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1 2 3 | User Manual | Users Manual | 1.17 MiB | / October 01 2018 |
LBL014003 Rev 001 Dexcom G6 User Guide 0 Table of Contents Part 1: Get Started Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey 1.1 Introduction 1.2 Resources 1.3 Your Dexcom Account 1.4 What's Covered and What's Coming Chapter 2: Indications for Use and Safety Statements 2.1 Introduction 2.2 What Are Safety Statements?
2.3 How to Read Safety Statements 2.4 Overview of Safety Statements 2.5 What's Covered and What's Coming Chapter 3: Risks and Benefits 3.1 Risks 3.2 Benefits 3.3 What's Covered and What's Coming Part 2: Let's G6! The Basics Chapter 4: What is the G6?
4.1 Introduction 4.2 G6 CGM System 4.3 What's New for G6?
4.4 G6 Components 4.5 What's Covered and What's Coming Chapter 5: Set Up Your Display Devices 5.1 Introduction 5.1 Choose the App, Receiver, or Both 5.3 App 5.4 Receiver 5.5 What's Covered and What's Coming Chapter 6: Start Your Sensor 6.1 Introduction 6.2 Prepare to Insert Sensor 6.3 Choose Sensor Site 6.4 Insert Sensor 6.5 Attach Transmitter 6.6 Pair and Start Your Sensor 6.7 Pairing Tips 6.8 What's Covered and What's Coming Chapter 7: Calibrate 7.1 Introduction 7.2 Calibration Overview 7.3 Prepare to Calibrate 7.4 G6 Calibrations 7.5 Calibrate Only When Prompted (and Exceptions) 7.6 Check in with Jake and Kelly 7.7 What's Covered and What's Coming Part 3: Next Steps Chapter 8: Home Screen 8.1 Introduction 8.2 Home Screen Overview 8.3 Glucose Information 8.4 Navigation and Status Bar 8.5 What's Covered and What's Coming Chapter 9: Events 9.1 Introduction 9.2 Event Overview 9.3 Enter Insulin Event 9.4 Other Events 9.5 Edit and Delete an Event in Your App 9.6 View Events 9.7 What's Covered and What's Coming Chapter 10: Alarm and Alerts 10.1 Introduction 10.2 Alarm and Alerts 10.3 Check in with Kelly xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx LBL014003 Rev 001 Dexcom G6 User Guide 1 10.4 Confirming Alarm/Alerts 10.5 Customizing Your Alerts Overview 10.6 Why Customize Alerts?
10.7 Check In with Jake and Kelly 10.8 App: Alert Schedule 10.9 What was Covered and What's Coming Chapter 11: Treatment Decisions 11.1 Introduction 11.2 Your HCP Is Your Partner 11.3 Using your G6 for Treatment Decisions 11.4 Check In With Jake and Kelly 11.5 You Decide!
11.6 What's Covered and What's Coming Chapter 12: Share Information With Your Support Team 12.1 Introduction 12.2 Share and Follow 12.3 Check In With Jake and Kelly 12.4 CLARITY Overview 12.5 What's Covered and What's Coming Chapter 13: End Sensor and Transmitter Sessions 13.1 Introduction 13.2 End Your Sensor Session 13.3 Remove Sensor 13.4 End of Transmitter Battery 13.5 Pair New Transmitter 13.6 What's Covered and What's Coming Chapter 14: Troubleshooting 14.1 Introduction 14.2 Alarm/Alerts and Readings 14.3 Applicator 14.4 App 14.5 Receiver 14.6 Calibration 14.7 Transmitter 14.8 Sensor 14.9 Share Part 4: Appendices Appendix A: Glossary Appendix B: Need Help? You're Not Alone. B.1 Dexcom Technical Support Team B.2 Dexcom Patient Care Team B.3 Dexcom Sales Support Team B.4 Corporate Appendix C: Go Through Security and Fly C.1 Introduction C.2 Going Through Security C.3 In the Plane Appendix D: Extend Your App D.1 Introduction D.2 Today View (Apple) D.3 Quickl Glance (Android) D.4 Smart Watches Appendix E: Take Care of Your G6 E.1 Introduction E.2 G6 Maintenance E.3 Storage E.4 Checking App and Receiver Information E.5 System Disposal Appendix F: Warranty F.1 Introduction F.2 Receiver Warranty Information F.3 Transmitter Warranty Information F.4 Dexcom's Obligations Under the Limited Warranty Appendix G: Technical Information G.1 Device Performance Characteristics G.2 Product Specifications G.3 FCC Requirements Appendix H: Label Symbols Appendix I: Alarm/Alerts Vibrations and Sounds LBL014003 Rev 001 Dexcom G6 User Guide xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx xx 2 Index xx LBL014003 Rev 001 Dexcom G6 User Guide 3 LBL014003 Rev 001 Dexcom G6 User Guide 4 Chapter 1 Get Started:
Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey 1.1 Introduction Welcome to the G6 continuous glucose monitoring (CGM) family!
This User Guide supports you in getting to know your G6. We also have numerous other resources available to help you to get the most out of your G6. After this chapter, youll be able to:
Locate different training resources Explain why you need a Dexcom account Images in this User Guide are representational and may differ from your system. 1.2 Resources Tutorial Our tutorial walks you through your first sensor session, including picking a display device, inserting the sensor, and using alarm/alerts. Your First Sensor Session tutorial is available two ways:
Online: dexcom.com/Support USB card: In the receiver package In-App Videos Watch the videos in your app to find out more:
Overview: See how your CGM shows where your sensor glucose is now, where its going, and where its been Sensor Insertion: Walks through inserting your sensor Transmitter Attachment: Walks through snapping your transmitter into place Treatment Decisions: Learn how to use your G6 to make treatment decisions, like dosing for highs and treating for lows You can watch these videos when you set up your app or anytime at Settings > Help > Videos. Guides Getting Started Guides Two guides included in your receiver package:
Getting Started: Your First Sensor Session complements the tutorial by providing the same instructions in a book. You can use it with the tutorial or on its own!
Beyond Getting Started: Everything Else has information for you to refer to later, like how to troubleshoot issues and warranty details. User Guide This User Guide gives you the most extensive overview of the system, detailing features, important safety information, and so much more. To download an eBook of the User Guide visit dexcom.com/guides. The G6 User Guide is grouped into four parts:
Part 1: Get Started LBL014003 Rev 001 Dexcom G6 User Guide 5 Chapter 1: Begin Your Dexcom G6 Continuous Glucose Monitoring System (G6) Journey Chapter 2: Indications for Use and Safety Statements Chapter 3: Risks and Benefits Part 2: Lets G6! The Basics Chapter 4: What Is the G6?
Chapter 5: Set Up Your Display Devices Chapter 6: Start Your Sensor Session Chapter 7: Calibrate Part 3: Next Steps Chapter 8: Home Screen Chapter 9: Events Chapter 10: Alarm and Alerts Chapter 11: Treatment Decisions Chapter 12: Share Information With Your Support Team Chapter 13: End Sensor and Transmitter Sessions Chapter 14: Troubleshooting Part 4: Appendices Appendix A: Glossary Appendix B: Need Help? Youre Not Alone!
