This Limited Warranty is based on the Purchaser properly using the CGM system in a timely manner and in accordance with the documentation provided by Dexcom. You are not permitted to use the CGM system otherwise. You understand that misusing the CGM system, improperly accessing it or the information it 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. All surfaces and other externally exposed parts that are scratched or damaged due to normal use. or adjustment. 4. Malfunctions resulting from the use of the Transmitter in conjunction with accessories, ancillary products, and peripheral equipment, whether hardware or software, not furnished or approved by Dexcom. 5. Defects or damage from improper testing, operation, maintenance, installation, 6. Installation, maintenance, and service of products or services other than the CGM system (which may be subject to a separate limited warranty), whether provided by Dexcom or any other party; this includes your cell phone or smart device and your connection to the Internet. 7. Equipment which has been taken apart physically or which has had any of its software accessed in any unauthorized manner. 8. Water damage to Transmitter. a. Beyond specifications listed in Dexcom G5 Mobile CGM Systems User Guide. b. User Guide is included in the Dexcom G5 Mobile Systems Receiver package. c. Located on dexcom.com. 218 Dexcom G5 Mobile System User GuideWarranty: The Fine Print 13.4 Dexcoms Obligations Under the Limited Warranty During the Warranty Period, Dexcom will replace, without charge to purchaser, any defective Dexcom G5 Mobile Transmitter. 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. Transmitters Serial Number 4. Sellers name and address Call Dexcom Technical Support Department for delivery information or help:
Toll free: 1.877.339.2664 Charges may apply: 1.858.200.0200 Upon receipt, Dexcom will promptly replace the defective Transmitter. If Dexcom determines the Transmitter isnt covered by this Limited Warranty, Purchaser must pay all shipping charges for the Transmitters return by Dexcom. Limits on Dexcoms Warranty and Liability Obligations The Limited Warranty described above is the exclusive warranty for the Transmitter, and in lieu of all other warranties, expressed or implied, either in fact or by operations of law, statutory or otherwise. Dexcom expressly excludes and disclaims all other warranties, including without limitation any warranty merchantability, fitness for a particular purpose, or non-infringement, except to the extent prohibited by applicable law. Dexcom shall not be liable for any special, incidental, consequential, or indirect damages, however caused, and on any theory of liability, arising in any way out of the sale, use, misuse, or inability to use, any Dexcom G5 Mobile CGM System or any feature or service provided by Dexcom for use with the Dexcom G5 Mobile CGM System. These limits on Dexcoms warranty and liability obligations apply even if Dexcom, or its agent, has been advised of such damages and notwithstanding any failure of essential purpose of this Limited Warranty and the limited remedy provided by Dexcom. 219 Dexcom G5 Mobile System User GuideWarranty: The Fine Print This Limited Warranty is only provided to the original Purchaser and cant be transferred to anyone else, and states Purchasers 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. 220 Dexcom G5 Mobile System User GuideWarranty: The Fine Print Chapter 14 Everything Else G5:
How to Take Care of Your Dexcom G5 Mobile CGM System 14.1 Introduction There are not a lot of moving parts in the Dexcom G5 Mobile CGM System, so maintenance is relatively simple: keep it clean, keep display device (s) dry and protected, use accessory parts, like the USB cable, etc., given to you with the system and store according to each pieces labeling instructions. This chapter only covers Dexcom parts (sensor, transmitter, and receiver). Follow the manufacturers instructions when caring for your smart device. After this chapter, you will be able to:
1. Demonstrate proper maintenance a. Sensor b. Transmitter c. Receiver d. Charge receiver battery 2. Determine what accessories you may use 3. Identify the best storage methods 4. How to safely dispose of a. Sensor b. Transmitter c. Receiver a. Sensor b. Transmitter c. Receiver 221 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System 14.2 Basic Maintenance Sensor 1. Keep in sterile package until ready for use. 2. Check package label for expiration date. a. Expiration date format is YYYY-MM-DD (year-month-day) format. b. Dont use if sensor has expired. i. May provide inaccurate sensor glucose readings. ii. May be unsterile. Transmitter 1. Keep in box until ready for use. a. Check transmitter and dont use if damaged. 2. Transmitter is reusable, however 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 to its packaging or another safe place. b. Store between 32 F-113 F. Receiver 1. Check receiver casing, if its cracked or damaged, dont use. a. May get an electric shock. 2. Keep receiver dryit is only splash resistant. a. Dont submerge in liquid. b. Dont spill fluids on receiver. 3. Keep battery charged. a. Only use Dexcom USB charging/download cable. 4. Keep the micro USB port cover closed if not using USB cable. a. Prevents fluid from getting inside receiver. Charging Receivers Battery The receivers status bar lets you see its battery level and prompts you when the battery is getting low. While the receiver is being charged, you will continue to get your sensor glucose readings if the transmitter and receiver are within 20 feet of each other. 222 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System Each charge lasts approximately three days. If your receivers battery was drained, after charging, you may need to reset its time and date. If this is required, the system tells you to reset and takes you to the time/date setting screens. Step What you see What it means What you do 1 2 Low Battery Charge your battery. Open USB port door. Plug USB cable into port for recharging. Micro USB Port
(Continued on next page) 223 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System Step What you see What it means
(Continued from previous page) 3 4 Micro USB Cable Wall Charger
(Continued on next page) What you do Plug into receiver to charge battery. Dont plug into a computer port to charge Dont use an external USB hub, it doesnt 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. Plug wall charger into an electrical outlet to charge receivers battery. Dont block access to the charger. 224 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System Step What you see What it means What you do
(Continued from previous page) 5 6 6 Accessories Battery Charging Keep charging until icons are solid. Battery Charged USB Port Door Unplug wall charger from outlet when fully charged. Remove USB cable from receiver. Close USB port door after removing USB cable to keep receiver clean and dry. 1. Only use Dexcom-supplied parts (including cables and chargers). a. Use of non-Dexcom supplied parts may affect safety and performance. 2. Insert cables only as directed. a. Do not force cables in place. 3. Look at cables for signs of wear and tear. Do not use if worn or damaged. There is no repair service available for any Dexcom G5 Mobile CGM System parts. 225 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System If you experience problems, call Dexcom Technical Support, available 24 hours, 7 days a week, toll free at 1.877.339.2664 or toll at 1.858.200.0200 to report the issue. 14.3 Storage Storing your Dexcom G5 Mobile CGM System correctly helps prevents system failures. Sensor 1. Keep the sensor in its sterile packaging until you are ready to use it. 2. Store at temperatures between 36 F-77 F. a. Stored outside of this range may cause inaccurate sensor glucose readings. b. May store in refrigerator if its within this temperature range. c. Sensors should not be stored in freezer. 3. Store at humidity levels between 15%-85% relative humidity. Transmitter 1. Keep transmitter protected when not in use. 2. Store at temperatures between 32 F-113 F. 3. Store at humidity levels between 10%-95% relative humidity. Receiver 1. Keep receiver protected when not in use. 2. Fully charge the battery before storing for over 3 months. 3. Store at temperatures between 32 F-104 F. 4. Store at humidity levels between 10%-95% relative humidity. 226 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System 14.4 Checking App and Receiver Information CHECKING YOUR APP & RECEIVER SOFTWARE 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. Available Information Insertion Time Last Calibration Transmitter Battery Transmitter SN Serial Number Part Number Part Revision Software Number 227 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System 14.5 System Disposal 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 areas local waste management authorities for proper disposal instructions. Taking care of your Dexcom G5 Mobile CGM System is pretty easy. In the next chapter, traveling with your Dexcom G5 Mobile CGM System, youll learn how simple it is to see the world with your Dexcom G5 Mobile CGM System!
228 Dexcom G5 Mobile System User GuideHow to Take Care of Your Dexcom G5 Mobile CGM System Chapter 15 Everything Else G5:
On the Go With Dexcom G5 Mobile CGM System: Getting Through Security 15.1 Introduction Dexcom G5 Mobile 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 only covers the Dexcom G5 Mobile CGM System. It doesnt cover steps you need to take when traveling with your smart device. See your smart devices instruction for use to learn how to travel with it. After this chapter, you will be able to:
1. Explain proper procedure if you prefer a full body pat down. 2. Describe steps needed for a TSA officer to inspect Dexcom G5 Mobile CGM System components. 3. Identify when your display device(s) can be on during a flight. 4. Contact TSA directly with your security questions. 15.2 Going Through Security Walk-Through Metal Detectors Transmitter and Sensor No worries about wearing your transmitter and sensor when going through security. Go through walk-in metal detectors or, if you prefer, be handwanded without worrying about damaging your transmitter or sensor. If youre concerned or uncomfortable about walking through the metal detector, the Transportation Security Administration (TSA) requests you tell the Security Officer youre 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 cant be removed because its inserted under the skin. 229 Dexcom G5 Mobile System User GuideOn the Go With Dexcom G5 Mobile CGM System: Getting Through Security X-Ray Machines Receiver, Extra Sensors Dont put your Dexcom G5 Mobile CGM System components through x-ray machines. Before your screening process begins, ask the TSA Officer to perform a visual inspection of the receiver and your extra sensors. Place all Dexcom G5 Mobile components in a separate bag before handing over to the Security Officer. For other medical supplies, such as medications, meters, and strips, check manufacturers instructions or the TSA website. Body Scanners Use of AIT body scanners has not been studied and therefore we recommend hand-wanding or full body pat down and visual inspection in those situations. In the Plane You may keep the receiver on:
1. Before take-off 2. While in flight 3. After landing The Dexcom G5 Mobile CGM System is safe for use on U.S. commercial airlines. If you choose to use your smart device, the airlines request you put your smart devices in airplane mode. You can do this, but still keep your Bluetooth on and you will be able to receive sensor glucose information on your smart device. Technical Information The Dexcom G5 Mobile Transmitter is an M-PED with emission levels that meet RTCA/DO160, Section 21, Category M. Per FAA Advisory, Circular #91-21, 1B, dated 8/25/06. 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 (ESD) and electromagnetic interference (EMI). Still Have Questions?
Visit the TSAs website if you have any questions or concerns at tsa.gov. 230 Dexcom G5 Mobile System User GuideOn the Go With Dexcom G5 Mobile CGM System: Getting Through Security Email: TSA-ContactCenter@dhs.gov Phone: Call 1.866.289.9673 231 Dexcom G5 Mobile System User GuideOn the Go With Dexcom G5 Mobile CGM System: Getting Through Security Page intentionally left blank 232 Dexcom G5 Mobile System User GuideOn the Go With Dexcom G5 Mobile CGM System: Getting Through Security Chapter 16 Everything Else G5:
Need Help? Youre Not Alone!
Dexcom has two support teams to help you, each with their own specialty:
Technical Support Team Patient Care Team 16.1 Dexcom Technical Support Provides replacement units, resolves technical issues or takes product complaints. Call your Dexcom Technical Support Team, 24 hours a day, 7 days a week, if something is wrong with your Dexcom G5 Mobile CGM System. By Phone Dexcom Technical Support Phone Numbers:
Toll Free: 1.877.339.2664 Toll Call: 1.858.200.0200 By Email Email: TechSupport@dexcom.com If you prefer to email, to help us help you best, include the following information in your email:
Name of patient Date of Birth The technical issue you When the problem happened (date and time) Patients address Patients phone number Item SKU number and description (e.g., name of the device) Lot number and/or serial number(s) of affected devices (e.g., sensor) 233 Dexcom G5 Mobile System User GuideNeed Help? Youre Not Alone! What Can They Help Me With?
