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Dexcom G5 User Manual

Dexcom G5 User Manual

Mobile continuous glucose monitoring

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G5 Mobile System User Guide

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Summary of Contents for Dexcom G5

Page 1 G5 Mobile System User Guide Glossary...
Page 2: Table Of Contents
What’s the G5 Mobile? ............... 42 4.1 Introduction..................42 4.2 Safety Statement ................42 4.3 The G5 Mobile .................. 44 4.4 What’s New to the G5 Mobile? ............46 4.5 System Information ................47 4.6 System Components ................ 47 4.7 Smart Device Overview ..............55 Chapter 5 ...................
Page 3 5.3 Why Different Monitoring Methods? ..........58 5.4 G5 Mobile App.................. 58 5.5 Receiver .................... 71 Chapter 6 ................... 78 Starting a Sensor Session: Inserting Sensor, AttachingTransmitter, and Starting Your Session ................78 6.1 Introduction..................78 6.2 Safety Statements ................79 6.3 Prepping for Sensor Insertion ............
Page 4 11.6 Receiver: Default Beeps and Vibrations ........205 11.7 Clearing Alarm/Alerts ..............210 Chapter 12 ..................213 On the Go With G5: Customizing Your Alarm and Alerts ....213 12.1 Introduction ................. 213 12.2 Safety Statement ................213 12.3 Changing App Alarm and Alerts ........... 214 12.4 Changing Receiver Alarm and Alerts ..........
Page 5 14.5 Checking App and Receiver Information ........252 14.6 System Disposal ................253 Chapter 15 ..................255 On the Go With G5 Mobile: Getting Through Security ......255 15.1 Introduction ................. 255 15.2 Safety Statements ................ 255 15.3 Going Through Security ..............256 Chapter 16 ..................
Page 6 20.7 Dexcom Follow App ..............364 20.8 Troubleshooting ................367 G5 Mobile System User Guide Glossary...
Page 7 GETTING STARTED • Glossary • Getting Started • Indications for Use and Safety Statement • Risks and Benefits G5 Mobile System User Guide Glossary...
Page 8 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 G5 Mobile app was developed as a display for continuous glucose monitoring. Apple Watch Accessory device for iPhones ®...
Page 9 Contraindication A safety statement outlining specific situations where the G5 Mobile should not be used because it may be harmful to you. The risk of use clearly outweighs any possible benefit. G5 Mobile System User Guide...
Page 10 It’s important to treat hypoglycemia. If left untreated, hypoglycemia can lead to serious complications. The default Low Glucose Alert in the G5 Mobile is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemic setting for you.
Page 11 The removal poses a security risk and data may become vulnerable. Do not use, install or run the G5 Mobile app on a jailbroken smart device. The app may not work correctly on a jailbroken smart device.
Page 12 Also used to send calibration data from the receiver or smart device to the transmitter. Safety Statement A statement of the intended uses of G5 Mobile and relevant warnings, precautions, and contraindications. Sensor Session The seven-day monitoring period after inserting a new sensor.
Page 13 G5 Mobile, their consequences, and how to avoid the hazard. (Continued on next page) (Continued on next page) G5 Mobile System User Guide Glossary...
Page 14: Chapter 1
As a continuous glucose-monitoring (CGM) device, the G5 Mobile System allows you to break free from constant fingersticks. But how do you use the G5 Mobile? 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.
Page 15: Self-Paced Resources
Knowing about the G5 Mobile 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 G5 Mobile: 1. Tutorials 2. Getting Started Guide 3.
Page 16 Accessing the GSG: • Booklet in the receiver package Both the tutorial and the GSG give you a brief look at the G5 Mobile. But what if you want more detailed information? User Guide Your G5 Mobile encyclopedia! This user guide gives you the most extensive overview of the system detailing features, important safety information, and so much more.
Page 17 Ending a Sensor Session & Transmission Session • Next Steps - Getting the Most out of Your G5 Mobile Part 3: Once you are up and running, how you can maximize the G5 Mobile features: Reading Trend Graph Screens and Recognizing Trends • Events •...
Page 18: Your Dexcom Account
1.3 Your Dexcom Account You’ll need a username and password to set up the G5 Mobile app and for reordering supplies. If you haven’t already done so, go to dexcom.com and set up your own account.
Page 19 Statements. The next chapter, Indications for Use and Safety Statement, lists all Safety Statements along with how to read and interpret them. Next you’ll learn about when and how to use the G5 Mobile safely. Dexcom G5 Mobile System User Guide...
Page 20: Chapter 2
Indications for Use and Safety Statement 2.1 Introduction We want the G5 Mobile 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 that if you just ®...
Page 21: Safety Statements
This user guide presents Safety Statements two ways: 1. In this chapter’s Overview of Safety Statements Lists all Safety Statements Includes a section reviewing how the statements are formatted 2. Within each chapter Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 22 An action you should or should not take Italicized 3. Why a. A statement of the potential harm 4. Consequences a. What could happen if you don’t follow the instructions Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 23: Overview Of Safety Statements
CGM system Warnings, which review warnings and precautions you take with most CGM systems; and second, Hardware/Software Warnings and Precautions, which list warnings and precautions specific to the system components. Indications and Contraindications Indications Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 24 What are the 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.
Page 25: General Cgm System Warnings
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 system from harm. Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 26: Calibration Warning And Precautions
2.6 Calibration Warning and Precautions Calibration is the process of making sure your sensor continues to be accurate. Your sensor doesn’t automatically know what your glucose levels Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 27 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 Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 28: System/Hardware/Software Warnings And Precautions
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 1.888.738.3646 or toll at 1.858.200.0200. Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 29 Sensor Package Don’t use sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection. Clean and Dry Before Using Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 30 Choking The transmitter is small and may pose a choking hazard. Don’t put it in your mouth or allow children to play with it. Precaution Reusable: Don’t Throw Away Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 31 Dexcom G4 PLATINUM CGM System’s transmitter and receiver. The Dexcom G5 Mobile CGM System won’t work if you mix receiver and transmitter components from different generations, resulting in you missing a severe low or high glucose event.
Page 32 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 Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 33 (like a smart watch or other wearable smart devices) might override your smart device’s Alerts and Alarm. To receive Alarm or Alerts you must: Settings 1. Make sure app Notifications are turned on in the menu. Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 34 Receiver Warning and Precautions Warning Don’t Use Damaged Goods If your receiver is damaged or cracked, don’t use it. This could create an electrical safety hazard or malfunction, causing possible electrical shocks. Avoid Strangulation Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 35 Define a Safety Statement • Explain the difference between an indication and a contraindication Describe what a precaution is • Describe the importance of warnings Correctly read a chapter’s Safety Statement Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 36 • Provide an overview of Safety Statements by category What’s Next? In our next chapter, you will learn about the risks and benefits of using the system. Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 37: Chapter 3
When using any medical device, there are risks and benefits. In this chapter, you’ll learn what they are, so you can better understand the pros and cons of CGM and the G5 Mobile System. First, let’s review some possible risks.
Page 38: Benefits
24/7, at 1.888.738.3646 or toll at 1.858.200.0200 within 24 hours. Those are the risks, let’s now review the benefits! 3.2 Benefits Daily habits impact your BG levels. With the G5 Mobile, you can track how your exercise, carbs, stress levels, medication, or illness influence your glucose levels.
Page 39 (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 the G5 Mobile System helps reduce hypoglycemia (Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group et al, 2008).
Page 40 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. Dexcom G5 Mobile System User Guide Risks and Benefits...
Page 41 Introduction to the G5 Mobile • Initial Setup • Starting a Sensor Session: Inserting the Sensor & Attaching the Transmitter • Calibration • Ending a Sensor Session & Transmitter Session Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System?
Page 42: Chapter 4
Explain each part’s function 4.2 Safety Statement If you’ve 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,” “G4 PLATINUM,” or “Dexcom G5 Mobile/G4 PLATINUM”...
Page 43 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.
Page 44: The G5 Mobile
Number(s) 4.3 The G5 Mobile The G5 Mobile 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 measurements.
Page 45 The G5 Mobile 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. Chapter 5 covers how to set up your smart device with the G5 Mobile app.
Page 46: What's New To The G5 Mobile
In Chapter 11, you can learn more about the Alarm and Alerts feature. Viewing Your Glucose Values The G5 Mobile allows you to see your last 1-3-6-12-24 hours of your sensor graph glucose readings. On the receiver, from the home screen, tap to view.