Appendix C: Security and Air Travel Appendix D: Extend Your App Appendix E: Take Care of Your G6 Appendix F: Warranty Appendix G: Technical Information Appendix H: Label Symbols Appendix I: Alarm/Alert Vibrations and Sounds How to Use Your User Guide Start with the table of contents. The chapters include information that guides you through your sensor session, from setting it up to taking it off. All chapters in the G6 User Guide are laid out the same way: The beginning of each chapter lists what youll be able to do after youve finished, followed by the chapters content. At the end, theres a recap of what was covered and whats in the next chapter. The appendices have additional information you may want to reference. For example, what do you do with your G6 at airport security, how to find out about the warranty, and taking care of your device. 1.3 Your Dexcom Account Youll need a Dexcom username and password to set up the G6 App (app) and for reordering. If you havent already, go to dexcom.com and set up an account. Or, if you prefer, create your account in the app during setup. 1.4 Whats Covered and Whats Coming Now You Can:
Locate different training resources Explain why you need a Dexcom account Whats Next?
Next youll learn when and how to use the G6 safely. LBL014003 Rev 001 Dexcom G6 User Guide 6 Chapter 2 Get Started:
Indications for Use and Safety Statements 2.1 Introduction In this chapter, youll learn how to use the G6 safely. Review this chapter before using the G6. Youll find:
How following the safety statements keeps you safe How to interpret safety statements An overview of safety statements 2.2 What Are Safety Statements?
Safety statements are brief explanations meant to keep you and the system safe while using the G6. There are four types:
Warnings: Describe serious even life-threatening situations to avoid when you use the G6 Precautions/Cautions: Are steps you take when using the G6 to prevent minor or moderate harm to you or the system Indications: Show who should use the system as well as when, why, and how they should use it Contraindications: Let you know when not to use the G6. If used in these situations, you may hurt yourself or the system 2.3 How to Read Safety Statements You see safety statements in two formats:
List: All safety statements are listed in the next section Boxes: Chapters include boxes with the safety statements related to that content Within chapters, each safety statement is in a box, broken down into four sections, like the example below:
2.4 Overview of Safety Statements This section reviews all safety statements what you should or shouldnt do, why, and what could happen. The statements are grouped by system function or feature. Review the safety statements to be aware of the indications, contraindications, warnings, precautions, and cautions listed below. If you dont follow these instructions, you could over or under treat because you may not realize your glucose is very low or high (hypoglycemia or hyperglycemia). And of course, seek medical attention when appropriate. General CGM System Safety Statements Indication Who, What, and Why?
o Who:
You can use the system if youre 2 years or older and have diabetes. To get the G6, your healthcare LBL014003 Rev 001 Dexcom G6 User Guide 7 professional (HCP) writes you a prescription. Dont share your device. Use one Dexcom account for each patient. o What:
The system tracks your glucose patterns and detects trends while they happen. The G6 is designed to replace fingerstick blood glucose (BG) testing for diabetes treatment decisions. o Why:
Manage your diabetes using the system information readings, arrows, and alarm/alerts. Every 5 minutes, the sensor reports your sensor glucose reading (reading) on your display device. Over time, youll see trends and patterns. The system shows you your low and high glucose periods so you can act when needed and create long-term treatment plans with your HCP. These actions and plans help you spend more time in your target glucose range and reduce your A1C. Contraindication No MRI/CT/Diathermy MR Unsafe Dont wear your CGM (sensor, transmitter, receiver, or smart device) for magnetic resonance imaging
(MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The system hasnt been tested in those situations. Magnetic fields and heat could stop readings or alarm/alerts. Without readings or alarm/alert notifications, you might miss a severe low or high glucose event. Warnings Read User Materials Before you use your G6, carefully read the materials included with it. If you dont, you might:
o Not use the system correctly o Not understand system information o Affect how well it works Dont Ignore Low/High Symptoms Dont ignore how you feel. If your glucose alerts and readings dont match what youre feeling, use your blood glucose meter (meter) to make diabetes treatment decisions or, if needed, seek immediate medical attention. When in doubt, get your meter out. No Number, No Arrow, No CGM Treatment Decision If your G6 doesnt show a number or arrow, or your readings dont match your symptoms, use your meter to make diabetes treatment decisions. No number, no arrow, no treatment decision. When in doubt, get your meter out. Dont Use If Dont use the system if you are:
o Pregnant o On dialysis o Critically ill We havent tested people in these conditions so we dont know if these affect accuracy. Follow system instructions. If you dont, you could have a severe low or high glucose event. Calibration Safety Statements Warnings Dont Wait Calibrate!
The system needs your meter values every day to provide accurate information. Calibrate immediately when notified. If you havent calibrated when notified, use your meter to make treatment decisions until you calibrate your G6. When you insert a new sensor be sure to calibrate as soon as the system notifies you. Youre notified to calibrate twice, then once more after 12 hours, and again 12 hours later. For the rest of your session, you are notified at least once every 24 hours. Use Meter During Startup When you start a new sensor, you wont get any readings or alarm/alerts until you enter two calibrations. Use your meter to make treatment decisions during the 2-hour sensor warmup period. LBL014003 Rev 001 Dexcom G6 User Guide 8 Use Fingersticks Use fingertips to calibrate from your meter. Blood from other places may be less accurate and not as timely. Follow system instructions. If you dont, you could have a severe low or high glucose event. Precautions Be Accurate, Be Quick Enter the exact BG value displayed on your meter within 5 minutes of using your meter. Dont enter the G6 reading as a calibration. Dont Calibrate When Glucose Rate Is Changing Fast Dont calibrate when your trend arrow is up, double-up, down, or double-down because your BG is changing at more than 2 mg/dL per minute. Follow system instructions. If you dont, you could have a severe low or high glucose event. System/Hardware/Software Safety Statements Warnings Wire Breaks Off Dont ignore broken or detached sensor wires. A sensor wire could remain under your skin. If this happens, please contact our 24/7 Technical Support. If a sensor wire breaks off under your skin and you cant see it, dont try to remove it. Contact your HCP. Also seek professional medical help if you have symptoms of infection or inflammation redness, swelling, or pain at the insertion site. Where to Insert: Belly or Behind?