The Dexcom Technical Support Team helps you with all CGM system related issues as well as software related issues. Dexcom Technical Support does not offer medical advice. 16.2 Patient Care Team The Patient Care Team (PCT) is a group of Certified Diabetes Educators (CDE) and Registered Nurses (RNs) offering you customer care and individualized education services around Dexcom CGM. Your PCT provides education and support throughout your CGM experience, such as:
Initial CGM Product Training Ongoing Dexcom product education (e.g., how to use a specific feature) How to maximize Dexcom CGM use Dexcom CGM reporting software and features How to review and understand Dexcom CGM reports By Phone Available Monday-Friday 5:30 am-8:00 pm PST (subject to change) Toll Free: 1.877.339.2664 Toll Call: 1.858.200.0200 By Email Email: patientcare@dexcom.com If you prefer to email, to help us help you best, include the following information in your email:
Name DOB Contact phone number Reason for inquiry or education needed For additional Dexcom CGM education, check the Dexcom website:
dexcom.com/web-based-education 234 Dexcom G5 Mobile System User GuideNeed Help? Youre Not Alone! 16.3 Sales Support Team Inside Sales Support Team For help with:
First-time orders Re-orders Tracking shipments Locating a local Dexcom representative By Phone Dexcom Inside Sales Support Phone Numbers:
Toll Free: 1.877.339.2664 Toll Call: 1.858.200.0200 By Email Dexcom Inside Sales Support Email: CustomerService@dexcom.com By Fax 1.877.633.9266 16.4 Corporate Dexcom Website:
Dexcom.com Dexcom Address:
6340 Sequence Drive San Diego, CA 92121 235 Dexcom G5 Mobile System User GuideNeed Help? Youre Not Alone! Page intentionally left blank 236 Dexcom G5 Mobile System User GuideNeed Help? Youre Not Alone! Chapter 17 Everything Else G5:
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 Dexcom G5 Mobile CGM System performs. The Dexcom G5 Mobile CGM System (the System) uses a glucose sensor to continuously measure and monitor your glucose levels. The sensor is calibrated using a commercially available blood glucose meter. Once calibrated, the System reports glucose readings up to every 5 minutes. The System was evaluated clinical studies in which System readings were compared to blood glucose values to assess its performance and how well the System readings compare to a laboratory test method that measures blood glucose values. Additionally, subjects performed self-monitoring blood glucose meter tests at home to assess the System performance in real use environment. Although the performance characteristics of the System are presented in the following, there is no commonly accepted statistical approach for capturing performance of continuous glucose monitors
(CGMs), such as the Dexcom G5 Mobile CGM System. Clinical Study Overview The System performance was evaluated in four separate prospective clinical studies. Two studies included adults, and two studies included pediatrics. In the following sections and tables, the studies will be identified as follows:
Adult Studies (18 years and older) Original Adult Study: the Receiver included software version SW10050 Software 505 Adult Study: the Receiver included software version SW10505 Pediatric Studies (2 to 17 years) Original Pediatric Study: the Receiver included software version SW10050 Software 505 Pediatric Study: the Receiver included software version SW10505 The Dexcom G5 Mobile CGM System 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). 237 Dexcom G5 Mobile System User GuideTechnical Information Differences between the studies include the number of subjects enrolled, the number of Systems worn by each participant, the SMBG meter used, and the number of clinic days each subject participated in during the study. An overview of each study is provided here. The Original Adult Study enrolled 72 subjects, and the Software 505 Adult Study enrolled 51 subjects. All subjects had Type 1 or Type 2 diabetes mellitus, and required insulin or oral medication to manage their diabetes. In the Original Adult Study, 83% of subjects had Type 1 diabetes, and 17% of subjects had Type 2 diabetes. In the Software 505 Adult Study, 86% of subjects had Type 1 diabetes, and 14% of subjects had Type 2 diabetes. Both studies included subjects greater than 18 years of age. Subjects in both studies used the System for seven days. In the Original Adult Study, thirty-six subjects each wore 2 sensors; in the Software 505 Adult Study, all subjects wore 1 sensor only. Throughout the 7-day wear period, the sensor was calibrated with an average of 2 fingersticks per day (approximately once every 12 hours). In the Original Adult Study, subjects used the LifeScan OneTouch Ultra2 meter and in the Software 505 Adult Study, subjects used Bayers CONTOUR NEXT USB meter. In the Original Adult Study, all subjects were evaluated in a controlled clinic environment on all three clinic days: Day 1, Day 4, and Day 7 of the 7-day wear period. In the Software 505 Adult Study, subjects were evaluated in one of the three clinic days so there are fewer data samples than in the Original Adult Study. While using the System in the clinic, subjects had their blood glucose measured every 15 minutes with a reliable laboratory method, the Yellow 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 blood glucose 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. Overview of Pediatric Studies The System performance for children and adolescents was evaluated in two separate prospective clinical studies: the Original Pediatric Study (SW10050) and the Software 505 Pediatric Study
(SW10505). Differences between the studies include the number of subjects enrolled, the number of Systems worn by each participant, the SMBG meter used, the length of time subjects were evaluated in a controlled clinic environment and whether or not subjects ages 13-17 had their glucose levels intentionally manipulated during the study. An overview of each study is provided here. The Original Pediatric Study enrolled 176 subjects, with 16% of subjects younger than 6-years old, and the Software 505 Pediatric Study enrolled 79 subjects, with 20% of subjects younger than 6-years old. All subjects had Type 1 or Type 2 diabetes mellitus and required insulin or oral medication to manage their diabetes. In the Original Pediatric Study, about 99% of subjects had Type 1 diabetes and 1% had Type 2 diabetes. In the Software 505 Pediatric Study, all subjects had Type 1 diabetes. Sensors were inserted in either the abdomen or upper buttocks. Subjects in all studies used the System for seven days. In the Original Pediatric Study, all subjects wore 2 sensors; in the Software 505 Pediatric Study, all subjects wore 1 sensor only. Throughout 238 Dexcom G5 Mobile System User GuideTechnical Information the 7-day wear period, the sensors were calibrated with an average of 2 fingersticks per day
(approximately once every 12 hours), using self-monitoring blood glucose (SMBG) meter values. The Original Pediatric Study used the LifeScan OneTouch Verio IQ meter; the Software 505 Pediatric Study used Bayers CONTOUR NEXT USB meter. All subjects were evaluated in a controlled clinic environment on Day 1, Day 4 or Day 7 of the 7-day wear period. While using the System in the clinic, subjects provided at least two fingerstick measurements per hour, and 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. Readings from the System were reported every 5 minutes and paired with YSI values collected every 15 minutes in order to characterize how well the System readings agreed with laboratory standard blood glucose 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. 239 Dexcom G5 Mobile System User GuideTechnical Information Table 1-A. System Agreement to YSI within CGM Glucose Ranges (Adult) CGM Glucose Range1
(mg/dL) Study2 Number of Paired CGM-YSI Overall 40-60 61-80 81-180 181-300 301-350 351-400 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 9152 2263 512 120 781 226 3853 738 2784 798 775 229 447 152 Percent Within 15/15%
Percent Within 20/20%
Percent Within 30/30%
YSI 71%
86%
67%
89%
73%
91%
67%
84%
72%
86%
82%
86%
74%
80%
YSI 82%
93%
78%
94%
85%
96%
78%
92%
84%
93%
91%
94%
84%
92%
YSI 92%
98%
88%
98%
94%
99%
91%
98%
93%
98%
97%
98%
91%
97%
Percent Greater than 40/40%
YSI 3%
1%
6%
0%
2%
0%
3%
1%
4%
1%
2%
1%
5%
0%
1CGM readings are within 40-400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 240 Dexcom G5 Mobile System User GuideTechnical Information Table 1-B. System Agreement to YSI within CGM Glucose Ranges
(Pediatric) CGM Glucose Range1
(mg/dL) Study2 Number of Paired CGM-YSI Overall 40-60 61-80 81-180 181-300 301-350 351-400 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 2922 2262 19 86 76 142 1155 805 1380 957 206 209 86 63 Percent Within 15/15%
Percent Within 20/20%
Percent Within 30/30%
YSI 55%
81%
63%
54%
61%
77%
56%
78%
55%
89%
48%
81%
48%
64%
YSI 68%
91%
74%
74%
82%
82%
69%
88%
68%
96%
62%
91%
61%
81%
YSI 85%
96%
79%
91%
92%
90%
84%
97%
85%
99%
80%
94%
79%
83%
Percent Greater than 40/40%
YSI 7%
2%
21%
3%
4%
3%
6%
1%
7%
1%
11%
5%
12%
8%
1CGM readings are within 40-400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). Agreement Relative to YSI Agreement between the System and blood glucose values is characterized using paired System and YSI values. The System and YSI results were compared by pairing the YSI blood glucose value to a System glucose reading that occurred immediately after the YSI was collected. The agreement of the System to blood glucose value was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and greater than 40% of the YSI values. For readings less than or equal to 80 mg/dL the absolute difference in mg/dL between the two glucose results was calculated. For values greater than 80 mg/dL the absolute percent difference (%) from the YSI values was calculated. The percentages of total readings within 15 mg/dL or 15%, 20 mg/dL 241 Dexcom G5 Mobile System User GuideTechnical Information or 20%, 30 mg/dL or 30% or greater than 40 mg/dL or 40% are provided in Table 1-A and 1-B. The tables are categorized within CGM glucose ranges. When you see a CGM reading on your receiver, this table shows you how likely that reading matches your blood glucose level (measured by YSI in the study). For example, in the SW10505 Adult Study (Table 1-A), the total number of data pairs considered in the analysis was 2263. Of these, 93% of the System readings fall within 20 mg/dL of the YSI blood glucose values 80 mg/dL and within 20% of YSI blood glucose values > 80 mg/dL. 242 Dexcom G5 Mobile System User GuideTechnical Information Table 2-A. Number and Percentage of YSI Values When CGM Readings are LOW or HIGH (Adult) CGM Readings Study1 CGM-YSI Pairs
< 55
< 60
< 70
< 80 80 YSI mg/dL n 66 84 Original Cumulative Percent 42%
54%
n 11 16 123 79%
17 142 92%
18 Cumulative Percent 61%
89%
94%
100%
LOW Software 505 13 8%
0 0%
YSI mg/dL CGM Readings Study1 CGM-YSI Pairs
> 340
> 320
> 280
> 240 240 HIGH Original Software 505 n Cumulative Percent n Cumulative Percent 189 76%
40 220 89%
43 238 96%
45 246 99%
45 89%
96%
100%
100%
2 1%
0 0%
Total 155 18 Total 248 45 1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 243 Dexcom G5 Mobile System User GuideTechnical Information Table 2-B. Number and Percentage of YSI Values When CGM Readings are LOW or HIGH (Pediatric) YSI mg/dL CGM Readings Study1 CGM-YSI Pairs
< 55
< 60
< 70
< 80 80 LOW Original Software 505 n Cumulative Percent n Cumulative Percent 0 0%
3 0 0%
5 0 0%
10 0 0%
15 19%
31%
63%
94%
13 100%
1 6%
YSI mg/dL CGM Readings Study1 CGM-YSI Pairs
> 340
> 320
> 280
> 240 240 HIGH n 38 51 68 69 Original Cumulative Percent 54%
73%
97%
99%
Software 505 n 14 19 22 23 Cumulative Percent 58%
79%
92%
96%
1 1%
1 4%
Total 13 16 Total 70 24 1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). Agreement When CGM Reads LOW or HIGH The System reports glucose readings between 40 and 400 mg/dL. When the System determines the glucose reading is below 40 mg/dL, it displays LOW in the Receiver Status Box. When the Dexcom G5 Mobile System determines that the glucose level is above 400 mg/dL, it displays HIGH in the Receiver Status Box. Because the System does not display glucose values below 40 mg/dL or above 400 mg/dL, the comparisons to the actual blood glucose 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). 244 Dexcom G5 Mobile System User GuideTechnical Information For example, in the Software 505 Adult Study (Table 2-A), when the System displayed LOW (18 occasions), 100% (18 out of 18) of the YSI values were less than 80 mg/dL, and 94% (17 out of 18) of the YSI values were less than 70 mg/dL. When the System displayed HIGH (45 occasions), 100% (45 out of 45) of the YSI values were greater than 240 mg/dL, and 100% (45 out of 45) of the YSI values were greater than 280 mg/dL. 245 Dexcom G5 Mobile System User GuideTechnical Information Table 3-A. Concurrence of CGM Readings and YSI Values (Original Adult Study) CGM
(mg/dL)
< 40 40-60 61-80 81-120 121-160 161-200 201- 250 251- 300 301- 350 351- 400
> 400 Row Percentage of Matched Pairs in each CGM Glucose Range YSI (mg/dL)
< 40 40-
60 61-
80 81-
120 121-
160 161-
200 201-
250 251-
300 301-
350 351-
400
>
400 Number of Paired CGM-YSI 6% 48% 37% 7%
