Dexcom 9588 G5x Transmitter User Manual

Dexcom, Inc. G5x Transmitter

User Manual

Dexcom G5x Mobile System User Guide Table of Contents 1 X" ®" PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 2 Table of Contents !"#$$%&'())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(*"+,%-./&(0())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(01"2/3455453(6#7&(8/9:#; G5®x +#5.457#7$(!"7:#$/(<#54.#&453(='$./;(>!?9@(A#7&5/'())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(01"1.1"Introduction"...................................................................................."14"1.2"Self-Paced"Resources"......................................................................"15"1.3"Your"Dexcom"Account"....................................................................."18"+,%-./&(B())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BC"D5E4:%.4#5$(F#&(G$/(%5E(=%F/.'(=.%./;/5.()))))))))))))))))))))))))))))))))))))))))))))(BC"2.1"Introduction"...................................................................................."20"2.2"Important"User"Information"............................................................"20"2.3"Safety"Statements"..........................................................................."21"2.4"Overview"of"Safety"Statements"......................................................."23"2.5"General"CGM"System"Warnings"......................................................"25"2.6"Calibration"Warning"and"Precautions"............................................."27"2.7"System/Hardware/Software"Warnings"and"Precautions"................"28"+,%-./&(H())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(HI"J4$K$(%5E(2/5/F4.$()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(HI"3.1"Risks"................................................................................................"37"3.2"Benefits"..........................................................................................."39"+,%-./&(1())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(1B"L,%.(D$(.,/(!?9M())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(1B"4.1"System"Description"........................................................................."42"4.2"Safety"Statement"............................................................................."42"4.3"The"G5x"..........................................................................................."44"4.4"What’s"New"to"the"G5x?"................................................................."46"4.5"System"Information"........................................................................."47"4.6"System"Components"......................................................................."47"4.7"Smart"Device"Overview"..................................................................."57"+,%-./&(?())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(?N"=/.(G-(6#7&(84$-"%'(8/O4:/$())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(?N"5.1"Introduction"...................................................................................."59"5.2"Safety"Statement"............................................................................."59"5.3"Why"Different"Monitoring"Methods?"............................................."60"5.4"App".................................................................................................."61"PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 3 5.5"Dexcom"Receiver"............................................................................."74"+,%-./&(P())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(*0"=.%&.453(%(=/5$#&(=/$$4#5Q(D5$/&.453(=/5$#&R(S..%:,453(T&%5$;4../&R(%5E(=.%&.453(6#7&(=/$$4#5())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(*0"6.1"Overview"........................................................................................."81"6.2"Safety"Statements"..........................................................................."82"6.3"Prepping"for"Sensor"Insertion"........................................................."85"6.4"Choosing"Your"Insertion"Site"..........................................................."88"6.5"Inserting"Your"Sensor"......................................................................"90"6.6"Attaching"Your"Transmitter"............................................................."94"6.7"Loose"Transmitter"Holder"..............................................................."97"6.8"Starting"Your"Sensor"Session"..........................................................."97"6.9"Receiver"Bluetooth"Tips"................................................................."102"6.10"Sensor"Session"Warmup".............................................................."106"+,%-./&(I())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0C*"+%"4U&%.4#5())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0C*"7.1"Introduction".................................................................................."108"7.2"Safety"Statements"........................................................................."109"7.3"Calibration"Overview"....................................................................."111"7.4"When"to"Calibrate"........................................................................."113"7.5"Calibration"Notifications"..............................................................."114"7.6"Preparing"for"Calibration"..............................................................."118"7.7"Ready?"Set?"Calibrate!".................................................................."119"7.8"Calibration"Errors".........................................................................."126"+,%-./&(*())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0BN"V5E453(6#7&(=/5$#&(=/$$4#5(%5E(T&%5$;4../&(=/$$4#5())))))))))))))))))))))))))(0BN"8.1"Introduction".................................................................................."129"8.2"Safety"Statements"........................................................................."129"8.3"Ending"Your"Sensor"Session".........................................................."130"8.4"Remove"Sensor,"Transmitter,"and"Transmitter"Holder"................."145"8.5"End"of"Transmitter"Battery"............................................................"148"8.6"Pair"New"Transmitter"...................................................................."151"+,%-./&(N())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0P0"W#;/(=:&//5R(J%./(#F(+,%53/(S&&#X$R(%5E(V&&#&$()))))))))))))))))))))))))))))))(0P0"9.1"Introduction"to"Home"Screens"......................................................"161"9.2"Safety"Statements"........................................................................."161"9.3"Overview"of"Home"Screen"............................................................."163"PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

$Dexcom G5x System User Guide Glossary 4 Apple"Today"View"Widget"..................................................................."171"9.4"Rate"of"Change"Arrows"................................................................."181"9.5"Error"Messages".............................................................................."182"+,%-./&(0C())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(0*N"8%4"'(VO/5.$(SFF/:.(6#7&(!"7:#$/(T&/5E$(%5E(Y%../&5$())))))))))))))))))))))))(0*N"10.1"Introduction"................................................................................"189"10.2"What"Is"an"Event?"......................................................................."189"10.3"Entering"Events"..........................................................................."198"10.4"Viewing"Events"............................................................................"207"+,%-./&(00())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BCN"=/5$#&(!"7:#$/(S"%&;(%5E(S"/&.$())))))))))))))))))))))))))))))))))))))))))))))))))))))))(BCN"11.1"Introduction"................................................................................"209"11.2"Safety"Statements"......................................................................."210"11.3"Alarm"and"Alerts"........................................................................."213"11.4"Alarm"and"Alerts"Screens"............................................................"215"11.5"App:"Alarm/Alert"Recommended"Settings".................................."221"11.6"Receiver:"Default"Beeps"and"Vibrations"......................................"222"11.7"Clearing"Alarm/Alerts".................................................................."226"+,%-./&(0B())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BBN"Next%StepsQ()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BBN"Z5(.,/(!#(L4.,(!?9Q(+7$.#;4[453(6#7&(S"%&;(%5E(S"/&.$())))))))))))))))))))(BBN"12.1"Introduction"................................................................................"229"12.2"Safety"Statement"........................................................................."229"12.3"Changing"app"Alarm"and"Alerts"..................................................."230"12.4"Changing"Receiver"Alarm"and"Alerts"..........................................."243"V\VJ6TWD]!(V^=V(!?9()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B?B"+,%-./&(0H())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B?H"L%&&%5.'Q(T,/(_45/(Y&45.()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B?H"13.1"Introduction"................................................................................"253"13.2"Receiver"Warranty"Information".................................................."253"13.3"Transmitter"Warranty"Information"............................................."256"13.4"Dexcom’s"Obligations"Under"the"Limited"Warranty"..................."257"+,%-./&(01())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BPC"W#X(.#(T%K/(+%&/(#F(6#7&(!?9())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BPC"14.1"Introduction"................................................................................"260"14.2"Basic"Maintenance"......................................................................"260"PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor$

Dexcom G5x System User Guide Glossary 5 14.3"Storage"........................................................................................"268"14.4"Checking"app"and"Receiver"Information"....................................."269"14.5"System"Disposal".........................................................................."270"+,%-./&(0?())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BIB"Z5(.,/(!#(L4.,(!?9Q(!/..453(T,&#73,(=/:7&4.'()))))))))))))))))))))))))))))))))))(BIB"15.1"Introduction"................................................................................"272"15.2"Safety"Statement"........................................................................."272"15.3"Going"Through"Security"..............................................................."273"+,%-./&(0P())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BIP"]//E(W/"-M(6#7`&/(]#.(S"#5/a())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(BIP"16.1"Dexcom"Technical"Support"Team"................................................"276"16.2"Dexcom"Patient"Care"Team"........................................................."277"16.3"Dexcom"Sales"Support"Team"......................................................."278"16.4"Corporate"...................................................................................."279"+,%-./&(0I())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B*C"T/:,54:%"(D5F#&;%.4#5()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(B*C"17.1"Device"Performance"Characteristics"..........................................."280"17.2"Product"Specifications"................................................................."325"17.3"FCC"Requirements"......................................................................."334"+,%-./&(0*())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(HHP"T&#7U"/$,##.453()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(HHP"18.1"Introduction"................................................................................"336"18.2"Safety"Statements"......................................................................."336"18.3"Troubleshooting".........................................................................."337"+,%-./&(0N())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?H"=';U#"$(#5(Y%:K%3/(^%U/"$()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?H"=WSJD]!(D=(+SJD]!())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?P"+,%-./&(BC())))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?I"8/9:#;(Shareb()))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))))(H?I"20.1"Learning"About"Dexcom"Share"...................................................."357"20.2"Dexcom"Share"Overview"............................................................."363"20.3"Risks"and"Benefits"......................................................................."366"20.4"Safety"Statement"........................................................................."367"20.5"Setting"Up"Dexcom"Share"............................................................"371"20.6"Using"Dexcom"Share"..................................................................."380"20.7"Dexcom"Follow"App"...................................................................."386"PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 6 20.8"Troubleshooting".........................................................................."389" PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 7 1 GETTING STARTED • Glossary • Getting Started • Indications for Use and Safety Statement • Risks and Benefits PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 8 Glossary A1C Blood test used to diagnose type 1 or 2 diabetes and to gauge how well you’re managing your diabetes. The A1C test result reflects your average blood sugar level for the past two to three months. Accessory Device Hardware, connected to your smart device by Bluetooth, you use to get easy access to some of its features. For example, Bluetooth headset, Apple watch, or smart watch. Also called wearables. Alternative Site Testing Using a blood sample from non-fingertip (alternative) sites such as the palm, forearm, or upper arm for meter readings. Do not use alternative site testing to calibrate the Dexcom G5®x CGM System (G5x), only use fingerstick measurement. App A self-contained program or piece of software designed to fulfill a particular purpose; an application, especially as downloaded by a user to a smart or mobile device. The Dexcom G5® Mobile app (app) was developed as a display for continuous glucose monitoring. Apple Watch® Accessory device for iPhone®. Blood Glucose (BG) An abbreviation of blood glucose. Blood glucose PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 9 (BG) value is the amount of glucose in the blood measured by a BG meter. Blood Glucose Meter/Meter/BG Meter A medical device used to measure how much glucose is in the blood. Calibration A comparison or measurement between your meter’s fingerstick BG values and the sensor’s interstitial fluid glucose readings. Although blood and interstitial fluids are similar, glucose concentration is higher in your blood. Calibration allows alignment between your sensor and meter readings. When you calibrate, you take a fingerstick measurement from your meter then enter the value into your receiver or smart device. The system uses that value to verify that the sensor glucose reading is on track. Continuous Glucose Monitoring (CGM) A system that uses a sensor inserted under the skin to check glucose levels in interstitial fluid. A transmitter sends sensor glucose readings to a display device. Users must confirm glucose levels with a BG meter before making a change in treatment. Contraindication A safety statement outlining specific situations where the system should not be used because it may be harmful to you. The risk of use clearly outweighs any possible benefit. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 10 Hyperglycemia High BG. Same as “high” or high blood sugar. Hyperglycemia is characterized by an excess of glucose in the bloodstream. It’s important to treat hyperglycemia. If left untreated, hyperglycemia can lead to serious complications. The default High Glucose Alert in the G5x is set to 200 mg/dL. Consult your healthcare professional to determine the appropriate hyperglycemic setting for you. Hypoglycemia Low BG. Same as “low” or low blood sugar. Hypoglycemia is characterized by a low level of glucose in the bloodstream. It’s important to treat hypoglycemia. If left untreated, hypoglycemia can lead to serious complications. The default Low Glucose Alert in the G5x is set to 80 mg/dL. Consult your healthcare professional to determine the appropriate hypoglycemic setting for you. Indications A condition making a particular treatment or procedure advisable. How, for what purposes, and under what circumstances you should use the G5x. Indications let you know who should use the G5x and when. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 11 IP The International Electrotechnical Commission (IEC) is a nonprofit, non-governmental, international organization created to produce safety standards for electronics. One of the safety standards it designed is the Ingress Protection (IP) Marking, which classifies and rates how protected an electronic device is against dust, water, accidental contact, etc. IP ratings are numerical, with the number based on the conditions the electronic device comes across. An IP22 rating lets you know your electronic device won’t allow you to stick your fingers in it and won’t get damaged or be unsafe during specific testing with water dripping down. An IP28 rating tells you your electronic device won’t let you stick your fingers in it and is safe for long-term immersion in liquid up to a specified pressure. Jailbroken The removal of limitations and security measures set by the manufacturer on a smart device. The removal poses a security risk, and data may become vulnerable. Do not use, install, or run the Dexcom G5 Mobile app on a jailbroken smart device. The app may not work correctly on a jailbroken smart device. Landscape When your smart device is oriented sideways. mg/dL Milligrams per deciliter. The standard unit of measure for glucose readings in the United States. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 12 Portrait When your smart device is oriented vertically. Precaution A safety statement regarding any special care to be exercised by you or your healthcare professional for the safe and effective use of the G5x. RF Radio-frequency (RF) transmission used to send glucose information from the transmitter to the receiver or smart device. Also used to send calibration data from the receiver or smart device to the transmitter. Safety Statement A statement of the intended uses of G5x and relevant warnings, precautions, and contraindications. Sensor Session The seven-day monitoring period after inserting a new sensor. During this time frame, your glucose is being monitored and reported every five minutes, with data being sent to your display device(s). Smart/Mobile Device Electronic device that can be wirelessly connected to networks over Wi-Fi, Bluetooth, or a cellular data connection (3G, 4G, etc. Examples are smartphones, tablets, and smart watches. Today View Swipe down to access information and notifications on your iPhone, iPad®, and iPod®. Warning A safety statement letting you know the following feature has important hazard information. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Glossary 13 Describes serious and life-threatening circumstances of using the G5x, their consequences, and how to avoid the hazard. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey 14 Chapter 1 Getting Started: Beginning Your Dexcom G5®x Continuous Glucose Monitoring System (G5x) Journey 1.1 Introduction Welcome to the G5x family! We are excited you chose us to partner with you in your journey to manage your diabetes. As a continuous glucose monitoring (CGM) device, the G5x allows you to break free from constant fingersticks. But how do you use the G5x? What are its features? Do you need to avoid anything? Where do you even begin? This chapter is the first step to answering these and many other questions. After this chapter, you will be able to: • Describe different training resources • Locate tutorials about using the G5x in your diabetes management • Find G5x’s step-by-step instructions • Recall how to use the user guide • Explain why you need a Dexcom® account We have numerous resources available to help you get the most out of your G5x. Between our self-paced training resources and our friendly and knowledgeable Dexcom customer support teams, help is always available. First Things First - Learning How to Learn Knowing about the G5x 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 G5x: 1. Tutorials 2. Getting Started Guide PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey 15 3. User Guide No matter which resource(s) you select, make sure you review them prior to using your new CGM system. 1.2 Self-Paced Resources Tutorials Along with step-by-step instructions, our tutorials illustrate how real-time CGM can assist in your daily diabetes management. The following is a list of tutorials and how to access them. Online Tutorials First Steps With Your Dexcom CGM Designed for those who have never used a Dexcom CGM. This tutorial covers what to expect in your first week and includes links to step-by-step videos on how to insert your sensor, calibrations, ending a sensor session, etc. Next Steps With Your Dexcom CGM Just finished First Steps or already familiar with how a CGM can benefit you? This tutorial covers looking at trends and introduces some advanced features including our reporting tools. Accessing Online Tutorials: From dexcom.com homepage, click Support. Once you have viewed the online tutorials, you should be pretty comfortable with what CGMs do and how the G5x can help you. Offline Tutorials You don’t need to be tied to the Internet to view our instructional tutorials, they’re also available offline. Accessing Offline Tutorials: PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey 16 USB Card in the receiver package. Guides Getting Started Guide (GSG) The G5x GSG complements the tutorials by providing the same step-by-step instructions in a booklet form or within the app. One of the great things about the GSG is you can use it in conjunction with the videos, taking notes as you go! Accessing the GSG: Booklet in the receiver package. Both the tutorial and the GSG give you a brief look at the G5x. But what if you want more detailed information? User Guide Your G5x reference book! This user guide gives you the most extensive overview of the system, detailing features, important safety information, and so much more. To download an eBook of the user guide or request a printed user guide, visit dexcom.com/guides. The G5x user guide is grouped into six separate parts: Part 1: Getting Started • Glossary • Getting Started o Learning how to learn about the G5x o Registering at dexcom.com • Indications for Use and Safety Statement • Risks and Benefits Part 2: Let’s G5x! The Basics PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey 17 • Introduction to the G5x • Initial Setup • Starting a Sensor Session: Inserting the Sensor and Attaching Transmitter • Calibration • Ending a Sensor Session and Transmitter Session Part 3: Next Steps - Getting the Most out of Your G5x Once you are up and running, how you can maximize the G5x features: • Reading Trend Graph Screens and Recognizing Trends • Events • Alarm and Alerts • Sounds for Alarm, Alerts, and System Messages Part 4: Everything Else G5x • Warranty • G5x Maintenance • Travel Tips • Customer Service Contacts • Technical Information • Troubleshooting • Symbols on Package Labels At the end of your G5x user guide, Part 5, is the user guide for Dexcom Share®™. Part 5: Sharing Is Caring • Dexcom Share o What Is Dexcom Share? o Setting Up Dexcom Share o How to Use Dexcom Share PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey 18 o Your Followers o Troubleshooting Part 6 • Index for G5x System and Dexcom Share How to Use Your User Guide All chapters in the G5x user guide are laid out the same way: The beginning of each chapter lists what you’ll be able to do after you have finished, after that, any applicable safety statements you need to know, followed by the chapter’s content. At the end, there’s a recap of what was covered and what’s in the next chapter. 1.3 Your Dexcom Account You’ll need a username and password to set up the G5 Mobile app (app) and for reordering. If you haven’t already done so, go to dexcom.com and set up your own account. Or, if you prefer, the app walks you through creating your log-in credentials as part of your initial app setup. Summary Now You Can: • Describe different training resources • Locate tutorials about using the G5x • Find step-by-step instructions for the G5x • Recall how to use the user guide • Explain why you need a Dexcom® account What’s Next? Now you are familiar with how to use this user guide and where to go for help. Throughout the user guide you’ll see color-coded boxes containing Safety Statements. The next chapter, Indications for Use and Safety Statement, lists all Safety Statements along with how to read and interpret them. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Beginning Your Dexcom G5x Continuous Glucose Monitoring System (G5x) Journey 19 Next you’ll learn about when and how to use the G5x safely. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 20 Chapter 2 Getting Started: Indications for Use and Safety Statement 2.1 Introduction We want the G5x to be a valuable tool in your diabetes management. Like any system, there are steps to take to get the most out of it. As excited as you are about getting started, did you know if you just took Tylenol®, maybe you should wait? Did you know taking Tylenol is contraindicated? In this chapter, you’ll learn about some key areas that might prevent you from having the best CGM experience, or, if you’re not careful, might even harm you or the system. You’ll even learn what a contraindication is! 2.2 Important User Information Each part of your system has instructions including indications, contraindications, warnings, precautions, and other important user information. Please review the instructions for each part of the system in this user guide before using the G5x. This chapter is important to read. It helps you use the G5x safely and covers: • What is a Safety Statement? o Telling the difference between an indication and a contraindication o Explaining why warnings are so important o Defining precautions • How to read a chapter’s Safety Statement • Overview of Safety Statements PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 21 Let’s start with definitions, look at a Safety Statement example used throughout the User Guide, and then review the Safety Statements broken down into the system’s components. Safety Statement A Safety Statement is a brief statement of the G5x’s indications, relevant warnings, precautions, or its contraindications (when to avoid using it). The Safety Statements are meant to keep you and the system safe while using the G5x: 1) Indications How, for what purposes, and under what circumstances you should use the G5x. Indications let you know who should use the G5x and when. Indications are the who, what, and why of the G5x. 2) Contraindications Contraindications let you know when not to use the G5x. If used during these situations, you may hurt yourself or the system; the risk of use clearly outweighs the benefit. 3) Warning Important hazard information: Describes serious or life-threatening circumstances to stay away from while using the G5x, their consequences, and how to avoid danger. 4) Precaution Special steps you need to take while using the G5x, preventing minor or moderate injury to either you or the system. 2.3 Safety Statements This user guide presents Safety Statement two ways: 1. In this chapter’s Overview of Safety Statements PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 22 o Lists all Safety Statements o Includes a section reviewing how the statements are formatted 2. Within each chapter o Lists only those statements applicable to that specific chapter Chapter’s Safety Statements Each chapter will list all applicable indications, contraindications, warnings, and precautions. Some chapters will have multiple Safety Statements; others have none. Safety Statements are located toward the front so you can keep them in mind as you learn about that chapter’s topic. The same statement may be repeated throughout the user guide. It’s important to recognize which factors could prevent the system from working correctly, or even harm you. Within chapters, each color-coded Safety Statement is in a box, broken down into four sections: 1. Type of statement a. Bold and color-coded • WARNING-Red • PRECAUTION-Blue • INDICATION-Green • CONTRAINDICATION-Purple 2. Do’s/Don’ts a. An action you should or should not take b. Italicized 3. Why a. A statement of the potential harm 4. Consequences a. What could happen if you don’t follow the instructions PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 23 The following is an example of a chapter’s Safety Statement and how to read it. Warning Do: Calibrate at least once every 12 hours Why: Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings Consequences: Missing severe low (hypoglycemia ) or high (hyperglycemia) Alarm or Alerts Since this is a Warning, you know it covers important safety information. Italics are the Do/Don’t steps to follow: Calibrate at least once every 12 hours. Below the italics is a statement explaining Why you need to follow the steps: Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings. And finally what happens, or the Consequences, if you don’t: Missing a severe low (hypoglycemia) or high (hyperglycemia) glucose event. 