Page 47: System Information
As an example, the Calibration chapter will review all calibration messages you may see. Now that you know what the G5 Mobile does and what’s new, let’s open your G5 Mobile packages, see what’s inside, and review each item.
Page 48 Throughout this guide, all images are representational. Your product may look slightly different. Sensor Box Single use sensor(s) Transmitter Box Reusable transmitter Receiver Box Receiver Two extra colored cases Receiver’s USB charging and download cable Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System?
Page 49 AC power adapter Welcome card Getting Started Guide Training Tutorial USB card Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System?
Page 50 This section is meant as a quick overview of each part; specifics for each are found in following chapters. For detailed product specifications and technical information, please go to Chapter 17. The G5 Mobile is comprised of four key parts: 1. Single use sensor 2. Reusable transmitter 3.
Page 51 Figure 1. G5 Mobile Sensor Applicator and Pod Applicator and Sensor Pod What it’s called What it does Applicator Contains small insertion needle and sensor wire. Inserts sensor wire under the skin. Applicator Barrel Disposable, for single use only. Removed after insertion.
Page 52 Attached to sensor pod. Discarded with pod after session. Transmitter Overview Figure 2. G5 Mobile Transmitter Front and Back Image is representational only. Your transmitter may look different. Snapping into the sensor pod, the gray plastic transmitter wirelessly sends your glucose information to your display devices—receiver and/or smart device.
Page 53 If you want to use the receiver along with a smart device, you need to set them up separately. Remember, you can’t use a combination of smart devices during a sensor session; select just one. Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System?
Page 54 Battery can only be charged using the adapter/wall charger USB cable Plug into adapter/wall charger Wall Charger wall charger Plug into an electrical outlet to charge receiver’s battery Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System?
Page 55: Smart Device Overview
Press briefly to wake it up. 4.7 Smart Device Overview The 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.
Page 56 • Explain each part’s function Next Steps Your next step in getting started with the G5 Mobile is selecting how to continuously receive your sensor glucose readings: the G5 Mobile app, the receiver, or a combination. Our next chapter helps you set up both!
Page 57: Chapter 5
Set Up Your Display Devices 5.1 Introduction In the previous chapter, you received a high level overview of the G5 Mobile and learned you can monitor your glucose levels with different display devices. Now it’s time to set up your G5 Mobile app and your receiver.
Page 58: Why Different Monitoring Methods
The next section walks you through the initial setup for the app. To set up the receiver, go to Chapter 5.5. If you want to use both the G5 Mobile app and the receiver, you need to set up each individually.
Page 59 If your smart device is broken or lost, use receiver until it’s fixed or replaced. G5 Mobile App Installation Installing the app is easy! Simply download the G5 Mobile app from your smart device’s store. However, if your smart device has been jailbroken, do not install the app.
Page 60 But what if you are unclear about a step? The G5 Mobile app has prompts allowing you to get more information. If you are unsure of something during your initial setup process, look at the screen for additional information prompts. Informational prompts include, but aren’t I don’t understand, Learn More,...
Page 61 Step What you see What you do G5 Mobile app icon to open app. Introductory Screens Swipe through introductory screens or tap Log In Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 62 Enter existing Need a Dexcom username and password? Sign Up. Username/Password Complete fields Login once. Introductory Screens Let’s Get Started Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 63 Default is 80 mg/dL. Scroll to select another amount. Save to move forward. Once your Low Glucose Alert is set, you’ll receive an Alert if your glucose dips below your set amount. Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 64 Setting Up Your App Alarm/Alerts and Basic Settings Make sure you get your Alarm/Alerts notifications. appropriate response Tap the to move forward and set your notifications. Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 65 Setting Up Your App Alarm/Alerts and Basic Settings The next screens provide suggestions for Do Not Disturb device volume, , and other basic settings. appropriate answer to move forward. Connecting/Pairing Transmitter With App Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 66 Next Bluetooth Verify is on. Bluetooth The app will check to see if turned “on.” Connecting/Pairing Transmitter With App Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 67 For information on how to pair transmitter after initial setup, see Chapter 8. Center longest barcode within green brackets. Take Photo Connecting/Pairing Transmitter With App Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 68 Check mark confirms successful transmitter SN scan. If unable to use app’s scanning device: Enter transmitter SN by hand Connecting/Pairing Transmitter With App Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 69 Use keyboard to enter transmitter SN. Confirm correct SN . Save Insert sensor and attach transmitter following video’s instructions. See Chapter 6 for more information. Connecting/Pairing Transmitter With App Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 70 Pair At prompt, Tap to pair app with smart device. Connecting/Pairing Transmitter With App Make sure your transmitter and smart device have paired before starting your sensor session Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 71: Receiver
When you see the sensor warmup timer, your initial setup is complete. Congratulations! If you have any issues setting up the G5 Mobile app, always contact Technical Support (available 24/7) at: • TechSupport@dexcom.com •...
Page 72 Before starting a session, you may want to check the receiver’s battery level. If it is less than half, go to Chapter 4 for charging instructions. Initial Receiver Setup Step What you see What you do Initial Screens Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 73 Press and hold for two seconds to turn receiver on. Wait for the Dexcom screen to appear. Wait. Within 20 seconds, receiver will beep and vibrate briefly to show the speaker and vibration motor are working. Date/Time The green box shows what is selected.
Page 74 SN number. For information on how to pair transmitter after initial setup, see Chapter 8. If transmitter package isn’t available: • SN is on transmitter’s back Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 75 System default is set at 80 mg/dL. Save to save at present levels and close. To change value: up/down arrows to change value at 5 mg/dL increments. Save to save and close. Setting High Alert Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 76 Now that 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: Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 77 1. Inserting the sensor. 2. Attaching the transmitter. 3. Pairing the transmitter to your device. 4. Two-hour sensor warmup. 5. Initial calibrations. Dexcom G5 Mobile System User Guide Set up Your Display Devices...
Page 78: Chapter 6
30 minutes to your wait time. Good news is you don’t 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 G5 Mobile settings, whatever you choose during that time frame.
Page 79: Safety Statements
Why: Sensors may fracture on rare occasions. MRI with broken wire For patients undergoing an MRI with a retained wire broken off from a G5 sensor, in vitro MRI testing did not detect any safety hazards. There was no significant migration or heating of the wire, and imaging artifacts were limited to the area around the wire.
Page 80 Warning Insert the sensor component of the G5 Mobile in a site other than Don’t: the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). Why: The placement and insertion of the G5 Mobile sensor is not approved for other sites.
Page 81: Prepping For Sensor Insertion
Consequences: You might miss a severe low or high glucose event. 6.3 Prepping for Sensor Insertion Before inserting a sensor, make sure you have everything you need. Some items are included in the G5 Mobile’s packages, others are not. Dexcom G5 Mobile System User Guide Calibration...
Page 82 Included in Your 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 pack with important label information. expiration date. Check Single use sensor applicator.
Page 83 Figure 3. G5 Mobile Sensor Applicator and Pod The following table reviews the sensor applicator components in order of use. Order of Name What it does Sterilized for your protection. Sensor Pack Open to remove applicator and sensor. Holds the sensor/transmitter in place Adhesive Patch on your skin.
Page 84: Choosing Your Insertion Site
Make sure test strips haven’t expired and work with your meter. Before removing the sensor applicator out of its sterile pack, determine the best place to insert your sensor. 6.4 Choosing Your Insertion Site Dexcom G5 Mobile System User Guide Calibration...
Page 85 Back of body (Upper buttocks) • Remove the sensor and applicator from its sterile pack only at time of • Place at least 3 inches from your insulin pump infusion set or injection site Dexcom G5 Mobile System User Guide Calibration...
Page 86: Inserting Your Sensor
You’ve collected all of the needed items to begin a sensor session, viewed the tutorials, reviewed the sensor applicator, and prepped the sensor pod site. You’re now ready to insert your sensor! Step Picture What you do Preparation Dexcom G5 Mobile System User Guide Calibration...
Page 87 Do not get any skin adhesive inside • the oval Let skin adhesive dry (see • manufacturer’s instructions) Insert sensor on clean skin at the • center of the oval Preparation Dexcom G5 Mobile System User Guide Calibration...
Page 88 Attaching Sensor Pod adhesive backing tabs. Pull sticky adhesive patch. Don’t touch Inserting Sensor Wire sensor Place horizontally, not vertically, on skin. the adhesive patch Move fingers around several times to secure tape. Preparation Dexcom G5 Mobile System User Guide Calibration...