4% 49% 36% 11%
1%
1%
0% 22% 51% 24% 1%
0%
0%
0%
2% 17% 66% 13% 1%
0%
0%
0%
0%
1% 25% 60% 13% 2%
2% 28% 53% 16% 2%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
3% 21% 51% 21% 3%
0%
0%
0%
0%
4% 19% 49% 24% 3%
0%
0%
0%
3% 28% 51% 16% 1%
3% 10% 43% 38% 7%
1%
6% 21% 57% 15%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
155 512 781 1706 1492 1240 1181 1018 775 447 248 246 Dexcom G5 Mobile System User GuideTechnical Information Table 3-B. Concurrence of CGM Readings and YSI Values (Software 505 Adult Study) CGM
(mg/dL)
< 40 40-60 61-80 81-120 121-160 161-200 201- 250 251- 300 301- 350 351- 400
> 400 Row Percentage of Matched Pairs in each CGM Glucose Range YSI (mg/dL)
< 40 40-
60 61-
80 81-
120 121-
160 161-
200 201-
250 251-
300 301-
350 351-
400
>
400 Number of Paired CGM-YSI 6% 83% 11%
0%
2% 74% 22% 3%
0%
0%
0% 19% 68% 13% 0%
0% 19% 72% 8%
0%
0%
0%
1%
0% 17% 72% 11%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0% 25% 59% 16% 0%
0% 16% 70% 13% 1%
0%
0%
0%
0%
2% 16% 61% 14% 7%
0%
0%
0%
2% 28% 59% 10% 1%
0%
0%
4% 47% 45% 5%
0% 20% 38% 42%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
18 120 226 347 246 286 376 281 229 152 45 247 Dexcom G5 Mobile System User GuideTechnical Information Table 3-C. Concurrence of CGM Readings and YSI Values (Original Pediatric Study) CGM
(mg/dL)
< 40 40-60 61-80 81-120 121-160 161-200 201- 250 251- 300 301- 350 351- 400
> 400 Row Percentage of Matched Pairs in each CGM Glucose Range YSI (mg/dL)
< 40 40-
60 61-
80 81-
120 121-
160 161-
200 201-
250 251-
300 301-
350 351-
400
>
400 Number of Paired CGM-YSI 0%
0%
0% 54% 31% 15% 0%
0% 21% 58% 16% 5%
0% 21% 45% 30% 4%
0%
0%
1% 20% 66% 12% 1%
1% 36% 54% 7%
0%
0%
0%
1%
0%
0%
0%
0%
0%
1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
2%
0%
4% 40% 48% 6%
9% 44% 41% 5%
1%
0%
0%
0%
0%
2%
0%
0%
0%
7% 50% 36% 3%
2% 18% 59% 21% 0%
0%
0%
3% 28% 50% 16% 2%
1%
14% 41% 36% 7%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
13 19 76 338 511 596 658 432 206 86 70 248 Dexcom G5 Mobile System User GuideTechnical Information Table 3-D. Concurrence of CGM Readings and YSI Values (Software 505 Pediatric Study) Row Percentage of Matched Pairs in each CGM Glucose Range YSI (mg/dL)
< 40 40-
60 61-
80 81-
120 121-
160 161-
200 201-
250 251-
300 301-
350 351-
400
>
400 Number of Paired CGM-YSI CGM
(mg/dL)
< 40 40-60 61-80 81-120 121-160 161-200 201- 250 251- 300 301- 350 351- 400
> 400 0%
0%
0%
0%
0%
0%
0%
0%
0%
6% 25% 63% 6%
0% 33% 60% 6%
0%
1%
8% 64% 26% 2%
1% 15% 69% 13% 1%
0% 15% 66% 18% 1%
0%
0%
0%
1%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
1% 18% 66% 15% 0%
1% 17% 68% 14% 0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0%
0% 26% 58% 16% 0%
4% 40% 46% 9%
3% 14% 62% 21% 0%
4% 13% 29% 38% 17%
0%
0%
0%
0%
0%
0%
0%
0%
0%
16 86 142 314 313 355 444 336 209 63 24 0%
0%
0%
0%
0%
0%
Concurrence of System and Laboratory Reference Table 3-A (Original Adult Study), 3-B (Software 505 Adult Study), 3-C (Original Pediatric Study) and 3-D (Software 505 Pediatric Study) are categorized by ranges of CGM glucose readings. These tables describe, for each range of CGM glucose readings, what percentage of paired YSI values were in the same glucose range (shaded) or in glucose ranges above and below the paired CGM readings. For example, based on the Software 505 Adult Study, when CGM readings are within 81 to 120 mg/dL, you can expect your blood glucose levels are within 81 to 120 mg/dL 72% of time. 249 Dexcom G5 Mobile System User GuideTechnical Information Table 4-A. System Difference to YSI within CGM Glucose Ranges (Adult) CGM Glucose Range1
(mg/dL) Overall
*40-60
*61-80 81-180 181-300 301-350 351-400 Study2 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Number of Paired CGM-YSI Mean Percent Median Percent Difference Difference Mean Absolute Percent Median Absolute Percent Difference Difference 9152 2263 512 120 781 226 3853 738 2784 798 775 229 447 152 2.9%
2.5%
-10.0
-3.3
-2.4 0.8 4.8%
3.9%
2.1%
0.6%
3.8%
4.1%
10.4%
7.2%
1.7%
2.4%
-8.2
-2.1
-0.4 1.4 3.0%
4.1%
0.0%
0.4%
2.8%
3.4%
7.7%
6.3%
13.3%
9.0%
13.5 6.9 11.4 6.7 13.8%
9.6%
11.9%
8.0%
9.8%
8.0%
12.8%
9.2%
9.8%
7.0%
9.7 4.8 8.6 5.4 9.8%
8.2%
9.2%
6.1%
7.9%
5.8%
9.1%
7.2%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505).
*For CGM 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent differences (%). 250 Dexcom G5 Mobile System User GuideTechnical Information Table 4-B. System Difference to YSI within CGM Glucose Ranges
(Pediatric) CGM Glucose Range1
(mg/dL) Overall
*40-60
*61-80 81-180 181-300 301-350 351-400 Study2 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Number of Paired CGM-YSI Mean Percent Median Percent Difference Difference Mean Absolute Percent Median Absolute Percent Difference Difference 2922 2262 19 86 76 142 1155 805 1380 957 206 209 86 63 13.5%
11.6%
1.8%
-18.1
-15.3
-3.7
-4.8 11.9%
1.9%
14.8%
2.2%
19.2%
7.8%
18.5%
14.9%
1.2%
-9.1
-13.2
-2.3
-1.0 9.7%
0.7%
12.4%
1.0%
15.9%
6.5%
15.5%
11.6%
17.4%
10.4%
19.2 16.1 13.4 11.8 17.0%
10.6%
17.4%
8.1%
19.4%
11.0%
19.1%
15.2%
13.5%
7.9%
9.1 13.2 10.6 7.7 13.0%
8.1%
13.3%
6.5%
15.9%
7.9%
15.5%
11.6%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505).
*For CGM 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent differences (%). 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. 251 Dexcom G5 Mobile System User GuideTechnical Information In the example above, the System reading is less than the YSI value, so the percent difference reading is negative. The mean percent difference is the average of all positive and negative percent differences between the two devices; it tells you if the System reads higher or lower on average than the YSI within each glucose range. Another estimate used to show the accuracy of the System is the absolute percent difference. The absolute percent difference tells you the percent difference or distance between the System and YSI values, but does not tell you whether the System is reading, on average, higher or lower than the YSI laboratory standard. The mean absolute percent difference is the average distance (regardless if positive or negative) between System readings and YSI values. Accuracy measures in differences for both the Original Adult and Software 505 Adult Studies are summarized in Table 4-A. Accuracy measures in differences for both the Original Pediatric and Software 505 Pediatric Studies are summarized in Table 4-B. Table 4-A and 4-B are categorized within CGM glucose ranges. For example, in the Software 505 Adult Study (Table 4-A), overall, on average, the System reads 2.5% different (Mean Percent Difference) than the reference and 9.0% absolute different (Mean Absolute Difference) than the reference values. The Median Percent Difference shows that half of the time the System reads 2.4% or less than the YSI blood glucose values and the Median Absolute Percent Difference shows that half of the time the System reads about 7.0% or less than the YSI blood glucose values. 252 Dexcom G5 Mobile System User GuideTechnical Information Table 5-A. Hypoglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult) Hypoglycemia Alert Level
(mg/dL) 55 60 70 80 90 Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 True Alert Rate False Alert Rate Hypoglycemia Detection Rate Hypoglycemia Missed Detection Rate 50%
71%
64%
85%
79%
92%
87%
95%
90%
96%
50%
29%
36%
15%
21%
8%
13%
5%
10%
4%
71%
68%
75%
83%
83%
91%
86%
90%
89%
94%
29%
32%
25%
17%
17%
9%
14%
10%
11%
6%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 253 Dexcom G5 Mobile System User GuideTechnical Information Table 5-B. Hypoglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years) Hypoglycemia Alert Level
(mg/dL) 55 60 70 80 90 100 Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 True Alert Rate 0%
22%
11%
42%
47%
68%
55%
86%
69%
90%
75%
91%
False Alert Rate 100%
78%
89%
58%
53%
32%
45%
14%
31%
10%
25%
9%
Hypoglycemia Detection Rate Hypoglycemia Missed Detection Rate 0%
75%
25%
78%
50%
75%
55%
91%
62%
93%
62%
93%
100%
25%
75%
23%
50%
25%
45%
9%
38%
7%
38%
7%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 254 Dexcom G5 Mobile System User GuideTechnical Information Table 5-C. Hypoglycemia Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5 Years) Hypoglycemia Alert Level
(mg/dL) 55 60 70 80 90 100 Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 True Alert Rate False Alert Rate Hypoglycemia Detection Rate Hypoglycemia Missed Detection Rate 3%
25%
11%
20%
29%
20%
35%
61%
51%
78%
64%
82%
97%
75%
89%
80%
71%
80%
65%
39%
49%
22%
36%
18%
57%
100%
62%
100%
77%
100%
85%
100%
89%
100%
91%
100%
43%
0%
38%
0%
23%
0%
15%
0%
11%
0%
9%
0%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). Low and High Glucose Alerts 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 blood glucose 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. The Low Glucose Alert Estimates of how well the adjustable Low Glucose Alert performs are presented in Table 5-A, 5-B and 5-C. Table 5-A represents the hypoglycemia alert evaluation within 15 minutes of the YSI value in the adult studies. Table 5-B represents the alert evaluation within 15 minutes of the YSI value for a subset of the pediatric populationsubjects age 6 to 17 years who had YSI measurements every 15 minutes. 255 Dexcom G5 Mobile System User GuideTechnical Information Table 5-C represents the alert evaluation within 30 minutes of an SMBG reading for 2- to 5-year old subjects in the pediatric studies. Hypoglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the % of time the device alarmed when the blood glucose level was at or below the alert setting within 15 or 30 minutes before or after the device alarmed. The False Alert Rate is the % of time the device alarmed when the blood glucose level was above the alert setting within 15 or 30 minutes before or after the device alarmed. For example, if you set the Low Glucose Alert to 70 mg/dL and your alarm sounds, how often can you expect your blood sugar to actually be low? In the Software 505 Adult Study (Table 5-A), when your alarm sounds, you can expect your blood sugar to be below 70 mg/dL approximately 92% of the time and above 70 mg/dL approximately 8% of the time within the 15 minute period before or after your alarm sounds. 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 blood glucose level was at or below the alert setting and device alarmed within 15 or 30 minutes before or after the blood glucose was at or below the alert settings. The Hypoglycemia Missed Detection Rate is the % of time the blood glucose was at or below the alert setting, but the device did not alarm within 15 or 30 minutes before or after the blood glucose was at or below the alert setting. For example, if you set the Low Glucose alert to 70 mg/dL, how often will your alarm alert you if your blood glucose goes below 70 mg/dL? In the Software 505 Adult Study (Table 5-A), when your blood sugar goes below 70 mg/dL, you can expect your alarm to sound 91% of the time and not to sound approximately 9% of time within the 15 minute period before or after your blood sugar goes below 70 mg/dL. 256 Dexcom G5 Mobile System User GuideTechnical Information Table 6-A. Hyperglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult) Hyperglycemia Alert Level
(mg/dL) 120 140 180 200 220 240 300 Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 True Alert Rate False Alert Rate Hyperglycemia Detection Rate Hyperglycemia Missed Detection Rate 95%
98%
94%
97%
92%
97%
92%
96%
91%
94%
91%
93%
82%
86%
5%
2%
6%
3%
8%
3%
8%
4%
9%
6%
9%
7%
18%
14%
98%
100%
97%
99%
97%
99%
97%
98%
95%
98%
94%
95%
86%
90%
2%
0%
3%
1%
3%
1%
3%
2%
5%
2%
6%
5%
14%
10%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 257 Dexcom G5 Mobile System User GuideTechnical Information Table 6-B. Hyperglycemia Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Pediatric, Ages 6-17 Years) Hyperglycemia Alert Level
(mg/dL) 120 140 180 200 220 240 300 Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 True Alert Rate False Alert Rate Hyperglycemia Detection Rate Hyperglycemia Missed Detection Rate 91%
98%
87%
97%
75%
94%
71%
94%
67%
93%
62%
88%
43%
69%
9%
2%
13%
3%
25%
6%
29%
6%
33%
7%
38%
12%
57%
31%
98%
99%
99%
98%
99%
98%
98%
97%
97%
96%
96%
94%
93%
2%
1%
1%
2%
1%
2%
2%
3%
3%
4%
4%
6%
7%
84%
16%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 258 Dexcom G5 Mobile System User GuideTechnical Information Table 6-C. Hyperglycemia Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After (Pediatric, Ages 2-5 Years) True Alert Rate False Alert Rate Hyperglycemia Detection Rate Hyperglycemia Missed Detection Rate Hyperglycemia Alert Level
(mg/dL) 120 140 180 200 220 240 300 Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original 92%
97%
90%
98%
87%
99%
85%
98%
81%
Software 505 100%
Original Software 505 Original Software 505 80%
99%
71%
95%
8%
3%
10%
2%
13%
1%
15%
2%
19%
0%
20%
1%
29%
5%
98%
99%
98%
100%
96%
93%
96%
93%
95%
97%
95%
98%
90%
96%
2%
1%
2%
0%
4%
7%
4%
7%
5%
3%
5%
2%
10%