All patients can use their bellies. Patients 2 to 17 years old can also choose their upper behinds. Look for a place on your belly or upper behind where you have some padding. The sensor is not tested or approved for other sites. Talk to your HCP about the best site for you. Ages 2-17 years: Insert in your belly or upper behind Ages 18 and older: Insert in your belly Where to Store You can store your sensors at room temperature or in your refrigerator as long as its between 36 F and 86 F. Dont store sensors in the freezer. Follow system instructions. If you dont, you could have a severe low or high glucose event. Precautions Dont Use if Expired Dont use expired sensors, because they may give incorrect results. Check the package label for the expiration date. Its in YYYY-MM-DD format. Check Package Dont use sensor if its sterile package has been damaged or opened, because it might cause an infection. Clean and Dry Skin LBL014003 Rev 001 Dexcom G6 User Guide 9 Clean and dry your hands and your insertion site before inserting your sensor. Wash your hands with soap and water, not gel cleaners, and then dry them before opening the sensor package. If your hands are dirty when you insert the sensor, you may get germs on the insertion site and get an infection. Clean your insertion site with alcohol wipes to prevent infections. Dont insert the sensor until your skin is dry. If your insertion site is not clean and completely dry, you run the risk of infection or the transmitter holder not sticking well. Make sure you dont have insect repellant, sunscreen, perfume, or lotion on your skin. Where to Insert: Things to Check Keep the safety guard on until you put the G6 applicator against your skin. If you remove the safety guard first, you may hurt yourself by accidentally pushing the button that inserts the sensor before you mean to. Change your insertion site with each sensor. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation. Sensor placement is important. Choose a site:
o At least 3 inches from insulin pump infusion set or injection site o Away from waistband, scarring, tattoos, irritation, and bones o Unlikely to be bumped, pushed, or laid on while sleeping Follow system instructions. If you dont, you could have a severe low or high glucose event. Transmitter Safety Statements Warnings Inspect Dont use a damaged or cracked transmitter. A damaged transmitter could cause injuries from electrical shocks and may make the system not work correctly. Use as Directed The transmitter is small and may pose a choking hazard. Dont put it in your mouth or let children hold it without adult supervision. Follow system instructions. If you dont, you could have a severe low or high glucose event. Precautions Reuse Dont Throw Away When ending a session, dont throw away the transmitter. The transmitter is reusable until the system notifies you that the transmitter battery is about to expire. Dont Share Never share your transmitter. The system is a prescription-only medical device and is meant for your use only. The transmitter is tied to the sensor glucose readings. If used by more than one person, the glucose readings, reports, alarm/alerts, etc., may be wrong. Follow system instructions. If you dont, you could have a severe low or high glucose event. System Safety Statements Precautions Treatment Decisions Use your sensor glucose reading and trend arrow to make treatment decisions. Use Correct Transmitter, Receiver, and Sensor G6 components are not compatible with any previous Dexcom products. Do not mix transmitters, receivers, and sensors from different generations. Dont Use When Glucose Rate Is Changing Fast Your sensor reading may be wrong when your glucose is changing 3 mg/dL or more each minute. This LBL014003 Rev 001 Dexcom G6 User Guide 10 can happen during exercise or after a meal. Going Through Security Check Point When wearing your system, ask for hand-wanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner (also called a millimeter wave scanner) or putting any part of the system in the baggage x-ray machine. You can wear the system for the walk-through metal detector. If you do, use your meter for treatment decisions until you leave the security area. Because we havent tested every x-ray and scanner, we dont know if they damage the system. Not sure what kind of machine it is? Be safe either ask the TSA officer, request hand-wanding, or request full-body pat-down. Follow system instructions. If you dont, you could have a severe low or high glucose event. Receiver and Smart Device Safety Statements Precautions Keep Transmitter Close to Display Device Keep your transmitter and display device within 20 feet with no obstacles (like walls or metal) between them. Otherwise, they might not be able to communicate. If water is between your transmitter and the display device -- for example, if youre showering or swimming keep them closer to each other. The range is reduced because Bluetooth doesnt work as well through water. Get Alarm/Alerts on Display Device You Use To get your alarm/alerts, set them on the display device you use. Your receiver wont get the alarm/alerts you set on your app. Likewise, your app wont get the alarm/alerts you set on your receiver. Is It On?
If the receiver or smart device is turned off (shut down), it will not show readings or alarm/alerts. Make sure your display device is turned on. Follow system instructions. If you dont, you could have a severe low or high glucose event. Smart Device Safety Statements Warnings Check Settings When using your smart device, check:
o Volume/muted/headphones You get a visual notification and a vibration (if your device has a vibration feature). You may not hear the sound on your first notification. If you dont clear it within 5 minutes, the alarm/alert repeats at half volume and at full volume after 10 minutes. Your alarm and important alerts sound and display information even when your volume is low or muted. Specifically, if your smart device is on mute, only these notifications make a sound:
o Glucose Alarm/Alerts:
Urgent Low Urgent Low Soon Low Glucose High Glucose Rise Rate Fall Rate No Readings Alert o System Alerts:
Calibration Required (after 2-hour sensor warmup) Calibration Error Sensor Expired Replace Sensor Transmitter (not working) No Storage Error App Stopped LBL014003 Rev 001 Dexcom G6 User Guide 11 Theres one exception: On Apple devices, Signal Loss doesnt sound when your volume is low or muted. When you have headphones connected to your Android, alarm/alerts will sound through the headphones and the speaker. On your Apple, they will sound only in the headphones. o Bluetooth: Your transmitter talks to your app with Bluetooth. Make sure your smart device Bluetooth is on. If not, you will not get alarm/alerts or CGM information. o Notifications:
Make sure your smart device settings allow Dexcom app notifications to show on your Lock screen. Apple: During setup, enable Dexcom app notifications or you wont get alarm/alerts. o Battery: The app must always be running in the background and may drain your smart device battery. Keep the battery charged. o Compatibility: Before upgrading your smart device or its operating system, check dexcom.com/compatibility. Automatic updates of the app or your device operating system can change settings or shut down the app. Always update manually and verify correct device settings afterward. o Time: Let the date and time on your smart device automatically update when you travel across time zones or switch between standard and daylight saving times. Dont manually change your smart device time, because it can make the time on the trend screen wrong and the app may stop displaying data. Follow system instructions. If you dont, you could have a severe low or high glucose event. Precautions Check Accessory Devices Do you use headphones with your smart device? What about Bluetooth speakers or a smart watch?