Page 89 Place thumb on the plunger Push completely down the applicator barrel. You should hear 2 clicks. NOTE: Finger placement is important for correct insertion. Removing Applicator and Collar Dexcom G5 Mobile System User Guide Calibration...
Page 90 Follow local ordinances when disposing the applicator. What’s left? Sensor pod Transmitter latch You have successfully inserted the sensor! At this point, you should have two items attached: Dexcom G5 Mobile System User Guide Calibration...
Page 91: Attaching Your Transmitter
SN into your display device. Chapter 5 covers entering transmitter’s SN number during initial setup. See Chapter 8 for pairing your transmitter after the startup wizard Attaching Transmitter Step Picture What you do Dexcom G5 Mobile System User Guide Calibration...
Page 92 Step Picture What you do transmitter Keep finger on holding it in place. transmitter latch Push up and forward over the transmitter’s wide end with your other hand. You should hear 2 clicks. Dexcom G5 Mobile System User Guide Calibration...
Page 93: Loose Sensor Pod
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 Dexcom G5 Mobile System User Guide Calibration...
Page 94: Starting Your Sensor Session
BG values into either the smart device or the receiver. We’ll first review starting the sensor session for the app. Dexcom App: Starting a Session Step What you see What you do Dexcom G5 Mobile System User Guide Calibration...
Page 95 Screen provides countdown to sensor warmup. The orange dashes darken as the countdown moves forward. smart device Keep within 20 feet of transmitter during the sensor warmup period. Step What you see What you do Dexcom G5 Mobile System User Guide Calibration...
Page 96 Chapter 7 covers calibrating. Initial calibration prompt tells you when warmup is complete. Sensor warmup is complete. You’re ready to calibrate! Receiver: Starting a Session Step What you see What you do Dexcom G5 Mobile System User Guide Calibration...
Page 97 Check 10 minutes after Bluetooth starting for icon. • Solid: Connected/paired • Blinking: Searching/not paired Don’t start a sensor session until they are paired. Start Sensor Dexcom G5 Mobile System User Guide Calibration...
Page 98 NOTE: After sensor starts, Sensor option disappears from Main Stop Sensor Menu and appears. Wait. In the upper right corner, icon shows countdown of the two-hour sensor warmup. Sensor warmup is complete. You’re ready to calibrate! Dexcom G5 Mobile System User Guide Calibration...
Page 99: Receiver Bluetooth Tips
Don’t calibrate. Use BG meter for BG reading. No sensor glucose readings display until error is fixed. More than 30 minutes? Contact Technical Support (available 24/7) at: • TechSupport@dexcom.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 Dexcom G5 Mobile System User Guide Calibration...
Page 100: 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 G5 Mobile’s display devices. Once the sensor warmup is complete, you’re ready to enter your initial calibrations! The next chapter shows you how.
Page 101: Chapter 7
Recognize when you can enter a fingerstick measurement for calibration Recognize when you shouldn’t enter the a fingerstick measurement for calibration Determine if you need to calibrate outside of the normal calibration requirements • Initiate startup calibration • Perform update calibrations Dexcom G5 Mobile System User Guide Calibration...
Page 102: Safety Statements
May be different for each person. Consequences: Without correct readings you might miss a severe low glucose event. Warning Never use the G5 Mobile sensor glucose readings for treatment Don’t: decisions. Only use BG values from your BG meter for treatment decisions (for example, how much insulin to take).
Page 103 • Falling more than 3 mg/dL each minute Why: Calibrating during significant rise/fall of BG may affect accuracy of sensor glucose readings. Consequences: You may miss a severe low or high glucose event. Dexcom G5 Mobile System User Guide Calibration...
Page 104: Calibration Overview
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? Dexcom G5 Mobile System User Guide Calibration...
Page 105 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 G5 Mobile uses your meter’s BG value to make sure the sensor glucose readings remain accurate throughout your session.
Page 106: When To Calibrate
1. Inserted your sensor and entered initial two calibrations on Monday at 2. Entered update calibrations at 10 that night. 3. For the rest of the seven-day sensor period, you enter update calibrations at 10 and 10 Dexcom G5 Mobile System User Guide Calibration...
Page 107: Calibration Prompts
BG values, your glucose readings begin. If you don’t 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. Dexcom G5 Mobile System User Guide Calibration...
Page 108 First Calibration Smart Device: Lock Screen Smart Device: Follow steps Sensor In App in Chapters warmup is 7.6 and 7.7. complete. Immediately Ready for first prepare for of two initial next calibrations. calibration. Receiver Dexcom G5 Mobile System User Guide Calibration...
Page 109 7.6 and 7.7. Ready for Next second BG calibration in meter value. 12 hours. Receiver Your sensor glucose readings begin in approximately five minutes once the device(s) accepts your calibrations. Update Calibration Prompts Dexcom G5 Mobile System User Guide Calibration...
Page 110 BG values • next are very calibration. different from Receiver sensor glucose readings Message to clear prompt on your smart device; to clear a prompt on your receiver, Tap Sound/Vibration Prompts Dexcom G5 Mobile System User Guide Calibration...
Page 111: Preparing For Calibration
4. Verify test strips are current and, if required, coded correctly with meter. Bluetooth 5. Check: Is 6. Use fingerstick BG values only. a. Other sites are not as accurate. b. Must enter within five minutes of taking BG meter value. Dexcom G5 Mobile System User Guide Calibration...
Page 112: Ready? Set? Calibrate
Next are steps to enter your calibrations using the app, followed by the steps for entering your calibrations into the receiver. Initial Calibration With Your G5 Mobile app Step What you see What you do...
Page 113 Update calibration: Enter single meter BG value. Double-check your numbers. Enter meter’s Entering wrong value using number values, or values pad. taken more than 5 Save minutes ago, can affect the sensor’s accuracy. Dexcom G5 Mobile System User Guide Calibration...
Page 114 If not correct: Cancel Reenter correct value. circle to enter your second BG value. Follow steps 2-3 and enter second reading. Meter icon has no calibration prompt. Your calibration was successful. Calibration accepted. Dexcom G5 Mobile System User Guide Calibration...
Page 115 Initial Calibration With Your Receiver Step What you see What you do Additional Info power button Press briefly to wake up You won’t see receiver. calibration prompts when receiver screen is black. Dexcom G5 Mobile System User Guide Calibration...
Page 116 Save • BG level isn’t recorded Cancel and reenter Verify BG value is BG value. correct. Fingerstick If incorrect: measurement must Cancel be within the last Reenter BG value. five minutes. Dexcom G5 Mobile System User Guide Calibration...
Page 117: Calibration Errors
Calibration(s) 12 hours. accepted. 7.8 Calibration Errors Before or during your calibration process, your display device may show error prompts. If the prompts don’t go away after 15 minutes, refer to Chapter 18, Dexcom G5 Mobile System User Guide Calibration...
Page 118 Wait 5 minutes. Retake fingerstick Sensor can’t measurement at calibrate now. prompt. Enter BG value. Receiver Smart Device: In App Additional calibration needed System didn’t immediately. accept recent Calibrate. calibration. No sensor glucose readings. Receiver Dexcom G5 Mobile System User Guide Calibration...
Page 119 Determine if you need to calibrate outside of the normal calibration guidelines • Initiate startup calibration • Perform update calibrations • Correctly enter your fingerstick measurement Receiver • Identify calibration errors What’s Next? Dexcom G5 Mobile System User Guide Calibration...
Page 120 In the next chapter, you’ll learn how to end a typical seven-day sensor session, what to do if you need to end your sensor session early, along with removing the transmitter and determining if you need to replace it. Dexcom G5 Mobile System User Guide Calibration...
Page 121: Chapter 8
8.1 Introduction G5 Mobile sensor sessions last seven days. This chapter reviews what you should expect when your session is about to expire and removing the sensor and transmitter. It also covers how to determine if you need to end your session early.
Page 122: Ending Your Sensor Session
Smart Device: Clock will countdown until In App session has ended. Continue to get sensor glucose readings. Receiver Device What you see What it means At Two Hours Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 123 Device What you see What it means At Thirty Minutes Smart Device: Lock Screen Thirty minutes remain. Continue to get sensor glucose readings. Smart Device: In App Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 124 What it means Session Stopped Sensor session has stopped. Smart Device: Lock Screen • No sensor glucose readings Smart Device: • Prompts for new In App session Receiver Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 125 When your display device has system errors, you may not receive any sensor glucose readings and you should not calibrate. Prompts to End Sensor Session Early System Prompts Device What you see What it means Sensor issues detected. Smart Device: Lock Screen Session ends automatically. Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 126 Check transmitter—is it properly In App inserted into sensor pod? Make sure you haven’t taken acetaminophen. If not corrected after 3 hours: Contact Dexcom • Receiver Technical Support Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 127 The G5 Mobile 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.
Page 128 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. Receiver: Temporary Shutdown Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 129: Remove Sensor Pod And Transmitter
2. Separate the transmitter from the sensor pod. 3. Discard the sensor pod following your local waste management regulations for disposing of blood-contacting parts (sensor and applicator). Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 130 What you do adhesive patch Grasp end of adhesive patch Peel up and away from your sensor pod transmitter body to remove sensor pod on flat surface. Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 131: End Of Transmitter Battery
Order a new transmitter. Receiver Device What you see What it means Transmitter battery will expire in Smart Device: two weeks. Lock Screen Order a new transmitter. Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 132 To make sure you have a transmitter that’s ready for a new sensor session, you may want to reorder a new one at dexcom.com/order, by calling Customer Service (see Chapter 16.1), or through the channels you used before, at your first low battery prompt.
Page 133: Pair New Transmitter
Part of pairing the transmitter is entering it’s SN into your display device, inserting the sensor, and attaching the transmitter. After the transmitter and display device are paired,start a new sensor session. Step What you see What you do Menu Settings Transmitter Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 134 (If you don’t have the box, go to step 6a.) Center longest barcode within green brackets. Take Photo Check mark confirms successful transmitter SN scan. Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 135 Enter transmitter SN by hand Use keyboard to enter transmitter SN. Confirm correct SN . Save Insert sensor and attach transmitter. See Chapter 6 for more information. Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 136 Receiver Step What you see What you do power button Press and hold the for 2 seconds to turn receiver on. Menu icon Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 137 SN. number to select it. To choose a letter, tap up from 9 or down from 0. Save to save and close. Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session...
Page 138 You can set up your app and receiver, start a sensor session, calibrate, as well as end your sensor session and know when to replace your transmitter. But the G5 Mobile can do much more. In the next part, Part 3: Next Steps, you will learn how to get the most out of your G5 Mobile. Dexcom G5 Mobile System User Guide...
Page 139 OUT OF YOUR G5 MOBILE • Reading Trend Graph Screens and Recognizing Trends • Events • Alarm and Alerts • Sounds for Alarm, Alerts, and System Messages Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 140: Chapter 9
Chapter 9 Next Steps - Getting the Most out of Your G5 Mobile: Home Screen, Rate of Change Arrows, and Errors 9.1 Introduction to Home Screens In the previous chapter, you learned about calibrations: why they are important and how to do them. Within five minutes of entering your two initial calibrations your sensor glucose readings begin! In this chapter, you’ll learn three things.
Page 141 • Consequences: Without correct readings you might miss a severe low event. Warning Never use the G5 Mobile sensor glucose readings for treatment Don’t: decisions. Only use BG values from your BG meter for treatment decisions (for example, how much insulin to take).
Page 142: Overview Of Home Screen
While the screen does look different between the receiver, smart device, Apple Today View, and Apple Watch, the information is the same. The G5 Mobile app has two ways to view data based on how you hold your smart device:...
Page 143 The app’s home screen has two main sections: 1. Task Bar a. Allows you to change settings, enter data, etc. 2. Glucose Information a. Reflects sensor glucose readings and trends. Task Bar Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 144 Figure 6. Example App Home Screen on Smart Device Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 145 • Carbs Enter different events capturing • Insulin Event activities • Exercise affecting your glucose. • Health (See Chapter 10). Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 146 Once activated, Dexcom icon Share Dexcom Share access Dexcom icon is colored. Share App Glucose Information App: Portrait App: Landscape What it means Glucose Information: Review Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 147 Shown in milligrams per deciliter (mg/dL). Yellow: At or • above target • Gray: Within range • Red: At or below target Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 148 Slide finger across screen to view rest of day’s sensor glucose readings. Rate of Change Arrow Direction and number of arrows show sensor glucose change rate. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 149 Range and Alert Levels Yellow: High • Alert level Gray: Within • range Red: Low Alert • level or, if that’s disabled, 55 mg/dL (Urgent Low Glucose Alarm) Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 150 Check your CGM on your smart device without opening the app, even when the smart device is locked. Swipe down from the top edge of your Apple mobile device to find the Dexcom widget in your Today view; the widget installs when you install the app. (See your smart device instructions for customizing your Today view.)
Page 151 Color of circle changes: Sensor Take Yellow: At • Glucose appropriate or above Reading action. target Gray: Within • target range • Red: At or below target Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 152 What you do Review and take appropriate action based on fingerstick BG Shows direction value. and speed your (See Chapter 9) Trend Arrow glucose is changing. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 153 This section gets you familiar with the receiver’s home screen. In other chapters, you’ll see how to enter data or make system changes. Like your smart device, your receiver has a touchscreen.. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 154 Events. • Glucose Information: Shows your sensor glucose readings and trends. Receiver Status Bar Receiver Name What it does What you do Status Bar: System Information Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 155 Receiver’s Bluetooth Shows always on. Bluetooth Bluetooth connected. If blinking, move receiver closer to transmitter. Do nothing. Shows system Time To change, go time. to Settings. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 156 What it does What you do Task Bar: Complete Tasks Goes to the Main Menu, Tap applicable Task Bar enter BG meter icon values, and record Events. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 157 BG Meter with red Calibration enter fingerstick circle and Prompt. BG value (see number Chapter 7). BG Meter No need to without red Do nothing. calibrate. circle Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 158 Displays your glucose information: • Current glucose number Review and take Glucose appropriate • Direction Information action. your glucose is heading • Graph of glucose trend Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 159 • below target Review and take appropriate Shows direction action based on and speed your Trend Arrow fingerstick BG glucose is value. changing. (See Chapter 9) Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 160 Apple Watch Home Screen This section gets you familiar with the Apple Watch home screen. Like your smart device, your Apple Watch has a touchscreen. Apple Watch Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 161 • Direction Screen action. your glucose is heading • Graph of glucose trend Shows most Sensor Take recent sensor Glucose appropriate glucose reading. Reading action. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 162 Gray: Target • fingerstick BG range value. Red: Low • Alert setting (See Chapter 9) or, if that’s disabled, 55 mg/dL (Urgent Low Glucose Alarm) Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 163: Rate Of Change Arrows
1-2 mg/dL each minute • Up to 30 mg/dL in 15 minutes Rising or Falling Changing: • 2-3 mg/dL each minute • Up to 45 mg/dL in 15 minutes Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 164: Error Messages
You will not get any sensor glucose readings or rate of change arrows on either display device until the error is fixed. Check with your BG meter to monitor your glucose during these error periods. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 165 Wait up to 30 minutes while transmitter restores communication. Receiver Bluetooth Smart Device: Lock Screen Smart device: Exit app. Settings Bluetooth Smart Device: Bluetooth Turn In App Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 166 Outside of your calibration • schedule? Receiver In a sensor session? • System Found Temporary Sensor Issue Don’t calibrate. Smart Device: Lock Screen System may correct problem on its Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 167 (see Chapter 16.1) Remove sensor • Insert new sensor • Calibration Required Error in calibrating. Smart Device: Lock Screen Verify you did not enter a BG Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 168 BG meter value. Wait 15 minutes. Smart Device: In App If no sensor glucose readings appear on the display, the sensor needs to be replaced. Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 169 • Bluetooth • Turn Off and Receiver On.Tap Settings Bluetooth .Turn and On. If error messages don’t go away after you followed necessary steps, and you Dexcom G5 Mobile System User Guide Home Screen, Rate of Change Arrows, and Errors...
Page 170 It’s important to track actions or well-being, to better understand that what you do or how you feel can change your trends. In the next chapter, you will learn how to enter Events into your G5 Mobile. Dexcom G5 Mobile System User Guide...
Page 171: Chapter 10
Chapter 10 Next Steps - Getting the Most out of Your G5 Mobile: 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”.
Page 172 An Event is an action or situation affecting your glucose levels. With the G5 Mobile, 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.