4%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 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 populationsubjects age 6 to 17 years who had YSI measurements every 15 minutes. Table 6-C represents the alert evaluation within 30 minutes of an SMBG reading for 2- to 5-year old subjects in the pediatric studies. Hyperglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the % of time the device alarmed when the blood glucose level was at or above the alert setting within 15 or 30 259 Dexcom G5 Mobile System User GuideTechnical Information minutes before or after the device alarmed. The False Alert Rate is the % of time the device alarmed when the blood glucose level was below the alert setting within 15 or 30 minutes before or after the device alarmed. For example, if you set the High Glucose alert to 200 mg/dL and your alarm sounds, how often can you expect your blood sugar to actually be high? In the Software 505 Adult Study (Table 6-A), when your alarm sounds, you can expect your blood sugar to be at or above 200 mg/dL approximately 96% of the time and not be above 200 mg/dL approximately 4% of the time within the 15 minute period before or after your alarm sounds. Hyperglycemia Detection Rate The Detection Rate shows how often the device recognizes and alerts you to an episode of hyperglycemia or how often it misses such an event. The Hyperglycemia Detection Rate is the % of time the blood glucose level was at or above the alert setting and the device alarmed within 15 or 30 minutes before or after the blood glucose was at or above the alert settings. The Hyperglycemia Missed Detection Rate is the % of time the blood glucose was at or above the alert setting, but the device did not alarm within 15 or 30 minutes before or after the blood glucose was at or above the alert setting. For example, if you set your High Glucose alert to 200 mg/dL, how often will your alarm alert you if your blood glucose 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. 260 Dexcom G5 Mobile System User GuideTechnical Information Table 7-A. Percentage of System Readings1 within YSI Values With Data Stratified in 2-Hour Increments After Calibration (Adult) Time from Calibration Study2 Number of Paired CGM-YSI 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8-10 hours 10-12 hours 12-14 hours Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 1929 469 1516 389 1547 383 1520 380 1555 347 1068 295 17 0 Percent Within 15/15%
Percent Within 20/20%
Percent Within 30/30%
YSI 78%
93%
69%
90%
69%
85%
68%
79%
71%
83%
65%
80%
65%
--
YSI 88%
97%
81%
97%
79%
91%
79%
90%
82%
92%
77%
90%
76%
--
YSI 96%
99%
91%
99%
91%
97%
92%
97%
92%
98%
91%
98%
82%
--
Percent Greater than 40/40%
YSI 2%
0%
4%
0%
5%
2%
3%
2%
4%
0%
4%
0%
12%
--
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 261 Dexcom G5 Mobile System User GuideTechnical Information Table 7-B. Percentage of System Readings1 within YSI Values with Data Stratified in 2-Hour Increments after Calibration (Pediatric) Time from Calibration Study2 Number of paired CGM-YSI 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8-10 hours 10-12 hours 12-14 hours Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 648 545 649 460 630 428 409 325 296 305 253 198 37 1 Percent within 15/15%
Percent within 20/20%
Percent within 30/30%
YSI 65%
83%
51%
72%
51%
77%
52%
88%
53%
86%
58%
89%
32%
YSI 75%
91%
67%
89%
61%
88%
68%
92%
69%
93%
74%
94%
38%
YSI 87%
97%
86%
96%
80%
95%
85%
94%
84%
97%
89%
98%
65%
100%
100%
100%
Percent greater than 40/40%
YSI 7%
1%
7%
2%
10%
2%
5%
3%
7%
1%
5%
0%
22%
100%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 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. Performance was estimated at each 2-hour interval and stratified by glucose values 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 in Table 7-A and 7-B. 262 Dexcom G5 Mobile System User GuideTechnical Information Table 8-A. Sensor Stability Relative to YSI (Accuracy Over Time1) - (Adult) Day of Wear Day 1 Day 4 Day 7 Study2 Original Software 505 Original Software 505 Original Software 505 Number of Paired CGM-
YSI 3023 680 3108 777 3021 806 Mean Absolute Percent Median Absolute Percent Percent Within 15/15%
Differences Differences YSI Percent Within 20/20%
YSI Percent Within 30/30%
YSI 16.7%
10.7%
11.4%
8.0%
11.9%
8.5%
13.2%
7.9%
8.2%
6.4%
8.9%
7.2%
59%
77%
77%
89%
76%
90%
71%
84%
87%
96%
87%
97%
86%
96%
95%
99%
95%
99%
Percent Greater than 40/40%
YSI 6%
2%
2%
0%
2%
0%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 263 Dexcom G5 Mobile System User GuideTechnical Information Table 8-B. Sensor Stability Relative to YSI (Accuracy Over Time1) -
(Pediatric, Ages 6-17 Years) Day of Wear Day 1 Day 4 Day 7 Study2 Original Software 505 Original Software 505 Original Software 505 Number of Paired CGM-
YSI 1016 740 810 795 1096 727 Mean Absolute Percent Median Absolute Percent Percent Within 15/15%
Differences Differences YSI Percent Within 20/20%
YSI Percent Within 30/30%
YSI 21.2%
12.7%
16.0%
8.1%
15.1%
10.4%
15.8%
8.5%
13.9%
6.7%
11.3%
8.4%
48%
75%
52%
89%
63%
80%
61%
83%
66%
97%
76%
91%
78%
91%
87%
100%
89%
98%
Percent Greater than 40/40%
YSI 15%
4%
3%
0%
4%
1%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 264 Dexcom G5 Mobile System User GuideTechnical Information Table 8-C. Sensor Stability Relative to SMBG (Accuracy Over Time1) -
(Pediatric, Ages 2-17 Years) Day of Wear Study2 Number of Paired CGM-
SMBG Mean Absolute Percent Median Absolute Percent Differences Differences Percent Within 15/15%
SMBG Percent Within 20/20%
SMBG Percent Within 30/30%
SMBG Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 3216 893 2148 436 1977 441 2830 850 1768 374 1704 410 2675 860 18.8%
14.8%
16.2%
13.2%
15.2%
13.8%
14.0%
10.7%
15.4%
11.4%
14.3%
12.3%
12.4%
11.3%
14.2%
10.7%
12.4%
10.4%
11.0%
11.3%
10.9%
8.5%
10.7%
8.7%
9.8%
9.2%
9.2%
8.6%
53%
64%
60%
69%
63%
66%
66%
79%
67%
74%
68%
72%
72%
79%
65%
79%
74%
81%
76%
77%
79%
91%
78%
86%
79%
80%
83%
90%
81%
91%
87%
95%
89%
91%
91%
97%
90%
96%
90%
93%
94%
96%
Percent Greater than 40/40%
SMBG 10%
5%
6%
3%
5%
2%
4%
1%
5%
1%
4%
2%
3%
2%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both 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. The average and median of the absolute percent differences are included in Table 8-A and 8-B showing consistent accuracy and sensor stability over the 7-day life of the sensor. 265 Dexcom G5 Mobile System User GuideTechnical Information Relative to SMBG (Pediatric Study) Performance was also estimated by calculating the percentage of system readings within various percentages of the SMBG values at each day of the sensor wear period (Table 8-C). The average and median of the absolute percent differences are included in the table. Precision of System Readings A subset of subjects wore two Systems at the same time. This was to look at how similarly two Systems function on the same subject (sensor precision). Precision was evaluated by comparing the glucose readings from the two Systems worn on the same subject at the same time. In the Original Adult Study, 36 subjects wore two Systems. Results showed that System readings from the two sensors generally agreed with each other within 9% (absolute percent difference) with a 7% coefficient of variation. In the Original Pediatric Study, all subjects wore two Systems. Results showed that System readings from the two sensors generally agreed with each other within 10%
(absolute percent difference) with a 7% coefficient of variation. Only one System was worn in the Software 505 Adult and Software 505 Pediatric Studies so precision data was not collected. Sensor Life 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. Ninety-eight percent (98%) of the sensors lasted until Day 7 (145-168 hours). There was 1 (2%) sensor that ended early, which lasted until day 5 of the sensor wear. In the Original Pediatric Study, 351 sensors were evaluated. Eighty-five percent (85%) of the sensors lasted until Day 7 (145-168 hours). In the Software 505 Pediatric Study, 77 sensors were evaluated. Ninety-four percent (94%) of the sensors lasted until Day 7 (145-168 hours). 266 Dexcom G5 Mobile System User GuideTechnical Information Table 9-A. Number of Readings Provided by Each Sensor Over 7-Days
(Adult)
% of Total Possible Readings Provided 0-25%
26-50%
51-75%
76-100%
Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Total Readings Provided
(Min-Max)
% of Systems Providing That Number of Readings 167-491 0 719-914 856-856 1267-1267 1253-1253 1811-1992 1497-1992 2%
0%
4%
2%
1%
2%
94%
96%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 267 Dexcom G5 Mobile System User GuideTechnical Information Table 9-B. Number of Readings Provided by Each Sensor Over 7-Days
(Pediatric)
% of Total Possible Readings Provided 0-25%
26-50%
51-75%
76-100%
Study1 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Total Readings Provided
(Min-Max)
% of Systems Providing That Number of Readings 103-427 60-223 569-954 877-891 1006-1484 1131-1342 1518-1992 1623-1990 3%
4%
3%
3%
9%
3%
86%
91%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 268 Dexcom G5 Mobile System User GuideTechnical Information Table 10-A. System Readings Within Wear Days (Adult) Statistic Study1 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Mean Median Standard Deviation Original Software 505 Original Software 505 Original Software 505 98%
98%
100%
99%
5%
3%
98%
99%
100%
100%
3%
2%
98%
98%
100%
100%
9%
8%
98%
98%
100%
100%
8%
11%
97%
96%
100%
100%
10%
15%
99%
99%
100%
100%
3%
2%
95%
97%
100%
100%
11%
13%
All Days2 97%
98%
100%
100%
8%
9%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 2A total of 108 sensors were included with the Original Study and 51 sensors were included with the Software 505 Study. 269 Dexcom G5 Mobile System User GuideTechnical Information Table 10-B. System Readings within Wear Days (Pediatric) Statistic Study1 Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 Mean Median Standard Deviation Original Software 505 Original Software 505 Original Software 505 97%
96%
99%
99%
6%
9%
96%
96%
99%
98%
10%
6%
96%
95%
99%
99%
9%
12%
95%
96%
99%
99%
12%
10%
94%
93%
99%
97%
14%
15%
94%
95%
99%
97%
14%
7%
92%
93%
98%
98%
17%
12%
All Days2 95%
95%
99%
98%
12%
11%
1Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 2A total of 108 sensors were included with the Original Study and 77 sensors were included with the Software 505 Study. Number of Readings Provided The System is capable of providing a reading up to every 5 minutes, or up to 288 readings per day. For a variety of reasons, the System may not display a glucose reading and readings are skipped. Table 9-A and 9-B estimate the number of readings you can expect to receive from the System over the entire 7-day period after calibration. Table 10-A and 10-B show the number of readings you can expect to receive from the System within each system wear day. For the Software 505 Adult Study (SW10505), 96% of Systems provided between 1,497 and 1,992 valid glucose readings (or more than 75% of the expected number of readings) as seen in Table 9-A. Adjusted within each system wear-day, the System in the Software 505 Adult Study provided an average of 98% of all expected glucose readings (288) as seen in Table 10-A. 270 Dexcom G5 Mobile System User GuideTechnical Information Table 11-A. System Agreement to SMBG Within CGM Glucose Ranges
(Adult) CGM Glucose Range1
(mg/dL) Overall 40-60 61-80 81-180 181-300 301-350 351-400 Study2 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Number of Paired CGM-SMBG Percent Within 15/15%
SMBG Percent Within 20/20%
SMBG Percent Within 30/30%
SMBG Percent Greater than 40/40%
SMBG 7508 2992 731 221 968 336 3141 1362 1960 826 450 161 258 86 69%
77%
75%
73%
78%
77%
65%
74%
68%
80%
77%
83%
75%
90%
81%
87%
84%
80%
86%
85%
78%
85%
81%
90%
88%
93%
85%
93%
94%
96%
92%
87%
95%
95%
93%
96%
94%
97%
98%
99%
95%
98%
2%
1%
4%
7%
1%
1%
2%
1%
3%
1%
1%
0%
2%
1%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 271 Dexcom G5 Mobile System User GuideTechnical Information Table 11-B. System Agreement to SMBG Within CGM Glucose Ranges
(Pediatric) CGM Glucose Range1
(mg/dL) Overall 40-60 61-80 81-180 181-300 301-350 351-400 Study2 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Number of Paired CGM-SMBG Percent Within 15/15%
SMBG Percent Within 20/20%
SMBG Percent Within 30/30%
SMBG Percent Greater than 40/40%
SMBG 16318 4264 487 240 1340 399 7084 1650 5627 1526 1176 319 604 130 64%
73%
44%
54%
59%
64%
62%
72%
69%
79%
65%
72%
58%
69%
76%
84%
55%
71%
70%
76%
74%
84%
80%
89%
77%
83%
72%
79%
89%
94%
68%
86%
85%
92%
90%
95%
90%
97%
90%
94%
86%
86%
5%
2%
19%
7%
7%
2%
5%
2%
5%
2%
4%
2%
6%
8%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505). 272 Dexcom G5 Mobile System User GuideTechnical Information Table 12-A. System Difference to SMBG Within CGM Glucose Ranges
(Adult) CGM Glucose Range1
(mg/dL) Overall
*40-60
*61-80 81-180 181-300 301-350 351-400 Study2 Number of Paired CGM-SMBG Mean Percent Median Percent Difference Difference Mean Absolute Percent Median Absolute Percent Difference Difference Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 7508 2992 731 221 968 336 3141 1362 1960 826 450 161 258 86
-0.4%
-2.6%
-9.3
-10.3
-1.0
-4.0 1.4%
-2.6%
-0.7%
-1.4%
-0.7%
-0.0%
5.0%
3.9%
-1.4%
-2.7%
-8.0
-6.0 1.0
-2.0 0.0%
-3.1%
-2.8%
-2.0%
-2.6%
0.0%
3.0%
3.2%
14.0%
11.3%
11.7 13.0 10.7 10.1 14.2%
11.4%
13.0%
9.5%
10.5%
8.3%
11.9%
8.1%
11.0%
8.6%
8.0 8.0 8.0 7.0 11.0%
8.9%
10.3%
7.4%
8.6%
6.0%
8.6%
6.7%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505).