When using accessories, keep in mind you may get your alarm/alerts on only one device or accessory, not all. After connecting any accessory devices, make sure that your smart device settings allow you to continue receiving alarms or alerts. Follow system instructions. If you dont, you could have a severe low or high glucose event. Receiver Safety Statements Warnings Dont Use if Damaged Dont use a receiver that is damaged or cracked. A damaged receiver could cause injuries from electrical shocks and may make the system not work correctly. Use Cable as Directed Use USB cable only as directed, and store safely. Misuse of the USB cable can be a strangulation risk. Follow system instructions. If you dont, you could have a severe low or high glucose event. Precautions Test Speaker and Vibrations You have to hear or feel alarm/alerts to react to them, so test your receiver speaker and vibrations regularly. To make sure the speaker and vibrations work, plug in the receiver to charge. The Speaker Test screen appears for a few seconds. Follow the directions on the screen to test the speaker and vibrations. If you hear and feel them, great! But if it doesnt beep and vibrate -- perhaps it got wet or was dropped -- contact Technical Support and use your app until the receiver is fixed. Keep Clean and Dry Dont submerge your receiver in water and dont get dirt or water in the USB port. That could damage it. Follow system instructions. If you dont, you could have a severe low or high glucose event. Caution Requires HCP Prescription U.S. law restricts the sale of the G6 Mobile to sale by, or on the order of, a physician. LBL014003 Rev 001 Dexcom G6 User Guide 12 Dexcom Share Safety Statements Important User Information Dexcom Share (Share) lets you send your sensor information from your app to your Followers smart devices! Read the indications, warnings, and precautions below to find out how you can safely use this app feature. Share and Managing Your Diabetes Safety Statements Indications Keep Followers Informed Use Share to send your sensor information from your smart device to your Followers smart devices. Use as Secondary Notice The information on your smart device is sent directly from your G6 transmitter. After it is on your device, Share sends it to your Followers. So your Followers information is always older than yours. Use your current information to manage your diabetes, not your Followers possibly outdated information. Your Followers can use the information they get to reach out to you and support you in managing your diabetes. The information they get is not meant to be used for treatment decisions, analysis, or teaching. Followers cant change your information. Warnings Use Your G6 to Make Treatment Decisions Dont use Share information for treatment decisions, like treating for a low or dosing for a high. Use the sensor information on your G6 instead. Take HCP Advice Has your HCP given you self-monitoring tasks? Keep doing them. Having Followers doesnt replace them. Follow system instructions. If you dont, you could have a severe low or high glucose event. Share Setup and Settings Safety Statements Warning Followers Must Follow and You Must Share You have to turn Share on to make it send your sensor information to your Followers. Followers have to download the Dexcom Follow app to see what you send. Follow system instructions. If you dont, you could have a severe low or high glucose event. Precautions Followers Dont Manage Your Diabetes, You Do Dont rely on your Followers to let you know you need to make a treatment decision. Stay on top of your diabetes management. Look at your system often. Respond to alarm/alerts. Dont wait for a Follower to reach out they may not be getting your sensor information because of a technical issue. Check Your Smart Device and Your Followers Smart Devices o Internet access required: Both smart devices need to be connected to the Internet to use Share. Try sending your follower an email from your device. If your follower gets it on their device, both smart devices are connected. o Batteries charged: Make sure the smart device batteries are charged. If either your or your Followers smart device batteries arent charged, Share wont work. Check Your Smart Device App on: Whenever you power on your smart device, tap the G6 app to open it. If the app isnt open, Share wont work. Check Followers Smart Devices o Sounds on: Followers must keep their smart device volume on, or at least the keep vibration on, so they can hear and/or feel alarm/alerts. Smart device settings trump Follow app settings LBL014003 Rev 001 Dexcom G6 User Guide 13 o Sharing gaps: Followers wont get your sensor information when their smart device is off, not connected to the Internet, or in Do Not Disturb or Airplane mode. When the Followers fix those issues, theyll start getting the current information but they wont get the information they missed o Cell carrier supports simultaneous voice and data: Most cell service carriers support using voice and data at the same time. Check yours and have Followers check theirs. If its not supported, Share wont work during phone calls. Share will restart when the call is over and send any waiting notifications Customize Share So Followers Can Support You o Customize Share to make sure your Followers have the information they need to help you manage your diabetes o Delay feature: Your Follower wont get notified until after the delay time you set o Not Share feature: You can stop sharing with a Follower any time by choosing Not Share. That Follower will stop getting any of your sensor information until you choose to Share again Follow system instructions. If you dont, you could have a severe low or high glucose event. 2.5 Whats Covered and Whats Coming Now You:
Can explain how safety statements keep you safe Can explain how to interpret safety statements Have an overview of safety statements Whats Next?
In the next chapter, youll learn the risks and benefits of using the G6. LBL014003 Rev 001 Dexcom G6 User Guide 14 Chapter 3 Get Started:
Risks and Benefits When using any medical device, there are risks and benefits. In this chapter, youll learn what they are. 3.1 Risks The risks with using G6 are:
Not getting your alarm/alerts Using G6 to make treatment decisions when you shouldnt Sensor insertion issues This section covers each of those risks in detail. Follow system instructions. If you dont, you could have a severe low or high glucose event. Not Getting Alarm/Alerts If you arent getting your alarm/alerts, you could have severe low or high glucose without knowing it. Check your display device:
Battery charged: If the display device battery is dead, you wont get readings or alarm/alerts. App on: Keep the app on so you get readings or alarm/alerts. Alerts on: Leave the alert function on to get alarm/alerts. Volume up: Keep the volume loud enough to hear your alarm/alerts. Speaker and vibrations work: If the speaker or vibrations arent working, you wont hear or feel your alarm/alerts. In range: Keep your display device no more than 20 feet from your transmitter, with no obstacles between them. They have to be that close to communicate. If they arent in range, you wont get readings or alarm/alerts. No System errors: If you get a system error - such as No Readings, Sensor Error, or Signal Loss - you wont get readings or alarm/alerts. During warmup and after session ends: You wont get alarm/alerts or readings during the 2-hour warmup or after a sensor session ends. See Troubleshooting (Chapter 14), recommended settings (Chapter 5), and notifications that sound while smart device is silenced/muted (Appendix I) for more information. Using G6 for Treatment Decisions You can use your G6 to treat for a low or dose for a high in all but these few situations:
No number, no arrow, no CGM treatment decision: If you have a reading and a trend arrow, you can use those to make a treatment decision. Otherwise use your meter. Dont wait calibrate: If youve calibrated immediately when prompted, your G6 is accurate and you can use it to make a treatment decision. Otherwise use your meter until you calibrate your G6. When in doubt, get your meter out: If you feel like your glucose is low or high but your G6 number is within your target range, verify with your meter. Likewise, if you care for someone using the G6, watch how they act. If their symptoms dont match the G6, use the meter. Use your G6 for treatment decisions, not your Followers: Dexcom Share allows you to share your sensor glucose information from your smart device to your Followers. The main risk with Share is misunderstanding its purpose. The information on your display device is the most current it comes straight from your transmitter so only use yours for treatment decisions. There can be technical issues and delays in sharing information. Followers can reach out and support you, but dont rely on them or their information to manage your diabetes for you. Some users found accuracy between different sensors varied significantly. When you insert each sensor, pay attention to its accuracy before deciding to use it for treatment decisions. For more information on how to make treatment decisions using your G6, see Chapter 11. For more information on Share, see Chapter 12. LBL014003 Rev 001 Dexcom G6 User Guide 15 Sensor Insertion Risks Its uncommon, but inserting the sensor can cause infection, bleeding, or pain, and wearing the adhesive patch can irritate your skin. Only a few patients in the G6 clinical studies got slight redness and swelling. No sensor wires broke; however, there is a remote chance a sensor wire could break or detach and remain under your skin. Sterile broken sensor wires usually dont pose a significant medical risk. If a sensor wire breaks off or detaches and remains under your skin, contact your HCP and Technical Support (24/7):