Page 173 Receiver’s screen or meal, up to reflects last 250 grams. number entered. Receiver Device What you see What it means What you do Insulin Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 174 Receiver’s screen units. reflects last number entered. Can’t enter type of insulin, only dosage. Receiver Device What you see What it means What you do Exercise Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 175 Default is 30 minutes. Enter intensity and duration. Type of exercise isn’t an option. Receiver Device What you see What it means What you do Health Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 176 Enter different health Events General well- (see following being. Health Events Menu table). Receiver Device What you see What it means What you do Event Time Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 177 You select the Event: no amounts are entered, just date and time. Health Events Menu Device What you see What it means Health Main Menu Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 178 What you see What it means Smart Device: In App Use Health Main Menu to access selections. Receiver Device What you see What it means Health Main Menu Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 179 As an example, you’re running late because of traffic (Stress) and quickly swing by a drive-thru to get lunch (Carbs of 85 grams). Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 180: Entering Events
Part 5. Enter Events: Smart Device In the G5 Mobile app, Events are just a tap away! The Event icon, a running man, is on the app’s home screen’s task bar in portrait mode (remember, you don’t have the task bar in landscape).
Page 181 What you see What you do Carbs Enter Carbs Event Using the above example, add up all carb grams from lunch. Enter “85” using keypad. Done Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 182 Event Time Enter Carbs Event Scroll and select date and time. Done Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 183 Save Cancel Enter Stress Event Events icon. Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 184 Health Enter Stress Event Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 185 Stress Done Event Time Enter Stress Event Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 186 Scroll and select date and time Done. Save Cancel. View Events Trend graph shows events. Turn to landscape to see more. Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 187 The receiver and app don’t talk to one another. If you enter an Event only into the receiver, while the information will appear on Dexcom reports, you won’t get an Event marker on your app’s Trend screen. The app has Event markers on its screen, but the receiver doesn’t.
Page 188 Minutes to select them. up/down arrow to change minutes. AM/PM to select it. up/down arrow to change between AM and PM. Done to save and close. Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 189 Confirmation screen. Save Enter Health Event Health. Stress Enter Health Event Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 190: Viewing Events
Save. 10.4 Viewing Events Events entered into your receiver can only be viewed on a Dexcom report; there are no markers on your receiver’s screen. On your smart device, turn to landscape to view your Event markers. A single small square marks all Events entered on your smart device.
Page 191 In the next chapter, you will learn about your trend’s Alarm and Alerts helping you monitor your glucose levels. You’ll also learn how you know when your system loses its signal and stops communicating. Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns...
Page 192: Chapter 11
Successfully clear an Alert • Receiver Your trending information is one of the greatest benefits of the G5 Mobile. It’s important to focus on your trends and rate of change arrows, rather than the exact number of your glucose reading.
Page 193: Safety Statements
Never assume the G5 Mobile’s Alarm/Alert vibrations are different Don’t: from other vibrating apps. Look at your smart device and check if vibration is a G5 Mobile Alarm or Alert. Why: Medical device apps don’t have special priority over your smart device’s features.
Page 194 If you set up one device and then use another, you won’t get an Alarm or Alert. Consequences: Missing severe low or high glucose Alarm or Alerts. Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 195: Alarm And Alerts
Think of them as an FYI: You need to know what’s 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). Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 196 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 a. Default setting is Off—No Alert. Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 197: Alarm And Alerts Screens
The default setting for Signal Loss is On. Now you have the basics for the G5 Mobile’s Alarm/Alerts features. Next, you will learn about each Alarm/Alert in more detail.
Page 198 Receiver Low/High Glucose Alerts Device What you see What it means Sensor glucose reading at or Smart Device: below your low Alert level. Lock Screen Shows most current sensor Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 199 In App Receiver Device What you see What it means Sensor glucose reading at or Smart Device: above your high Alert level. Lock Screen Shows most current sensor Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 200 Check BG meter to make Smart Device: treatment decisions. In App Receiver Rise Rate/Fall Rate Alerts Device What you see What it means Smart Device: Sensor glucose readings Lock Screen rising quickly. Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 201 Number of arrows shows how fast (2 mg/dL/min; 3+ mg/dL/min) glucose is rising. Check BG meter to make any treatment decisions. Smart Device: In App Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 202 Receiver Device What you see What it means Smart Device: Sensor glucose readings Lock Screen falling quickly. Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 203 Number of arrows shows how fast (2 mg/dL/min; 3+ mg/dL/min) glucose is falling. Check BG meter to make any treatment decisions. Smart Device: In App Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 204 What it means Smart Device: Your receiver and Lock Screen transmitter are not communicating. You will not receive glucose readings or Smart Device: Alarm/Alerts. In App Check BG meter to Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 205: App: Alarm/Alert Recommended Settings
• When your smart device is in Do Not Disturb mode, you won’t receive • any Alarm/Alerts. The G5 Mobile app can’t override the Do Not Disturb setting If you don’t enable your G5 Mobile push Notifications settings during •...
Page 206 Alarm level. After 30 Minutes: After clearing Alarm, continues to notify if sensor glucose readings remain at or below Alarm level. Low/High Glucose Alerts What you see Beeps and vibration Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 207 Alert level. Trend screen will continue to reflect Alert until sensor glucose readings go below Alert level. Rise Rate/Fall Rate Alerts What you see Beeps and vibration Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 208 Initial Default Alert: None/Off. After Setting Change: Vibrates 3 times. After 5 Minutes: Vibrates/beeps 3 times every 5 minutes until cleared or sensor glucose reading fall rate rises above Alert level. Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 209 Vibrates 2 times. After 5 Minutes: Vibrates/beeps 2 times every 5 minutes until cleared or sensor glucose reading drops below Alert level. Signal Loss Alert What you see Beeps and vibration Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 210: Clearing Alarm/Alerts
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 it means Alarm Alert Smart Device: Slide Lock Screen access app. Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 211 Alert’s 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 • Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 212 Low Glucose Alert if your glucose levels don’t improve, even though you cleared the message? How do you make your Alarm/Alerts fit your needs? Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts...
Page 213: Chapter 12
Chapter 12 Next Steps - Getting the Most out of Your G5 Mobile: 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 don’t reflect the glucose level that works best for you.
Page 214: Changing App Alarm And Alerts
If using both receiver and app 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.
Page 215 All customizable Alarm and Alerts. Current Alert settings. Alarm/Alert All Alerts have: want to change. On/Off switch • Notify me • options Sound options • Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 216 Repeat preset • change sound. at 30 minutes and can’t be changed Sound is the • only change option Steps to Customize App Alarm/Alerts Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 217 Customizing Alerts: App Step What you see What it means What you do Access Alerts Main Menu Main Menu Access Main Menu. icon. Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 218 Step What you see What it means What you do Access Alerts Main Alerts. Menu. Changing an Alert Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 219 High mg/dL. settings (mg/dL). High Alert Check Shows High Alert options and current • On - Orange settings. Off - Gray • Changing an Alert Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 220 Slide to Won’t get Alerts if Off. • On - Orange • Off - Gray Notify Me Change High Alert Above (mg/dL). Changing an Alert Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 221 Saves new High Alert glucose level (mg/dL). High Returns to Save Glucose Alert screen options. Notify Me Above at 190 mg/dL. Changing an Alert Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 222 Changing the current selection repeat setting. Scroll wheel Can select in 5- minute steps (range Stop at 1 hour. 15 minutes-4 hours). Changing an Alert Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 223 High Returns to Glucose Alert screen Save. options. Repeat shows how often you’ll get notified. Customize Alert Sound. sound. Changing an Alert Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 224 Sound again to sound setting. hear sound sample. Saves your new Alert sound. back arrow. High Return to Glucose Alert Menu. Changing an Alert Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 225 Any changes to the app will not carry over to the receiver. If using both, make the same changes in the receiver you made in your smart device. If you don’t, you may miss an Alarm or Alert. Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 226: Changing Receiver Alarm And Alerts
55 mg/dL or you confirm by tapping on your screen. The next table lists the different Sounds, starting with the quietest, working its way up to the loudest. Alarm/Alert Sounds Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 227 In a meeting? Select Vibrate Attentive . Going to a ball game after work? Select Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 228 What it means What you do Menu Go to Main Menu. icon. Sounds. Change your Sounds. Choose one your choice. Selected Sound is check marked. Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 229 Alerts Menu The Alerts menu gives you options for personalizing your glucose level Alerts and turning on your Rising/Falling and Signal Loss Alerts. Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 230 Follow these same steps for turning on the Rise/Fall Rate Alerts and adjusting your Low Alerts. Customizing Alerts: Receiver Step What you see What it means What you do Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 231 Change Low Alert Level Menu Go to Main Menu. icon. Alerts option from the Alerts. Main Menu. Alert’s current settings. Low. Change your current Low Alert level. Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 232 Alert keep prompting you. Initial screen shows current repeat up/down minutes. arrows. Change time frame in Stop at 60 minutes. 15-minute increments. Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 233 Now You Can: Customize your glucose trend Low/High Glucose Alerts • Receiver Adjust Alarm sound • Set up other Alerts • Low/High Repeat Rise/Fall Rate Dexcom G5 Mobile System User Guide On the Go With G5: Customizing Your Alarm and Alerts...
Page 234 Signal Loss What’s Next? Believe it or not, you are becoming a pro at using your G5 Mobile! You’ve 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!
Page 235: Everything Else G5
EVERYTHING ELSE G5 Warranty • Maintenance • • Travel Tips • Customer Service Contacts • Technical Information Troubleshooting • Symbols on Package Labels • Dexcom G5 Mobile System User Guide Warranty: The Fine Print...
Page 236: Chapter 13
What’s Covered and for How Long? Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser (“you” or “Purchaser”) that the 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”):...
Page 237 Dexcom’s Obligations Under the Limited Warranty During the Warranty Period, Dexcom will replace, without charge to purchaser, any defective G5 Movile receiver. To return, you must send the receiver to an authorized Dexcom Technical Support Department. Make sure you package the receiver adequately for shipping.
Page 238 G5 Mobile or any feature or service provided by Dexcom for use with the G5 Mobile.
Page 239: Transmitter Warranty Information
What’s Covered and for How Long? Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser that the 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)
Page 240: Dexcom's Obligations Under The Limited Warranty
13.4 Dexcom’s Obligations Under the Limited Warranty During the Warranty Period, Dexcom will replace, without charge to purchaser, any defective 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.
Page 241 G5 Mobile or any feature or service provided by Dexcom for use with the G5 Mobile.
Page 242 Limited Warranty. This Limited Warranty will be enforced to the maximum extent permitted by law. Dexcom G5 Mobile System User Guide Warranty: The Fine Print...
Page 243: Chapter 14
Chapter 14 Everything Else G5: How to Take Care of Your G5 Mobile 14.1 Introduction There are not a lot of moving parts in the G5 Mobile, so maintenance is relatively simple: • Keep it clean • Keep display device(s) dry and protected •...
Page 244: Safety Statements
Why: If dirt or water gets into the USB port, the receiver could become damaged and stop displaying readings or providing Alerts. Consequences: You might miss a severe low or high glucose event. Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 245 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. Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 246: Basic Maintenance
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 Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 247 Step What you see What it means What you do Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 248 What you see What it means What you do Low Battery Charge your battery. USB cable Plug into Micro USB Port port for recharging. Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 249 USB cable Plug into adapter/wall charger Plug wall charger Wall Charger into an electrical outlet to charge receiver’s battery. Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 250 Do not force cables in place. 3. Look at cables for signs of wear and tear. Do not use if worn or Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 251: Storage
There is no repair service available for any G5 Mobile parts. If you experience problems, report the issue to Technical Support (available 24/7) at: • TechSupport@dexcom.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 14.4 Storage Storing your G5 Mobile correctly helps prevent system failures.
Page 252: Checking App And Receiver Information
Part number • Part revision • Software • number Check: Insertion time • Last calibration • Device information Software • menu number and revision Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 253: System Disposal
Consult your area’s local waste management authorities for proper disposal instructions. Taking care of your G5 Mobile is pretty easy. In the next chapter, “On the Go With G5 Mobile: Getting Through Security,” you’ll learn how simple it is to...
Page 254 Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System...
Page 255: Chapter 15
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 covers only the G5 Mobile. It doesn’t cover steps you need to take when traveling with your smart device. See your smart device’s instructions to learn how to travel with it.
Page 256: Going Through Security
Never bring the G5 (sensor applicator, transmitter, and receiver) into Don’t: an AIT body scanner (airport body scanner). Never put any part of the G5 in the baggage x-ray machine. Request hand-wanding or full-body pat-down and visual inspection instead. Why: The system has not been tested in AIT scanners.
Page 257 Before your screening process begins, ask the TSA Officer to perform a visual inspection of the receiver and your extra sensors. Place all 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 manufacturer’s instructions or the TSA website.
Page 258 Phone: 1.866.289.9673 Dexcom G5 Mobile System User Guide On the Go With Dexcom G5 Mobile CGM System: Getting Through Security...
Page 259: Chapter 16
Chapter 16 Everything Else G5: Need Help? You’re Not Alone! Dexcom has three support teams to help you, each with their own specialty: Dexcom Technical Support Team • Dexcom Patient Care Team • Dexcom Sales Support Team • 16.1 Dexcom Technical Support The Dexcom Technical Support Team helps you with all CGM system–related...
Page 260: Dexcom Patient Care Team
• Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 16.2 Dexcom Patient Care Team The Dexcom Patient Care Team is a group of Certified ® Diabetes Educators (CDE ) and Registered Nurses (RNs) offering you customer care and individualized education services around Dexcom CGM.
Page 261: Dexcom Sales Support Team
Locating a local Dexcom representative • By Internet Dexcom online store: dexcom.com/order By Email Email: CustomerService@dexcom.com By Phone Dexcom Inside Sales Support phone numbers: Toll free: 1.888.738.3646 Toll call: 1.858.200.0200 By Fax Dexcom G5 Mobile System User Guide Need Help? You’re Not Alone!
Page 262: Corporate
1.877.633.9266 16.4 Corporate Dexcom Website: Dexcom.com Dexcom Address: 6340 Sequence Drive San Diego, CA 92121 Dexcom G5 Mobile System User Guide Need Help? You’re Not Alone!
Page 263: Chapter 17
NOTE: We recommend that you review the information in this chapter with your healthcare professional to understand how well the G5 Mobile performs. The G5 Mobile (the system) uses a glucose sensor to continuously measure and monitor your glucose levels. The sensor is “calibrated” using a commercially available BG meter.
Page 264 Software 505 Pediatric Study: the receiver included software version SW10505 The G5 Mobile incorporates the algorithm from software version SW10505 and has a new software number. Overview of Adult Studies The system performance for adults was evaluated in two separate prospective...
Page 265 6-17 also provided venous blood for comparison to a laboratory method, the Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer. Original Pediatric Study, This instrument is referred to as the “YSI.” In the Dexcom G5 Mobile System User Guide Technical Information...
Page 266 BG results. The remainder of the study took place at home, and the system performance was also paired with the comparative meter results, referred to as the “SMBG.” Dexcom G5 Mobile System User Guide Technical Information...
Page 267 Original 301-350 Software 505 Original 351-400 Software 505 CGM readings are within 40-400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 268 Original 301-350 Software 505 Original 351-400 Software 505 CGM readings are within 40-400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 269 2263. Of these, 93% of the system readings fall within ± 20 mg/dL of the YSI BG values ≤ 80 mg/dL and within ± 20% of YSI BG values > 80 mg/dL. Dexcom G5 Mobile System User Guide Technical Information...
Page 270 > 240 ≤ 240 Readings Pairs Original Cumulative Percent “HIGH” Software Cumulative 100% 100% Percent Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 271 When the 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 Dexcom G5 Mobile System User Guide Technical Information...
Page 272 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 273 25% 60% 13% 1492 161-200 28% 53% 16% 1240 201-250 21% 51% 21% 1181 251-300 19% 49% 24% 1018 301-350 28% 51% 16% 351-400 10% 43% 38% 21% 57% 15% > 400 Dexcom G5 Mobile System User Guide Technical Information...
Page 274 19% 68% 13% 81-120 19% 72% 121-160 17% 72% 11% 161-200 25% 59% 16% 201-250 16% 70% 13% 251-300 16% 61% 14% 301-350 28% 59% 10% 351-400 47% 45% 20% 38% 42% > 400 Dexcom G5 Mobile System User Guide Technical Information...
Page 275 21% 45% 30% 81-120 20% 66% 12% 121-160 36% 54% 161-200 40% 48% 201-250 44% 41% 251-300 50% 36% 301-350 18% 59% 21% 351-400 28% 50% 16% 14% 41% 36% > 400 Dexcom G5 Mobile System User Guide Technical Information...
Page 276 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 BG levels are within 81 to 120 mg/dL 72% of time. Dexcom G5 Mobile System User Guide Technical Information...
Page 277 Software 505 (SW10505). For CGM ≤ 80 mg/dL, the difference and absolute difference in mg/dL are included instead of percent differences (%). Table 4-B. System Difference to YSI Within CGM Glucose Ranges (Pediatric) Dexcom G5 Mobile System User Guide Technical Information...
Page 278 Both 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 (%). Dexcom G5 Mobile System User Guide Technical Information...