*For CGM 80 mg/dL, the differences in mg/dL are included instead of percent differences (%). 273 Dexcom G5 Mobile System User GuideTechnical Information Table 12-B. System Difference to SMBG Within CGM Glucose Ranges
(Pediatric) CGM Glucose Range1
(mg/dL) Overall
*40-60
*61-80 81-180 181-300 301-350 351-400 Study2 Number of Paired CGM-SMBG Mean Percent Median Percent Difference Difference Mean Absolute Percent Median Absolute Percent Difference Difference Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 16318 4264 487 240 1340 399 7084 1650 5627 1526 1176 319 604 130 2.2%
-0.7%
-22.1
-15.9
-11.8
-7.8 1.1%
-1.2%
5.7%
1.7%
9.6%
6.7%
12.7%
12.0%
0.9%
-1.1%
-17.0
-14.0
-8.0
-6.0
-1.0%
-2.6%
3.4%
0.9%
7.2%
5.9%
10.2%
8.9%
15.3%
12.5%
23.9 16.9 17.0 13.7 15.4%
12.1%
13.5%
10.1%
14.2%
11.8%
16.1%
15.7%
11.1%
9.5%
18.0 14.0 11.0 10.0 11.4%
9.5%
9.5%
7.7%
10.4%
8.9%
11.9%
10.6%
1CGM readings are within 40 to 400 mg/dL, inclusive. 2Both sets of study data are presented and are labeled as Original (SW10050) or Software 505
(SW10505).
*For CGM 80 mg/dL, the differences in mg/dL are included instead of percent differences (%). Agreement and Accuracy Relative to SMBG Agreement between the System and blood glucose 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. These results characterize the performance subjects expect during real-time use of the System in their daily diabetes management when comparing the System readings to their home blood glucose meter results. For readings less than or equal to 80 mg/dL, the absolute difference in mg/dL between the two glucose results was calculated. For values greater than 80 mg/dL, the absolute percent difference (%) from the SMBG values was calculated. The percentages of total readings within 274 Dexcom G5 Mobile System User GuideTechnical Information 15 mg/dL or 15%, 20 mg/dL or 20%, 30 mg/dL or 30%, 40 mg/dL or 40% or greater than 40 mg/dL or 40% were then calculated. For example, if the System reads 100 mg/dL, it is between 81-180 mg/dL range and you can expect the System readings to be within 20% of the SMBG values 85% of the time for the Software 505 Adult Study, as seen in Table 11-A. Overall, the System in the Software 505 Adult Study reads, on average, 2.6% lower (Mean Percent Difference) than SMBG values and 11.3% absolute different (Mean Absolute Percent Difference) than the SMBG values. The Median Percent Difference shows that half of the time the System reads lower in 2.7% or less than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 8.6% or less different than SMBG values, as seen in Table 12-A. Adverse Events No serious adverse events or device-related serious adverse events occurred during the studies. Mild to moderate skin irritation, such as erythema or edema, occurred at the sensor needle insertion area or around the adhesive area. No infection, bruising, or bleeding occurred at the sensor needle insertion area or the adhesive area. 17.2 Product Specifications User is the single use operator in the home environment. 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. Do not touch the metal connectors on the bottom of the transmitter and other open connectors on the receiver, charging cable and charger. Sensor Product Specifications Glucose Range Sensor Life Calibration Calibration Range Storage Condition Sterilization 40-400 mg/dL Up to 7 days Commercially available blood glucose meter 40-400 mg/dL Temperature: 36 F-77 F Humidity: 15%-85% RH Sterile by radiation 275 Dexcom G5 Mobile System User GuideTechnical Information Transmitter Product Specifications Part Number Dimensions (Including Sensor Pod) Weight (Including Sensor Pod) 9438-06 Length: 1.5 inches Width: 0.9 inches Thickness: 0.5 inches 0.4 ounces Power Supply Silver oxide batteries (not replaceable) Operational Conditions Equilibrium temperature of less than 0.5 C (0.9 F) above ambient Ambient temperature is 10 C-42 C (50 F-107.6 F) Storage Conditions Operating Altitude Limited Warranty Moisture Protection Protection Against Electrical Shock Humidity: 10%-95% RH Temperature: 32 F-113 F Humidity: 10%-95% RH
-1300 feet to 13800 feet 3 months IP28: Protection against insertion of large objects and immersion in water for up to 8 feet for 24 hours Type BF applied part Transmitter Performance Characteristics Parameter TX/RX Frequencies Bandwidth Maximum Output Power Modulation Data Rate Data Communication Range Performance Characteristic 2.402-2.480 GHz 1.02 MHz 1.0 mW EIRP Gaussian Frequency-Shift Keying 1 Mbps 20 feet The Dexcom G5 Mobile CGM System is safe for use on U.S. commercial airlines. The Dexcom G5 Mobile CGM System is an M-PED with emission levels that meet RTCA/DO160, Section 21, Category M. Per FAA Advisory, Circular #91-21, 1B, dated 8/25/06, any M-PED that meets this standard in all 276 Dexcom G5 Mobile System User GuideTechnical Information modes may be used onboard the aircraft without any further testing by the operator. This device can withstand exposure to common electrostatic (ESD) and electromagnetic interference (EMI). Guidance and Manufacturers Declaration Electromagnetic Immunity The transmitter (P/N 9438-06) is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment. Transmitter Electromagnetic Immunity Specifications Immunity Test Electrostatic Discharge (ESD) IEC 61000-4-2 Power Frequency
(50/60 Hz) Magnetic Field IEC 61000-4-8 IEC 60601 Test Level Transmitter Compliance Level Electromagnetic Environment Guidance 8 kV Contact 15 kV Air 8 kV Contact 15 kV Air 30 A/m 30 A/m Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Receiver Product Specifications Part Number Reading Frequency Dimensions TX/RX Frequencies Bandwidth Maximum Output Power Modulation Data Rate MT22719 Every 5 minutes Length: 4.0 inches Width: 1.8 inches Thickness: 0.5 inches 2.402-2.480 GHz 1.22 MHz 2.5 mW EIRP Gaussian Frequency-Shift Keying 1 Mbps
(Continued on next page) 277 Dexcom G5 Mobile System User GuideTechnical Information Weight Receiver Input Power Supply Communication Range Memory Storage Re-Chargeable Battery Use Charging Time Storage/Operating Conditions Operating Altitude Medium Priority Alarm Audible Output Moisture Protection Limited Warranty Control Classification
(Continued from previous page) 2.4 ounces 5V DC, 1A MT21255 20 feet 30 days of glucose data 7 days of tech support data 3 days 3 hours wall outlet The device behaves normally while being charged Do not hold the receiver while charging for over a minute There are no risks to connecting any part of the system to an MSO (Multiple Socket Outlet) Temperature: 32 F-104 F Humidity: 15%-95% RH, (Storage 10%-95% RH)
-1300 feet to 13800 feet 50 dBa at 1 meter IP22: Vertically falling drops Protection against insertion of large objects and dripping water 1 year Class II equipment No cleaning methods are recommended or tested for the receiver. The warranty life of the receiver is 1 year. The service life for the accessories is noted to be up to one year. If you have difficulty reading your receiver in bright sunlight, you may need to seek a shady location. Do not connect the receiver to any equipment not specified in IFU. Guidance and Manufacturers Declaration Electromagnetic Immunity 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. 278 Dexcom G5 Mobile System User GuideTechnical Information Receiver Electromagnetic Immunity Specifications Immunity Test Electrostatic Discharge (ESD) IEC 61000-4-2 Electrical Fast Transient/Burst IEC 61000-4-4 Surge IEC 61000-4-5 Surge IEC 61000-4-5 Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000-4-11 IEC 60601-1-11 Power Frequency
(50/60 Hz) Magnetic Field IEC 61000-4-8 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. If floors are covered with synthetic material, the relative humidity should be at least 30%. 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines Not applicable Mains power quality should be that of a typical commercial or hospital environment. 1 kV line(s) to line(s) 2 kV line(s) to earth 1 kV line(s) to line(s) Not applicable 1 kV line(s) to line(s) 2 kV line(s) to earth 1 kV line(s) to line(s) Not applicable Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. 0% UT for 1 cycle 0% UT for 1 cycle 0% UT for 0.5 cycle at 8 phase angles 0% UT for 0.5 cycle at 8 phase angles 70% UT (30% dip in Ut) for 25 cycles 70% UT (30% dip in Ut) for 25 cycles 0% UT for 250 cycles 0% UT for 250 cycles 30 A/m 30 A/m Mains power quality should be that of a typical commercial or hospital environment. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NOTE: UT is the a.c. mains voltage prior to application of the test level. Guidance and Manufacturers 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. 279 Dexcom G5 Mobile System User GuideTechnical Information System Electromagnetic Immunity Specifications Immunity Test IEC 60601 Test Level Transmitter Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000-4-6
(Receiver only) 3 Vrms 150 kHz to 80 MHz 6 Vrms Radiated RF IEC 61000-4-3 10 V/m at 80 MHz to 2700 MHz (AM Modulation) 10 V/m Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Recommended Separation Distance d = 1.2 P 150 kHz to 80 MHz d = 1.2 P 80 MHz to 800 MHz d = 2.3 P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. 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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Dexcom G5 MOBILE System is used exceeds the applicable RF compliance level above, the Dexcom G5 MOBILE System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Dexcom G5 MOBILE System. b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. 280 Dexcom G5 Mobile System User GuideTechnical Information Guidance and Manufacturers Declaration Electromagnetic Emissions 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. Electromagnetic Emissions Specifications Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 RF Emissions CISPR 11 Group 1 Class B The Dexcom G5 Mobile System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Dexcom G5 Mobile System is suitable for use in all establishments including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 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. The customer or the user of the receiver can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the receiver as recommended in the next table, according to the maximum output power of the communications equipment. Portable and mobile RF equipment include: baby monitors, Bluetooth wireless headsets, wireless routers, microwave ovens, laptops with internal Wi-Fi adapters, GSM cell phones, RFID scanners and hand-held security metal detector often used by security screeners. Minimum Recommended Distance Between Other RF Transmitters and the Dexcom Transmitter/Receiver Rated Maximum Output Power of Transmitter (W) 0.01 Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2 P 0.12 d = 1.2 P 0.12 d = 2.3 P 0.23
(Continued on next page) 281 Dexcom G5 Mobile System User GuideTechnical Information (Continued from previous page) Rated Maximum Output Power of Transmitter (W) Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.1 1 10 100 0.38 1.2 3.8 12 0.38 1.2 3.8 12 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in feet can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. USB Charging/Download Cable* Specifications Part Number Input/Output Type Length MT20655 5V DC, 1A USB A to USB micro B 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 unplugging charger from wall. Power Supply/Charger Specifications Part Number Class Input DC Output MT21255 II AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100 Vac 5V DC, 1A (5.0 Watts) 282 Dexcom G5 Mobile System User GuideTechnical Information 17.3 FCC Requirements The transmitter and receiver covered by this user guide have been certified under FCC ID:
G5 Mobile Transmitter: PH29715 G5 Mobile Receiver: PH29496 Although the transmitter and receiver have been approved by the Federal Communications Commission, there is no guarantee that they will not receive interference or that any particular transmission from either device will be free from interference. Compliance Statement (Part 15.19) This device complies with Part 15 of the FCC Rules. 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 users authority to operate the equipment. No modification of the equipment is allowed as it could create an unsafe condition. FCC Interference Statement (Part 15.105 (b)) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:
1. Reorient or relocate the receiving antenna. 2. 3. Connect the equipment into an outlet on a circuit different from that to which the receiver Increase the separation between the equipment and receiver. is connected. 4. Consult the dealer or an experienced radio/TV technician for help. This portable transmitter with its antenna complies with FCC/IC RF exposure limits for general population/uncontrolled exposure. 283 Dexcom G5 Mobile System User GuideTechnical Information Page intentionally left blank 284 Dexcom G5 Mobile System User GuideTechnical Information Chapter 18 Everything Else G5:
Troubleshooting 18.1 Introduction Sensor pod not sticking? Prompt wont go away? Not getting your sensor glucose readings?