TechSupport@dexcom.com Toll free: 1.888.738.3646 Toll call: 1.858.200.0200 3.2 Benefits Some benefits of using your G6 are:
Knowing your trends Making treatment decisions using your G6 Managing your diabetes Getting alerted for low and high readings This section covers each of those benefits in detail. Knowing Your Trends The G6 sends you a reading every 5 minutes. It also provides reports and views of your information so you can detect and reflect on trends, patterns, and how your body responds to different things, like exercise or pizza. This provides you with a more complete picture of your glucose and lets you see how your daily habits impact your A1C. Making Treatment Decisions Using G6 You can use your G6 reading and trend arrow to make treatment decisions like treating for a low or dosing for a high. See Chapter 11 for more information on treatment decisions. With G6, theres no need to confirm your reading with a fingerstick. This can reduce the pain and burden of excessive fingersticks (Aleppo 2017). Helping Your Diabetes Management The alarm/alerts features (Chapter 10) keep you aware of your glucose levels. Alarm/alerts notify you when your glucose goes outside your target range, goes too low, or is falling too fast. This lets you take action to prevent glucose from going too low or high (Pettus 2015). Over time, you spend more time in your target range and less time being too high or too low (Beck 2017; Lind 2017). This gives you more control over your glucose, may help you improve your A1C, and may reduce your risk of long-term diabetes-related complications (The Diabetes Control and Complications Trial Research Group 1993). Some patients gain peace of mind and a better quality of life when using real-time CGM, such as G6
(Polonsky 2017). Share may improve the quality of life and peace of mind for patients, their caregivers, and their support team because it sends Followers readings and alarm/alerts remotely. Followers can then reach out when readings go too low or high. References Aleppo, Grazia, Katrina Ruedy, Tonya Riddlesworth, Davida Kruger, Anne Peters, Irl Hirsch, Richard Bergenstal, Elena Toschi, Andrew Ahmann, Viral Shah, Michael Rickels, Bruce Bode, Athena Philis-
Tsimikas, Rodica Pop-Busui, Henry Rodriguez, Emily Eyth, Anuj Bhargava, Craig Kollman, and Roy Beck. 2017. Replace-BG: a randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in well-controlled adults with type 1 diabetes. Diabetes Care. 40(4):538-545. doi:
10.2337/dc16-2482. Beck, Roy, Tonya Riddlesworth, Katrina Ruedy, Andrew Ahmann, Richard Bergenstal, Stacie Haller, Craig Kollman, Davida Kruger, Janet McGill, William Polonsky, Elena Roschi, Howard Wolpert, and David Price for the DIAMOND Study Group. 2017. Effect of continuous glucose monitoring on glycemic control in adults with type 1 diabetes using insulin injections: the DIAMOND randomized clinical trial. JAMA. 317(4):371-378. doi:10.1001/jama.2016.19975. The Diabetes Control and Complications Trial Research Group. September 30, 1993. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 329:977-986. Lind, Marcus, William Polonsky, Irl Hirsch, Tim Heise, Jan Bolinder, Sofia Dahlqvist, Erik Schwarz, Arndis Finna Olafsdottir, Anders Frid, Hand Wedel, Elsa Ahlen, Thomas Nystom, and Jarl Hellman. 2017. LBL014003 Rev 001 Dexcom G6 User Guide 16 Continuous glucose monitoring vs conventional therapy for glycemic control in adults with type 1 diabetes treated with multiple daily insulin injections: the gold randomized clinical trial. JAMA. 317(4):379-387. doi:10.1001/jama.2016.19976. Pettus, Jeremy, David Price, and Steven Edelman. 2015. How patients with type 1 diabetes translate continuous glucose monitoring data into diabetes management decisions. Endocr Pract. 21(6):613-620. doi:
10.4158/EP14520.OR. Polonsky, William, Danielle Hessler, Katrina Ruedy, Roy Beck, for the DIAMOND Study Group. 2017. The impact of continuous glucose monitoring on markers of quality of life in adults with type 1 diabetes: further findings from the DIAMOND randomized clinical trial. Diabetes Care. 40(6):736-741. doi: 10.2337/dc17-
0133. 3.3 Whats Covered and Whats Coming Now You Can:
List the risks and benefits of using the G6 Whats Next:
Now lets take a look at the G6!
LBL014003 Rev 001 Dexcom G6 User Guide 17 LBL014003 Rev 001 Dexcom G6 User Guide 18 Chapter 4 Lets G6! The Basics:
What Is the G6?
4.1 Introduction This chapter is an overview of the G6 System. After this chapter, youll be able to:
Explain what G6 does List whats new in G6 Explain each components function 4.2 G6 CGM System The G6 is a medical device you use on yourself. It allows you to continually see your readings, updated every 5 minutes for up to 10 days, without the bother of taking constant fingerstick measurement. Youll see:
BG readings: Update every 5 minutes. Trend arrows: Show where your BG is heading. Alarm/alerts: Warn you when you need to take action, for example, when your BG is too high or too low. History: Graphs show the last 1, 3, 6, 12, and 24 hours of your readings. Reports: Web-based reports reflect your glucose trends and patterns. Share reports with your HCP when developing your diabetes management plans. 4.3 Whats New for G6?
Dexcoms G6 features include:
Treatment decisions: Use your sensor glucose information to make diabetes treatment decisions Calibrate once a day: After youre set up, you only need to calibrate every 24 hours and when notified Sensor session length: Wear your sensor for up to 10 days Overpatch: Use it to cover the patch and help keep your sensor on Urgent Low Soon: Get an alert when your glucose is quickly heading toward 55 mg/dL Treatment Decisions The G6 allows you to make treatment decisions without using your meter. With the G6 number and trend arrow, you know where your glucose is and where its heading. Based on your G6, you determine if you should dose, eat carbs, or do nothing no fingerstick needed!
You still need your meter to calibrate and as a backup when your CGM data do not reflect how you feel or if you dont have enough information on your home screen. For more information, go to Chapter 11. Urgent Low Soon Alert Sometimes glucose levels fall fast. Really fast. The Urgent Low Soon Alert lets you know when yours is falling so fast it will drop to 55 mg/dL in less than 20 minutes. This gives you time to prevent going too low. For this alert, it doesnt matter where your glucose is now; it matters where it is heading. For more information, go to Chapter 10. 4.4 G6 Components The G6 has three key parts:
Sensor Transmitter Display Device: Dexcom Receiver and/or Dexcom app on your smart device LBL014003 Rev 001 Dexcom G6 User Guide 19 Each part comes in its own package. Keep the packaging until youre no longer using its contents. Sensor Overview For your safety, the single-use sensor is packaged in a sterile sealed pouch. When you open the package, your sensor looks like one item, but its actually three: sensor applicator, transmitter holder, and sensor wire. The applicator helps you insert the sensor wire under your skin. After inserting the sensor wire, you can throw away the applicator. Youll see the transmitter holder held onto your body with the adhesive patch. The sensor wire is attached to the other side of the holder. Once inserted, the sensors thin, flexible wire measures your glucose levels in the fluid between your cells
(interstitial fluid) for up to 10 days. Heres the applicator:
Transmitter Overview The front and back of the transmitter look like this:
The transmitter snaps into the transmitter holder and wirelessly sends your glucose information to your display device(s). The transmitter is reuseable. If you have a new transmitter, open the package when youre ready to use it. Display Device Overview LBL014003 Rev 001 Dexcom G6 User Guide 20 You can choose which display device(s) to use: the Dexcom Receiver (receiver), the Dexcom G6 App (app) downloaded on your smart device, or both. They both show your readings, graphs, and trend arrows and alert you when theres something you should be aware of. For a list of current compatible smart devices and operating systems go to: dexcom.com/compatibility This User Guide is not meant to show you how to use your smart device. Contact your smart device support or read your smart device user guide for assistance. The receiver is not water resistant or waterproof and can get damaged if moisture gets inside, so keep it away from liquids and very high humidity as well as dirt and dust. If your receiver does get wet or dirty, test it to make sure the speaker and vibrations still work (see Chapter 14). You can change the receiver protective case. Just take off the black one and put on one of the colored ones. Be sure to line up the covers speaker holes with the receiver speaker. G6 and Previous Dexcom System Components The G6 is not compatible with previous generations such as the Dexcom G4 PLATINUM CGM System or the Dexcom G5 Mobile system. You cant mix the transmitter or receiver between the two systems. However, if you have the touchscreen Dexcom Receiver, you can upgrade it to G6. PRECAUTION Do: Use correct transmitter, receiver, and sensor. Why: G6 components are not compatible with any previous Dexcom products. Consequences: You could have a severe low or high glucose event. 4.5 Whats Covered and Whats Coming Now You Can:
Explain what G6 does List whats new in G6 Explain each components function Next Steps Your next step is setting up your display device(s). LBL014003 Rev 001 Dexcom G6 User Guide 21 Chapter 5 Lets G6! The Basics:
Set Up Your Display Devices 5.1 Introduction This chapter shows you how to choose and set up your display device(s). After this chapter, youll be able to:
Determine which display device(s) youll use Create a Dexcom username and password Implement the suggested settings on your smart device Download and set up the G6 app Set up your receiver 5.2 Choose the Receiver, the App, or Both You can use the receiver, the app, or both. Choose the device thats best for you. The main difference between them is the app has Dexcom Share (Share). It lets you send your glucose information to others in real time so they can support you in your care. You can also schedule long-acting insulin dose reminders in the app. On the other hand, the receiver is a dedicated medical device, so it isnt using battery life to support texts or photos, the way your smart device is. If youre concerned about missing an alarm/alert (for example, due to smart device settings, app shutting off due to lack of storage, low smart device battery, your smart device being damaged, lost, or stolen, etc.), bring your receiver with you. Whether you carry the app or the receiver, remember to keep your display device on. PRECAUTION Do: Make sure your display device is turned on. Why: If the receiver or smart device is turned off (Shut Down), it will not show readings or alarm/alerts. Consequences: You could have a severe low or high glucose event. The next section walks you through setting up the app. To set up the receiver, go to the following section. If you want to use both, you need to set each up individually. To set up accessory devices, see Appendix D. 5.3 App Before starting your first sensor, pick the smart device you want to use. You can use the receiver with one smart device during a session; however, you cant use multiple smart devices during the same session. Part of your setup is entering the transmitter serial number (SN). If by accident you enter the SN into more than one smart device, the system warns you and you wont be able to complete the setup process. Suggested Smart Device Settings See your smart device instructions to learn how to change its settings. Use the following with your CGM system:
Bluetooth on: Your transmitter and app communicate via Bluetooth. If its not on, you wont get alarm/alerts or readings. Notifications on:
o Enable Dexcom app notifications during app setup so you get alarm/alerts o Make sure your smart device settings allow Dexcom app notifications to show on your locked screen LBL014003 Rev 001 Dexcom G6 User Guide 22 Battery charged: The app must always be running in the background and may drain your smart device battery. Keep the battery charged. Update manually: Automatic updates of the app or your device operating system can change settings or shutdown the app. Always update manually and verify correct device settings afterward. Compatibility: For a list of smart devices and operating systems that work with the G6 app, check dexcom.com/compatibility. Before upgrading your smart device or its operating system, check the list. Time: Dont change your smart device time, because it can make the time on the home screen wrong and the app may stop displaying data. WARNING Do: When using your smart device, check:
Notifications: Make sure your smart device settings allow Dexcom app notifications to show on your locked screen. On: The app must always be running in the background. Bluetooth: Your transmitter talks to your app with Bluetooth. Make sure your smart device Bluetooth is on. Why: The app works only if the smart device, notifications, and Bluetooth are on. Consequences: You could have a severe low or high glucose event. App Installation and Setup Installing the app is easy! Simply download the G6 App from your app store. For information on how to install an app, see your smart device instructions. If your smart device has been jailbroken or rooted, do not install the app. The app may not work correctly or remain secure on a jailbroken/rooted smart device. Is this your first Dexcom CGM app? If so, the app will walk you through setting it up. Youll even set up your High and Low Alerts. If youve used the app before, the app will import your existing settings for your convenience. Either way, follow the instructions in the app it will know if youre new or not based on your Dexcom login. If you want more information about a step, tap Help or Learn More. If youd like, follow along with the steps below. App: Setup App: Setup 1 Tap Dexcom G6 to open it. App: Setup 2 Read and swipe through introductory screens. App: Setup LBL014003 Rev 001 Dexcom G6 User Guide 23 3 Enter existing username and password. Or, if you need a Dexcom username and password, tap Create Account. App: Setup 4 Tap Lets Get Started. App: Setup 5 The next screens go over legal and safety information, including a video on using your G6 to make treatment decisions. To see the video another time, go to Settings > Help > Videos. After reading each, tap the appropriate answer to get more information or move forward. App: Setup 6 Existing users only:
If youve already used the Dexcom app, the next screens will import your settings and show the new G6 features, including your Urgent Low Soon Alert. After reading each screen, tap the appropriate answer to move forward. App: Setup 7 New users only:
LBL014003 Rev 001 Dexcom G6 User Guide 24 If youre new to the Dexcom app, these screens go over your alarm/alerts. After reading each screen, tap Next to move forward. App: Setup 8 New users only:
Set your Low Alert. Youll get an alert if your glucose dips below the number you set. Default is 80 mg/dL. Scroll to select your level. Tap Save. App: Setup 9 New users only:
Set your High Alert. Youll get an alert if your glucose rises above the number you set. Default is 200 mg/dL. Scroll to select your level. Tap Save. App: Setup LBL014003 Rev 001 Dexcom G6 User Guide 25 10 Apple:
Make sure you get your alarm/alerts. When asked, tap Allow to receive alarm/alerts. Apple App: Setup 11 The next screen has recommendations for making sure you hear your alarms/alerts. After that, several screens go over the transmitter and making sure Bluetooth is on. Tap the appropriate answers to move forward or get more information. App: Setup 12 Android: The app may ask for access to your device location. Tap Allow. Android App: Setup 13 Enter transmitter SN by either taking a photo of the barcode on your box or entering it by hand. Photo instructions:
a. Get your transmitter box. Tap Take Photo. b. Turn transmitter box upside down on a flat surface with barcodes facing up. Center longest barcode in green brackets. c. Checkmark confirms you entered the SN. LBL014003 Rev 001 Dexcom G6 User Guide 26 Manually enter transmitter SN instructions:
a. Tap Manually Enter. b. Use keyboard to enter transmitter SN. Find your transmitter SN on the bottom of the transmitter box and the back of the transmitter. Confirm correct SN. Tap Save. App: Setup 14 Tap Start Video. Insert sensor and attach transmitter following videos instructions. After completing your initial app setup, set up the receiver if youd like to use that too. If not, go to Chapter 6 to start your initial sensor. If you have issues setting up the G6 Mobile app, contact Technical Support (available 24/7) at:
Email: TechSupport@dexcom.com Toll free: 1.888.738.3646 Toll: 1.858.200.0200 If youre having problems with your smart device, contact your smart device support line. 5.4 Receiver Receiver Setup Overview The receiver guides you through initial setup. Follow along with the steps below if youd like. LBL014003 Rev 001 Dexcom G6 User Guide 27 Your receiver has a touchscreen. Be sure your fingers are dry when you touch it. Dont worry if your receiver buzzes or makes other sounds during setup. After your initial setup is complete, you wont see the setup screens again but your settings can always be adjusted using menu options. Before putting your receiver in your pocket or purse, briefly press the power button to put the screen to sleep. This way, accidental jiggles and bumps dont turn into screen selections. Just tap the power button again to wake the screen up. Receiver: Setup Receiver: Setup 1 Press and hold power button for 2 seconds to turn receiver on. Wait for loading screen to appear. Receiver: Setup 2 Wait. Receiver: Setup 3 Welcome!
Tap Next. Receiver: Setup 4 Enter the date and time:
LBL014003 Rev 001 Dexcom G6 User Guide 28 The blue outlined box shows what is selected. Key for date boxes:
mm = month dd = day yyyy = year Key for time boxes:
hh = hour mm = minute AM/PM = switch between the two Tap each box. Tap up/down arrows to change value in box. Use this method throughout to enter information. When done, tap Save. If battery is ever completely drained, receiver will vibrate once and youll need to reset date and time. Receiver: Setup 5 The next few screens have information about your alarm/alerts. After reading each screen, tap Next. Receiver: Setup 6 Set your Low and High alerts using levels youve discussed with your HCP. The Low Alert default is 80 mg/dL; High is 200 mg/dL. Tap the up/down arrows to change the level. Tap Save. LBL014003 Rev 001 Dexcom G6 User Guide 29 Receiver: Setup 7 The next screen introduces your transmitter SN. Tap Next. Receiver: Setup 8 Find your transmitter SN on the bottom of the transmitter box and the back of the transmitter. Receiver: Setup 9 9 Enter your transmitter SN by tapping the up/down arrows. Tap Save. Receiver: Setup 10 In Chapter 6, youll see how to insert your sensor and attach your transmitter as well as how to pair and start LBL014003 Rev 001 Dexcom G6 User Guide 30 your sensor. 5.5 Whats Covered and Whats Coming Now You Can:
Create a Dexcom username and password Download the G6 Mobile app Set up the app with the recommended settings Set up your receiver Whats Next?
No matter which display device you use, next, youll insert your sensor. LBL014003 Rev 001 Dexcom G6 User Guide 31 Chapter 6 Lets G6! The Basics:
Start Your Sensor 6.1 Introduction After this chapter, youll be able to:
Prepare for sensor insertion Insert your sensor Attach transmitter to sensor Identify when the transmitter and display device pair Start sensor warmup 6.2 Prepare to Insert Sensor Before inserting a sensor, make sure you have everything you need. Dexcom Items:
Sensor package o Check expiration date on sensor tray. Dont use if expired. o Dont open the sensor tray until youre ready to insert the sensor. Transmitter box Your Items:
Alcohol wipes Your meter Optional Item:
If this is your first time inserting a sensor, watch the sensor insertion video to get a better understanding of the process. To see the sensor insertion video, go to:
The app:
o In the setup screens o In Settings > Help > Videos The tutorial:
o On the USB card in your receiver package o Online at dexcom.com/tutorial PRECAUTION Do: Check sensor package. Why: Dont use sensor if its sterile package has been damaged or opened. Consequences: Using an unsterile sensor might cause an infection. PRECAUTION Dont: Dont use expired sensors. Check the package label for the expiration date. Its in YYYY-MM-DD format. Why: Expired sensors may give incorrect results. Consequences: You could have a severe low or high glucose event. LBL014003 Rev 001 Dexcom G6 User Guide 32 6.3 Choose Sensor Site Choosing a comfortable, effective place for your sensor is important. Discuss ideal sensor insertion sites with your HCP. People from 2 to 17 years old can use either their upper behinds or bellies. Those 18 years and older can only use their belly. Tips Do:
Find a flat, pinchable area Place at least 3 inches from your insulin pump infusion set or injection site If needed, shave the area so adhesive patch sticks securely Make sure area is clean and free of lotions, perfumes, and medications Contact your HCP if sensor adhesive irritates your skin Dont:
Use same site for 2 sensors in a row Use sites where bones are close Use sites where sensor can be rubbed by your belt, waist band, seat belt strap or where you lay when you sleep PRECAUTION Do: Choose your sensor insertion site carefully. Choose a site:
At least 3 inches from insulin pump infusion set or injection site Away from waistband, scarring, tattoos, irritation, and bones Unlikely to be bumped, pushed, or laid on when sleeping Why: Inserting the sensor in these areas may affect sensor glucose readings. Consequences: You could have a severe low or high glucose event. Optional: Help Patch Stay On Are you concerned about the patch not sticking? There are two ways to help keep it on:
Before inserting your sensor: Make the sensor site stickier After inserting your sensor: Put on the overpatch or medical tape Both are described in detail below. Contact your HCP for specific questions regarding the use of medical tape, barrier wipes, or other adhesives. 6.4 Insert Sensor Overview Before you insert your sensor, get to know the applicator using the picture below. LBL014003 Rev 001 Dexcom G6 User Guide 33 Insert Sensor Insert Sensor 1 Wash and dry your hands. Insert Sensor 2 Clean insertion site with alcohol wipe. Let dry. Insert Sensor LBL014003 Rev 001 Dexcom G6 User Guide 34 3 Optional Step: Skin Adhesive Create an empty oval on the skin with the skin adhesive, such as Mastisol or SkinTac. Let skin adhesive dry. Insert sensor on clean skin in center of oval. Insert Sensor 4 Check sterile applicator pack. Dont use if its damaged or already opened. Peel off cover. Keep sensor packaging until sensor session is complete. Check sensor for damage. Insert Sensor 5 Pull off both tabs that cover the adhesive. Dont touch adhesive. Insert Sensor 6 Place applicator horizontally, not vertically, on skin. Firmly press down, sticking adhesive to your skin. LBL014003 Rev 001 Dexcom G6 User Guide 35 Insert Sensor 7 Fold and break safety guard and throw it away. Insert Sensor 8 Push and release button to insert sensor. Insert Sensor 9 Remove applicator. Throw out applicator following local guidelines for disposal of blood-contacting components. Insert Sensor 10 Whats left on you?
The adhesive patch with these attached:
Sensor wire underneath Transmitter holder on top You have successfully inserted the sensor!
Having problems?
LBL014003 Rev 001 Dexcom G6 User Guide 36 Do you have questions or need help? Contact Technical Support (available 24/7) at:
TechSupport@dexcom.com Toll free: 1.888.738.3646 Toll: 1.858.200.0200 WARNING Dont: If a sensor wire breaks off under your skin and you cant see it, dont try to remove it. Do: Seek professional medical help if you have symptoms of infection or inflammation redness, swelling, or pain at the insertion site. If either of these happens, contact Technical Support. Why: A sensor wire could remain under your skin. Consequences: You could miss a severe low or high glucose event. 6.5 Attach Transmitter Overview Now that youve inserted your sensor, attach your reuseable transmitter. Keep your current sessions transmitter box. The bottom label has important information you may need after youve attached the transmitter. Before attaching your transmitter, check youve entered the correct transmitter SN into your display device. Chapter 5 covers entering transmitter SN during initial setup. Once youve snapped the transmitter into the holder, you cant remove it until your session is over. Attach Transmitter Attach Transmitter 1 Remove transmitter from box. Attach Transmitter 2 Wipe back of transmitter with alcohol wipe. Let dry. Be careful with the back of the transmitter. Dont:
Touch it or the metal dots on it Scratch it it may harm the waterproof seal LBL014003 Rev 001 Dexcom G6 User Guide 37 Attach Transmitter 3 Slide the narrow end of transmitter into the narrow end of the holder. Attach Transmitter 4 Press the wide end of the transmitter until it clicks into the holder. Attach Transmitter 5 Secure patch by rubbing fingers around transmitter three times. Youre almost done starting your sensor!
Loose Transmitter Holder The transmitter holder should stay on your skin using its own adhesive, but the patch may start to peel up. If it peels up, or you want to prevent that, use either the overpatch or another adhesive, such as medical tape
(brand names include Blenderm, Tegaderm, Smith & Nephew IV3000, 3M tape) for extra support. Order LBL014003 Rev 001 Dexcom G6 User Guide 38 overpatches at dexcom.com/order. Tips for putting on the overpatch or extra adhesive tape:
Put overpatch or tape over white patch on all sides for even support Dont put overpatch or tape over or under the transmitter or its plastic holder Optional Step:
Put overpatch or medical tape over the patch. Overpatch Medical tape 6.6 Pair and Start Your Sensor Now start your sensor. During the warmup period, neither device provides alarm/alerts or readings. Your readings begin after the 2-
hour sensor warmup has passed and you enter the two calibration meter values into either the smart device or the receiver. Until then, use your meter. If you use both the receiver and the app, pair and start your sensor on each. Keep your display device within 20 feet of your transmitter for them to pair and communicate. Are you using the same transmitter you used for your last sensor? If so, your transmitter is already paired. PRECAUTION Do: Keep your transmitter and display device within 20 feet with no obstacles (like walls or metal) between them. Why: Otherwise, they might not be able to communicate. If water is between your transmitter and the display device for example, if youre showering or swimming -- keep them closer to each other. The range is reduced because Bluetooth doesnt work as well through water. Consequences: You could have a severe low or high glucose event. Well review pairing and starting a sensor for the app, then for the receiver. LBL014003 Rev 001 Dexcom G6 User Guide 39 App: Pair and Start Sensor App: Pair and Start Sensor 1 Wait up to 30 minutes while app and transmitter pair. Apple: At prompt, Tap Pair to pair transmitter with app. Apple App: Pair and Start Sensor 2 Tap Start Sensor to start your 2-hour sensor warmup. You wont get alarm/alerts or readings during sensor warmup. Use your meter when making a treatment decision during warmup. App: Pair and Start Sensor 3 Wait. Screen provides countdown to sensor warmup. The ring darkens as the countdown moves forward. Keep smart device within 20 feet of transmitter during the sensor warmup period. App: Pair and Start Sensor 4 Calibration Required means sensor warmup is complete. Open app. LBL014003 Rev 001 Dexcom G6 User Guide 40 App: Pair and Start Sensor 5 Sensor warmup is complete!
Youre ready to calibrate! Chapter 7 covers calibration. Receiver: Pair and Start Sensor Receiver: Pair and Start Sensor 1 Press power button briefly to wake up receiver. Receiver: Pair and Start Sensor 2 Wait. Receiver: Pair and Start Sensor 3 Your transmitter and receiver can communicate now! You may need to unlock your screen. If so, tap 1, then 2. LBL014003 Rev 001 Dexcom G6 User Guide 41 Receiver: Pair and Start Sensor 4 Tap Start Sensor. This starts the 2-hour sensor warmup. Receiver: Pair and Start Sensor 5 Wait. Keep your receiver within 20 feet during the warmup period. Ring darkens to track progress. You wont get alarm/alerts or readings during sensor warmup. Use your meter when making a treatment decision during warmup. After sensor starts, Start Sensor option disappears from Menu, and Stop Sensor appears. Receiver: Pair and Start Sensor 6 Sensor warmup is complete Youre ready to calibrate! See Chapter 7. LBL014003 Rev 001 Dexcom G6 User Guide 42 6.7 Pairing Tips Your transmitter and display device pair after you insert your sensor and attach your transmitter. (On the receiver, the Bluetooth symbol will blink while it is trying to pair with the transmitter.) It usually takes less than 10 minutes for your transmitter and display device to pair, but it can take up to 30 minutes. During this time:
Make sure your transmitter and display device are within 20 feet of each other Remove barriers between them If these errors display, your transmitter and display device are not communicating. App Notification App Receiver Verify display device and transmitter are within 20 feet of each other without obstruction. Wait up to 30 minutes. Tap Help for more information. Dont calibrate. Use meter for BG reading. More than 30 minutes? Contact Technical Support (available 24/7) at:
TechSupport@dexcom.com Toll free: 1.888.738.3646 Toll: 1.858.200.0200 You wont get alarm/alerts or readings until error is fixed. 6.8 Whats Covered and Whats Coming Now You Can:
Prepare for sensor insertion Insert your sensor Attach transmitter to sensor Identify when transmitter and display device pair Start sensor warmup LBL014003 Rev 001 Dexcom G6 User Guide 43 Whats Next?
The next chapter guides you through calibration. LBL014003 Rev 001 Dexcom G6 User Guide 44
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2019-03-15 | 2402 ~ 2480 | DTS - Digital Transmission System | Class II Permissive Change |
2 | 2017-07-14 | 2402 ~ 2480 | DTS - Digital Transmission System | |
3 | 2016-11-14 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 3 | Effective |
2019-03-15
|
||||
1 2 3 |
2017-07-14
|
|||||
1 2 3 |
2016-11-14
|
|||||
1 2 3 | Applicant's complete, legal business name |
Dexcom, Inc.
|
||||
1 2 3 | FCC Registration Number (FRN) |
0008514325
|
||||
1 2 3 | Physical Address |
6340 Sequence Dr
|
||||
1 2 3 |
San Diego, CA
|
|||||
1 2 3 |
United States
|
|||||
app s | TCB Information | |||||
1 2 3 | TCB Application Email Address |
v******@tuvsud.com
|
||||
1 2 3 |
v******@tuvam.com
|
|||||
1 2 3 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 3 | Grantee Code |
PH2
|
||||
1 2 3 | Equipment Product Code |
9949
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 3 | Name |
S**** R******
|
||||
1 2 3 | Title |
Sr. Staff, Product Standards Compliance
|
||||
1 2 3 | Telephone Number |
85852********
|
||||
1 2 3 | Fax Number |
858-2********
|
||||
1 2 3 |
s******@dexcom.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 3 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 2 3 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 04/15/2019 | ||||
1 2 3 | 01/10/2018 | |||||
1 2 3 | 05/10/2017 | |||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 3 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 3 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 3 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | G6 Receiver | ||||
1 2 3 | Scout Receiver | |||||
1 2 3 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 3 | Modular Equipment Type | Does not apply | ||||
1 2 3 | Purpose / Application is for | Class II Permissive Change | ||||
1 2 3 | Original Equipment | |||||
1 2 3 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 3 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 2 3 | Grant Comments | C2PC as described in this filing. Output power is conducted. | ||||
1 2 3 | Output power is conducted. | |||||
1 2 3 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 3 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 3 | Firm Name |
TUV SUD America, Inc.
|
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1 2 3 |
TUV SUD America Inc.
|
|||||
1 2 3 | Name |
W**** E********
|
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1 2 3 |
M**** E******
|
|||||
1 2 3 | Telephone Number |
813-2********
|
||||
1 2 3 | Fax Number |
978 9********
|
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1 2 3 |
W******@tuvsud.com
|
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0033800 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0033800 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
3 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0033800 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
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