Page 279 2.4% or less than the YSI BG values and the Median Absolute Percent Difference shows that half of the time the system reads about 7.0% or less than the YSI BG values. Dexcom G5 Mobile System User Guide Technical Information...
Page 280 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 281 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 282 YSI results at low and high BG levels and determining if the Alert may have sounded. The system and YSI values were compared by pairing the system reading that occurred immediately after the Dexcom G5 Mobile System User Guide Technical Information...
Page 283 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 284 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 285 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 286 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 287 Software 505 Original Software 505 Original Software 505 100% Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 288 Detection Rate is the % of time the BG was at or above the Alert setting, but the device did not Alarm within 15 or 30 minutes before or after the BG was at or above the Alert setting. Dexcom G5 Mobile System User Guide Technical Information...
Page 289 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 290 Software 505 Original 12-14 hours Software 505 CGM readings are within 40 to 400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 291 12-14 hours 100% 100% 100% Software 505 CGM readings are within 40 to 400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 292 11.9% 8.9% Software 505 8.5% 7.2% CGM readings are within 40 to 400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 293 15.1% 11.3% Software 505 10.4% 8.4% CGM readings are within 40 to 400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 294 12.4% 9.2% Software 505 11.3% 8.6% CGM readings are within 40 to 400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 295 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 296 Software 505 856-856 Original 1267-1267 51-75% Software 505 1253-1253 Original 1811-1992 76-100% Software 505 1497-1992 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 297 Software 505 877-891 Original 1006-1484 51-75% Software 505 1131-1342 Original 1518-1992 76-100% Software 505 1623-1990 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 298 Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). A total of 108 sensors were included with the Original Study and 51 sensors were included with the Software 505 Study. Dexcom G5 Mobile System User Guide Technical Information...
Page 299 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 300 Software 505 Original 351-400 Software 505 CGM readings are within 40 to 400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 301 Software 505 Original 351-400 Software 505 CGM readings are within 40 to 400 mg/dL, inclusive. Both sets of study data are presented and are labeled as Original (SW10050) or Software 505 (SW10505). Dexcom G5 Mobile System User Guide Technical Information...
Page 302 Both 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 (%). Dexcom G5 Mobile System User Guide Technical Information...
Page 303 Both 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 (%). Dexcom G5 Mobile System User Guide Technical Information...
Page 304: Product Specifications
No infection, bruising, or bleeding occurred at the sensor needle insertion area or the adhesive area. 17.2 Product Specifications Dexcom G5 Mobile System User Guide Technical Information...
Page 305 Transmitter Product Specifications Part Number 9438-06 Length: 1.5 inches Dimensions (Including Width: 0.9 inches Sensor Pod) Thickness: 0.5 inches Weight (Including Sensor 0.4 ounces Pod) Power Supply Silver oxide batteries (not replaceable) Dexcom G5 Mobile System User Guide Technical Information...
Page 306 IP28: Protection against insertion of large objects and immersion in water for up to 8 feet for 24 hours Moisture Protection Protection against submersion in water Protection Against Type BF applied part Electrical Shock Dexcom G5 Mobile System User Guide Technical Information...
Page 307 Data Communication Range 20 feet The G5 Mobile System is an M-PED (Medical-Portable Electronic Device), which meets the FAA RTCA /DO-160 edition G section 21, Category M. It can be used on aircraft according to the directions provided by the operator of the aircraft.
Page 308 Every 5 minutes Length: 4.0 inches Dimensions Width: 2.5 inches Thickness: 0.55 inches TX/RX Frequencies 2.402-2.480 GHz Bandwidth 1.22 MHz Maximum Output Power 2.5 mW EIRP Modulation Gaussian Frequency-Shift Keying Data Rate 1 Mbps Dexcom G5 Mobile System User Guide Technical Information...
Page 309 1 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 310 Field commercial or hospital IEC 61000-4-8 environment. NOTE: U is the a.c. mains voltage prior to application of the test level. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity Dexcom G5 Mobile System User Guide Technical Information...
Page 311 The G5 Mobile System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the G5 Mobile System should ensure that it is used in such an environment. System Electromagnetic Immunity Specifications...
Page 312 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The G5 Mobile System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the G5 Mobile System should ensure that it is used in such an environment.
Page 313 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 314: Fcc Requirements
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. Dexcom G5 Mobile System User Guide Technical Information...
Page 315 Dexcom G5 Mobile System User Guide Technical Information...
Page 316 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. 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. Dexcom G5 Mobile System User Guide Technical Information...
Page 317: Chapter 18
If any of these errors continue and the instructions don’t resolve the issue, please contact Technical Support (available 24/7) at: • TechSupport@dexcom.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 18.2 Safety Statements Following are the Safety Statements for the Troubleshooting chapter. Dexcom G5 Mobile System User Guide Troubleshooting...
Page 318: Troubleshooting
Types of obstruction differ and not all types have been tested. Obstructions can include water, walls, metal, etc. Water (for example, swimming, surfing, bathing, etc.) can severely limit communication range. Consequences: Missing severe low or high Alarm or Alerts. 18.3 Troubleshooting Dexcom G5 Mobile System User Guide Troubleshooting...
Page 319 Not receiving notifications are Alarm/Alerts. turned on. Check your smart device is not on Silent or Do Not Disturb (if applicable). Receiver Sensor Glucose Readings Device What you see Problem What you do Dexcom G5 Mobile System User Guide Troubleshooting...
Page 320 188 mg/dL glucose meter value = a 7% Receiver difference (this is still considered accurate). Outside of 20/20 rule: Calibrate again. Device What you see Problem What you do Dexcom G5 Mobile System User Guide Troubleshooting...
Page 321 Not getting Make sure you haven’t sensor glucose readings. taken acetaminophen. Don’t calibrate. Use BG Receiver meter for BG reading. If this continues for more than 3 hours, contact Technical Support (see Chapter 16). Dexcom G5 Mobile System User Guide Troubleshooting...
Page 322 Settings. Go to Alarm/Alerts or Receiver notifications Bluetooth display until Bluetooth Turn error is fixed. Off and On. App/Receiver: If this continues for more than 3 hours, contact Technical Support (see Chapter 16). Dexcom G5 Mobile System User Guide Troubleshooting...
Page 323 Safety lock stuck. • Follow direction of safety lock arrow See Chapter 6. Collar Use force when pulling the collar up. won’t pull white plunger Check is completely down—flush to the applicator barrel. Dexcom G5 Mobile System User Guide Troubleshooting...
Page 324 Put medical tape over sensor pod’s white adhesive patch (for example, Sensor pod Blenderm). won’t stick. Don’t place tape over the transmitter. Hardware Error Device What you see Problem What you do Dexcom G5 Mobile System User Guide Troubleshooting...
Page 325 10 seconds power Release After full button charge Receiver Press and hold session: for 2 seconds to Won’t turn on. turn back on receiver Connect charger Receiver will turn on. Processing screen appears. Dexcom G5 Mobile System User Guide Troubleshooting...
Page 326 Charge and icon. Wait a few seconds for Loading System Check Passed screen Receiver or Contact Technical displays Support Error screen unexpectedly. (see next rows). Device What you see Problem What you do Dexcom G5 Mobile System User Guide Troubleshooting...
Page 327 BG reading until resolved. See Chapter 16. This locks your screen. Write down error code. Repeated Contact Dexcom Receiver hardware Technical Support (see error. Chapter 16.1).. Check BG value using BG meter. Dexcom G5 Mobile System User Guide Troubleshooting...
Page 328 BG meter values range. are between 40-400 mg/dL. See Chapter 7. System didn’t accept recent App: Smart calibration (see question mark Device: Sensor get more information. In App Glucose Receiver: Readings troubleshooting Wait 15 minutes. Dexcom G5 Mobile System User Guide Troubleshooting...
Page 329 If error screen still In App Alarm/Alerts or appears enter 1 more notifications BG meter value. display until Wait 15 minutes. error is fixed. If no sensor glucose readings appear on the Dexcom G5 Mobile System User Guide Troubleshooting...
Page 330 Sensor session Support (See Chapter automatically 16). stopped. Use BG meter for BG No sensor reading. readings, You won’t get Alarm/Alerts or additional alerts after Receiver notifications clearing. display until error is fixed. Dexcom G5 Mobile System User Guide Troubleshooting...
Page 331 Insert a new sensor. Alarm/Alerts or For a replacement, notifications contact Technical display until Support (see Chapter error is fixed. Receiver 16.1). Device What you see Problem What you do Dexcom G5 Mobile System User Guide Troubleshooting...
Page 332 Device What you see Problem What you do Smart Device: In App Transmitter low Order a new battery prompt. transmitter. Receiver Dexcom G5 Mobile System User Guide Troubleshooting...
Page 333: Chapter 19
Symbols on Package Labels The following symbols may be found on the sensor, transmitter, and receiver packaging. These symbols tell you about the proper and safe use of the G5 Mobile System. Some of these symbols may not have meaning in your region, and are listed for informational purposes only.
Page 334 MR Unsafe European Council Directive 93/42/EEC Non-Ionizing Prescription Required Radiation Refer to Instruction Serial Number Manual/Booklet Ship By Date Sterile by Radiation Temperature Type BF Applied Part Limitation Use By Date Dexcom G5 Mobile System User Guide Symbols on Package Labels...
Page 335: Sharing Is Caring
SHARING IS CARING Share • Dexcom Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 336: Chapter 20
A setting on a smart device where wireless features are disabled in order to comply with airline regulations. Application or App A software program, such as the G5 Mobile app and ® the Dexcom Follow app, designed to run on a smart device.
Page 337 Follower A person that gets the Sharer’s shared information in the Dexcom Follow app. Follow Dashboard On the Dexcom Follow app, the Follow Dashboard shows the glucose information of up to five Sharers. Follower’s Smart Runs the Dexcom Follow app.
Page 338 Dexcom Cloud using an Internet connection. Hyperglycemia High BG. Same as “high.” The Default High Glucose Alert in the G5 Mobile is set to 200 mg/dL. Consult your healthcare professional to determine the appropriate hyperglycemia setting for you. Dexcom G5 Mobile System User Guide...
Page 339 Hypoglycemia Low BG. Same as “low.” The Default Low Glucose Alert in the G5 Mobile is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemia setting for you. Invite/Follow An email request for a person to download the Invitation Email Dexcom Follow app and get the Sharer’s shared...
Page 340 Data the Sharer receives on the G5 Mobile app. Although your Dexcom Follow app might be similar to what you see on your G5 Mobile app, it cannot be considered real-time because there are layers of communication between the G5 Mobile app and the Dexcom Follow app.
Page 341 Smart Device A cordless (unless charging), mobile (easily transportable), connected (via Wi-Fi, 3G, 4G, etc.) electronic device that can operate the G5 Mobile app or the Dexcom Follow app. Examples of smart devices are smartphones or tablets. For a list of compatible smart devices, see dexcom.com/compatibility.
Page 342: Dexcom Share Overview
Share 20.2 Dexcom Overview Share Dexcom is a feature within the G5 Mobile app. It allows for remote monitoring from one person, the Sharer, to another person, the Follower, of G5 Mobile data. Share Dexcom includes: G5 Mobile System •...
Page 343 Dexcom Follow app G5 Mobile transmitter* G5 Mobile/G4 PLATINUM Sensor* Internet/Wi-Fi or mobile data service/3G/4G/LTE* Bluetooth Must be purchased separately. A list of compatible devices can be found at dexcom.com/compatibility. Conditions Affecting Use Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 344: Risks And Benefits
Dexcom recommends charging the smart device while sharing. 20.3 Risks and Benefits Risks Share Dexcom is a feature of the G5 Mobile . The main risks involved with Share using the Dexcom feature are based on misunderstanding its purpose. Share...
Page 345: Safety Statement
The Dexcom feature may provide improved quality of life and greater peace of mind to patients, their caregivers and their support team by allowing the G5 Mobile Alarm, Alerts, and trend graphs to be checked remotely. 20.4 Safety Statement Intended Use...
Page 346 Share is a feature of the G5 Mobile. If you do not have the Dexcom G5 Mobile System User Guide, you can view it on dexcom.com or call 1.888.738.3646 to request a copy. Availability hours: Monday-Friday, 6am-6pm PST. Please contact your healthcare professional during hours the line is unavailable.
Page 347 Share Do not use Dexcom as the main source of CGM glucose trend information. Use the G5 Mobile receiver as the main device to track sensor glucose information, notifications and Alarm. Share At times, the patient will be unable to share data using Dexcom...
Page 348 BG values. If the patient’s smart device is powered off or restarted, make sure the G5 Mobile app is reopened after the smart device is turned back on in order to resume sharing.
Page 349: Setting Up Dexcom Share
Let you know when the Follower is not receiving your sensor glucose • readings and information Tips • Read the rest of the G5 Mobile user guide before using Dexcom Share Always confirm information with a BG meter before making treatment • decisions...
Page 350 Step What you see What you do Download the G5 Mobile app from your app store. See your smart device’s user manual for instructions. Download the G5 Mobile app to use Dexcom Share Launch the G5 Mobile app. Set up your smart device (see Chapter 5) before sharing.
Page 351 Share feature home screen. has not been turned on. Share Dexcom Read screen. Welcome Next when done. Screen. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 352 Step What you see What it means What you do Message about Next Internet access. How to know you Next are sharing your data. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 353 Let’s Get Started your Follower is move on and invite your not getting your Followers. sensor data. Inviting Followers Step What you see What you do Invite Followers to set up your Followers. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 354 Enter the Follower’s nickname and email address. Confirm Follower’s email address. The Follower will get a Follow Invitation email. Make sure the Follower can access this email account from smart device. Next Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 355 Follower to see your trend graph. 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. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 356 200 mg/dL for more than 2 hours, you can set up in the Follower’s Settings menu). Save for each Follower Setting “Save.” Next when done. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 357: Using Dexcom Share
After sending invitation, you cannot adjust the Follower’s settings. To add more Followers: Followers Share tab on the status screen. Invite up to a total of five (5) Followers. Share 20.6 Using Dexcom Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 358 Figure 9. Share Status Share Dexcom Status Icons Status Tab What it is Share Share icon is in color when Dexcom sending sensor glucose readings and information. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 359 The Sharer should tap the light gray icon to get started Share using Dexcom Share When a device or connection is not working, Dexcom will not work. The Sharer will not be able to send sensor glucose readings and data to Follower(s).
Page 360 NOTE: Whether or not Dexcom is working and the Followers are receiving glucose Alarm/Alerts, you must always refer to your 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.
Page 361 If the Sharer continues to see this, the Sharer Share should turn off then turn it back on. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 362 The Followers list allows the Sharer to manage Followers. In the Followers list the Sharer can: Invite a new Follower • See the status of Followers that have been invited • Glance at what options current Followers have • Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 363 Tap on a Follower to edit the Follower’s profile (nickname or ability to view trend graph) or remove a Follower. Remove a Follower by tapping “Remove Follower.” Once removed, that Follower won’t get glucose information or Alarm/Alerts. Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 364 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 G5 Mobile app. Followers only need to download and install the Dexcom Follow app. What the Dexcom Follow app does: •...
Page 365 No More Data - Prompt sent when active glucose sharing is stopped • Share for any reason, other than the Sharer turning “Off” The Follower should contact the Sharer for more information about the data interruption The Follower Dashboard Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 366 If the Sharer doesn’t allow the Follower to see the trend graph, he/she will only see the glucose reading and trend arrow. Figure 12. Follower Information If the Sharer chooses to have the Follower see the trend graph, he/she will see: Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 367 Your smart device works with the G5 Mobile app. • To see a list of supported smart devices and operating systems, go to: dexcom.com/compatibility The G5 Mobile app is open or running in the background • Your smart device has an active Internet connection (Wi-Fi, 3G, 4G, •...
Page 368 Smart device has 35 MB of available memory • Refer to the smart device user manual for further instructions Tips Share Read the G5 Mobile user guide before using the Dexcom • feature Always confirm information with a BG meter before you make •...
Page 369 INDEX for G5 MOBILE AND SHARE DEXCOM Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 370 Term XXXXX, Page## | Index Term XXXXX, Page## Term XXXXX, Page## Term XXXXX, Page## Dexcom G5 Mobile System User Guide Sharing is Caring...
Page 371 © 2016 Dexcom, Inc. All rights reserved. Covered by patents www.dexcom.com/patents. Dexcom, Dexcom Follow, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G5, Share Dexcom G5 Mobile, Dexcom are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries.
Page 372 Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA Phone: 1.858.200.0200 Technical Support: 1.888.738.3646 Web: dexcom.com LBL013715 Rev 004 MT23627 Dexcom G5 Mobile System User Guide Sharing is Caring...