Dont 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 prompts, and others dont. When more detailed answers or preventative measures are in a chapter, youll get a brief explanation here, and then get directed to the applicable chapter and section. After looking at the troubleshooting chapter, are you still not sure what to do? Or maybe your problem is hardware (e.g., receiver or transmitter failure). If your problem is not found here, follow the steps listed on your app screen, or call Technical Support. Please call the Dexcom Technical Support Team, 24/7, toll free at 1.877.339.2664 or toll at 1.858.200.0200 if any of these errors continue and the instructions dont resolve the issue. 18.2 Safety Statements Following are the Safety Statements for the Troubleshooting chapter. WARNING Do: Calibrate at least once every 12 hours. Why: Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings. Consequences: Missing severe low (hypoglycemia) or high (hyperglycemia) Alarm or Alerts. 285 Dexcom G5 Mobile System User GuideTroubleshooting PRECAUTION Do: Enter the exact BG value displayed on your BG meter within five minutes of a carefully performed fingerstick measurement. Why: Entering the wrong blood glucose values, or waiting more than five minutes before entry, might affect sensor accuracy. Consequences: You may miss a severe low or high glucose events. PRECAUTION Dont: Never prevent communication between transmitter and display devices. Do: Keep smart device and receiver within 20 feet of transmitter and away from obstructions. Why: If your transmitter display device(s) are more than 20 feet apart or are separated by an obstruction, they might not communicate. Types of obstruction differ and not all types have been tested. Obstructions can include water, walls, metal, etc. Water (e.g., swimming, surfing, bathing, etc.) can severely limit communication range. Consequences: Missing severe low or high Alarm or Alerts. 286 Dexcom G5 Mobile System User GuideTroubleshooting 18.3 Troubleshooting No Alarm/Alerts Device What you see Problem What you do Smart Device:
In App Receiver Not receiving Alerts See Chapter 11. Check Alarm/Alerts, sound and/or vibrations for notifications are on. Check your smart device is not on mute (if applicable).
(Continued on next page) 287 Dexcom G5 Mobile System User GuideTroubleshooting Sensor Glucose Readings Device What you see Problem What you do BG Meter Smart Device:
In App Receiver Sensor readings and BG meter glucose values often dont show the same
(Continued on next page) See Chapter 7. Differences are not uncommon. Readings from different body fluids reflect different numbers:
Meter - from blood Sensor - from interstitial fluid 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). Outside of 20/20 rule:
Calibrate again. 288 Dexcom G5 Mobile System User GuideTroubleshooting Device What you see Problem What you do
(Continued from previous page) Smart Device:
In App Receiver Smart Device:
In App Receiver Not getting sensor glucose readings Not getting sensor glucose readings See Chapter 9. Dont calibrate. Wait for more prompts. System may correct problem itself and continue to provide sensor glucose readings. 3 hours since last sensor reading: call Technical Support (see Section 16.1). See Chapter 9. Wait System will often resolve itself. If this continues for an extended period of time, call Technical Support to report error (see Section 16.1).
(Continued on next page) 289 Dexcom G5 Mobile System User GuideTroubleshooting Device What you see Problem What you do
(Continued from previous page) Smart Device:
In App Receiver Smart Device:
In App Receiver System display device and transmitter not communicating See Chapter 9. Dont calibrate. Wait 10 minutes. Move display device and transmitter within 20 feet of each other without obstruction. Wait another 10 minutes. App (if not resolved):
1. Go to Settings. 2. Tap Bluetooth. 3. Turn Bluetooth Off and On. No sensor glucose readings See Chapter 7. Wait up to 2 hours. System is counting down to when you do your initial calibration. 290 Dexcom G5 Mobile System User GuideTroubleshooting Applicator Picture Problem What you do Safety lock stuck See Chapter 6. Pull safety lock straight out:
Away from your body Follow direction of safety lock Up Arrow Collar wont pull up See Chapter 6. Use force when pulling the collar up. Check white plunger is completely downflush to the applicator barrel. Cant remove transmitter latch See Chapter 6. Dont pull it straight off. Hold sensor pod with one hand. Twist transmitter latch with other hand to break transmitter latch off. Sensor pod wont stick See Chapter 6. Put medical tape over sensor pods white adhesive patch (e.g., Blenderm). Dont place tape over the transmitter. 291 Dexcom G5 Mobile System User GuideTroubleshooting Hardware Error Device What you see Problem What you do Receiver Receiver Receiver Wont turn on:
Battery dead After full charge session:
Wont turn on See Chapter 4. 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. Insert end of paper clip into small circular hole on receivers back. Push down on paper clip. Receiver will vibrate. Processing screen appears. Charge receiver. Receiver Low Battery See Chapter 4. Charge receiver.
(Continued on next page) 292 Dexcom G5 Mobile System User GuideTroubleshooting Device What you see Problem What you do
(Continued from previous page) Receiver Corrupted database Receiver Smart Device:
In App System Recovery No Bluetooth See Chapter 16. Write down error code. Contact Dexcom Technical Support (see Section 16.1). Check BG value using BG meter. Prompt: Vibrates one time for four seconds and four beeps. See Chapter 16. Do nothing. Receiver is able to continue to work and recover from an error. App: Tap OK to clear Alert. Receiver: Press Select to clear Alert. See Chapter 5. Go to smart devices Settings. Make sure Bluetooth is On. If problem persists, please contact devices manufacturer. 293 Dexcom G5 Mobile System User GuideTroubleshooting Calibration Error Device What you see Problem What you do BG Meter Smart Device:
In App Receiver System will not accept calibration if outside of the 40-400 mg/dL range System didnt accept recent calibration (see Sensor Glucose Readings troubleshooting for a possible reason) No sensor glucose readings will be displayed until error is resolved See Chapter 7. Wait until your glucose is between 40-400 mg/dL. Calibrate only when your BG meter values are between 40-400 mg/dL. See Chapter 7. Wait 15 minutes. Enter 1 calibration. If error screen still appears enter 1 more BG meter value. Wait 15 minutes. If no sensor glucose readings appear on the display, the sensor needs to be replaced. Call Technical Support to report error (see Section 16.1). App:
Follow same instructions. Tap question mark to get more information.
(Continued on next page) 294 Dexcom G5 Mobile System User GuideTroubleshooting Device What you see Problem What you do
(Continued from previous page) Smart Device:
In App Receiver System didnt accept recent calibration See Chapter 7. Wait 15 minutes. Enter 1 BG meter value. Wait 15 more minutes. If error screen still appears enter 1 more BG meter value. Wait 15 minutes. 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. 295 Dexcom G5 Mobile System User GuideTroubleshooting Transmitter Error:
Device What you see Problem What you do Smart Device:
In App Receiver Smart Device:
In App Receiver Transmitter not working Sensor session automatically stopped No sensor glucose readings displayed Pairing Failed
(Continued on next page) See Chapter 16. Contact Technical Support to report issue (Section 16.1). Start checking BG value using BG meter. App:
Tap OK to clear Alert. Receiver:
Press Select to clear. Will not re-alert once cleared. Order new transmitter. See Chapter 6. Check Transmitter SN in display device is correct. If wrong:
Stop sensor session. Re-Enter correct transmitter SN. App:
Menu > Trans SN > Enter correct SN Receiver:
Settings > Trans SN > Enter correct SN If correct:
Call Tech Support (see Chapter 16). 296 Dexcom G5 Mobile System User GuideTroubleshooting Device What you see Problem What you do
(Continued from previous page) Smart Device:
In App Receiver Transmitter Low Battery See Chapter 16. App:
Tap OK to clear Receiver:
Press Select to clear. Will not re-alert once cleared. Order new transmitter. 297 Dexcom G5 Mobile System User GuideTroubleshooting Page intentionally left blank 298 Dexcom G5 Mobile System User GuideTroubleshooting Chapter 19 Everything Else G5:
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 G5 Mobile 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. Use By Date Caution Batch/Lot Number REF Part/Catalog Number Date of Manufacture STERILE R Sterile by Radiation Do Not Reuse Temperature Limitation SN Serial Number Class II Equipment Alternating Current
(Continued on next page) IP28: Protection Against Insertion of Large Objects and Immersion in Water IP22: Protection Against Insertion of Large Objects and Dripping Water Direct Current 299 Dexcom G5 Mobile System User GuideSymbols on Package Labels (Continued from previous page) Type BF Applied Part EC REP Authorized Representative in the European Community Manufacturer Non-Ionizing Radiation Humidity Limitation Marking Certifies Device Meets European Council Directive 93/42/EEC European Union WEEE Directive 2012/19/EU Do Not Use if Package is Damaged Electrical Equipment Designed Primarily for Indoor Use Ship By Date Input Keep Dry Refer to Instruction Manual/Booklet Prescription Required MR Unsafe Bluetooth 300 Dexcom G5 Mobile System User GuideSymbols on Package Labels Dexcom ShareSHARING IS CARING Page intentionally left blank Chapter 20 Sharing Is Caring:
Dexcom Share 20.1 Learning About Dexcom Share Glossary Airplane Mode Application or App App Store Blood Glucose Meter BG Value Bluetooth Default Delay Dexcom Share Cloud Dexcom Follow App Dexcom G5 Mobile/G4 PLATINUM Sensor A setting on a smart device where wireless features are disabled in order to comply with airline regulations. A software program, such as the Dexcom G5 Mobile App and the Dexcom Follow App, designed to run on a smart device. Internet store for downloading applications to a smart device. A device used to measure how much glucose is in the blood. The measurement of glucose in the blood. Bluetooth wireless technology allows devices to wirelessly communicate with each other. A manufacturers preset option for a device setting. Amount of set time that passes before a notification is sent to a Follower. A secure online storage server where Dexcom Share feature information is stored and then shared with Followers. Gets the Sharers glucose information and prompt data from the Dexcom Share Cloud. The Dexcom G5 Mobile System part that includes an applicator and sensor wire.
(Continued on next page) 303 Dexcom G5 Mobile System User GuideSharing Is Caring (Continued from previous page) Dexcom G5 Mobile System Dexcom G5 Mobile Transmitter Dexcom G5 Mobile App Dexcom Share CGM system made of a sensor, transmitter, and smart device/
receiver. The Dexcom G5 Mobile System part that wirelessly sends glucose information to the Dexcom G5 Mobile App. Receives glucose information from the Dexcom G5 Mobile Transmitter. Sends glucose information to the Dexcom Cloud using an Internet connection. Secondary notification using the following parts:
Dexcom G5 Mobile System Bluetooth wireless technology Sharers smart device Dexcom G5 Mobile App Internet Followers smart device Dexcom Follow App Do Not Disturb Follower Follow Dashboard Followers Smart Device Hyperglycemia 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). A person that gets the Sharers shared information in the Dexcom Follow App. On the Dexcom Follow App, the Follow Dashboard shows the glucose information of up to five (5) Sharers. Runs the Dexcom Follow App. High BG. Same as high. The default high alert in the Dexcom G5 Mobile CGM System is set to 200 mg/dL. Consult your healthcare professional to determine the appropriate hyperglycemic setting for you.