2.4 Overview of Safety Statements This section provides a review of Safety Statements containing the same elements described above (type of Safety Statement, an action, a statement of potential harm, and consequences) but listed in a narrative, not boxed, format. Here you’ll learn what indications and contraindications are and what to do to keep you safe and the system in proper working order. Safety Statements are broken down into two major categories. First, general CGM system 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 G5x components. Indications and Contraindications Indications PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 24 What are the G5x indications? Well, in technical terms, the indications are: The Dexcom G5x Continuous Glucose Monitoring (CGM) System (G5x) is a glucose monitoring system indicated for detecting trends and tracking patterns in persons (age 2 years and older) with diabetes. The system is intended for single patient use and requires a prescription. The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the system results should be based on the trends and patterns seen with several sequential readings over time. In Layman’s Terms But what does that mean? Indications are the who, what, and why of the G5x. Who The G5x is a single patient use device (meaning you can’t share the components with others) for people age 2 years and older with diabetes. What The G5x is a prescription-only glucose-monitoring device. G5x tracks your glucose patterns and detects trends. Working with your home blood glucose (BG) meter, the system is meant to complement, not replace, your BG meter. Why The CGM system’s trend and pattern information, its glucose Alarm/Alerts, combined with your meter’s actual BG value, can help you manage your diabetes. By identifying low and high glucose level periods, the G5x allows you to take action when needed and create long-term management strategies with your healthcare professional. Using trend information to see your highs and lows helps you stay inside your target range. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 25 The G5x’s trend and pattern information is based on a series of sensor glucose readings taken over a period of time. Work with your healthcare professional and create a game plan on how to best use your trend and pattern information in managing your diabetes. Contraindications Contraindications let you know when not to use the G5x; you may hurt yourself or damage the system. Remember, if used during certain situations, the risk of use may clearly outweigh any potential benefit. Within the chapters, contraindications are in purple boxes. MRI/CT/Diathermy Don’t wear the system (sensor, transmitter, and receiver) before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment. The system hasn’t been tested during MRI, CT scans, or with diathermy treatment. Magnetic fields and heat could damage the components, stopping sensor glucose readings or Alarm/Alert notifications. Without sensor glucose readings or Alarm/Alert notifications, you might miss a severe low or high glucose event. Medications Taking medications with acetaminophen (such as Tylenol or Excedrin® Extra Strength) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person. 2.5 General CGM System Warnings Warnings PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 26 Warnings outline important hazard information, describing any serious and/or life-threatening situations, their consequences, how to avoid danger while using the system and how to protect the G5x from harm. Review Training Materials Thoroughly review the training materials included with your system before using. Incorrect use could lead you to misunderstand system information or might affect its performance and you might miss a severe low or high glucose event. Treatment Decisions The system does not replace your BG meter. When making treatment decisions, such as the amount of insulin you need, only use your BG value. Don’t use the G5x sensor glucose readings because they can be different from your BG value. If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event. Don’t Ignore Low/High Symptoms If your sensor glucose readings don’t match your symptoms, measure your BG with a fingerstick. You may miss a severe low or high glucose event. Who Shouldn’t Use The system was not evaluated for the following persons: • Pregnant women • Persons on dialysis Do not use the Dexcom G5x System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients. The system’s accuracy hasn’t been tested in people falling into these groups and sensor glucose readings may be inaccurate, resulting in missing a severe low or high event. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 27 2.6 Calibration Warning and Precautions Calibration is the process of making sure your sensor continues to be accurate. Your sensor doesn’t automatically know what your glucose levels are—you have to teach your system what a given BG value is by entering in a KNOWN glucose value from your BG meter. Warning Calibrate on Schedule Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, resulting in you missing a severe low or high glucose event. Precautions Be Accurate, Be Quick Enter the exact BG value displayed on your BG meter within five minutes of a fingerstick. Entering the wrong BG values, or waiting more than five minutes before entry, might affect sensor performance, resulting in you missing a severe low or high event. Significant Glucose Rate Changes Don’t calibrate when your BG is changing at a significant rate: more than 2 mg/dL per minute. Look for rate of change arrows on your display device screen and don’t calibrate when you see: • A single arrow, pointing up o Rising 2-3 mg/dL each minute • Two arrows pointing up o Rising more than 3 mg/dL each minute • Single arrow pointing down o Falling 2-3 mg/dL each minute PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 28 • Two arrows pointing down o Falling more than 3 mg/dL each minute Calibrating during a significant rise/fall of your BG may affect accuracy of sensor glucose readings, resulting in you missing a severe low or high glucose event. Fingerstick Only Only use fingerstick measurements from your BG meter for calibration. Alternative site BG values from your arms, palm of your hand, etc., may be different and less accurate than your fingerstick BG values. Using alternative sites for calibration might affect sensor performance, resulting in you missing a severe low or high glucose event. Prior to Startup Calibration: Data/Alarm/Alert After starting a new sensor session, until completing your startup calibrations you won’t receive any sensor information such as readings, Alarm or Alerts. Without these, you may miss a severe low or high glucose event. Continue to take fingerstick measurements during a new sensor warmup period. Now that we have reviewed common CGM Safety Statements, let’s focus on the G5x components. 2.7 System/Hardware/Software Warnings and Precautions In this section, you will learn how to safely use the G5x’s hardware and software. Some sections have either Precautions or Warnings, others will have both. Sensor/Transmitter Holder Warnings and Precautions Warnings Sensor Breaking Off PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 29 On rare occasions, the sensor wire may break or detach from the transmitter holder. Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department, toll free at 1.888.738.3646 If a sensor wire breaks under the skin with no portion of it visible, don’t remove it. Contact your healthcare professional if you have redness, swelling, or pain at the insertion site. Placement Do not insert the sensor component of the system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the system is not approved for other sites. The system has not been tested in other areas and may not work properly if inserted in other areas. Storage During a sensor’s shelf life, store it between 36° F-86° F. While you don’t need to keep your sensor in a refrigerator, you can as long as the refrigerator is between 36° F-86° F. Never store sensors and/or sensor packages in a freezer. Storing the sensor incorrectly might cause the sensor glucose readings to be incorrect, resulting in you missing a severe low or high glucose event. Precautions Expiration Date Don’t use expired sensors. Before inserting, always check the package label for the expiration date using the YYYY-MM-DD format. If past the expiration date, don’t use because the sensor glucose readings might not be accurate, resulting in you missing a severe low or high glucose event. Sensor Package PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 30 Don’t use sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection. Clean and Dry Before Using Before opening the sensor package, wash your hands with soap and water, then dry. If your hands are dirty while inserting the sensor, you may contaminate the insertion site and get an infection. Before sensor insertion, clean the skin with alcohol wipes to prevent infections. Don’t insert the sensor until the cleaned insertion site is dry, and free from any lotions or perfumes. If your insertion site is not clean and completely dry, you run the risk of infection or the transmitter holder not sticking and falling off. Sensor Placement Don’t insert the sensor where bones are close to the skin’s surface (for example, over your ribs or hip bones). If you insert the sensor in these areas, you may feel excessive pain or damage your sensor. Don’t remove the safety guard before placing the applicator on the skin. If you remove the safety guard first, you may accidentally deploy the needle and hurt yourself. Change the site where you place the sensor with each new insertion. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation. Sensor placement is important. Choose a site: • At least 3 inches from insulin pump infusion set or injection site • Away from waistband, scarring, tattoos, irritation • Unlikely to be bumped or pushed Insertion in these areas might affect sensor performance, resulting in you missing a severe low or high glucose event. Transmitter Warnings and Precautions Warnings Inspect Transmitter PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 31 If your transmitter is damaged or cracked in any way, don’t use it. Damaged components could create an electrical safety hazard or malfunction, which might cause electrical shocks. Choking The transmitter is small and may pose a choking hazard. Don’t put it in your mouth or allow children to play with it. Precautions Reusable: Don’t Throw Away When ending a session, don’t throw away the transmitter. The transmitter is reusable and can be used in multiple sensor sessions. Keep using it until the system notifies you the transmitter battery is about to expire. Don’t Share Your Transmitter Never share your transmitter with another person. The system is a prescription-only medical device and is meant, or indicated, for your use only. Your transmitter is tied to your readings. If used by someone else, your reports, Alarm and Alerts, etc., would be wrong, resulting in you missing a severe low or high glucose event. System Precautions Next are precautions for the receiver, transmitter, sensor, and the system. Precautions Use Correct Transmitter, Receiver, and Sensor The G5x transmitter must be used with the G5x Sensor and is not interchangeable with the Dexcom G5®Mobile/G4® PLATINUM Sensor. The G5x transmitter is compatible with the G5 Mobile receiver. The G5x transmitter and receiver are not compatible with the Dexcom G4 PLATINUM CGM System’s transmitter and receiver. System Accuracy PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 32 System accuracy may be affected when your glucose is changing at a significant rate such as during exercise or after a meal. Significant glucose rise/fall rates: • Rising 2-3 mg/dL each minute • Rising more than 3 mg/dL each minute • Falling 2-3 mg/dL each minute • Falling more than 3 mg/dL each minute Airport Scanners Be aware of airport body scanners and baggage x-rays when you travel. Do not place any part of the G5x system in the baggage x-ray machine or body scanner. Ask for visual inspection instead: • Baggage x-ray machine: Instead of putting any part of your G5x through the baggage x-ray, ask the TSA officers to visually inspect it. • Body scanner: When you are wearing your G5x, request hand-wanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner. AIT is also called millimeter wave scanner. The system has not been tested in x-rays or AIT body scanners, and it is unknown if exposure to x-rays or AIT body scanners can affect the system performance and result in you missing a severe low or high glucose event. It is safe to wear the system through the walk-through metal detector or hand-wanding. If you are unsure of whether the airport scanner is a metal detector, an AIT body scanner or an x-ray, ask the TSA officer or request hand-wanding or full-body pat-down. Receiver and Smart Device Precautions The Dexcom receiver and your smart device share some warnings and precautions. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 33 Precautions Communication Range Do not separate the transmitter from the receiver or smart device by more than 20 feet. The transmission range from the transmitter to receiver or smart device is up to 20 feet without obstruction. Types of obstruction differ and not all have been tested. Obstructions can include water, walls, metal, etc. If your transmitter and display device(s) are more than 20 feet from each other or are separated by an obstruction, they might not communicate, resulting in you missing a severe low or high glucose event. As with any wireless device, water in reducing the communication distance. This applies to the transmitter and display devices. Take special care when swimming, taking a bath, or getting into a hot tub. Setting Alarm/Alert Notifications When using both a receiver and a smart device, you must set your settings separately in each. If you set up one device and then use another, you might not get an Alarm or Alerts, causing you to miss a severe low or high glucose event. Using an accessory device (like a smart watch) might override your smart device sounds. Alarms or Alerts might vibrate or be heard on the accessory instead of your smart device. After connecting any accessories, make sure that the smart device settings allow you to continue receiving Alarms or Alerts on the smart device. Is It On? If the receiver or smart device is turned off (Shut Down), it will not display sensor data, information, Alarm or Alerts. Make sure they are turned on; otherwise you won’t get sensor glucose readings or Alarm or Alerts, causing you to miss a severe low or high glucose event. Smart Device Warnings Next are warnings for just your smart device. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 34 Warnings Smart Device Settings The app can’t override your smart device’s internal settings. Also, accessory devices (like a smart watch or other wearable smart devices) might override your smart device’s Alerts and Alarm. To receive Alarm or Alerts you must: 1. Make sure app Notifications are turned on in the Setting’s menu. 2. Verify app hasn’t been shut down. 3. Turn Bluetooth® on. 4. Turn off Do Not Disturb (if available on your smart device). 5. Restart app after device is restarted. 6. Set Volume at a level you can hear. 7. Do not close app, always run app in the background. 8. Make sure accessory devices do not override your smart device settings. If your settings are incorrect, you might miss a severe low or high glucose event. App Alarm/Alert vibrations aren’t any different from other vibrating apps on your smart device. Medical device apps, like this app, don’t have any special priorities over your smart device’s features. G5 Mobile app notifications or Alerts may sound or feel the same as notifications from another app. The only way to know is to look at the screen. Did You Miss an Alarm or Alert? An Alarm or Alert can’t be heard through your smart device’s speakers if headphones are plugged in. Make sure you unplug your headphones when you are done using them, otherwise you might not hear an Alarm or Alert, causing you to miss a severe low or high glucose event. Receiver Warning and Precaution PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 35 Warning Don’t Use Damaged Goods If your receiver is damaged or cracked, don’t use it. This could create an electrical safety hazard or malfunction, causing possible electrical shocks. Avoid Strangulation Use USB cable only as directed and store safely. Misuse of the USB cable can present a strangulation risk. Precaution Test Receiver If your receiver gets wet or dropped, make sure the speaker and vibrations still work. To check, either plug it in, turn it on, or go to the Profiles menu and select Try It. If it doesn’t vibrate and beep, contact Technical Support. If the vibration motor and/or speaker on your receiver aren’t functioning properly you may miss a severe low or high Alarm/Alert. Use the app on your smart device until this issue is resolved Keep Receiver Clean and Dry Keep the USB port cover on the receiver closed whenever the USB cable is not attached and do not submerge in water. If dirt or water gets into the USB port, the receiver could become damaged and stop displaying readings or providing Alerts; you might miss a severe low or high glucose event. Caution U.S. law restricts the sale of the G5x to sale by or on order of a physician. Summary Now You Can: • Define a Safety Statement PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 36 • Explain the difference between an indication and a contraindication • Describe the importance of warnings • Describe what a precaution is • Correctly read a chapter’s Safety Statement • Provide an overview of Safety Statements by category What’s Next? In our next chapter, you will learn about the risks and benefits of using the G5x.PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 37 Chapter 3 Getting Started: Risks and Benefits When using any medical device, there are risks and benefits. In this chapter, you’ll learn what they are so you can better understand the pros and cons of CGM and the G5x. First, let’s review some possible risks. 3.1 Risks There are some risks with using real-time CGM. Not Receiving Alarm/Alerts If you aren’t getting your CGM Alarm/Alerts, you run the risk of not knowing you are having a severe glucose low or high. Some hardware issues preventing Alarm/Alerts: • Alert function is turned off • Transmitter or display device is out of range • Display device isn’t showing sensor glucose readings • Display device battery is dead • Unable to hear Alarm/Alerts or feel vibration • Speaker or vibration motor not working • App not running in the background • Smart device is on Do Not Disturb or Silent Mode See Troubleshooting in Chapter 18 or recommended settings in Chapter 11 for more information. Different Devices May Give Different Numbers PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 38 The sensor glucose reading can be different from your meter’s BG value. If the sensor’s glucose reading is higher than your meter’s BG value, you may miss a Low Alert. As an example, your last sensor glucose reading was 82 mg/dL, whereas your meter BG value shows 78 mg/dL. If your Low Alert is set at 80 mg/dL, you won’t receive an alert because the sensor glucose reading is 82 mg/dL. If you’re not receiving an Alarm/Alert, and not taking fingerstick measurements, you may be unaware of low or high glucose levels. Sensor Insertion Risks Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain, or skin irritations (for example, redness, swelling, bruising, itching, scarring, or skin discoloration). The chance of this happening is low. The G5x uses a different applicator than older systems. The G5x clinical studies showed slight redness and swelling occurring only in a few patients. Different people may have different skin sensitivity to the sensor adhesive. If skin irritation is seen, follow up with your healthcare professional on ways or tips to reduce or avoid sensor site irritation. With any sensor, if you don’t follow the instructions for sensor insertion, there is a chance you may mistakenly insert the sensor before you are ready. Be careful to ensure you place the sensor on your sensor insertion site before taking off the safety guard. After placing the applicator on the body, fold and break the safety guard. The safety guard can be a choking hazard. Carefully throw it away, especially if around children. During Dexcom’s G5x clinical studies, 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 don’t pose a significant medical risk. If a sensor wire breaks off or detaches and remains under your skin, contact your healthcare professional and call Dexcom’s Technical Support toll free, 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! PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 39 3.2 Benefits Daily habits impact your BG levels. With the G5x, you can track how your exercise, carbs, stress levels, medication, or illness influences your glucose levels. Knowing Your Trends Providing sensor glucose readings every five minutes, for up to seven days, the G5x helps you detect trends and patterns. Trend information reveals where your glucose is now, where it’s been, where it’s heading, and how fast it’s changing. Understanding your trends allows you to take proactive action, helping you avoid dangerously low or high glucose values. Using Dexcom Share (see Part 5) allows friends and family, your Followers, to monitor your glucose activity, adding another layer of support and peace of mind. Simplified Sensor Insertion The redesigned G5x sensor applicator allows you to insert a sensor with fewer steps while using just one hand. Fewer steps simplify the insertion process. Helping Your Diabetes Management Wearing the G5x on a consistent and ongoing basis helps you manage your diabetes. The Alarm/Alerts features (see Chapter 11) keep you aware of your glucose levels. Alerts notify you when your glucose goes outside your target range or is rapidly falling or rising, letting you take action before you get too low or too high. The Urgent Low Glucose Alarm lets you know when you are dangerously or urgently low, going below 55 mg/dL. By taking corrective measures, you reduce the time spent in your low/high range, while increasing time in your target range (Garg, S. Z., 2006) (Battelino, T., 2011). Real-time CGM can help improve your A1C as well as improve the quality of your glucose control. If you are at or below 7%, using a CGM such as the G5x helps reduce hypoglycemia (Tamborlane, W. V., 2008). PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 40 Lowering your A1C, increasing your time in your target range while decreasing time in low/high BG range is believed to reduce your risk of diabetes-related complications (Ohkubo, Y., 1995). In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM (Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group, 2010). What’s Next? You’ve read the Safety Statements, reviewed the risks and benefits; now let’s take a look at Dexcom’s G5x! References: Battelino, T., Phillip, M., Bratina, N., Nimri, R., Oskarsson, P., & Bolinder, J. (2011). Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes. Diabetes Care, 34(4), 795-800. Garg, S., Zisser, H., Schwartz, S., Bailey, T., Kaplan, R., Ellis, S., & Jovanovic, L. (2006). Improvement in Glycemic Excursions With a Transcutaneous, Real-Time Continuous Glucose Sensor: A Randomized Controlled Trial. Diabetes Care, 29(1), 44-50. Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group (2010). Quality-of-Life Measures in Children and Adults With Type 1 Diabetes. Diabetes Care, 33(10), 2175-2177. Ohkubo, Y., Kishikawa, H., Araki, E., Miyata, T., Isami, S., Motoyoshi, S., & Shichiri, M. (1995). Intensive Insulin Therapy Prevents the Progression of Diabetic Microvascular Complications in Japanese Patients With Non-insulin-dependent Diabetes Mellitus: A Randomized Prospective 6-year Study. Diabetes Research and Clinical Practice, 28(2), 103-117. Tamborlane, W. V., Beck, R. W., Bode, B. W., Buckingham, B., Chase, H. P., Clemons, R., ... & Xing, D. (2008). Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. The New England Journal of Medicine, 359(14), 1464-1476. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 41 2 LET’S G5x! THE BASICS • Introduction to the G5x • Initial Setup • Starting a Sensor Session: Inserting the Sensor and Transmitter • Calibration • Ending a Sensor Session and Transmitter Session PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 42 Chapter 4 Let’s G5x! The Basics: What Is the G5x? 4.1 System Description Now it’s time to get an overview of the the Dexcom G5x. After this chapter, you’ll be able to: • Explain the G5x • Describe options to view trends • Locate your historical readings • Recognize system components • Explain each part’s function 4.2 Safety Statement While you can use the G5 Mobile receiver with the G5x, you can’t use the sensor or transmitter from previous generations. If the transmitter or sensor box says “G5 Mobile” or “G4 PLATINUM,” don’t use them with the G5x. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 43 Warning Don’t: The system was not evaluated for the following persons: • Pregnant women • Persons on dialysis Don’t use the system in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Sensor glucose readings may be inaccurate in critically ill patients. Consequences: The system’s accuracy hasn’t been tested in people falling into these groups, and sensor glucose readings may be inaccurate, resulting in missing a severe low or high event. Precaution Do: The G5x transmitter must be used with the G5x Sensor and is not interchangeable with Dexcom the G5®Mobile/G4® PLATINUM Sensor. The G5x transmitter is compatible with the G5 Mobile receiver. Why: The G5x transmitter and G5 receiver are not compatible with the Dexcom G4 PLATINUM CGM System’s transmitter and receiver. Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) glucose event. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 44 G5x-Compatible Components G5x System Components Components Not Compatible with G5x G5x Sensor G5x Transmitter G5 Mobile Receiver G5 Mobile App G5 Mobile/G4 PLATINUM Sensor G5 Mobile Transmitter G4 PLATINUM Transmitter G4 PLATINUM Receiver with Share G4 PLATINUM Receiver 4.3 The G5x The G5x 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. A single-use sensor inserted under your skin measures your sensor glucose readings. A reusable transmitter sends your data to your display device. The G5x provides personalized trend Alerts, notifying you to proactively react when your glucose levels are getting too low or too high. Dexcom provides web-based reports reflecting your glucose trends and patterns. Share the reports with your healthcare professional when developing your diabetes management treatment plans. Some users of the G5x System may need a caregiver involved in their care. Please consult your physician for guidance. Options to View Your Trends The G5x transmitter works with a number of display devices, giving you flexibility to use what’s best for you, your situation, or your lifestyle. 1. Receiver PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 45 2. G5 Mobile app (app) on your smart device While the system works with different smart devices, they’re not interchangeable during a sensor session, so before starting one, select which smart device you want to use and stick with it throughout your session. You can’t use multiple smart devices at the same time, but you can combine the receiver with a smart device during a session. The G5x is the first CGM system where a smart device acts as a receiver. 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 app. The primary difference between the receiver and app is not the information they give you, but how that information is presented. The following are some of the shared CGM data and system information features. Tracking Real-Time CGM Data The receiver and app give you the ability to track your glucose trends in a number of different ways. Each device’s home screen opens to your glucose trend screen. Viewing Glucose Levels The receiver and app share many of the same glucose-monitoring features. Your glucose values are color-coded to highlight what zone you are in, allowing you, at a glance, to see what your levels are. Color-coded glucose levels: • Red - Low • Gray - Within your target range • Yellow – High Trend Arrows Glucose levels are not just about the numbers. The G5x includes trend arrows so you know the speed and direction of your glucose, allowing you to proactively react before your glucose gets too high or too low. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 46 Alarm/Alerts Being warned when your glucose value is too high or too low, falling or rising too quickly, or trending toward a severe low or high is very important. Warnings in the form of Alerts or an Alarm help you avoid getting too low or too high. Alarm and Alert notifications help keep you aware of your glucose trends and are made up of a combination of sounds, vibrations, and screens. There are a number of Alerts, but only one Alarm: when your glucose level dips below 55 mg/dL. Some customization options are available and are part of the setup process for the receiver and smart device. In Chapter 11, you can learn more about the Alarm and Alerts feature. Viewing Your Glucose Values The G5x allows you to see your last 1-3-6-12-24 hours of your sensor glucose readings. On the receiver, from the home screen, press Up/Down Arrows to view. On a smart device, hold upright in portrait mode to see the most recent three hours; turn sideways to landscape mode to view your glucose levels over the last 1-3-6-12-24 hours. Go to Chapter 9 to learn more about viewing your glucose trends. 4.4 What’s New to the G5x? Dexcom’s G5x has features not found in our previous generations. They include: • G5x sensor applicator • Redesigned transmitter and transmitter holder G5x Sensor Applicator Inserting a sensor has never been easier! The redesigned G5x sensor applicator allows you to insert a sensor with just one hand. Just peel away the adhesive’s backing, place the applicator on your body, fold and break off the safety guard, and push the applicator’s button. For detailed steps on sensor insertion, see Chapter 6. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 48 Single use sensor(s) Sold separately. Comes in a sterile pack. Insert Transmitter Transmitter package Reusable transmitter Receiver Receiver package PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 49 Receiver Receiver’s USB charging and download cable Receiver AC power adapter Welcome Card PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 50 Getting Started Guide Training Checklist attached to Getting Started Guide Training Tutorial USB Card Overview of System Components This section is meant as a quick overview of each part; specifics for each are found in following chapters. For detailed product specifications and technical information, please go to Chapter 17. The G5x is comprised of four key parts: 1. Applicator with single use sensor PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 51 2. Reusable transmitter 3. Rechargeable receiver 4. G5 Mobile app G5x optional: Dexcom Share Sensor Applicator Overview After removing the backing from the adhesive patch on the back of the sensor applicator, place the applicator on your skin and remove the safety guard. Push the orange button to insert the sensor wire and release the transmitter holder. The sensor wire is made of silver and platinum with polymer membranes. Once inserted, the thin and flexible wire measures your glucose levels in the fluid between your cells (interstitial fluid) for up to seven days. This section is meant as a quick overview. More information on using and inserting the applicator, sensor, and sensor wire can be found in Chapter 6. Figure 1. G5x Sensor Applicator and Transmitter Holder PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 52 Applicator and Transmitter Holder What it’s called What it does Applicator Applicator Contains small insertion needle and sensor wire. Inserts sensor wire under the skin. Disposable, for single use only. Removed after insertion. Safety Guard Keeps all moving parts in place before insertion. Prevents accidental sensor insertion. Fold and break to remove. Button Press to insert sensor wire and release transmitter holder. Transmitter Holder PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 53 Transmitter Holder Holds sensor wire and transmitter in place. Water resistant when transmitter is properly installed. Discarded after sensor session. Adhesive Patch Keeps transmitter holder attached to your skin. Sensor Wire Measures glucose levels in the fluid between your cells (interstitial fluid). Attached to transmitter holder once inserted under skin. Discarded with holder after session. Transmitter Overview Figure 2. G5x Transmitter Front and Back Please Note: Pictures above are representational only; your transmitter may look different. Snapping into the transmitter holder, the gray plastic transmitter wirelessly sends your glucose information to your display devices—receiver and/or smart PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 54 device. If you have a new transmitter, open the package when you are ready to use it. Transmitter features: • Reusable o Do not discard after sensor session. o Only for you, don’t share transmitter. • Water resistant • Can transmit data to your display devices for up to 20 feet o Range is less if you are in or under water. • Battery lasts approximately three months o Receiver or smart device notifies you when battery is running low. • Transmitter’s serial number is on the back More transmitter features and insertion information are in Chapter 6. Now that you are familiar with the sensor applicator and transmitter, let’s review the receiver. Receiver The receiver is a small hand-held device. Your receiver, along with your smart device, shows your sensor glucose readings, trend graphs, and trend arrows, and notifies you when your glucose is too high or too low or if there is something you should be aware of or need to do. The receiver is neither water resistant nor waterproof and can get damaged if moisture gets inside, so keep it away from any liquids and very high humidity as well as dirt and dust. Keeping the micro USB port closed helps prevent damaging fluids and dust from getting inside the receiver. If your receiver does get wet or dirty, test it to make sure the speaker and vibrations still work (see Chapter 12). If your receiver isn’t charged, see Chapter 14 for charging your receiver’s battery. If you want to use the receiver along with a smart device, you need to set them up separately. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 55 Remember, you can’t use a combination of smart devices during a sensor session; select just one. Receiver Overview What you see What it’s called What it does Receiver Provides data about your glucose trends via screen display, sounds, and vibration. Micro USB Port Plug USB cable into port for recharging. USB Port Door Close USB port door after removing USB cable to keep receiver clean and dry. Micro USB Cable Plug into receiver to charge battery. Don’t plug into a computer port to charge. Battery can only be charged using the adapter/wall charger. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 56 What you see What it’s called What it does Wall Charger Plug USB cable into adapter/wall charger. Plug wall charger into an electrical outlet to charge receiver’s battery. Don’t block access to the charger. Display Screen Shows sensor glucose readings, trend graphs and arrows, Alarm/Alerts, sensor session status. Change settings on Menu screen. Speaker Allows you to hear your Alarm/Alerts sounds. Navigation Wheel Arrows and button to help you navigate through the receiver’s menu options and choose features. Select Button Press to select menu option. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 57 What you see What it’s called What it does Left Arrow Press to go back to last item/screen or home screen. Right Arrow Press to highlight next item. Up/Down Arrows Press to scroll up or down to select menu items or set values. Press to scroll back and forth from the 3-hour trend graph to the 1-6-12-24 views. 4.7 Smart Device Overview The app was created to work with your smart device, giving you even more options in monitoring your glucose trends and patterns. The app is similar to all other apps. This user guide is not meant to show you how to use your smart device. Please contact your smart device support or read your smart device’s user guide for assistance. Summary Now You Can: • Explain the G5x PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide 58 • Describe options to view trends • Locate your historical readings • Recognize system components • Explain each part’s function Next Steps Your next step in getting started with the G5x is selecting how to continuously receive your sensor glucose readings: using the app, the receiver, or a combination. Our next chapter helps you set up both! PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 59 Chapter 5 Let’s G5x! The Basics: Set Up Your Display Devices 5.1 Introduction In the previous chapter, you received a high level overview of the G5x and learned you can monitor your glucose levels with different display devices. Now it’s time to set up your app and your receiver. After this chapter, you will be able to: • Create a Dexcom username and password • Download the app • Set up the app with the recommended settings • Successfully set up your receiver 5.2 Safety Statement While you can use the G5 Mobile receiver with the G5x, you can’t use the sensor or transmitter from previous generations. If the transmitter or sensor box says “G5 Mobile” or “G4 PLATINUM,” don’t use them with the G5x. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 60 Precaution Do: The G5x transmitter must be used with the G5x Sensor and is not interchangeable with the Dexcom G5® Mobile/G4® PLATINUM Sensor. The G5x transmitter is compatible with the G5 Mobile receiver. Why: The G5x transmitter and G5 receiver are not compatible with the Dexcom G4 PLATINUM CGM System’s transmitter and receiver. Consequences: Missing a severe low (hypoglycemia) or high (hyperglycemia) glucose event. G5x-Compatible Components G5x System Components Components Not Compatible with G5x G5x Sensor G5x Transmitter G5 Mobile Receiver G5 Mobile App G5 Mobile/G4 PLATINUM Sensor G5 Mobile Transmitter G4 PLATINUM Transmitter G4 PLATINUM Receiver with Share G4 PLATINUM Receiver 5.3 Why Different Monitoring Methods? Your convenience! By offering two separate monitoring systems, the app or receiver, you can choose to monitor your glucose levels in the handiest method at that moment. Forgot your receiver at home? Use your smart device! Battery died on your smart device? Smart device memory full? Your receiver has you covered! PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 61 With the exception of Dexcom Share, the primary difference between the two monitoring systems is not the data itself, but how it’s presented. The next section walks you through the initial setup for the app. To set up the receiver, go to Section 5.5. If you want to use both the app and the receiver, you need to setup each individually. Once you have completed the initial setup, you’re one step closer to beginning your sensor session! 5.4 App Before starting your first sensor session, pick the smart device you want to use. As mentioned in the previous chapter, you can use the receiver with one smart device during a session; however, you can’t use multiple smart devices during the same session. While your smart device can have the app installed, part of your initial setup is entering the transmitter’s serial number (SN). If by accident you enter the SN into more than one smart device, the system warns you and you won’t be able to complete the setup process. Suggested Smart Device Settings Bluetooth is designed for wireless communication between devices (unlike Wi-Fi®, which wirelessly connects devices to the Internet). Your transmitter communicates to your app via Bluetooth® Smart! Before beginning, make sure your smart device’s Bluetooth is available and turned on. Refer to your smart device’s user guide if you have questions on how to change your smart device settings. • While checking your Bluetooth settings, check to see Silent and Do Not Disturb are off. Your app does not override these settings; if you have them on, you will miss Alarm/Alerts • After verifying all your settings are correct, there is one more thing to check. Make sure your smart device’s Volume is loud enough for you to hear any Alarm/Alerts • Make sure your smart device settings allow your Alarm/Alerts to always show on your lock screen PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 63 But what if you are unclear about a step? The app has notifications allowing you to get more information. If you are unsure of something during your initial setup process, look at the screen for additional information notifications. Informational notifications include, but aren’t limited to: I don’t understand, Learn More, or Question Mark. Tap your informational notification to get more information. To close out of the information notification, tap the X in the upper right-hand corner. Initial App Setup Step What you see What you do Introductory Screens 1 Tap app icon to open app. Introductory Screens PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 65 4 Tap Let’s Get Started. 5 The next screens are the Terms of Use, safety warnings, contraindications, and the recommended settings. Once each screen is read, tap the appropriate answer to move forward. Tap Full Safety Statement or, when applicable, I don’t understand to get more information. Setting Up Your App Alarm/Alerts and Basic Settings PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 66 6 Set your Low Glucose Alert. Default is 80 mg/dL. Scroll to select another amount. Tap Save to move forward. Once your Low Glucose Alert is set, you’ll receive an Alert notification if your glucose dips below your set amount. 7 Set your High Glucose Alert. Default is 200 mg/dL. Scroll to select another amount. Tap Save to move forward. Once your High Glucose Alert is set, you’ll receive an Alert notification if your glucose rises above your set amount. Setting Up Your App Alarm/Alerts and Basic Settings PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 67 8a Make sure you get your Alarm/Alerts notifications. Tap the appropriate response to move forward and set your notifications. 8b Tap OK to receive Alarm/Alerts notifications. Setting Up Your App Alarm/Alerts and Basic Settings PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 68 9 The next screens provide suggestions for device volume, Do Not Disturb, and other basic settings. Tap appropriate answer to move forward. Connecting/Pairing Transmitter With App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 69 10 Tap Next. 11 Verify Bluetooth is on. The app will check to see if Bluetooth is turned “on.” Connecting/Pairing Transmitter With App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 70 12a Turn transmitter box upside down on a flat surface with barcodes facing up. Center longest barcode within green brackets. For information on how to pair transmitter after initial setup, see Chapter 8. 12b Center longest barcode within green brackets. Tap Take Photo Connecting/Pairing Transmitter With App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 71 12c Check mark confirms successful transmitter SN scan. 13a If unable to use app’s scanning device: Tap Enter transmitter SN by hand. Connecting/Pairing Transmitter With App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 72 13b Use keyboard to enter transmitter SN. Confirm correct SN . Tap Save. 14 Insert sensor and attach transmitter following video’s instructions. See Chapter 6 for more information. Connecting/Pairing Transmitter With App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 73 15 Wait up to 30 minutes for smart device and transmitter to connect. 16 At notification, Tap Pair to pair app with smart device. Connecting/Pairing Transmitter With App 17 Make sure your transmitter and smart device have paired before starting your sensor session PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 74 18 Tap the Sensor warmup circle to start your two-hour sensor warmup. When you see the sensor warmup timer, your initial setup is complete. Congratulations! If you have any issues setting up the G5 Mobile app, always contact Technical Support (available 24/7) at: • TechSupport@dexcom.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 If you are having problems with your smart device, contact your smart device’s support line. After completing your initial app setup, set up the receiver or go to Chapter 6 to start your initial sensor session. 5.5 Dexcom Receiver In the previous chapter, you learned about the receiver’s components. The following is a refresher to help in your initial setup. Display Screen: • Trend screen PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 75 • Menu selection screen Navigation Wheel: • Select o Button in the middle of the navigation wheel ! Center button does not say “Select” o Press to: ! Turn on receiver ! Select options/features ! Accept changes ! Move forward through menus/features • Up/Down o Scroll through trend screens o Highlight menu items o Change values • Left o Go back to last item or screen • Right o Go to next item or screen Initial Setup of the Dexcom Receiver Press Select to turn receiver on. The first screen you see is the startup screen with ascending green bars. Once complete, a setup wizard guides you through the initial setup steps. Don’t be worry if your receiver buzzes or makes other sounds during this process. After your initial setup is complete, you won’t see the setup wizard again. Your settings can always be adjusted using menu options. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 76 How you complete your initial setup differs between the receiver and your smart device; however, the data is the same. Setup Wizard Notifications: • Time/Date • Transmitter Serial Number o Back of transmitter o Back of transmitter’s box • Setting Low Glucose Alert • Setting High Glucose Alert Before starting a session, you may want to check the receiver’s battery level. If it is less than half, go to Chapter 4 for charging instructions. Initial Receiver Setup Step What you see What you do Initial Screens 1 Press Select to turn receiver on. 2 Wait. Time/Date PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 77 3 Press Up/Down Arrow to change year. Press Right Arrow to move forward. Press Up/Down Arrow to change month. Press Right Arrow. Press Up/Down Arrow to change day. Press Right Arrow to move to time. Time/Date 3b Press Up/Down Arrow to change hour. Press Right Arrow. Press Up/Down Arrow to change minutes. Press Right Arrow. Press Up/Down Arrow to select AM/PM. Press Select to save and close. NOTE: After initial setup, if battery is drained, receiver will vibrate once and you will need to reset date and time. Transmitter 4a Turn transmitter box upside down to locate SN number. For information on how to pair transmitter after initial setup, see Chapter 8. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 78 4b If transmitter package isn’t available: • SN is on transmitter’s back 4c Press Up/Down Arrows to select and enter transmitter SN. Press Right Arrow to move to next digit. Press Select to save and close. Setting Low Alert 5a System default is at 80 mg/dL. Press Select to save at present levels and close. 5b To change value: Press Up/Down Arrows to change value at 5 mg/dL increments. Press Select to save and close. Setting High Alert PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 79 6a System default is at 200 mg/dL. Press Select to save at present levels and close. 6b To change value: Press Up/Down Arrows to change value at 10 mg/dL increments. Press Select to save and close. These steps are enough to get you going; now you can start your sensor session! Summary Now You Can: • Create a Dexcom username and password • Download the Dexcom G5 Mobile app • Set up app with the recommended settings • Successfully set up your receiver What’s Next? 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: 1. Inserting the sensor. 2. Attaching the transmitter. 3. Pairing the transmitter to your device. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Set up Your Display Devices 80 4. Two-hour sensor warmup. 5. Startup calibrations. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 81 Chapter 6 Let’s G5x! The Basics: Starting a Sensor Session: Inserting Sensor, Attaching Transmitter, and Starting Your Session 6.1 Introduction Now that your display devices are set up, you’re ready to begin a sensor session. If this is your first time inserting a sensor, you may want to watch the G5x sensor insertion video to get a better understanding of the process. There are three ways to get the sensor insertion video: 1. Through the app 2. On the USB card in your receiver package 3. Online at dexcom.com: a. Top of page, click Support After inserting the sensor, start the sensor warmup on your smart device and receiver. The sensor warmup takes approximately two hours; during this time your body is getting used to the new sensor, allowing for more accurate sensor glucose readings. Once the two-hour sensor warmup has passed, you enter two back-to-back fingerstick measurements to calibrate the sensor’s glucose readings with your fingerstick measurements (Calibration is covered in the next chapter). Make sure you give yourself enough time to finish the startup session. Remember your smart device’s Bluetooth needs to pair with the transmitter, adding up to 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 G5x settings, whatever you choose during that time frame. Keep your display device(s) handy during the warmup period—it shows how much time has passed, notifying you with beeps and an icon when your sensor session is ready for its startup calibrations. After this chapter you will be able to: PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

$Dexcom G5x System User Guide Calibration 82 • Identify sensor applicator features • Properly prepare for sensor insertion • Choose the best location to insert your sensor • Correctly insert your sensor • Prepare transmitter for placement • Correctly attach transmitter to transmitter holder • Outline what happens during the sensor warmup • Identify countdown icon 6.2 Safety Statements Following are some important Precautions and Warnings to review; we want to make sure you and the system are safe before starting a sensor session. Warning Don’t: If a sensor breaks under the skin with no portion visible above the skin, don’t remove it. Do: Contact your healthcare professional if you have redness, swelling, or pain at the insertion site. Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department: Email: TechSupport@dexcom.com Toll free: 1.888.738.3646 Toll call: 1.858.200.0200 Why: Sensors may fracture on rare occasions. MRI with broken wire For patients undergoing an MRI with a retained wire broken off from a G5x sensor, in-vitro MRI testing did not detect any safety hazards. There was no significant migration or heating of the wire and imaging artifacts were limited to the area around the wire. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor$

Dexcom G5x System User Guide Calibration 83 Warning Do: During a sensor’s shelf life, store it between 36° F-86° F. Why: Storing the sensor incorrectly might cause the sensor glucose readings to be incorrect. Never store sensors and/or sensor packages in the freezer. Consequences: Missing a severe low or high glucose event. Warning Don’t: Insert the sensor component of the system in a site other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). Why: The placement and insertion of the sensor component of the system is not approved for other sites. Consequences: The system has not been tested in other areas and may not work properly if inserted in other areas. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 84 Warning Don’t: Use the system sensor glucose readings for treatment decisions. Do: When making treatment decisions, such as the amount of insulin you need, only use your BG value from your BG meter. Why: Since they measure your glucose from different body fluids, sensor glucose readings can be different from your meter’s BG values. Consequences: If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event. Precaution Don’t: Insert the sensor where bones are close to the skin’s surface (for example, over your ribs or hip bones). Why: If you insert the sensor in these areas, you may feel excessive pain or damage your sensor. Precaution Do: Change the site where you place the sensor with each new insertion. Sensor placement is important. Choose a site: • At least 3 inches from insulin pump infusion set or injection site • Away from waistband, scarring, tattoos, irritation • Unlikely to be bumped or pushed Why: Using the same site too often might not allow the skin to heal. Also, insertion in these areas might affect sensor performance. Consequences: Missing a severe low or high glucose event. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 85 Precaution Don’t: Use sensor if its sterile package has been damaged or opened. Why: Make sure the sterile sensor pack has not been damaged or previously opened. If opened or damaged, sensor may be unsterile. Consequences: Using a non-sterile sensor might cause an infection. Precaution Don’t: Don’t remove the safety guard before placing the applicator on the skin. Why: If you remove the safety guard first, you may accidentally deploy the needle and hurt yourself. Precaution Don’t: Get dirt or water in the receiver’s USB port or submerge in water. 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. 6.3 Prepping for Sensor Insertion Before inserting a sensor, make sure you have everything you need. Some items are included in your G5x packages, others are not. Included in Your G5x Packages For sensor insertion, you need the sensor and transmitter. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 86 Sensor Applicator Inside Sensor Box What you see What it is Sterilized applicator and sensor tray with important label information. Check expiration date. Do not use if it is past the expiration date. Open when ready to use. Single use sensor applicator. Knowing what each applicator piece does helps you successfully insert your sensor. Chapter 4, Section 4.6 gave you an overview of the sensor applicator. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 87 Figure 3. G5x Sensor Applicator and Transmitter Holder The following table reviews the sensor applicator components in order of use. Sensor Applicator Components Order of Use Name What it does 1 Adhesive Patch Keeps transmitter holder securely on your skin. 2 Safety Guard Prevents applicator from inserting sensor wire before you are ready. 3 Applicator Inserts sensor under your skin. 4 Transmitter Holder Holds sensor wire in place under skin. Holds transmitter. Transmitter Transmitter Box What you see What it is Bottom of box with important label information. Keep box until transmitter battery dies. Please Note: Picture is representative only; your transmitter box may look different. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 88 Reusable transmitter. Please Note: Picture is representative only; your transmitter may look different. In the previous chapter, you entered your transmitter SN into your display devices and made sure your smart device and/or receiver connected with the transmitter. You won’t be able to start a sensor session if your transmitter isn’t paired with your receiver and/or smart device. Not included in packages: 1. Alcohol wipes 2. Your BG meter 3. Your test strips Before starting, check your BG meter; make sure it’s in good working order following manufacturer’s directions and the meter’s date and time match your display device’s date and time. Make sure test strips haven’t expired and work with your meter. Before removing the sensor applicator from its sterile pack, determine the best place to insert your sensor. 6.4 Choosing Your Insertion Site Choose a place on your belly (or if user is between the ages of 2 and 17, upper buttocks) to insert the sensor; the site should be either above or below your belt line. The best areas are usually flat, “pinchable,” and free from where rubbing can occur (along the waistband, seat belt strap, or where you lie when sleeping). For more help on ideal sensor insertion sites, contact your healthcare professional. Insertion Sites Location Where it is PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 89 Front of body (belly area) for ages 2 years and older. If user is between the ages of 2 years and 17: Back of body (upper buttocks) Do: • Remove the sensor applicator and attached transmitter holder from its sterile pack only at time of use • 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, medications Don’t: • Never use same site repeatedly for sensor insertion • Never use same site for 2 sensor sessions in a row If you have concerns about the transmitter holder not sticking, before inserting your sensor, you can make the sensor site stickier to help ensure the transmitter holder does not peel up. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 90 Optional Site Preparation Use optional skin adhesives (Mastisol™, SkinTac™) as part of your insertion site preparation to help keep your transmitter holder attached. Apply the skin adhesive after you selected and cleaned your insertion site. Create an empty sideways oval, making sure you don't get any skin adhesive inside the oval. . Let the oval dry based on skin adhesive manufacture’s instructions. Once dry, your skin may feel slightly sticky. See Step 3 in the next table for directions. NOTE: Contact your healthcare professional for specific questions regarding the use of medical tape, barrier wipes, and/or other adhesives as it relates to your use of Dexcom CGM. 6.5 Inserting Your Sensor You’ve collected all of the needed items to begin a sensor session, viewed the tutorials, reviewed the sensor applicator, and prepped the transmitter holder site. You’re now ready to insert your sensor! Inserting Sensor Step Picture What you do Preparation 1 Wash and dry your hands. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 91 2 Clean insertion site with alcohol wipe. Let dry. 3 Optional Step: Skin Adhesive Create a empty sideways oval on the skin • 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 4 Check pack. Is it damaged or already opened? • If yes, do not use Peel lid off of sensor pack Keep sensor packaging until sensor session is complete. Attaching Transmitter Holder PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 92 5 Place hand over pack’s opening 6 Gently roll pack so applicator falls out and rests in the palm of your hand. Closely inspect sensor applicator, to check it has not been damaged. Remove Adhesive Backing 7 2-step process: 1. Remove large tab covering adhesive patch. 2. Remove small tab. Don’t touch adhesive after removing backing. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 93 Inserting Sensor Wire and Transmitter Holder 8 Place applicator horizontally, not vertically, on skin. Firmly press down, sticking adhesive patch to your skin. 9 Fold and break safety guard. Throw safety guard away. 10 Push button to insert sensor. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 94 11 Release button and remove applicator. Throw out applicator following local guidelines for disposal of blood-contacting components. What’s left on your skin? • Sensor wire • Transmitter holder You have successfully inserted the sensor! Now the transmitter holder and sensor wire are attached to your body. Having problems? If it’s the first time inserting a sensor, you may have questions or need help. If you do, please contact Technical Support (available 24/7) at: • TechSupport@dexcom.com • Toll free: 1.888.738.3646 • Toll call: 1.858.200.0200 The next step is attaching your transmitter to the transmitter holder. 6.6 Attaching Your Transmitter Now that you have inserted your sensor, you need to attach your transmitter. Since the transmitter is reusable, you don’t need a new one every time you start a sensor session. Keep your current session’s transmitter box. The bottom label has important information you may need after you’ve attached the transmitter. Once the transmitter has been attached, you can’t remove it PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 95 until your session is over. Chapter 8 reviews when and how to remove your transmitter. Before attaching your transmitter, check you’ve entered the correct transmitter SN into your display device. Chapter 5 covers entering transmitter’s SN number during initial setup. See Chapter 8 for pairing your transmitter after the startup wizard Attaching Transmitter Step Picture What you do 1 Remove transmitter from box only when you are ready to insert it. Keep box. Get alcohol wipe. 2 Wipe back of transmitter with alcohol wipe. Let dry for 2-3 minutes. Do not let the back of transmitter touch your skin. Do not scratch transmitter’s back; this can harm the waterproof seal. Do not touch metal dots on transmitter’s bottom. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 96 3 Hold transmitter’s round end. Slide transmitter’s narrow tip into slot at the narrow end of transmitter holder. Step Picture What you do 4 Press down firmly on round end of the transmitter until it clicks into place. 5 Move fingers around top of adhesive patch three times to secure tape. You’re almost done starting your sensor session! Inserting the sensor, attaching the transmitter, and the two-hour sensor warmup are the same, regardless of whether you use the receiver or app. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 97 The remaining steps vary from app to receiver: 1. Letting your device know you need to start the sensor warmup. 2. Following your warmup countdown. 6.7 Loose Transmitter Holder The transmitter holder should be able to stay on your skin using its own adhesive. If the patch peels up, use medical tape (such as Blenderm™, Tegaderm™, Smith & Nephew IV3000®, 3M™ tape) for extra support. • Tape over white adhesive patch on all sides for even support • Don’t tape over the transmitter or any plastic parts of the transmitter holder • Don’t tape under transmitter holder • Don’t leave any substance on the skin where you insert the sensor Figure 4. The Right Way to Use Tape for Extra Support Image is representational only. Your transmitter may look different. 6.8 Starting Your Sensor Session If you choose to use both the receiver and the app, each system requires individual setups (see Chapter 5). After pairing the transmitter to your display device(s), inserting your sensor, and attaching the transmitter to the transmitter holder, your next step is telling PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 98 your device(s) you want to start a sensor session. Transmitters are reusable; pairing is required only when using a new transmitter. During the warmup period, neither device will provide any sensor glucose readings. Your sensor glucose readings begin after the two-hour sensor warmup has passed and you entered the two startup calibration BG values into either the smart device or the receiver. We’ll first review starting the sensor session for the app. Dexcom App: Starting a Session Step What you see What you do 1 Wait for Pair Successful notification. Tap green checkmark in black square. 2 Tap sensor warmup circle to start your two-hour sensor warmup. NOTE: You will NOT get any sensor glucose readings, Alarm/Alerts during your two-hour sensor warmup period. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 99 3 Wait. Screen provides countdown to sensor warmup. The orange dashes darken as the countdown moves forward. Keep smart device within 20 feet of transmitter during the sensor warmup period. Step What you see What you do 4 Locked screen. Startup calibration notification tells you when warmup is complete. Chapter 7 covers calibrating. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 100 5 Startup calibration notification 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 1 Press Select to turn on receiver. Step What you see What you do PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 101 2 Make sure receiver and transmitter are connected/paired before starting sensor session. Check receiver 10 minutes after starting for Bluetooth icon. • Solid: Connected/paired • Blinking: Searching/not paired Don’t start a sensor session until they are paired. Once connected/paired: Press Select to go to the Main Menu 3 Press Down Arrow to highlight Start Sensor. Press Select to start new sensor session. NOTE: After sensor starts, Start Sensor option disappears. 4 “Start Sensor” progress bar confirms two-hour sensor warmup. Keep your receiver within 20 feet during the warmup period. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 102 5 Receiver returns to the trend graph screen. Step What you see What you do 6 Wait. Screen provides countdown of the two-hour sensor warmup. 7 Sensor warmup is complete. You’re ready to calibrate! 6.9 Receiver Bluetooth Tips Your transmitter and receiver begin communicating once you start a sensor session. After approximately 30 minutes, if the Bluetooth symbol is solid, and not blinking, your transmitter and receiver are talking to each other. • If blinking, Bluetooth is looking for your transmitter o Make sure your transmitter and receiver are within 20 feet of each other PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 103 o Don’t start a sensor session until they are paired. If the Bluetooth icon isn’t on the receiver and the Signal Loss icon appears in the receiver’s upper right corner of the status bar, they’re not communicating. No Communication Between Transmitter and Receiver Step What you see What you do 1 Check correct transmitter SN is in receiver. • SN is on the label on bottom of transmitter box Press Select to go to Main Menu. 2 Press Down Arrow to Settings. Press Select. 3 Press Down Arrow to Transmitter. Press Select. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 104 Step What you see What you do 4 Press Select. 5 Check correct transmitter SN is in receiver. • SN is on the label on bottom of transmitter box Compare SN in receiver to SN on transmitter box. If correct, call our 24/7 Technical Support department, toll free at 1.888.738.3646 or toll at 1.858.200.0200 for help. Press Select to exit screen. Press Left Arrow twice to go to Main Menu. If Wrong SN Entered 6 Press Left Arrow twice to go to Main Menu. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 105 Step What you see What you do 7 If sensor session has started, to correct the transmitter SN, you must stop the sensor session. Press Down Arrow to Stop Sensor. Press Select. 8 Press Select to stop session. If Wrong SN Entered 9 Wait for sensor session to end. 10 From Main Menu: Press Down Arrow to Settings. Press Select. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 106 Step What you see What you do 11 Press Down Arrow to Transmitter. Press Select. 12 Highlight Transmitter SN. Press Select. 13 Enter correct SN using Up/Down Arrow. Press Up/Down Arrow to select and enter transmitter SN. Press Right Arrow to move to next digit. Press Select to save and close. Press Left Arrow twice to return to Main Menu. 14 Start Sensor Session. Press Up/Down Arrow to highlight Start Sensor. Press Select. 6.10 Sensor Session Warmup PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 107 The sensor takes about two hours to adjust to your body. While you are in the sensor warmup period, you can customize your settings. Chapter 12 steps you through how to personalize your G5x display devices. Once the sensor warmup is complete, you’re ready to enter your startup calibrations! The next chapter shows you how. Summary Now You Can: • Identify sensor applicator features • Properly prepare for sensor insertion • Choose the best location to insert your sensor • Correctly insert your sensor • Prepare transmitter for placement • Properly attach transmitter to transmitter holder • Outline sensor warmup • Identify countdown icon What’s Next? The next chapter guides you through the calibration steps. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 108 Chapter 7 Let’s G5x! The Basics: Calibration 7.1 Introduction In the previous chapter, you learned how to insert your sensor, transmitter, and start a new sensor session. You’re now ready to begin your last step before getting your sensor glucose readings: Calibration. This chapter reviews not just your startup calibration, but also update calibrations required throughout your sensor session. After this chapter, you will be able to: • Calibration overview o Define calibration o Explain the importance of calibration o Identify steps to ensure a successful calibration • Recognize steps in taking accurate BG measurement o Identify the correct BG site for calibrations o Prepare finger for fingerstick measurement • Determine if you should/should not calibrate o Recognize when you can enter a fingerstick measurement for calibration o Recognize when you shouldn’t enter a fingerstick measurement for calibration o Determine if you need to calibrate outside of the normal calibration requirements • Initiate startup calibration • Perform update calibrations PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 109 • Correctly enter your fingerstick measurement o In the app o In the receiver • Identify calibration errors 7.2 Safety Statements Contraindication Don’t: Take medications containing acetaminophen while wearing the sensor. Why: Taking medications with acetaminophen (such as Tylenol or Excedrin Extra Strength) while wearing the sensor may falsely raise your sensor glucose readings. The level of sensor inaccuracy: 1. Depends on amount of acetaminophen active in your body. 2. May be different for each person. Consequences: Without correct readings you might miss a severe low or high glucose event. Warning Don’t: Use the system sensor glucose readings for treatment decisions. Do: When making treatment decisions, such as the amount of insulin you need, only use your BG value from your BG meter.. Why: Since they measure your glucose from different body fluids, sensor glucose readings can be different from your meter’s BG values. Consequences: If sensor glucose readings are used in determining treatments, it could result in you missing a severe low or high glucose event. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 110 Warning Do: Calibrate at least once every 12 hours. Why: Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate. Consequences: Missing severe low (hypoglycemia ) or high (hyperglycemia) glucose event. Precaution Do: Look for rate of change arrows on your display device screen. Trend arrows help you determine if you can calibrate now or should wait. Don’t: Calibrate when your BG is changing at a significant rate: more than 2 mg/dL per minute. Don’t calibrate when you see: • A single arrow, pointing up o Rising 2-3 mg/dL each minute • Two arrows pointing up o Rising more than 3 mg/dL each minute • Single arrow pointing down o Falling 2-3 mg/dL each minute • Two arrows pointing down o Falling more than 3 mg/dL each minute Why: Calibrating during a significant rise/fall of your BG may affect accuracy of sensor glucose readings. Consequences: You may miss a severe low or high glucose event. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 111 Precaution Do: Enter the exact BG value displayed on your BG meter within five minutes of a fingerstick. Why: Entering the wrong BG values, or waiting more than five minutes before entry, might affect sensor performance. Consequences: You may miss a severe low or high glucose event. Precaution Do: Only use fingerstick measurements from your BG meter for calibration. Don’t: Use alternative site BG values from your arms, palm of your hand, etc. Why: Alternative site BG values may be different and less accurate than your fingerstick BG values. Consequences: You may miss a severe low or high glucose event. 7.3 Calibration Overview What Is a Calibration? As you learned earlier, the sensor glucose readings come from measuring the glucose fluids found between your cells (interstitial fluids). Although blood and interstitial fluids are similar, sensor glucose readings can be different between your fingerstick and your CGM. Calibration provides a comparison, or measurement, between your meter’s fingerstick measurement and the sensor’s glucose readings, allowing alignment between the sensor and meter. Your BG meter “teaches” the sensor your glucose values through calibration. Just like a clock can need adjusting—calibrations allow your CGM to adjust to your body. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 112 Why Is Calibrating Important? Calibrations are a must to make sure the CGM system is performing at its best. By calibrating when the system notifies you that a calibration is due, the G5x uses your meter’s BG value to make sure the sensor glucose readings remain accurate throughout your session. How Do I Calibrate? Take a fingerstick measurement from your meter, and simply enter the meter’s BG value into one of your display devices. This chapter lets you know what precautions you need to take before taking your BG meter value, then entering your data. Up to now, you needed to enter information such as Alerts, transmitter SN, etc., separately for the receiver and smart device. Calibration is different. You only need to enter calibrations into one device. Don’t enter your BG values into both devices: enter into either your app or the receiver. If you enter your meter’s BG value into your receiver, it takes about five minutes for your sensor glucose readings to begin. In approximately ten minutes, you can view the readings in the other display device. How Often Do I Calibrate? There are three primary “must do” calibration events, each with its own notifications: 1. Two startup calibrations once your warmup session is complete. 2. Update calibrations done twice daily, once every 12 hours. 3. When you’re notified. If you receive a calibration notification outside of your scheduled calibration schedule, either the system doesn’t accept your most recent calibration or your meter’s BG value is very different from the sensor’s glucose reading. Don’t worry about keeping track of the time between calibrations; the system will notify you when you are ready for another. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 113 Now that you have an overview of calibration, let’s review some contraindications, warnings, and precautions you need to know and follow before you calibrate. 7.4 When to Calibrate Calibrating on a regular schedule aligns your sensor glucose readings with your meter’s BG values. Without calibrations, your sensor may be inaccurate, and as a result, so will your display device’s sensor glucose readings, Alerts, and notifications, etc. There are important times when you must calibrate: 1. Startup Calibration: two hours after you insert your sensor. 2. 12 Hour Update Calibration: every 12 hours after two-hour startup calibration. 3. When system notifies you. With calibration notifications, your sensor and display device help you keep your calibration schedule on track. If your BG values are not between 40-400 mg/dL, the system won’t accept your calibration. Wait until you are within the 40-400 mg/dL range before entering your BG values. Startup Calibration: Sensor Startup Completed 1. At notifications (see next table) enter two back-to-back fingerstick measurements into just one device. 2. No need to do startup calibrations twice. a. Calibration data flows between the receiver and your app. b. Five minute reporting delay between devices. 3. First update calibration is 12 hours after your startup calibration. Update Calibration Enter an update calibration every 12 hours after your initial calibration. Below is a sample calibration schedule. As you can see from the calendar’s BG meters, you: 1. Inserted your sensor and entered initial two calibrations on Monday at 10 AM. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 114 2. Entered update calibrations at 10 PM that night. 3. For the rest of the seven-day sensor period, you enter update calibrations at 10 AM and 10 PM. Figure 5. Example Minimum Calibration Schedule During Seven-Day Sensor Session Update calibrations are typically 12 hours since your last calibration; however, they can be sooner. As an example, if you know your next calibration is due at 10 PM, but you want to go to bed at 9 PM, you can do the calibration before bedtime, resetting the 12-hour count down. 1. Enter one fingerstick measurement at least every 12 hours. 2. Display devices provide calibration prompts. 3. You may be prompted to enter additional fingerstick measurements as needed. 7.5 Calibration Notifications Sensor Session Startup Calibration Notifications PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 115 Once your two-hour sensor warmup is complete, your display device tells you it’s time to enter the first of your two back-to-back startup calibrations. Once the system has accepted your BG values, your glucose readings begin. If you don’t enter your BG values right away, the system reminds you every 15 minutes. Remember, use only your BG meter for calibrations, and never enter values from your CGM. Startup Calibration Notifications Device What you see What it means What you do First Calibration Smart Device: Lock Screen Sensor warmup is complete. Ready for first of two startup calibrations. Follow steps in Section 7.6 and 7.7. Immediately prepare for next calibration. Smart Device: In App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 116 Receiver Device What you see What it means What you do Second Calibration Smart Device: Lock Screen Sensor accepted first calibration. Ready for second BG meter value. Follow steps in Section 7.6 and 7.7. Next calibration in 12 hours. Smart Device: In App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 117 Receiver Your sensor glucose readings begin in approximately five minutes once the device(s) accepts your calibrations. Update Calibration Notifications Once your startup calibration is done, your update calibration schedule begins. The steps to enter your update calibrations are the same as your startup calibration, including only entering values in one display device. The only difference is, with update calibrations, enter your BG meter value just once. The default BG value is your current reading if available or 120 mg/dL. Like the reminders you received with your startup calibration, if you don’t enter your BG meter values right away, the system notifies you every 15 minutes. Update Calibration Notifications Device What you see What it means What you do Smart Device: Lock Screen Enter update calibration. If message doesn’t go away: • System didn’t accept calibration Follow steps in Section 7.6 and 7.7 to calibrate. Immediately prepare for next calibration. Smart Device: In App PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 118 Receiver • BG values are very different from sensor glucose readings Tap Message to clear notification on your smart device. To clear a notification on your receiver, press Select. Sound/Vibration Notifications In case you can’t look at your screen, both the smart device and receiver provide, with the exception of your regular 12-hour update calibration, beep/vibration notifications to let you know it’s time to calibrate or if there was a system calibration error. For more information on setting your sound/vibration notifications and how to clear them, please see Chapter 9. Smart Device Calibration notifications will Alert you with a triple beep if your smart device is not on Silent or Do Not Disturb. Receiver The receiver Alerts you with an initial vibration for calibration notifications. If not cleared, you receive a vibrate/beep every five minutes until confirmed. 7.6 Preparing for Calibration Your sensor depends on you to help make its sensor glucose readings accurate. If you don’t prepare properly for the calibration, your sensor may not provide you with the most accurate sensor glucose readings. Nine Steps to Successful Calibration: Do: PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 119 1. Wash and dry your hands before staking a fingerstick measurement. 2. Always use the same meter you routinely use to measure your BG. a. BG meter and strip accuracy vary between meter brands. b. Switching within a session might cause sensor glucose readings to be less accurate. 3. Follow meter’s instructions exactly when taking your fingerstick measurement. 4. Verify test strips are current and, if required, coded correctly with meter. 5. Check: Is Bluetooth on? a. If off, can’t calibrate 6. Use fingerstick BG values only. a. Other sites are not as accurate. b. Must enter within five minutes of taking BG meter value. c. Enter exact BG value from your meter for each calibration. Don’t: 7. Don’t take acetaminophen-containing medication during your session (for example, Tylenol). a. See your healthcare professional to better understand how long acetaminophen is active in your body. 8. Don’t calibrate if your BG values are under 40 mg/dL or over 400 mg/dL. a. If BG value is outside of this range, receiver doesn’t understand these values and won’t calibrate. i. You must wait until your BG is in the range to calibrate. 9. Don’t calibrate if trend arrows are going straight up or down a. Glucose is changing too quickly for an accurate calibration. Be safe—if BG is low, first treat low blood sugar, and then calibrate. 7.7 Ready? Set? Calibrate! You’ve followed the nine steps above, have a valid BG value from your meter, and your display device keeps alerting you: Calibrate! Calibrate! Calibrate! Remember: PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 120 You don’t have to take a fingerstick measurement for each display device when calibrating. Once you enter the reading into one, data is pushed to the other within ten minutes. Next are steps to enter your calibrations using the app, followed by the steps for entering your calibrations into the receiver. Startup Calibration in the App Step What you see What you do Additional Info 1 Tap circle. Startup calibration: Enter two back-to-back meter BG values. Update calibration: Enter one meter BG value. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 121 Step What you see What you do Additional Info 2 Enter meter’s BG value using number pad. Tap Save. Double-check your numbers. Entering wrong values, or values taken more than five minutes ago, can affect the sensor’s accuracy. 3 Verify value is correct. Tap Save. If not correct: Tap Cancel. Reenter correct value. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 122 Step What you see What you do Additional Info 4 Tap circle to enter your second BG value. Follow steps 2-3 and enter second reading. 5 Meter icon has no calibration notification. Calibration accepted. Your calibration was successful. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 123 Step What you see What you do Additional Info 6 Wait for next calibration notification in 12 hours. Default Home trend screen. Calibration accepted. Startup Calibration With Your Receiver Step What you see What you do Additional Info 1 Press Select to turn on receiver. Press Select again for Main Menu. You won’t see calibration notifications when receiver screen is black. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 124 Step What you see What you do Additional Info 2 Press Up/Down Arrow. Highlight Enter BG. Press Select. 3 Press Up/Down Arrow to change numbers. Stop at meter’s BG value. Press Select. Sensor default reading is 120 mg/dL. If sensor glucose reading is within the last 15 minutes, screen will show sensor’s actual reading. 4a Verify BG value is correct. If correct: Press Select. If Select is not pressed: • Receiver times out • BG level isn’t recorded PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 125 Step What you see What you do Additional Info 4b Verify BG value is correct. If incorrect: Press Right Arrow to Cancel. Press Select. Reenter BG value. Cancel and reenter BG value. Fingerstick measurement must be within the last five minutes. 5 Wait. “Thinking” screen. BG value is accepted. 6 Immediately take another meter reading. Enter meter’s BG value. First calibration accepted. Time for second calibration. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 126 Step What you see What you do Additional Info 7 Wait for next calibration notification in 12 hours. Default trend screen. Calibration(s) accepted. 7.8 Calibration Errors Before or during your calibration process, your display device may show error notifications. If the notifications don’t go away after 15 minutes, refer to Chapter 18, Troubleshooting. Calibration Error Notifications Device What you see What it means What you do Smart Device: In App Sensor can’t calibrate now. Wait 10-15 minutes. Retake fingerstick measurement at notification. Enter BG value. Receiver PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 127 Device What you see What it means What you do Smart Device: In App System didn’t accept recent calibration. Additional calibration needed immediately. Calibrate. No sensor glucose readings. Receiver Approximately five minutes after entering your second BG meter value, your display device(s) will start providing sensor glucose readings and glucose level trends. While each display device may have different ways of presenting sensor glucose readings and trends, the meanings are the same. Fingerstick measurements entered into one device will be available in the other approximately ten minutes after entering data. Summary Now You Can: • Calibration overview o Define calibration o Explain the importance of calibration o Identify steps to ensure a successful calibration • Recognize steps required to take accurate BG measurements o Identify the best BG site for calibrations o Prepare finger for fingerstick measurement • Determine if you should/should not calibrate PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Calibration 128 o Recognize when you can enter BG meter values o Recognize when you should not enter BG meter values o Determine if you need to calibrate outside of the normal calibration guidelines • Initiate startup calibration • Perform update calibrations • Correctly enter your fingerstick measurement o App o Receiver • Identify calibration errors What’s Next? In the next chapter, you’ll learn how to end a typical seven-day sensor session, what to do if you need to end your sensor session early, along with how to remove the transmitter and determining if you need to replace it. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

Dexcom G5x System User Guide Ending Your Sensor Session and Transmitter Session 129 Chapter 8 Let’s G5x! The Basics: Ending Your Sensor Session and Transmitter Session 8.1 Introduction G5x sensor sessions last seven days. This chapter reviews what you should expect when your session is about to expire, and removing the sensor and transmitter. It also covers how to determine if you need to end your session early. After this chapter, you will be able to: • Identify replace sensor notifications at the end of a seven-day sensor session • Recognize when you have to end a sensor session early • Successfully end a sensor session early o Identify how you can prevent sensor session failures • Remove your transmitter holder with transmitter attached • Separate transmitter from its holder • Determine if transmitter can be used for another sensor session • Pair a new transmitter To keep up with your glucose trends, it’s important to begin a new sensor session as quickly as possible. After a sensor session ends, the sensor stops taking your sensor glucose readings. You won’t get your trends, nor will you get any Alarm or Alerts. Before stopping a session and removing the transmitter and its holder, review the following safety statements to make sure you don’t harm yourself. 8.2 Safety Statements PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor

$Dexcom G5x System User Guide Ending Your Sensor Session and Transmitter Session 130 Warning Don’t: If a sensor breaks under the skin with no portion visible above the skin, don’t remove it. Do: Contact your healthcare professional if you have redness, swelling, or pain at the insertion site. Within 24 hours of experiencing a broken sensor wire, please call our 24/7 Technical Support department:: Email: TechSupport@dexcom.com Toll free: 1.888.738.3646 Toll call: 1.858.200.0200 Why: Sensors may fracture on rare occasions. MRI with broken wire For patients undergoing an MRI with a retained wire broken off from a G5x sensor, in-vitro MRI testing did not detect any safety hazards. There was no significant migration or heating of the wire and imaging artifacts were limited to the area around the wire. Precaution Don’t: When ending a session, don’t throw away the transmitter. Do: Keep using it until the system notifies you the transmitter battery is about to expire. Why: The transmitter is reusable and can be used in multiple sensor sessions. 8.3 Ending Your Sensor Session There are different ways your session might end. PDF compression, OCR, web optimization using a watermarked evaluation copy of CVISION PDFCompressor$

Dexcom 9588 G5x Transmitter User Manual

Dexcom, Inc. G5x Transmitter

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