(Continued on next page) 304 Dexcom G5 Mobile System User GuideSharing Is Caring Hypoglycemia Invite/Follow Invitation Email Jailbroken mg/dL Mobile Data Connections No More Data prompt Not Sharing Obstruction Profile Prompt Range
(Continued from previous page) Low BG. Same as low. The default low alert the Dexcom G5 Mobile CGM System is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemic setting for you. An email request for a person to download the Dexcom Follow App and get the Sharers shared information. The removal of limitations set by the manufacturer on a smart device. Do not use jailbroken smart devices with Dexcom Share. Milligrams per deciliter. The standard unit of measure for sensor glucose information in the United States. Cellular networks, such as 3G, 4G and LTE, used by a smart device to access the Internet. Prompts the Follower when the Sharer is unable to share glucose information. When the Sharer chooses to temporarily not share glucose data with the Follower. An object that stops the wireless communication between devices, such as wall thickness or radio waves. Located in Follow Dashboard and displays the Sharers glucose information, trend arrow and profile picture. A visual message that appears on the screen of the Followers smart device. Prompt may also include a sound, depending on the smart devices settings. Maximum distance two devices can communicate wirelessly without obstruction.
(Continued on next page) 305 Dexcom G5 Mobile System User GuideSharing Is Caring Real-Time CGM Repeat Sensor Glucose Reading Sharer Sharing Simultaneous Voice and Data Smart Device Standard Home Glucose Monitoring Trend Arrow Trend Graph
(Continued from previous page) Data the Sharer receives on the Dexcom G5 Mobile App. Although your Dexcom Follow App might be similar to what you see on your app, it cannot be considered real-time because there are layers of communication between the Dexcom G5 Mobile App and the Dexcom Follow App. Amount of time the Follower chooses before they wish to receive a repeated notification. A glucose measurement taken by the Dexcom G5 Mobile System. The person who uses the Dexcom G5 Mobile System. The act of electronically transmitting glucose information from the Sharers smart device to the Followers smart device. The ability to make a phone call and access the Internet on the same cellular connection at the same time. A smart device is a cordless electronic device (unless charging), mobile (easily transportable), connected (via Wi-Fi, 3G, 4G, etc.) that can operate the Dexcom G5 Mobile App or the Dexcom Follow App. Examples of smart devices are smartphones or tablets. For a list of compatible smart devices, see dexcom.com/compatibility. Self-monitoring of BG using blood taken from the finger and a BG meter. The arrow next to the Sharers glucose value, located on the Sharers profile on the Dexcom Follow App. This is the same trend arrow that is found on the Dexcom G5 Mobile Receiver. Displays the pattern of the Sharers glucose information.
(Continued on next page) 306 Dexcom G5 Mobile System User GuideSharing Is Caring (Continued from previous page) Wi-Fi or Wireless Internet A wireless technology that allows electronic devices access to 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 Dexcom G5 Mobile App. It allows for remote monitoring from one person, the Sharer, of Dexcom G5 Mobile CGM data to another person, the Follower. Dexcom Share includes:
Dexcom G5 Mobile CGM System Sharers smart device Dexcom G5 Mobile App Internet connection Followers smart device Dexcom Follow App You cannot use the Share feature with Dexcom G5 Mobile Receiver. Once the Sharer activates the Share feature in their Dexcom G5 Mobile App, the smart device transfers sensor glucose readings to the Dexcom Share Cloud using either Wi-Fi or a cellular data plan. Then, the sensor glucose readings are sent from the Dexcom Share Cloud to the Followers smart device using Wi-Fi or the Followers cellular data plan. Figure 10. Sharing The Sharer must be within 20 feet of their smart device in order to send data to their Follower or it will not work. 307 Dexcom G5 Mobile System User GuideSharing Is Caring Dexcom Share Parts Sharers smart device*1 Followers smart device*1 Dexcom G5 Mobile App Dexcom Follow App Dexcom G5 Mobile Transmitter*
Dexcom G5 Mobile/G4 PLATINUM Sensor*
Internet/Wi-Fi or mobile data service/3G/4G/LTE*
Bluetooth
*Must be purchased separately. 1A list of compatible devices can be found at dexcom.com/compatibility. 308 Dexcom G5 Mobile System User GuideSharing Is Caring Conditions Affecting Use Once sharing is active, make sure the Shares and Followers smart device settings are not altered. Make sure the Sharers and Followers smart devices have:
Enough battery power to maintain sharing Sharers smart device has Internet connection Notifications turned on. If turned off, Follower wont receive any notifications Followers smart device has an Internet connection Dexcom recommends charging the smart device when sharing. 20.3 Risks and Benefits Risks Dexcom Share is a feature of the Dexcom G5 Mobile Continuous Glucose Monitoring
(CGM) System. The main risks involved with using the feature Dexcom Share are based on misunderstanding its purpose. Remember that the Dexcom Share in the Dexcom G5 Mobile CGM System is a secondary notification feature, not a real-time remote monitoring system. With using the Dexcom Share feature, there are 3 distinct parts of glucose monitoring:
1. Blood glucose meter - use this to make any treatment decisions. 2. Dexcom G5 Mobile CGM System - use the Dexcom G5 Mobile CGM System to complement, but not replace, information obtained from the blood glucose meter. It detects glucose trends and tracks glucose patterns. 3. Dexcom Share - this is an optional add-on to the Dexcom G5 Mobile CGM System that can share glucose information and notifications with up to five (5) other people. Shared sensor glucose readings and information can add another level of awareness. Using the wrong glucose information for treatment decisions could lead to low or high glucose. Blood glucose values from a blood glucose meter may differ from the information displayed on Dexcom Follow App. All treatment decisions should be made using a blood glucose value from your meter, not the glucose information displayed on the Dexcom Follow App. Followers who are concerned by notifications on the Dexcom Follow App should contact the patients and remind them to check their blood glucose with a blood glucose meter 309 Dexcom G5 Mobile System User GuideSharing Is Caring 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. Any problems with smart device(s), Bluetooth, wireless Internet connection, mobile data connection, Dexcom Share Cloud or not being in the communication range could cause data to not be shared with the Follower. In addition, if the Delay setting is too long, the Follower might not be aware of glucose level changes in a reasonable time. Therefore, the Dexcom Share feature should be used only to give a secondary level of awareness and should not be expected to always communicate and transfer sensor glucose readings and information. Benefits Patients usually respond when their continuous glucose monitoring (CGM) systems alert them. However, experts advise that an additional CGM alert to another person may be helpful in increasing the detection of low glucose or high glucose values, especially at night. The Dexcom Share feature enables this additional awareness, even when the Sharer and Follower are not in the same place. The Dexcom Share feature may provide improved quality of life and greater peace of mind to patients, their caregivers and their support team by allowing the Dexcom G5 Mobile Continuous Glucose Monitoring System Alerts, Alarms and trend graphs to be checked remotely. 20.4 Safety Statement Intended Use The purpose of Dexcom Share Direct Secondary Displays is to notify another person, the Follower, of the patients Dexcom Continuous Glucose Monitoring (CGM) System sensor glucose information. The Secondary Displays is intended for providing secondary notification of a continuous glucose monitoring system and does not replace real time continuous glucose monitoring
(Dexcom G5 Mobile System) or standard home blood glucose monitoring. The Dexcom Share Direct Secondary Displays is not intended to modify or analyze data received from the continuous glucose monitor system. Nor is it intended to instruct, or to transmit information to the continuous glucose monitor system. 310 Dexcom G5 Mobile System User GuideSharing Is Caring 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. The Dexcom Share Direct Secondary Displays is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system. Important User Information Please review the indications, contraindications, warnings, precautions, cautions and other important information in the Dexcom G5 Mobile System User Guide. Dexcom Share is a feature of the Dexcom G5 Mobile System. If you do not have the Dexcom G5 Mobile System User Guide, you can view it on dexcom.com or call 1.877.339.2664 to request a copy. Availability hours: Monday-Friday, 6am-6pm PST. Please contact your healthcare professional during hours the line is unavailable. Contraindications Do not bring the smart device (e.g., mobile phone, tablet computer) into a room containing medical equipment such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or diathermy. These smart devices have not been tested with this equipment. Exposure to these types of equipment could heat and damage the smart devices so that they are unable to send or receive glucose information. Warnings Dosing decisions should not be made based on this device. The user should follow instructions on the continuous glucose monitoring system. This device is not intended to replace self-monitoring practices advised by a physician. Dexcom Share does not work alone. Dexcom Share does not replace the Dexcom G5 Mobile System 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 blood glucose meter. Always use the values from a blood glucose meter for treatment decisions. Blood glucose values may differ from the sensor glucose information. Using the sensor glucose information for treatment decisions could lead to low or high blood glucose values. 311 Dexcom G5 Mobile System User GuideSharing Is Caring Precautions Do not use Dexcom Share as the main source of CGM glucose trend information. Use the Dexcom G5 Mobile Receiver as the main device to track sensor glucose information, notifications and alarms. At times, the patient will be unable to share data using Dexcom Share, and the Follower might miss helping the patient in the event of low or high blood glucose values. Do not rely solely on the Follower to alert the patient of low or high glucose events or other important information. At times, the Follower may not receive data, and the patient will not be notified of this fact. When using Dexcom Share, make sure Share is turned On. If not, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values. If the patients smart device does not have a connection or loses the connection, the patient will be unable to share data, and the Follower might miss helping the patient in the event of low or high blood glucose values. Do not use Dexcom Share unless both the patients and Followers smart devices have active Internet connections in order to share data. If either the patient or the Follower does not have a connection, loses their connection, turns off the connection (Airplane Mode) or if the smart device is in Do Not Disturb mode, the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values. To check this, make sure that the Followers smart device can receive text messages. Follow notifications and text messages work by a similar process. Make sure the patients and Followers smart devices have charged batteries or are connected to electrical outlets. If the smart device shuts down due to 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 blood glucose values. If the patients smart device is powered off or restarted, make sure the Dexcom G5 Mobile App is reopened after the smart device is turned back on in order to resume sharing. If the G5 Mobile 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 blood glucose values. Do not turn off sounds in the Followers smart device at any time that he or she wants Follow notifications to be heard. The smart device settings override the Dexcom Follow App, and all notifications will be silent even if the Follower has selected a Dexcom Follow App notification sound. If the smart device has a vibrate feature and vibrate is On, the Dexcom Follow App notifications will only vibrate. 312 Dexcom G5 Mobile System User GuideSharing Is Caring Check the delay settings on the patients smart device to make sure they are not too long. The Follower will not receive notifications until after the time period in the delay has passed, and the Follower might miss helping the patient in the event of low or high blood glucose values if the delay is too long. The patient should not choose to Not Share with the Follower at any time when he or she wants the Follower to get notifications. During the time the patient chooses to Not Share, the Follower will not receive notifications and might miss helping the patient in the event of low or high blood glucose values. Check the Dexcom Follow Apps trend graph if the Followers smart device has been off or if there is no data connection (e.g., Internet/Wi-Fi or mobile data service/3G/4G/LTE is lost, connection is turned off in Airplane Mode, or smart device touch is placed in Do Not Disturb mode). When the smart device is turned back on, the Follower will only receive the most recent notification and might miss helping the patient in the event of prior low or high blood glucose values. Sharers and Followers should check whether their cellular service carriers support voice and data at the same time (simultaneous voice and data). If their carriers do not support simultaneous voice and data, the Dexcom G5 Mobile App may not be able to share glucose readings and the Dexcom Follow App may not be able to receive notifications or glucose readings during phone calls. Dexcom Share will resume sharing after the phone call has ended, and the Follower will receive any waiting notifications after the phone call has ended. 20.5 Setting up Dexcom Share Dexcom Share Description What Dexcom Share does:
Connects your smart device with your Followers smart device via either a Wi-Fi or mobile data connection (connect to Wi-Fi through a secured network to maintain data security) Invites and sends Followers your setting recommendations Displays the status of your smart device, and the Dexcom Share Cloud Confirms your sensor glucose readings are being shared with your Follower(s) What Dexcom Share does not do:
Let you know when the Follower is not receiving your sensor glucose readings and information 313 Dexcom G5 Mobile System User GuideSharing Is Caring Tips Dexcom Share sure it is working Read the rest of the Dexcom G5 Mobile CGM System User Guide before using Always confirm information with a BG meter before making treatment decisions Check the status screen after turning Dexcom Share On on the smart device to make Installing the Dexcom G5 Mobile App Step What you see What you do 1 2 Download the Dexcom G5 Mobile App from your app store. See your smart devices user manual for instructions. Download the Dexcom G5 Mobile App to use Dexcom Share. Launch the Dexcom G5 Mobile App. Setup your smart device (see the Dexcom G5 Mobile User Guide) before sharing. Once your App has set up, activate Dexcom Share. A series of screens walk you through Dexcom Shares features highlighting important information. 314 Dexcom G5 Mobile System User GuideSharing Is Caring Activating Your Share Feature Step What you see What it means What you do 1 2 Activates Dexcom Share. If Dexcom Share icon is gray, your Share feature has not been turned on. Tap Dexcom Share icon in the upper right corner of your smart devices home screen. Dexcom Share Welcome Screen. Read screen. Tap Next when done.
(Continued on next page) 315 Dexcom G5 Mobile System User GuideSharing Is Caring Step What you see What it means What you do
(Continued from previous page) 3 4 Message about Internet access. Tap Next. How to know you are sharing your data. Tap Next.
(Continued on next page) 316 Dexcom G5 Mobile System User GuideSharing Is Caring Step What you see What it means What you do
(Continued from previous page) 5 How to know your Follower is not getting your sensor data. Tap Lets Get Started to move on and invite your Followers. 317 Dexcom G5 Mobile System User GuideSharing Is Caring Inviting Followers Step What you see What you do 1 Tap Invite Followers to set up your Followers.
(Continued on next page) 318 Dexcom G5 Mobile System User GuideSharing Is Caring Step What you see What you do
(Continued from previous page) 2 Enter the Followers nickname and email address. Confirm Followers email address. The Follower will get a Follow Invitation email. Make sure the Follower can access this email account from their smart device. Tap Next.
(Continued on next page) 319 Dexcom G5 Mobile System User GuideSharing Is Caring Step What you see What you do
(Continued from previous page) 3 Tap Allow Trend Graph Views On/Off switch if you want Follower to see your trend graph. Tap Next. 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.
(Continued on next page) 320 Dexcom G5 Mobile System User GuideSharing Is Caring Step What you see What you do
(Continued from previous page) 4 Choose if your Follower gets your urgent low, low and high sensor glucose Alarm/Alerts. Choose if you want your Follower to get prompts if they are not receiving your sensor glucose readings. 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 in the Follower Settings Menu). Tap Save for each Follower Setting Save. Tap Next when done.
(Continued on next page) 321 Dexcom G5 Mobile System User GuideSharing Is Caring Step What you see What you do
(Continued from previous page) 5 6 Before Follower invitation is sent, review the Summary screen. Tap Send Invitation. After sending invitation, you cannot adjust the Followers settings. To add more Followers:
Tap Followers tab on the Share Status screen. Invite up to a total of five (5) Followers. 322 Dexcom G5 Mobile System User GuideSharing Is Caring 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 11. Dexcom G5 Mobile App Home Screen Dexcom Share Status Icons Status Tab What it is 1 The Share icon is in color when Dexcom Share is sending sensor glucose readings and information. The Share icon is gray with a red circle when Dexcom Share is not working. The sharer should tap on the grayed out Share icon when it is not working to get further information about the error.
(Continued on next page) 323 Dexcom G5 Mobile System User GuideSharing Is Caring Status Tab What it is
(Continued from previous page) 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. The Sharer will not be able to send their sensor glucose readings and data to their Follower. Troubleshooting Status Issues Dexcom Shares status bar is a useful tool. It can help identify if there is a problem and Dexcom Share is not working. The following table provides troubleshooting tips for the Share status bar. 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 12. 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 Dexcom G5 Mobile display device for your sensor glucose readings and alerts. All treatment decisions must be based on your BG value from your BG meter. 324 Dexcom G5 Mobile System User GuideSharing Is Caring What you see What it means What you do Green Check:
All connections are working N/A. The Sharer should make sure:
Issue with:
Sharers CGM data Your smart device There is a glucose value on the smart device Transmitter is in range of the smart device Tap on blue ? to learn more about how to troubleshoot this issue The Sharer should 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.
(Continued on next page) 325 Dexcom G5 Mobile System User GuideSharing Is Caring What you see What it means What you do
(Continued from previous page) The Sharer should make sure:
Issue with:
Sharers Internet connection Dexcom Share Cloud Their Wi-Fi or cellular connection is ON They are in an area that has cellular reception They are not on a voice call 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 Follower List The Followers list allows the Sharer to manage their Followers. In the Follower list you can:
Invite a new Follower See the status of Followers you have invited Glance at what options your current Followers have Icon/Status What you see What it means Invite a new Follower.
(Continued on next page) 326 Dexcom G5 Mobile System User GuideSharing Is Caring What you see What it means
(Continued from previous page) Follower is set to get prompts from their Sharer. Follower is able to view their Sharers trend graph. Follower did not accept their Sharers Follow Invitation email within 7 days. The Sharer can invite their Follower again by pressing 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. Follower will not get any of the Sharers glucose information, Alarm/Alerts, or trend graph updates. Editing/Removing Followers Tap on a Follower to edit the Followers profile (nickname or ability to view trend graph) or remove a follower. Remove a follower by tapping Remove Follower. Once removed, they wont get glucose information or Alarm/Alerts. NOTE: The Sharer cannot change any Follower settings after the Follow Invitation email is sent. 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. 327 Dexcom G5 Mobile System User GuideSharing Is Caring For reasons of safety and intended use, the Follower will get a message telling them their Sharers data was set to Not Sharing. The Followers dashboard will show the Sharer has stopped sharing glucose information. 20.7 Dexcom Follow App Dexcom Follow App Description The Dexcom Follow App is a separate App from the Dexcom G5 Mobile App. Your Followers only need to download and install the Dexcom Follow App. What the Dexcom Follow App does:
Allows Follower to view the Sharers glucose information Allows Follower to get Alerts and Alarms Allows the Follower to view the Sharers trend graph What the Follower app does not do:
Provide treatment advice Interact with the Dexcom G5 Mobile App Receiving Dexcom Follow Invitation Email After getting the Sharers Follow invitation by email, the Follower sets up their smart device. Glucose Alarm and Alerts A glucose prompt is a visual message saying Glucose notification from [Sharers name]
that appears on the screen of the Followers smart device. The prompt may include sounds, depending on their smart devices settings. Types of prompts your Followers get:
Low Sensor Glucose Reading Urgent Low Sensor Glucose Reading (< 55 mg/dL) High Sensor Glucose Reading Your Follower can change some of the initial settings to fit their needs. The Follower cannot change your permission settings to see your Trend Graph. Sharer Status Changes That Notify the Follower Some Sharer status changes will prompt your Followers. 328 Dexcom G5 Mobile System User GuideSharing Is Caring Not Sharing - Sharer decides to temporarily stop sharing Removed by Sharer - Sharer removes Follower No More Data - Prompt Sent when active glucose sharing is stopped for any reason, other than the Sharer turning Share Off The Follower should contact the Sharer for more information about the data interruption The Follower Dashboard Figure 13. Follower Dashboard If you dont allow your Follower to see your Trend Graph, they will only see your glucose reading and trend arrow. 329 Dexcom G5 Mobile System User GuideSharing Is Caring Sharers picture Sharers glucose reading and trend arrow Figure 14. Follower Information How long ago the Sharers glucose reading and trend arrow were last updated If you choose to have your Follower see your Trend Graph, they see:
Sharers name Notification settings Sharers glucose reading Home icon Time duration setting of 3, 6, 12 or 24 hours Trend graph Trend arrow Glucose range
(between high and low alerts) Figure 15. Follower Information With Trend Graph 20.8 Troubleshooting Dexcom Share Troubleshooting Troubleshooting Status - See the Troubleshooting Status Issues portion of Section 20.6. 330 Dexcom G5 Mobile System User GuideSharing Is Caring Figure 16. Sharing Status Troubleshooting Sharing Checklist To share, you need to:
Make sure your smart device works with the Dexcom G5 Mobile App. To see a list of supported smart devices and operating systems, go to: dexcom.com/compatibility The Dexcom G5 Mobile App is open or running in the background Smart device has an active Internet connection (Wi-Fi, 3G, 4G, LTE). The Sharer can check to see if the Internet connection is working by trying to open a web page on the Sharers smart device If on a phone call using your smart device, your CGM information may not upload into the Share Cloud while on your call Airplane Mode turned off Do Not Disturb is turned off Smart device sound is on in order to hear prompts Smart device is sufficiently charged or charging Smart device is within 20 feet of the transmitter Smart device has 35 MB of available memory Refer to the smart device user manual for further instructions Tips Read the Dexcom G5 Mobile CGM System User Guide before using the Dexcom Share feature Always confirm information with a BG meter before you make treatment decisions 331 Dexcom G5 Mobile System User GuideSharing Is Caring Page intentionally left blank 332 Dexcom G5 Mobile System User GuideSharing Is Caring Index A Alarm, 175 App Recommended Settings, 183 Clearing, 188 Prompts, 178 Receiver Beeps and Vibrations, 184 What is an, 176 Alarm and Alerts Changing Receiver, 204 Customizing, 195 Alerts, 175 Clearing, 188 Default, 176 Low Repeat/High Repeat, 185 Low/High Glucose, 179,180 Main Menu, 207 Receiver Rise Rate/Fall Rate, 181, 182 Rise Rate/Fall Rate/Repeat/Signal Loss, 177 What are, 176 Default Beep and Vibrations, 184 C Calibration, 92 Entering into app, 101 Entering into your receiver, 104 Errors, 106 Preparing for, 100 Prompts, 96, 98, 99 What is it, 92 When to Calibrate, 95 Why is Calibrating important, 92 CGM System Basic Maintenance, 222 Different Monitoring Methods, 50 Disposal, 228 Overview, 42 Storage, 226 E Error Messages, 147 Event Categories, 154 Definition, 153 Events, 153 Entering Viewing, 170 App, 162 Receiver, 168 G Glucose Information Rate of Change Arrows, 146 Trend Screen, 137, 145 R Rate of Change Arrows, 138, 146 Receiver Home Screen, 142 Initial set up, 64 Overview, 46 Indications, 18 S Safety Statement Contraindications, 19 Precautions, 21, 23, 24, 25, 27 Warnings, 20, 21, 22, 24, 26 Sensor Insertion Choosing site, 75 Sensor Session Attaching transmitter, 80 Definition, 8 Ending, 110 Ending Early 333 Dexcom G5 Mobile System User GuideIndex Inserting sensor, 76 App, 119 Receiver, 121 Ending Seven Day, 111 Prepping for Sensor Insertion, 72 Preventing Sensor Failures, 123 Receiver: Starting a Session, 84 Remove Sensor Pod and Transmitter, 124 Starting a, 69 Starting with app, 83 Sensor Session Warmup Warmup, 90 Signal Loss Alert Signal Loss, 183, 187, 208 Sound/Vibration Prompts, 116 System Components, 39 T Technical Information, 237 Transmitter Attaching, 80 Battery Messages, 127 Connecting/Pairing Transmitter with App, 58 Connecting/Pairing with Receiver, 66 End of Transmitter Battery, 127 Overview, 45 Remove from Sensor Pod, 124 Safety Statements, 24 Troubleshooting, 287 W Warranty, 215 Notes ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ ________________________________ 334 Dexcom G5 Mobile System User GuideIndex 2016 Dexcom, Inc. All rights reserved. Covered by patents www.dexcom.com/patents. Dexcom, Dexcom Follow, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G5, Dexcom G5 Mobile, Dexcom Share, Follow Dashboard, and G5 are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. All other product or company names that may be mentioned in this publication are tradenames, trademarks or registered trademarks of their respective owners. Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA Phone: 1.858.200.0200 Tech Support: 1.877.339.2664 Web: dexcom.com LBL012787 Rev 006 MT22864
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2016-04-19 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 | Effective |
2016-04-19
|
||||
| 1 | Applicant's complete, legal business name |
Dexcom, Inc.
|
||||
| 1 | FCC Registration Number (FRN) |
0008514325
|
||||
| 1 | Physical Address |
6340 Sequence Dr
|
||||
| 1 |
San Diego, CA
|
|||||
| 1 |
United States
|
|||||
| app s | TCB Information | |||||
| 1 | TCB Application Email Address |
v******@tuvam.com
|
||||
| 1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
| app s | FCC ID | |||||
| 1 | Grantee Code |
PH2
|
||||
| 1 | Equipment Product Code |
9715
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 | Name |
S******** R********
|
||||
| 1 | Title |
Sr. Staff, Product Standards Compliance
|
||||
| 1 | Telephone Number |
85852********
|
||||
| 1 | Fax Number |
858-2********
|
||||
| 1 |
s******@dexcom.com
|
|||||
| app s | Technical Contact | |||||
| n/a | ||||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 10/10/2016 | ||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 | Equipment Class | DTS - Digital Transmission System | ||||
| 1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Spread Spectrum Device | ||||
| 1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 | Modular Equipment Type | Does not apply | ||||
| 1 | Purpose / Application is for | Original Equipment | ||||
| 1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
| 1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
| 1 | Grant Comments | Output power is conducted. | ||||
| 1 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 | Firm Name |
TUV SUD America Inc.
|
||||
| 1 | Name |
M******** E********
|
||||
| 1 | Telephone Number |
813-2********
|
||||
| 1 | Fax Number |
978 9********
|
||||
| 1 |
W******@tuvsud.com
|
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| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0004800 | ||||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC