Dexcom 9433 Glucose Monitor User Manual LBL 010797 Rev01 Users Guide IUO indd

Dexcom, Inc. Glucose Monitor LBL 010797 Rev01 Users Guide IUO indd

Users Manual

USER’S GUIDEG4-Global Continuous Glucose Monitoring SystemCAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
G4-Global Continuous Glucose Monitoring System
4 | Continuous Glucose Monitoring SystemIMPORTANT CONTACTS AND NUMBERSDexCom Website: www.DexCom.comYour Transmitter ID Number:Your Transmitter Expiration Date:Your Receiver ID:Your Healthcare Professional:Nearest Hospital:Other Notes:© 2010 DexCom, Inc. All rights reserved.DexComTM, STS®, SEVEN®, DexCom DM®, DexCom Studio® Software, GVITM, OpenChoiceTM, Take Control – Live Uninterrupted®, Live Uninterrupted®, Between the LinesTM, SENSYNCTM, Stay Between the Lines®, DexCom Glucose Sensing™, Glucose Sensor Company™ and Dex™ are trademarks of DexCom, Inc. All other trademarks and copyrights are the property of their respective owners.
G4-Global System User’s Guide | 5G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM KIT CONTENTS:G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEMG4-Global Sensor and Applicator G4-Global ReceiverG4-Global Transmitter NOTE: Sensors are sold separately. Commercially distributed blood glucose meter required for use. Make sure to use the correct version of DexCom Studio® with your G4-Global System. The G4-Global Sensor works with the G4-Global family of products. The G4-Global Sensor, Transmitter and Receiver are not backwards compatible with the SEVEN/SEVEN® PLUS Transmitter and Receiver.• Transmitter• Receiver• DexCom Studio® Accessory Software• Receiver Charging Cable• Receiver Case• User’s Guide• Quick Start GuideThe G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes.
6 | Continuous Glucose Monitoring SystemDexCom would like to thank you for purchasing the G4-Global Continuous Glucose Monitoring System (G4-Global System)! When you use the G4-Global System, you will see real-time continuous glucose readings every 5 minutes for up to 7 days. These readings will help you detect trends and patterns in your glucose levels. Glucose trends let you see where your glucose levels have been, which direction your levels are headed, and how fast they may be rising or falling.The G4-Global System is made up of three technologies that all work together: the Sensor, the Transmitter, and the Receiver. The Sensor is a disposable unit that you insert into your abdomen (belly) to continuously monitor your glucose levels for up to 7 days. The Transmitter is a reusable device that snaps into the Sensor Pod. Your Transmitter will wirelessly send your Sensor-measured glucose information to your Receiver. The Receiver is a hand-held device that receives and displays your glucose information every 5 minutes.The Receiver displays your current glucose reading and shows your glucose trend information from the past 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour periods. You will also see adjustable High and Low Glucose Alerts, and a Low Glucose ALARM to tell you when you are outside of your target glucose levels. Rise and Fall (Rate of Change) Alerts will let you know when your glucose levels are changing fast.You can use any FDA-cleared blood glucose meter for calibration on the G4-Global System.This User’s Guide describes how to use your G4-Global System from start to fi nish of a continuous glucose monitoring session. Important safety information, warnings, precautions, cautions, and contraindications of the G4-Global System are described in the next few pages and throughout this guide. Be sure to read this entire User’s Guide before beginning a continuous glucose monitoring session.
G4-Global System User’s Guide | 7INDICATION FOR USEThe G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The G4-Global System is intended for use by patients at home and in health care facilities. The device is for prescription use only.The G4-Global Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.The G4-Global Continuous Glucose Monitoring 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 G4-Global System results should be based on the trends and patterns seen with several sequential readings over time.IMPORTANT SAFETY INFORMATIONRead this entire guide before using your G4-Global Continuous Glucose Monitoring System. If you do not understand something or have any questions, please ask your Diabetes Management Team or another health care provider. Contraindications, warnings, precautions, cautions, and other important safety information can be found in this section and in boxes throughout your G4-Global System User’s Guide. The Troubleshooting section (Chapter 9) contains important information on troubleshooting your G4-Global System. The Technical Information section (Chapter 11, Section 11.2) provides information on the performance characteristics of the device.CONTRAINDICATIONS• The G4-Global System must be removed prior to Magnetic Resonance Imaging (MRI).• Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device.
8 | Continuous Glucose Monitoring SystemWARNINGS• This device is not designed to replace a blood glucose meter. The G4-Global System must be used with a blood glucose meter.• Treatment decisions should not be based solely on results from the G4-Global System. You must confi rm results with fi ngerstick readings from a blood glucose meter before making therapeutic adjustments.• Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use fi ngerstick readings from your blood glucose meter to check the G4-Global System results.• You should update the G4-Global System calibration every 12 hours at a minimum. The performance of the G4-Global System when calibrated less frequently than every 12 hours has not been studied.• Sensors may fracture on rare occasions. If a Sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or infl ammation—redness, swelling or pain—at the insertion site. If you experience a broken Sensor, please report this to our Technical Support department.• The G4-Global System is not approved for use in children or adolescents, pregnant women or persons on dialysis.• The safety and effectiveness of the G4-Global System has not been evaluated for Sensor Probe insertion sites other than the skin of the abdomen.PRECAUTIONS• Always wash hands with soap and water before opening the Sensor package. After opening the package, avoid touching the adhesive area.• Before inserting the Sensor, always clean the skin at the Sensor insertion location with a topical antimicrobial solution, such as isopropyl alcohol. Do not apply the Sensor until the cleaned area is dry.• Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing, accessories, or subjected to rigorous movement during exercise.• Avoid injecting insulin or placing an insulin pump infusion set within 3 inches (7.62 centimeters) of the Sensor.
G4-Global System User’s Guide | 9• The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.• The Sensor has currently only been tested in adult persons with type 1 and type 2 diabetes. The device has not been tested in children or adolescents, pregnant women, or persons on dialysis.CAUTIONU.S. federal law restricts the sale of the G4-Global System to sale by or on order of a physician.
10 | Continuous Glucose Monitoring SystemG4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM: SYSTEM KIT CONTENTS 5INTRODUCTION: 6INDICATION FOR USE 7IMPORTANT SAFETY INFORMATION 7CHAPTER 1: THE G4-GLOBAL SYSTEM BASICS 131.1 Sensor Overview 151.2 Transmitter Overview 161.3 Receiver Overview 171.4 Moving Through the Receiver Screens 19CHAPTER 2: G4-GLOBAL SYSTEM SET UP 232.1 The Set Up Wizard 252.2 Turning the Receiver On 262.3 Setting the Time and Date 272.4 Entering Your Transmitter ID 282.5 Changing Your High and Low Alerts 292.6 Charging Your Receiver Battery 31CHAPTER 3: USING A SENSOR 333.1 Before You Start 353.2 Removing the Sensor From Its Packaging 373.3 Choosing an Insertion Site 373.4 Placing the Sensor 383.5 Sensor Insertion 393.6 Transmitter Attachment 403.7 Starting a Sensor Session 423.8 Transmitter and Receiver Communication 423.9 Sensor Startup Period 443.10 The G4-Global System and Water 443.11 Taping the Sensor Pod 44CHAPTER 4: CALIBRATING YOUR G4-GLOBAL SYSTEM 454.1 Calibration Overview 474.2 How to Calibrate 48table of contents
G4-Global System User’s Guide | 114.3 Startup Calibration 504.4 Calibration Update 514.5 Re-Calibration 52CHAPTER 5: CONTINUOUS GLUCOSE READINGS, 55TRENDS, ALERTS AND ALARM5.1 Glucose Readings 585.2 Glucose Trends 615.3 Glucose Alerts and Low Glucose ALARM 62 5.3.1 High Glucose Alert 63 5.3.2 Low Glucose Alert 64 5.3.3 Low Glucose ALARM 65 5.3.4 Rise and Fall Glucose rate Alerts 655.4 Glucose Status Area on Trend Graphs 67 5.4.1 Glucose Status Area Symbols 67 5.4.2 Missing Glucose Readings 68 5.4.3 System Glucose Errors 69 5.4.4 Out of range/No Antenna 705.5 Temporary Sensor Shut Down 71CHAPTER 6: COMPLETING YOUR CONTINUOUS GLUCOSE MONITORING SESSION 736.1 Removing a Sensor 756.2 Automatic Sensor Shut-Off 766.3 Early Sensor Shut-Off 77 6.3.1 Early Shut-Off – Sensor Failure 77 6.3.2 Manual Sensor Shut-Off – “Stop Sensor” 776.4 Transmitter Removal 79CHAPTER 7: BASIC SETTINGS 817.1 The Settings Menu 83 7.1.1 Getting to the Settings Menu 83 7.1.2 Setting Your Receiver Date and Time 83 7.1.3 Entering Your Transmitter ID 84 7.1.4 Checking Information About Your Receiver 867.2 Setting Your Alerts 87 7.2.1 Factory Alert Settings 87 7.2.2 Getting to the Alerts Menu 89 7.2.3 Setting Glucose Alerts 89
12 | Continuous Glucose Monitoring SystemCHAPTER 8: ADVANCED FEATURES - BEYOND THE BASICS 958.1 Activating Advanced Features 978.2 Diabetes Events 98 8.2.1 Selecting an Event 98 8.2.2 Setting the Date and Time for an Event 99 8.2.3 Carbohydrates 99 8.2.4 Insulin 100 8.2.5 Exercise 101 8.2.6 Health 1028.3 DexCom Studio® Software 1038.4 Rise and Fall Glucose Rate Alerts 1038.5 Setting Other Alerts 1058.6 Setting the Out of Range Alert 1068.7 Setting a Snooze Time for Your High and Low Glucose Alerts 108CHAPTER 9: TROUBLESHOOTING 1099.1 Sensor Insertion Troubleshooting 1119.2 Calibration Troubleshooting 112 9.2.1 Blood Drop Prompts 112 9.2.1.1 Types of Blood Drop Prompts 112 9.2.1.2 Status Area Symbols During Blood Drop Prompts 1149.3 Sensor Failed Troubleshooting 1159.4 Calibration Error Troubleshooting 1169.5 Receiver and Cables Troubleshooting 117 9.6 Receiver and Transmitter Communication Troubleshooting 118CHAPTER 10: TAKING CARE OF YOUR G4-GLOBAL SYSTEM 11910.1 Maintenance 12110.2 Storage 12210.3 Cleaning and Disinfecting 122CHAPTER 11: STUDY RESULTS 12511.1 Pivotal Study Results 12711.2 Product Specifi cations 14511.3 FCC Requirements 154CHAPTER 12: APPENDIX 155Appendix I, Other Alerts 157Appendix II, Receiver Screens and Prompts 160Glossary 164Symbols Used in Labeling 166Index 168
chapter oneonTHE G4-GLOBAL SYSTEM BASICS
G4-Global System User’s Guide | 151.1 SENSOR OVERVIEWThe Sensor is the System component that continuously measures your glucose levels. You will use a blood glucose meter to calibrate your glucose readings measured by the Sensor. The Transmitter collects the Sensor readings and sends them to the Receiver using wireless, radio frequency (RF) technology. This happens every 5 minutes for up to 7 days.The Sensor unit has an Applicator (needle, sensor, plastic housing), Sensor Probe, and Sensor Pod. The Applicator includes a Safety Lock/Transmitter Key to keep the needle in place until you are ready to insert. After taking off the Safety Lock, you will insert the Sensor Probe just beneath the skin (subcutaneous tissue) of your belly using a small needle inside the Applicator. The needle is inserted just under the skin at an angle and carries the Sensor Probe with it. After you insert the needle and Sensor Probe, you will pull the needle back into the Applicator. This leaves the Sensor Probe behind to continuously measure your glucose levels. The Applicator, with the needle inside, is pulled off from the Sensor Pod and should be thrown away. Save the Safety Lock/Transmitter Key because you can use it to remove the Transmitter at the end of a continuous monitoring session.The Sensor Probe lies underneath your skin at an angle and continuously measures your glucose levels for up to 7 days. The Sensor Pod and Transmitter (once snapped in) remain on your belly for the entire Sensor session. The Sensor insertion site is similar to an insulin pump infusion site.PlungerApplicator (needle/sensor probe inside)Transmitter LatchSafety Lock/Transmitter ReleaseCollarSensor PodRelease Tab
16 | Continuous Glucose Monitoring System1HELPFUL HINTS:• Your Transmitter is re-used for many Sensor uses.• If you see the Out of Range Symbol in the upper right corner of the Trend Graph, your Transmitter and Receiver are no longer talking. This can happen even when your Sensor/Transmitter and Receiver are within 20 feet (6 meters) of each other. • The Receiver and Transmitter are designed and tested to withstand common electromagnetic interference, including airport security systems.1.2 TRANSMITTER OVERVIEWThe Transmitter wirelessly sends your glucose information from the Sensor to the Receiver. Once you insert the Sensor, you will snap the Transmitter into the Sensor Pod using the Transmitter Latch. The same Transmitter is used when you change Sensors. The Transmitter battery will last about 6 months. As the Transmitter nears the end of its battery life, it can sometimes lose communication with the Receiver. This can happen even if the Receiver and Sensor/Transmitter are within 20 feet (6 meters) of each other. The Transmitter (Low Battery) screen will fi rst appear when there are about 2 weeks of battery life remaining. Press any Receiver button to clear the ALARM. This ALARM will reappear every day for 2 weeks, or until the Transmitter is replaced. Once the Transmitter battery has drained, you will need to replace the Transmitter because it can no longer communicate (talk) to the Receiver. You can easily set up a new Transmitter to talk with your Receiver (see Chapter 2, Section 2.4).Install Transmitter in Sensor Pod Transmitter InstalledTransmitter LatchRemove Transmitter Latch
G4-Global System User’s Guide | 171.3 RECEIVER OVERVIEW The Receiver looks like a small MP3 player and shows your Sensor-measured glucose information. The G4-Global Receiver only shows glucose readings in the milligrams per deciliter (mg/dL) unit of measure. In the United States, mg/dL is the standard unit used for glucose testing systems (i.e., blood glucose meters). Please check with your Diabetes Management Team if you have questions about the unit of measure displayed on your Receiver.Keep the Receiver within 20 feet (6 meters) of the Sensor/Transmitter at all times for your G4-Global System to work best. Good places to keep the Receiver are on your belt in the Receiver case provided or in your pocket.EXAMPLE: 3-Hour Trend Graph ScreenTrend Graph HoursTrend ArrowTimeMost recent 5-minute glucose readingHigh Glucose Alert SettingLow Glucose Alert Setting Plot of most recent glucose reading
18 | Continuous Glucose Monitoring System1There are 5 Receiver buttons to move you through the display screens that control setup and operation. The screens display glucose readings and trend graphs (“Trend Graphs”) and allow you to change your Receiver settings (“Menu Screens”). You program your Receiver with a specifi c Transmitter ID Number so your Receiver and Transmitter can talk with each other. Each time you insert a new Sensor, you will need to notify the Receiver (see Chapter 3, Section 3.8).Each Sensor must be “calibrated” before glucose readings are displayed on the Receiver. To calibrate, you manually enter fi ngerstick readings (see Chapter 4, Section 4.1) from any FDA-cleared meter.UP TOGGLE buttonDOWN TOGGLE buttonSELECT buttonRIGHT TOGGLE buttonLEFT TOGGLE button
G4-Global System User’s Guide | 191.4 MOVING THROUGH THE RECEIVER SCREENS1. Turn the Receiver on by pressing the SELECT button.2. The 3-Hour Trend Graph will appear. a. The default screen is the 3-Hour Trend Graph, but you may view glucose information for shorter or longer periods by pressing the TOP or BOTTOM TOGGLE button to see the 1-Hour, 6-Hour, 12-Hour, and 24-Hour Trend Graphs.3. From any Trend Graph, press the SELECT button to display the Main Menu. a. Press the TOP or BOTTOM TOGGLE button to scroll through and highlight different Menu options. b. Press the SELECT button when the option you want is highlighted. You will then enter that Menu. c. Press the LEFT TOGGLE button to return to the previous Menu.NOTE: Main Menu options take up more than one screen, and certain options only appear at certain times.
20 | Continuous Glucose Monitoring System14. More information on Main Menu options can be found in the sections listed below:See Appendix I, “Other Alerts”, for a list of prompt screens that may appear on the Receiver during use.Menu Purpose User’s Guide ReferenceTrend Graph To display the Trend Graphs.• The 3-Hour Trend Graph is the default screen displayed whenever you turn the Receiver on.Chapter 1Start Sensor To start a new Sensor session.• This option only appears if a Transmitter ID has been entered and you are not in the middle of a Sensor session.Chapter 3Enter BG To enter your fi ngerstick blood glucose readings for calibration.Chapter 4Events To enter personal information about meals, insulin, exercise, and health status.Chapter 8Alerts,High/low To change the settings for notifi cations of High and Low Alerts from your Receiver.Chapters2 and 7Alerts, Rise/Fall rate, Other, and Out of RangeTo change the settings for notifi cations of Rise/Fall Rate (Rate of Change) Alerts, Other Alerts and Out of Range Alerts.Chapter 8Settings To change the time, date and Transmitter ID number, to look up your G4-Global System hardware and software version numbers, to view Transmitter battery status, last calibration value, Sensor insertion time, and to enable Advanced features.Chapters2 and 7Shutdown To temporarily turn off all communications between your Sensor, Transmitter and Receiver.Chapter 5Stop Sensor To end a Sensor session early.• This option only appears when you are in the middle of a Sensor session.Chapter 6
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chapter twoG4-GLOBAL SYSTEM SETUPpter twoLOBAL SYSTE
G4-Global System User’s Guide | 25This chapter will help you set up your G4-Global System. You will want to read this chapter before you insert and start a new Sensor session.2.1 THE SETUP WIZARDThe Receiver Setup Wizard will guide you through the fi rst-time setup of your G4-Global system.Before setting up your Receiver, remove the Transmitter from the box.1. Turn your Receiver on by pressing the SELECT button on the Receiver. When you turn the Receiver on for the fi rst time, the Setup Wizard will help you get started by prompting you to enter the following setup information:2. Set the Time and Date3. Enter your Transmitter IDYour Transmitter ID can be found in any of the following locations: - On the Transmitter card located inside your Global System Kit - On the outside of the Transmitter box label - Engraved on the back of the Transmitter itselfIf you have diffi culty locating your Transmitter ID, please contact DexCom Technical Support.NOTE: In order to save battery life, the Transmitter is stored in a tray with a small magnet attached. This prevents the Transmitter from turning on until it is removed from the tray. The Transmitter will turn on 10 minutes after being removed from the tray.
26 | Continuous Glucose Monitoring System4. Set your Low and High Glucose Alert LevelsThe Setup Wizard is now completed. You will now need to insert a Sensor and start a Sensor session to begin a continuous glucose monitoring session (see Chapter 3).22.2 TURNING THE RECEIVER ON1. Press the SELECT button to turn the Receiver on. The 3-Hour Trend Graph will appear.2. Press the SELECT button to display the Main Menu.NOTE: • When using the Setup Wizard, the Low and High Glucose Alerts are already turned on and are set to vibrate and beep. Only the Low Alert and High Alert “levels” can be adjusted in the Setup Wizard. To make other changes, see Section 2.5.• See Sections 2.3, 2.4 and 2.5 and Chapter 7 for more information on setting the time and date, entering Transmitter ID, and Low and High Glucose Alerts from the Main Menu.
G4-Global System User’s Guide | 272. Check that the current date and time are correctly set in the Receiver. Press the RIGHT TOGGLE button to highlight each value in the date and time. Then, press the TOP or BOTTOM TOGGLE button to make any adjustments, and then press the RIGHT TOGGLE button to move to the next value. After choosing AM or PM, press the SELECT button. You will return to the Settings menu.2.3 SETTING THE TIME AND DATE1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the SELECT button. Next, scroll to “Time/Date” and press the SELECT button.
28 | Continuous Glucose Monitoring System2. Starting with the fi rst value, press the TOP or BOTTOM TOGGLE button to make any adjustment, and then press the RIGHT TOGGLE button to move to the next value. After entering the 5th number, press the SELECT button. You will return to the Settings menu.Your Transmitter ID can be found in any of the following locations: - On the Transmitter card located inside your Global System Kit - On the outside of the Transmitter box label - Engraved on the back of the Transmitter itselfIf you have diffi culty locating your Transmitter ID, please contact DexCom Technical Support.2.4 ENTERING YOUR TRANSMITTER IDBefore you can use your G4-Global System, you must enter the Transmitter ID into the Receiver. The Transmitter ID is a series of 2 letters and 5 numbers on the back of the Transmitter. Entering the ID will begin the unique wireless radio frequency (RF) communication between the Transmitter and Receiver. To enter the Transmitter ID, perform the following steps:1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the SELECT button. Next, scroll to “Transmitter ID” and press the SELECT button.NOTE: You can only enter your Transmitter ID when you are not in a Sensor session. During a Sensor session, “Transmitter ID” will not appear as an option on the Settings menu.2
G4-Global System User’s Guide | 292.5 CHANGING YOUR HIGH AND LOW ALERTSHigh Alerts and Low Alerts provide information about your glucose levels and trends. See Chapter 5, Section 5.3 for more information. You can turn the High Alert and/or Low Alert on or off, and choose how the Alerts are delivered (vibrate and beep, or vibrate only). You can also select the glucose value the Receiver will use to trigger a High or Low Alert.The options for setting both a High Alert and a Low Alert are the same. The following steps will show you how to change your High Alert settings.1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Alerts” and press the SELECT button. Next, scroll to “High Alert” or “Low Alert” and press the SELECT button.2. On the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose the “On/Off” option. The High Alert is currently set to “On”. If you do not want to receive this type of Alert press the SELECT button to choose “Off”.NOTE: The High and Low Alerts are already turned on when you turn the Receiver on for the fi rst time during Setup Wizard.Example-High Alert menu
30 | Continuous Glucose Monitoring System24. Next, on the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “Level” and press the SELECT button. Press the TOP or BOTTOM TOGGLE button to enter your Alert value (120 to 400 mg/dL in 10 mg/dL increments for a High Alert and 60 to 100 mg/dL in 5 mg/dL increments for a Low Alert). The starting value that fi rst appears on this screen is the default value of 200 mg/dL (High Alert) and 80 mg/dL (Low Alert), or the values you set in the Setup Wizard.You have the option to set a snooze time to re-alert you (see Chapter 8, Section 8.7, Setting a Snooze Time for Your High and Low Alerts).Example-High Alert3. Next, on the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your Alert delivery option, and press the SELECT button. - Vibrate Then Beep (vibrate, then a vibrate and a beep every 5 minutes) ° High Alert Beep (a series of tones in ascending order, followed by a few steady high tones) ° Low Alert Beep (a series of tones in descending order, followed by a few steady low tones) - Vibrate Only (vibrate every 5 minutes)NOTE: Alerts can be acknowledged by pressing any button on the Receiver.Example-High Alert
G4-Global System User’s Guide | 312.6 CHARGING YOUR RECEIVER BATTERYThe Receiver battery is rechargeable like a cellular phone. The rechargeable battery will last for about 3-5 days before you need to charge it with the Receiver Charging Cable. Your rechargeable battery life depends on how often you turn your Receiver on, your Alert settings, and how often you enter Event information using the Events feature. The Receiver will tell you when the battery charge is low.The Receiver Battery may be charged using one of the following options: • Receiver charging cable for wall charging (cable included with kit) • PC cable for computer charging (cable available separately)It takes about 3 hours to fully charge an empty battery with the wall charger, and about 5 hours when the Receiver is connected to a computer.To recharge your battery, follow the instructions below:1. Open the connection port cover on the right side of the Receiver. Plug the Receiver end of the Receiver charging or PC cable into the connection port on the Receiver.2. Plug the other end of the cable to the wall outlet or to the USB port on your computer, depending on the cable you are using.3. The Battery Charging screen will appear on the Receiver.4. After a few seconds the Trend Graph will reappear with the Battery Charging Symbol shown in the upper left corner next to the Antenna Symbol .Low BatteryBattery Charging
32 | Continuous Glucose Monitoring System25. As the battery charges, the Battery Symbol will begin to fi ll in (green). When the battery is fully charged, the Battery Symbol will be completely fi lled in.6. After the charge is complete, remove the cable from the Receiver and the wall outlet or computer USB port.HELPFUL HINTS:• Charge your Receiver battery before each Sensor insertion. Periodically check your battery level to make sure it has enough charge.• If your battery drains and is not charged for about 6 months, the backup battery might also drain. When this happens, you will need to reset your Receiver time and date (see Section 2.3).• Only use the DexCom battery charger provided in the Starter Kit. Do not use any other battery charger.Start Fully Charged
chapter threeeUSING A SENSOR
G4-Global System User’s Guide | 35To use your G4-Global Continuous Glucose Monitoring System you will need a Sensor, a Transmitter, and a Receiver. You will also need a blood glucose meter and test strips for calibration. Once inserted and calibrated, the Sensor will continuously measure and display your glucose readings for up to 7 days (167 hours after the 1-hour Startup period). The following sections will show you how to insert the Sensor and start a new continuous glucose monitoring session.3.1 BEFORE YOU START Wash your hands thoroughly.  Make sure you charge your Receiver completely. See Chapter 2, Section 2.6 for directions. Check that the date and time are correct on the Receiver. If this is a new Transmitter, make sure the correct Transmitter ID Number has been entered into your Receiver (See Chapter 2, Section 2.4). Check the expiration date on the Sensor, before you start, to make sure you are not using an expired Sensor. The expiration date format is YYYY-MM-DD. Quality check (“QC”) your blood glucose meter per the manufacturer’s instructions to make sure it is providing you the best readings for calibration (e.g., check the code number and use the control solution if applicable). Clean the bottom of the Transmitter with a damp cloth or alcohol wipe, and dry before you start a new Sensor session. Make sure your blood glucose meter and Receiver date and time match.
36 | Continuous Glucose Monitoring SystemHELPFUL HINT: Always check the expiration date on the Sensor packaging before opening the Sensor for use. Never use expired Sensors. The expiration date format is YYYY-MM-DD.The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes.3REVIEW THE SENSOR APPLICATORReview the Sensor Applicator picture below before using a new Sensor.PlungerApplicator (needle/sensor probe inside)Transmitter LatchSafety Lock/Transmitter ReleaseCollarSensor PodRelease Tab
G4-Global System User’s Guide | 373.2 REMOVING THE SENSOR FROM ITS PACKAGING• Carefully remove the Sensor from its packaging. Look closely at the Sensor to make sure it is not damaged.• The Applicator is a single use, disposable unit. The Safety Lock prevents you from accidentally releasing the needle before you are ready.The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.3.3 CHOOSING AN INSERTION SITEChoose a site on a fatty area of your belly to place the Sensor. You can choose a site above or below your belt line. The best areas to insert your Sensor are usually fl at, “pinchable,” and free from where rubbing can occur (i.e., pant line, seatbelts).• Avoid areas with scarring, tattoos, or rough patches of skin from your insulin injections or pump. • Choose an area that is at least 3 inches (7.62 centimeters) from where you plan to inject insulin or from where your pump infusion site is located.• Avoid using the same spot repeatedly for Sensor insertion. Never use the same site for 2 Sensor sessions in a row.• You may need to shave the area where you plan to put the Sensor so that the adhesive patch sticks securely. • Make sure there are no traces of lotions, perfumes or medications on the area. Clean the area fi rst with an alcohol swab. Make sure the area is clean and completely dry before you insert the Sensor.Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing, accessories, or subjected to rigorous movement during exercise.Avoid injecting insulin or placing an insulin pump infusion set within 3 inches (7.62 centimeters) of the Sensor.
38 | Continuous Glucose Monitoring SystemRemove the Adhesive backing Adhere the Sensor on the skinRemove the Safety Lock/Transmitter Key33.4 PLACING THE SENSOR1. After you have cleaned your skin, remove the adhesive backing from the Sensor Pod. Hold the Sensor by the plastic Applicator and try not to touch the sticky adhesive patch.2. Place the Sensor on the area. You can place the Sensor fl at facing to the left or right of your belly button. Make sure the Sensor is placed in the same direction shown in the picture below. You should not place the Sensor pointing in the up or down direction.3. After placing the Sensor, press fi rmly on and around the outside of the adhesive patch to make sure it is fl at. a. Pressing the patch to remove any wrinkles should help it stick better. b. Press fi rmly over the entire patch area.4. Hold on to the Applicator. Then pull the Safety Lock/Transmitter Key straight out away from the applicator, in the direction the arrow shows below.
G4-Global System User’s Guide | 393.5 SENSOR INSERTIONOnce you have placed the Applicator on your belly and removed the Safety Lock (see Section 3.4), you are ready to insert the Sensor. Follow these 4 steps to successfully insert your Sensor.1. Hold down the Pod with one hand. With your other hand, place two fi ngers above the collar on the barrel of the Applicator. 2. Place your thumb on the plunger. Push the plunger down completely. This action inserts the needle and Sensor Probe under your skin.When you are pushing down on the plunger, do not pull back on the collar.3. To remove the needle, keep holding the Sensor Pod with one hand. With your other hand, place two fi ngers under the collar. Then pull the collar back towards your thumb. Stop when you hear 2 “clicks” or cannot pull back any more. This step pulls the needle back into the Applicator and keeps the Sensor Probe under your skin. a. Remember to do this in the correct order: push plunger down, then pull collar up.HELPFUL HINT: The Safety Lock also serves as the Transmitter Key that is used later for Transmitter removal. Keep this piece to help you remove the Transmitter at the end of a continuous glucose monitoring session. When your glucose monitoring session is over, follow the steps in Chapter 6, Section 6.4 to remove the Transmitter. “ 2 CLICKS”Pull back the collar - Retract the Needle“CLICK”Push down the plunger – Insert the Needle and Sensor Probe
40 | Continuous Glucose Monitoring System4. Squeeze the ribbed release tabs on the sides of the Sensor Pod to remove the Applicator. When you squeeze the front release tabs, the back tabs will widen, allowing you to pull off the Applicator. After this step, only the Sensor Pod will be left on your body. a. Make sure the Transmitter Latch is down (against your body) to remove the Applicator. 5. The used Applicator can be thrown in the trash.If you have any problems with insertion, save the Sensor and Applicator and contact DexCom.3.6 TRANSMITTER ATTACHMENTThe Transmitter wirelessly sends your Sensor glucose information to the Receiver. Once you have inserted your Sensor, you will need to snap the Transmitter into the Sensor Pod. Follow the steps below to attach your Transmitter. 1. Clean and dry the bottom of the Transmitter with a damp cloth or an alcohol wipe before every use. a. Be careful not to touch the metal circles on the bottom of the Transmitter.2. Place the Transmitter in the Sensor Pod with the fl at side facing down.3. Pull the Transmitter Latch over the Transmitter to snap the Transmitter into place. The Transmitter should lie fl at in the Sensor Pod. You should hear 2 “clicks.” a. If you do not hear 2 clicks, the Transmitter might not be fully snapped in. 4. Make sure both sides of the Transmitter are secure inside the Sensor Pod. a. Do this by sliding your fi rst and second fi ngers under the edge of the Sensor Pod (with your fi ngernails against your skin under the Latch). b. Place your thumb on top of the Transmitter. c. Then squeeze together to make sure the Transmitter has been snapped in.Release the Applicator3
G4-Global System User’s Guide | 41HELPFUL HINTS:• Make sure you hear 2 clicks when you snap the Transmitter in place (see Step 3). This helps ensure your device is water resistant (see Section 3.10).• Make sure that you have entered the correct Transmitter ID into your Receiver. See Chapter 2, Section 2.4 for instructions on how to enter the Transmitter ID into your Receiver.Install Transmitter in Sensor Pod Transmitter InstalledTransmitter LatchRemove Transmitter Latch5. Remove the Transmitter Latch by holding the end of the Latch and quickly twisting off the Latch away from your body.
42 | Continuous Glucose Monitoring System3.8 TRANSMITTER AND RECEIVER COMMUNICATION3.7 STARTING A SENSOR SESSIONAfter you have checked that your Transmitter and Receiver are talking, you need to tell the Receiver that you have inserted a new Sensor.To tell the Receiver that you have inserted a new Sensor, follow the steps below. 1. Press the SELECT button to turn the Receiver on.2. From any Trend Graph, press the SELECT button to display the Main Menu.3. Press the TOP or BOTTOM TOGGLE button to scroll until you highlight “Start Sensor.”4. Press the SELECT button to confi rm the start of a new Sensor session. The Start Sensor Processing screen will appear to let you know your Sensor session has begun.5. Your Receiver will then return to the 3-Hour Trend Graph.HELPFUL HINTS:• The Start Sensor menu option will now disappear from the Main Menu. The option will only appear again after an active Sensor session ends. • Each time you insert a new Sensor and press SELECT to start a new Sensor session, you will start a new 1-hour Startup period. CONTRAINDICATION: The G4-Global System must be removed prior to Magnetic Resonance Imaging (MRI).3
G4-Global System User’s Guide | 43Keep your Receiver within 20 feet (6 meters) of the Sensor/Transmitter for best communication. To check that the Receiver and Transmitter are talking, press the SELECT, LEFT or RIGHT TOGGLE button to see the Trend Graph.Note the difference between the two Antenna Symbols below: This Antenna Symbol shows that the Transmitter and Receiver are talking. This Out of Range Symbol shows the Transmitter and Receiver are not talking.If you see the Out of Range Symbol in the upper right corner of the screen, then review the following troubleshooting tips.• Is the Receiver within 20 feet (6 meters) of your Sensor/Transmitter? If the Receiver is not close enough, then move it within 20 feet (6 meters) of the Sensor/Transmitter. Check in 5-10 minutes to see if the Antenna Symbol appears and the Out of Range symbol disappears.• If the Receiver and Sensor/Transmitter are still not talking, then check to make sure the correct Transmitter ID Number is entered into your Receiver (see Chapter 2, Section 2.4).• If the correct Transmitter ID has been entered into your Receiver and the Receiver and Transmitter are still not talking, then contact DexCom.HELPFUL HINTS:The Transmitter and Receiver may lose communication at the following times: • When they are near metallic objects. • While you are lying on a water bed. • When you are using an electric blanket.
44 | Continuous Glucose Monitoring SystemAt the end of the 1-hour Startup period the Receiver will let you know that it is time to calibrate your Sensor. Chapter 4 tells you how to calibrate your Sensor.3.10 THE G4-GLOBAL SYSTEM AND WATERYour Sensor (including the installed Transmitter) is water resistant when showering, bathing, or swimming. The Sensor has been tested to be water resistant when submerged for up to 3 feet (0.9 meters) for a maximum of 30 minutes. For added protection you can use a shower cover. The Receiver is not water resistant. Do not get your Receiver wet at any time.3.11 TAPING THE SENSOR PODThe Sensor Pod should stay securely attached using its own adhesive. But, if the patch is peeling up, you can use medical tape (such as BlendermTM) for extra support. If you use tape, only tape over the white adhesive patch on all sides for even support. Do not tape over the Transmitter or any of the plastic parts of the Sensor Pod. Do not tape under the Sensor Pod or leave any substance on the skin where you insert the Needle.3.9 SENSOR STARTUP PERIODThe Sensor needs a 1-hour Startup period. This is so the Sensor can get used to its new insertion site. During the Startup period, check every so often to make sure the Antenna Symbol is in the upper left corner of the Trend Graph. Also make sure your Receiver battery is fully charged.When you press the SELECT button during the Startup period to turn the Receiver display on, your Trend Graph will include a 1-hour Countdown Symbol in the upper right hand corner.Over time, the Countdown Symbol will fi ll to indicate that you are getting closer to initial calibration time. See the pictures below for an example of what this looks like.3Start [0-12] [12-24] [36-48] Ready for calibration[24-36]
chapter fourchapter fourCALIBRATING YOUR G4-GLOBAL SYSTEM
G4-Global System User’s Guide | 47The G4-Global System requires you to “calibrate” the Sensor glucose readings to your blood glucose meter. The purpose of calibration is to convert the measurement of glucose by the Sensor into a reading similar to the one provided by your meter.4.1 CALIBRATION OVERVIEWWhen calibrating, you need to manually enter your fi ngerstick readings into the Receiver. You can use any FDA-cleared blood glucose meter.You will need to perform three types of calibration on your Receiver:1. Startup Calibration 2. Calibration Update 3. Re-calibrationStartup Calibration happens at the end of the 1-hour Startup Period and takes 2 fi ngerstick readings. Calibration Update is a calibration that must be performed every 12 hours (about 1 fi ngerstick reading, 2 times per day). The Receiver will remind you when these calibrations are needed. Re-calibration may be required if one of the fi ngerstick readings entered for Startup Calibration or Calibration Update is not accepted by the Receiver. The sections in this Chapter tell you how to calibrate your system. The sections also describe Startup Calibration, Calibration Update, and how to Re-calibrate in more detail.HELPFUL HINT: Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. You must take your blood glucose readings from your fi ngertips only for calibration.CONTRAINDICATION: Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device.
48 | Continuous Glucose Monitoring System4.2 HOW TO CALIBRATEFor Calibration, you must enter the exact fi ngerstick reading from your meter. Readings must be between 40-400 mg/dL and must have been taken within the past 5 minutes. Entering incorrect fi ngerstick readings, or fi ngerstick readings that occurred more than 5 minutes ago, will affect device performance.The steps below show you how to enter your fi ngerstick readings for calibration:1. Take a fi ngerstick reading using your meter.2. From any Trend Graph, press the SELECT button to display the Main Menu.3. Use the TOP or BOTTOM TOGGLE button to scroll until you highlight “Enter BG.”4. Press the SELECT button to choose this option. You will see a screen with a blood drop and a number in mg/dL units. a. During initial calibration the Receiver will default to the reading of 120 mg/dL as your starting point. b. If there has been a glucose reading in the past 15 minutes, the Enter BG screen will display your current continuous glucose reading as your starting point. Do not use the continuous glucose reading for calibration. Use only fi ngerstick readings from your meter.4NOTE: “Enter BG” will be the second Main Menu option when you are not in the middle of a Sensor session.
G4-Global System User’s Guide | 495. To enter the fi ngerstick reading taken from your meter, press the TOP or BOTTOM TOGGLE button until you fi nd the correct reading and then press the SELECT button. a. Pressing the TOP or BOTTOM TOGGLE button lets you scroll by 1 mg/dL. To scroll faster, hold down the TOP or BOTTOM TOGGLE button.6. Confi rm that the fi ngerstick reading you entered is correct. a. If the fi ngerstick reading displayed is correct, press the LEFT TOGGLE button to highlight “OK” and then press the SELECT button. b. If the fi ngerstick reading displayed is incorrect, press the SELECT button (with “Cancel” highlighted) to return to the Enter BG screen. Repeat the steps for re-entering the correct reading. c. If you do not press any button, the Receiver will “time out” and no fi ngerstick reading will be entered.7. The Enter BG Processing screen will appear to let you know the fi ngerstick reading is being processed for calibration.8. For Startup Calibration, repeat these steps for the second fi ngerstick reading.9. A glucose reading will appear on the Receiver right away, and glucose readings will be updated every 5 minutes.10. If readings do not appear immediately, see Chapter 9, Section 9.2.
50 | Continuous Glucose Monitoring SystemHELPFUL HINTS:• Make sure a glucose reading is displayed at the top of the Trend Graph, or a Blood Drop Symbol is displayed in the top right corner of the Trend Graph, before calibration.• Only fi ngerstick readings between 40-400 mg/dL can be used for calibration. If 1 or more of your readings entered was outside of this range, the Receiver will not calibrate. You will have to wait to until your blood glucose is in this range to calibrate.• Always make sure the Antenna Symbol is displayed in the upper leftcorner of the Trend Graph before you enter fi ngerstick readings for calibration.• You should always use the same meter you routinely use to measure your blood glucose to calibrate. Do not switch your meter in the middle of Sensor session.44.3 STARTUP CALIBRATIONOne (1) hour after you start the Sensor session (see Chapter 3, Section 3.7) the Receiver will tell you that you need to calibrate. The Receiver will show the Double Blood Drop Prompt. If your Alerts are set to the factory default settings, the Receiver will also vibrate and beep to tell you it is ready for calibration.1. You can also set your Receiver to vibrate only (see Chapter 8, Section 8.5).2. When you see this screen, press any Receiver button to clear the display.3. Take 2 fi ngerstick readings with your meter and enter them into the Receiver (see Section 4.2).NOTE: Your fi ngerstick readings must be between 40 mg/dL and 400 mg/dL for calibration. The Receiver cannot use fi ngerstick readings outside of this range for calibration.Double Blood Drop Prompt
G4-Global System User’s Guide | 514.4 CALIBRATION UPDATE Calibration Update is required every 12 hours to make sure your Sensor readings remain accurate and are close to your blood glucose meter readings. You can enter any fi ngerstick readings you take during a Sensor session. If you have not entered any fi ngerstick readings in the past 12 hours, the Receiver will ask you for a fi ngerstick reading to update its calibration. The steps below show you how to enter this calibration.HELPFUL HINTS:• If your readings are less than 40 mg/dL or greater than 400 mg/dL, you should determine if you should treat yourself fi rst, and then calibrate when it is convenient for you.• If you choose to clear the Double Blood Drop Prompt and calibrate later, the Blood Drop Symbol will appear in the top right corner of the Trend Graph.• Once you clear the Double Blood Drop Prompt, it will reappear every 15 minutes until you successfully calibrate. • Always make sure the Antenna Symbol is visible in the upper left corner before you calibrate.You must update G4-Global System calibration every 12 hours at a minimum. The performance of the System when calibrated less frequently than every 12 hours has not been studied.You must enter the exact fi ngerstick reading that your blood glucose meter displays. Enter all fi ngerstick readings for calibration within 5 minutes. Entering incorrect fi ngerstick readings, or fi ngerstick readings that occurred more than 5 minutes ago, will affect device performance.
52 | Continuous Glucose Monitoring System1. If you see the Single Blood Drop Prompt shown to the right, clear this display by pressing any Receiver button. The Single Blood Drop Prompt will not go away until you press a button.2. Take a fi ngerstick reading at this time. Enter this reading in the Receiver to update calibration.3. This screen will appear every 15 minutes until you enter a new fi ngerstick reading that is accepted for calibration.4. If this screen reappears shortly after you have entered a new fi ngerstick reading, review Chapter 5, Section 5.4.4.5 RE-CALIBRATIONWhen you enter a fi ngerstick reading for 12-Hour Update Calibration (Section 4.3), the System checks how well it is functioning compared to the blood glucose meter. During each Calibration Update attempt, the System may tell you that another fi ngerstick reading is needed. This Re-calibration can also be prompted during Startup Calibration. The Single Blood Drop Prompt will appear (shown to the right).You can clear this Screen by pressing any Receiver button. The display will return to the Trend Graph. A Blood Drop Symbol will appear on the top right of the Trend Graph screen.This Blood Drop Symbol tells you that the System needs at least one more fi ngerstick reading. You will not see glucose readings or trends, or get Alerts/Low Glucose ALARM when the Blood Drop Symbol is still displayed.4Single Blood Drop PromptSingle Blood Drop PromptAwaiting Fingerstick Reading (Blood Drop) SymbolNo glucose data
G4-Global System User’s Guide | 53HELPFUL HINT: Refer to Section 8.4, “Error Code Troubleshooting,” if you see the “15 Minute Calibration Error Screen” or the “1 Hour Calibration Error Screen” on your Receiver during calibration.You should take another fi ngerstick reading and enter it into the Receiver. 1. Your System should calibrate immediately.2. After successful Re-calibration the System will display glucose readings, trends and provide Alerts/Low Glucose ALARM again.15 Minute Calibration Error screen 1 Hour Calibration Error screen
54 | Continuous Glucose Monitoring System4THIS PAGE LEFT INTENTIONALLY BLANK
chapter fi veCONTINUOUS GLUCOSE READINGS, TRENDS, ALERTS AND ALARMTREN
G4-Global System User’s Guide | 57This chapter will teach you how to view your G4-Global System continuous glucose readings and trend information. Once you have successfully calibrated, the G4-Global Receiver will display your glucose readings every 5 minutes. This will tell you how your glucose levels are changing. Your blood glucose meter only gives your blood glucose level at one point in time (like a still picture). However, the G4-Global System Trend Graphs and Trend (Rate of Change) Arrows will help you understand the direction your glucose level is moving (like a video camera).The G4-Global Sensor sits in the fl uid under your skin, not in your blood. The Sensor calculates a glucose reading from this fl uid when you calibrate your System. So, the glucose reading you see on your Receiver may be about 5-10 minutes behind the fi ngerstick reading you get from your meter. If your meter reading is above 80 mg/dL, the G4-Global System readings can be 10 – 20% different from your meter readings. If your meter reading is below 80 mg/dL, the G4-Global System readings can be up to 20 mg/dL different from your meter readings.It is important that you focus on the trends and rate of change on your Receiver, rather than the exact glucose reading. The Trend Graphs and Arrows will help you determine how fast your glucose level is rising or falling. Chapter 11, Section 11.2 tells you how closely your G4-Global System readings will be to a laboratory analyzer in the doctor’s offi ce.Glucose Alerts and the Low Glucose ALARM are designed to help you stay within your target glucose zones. Your Low and High Glucose Alerts, and Rise and Fall (Rate of Change) Alerts can tell you when you fall outside of your target glucose range. Your Alerts are personal tools that you can set (see Chapter 2,Section 2.5), and are determined by you and your Diabetes Management Team. Your Low Glucose ALARM can tell you when your glucose levels may be reaching potentially dangerous low levels. You must update G4-Global System calibration every 12 hours at a minimum. The performance of the System when calibrated less frequently than every 12 hours has not been studied. Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device.
58 | Continuous Glucose Monitoring System5Treatment decisions should not be based solely on results from the G4-Global System. You must confi rm System readings with a fi ngerstick reading on a blood glucose meter before making therapeutic adjustments.You must update G4-Global System calibration every 12 hours at a minimum. The performance of the System when calibrated less frequently than every 12 hours has not been studied.The G4-Global System also lets you enter information about your meals, insulin, exercise, and health. That way you and your Diabetes Management Team can view a bigger picture of your diabetes management plan. Your Diabetes Management Team can transfer this information to the DexCom Studio® Accessory Software to see how you are doing over a long period of time.5.1 GLUCOSE READINGSPress any button on the Receiver to display the 3-Hour Trend Graph. This is the default screen whenever you turn your Receiver on. The following information will appear:EXAMPLE: 3-Hour Trend Graph ScreenTrend Graph HoursTrend ArrowTimeMost recent 5-minute glucose readingHigh Glucose Alert SettingLow Glucose Alert Setting Plot of most recent glucose reading
G4-Global System User’s Guide | 59• The G4-Global System reports glucose readings from 40-400 mg/dL and updates glucose readings every 5 minutes.The Receiver displays “LOW” when the most recent glucose reading is less than 40 mg/dL, and “HIGH” when the most recent glucose reading is greater than 400 mg/dL.• Each “dot” on the Trend Graph is a glucose reading.• Every Trend Graph shows the current time.• The gray zone on the Trend Graphs indicates the area in between the High Alert and Low Alert settings (see Chapter 2, Section 2.5 to change these settings).You can see Trend Graphs of your glucose information from the past 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour periods by pressing the TOP or BOTTOM TOGGLE button on your Receiver. Trend Graphs show you where your glucose levels have been and where your glucose levels are headed.The glucose reading is in milligrams per deciliter (mg/dL) units.“Low”Less than 40 mg/dL “High”Greater than 400 mg/dL
60 | Continuous Glucose Monitoring System5(Scroll up from the 3-Hour Graph to reach the 1-Hour Graph)1-Hour Trend Graph: The 1-Hour (1 Hr) Trend Graph shows your current glucose reading and the last 1 hour of glucose readings.3-Hour Trend Graph: The 3-Hour (3 Hr) Trend Graph shows your current glucose reading and the last 3 hours of glucose readings (this is your default Trend Graph screen).(Scroll down from the 3-Hour Graph to reach the 6-Hour Graph)6-Hour Trend Graph: The 6-Hour (6 Hr) Trend Graph shows your current glucose reading and the last 6 hours of glucose readings.(Scroll down from the 6-Hour Graph to reach the 12-Hour Graph)12-Hour Trend Graph: The 12-Hour (12 Hr) Trend Graph shows your current glucose reading and the last 12 hours of glucose readings.(Scroll down from the 12-Hour Graph to reach the 24-Hour Graph)24-Hour Trend Graph: The 24-Hour (24 Hr) Trend Graph shows your current glucose reading and the last 24 hours of glucose readings.
G4-Global System User’s Guide | 615.2 GLUCOSE TRENDSIn addition to your current glucose reading and Trend Graphs, Trend (Rate of Change) Arrows may appear to show you how your glucose readings are changing.The Trend Arrows appear to the right of your current glucose reading.Trend Arrows appear hereThis table shows the different Trend Arrows your Receiver will display:Constant: Your glucose is steady (not increasing/decreasing more than 1 mg/dL each minute)Slowly rising: Your glucose is rising 1-2 mg/dL each minuteRising: Your glucose is rising 2-3 mg/dL each minuteRapidly rising: Your glucose is rising more than 3 mg/dL each minuteSlowly falling: Your glucose is falling 1- 2 mg/dL each minuteFalling: Your glucose is falling 2-3 mg/dL each minuteRapidly falling: Your glucose is falling more than 3 mg/dL each minuteno arrow No Rate of Change Information: The Receiver cannot always calculate how fast your glucose is rising or falling
62 | Continuous Glucose Monitoring System5.3 GLUCOSE ALERTS AND LOW GLUCOSE ALARMThe G4-Global System lets you create your own personal settings for how you want the Receiver to tell you what is going on. The Low and High Glucose Alerts will tell you when you fall outside of your target glucose range. Rise and Fall (Rate of Change) Alerts let you know when your glucose levels are changing fast (see Chapter 8, Section 8.4). The G4-Global System also features a non-adjustable Low Glucose ALARM that will tell you when your glucose levels may be reaching potentially dangerous low levels. In addition to the Alert screens that appear on your Receiver display, you can also set High and Low Glucose Alerts to notify you with vibrations and beeps. This feature can be helpful during times when you are not able to test your blood glucose on your meter (such as sleeping, driving, exercise, or long meetings).5HELPFUL HINTS:• Trend Arrows do not appear when there is Missing Glucose Information (see Section 5.4). If the Symbol, the Wait Symbol , the Out of Range Symbol , or the Blood Drop Symbol appears in the upper right corner, the Trend Arrows will not appear.• If the Trend Arrow is missing, but you are concerned that your blood glucose level may be rising or falling, take a fi ngerstick test on your blood glucose meter to check your readings.
G4-Global System User’s Guide | 635.3.1 HIGH GLUCOSE ALERTWhen your G4-Global System readings are at or above your High Alert level, the screen shown to the right will appear. You can also set the Receiver to beep and vibrate when this screen appears (see Chapter 2, Section 2.5). The default level is set at 200 mg/dL, but you can adjust this value.When you set the High Glucose Alert, the level is indicated by the top of the gray zone on the Trend Graphs. (If the Low Glucose Alert is not set, the High Glucose Level is indicated by a horizontal gray line.)The Receiver will continue to alert you until you press any Receiver button to clear the Alert, or until your glucose readings drop below your High Glucose Alert level. You can choose to have the Receiver re-alert you every 15, 30 minutes or 1, 2, 3, 4, or 5 hours after clearing the Alert, by changing your Snooze settings (see Chapter 8, Section 8.7). Snooze settings for the High Glucose Alert are only available if Advanced features is turned on (see Chapter 8, Section 8.1).High Glucose Alert set at 200 mg/dLHigh Glucose Alert Setting
64 | Continuous Glucose Monitoring System55.3.2 LOW GLUCOSE ALERTWhen your G4-Global System readings are at or below your Low Alert level, the screen shown to the right will appear. You can also set the Receiver to beep and vibrate when this screen appears (see Chapter 2, Section 2.5). The default level is set at 80 mg/dL, but you can adjust this value.When you set the Low Glucose Alert, the level is indicated by the bottom of the gray zone on the Trend Graphs. (if the High Glucose Alert is not set, the Low Glucose Level is indicated by a horizontal gray line.)The Receiver will continue to alert you until you press any Receiver button, or until your glucose readings rise above your Low Glucose Alert level. You can choose to have the Receiver re-alert you every 15, 30 minutes or 1, 2, 3, 4, or 5 hours after clearing the Alert, by changing your Snooze settings (see Chapter 8, Section 8.7). Snooze settings for the Low Glucose Alert are only available if Advanced features is turned on (see Chapter 8, Section 8.1).Low Glucose Alert set at 80 mg/dLLow Glucose Alert SettingSymptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use fi ngerstick readings from your blood glucose meter to check the System results.
G4-Global System User’s Guide | 655.3.3 LOW GLUCOSE ALARMThe G4-Global System also has an automatic Low Glucose ALARM set at 55 mg/dL. This ALARM is a feature in addition to your personal Low and High glucose Alerts. You cannot change or turn off this ALARM or its Re-ALARM settings.• When your glucose reading is at or below 55 mg/dL the Receiver will notify you with 3 ALARMS (each 5 minutes apart) that beep/vibrate as follows: - 1st ALARM: Vibrate - 2nd ALARM: Vibrate, then a series of rapid descending tones followed by 3 constant tones. Series is repeated 3 times. - 3rd ALARM: Vibrate, then a series of rapid descending tones followed by 3 constant tones. Series is repeated 3 times. (louder)• The Receiver will vibrate and beep every 5 minutes after the 3rd ALARM if your readings are still at or below 55 mg/dL, until you press any Receiver button to clear it.• For Low Glucose ALARMs the Receiver will display the screen to the right.• Re-ALARM: The Receiver will automatically notify you again in 30 minutes after you press any Receiver button to clear it, if your glucose readings are still at or below 55 mg/dL.Low Glucose ALARM5.3.4 RISE AND FALL GLUCOSE RATE ALERTSYou can activate these Alerts (see Chapter 8, Section 8.4), to have the Receiver tell you if your glucose readings are rising or falling fast.You can set the Rise Rate (how fast you are going up) to one of two different Rise Rate levels, or choose to turn this Alert off. Depending on your selection, you will be notifi ed if your glucose level is rising 2 mg/dL or more each minute, or 3 mg/dL or more each minute.
66 | Continuous Glucose Monitoring SystemYou can set the Fall Rate (how fast you are going down) to one of two different Fall Rate levels, or choose to turn this feature off. Depending on your selection, you will be notifi ed if your glucose level is falling 2 mg/dL or more each minute, or 3 mg/dL or more each minute.If your glucose reading rises or falls at or above/below the Alert setting you chose, the Receiver will display an Alert. You can also set the Alert to vibrate or beep (see Chapter 8, Section 8.4). Two examples are shown below:If you set your Fall Rate to 2 mg/dL per minute and your glucose readings fall at this rate or faster, the FALLING Single Arrow screen will appear and vibrate/beep according to your settings.If you set your Rise Rate to 3 mg/dL per minute and your glucose readings rise at this rate or faster, the RISING Double Arrow screen will appear and vibrate/beep according to your settings.5NOTE: To set Rise and Fall Glucose Rate Alerts, Advanced features must be turned on (see Chapter 8, Section 8.1).Example-Fall AlertExample-Rapid Rise Alert
G4-Global System User’s Guide | 675.4 GLUCOSE STATUS AREA ON TREND GRAPHS5.4.1 GLUCOSE STATUS AREA SYMBOLSDuring your Sensor session the “Status Area” in the upper right hand corner of the Trend Graph may display any of the information below.This device is not designed to replace a blood glucose meter. When there is Missing Glucose Information, rely on fi ngerstick readings from your blood glucose meter.Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, confi rm them with fi ngerstick readings from your blood glucose meter.Calibration NeededA blood drop means your System requires you to enter another fi ngerstick reading. You may need to enter a fi ngerstick reading for your 12-hour calibration, or the Receiver might need an additional fi ngerstick reading to improve its calibration. (See Chapter 4, Section 4.2.)Glucose Reading ErrorThree question marks mean the Receiver does not understand the Sensor signal. You should wait for more prompts and do not enter any fi ngerstick readings when you see this symbol. (See Section 5.4.3.)RF ErrorAn antenna symbol with a line through it and a circle around it, means the Sensor/Transmitter and Receiver are out of range. Make sure the Receiver and Sensor/Transmitter are within 20 feet (6 meters) of each other. (See Section 5.4.4.)
68 | Continuous Glucose Monitoring System5.4.2 MISSING GLUCOSE READINGSAt certain times, a notifi cation symbol may appear in the Status Area of the Trend Graph. These notifi cations are helpful in troubleshooting why glucose readings do not appear on the Receiver. The table in the previous section shows the symbols that might appear in the Status Area.Missing Glucose Information can happen when: 1. The System needs another fi ngerstick reading for calibration because the Sensor readings do not match the recent fi ngerstick reading you just entered. 2. The Receiver does not understand the Sensor signal. 3. The Sensor/Transmitter and Receiver are out of range. Make sure the Sensor/Transmitter and Receiver are within 20 feet (6 meters) of each other.For calibration errors see Chapter 8. The following sections will tell you what happens when the Receiver does not understand the Sensor signal, and when your Sensor/Transmitter and Receiver are out of range. If your Receiver is not displaying glucose information, look at the Status Area on the Trend Graph.Status Area5515 Minute Calibration ErrorMeans the Sensor cannot calibrate right now. If you see this screen, enter at least 1 more calibration fi ngerstick reading after about 10-15 minutes. If the Sensor still cannot calibrate using this additional fi ngerstick reading, the Sensor needs to be replaced. (See Chapter 8, Section 8.4.)1 Hour Calibration ErrorMeans the Sensor is not calibrating properly. If you see this screen, wait about one hour and then enter at least 1 more fi ngerstick reading. If no readings display on the Receiver after this additional fi ngerstick, the Sensor needs to be replaced.WaitThe single hourglass means the Receiver has detected a potential problem with the Sensor signal. You should wait about 30 minutes for more prompts. Do not enter any fi ngerstick readings when you see this symbol.
G4-Global System User’s Guide | 69HELPFUL HINTS:• If you see in the Status Area of the Trend Graph, it is recommended that you wait out this period of time. Do not calibrate your System during this time. • When you see , taking fi ngerstick readings with your meter and entering them does not help the System display more glucose readings. Any fi ngerstick readings that you enter during will be ignored by the System.• Wait until you see a Single Blood Drop in the Status Area before entering a calibration value into your Receiver.5.4.3 SYSTEM GLUCOSE ERRORSSometimes the G4-Global System may tell you that it cannot provide a glucose reading. When this occurs you will see 3 question marks ( ) in the Status Area.Check the placement of your Sensor to make sure it is still sticking securely to your skin. Also make sure nothing is rubbing the Sensor Pod (i.e. clothing, seat belts, etc.).Check to see if the Transmitter is snapped in on both sides. This error can happen when the G4-Global System detects problems with the glucose signal or Sensor insertion area. Chapter 9 tells you how often you might expect to see this error. Sometimes the G4-Global System can correct the problem and continue providing glucose readings. However, if it has been 3 hours since your last glucose reading appeared, contact Technical Support.No Glucose Data
70 | Continuous Glucose Monitoring System5HELPFUL HINTS:• You can set an Out of Range Alert to notify you when the Receiver and Sensor/Transmitter are not talking (see Chapter 8, Section 8.6). You can also set the amount of time the Transmitter can be out of range before the Receiver alerts you.• The Sensor/Transmitter and Receiver may lose communication during the following circumstances: while you are lying on a waterbed, while you are near other metallic objects, or when you are using an electric blanket.5.4.4 OUT OF RANGE/NO ANTENNA • When you see the Out of Range Symbol in the Status Area, this means the Receiver has “missed” the last glucose reading sent by the Transmitter. • If you see this Symbol, make sure the Receiver is within 20 feet (6 meters) of the Sensor/Transmitter. If not, move the Receiver closer and wait at least 5 minutes.• Once you have moved the Receiver closer and waited 5-10 minutes, the Out of Range Symbol in the Status Area should disappear. The Antenna Symbol should reappear in the upper left corner, and you should receive a glucose reading.• If you are still having trouble receiving System readings because of this problem, contact DexCom Technical Support.No Glucose Data
G4-Global System User’s Guide | 71HELPFUL HINTS:• Remember that your Alerts and Low Glucose ALARM will not work when the Receiver is shut down.• Your Sensor session will stop 7 days after you start the Sensor session. Shutting down the Receiver does not extend Sensor life beyond 7 days.5.5 TEMPORARY SENSOR SHUT DOWNThere may be times when you want to temporarily shut down your Receiver. Shutdown will stop all communication between the Transmitter and Receiver, and will turn the Receiver off. You will not receive glucose readings or any Alerts/Low Glucose ALARMs while the Receiver is shut down, but your current Sensor session will remain in progress. Follow these steps to shut down your Receiver:1. From the Main Menu, scroll to and highlight “Shutdown”. Press the SELECT button.2. Confi rm that you want to shutdown your Receiver. a. If you want to shutdown, press the LEFT TOGGLE button to highlight “OK” and then press the SELECT button. b. If you want to cancel the shutdown, press the SELECT button (with “Cancel” highlighted) to return to the Main Menu.3. To turn the Receiver back on and resume communication with the Transmitter, press the SELECT button. It may take up to 20 seconds for the display to turn back on.
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hapter sixchapter sixCOMPLETING YOUR CONTINUOUS GLUCOSE MONITORING SESSION
G4-Global System User’s Guide | 75At the end of your Sensor session (or wear period), you will need to remove the Sensor. Gently peel up the adhesive patch from your skin (this will pull out your Sensor Probe). Then remove the Transmitter from the Sensor and keep it for your next continuous glucose monitoring session (see Section 6.4).6.1 REMOVING A SENSORYour Sensor session will end on time when the Sensor expires (after 7 days). You can also choose to end the session early, or it might end early (less than 7 days) due to a Sensor failure. Once your Sensor session has ended, glucose readings will no longer be shown on the Receiver. The Trend Graphs will indicate that the Sensor session has ended by displaying a red Stoplight Symbol in the upper right corner.HELPFUL HINT: Remember to save your Transmitter after each Sensor removal. The same Transmitter is used for each session until you have reached the end of the Transmitter battery life. The Sensor can be thrown in the trash.A Stop Sign indicates that your Sensor session has ended
76 | Continuous Glucose Monitoring SystemOnce the Replace Sensor Now screen appears, press any button on the Receiver to clear this notifi cation.6.2 AUTOMATIC SENSOR SHUT-OFFThe Receiver will tell you how much time you have remaining until your G4-Global Sensor session is complete. The Sensor Expiration screen will appear at 6 hours, 2 hours and 30 minutes before your 7-day session ends. You can to set the Receiver to vibrate and/or beep with these displays if you choose (see Chapter 8, Section 8.5). After the 6-hour, 2-hour, and 30-minute reminders, you will still continue to receive glucose readings. You can clear any of these screens by pressing any button on the Receiver. You must remove your Sensor after the fi nal Sensor Expiration screen (00:00:00) appears.6Sensor Expiration Notifi cation End of session6-hour Sensor Expiration Notifi cation30-minute Sensor Expiration Notifi cation2-hour Sensor Expiration Notifi cation
G4-Global System User’s Guide | 776.3.1 EARLY SHUT-OFF – SENSOR FAILUREDuring a session the Receiver may detect a series of issues with your Sensor signal where it can no longer determine your glucose reading (see Chapter 9, Section 9.3). At this time the CGM session will end and show the screen to the right.If you see this screen then your continuous glucose monitoring session has ended. Press any button on the Receiver to clear this screen.6.3.2 MANUAL SENSOR SHUT-OFF – “STOP SENSOR”To manually end your Sensor session, select “Stop Sensor” from the Main Menu. This option will only appear if you are in the middle of an active Sensor session (you have already started a Sensor session and the Sensor has not expired or failed). See Chapter 6, and Chapter 9, Section 9.3.With “OK” highlighted, press the SELECT button to confi rm that you want to stop the Sensor session.Sensor Failed Screen6.3 EARLY SENSOR SHUT-OFFIn some cases your Sensor session may end before you have completed a full 7-day period. You should review Chapter 11, Section 11.2 in this User’s Guide to determine how often you should expect this to happen. Examples of why this may occur are described below.
78 | Continuous Glucose Monitoring SystemHELPFUL HINTS:• If you removed your Sensor before stopping the Sensor session on the Receiver, the Sensor Failed screen will appear automatically. You must press SELECT before inserting a new Sensor. Look closely at the Sensor to make sure it is not damaged.• You cannot reverse the decision to stop a Sensor session after pressing the SELECT button. Press the LEFT TOGGLE button to return to the Main Menu if you do not want to stop the Sensor session.The Stop Sensor processing screen will appear to let you know the Sensor session is stopping. Once the session has stopped, a Red Stoplight Symbol will appear in the upper right corner of the Trend Graph.6
G4-Global System User’s Guide | 796.4 TRANSMITTER REMOVALWhen you are ready to remove the Sensor, make sure to pull out the Sensor Pod with the Transmitter still inside. Once the Sensor Pod is off your body, you will need to remove the Transmitter. To do this you can use either of the two methods below:Method 1The Safety Lock/Transmitter Key once removed from the Applicator (see Chapter 3, Section 3.5) can be used as a tool to remove the Transmitter. 1. Place the Sensor Pod on a table. 2. Hold the rounded edge of the Transmitter Key. 3. Make sure the jagged edge of the Transmitter Key is facing down (the direction away from the removal arrow) as shown below:4. Insert the jagged edges so that they “hug” the Transmitter wings in the Sensor Pod. Press the Transmitter Key down until you cannot press down anymore, and the Transmitter wings will “pop” out of the Sensor Pod.5. Remove the Transmitter and store it in a cool, dry place until your next glucose monitoring session.Method 2If you did not save the Transmitter Key, you can simply use your pointer fi nger on each hand and spread out the tabs at the back of the Sensor Pod (end closest to the wings). The Transmitter wings will “pop” out of the Sensor Pod.Transmitter Key(from Applicator)Sensor Pod with Transmitter Key snapped in
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chapter sevenBASIC SETTINGSr sevBASIC
G4-Global System User’s Guide | 837.1 THE SETTINGS MENU7.1.1 GETTING TO THE SETTINGS MENU1. Press any button to turn on the Receiver. The 3-Hour Trend Graph will appear.2. Press the SELECT button to display the Main Menu.3. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the SELECT button. The Settings menu will appear.7.1.2 SETTING YOUR RECEIVER TIME AND DATE1. From the Settings menu, press the TOP or BOTTOM TOGGLE button to scroll to “Time/Date” and press the SELECT button.2. Check that the current date and time are correctly set in the Receiver. Press the RIGHT TOGGLE button to highlight each value in the date and time. Then, press the TOP or BOTTOM TOGGLE button to make any adjustments and then press the RIGHT TOGGLE button to move to the next value. After choosing AM or PM, press the SELECT button. You will return to the Settings menu.
84 | Continuous Glucose Monitoring System77.1.3 ENTERING YOUR TRANSMITTER IDAny time you switch to a new Transmitter and/or Receiver (as a replacement to the Transmitter and Receiver that came in your kit) you must enter the Transmitter ID into your Receiver. The Transmitter ID is a series of 2 letters and 5 numbers on the back of the Transmitter. Entering the ID will begin the unique wireless radio frequency (RF) communication between the Transmitter and Receiver.To enter the Transmitter ID, perform the following steps:1. From the Settings menu, press the TOP or BOTTOM TOGGLE button to scroll to “Transmitter ID” and press the SELECT button.HELPFUL HINTS:• The date in the Receiver is set at the factory to Pacifi c Standard Time (PST).• Make sure to set the correct date and time on your Receiver.• When setting values for the time or date, press and hold the TOP or BOTTOM TOGGLE button to scroll through the fi elds more quickly.• You might need to reset the Receiver’s time and date if the rechargeable battery is drained. If this happens, the Time Loss Alert will automatically take you to the Time/Date Setting Screen.NOTE: You can only set your Transmitter ID when you are not in a Sensor session. During a Sensor session, “Transmitter ID” will not appear as an option on the Settings menu.
G4-Global System User’s Guide | 852. Starting with the fi rst number (do not enter the fi rst 2 letters), press the TOP or BOTTOM TOGGLE button to make any adjustment and then press the RIGHT TOGGLE button to move to the next value. After entering the 5th number, press the SELECT button. You will return to the Settings menu.Your Transmitter ID can be found in any of the following locations: - On the Transmitter card located inside your G4-Global System Kit - On the outside of the Transmitter box label - Engraved on the back of the Transmitter itselfIf you have diffi culty locating your Transmitter ID, please contact DexCom Technical Support.
86 | Continuous Glucose Monitoring System77.1.4 CHECKING INFORMATION ABOUT YOUR RECEIVERAt any time you can check your Receiver for information about your G4-Global System.1. From the Settings menu, press the TOP or BOTTOM TOGGLE button to scroll to “Device Info” and press the SELECT button.2. Information about your Sensor session and System will appear. Scroll down to see all the information. Press the LEFT TOGGLE button to return to the Settings menu.Device Info:• Insertion Time • Part Number• Last Calibration • Part Revision• Transmitter Battery • Software Version• Transmitter ID • Software Revision
G4-Global System User’s Guide | 877.2 SETTING YOUR ALERTS7.2.1 FACTORY ALERT SETTINGSThe G4-Global System is shipped from the factory with the following “default” settings for Alerts. (See the table below.)Screen Alert Type Default Setting Default Prompt Vibrate/Beep Default Re-alert SettingHigh Alert On-200 mg/dLVibe then Beep (vibrate fi rst, then 2 high beeps and vibrate)None (no Re-alerts after pressing any Receiver button to clear)Low Alert On-80 mg/dLVibe then Beep (vibrate fi rst, then 3 low beeps and vibrate)None (no Re-alerts after pressing any Receiver button to clear)Rise Alert Off Disabled (None) None (no Re-alerts after pressing any Receiver button to clear)
88 | Continuous Glucose Monitoring SystemScreen Alert Type Default Setting Default Prompt Vibrate/Beep Default Re-alert SettingFall Alert Off Disabled (None) None (no Re-alerts after pressing any Receiver button to clear)Other Alerts(See Chapter 11, Appendix 1 for a detailed list of all “Other Alerts.”)On Vibe then Beep (vibrate fi rst, then medium beep tone)Depends on the Alert Type (See Chapter 12, Appendix 1)Out of Range AlertOff Disabled (None) Continues to Re-alert you until you come back into range.7
G4-Global System User’s Guide | 897.2.2 GETTING TO THE ALERTS MENU1. Press the SELECT button to turn on the Receiver. The 3-Hour Trend Graph will appear.2. Press the SELECT button to display the Main Menu.3. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Alerts” and press the SELECT button. The Alerts menu will appear.7.2.3 SETTING GLUCOSE ALERTSThe High Alert, Low Alert, Rise Rate Alert, and Fall Rate Alert (see Chapter 5)provide information about your glucose levels and trends. The following will show you how to change the High Alert, Low Alert, Rise Rate Alert, and Fall Rate Alert settings.NOTE: To receive Rise Rate and Fall Rate Alerts, Advanced Features must be turned on (see Chapter 8, Section 8.1).
90 | Continuous Glucose Monitoring System7High and Low Glucose AlertsThe following steps will show you how to change your High Alert Settings.1. From the Alerts menu, press the TOP or BOTTOM TOGGLE button to select “High Alert” or “Low Alert” and press the SELECT button.2. On the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “On/Off”. The High Alert is currently set to “On”. If you do not want to receive this type of Alert press the SELECT button to choose “Off”.3. Next, on the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option, and press the SELECT button. - Vibrate Then Beep (vibrate, then a vibrate and a beep every 5 minutes) ° High Alert Beep (a series of tones in ascending order, followed by a few steady high tones) ° Low Alert Beep (a series of tones in descending order, followed by a few steady low tones) - Vibrate Only (vibrate every 5 minutes)NOTE: The options for setting both a High Alert and a Low Alert are the same.Example-High Alert menuExample-High AlertNOTE: Alerts can be acknowledged by pressing any button on the Receiver.
G4-Global System User’s Guide | 914. Next, on the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “Level” and press the SELECT button. Press the TOP or BOTTOM TOGGLE button to enter your Alert value (120 to 400 mg/dL in 10 mg/dL increments for a High Alert and 60 to 100 mg/dL in 5 mg/dL increments for a Low Alert). The starting value that fi rst appears on this screen is the default value of 200 mg/dL (High Alert) and 80 mg/dL (Low Alert), or the values you set in the Setup Wizard.You have the option to set a snooze time to re-alert you (see Chapter 8, Section 8.7).Example-High Alert
92 | Continuous Glucose Monitoring System7NOTE: Alerts can be acknowledged by pressing any button on the Receiver.Rise and Fall Rate AlertsThe following steps will show you how to change your Fall Rate Alert settings.1. From the Alerts menu, press the TOP or BOTTOM TOGGLE button to select “Rise Rate” or “Fall Rate” and press the SELECT button.2. On the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “On/Off”. Then, press the SELECT button to select “On”. If you do not want to receive this type of Rate Alert press the SELECT button to choose “Off”.3. Next, on the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option and press the SELECT button. - Vibrate Then Beep (vibrate, then a vibrate and a beep every 5 minutes) ° Rise Rate Beep (a series of rapid ascending tones, repeated 3 times) ° Fall Rate Beep (a series of rapid descending tones, repeated 3 times) - Vibrate Only (vibrate every 5 minutes)Example-Fall Rate menuExample-Fall RateNOTE:• The options for setting both a Rise Rate Alert and a Fall Rate Alert are the same.• To use the Rise and Fall Rate Alerts feature, Advanced Features must be turned on. (See Chapter 8, Section 8.1.)
G4-Global System User’s Guide | 93Example-Rapid Rise Alert4. Next, on the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “Level” and press the SELECT button. Then, choose whether the alerts should be delivered when your glucose levels are falling either “2 mg/dL/min” (2 mg/dL or more per minute), or “3 mg/dL/min” (3 mg/dL or more per minute). Press the SELECT button.When fi nished, press the LEFT TOGGLE button to return to the Alerts menu.Example-Fall RateNOTE: When you choose “2 mg/dL/min” for your Rise or Fall Rate Alert, one arrow will appear on the screen when you receive an Alert. Two arrows (meaning Rapid) will appear when you select “3 mg/dL/min” for your Rise or Fall Rate Alert.Example-Fall Rate Alert
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chapter eightADVANCED FEATURES BEYOND THE BASICSchapter eightSS
G4-Global System User’s Guide | 97Advanced features allows you to do the following:• Enter events related to your carbohydrate consumption, insulin usage, exercise and overall health. Event information can be downloaded to a PC along with your glucose readings and viewed using the DexCom Studio® Accessory Software.• Expand and customize the Alerts feature so that the Receiver can: - notify you when and how fast your glucose levels are rising or falling - deliver other Alerts according to your preference - notify you when your Sensor/Transmitter and Receiver are out of range8.1 ACTIVATING ADVANCED FEATURESTo use the Receiver’s Advanced features, the Advanced features setting must be turned on. 1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the SELECT button. Next, scroll to “Advanced” and press the SELECT button.2. On the “Advanced” screen, press the SELECT button to turn Advanced features On (or Off). Press the LEFT TOGGLE button to return to the Settings screen.
98 | Continuous Glucose Monitoring System88.2 DIABETES EVENTSWith the G4-Global System you can enter meal, insulin, physical activity, and health information. This information can help you and your Diabetes Management Team review your glucose trends and patterns and may help you make better decisions about your diabetes management plan. These events can be downloaded to a PC along with your glucose readings and reviewed later with the DexCom Studio® Accessory Software.8.2.1 SELECTING AN EVENTWhen Advanced features is turned on, “Events” will appear as an option on the Main Menu.1. Press the TOP or BOTTOM TOGGLE button to choose “Events” and press the SELECT button.From the Events menu you can choose “Carbs”, “Insulin”, “Exercise” or “Health”.
G4-Global System User’s Guide | 998.2.2 SETTING THE DATE AND TIME FOR AN EVENTWhen you enter an event you will be prompted to check that the date and time for that event are correct. The default date and time for events you enter is the current date and time stored in the Receiver.1. To change the date and time for an event, press the RIGHT TOGGLE button to highlight each value in the date and time. Then, press the TOP or BOTTOM TOGGLE button to make any adjustments and then press the RIGHT TOGGLE button to move to the next value. After choosing AM or PM, press the SELECT button. You will advance to the Event confi rmation screen.8.2.3 CARBOHYDRATESThe Carbs Event lets you enter the amount of carbohydrates you have consumed, up to 250 grams for any particular date and time.1. Press the TOP or BOTTOM TOGGLE button to choose “Carbs” and press the SELECT button.2. Press the TOP or BOTTOM TOGGLE button to enter your carb amount (0-250 grams), and press the SELECT button. The number that fi rst appears on this screen will be the last number you entered or the default amount of 50 grams.NOTE: If you change the date or time for any event, it only applies to that event and will not change the current date and time in your Receiver.
100 | Continuous Glucose Monitoring System4. Check that the date and time for this entry are correct.5. Confi rm the entry. Press the LEFT or RIGHT TOGGLE button to choose either “OK” to confi rm this entry or “Cancel” to discard this entry, and press the SELECT button. You will return to the Events menu.8.2.4 INSULINThe Insulin Event lets you enter the amount of insulin you have taken, up to 250 units for any particular date and time. You can only enter an insulin amount, not the type of insulin taken.1. Press the TOP or BOTTOM TOGGLE button to choose “Insulin” and press the SELECT button.2. Press the TOP or BOTTOM TOGGLE button to enter your insulin amount (0-250 units), and press the SELECT button. The number that fi rst appears on this screen will be the last number you entered or the default amount of 10 units.3. Check that the date and time for this entry are correct.4. Confi rm the entry. Press the LEFT or RIGHT TOGGLE button to choose either “OK” to confi rm this entry or “Cancel” to discard this entry, and press the SELECT button. You will return to the Events menu.8
G4-Global System User’s Guide | 1018.2.5 EXERCISEThe Exercise Event lets you enter the intensity (Light, Medium, or Heavy) and duration (up to 360 minutes), for any particular date and time.1. Press the TOP or BOTTOM TOGGLE button to choose “Exercise” and press the SELECT button.2. Press the TOP or BOTTOM TOGGLE button to enter your exercise intensity level, and press the SELECT button.3. Press the TOP or BOTTOM TOGGLE button to enter your exercise duration (0-360 minutes), and press the SELECT button. The number that fi rst appears on this screen is the default amount of 30 minutes.4. Check that the date and time for this entry are correct.5. Confi rm the entry. Press the LEFT or RIGHT TOGGLE button to choose either “OK” to confi rm this entry or “Cancel” to discard this entry, and press the SELECT button. You will return to the Events menu.
102 | Continuous Glucose Monitoring System8.2.6 HEALTHThe Health Event lets you enter episodes of Illness, Stress, High Symptoms, Low Symptoms, Cycle (menstrual) or Alcohol consumption, for any particular date and time.1. Press the TOP or BOTTOM TOGGLE button to choose “Health” and press the SELECT button.2. Press the TOP or BOTTOM TOGGLE button to enter your health event, and press the SELECT button.3. Check that the date and time for this entry are correct.4. Confi rm the entry. Press the LEFT or RIGHT TOGGLE button to choose either “OK” to confi rm this entry or “Cancel” to discard this entry, and press the SELECT button. You will return to the Events menu.8
G4-Global System User’s Guide | 1038.3 DEXCOM STUDIO SOFTWAREThe DexCom Studio® Accessory Software comes with your G4-Global System. This software allows you to view trends and track patterns and create customizable charts to display your glucose trends.Change the date ranges to view long- or short-term patterns and trends. Plus, you can use data from current and previous G4-Global System downloads and save or print fi les that you can take to your next doctor visit.For system requirements refer to the DexCom website (www.dexcom.com). The DexCom Studio® Help File gives you more information on how to use this software.8.4 RISE AND FALL GLUCOSE RATE ALERTSRate Alerts notify you when your glucose levels are rising (Rise Alert) or falling (Fall Alert), and by how much. You can turn the Rise and/or Fall Rate Alert on or off, and choose how the Alerts are delivered (vibrate and beep, or vibrate only). You can also choose whether the Alert should be delivered when your glucose is either rising or falling 2 mg/dL or more per minute, or 3 mg/dL or more per minute.When Advanced features is turned on, “Rise Rate” and “Fall Rate” will appear as additional options on the Alerts menu. The options for setting both a Rise Rate Alert and Fall Rate Alert are the same.The following steps will show you how to change your Fall Rate Alert settings.1. Press the TOP or BOTTOM TOGGLE button to choose “Rise Rate” or “Fall Rate” and press the SELECT button.NOTE: To receive Rise and Fall Rate Alerts, Advanced Features must be turned on.
104 | Continuous Glucose Monitoring System2. On the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “On/Off”. Then, press the SELECT button to select “On”. If you do not want to receive this type of Rate Alert press the SELECT button to choose “Off”.3. Next, on the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option and press the SELECT button. - Vibrate Then Beep (vibrate, then a vibrate and a beep every 5 minutes) ° High Alert Beep (a series of tones in ascending order, done in pairs) ° Low Alert Beep (a series of tones in descending order, done in pairs) - Vibrate Only (vibrate every 5 minutes)4. Next, on the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “Level” and press the SELECT button. Then, choose whether the alerts should be delivered when your glucose levels are falling either “2 mg/dL/min” (2 mg/dL or more per minute) or “3 mg/dL/min” (3 mg/dL or more per minute). Press the SELECT button.When fi nished, press the LEFT TOGGLE button to return to the Alerts menu.8Example-Fall Rate menuExample-Fall RateNOTE: Alerts can be acknowledged by pressing any button on the Receiver.Example-Fall Rate
G4-Global System User’s Guide | 1058.5 SETTING OTHER ALERTSThe G4-Global System provides many other notifi cations. See Chapter 12, Appendix I for a complete list of these “Other Alerts.”When Advanced features is turned on, “Other Alerts” will appear as an additional option on the Alerts menu. The default “Type” for all of the “Other Alerts” is “Vibrate Then Beep”, a setting that will notify you with vibrations and a series of rapid ascending then descending tones, when these Alerts occur. This setting can be changed to “Vibrate Only” or “Silent”.1. Press the TOP or BOTTOM TOGGLE button to choose “Other Alerts” and press the SELECT button.2. “Type” is highlighted. Press the SELECT button.NOTE: When you choose “2 mg/dL/min” for your Rise or Fall Rate Alert, one arrow will appear on the screen when you receive the Alert. Two arrows (meaning Rapid) will appear when you select “3 mg/dL/min” for your Rise or Fall Rate Alert.Example-Fall Alert Example-Rapid Rise Alert
106 | Continuous Glucose Monitoring System83. Press the TOP or BOTTOM TOGGLE button to change “Vibrate Then Beep” to “Vibrate Only” or “Silent” option and press the SELECT button.When fi nished, press the LEFT TOGGLE button to return to the Alerts menu.8.6 SETTING THE OUT OF RANGE ALERTThe Out of Range Alert lets you know when the Sensor/Transmitter and Receiver are not talking to each other. Typically, you should keep the Sensor/Transmitter and Receiver within 20 feet (6 meters) of each other. When the Sensor/Transmitter and Receiver are too far apart and are not talking, you will not receive glucose readings from the Sensor. When this happens, the Out of Range Symbol will appear in the upper right corner of the Trend Graph and the screen to the right will appear. The amount of time the devices are out of range will appear on the Out of Range Alert screen.When Advanced features is turned on, “Out of Range” will appear as an additional option on the Alerts menu.The default setting for the Out of Range Alert is off (“disabled”). But if you choose to turn this Alert on, you can then set the Alert to either “Vibrate Then Beep” or “Vibrate Only”. “Vibrate Then Beep” notifi es you with vibrations and a series of 3 ascending tones, repeated 3 times, followed by 5 buzzers. You can also set the amount of time (between 20 and 200 minutes) the Transmitter can be out of range before the Receiver alerts you. If you go out of range, the Receiver will continue to re-alert you until you come back in range again, or press any button on the Receiver.1. Press the TOP or BOTTOM TOGGLE button to choose “Out of Range” and press the SELECT button.
G4-Global System User’s Guide | 1072. On the Out of Range menu, press the TOP or BOTTOM TOGGLE button to choose “On/Off”. Then, press the SELECT button to select “On”. If you do not want to receive Out of Range Alerts press the SELECT button to choose “Off”.3. Next, on the Out of Range menu, press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option and press the SELECT button.4. Next, on the Out of Range menu, press the TOP or BOTTOM TOGGLE button to choose “Time” and press the SELECT button. Then, press the TOP or BOTTOM TOGGLE button to choose the elapsed time, after which the Receiver will alert you and continue to re-alert you until you are back in range. Press the SELECT button.When fi nished, press the LEFT TOGGLE button to return to the Alerts menu.
108 | Continuous Glucose Monitoring System8.7 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTSYou have the option to set a snooze time (every 15 minutes up to 5 hours) in between High and Low glucose Re-alerts.TOGGLE button to choose “Snooze” and press the SELECT button.2. Press the TOP or BOTTOM TOGGLE button to select the amount of time (in 15 minute increments) in between the fi rst Alert and Re-alerts. Press the SELECT button. If you set the amount of time to zero there will be no Re-alerts.When fi nished, press the LEFT TOGGLE button to return to the Alerts menu.8Example-High AlertExample-High AlertNOTE: To set a snooze time for your High and Low Alerts, Advanced Features must be turned on.
chapter ninechapter nineTROUBLESHOOTING
G4-Global System User’s Guide | 1119.1 SENSOR INSERTION TROUBLESHOOTINGSensor Insertion Diffi culties• I am having trouble taking out the Safety Lock/Transmitter Key: - Make sure to pull straight out using the arrows on the Safety Lock as a guide. - Do not wiggle back and forth.• I am not able to pull the Collar up: - Make sure the plunger is completely pressed down before pulling the collar up. - When pulling the Collar up you should hear 2 clicks. - Try using more force when pulling the collar up.• I am not able to remove the Applicator from the Sensor Pod: - Pull the Collar all the way up. It should be very close to the top of the Applicator. - Make sure the Transmitter Latch is down before squeezing the Release Tabs. - Then squeeze the ribbed Release Tabs (on the side), and lift the Applicator away from your body.• Removing the Transmitter Latch is diffi cult: - Hold the Sensor Pod down with one hand and twist the Latch with the other hand to remove it. - Do not try to snap it straight off.Sensor Pod is Not Sticking Long Enough• Do not use any cream or lotion on your skin where you attach the Sensor Pod.• Clean the skin and make sure it is completely dry before you attach the Sensor Pod. Do not leave any substance on the skin where the Needle inserts.• You may use medical tape (such as BlendermTM) over the white adhesive patch of the Sensor Pod, but do not place the tape over the Transmitter or the plastic parts of the Sensor Pod.The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes.Release the Applicator
112 | Continuous Glucose Monitoring System99.2 CALIBRATION TROUBLESHOOTINGPrompts may appear during or shortly after you try to calibrate your System. Review the following troubleshooting tips so that your calibration is successful. • Make sure you have inserted a Sensor and started a Sensor session • Do not use expired Sensors• Store Sensors at room temperature (see Chapter 9 for Maintenance and Storage of your System)• Make sure your meter readings are between 40 and 400 mg/dL before you calibrate• Quality check your blood glucose meter per the manufacturer’s instructions9.2.1 BLOOD DROP PROMPTS9.2.1.1 TYPES OF BLOOD DROP PROMPTSThis section describes the three blood drop symbols you will see. The next section (Section 9.2.1.2) describes what to do when you see one of these symbols.Repeat Double Blood Drop PromptIf Startup calibration is not successful, the Receiver will continue to display this screen until you correct the problem. If you have followed these steps and you still receive the Double Blood Drop Prompt, then one of the following errors has occurred:• Both fi ngerstick readings you took and entered for your fi rst calibration were outside of the 40-400 mg/dL range, or• The Receiver and Transmitter were not talking (Out of Range Symbol appears in the Status Area) with each other at the time you took the 2 fi ngersticks entered for calibration, or• The Receiver could not understand ( appears in the Status Area) your Sensor signal at the time you entered the fi ngerstick readings for calibration.Double Blood Drop Prompt
G4-Global System User’s Guide | 113Additional Startup Blood Drop PromptThe Additional Startup Blood Drop Prompt (with 1 checked) means you need 1 more fi ngerstick reading for Startup Calibration.This screen will appear and the Receiver will make a medium tone and vibrate once (if set to “Vibe then beep”). The Receiver will continue to show the Additional Startup Blood Drop Prompt screen every 15 minutes until the fi ngerstick reading is successfully entered into the Receiver.Single Blood Drop PromptThe Single Blood Drop Prompt means you need 1 more fi ngerstick reading to calibrate. This symbol will appear when it is time for the 12-Hour Calibration Update or if the Receiver needs another fi ngerstick reading for Re-calibration. • 12-Hour Update: The screen will prompt you again every 15 minutes until a new fi ngerstick reading is successfully entered.• Additional fi ngerstick needed: The Receiver will vibrate and will make a sound. The Receiver will notify you two more times (to enter a fi ngerstick), or until a new fi ngerstick reading is successfully entered.Additional Blood Drop PromptSingle Blood Drop Prompt
114 | Continuous Glucose Monitoring System99.2.1.2 STATUS AREA SYMBOLS DURING BLOOD DROP PROMPTSIf you are prompted repeatedly by the Double Blood Drop screen, Additional Startup Blood Drop screen (1 checked), or the Single Blood Drop screen, make sure you fi rst check the Status Area on your Receiver before you take another fi ngerstick reading. Then follow the steps below:1. Clear the prompt from the Screen by pressing any button on the Receiver.2. Check the Status Area in the upper right corner of your Receiver. You will decide what to do based on the symbol that is shown in the Status Area: a. If the Double Blood Drop Prompt Symbol is displayed: • Take 2 more fi ngerstick readings if you are prompted by the Double Blood Drop. b. If the Additional Startup Blood Drop Prompt Symbol is displayed: • Take 1 more fi ngerstick reading if you are prompted by the Additional Startup or Single Blood Drop. (Readings must be within 40-400 mg/dL).0 c. If the “Single” Blood Drop Symbol prompt is displayed: • Enter your fi ngerstick readings into the Receiver. d. If is displayed, your Receiver cannot understand your Sensor signal. Do not take any more fi ngerstick readings for calibration at this time. Wait until you see one of the Blood Drop Prompts and review Steps 1 and 2.“Unknown Glucose Reading” SymbolDouble Blood Drop Prompt
G4-Global System User’s Guide | 115 e. If the Out of Range Symbol is displayed, do not take any more fi ngerstick readings for calibration at this time. Move the Receiver and Transmitter so that they are within 20 feet (6 meters) of each other and wait at least 5 minutes.1. Make sure your Transmitter ID is entered into the Receiver (see Chapter 2, Section 2.4)2. Make sure your Transmitter is fully snapped inIf you are still having problems with communication review Chapter 5, Section 5.4.4. When you are prompted with any of the Blood Drop Prompt screens again, review the steps at the beginning of this section to calibrate.HELPFUL HINT: If you are still having trouble with G4-Global System calibration (e.g., receiving repeated prompts) following these steps, contact DexCom Technical Support at 1-888-SEVENGO (738-3646) for help. 9.3 SENSOR FAILED TROUBLESHOOTINGIn some cases your Sensor session may stop before the end of a full 7-day period. Follow the guidelines below to have the best results with your System.• Do not use expired Sensors• Store Sensors at room temperature (see Chapter 10, Section 10.2)• Quality check your blood glucose meter• Make sure your Transmitter is snapped in fully• Make sure your Sensor Pod is not dislodged or peeling upOut of Range Symbol
116 | Continuous Glucose Monitoring System9.4 CALIBRATION ERROR TROUBLESHOOTINGThe screen to the right means your Sensor cannot calibrate. If you see this screen, enter at least 1 more calibration fi ngerstick reading after about 10-15 minutes. If no readings are displayed after this additional fi ngerstick, the Sensor may need to be replaced.If you clear this screen by pressing any button on the Receiver, you will see this symbol ( ) in the Status Area.The screen to the right tells you that the Sensor is not calibrating correctly. If you see this screen, wait approximately one hour. Then, enter at least 1 more calibration fi ngerstick reading. If no readings are displayed after this additional fi ngerstick, the Sensor may need to be replaced.If you clear this screen by pressing any button on the Receiver, you will see this symbol ( ) in the Status Area.Receiver Error CodeAn error code displayed on your Receiver means the Receiver may not be working properly. An example is shown to the right:9Receiver Error Code Screen15 Minute Calibration Error Screen1-Hour Calibration Error ScreenDuring use your System may detect problems that make your Sensor unable to calculate glucose readings (see Chapter 5, Section 5.4.3). At this time the Sensor session will stop automatically and the following screen will appear.Sensor Failed Screen
G4-Global System User’s Guide | 117Note any code that may appear on the screen, and contact DexCom Technical Support at 1-888-SEVENGO (738-3646). Continue to check blood glucose readings using your meter.System Recovery CheckThis screen indicates that the System discovered an error that it was able to fi x itself. Press any button on the Receiver to clear this display, and your continuous monitoring session will continue.System Recovery Check Screen9.5 RECEIVER AND CABLES TROUBLESHOOTINGBattery and Charging Diffi culties1. Remember to charge your Receiver battery. a. The charge will last approximately 3-5 days, depending on how often you turn on your Receiver, use the Alerts, and enter Events. b. Make sure you are not pressing buttons by mistake if you carry the Receiver in your pocket or bag. c. Check the Battery image on your Trend Graphs to see how much charge is left in the battery. d. The Receiver takes about 3 hours to charge fully if using the wall charger, and about 5 hours to charge fully using the USB charger.2. Make sure the Charging Cable is fully inserted in the Receiver and in the electrical outlet. a. Pull the cable out carefully. b. Only use DexCom cables.3. If your battery drains and is not charged for a few weeks, the time and date may be lost. When this happens, you will need to reset your Receiver’s time and date (see Chapter 2, Section 2.3).4. Only use the DexCom battery charger.
118 | Continuous Glucose Monitoring System9Alerts Not Working1. Make sure you have not disabled the sound and/or vibrations for the Alerts. Chapter 2, Section 2.5 explains how to change these Alert options.2. Check to be sure that Advanced Features is turned on. If not, you will not receive Rise and Fall Rate Alerts.3. Remember “Vibe then Beep” will vibrate during the fi rst alert and then will beep during the re-alert. If you do not hear a sound during the fi rst alert, this is normal.9.6 RECEIVER AND TRANSMITTER COMMUNICATION TROUBLESHOOTINGThis screen will appear once the Transmitter nears the end of its battery life (see Chapter 1, Section 1.2). Contact DexCom to order a new Transmitter.The screen to the right tells you that the Transmitter is not working correctly. If you get this alert during a Sensor session in progress, your Sensor session will automatically stop. Note this alert and contact DexCom Technical Support at 1-888-SEVENGO (738-3646). Continue to check blood glucose readings using your meter.Low TransmitterBattery ScreenTransmitter Failed Screen
chapter tenTAKING CARE OF YOUR G4-GLOBAL SYSTEMchaptTAKINGG4-G
G4-Global System User’s Guide | 12110.1 MAINTENANCEThe G4-Global Receiver requires minimal maintenance. Keep the following tips in mind:Sensor and Transmitter• Insert the Sensor only as directed.• Snap the Transmitter completely into the Sensor Pod in the correct alignment.• Calibrate the G4-Global Receiver every 12 hours as directed.• Do not wear the Sensor/Transmitter in water deeper than 3 feet and do not wear the Sensor/Transmitter in water for over 30 minutes.• Remove the Sensor and Transmitter as directed.• Wipe the Transmitter clean with a wet cloth or alcohol wipe between uses.• Keep the Transmitter clean and protected when not in use.Receiver• Do not get the Receiver wet.• Keep the Receiver in its carrying case or otherwise protected.• Charge the Receiver when the battery gets low.Accessories• Insert cables only as directed. Only use cables intended for use with the G4-Global Receiver. Do not force cables in place.• Observe cables for signs of wear and tear.• Maintain your fi ngerstick blood glucose meter as directed by the manufacturer.• Only use DexCom-supplied parts (including cables and chargers). Use of other parts might degrade safety.
122 | Continuous Glucose Monitoring System10.2 STORAGESensor• Keep the Sensor in its sterile packaging until you are ready to use it.• Do not insert Sensors past the expiration date printed on the Sensor packaging.• Storage Temperature should be 36°-77° F (2°-25° C) for the length of its shelf life. You may store your Sensors in the refrigerator if it is within this temperature range.Transmitter• Keep the Transmitter clean and protected when not in use.• Transmitter Warranty is 6 months.• Storage Temperature should be 32°- 113° F (0°- 45° C).Receiver• Keep the Receiver clean and protected when not in use.• Receiver Warranty is 1 year.• Storage Temperature should be 32°- 113° F (0°- 45° C).• Store at Humidity levels between 10-95% Relative Humidity.10PRECAUTION:• Always disinfect and clean the Transmitter after removing it from the body/patient.• Always clean and/or disinfect the Receiver while it is DISCONNECTED from any cables or electrical outlets.WARNING: Review all contraindications, warnings, precautions and detailed procedures in the User’s Guide before using the G4-Global System.10.3 CLEANING AND DISINFECTING
G4-Global System User’s Guide | 123For Single-Patient UseCleaning1. Use an alcohol wipe, or equivalent to clean the outside of the Receiver and Transmitter. Avoid using wipes that contain adhesive properties. (e.g. Smith + Nephew IV Prep™).2. Place the Receiver and Transmitter on a clean, dry cloth and air dry for 2-3 minutes.For Multi-Patient UsePreparation1. Use precaution when handling products worn by another person.2. Wash hands thoroughly.3. Wear personal protective equipment as appropriate (gloves, protective goggles, gowns, etc.).Disinfection4. Wipe down the outer surface of each component with Steris® Coverage® Spray TB Plus, or equivalent sterilant.5. Allow contact time for 3 minutes at room temperature (20°C/68°F).NOTE:• Always clean the Receiver and Transmitter after each use.• Do NOT use bleach or acetone to clean the Receiver and Transmitter.NOTE: Do NOT get the DexCom Receiver wet. Ensure the wipe is slightly damp, but not wet enough to leave drops of liquid on the Receiver surface (particularly the openings and buttons).
124 | Continuous Glucose Monitoring System107. Verify that any signs of bodily fl uids have been wiped away. The presence of bodily fl uids is rare.8. Place the Receiver and Transmitter on a clean, dry cloth and air dry for 2-3 minutes.9. When completely dry, place the Receiver and Transmitter in a sealed bag with the cleaning method and date. For example:10. Dispose of gloves as biohazard waste and wash your hands immediately after completing disinfection and cleaning of Receiver and Transmitter.NOTE: Do NOT get the DexCom Receiver wet. Ensure the wipe is slightly damp, but not wet enough to leave drops of liquid on the Receiver surface (particularly the openings and buttons).NOTE: Include the following information in the Multi-Patient Use Disinfection and Cleaning Record: Device Information, Date of Disinfection and Cleaning, Method of Disinfection (e.g. disinfectant), and Method of Cleaning (e.g. 70% or 99% IPA).Cleaning6. Use an alcohol wipe, or equivalent, to clean the outside of the Receiver and Transmitter. Avoid using wipes that contain adhesive properties (e.g. Smith + Nephew IV Prep™).
chapter eleveapter elevenSTUDY RESULTS
G4-Global System User’s Guide | 12711.1 DEVICE PERFORMANCE CHARACTERISTICSThe G4-Global Receiver uses a glucose Sensor to continuously measure and monitor your glucose levels. The Sensor is “calibrated” using your OneTouch® Ultra® blood glucose meter (Auto Upload) or a FDA-cleared blood glucose meter (using the OpenChoiceTM feature). Once calibrated, the G4-Global Receiver reports glucose readings up to every 5 minutes. In a clinical study, G4-Global Receiver readings were compared to blood glucose measurements in order to assess its performance or how well the G4-Global Receiver measurements compare to a laboratory method that measures blood glucose levels. Clinical Study fi ndings are presented below. Although presentations to characterize performance of the G4-Global Receiver are given below, there is no commonly accepted statistical approach for capturing performance of continuous glucose monitors such as the G4-Global Receiver. Performance may be best understood by viewing graphs called “time-elapsed plots”. In these plots, the readings from the G4-Global Receiver were recorded over time and were overlaid with readings taken at the same time with a reference laboratory method. Three representative time-elapsed plots are presented in this section (see Figures 2-3). They are examples of excellent, average and poor G4-Global Receiver performance.Participants enrolled in the clinical study and certain conditions of the study tend to result in above average glucose control. This, in turn, may result in the appearance that the G4-Global Receiver agrees with blood glucose levels better than it does under typical conditions. The following are some examples of why performance of the G4-Global Receiver might be idealized in this study.• The average Hemoglobin A1c among the 53 participants was 7.4%. Many people with diabetes have higher A1c levels, indicating poorer control of their glucose levels.• While subjects participated in the clinic portion of the study, they were more limited in their activities than someone at home. They were also provided with all their meals. Subjects who are more active, or with poor eating habits, may create more challenging conditions for the G4-Global Receiver.• Blood Glucose meters used in the study were well maintained. Because the meter is used to calibrate the G4-Global Receiver, performance may be poorer if the meter is not well maintained. It is important to carry out quality-control checks on the meter and code the meter according to the manufacturer’s instructions to optimize performance of the G4-Global Receiver.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
128 | Continuous Glucose Monitoring System11Clinical Study ResultsTo evaluate performance of the G4-Global Receiver, 53 participants were enrolled in a clinical study conducted at 3 clinics. All participants had Type 1 or Type 2 diabetes mellitus, and required insulin to manage their diabetes. About 81% of participants had Type 1 diabetes and about 19% had Type 2 diabetes. Subjects ranged in age from 23 to 72 years old.Participants used the G4-Global Receiver for approximately 7 days (each participant wore 1 or 2 Sensors for 7 days.) Receivers were calibrated approximately 2 times per day, on average, over the 7-day period using the Lifescan® OneTouch® Ultra meter. Throughout the 7-day wear period, the Receiver was calibrated the most on day 1, with an average of 3 fi ngersticks per day (2 to start up and 1 in the evening), and was calibrated with an average of 2 fi ngersticks per day for days 2-7 (approximately every 12 hours).All participants used the G4-Global Receiver in a controlled clinic environment on Day 1, Day 4, or Day 7 of the 7-day wear period. The remainder of the study took place at home. While using the G4-Global Receiver in the clinic 49 of the 53 participants had their blood glucose measured every 15 minutes with a reliable laboratory method, the Yellow Springs Instrument 2300 STAT Plus glucose analyzer. This instrument is referred to as the “YSI.” Readings from the G4-Global Receiver were paired with YSI readings in order to characterize how well G4-Global Receiver results agreed with blood glucose results. For the remainder of the study, participants used the G4-Global Receiver at home and results were paired with OneTouch Ultra blood glucose meter results. During Start-Up Calibration (see Chapter 4), all participants (100%) were able to calibrate successfully after the 2 hour Start-up period. For Calibration Updates/Re-Calibration (see Chapter 4) 97% of the time participants only needed one attempt to update calibration. Two-percent (2%) of Calibration Updates required a second attempt, and less than one-percent (<1%) of Calibration Updates needed more than three attempts.AgreementAgreement between the G4-Global Receiver and glucose levels is characterized using paired G4-Global Receiver and YSI results. The G4-Global Receiver and YSI readings were compared by pairing the YSI blood glucose reading to a G4-Global Receiver glucose reading that occurred approximately 5 minutes after the YSI reading was collected.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 129Table 1. Percentage of G4-Global Receiver Results Falling Within 20, 30, and Greater Than 40 Percent of the Paired YSI Results, at Various Glucose ConcentrationsYSI Readings (mg/dL)Number of Paired Readings% of G4-Global Receiver Readings Within 20%*% of G4-Global Receiver Readings Within 30%*% of G4-Global Receiver Readings Greater than 40%* of YSI40-400 1827 76% 90% 5%40-80 277 73% 87% 6%81-180 801 74% 89% 5%181-300 563 81% 93% 3%301-400 186 75% 95% 2%* For the 40-80 mg/dL range the absolute difference is presented as the difference in mg/dL between the G4-Global Receiver and YSI, rather than the percent.The agreement of the G4-Global Receiver to blood glucose levels was assessed by calculating the percentage of G4-Global Receiver readings that were within 20%, 30%, and greater than 40% of the YSI readings. For readings less than or equal to 80 mg/dL the difference in mg/dL between the two glucose readings was calculated. For readings greater than 80 mg/dL the percent difference (%) from the YSI reading was calculated. The percentages of total readings within 20 mg/dL or 20%, 30 mg/dL or 30%, or greater than 40 mg/dL or 40% were then calculated. The total number of data pairs considered in this analysis was 1,827. Results are shown in Table 1.The G4-Global Receiver reports glucose concentrations between 40 and 400 mg/dL. When the G4-Global Receiver determines the glucose level is below 40 mg/dL, it displays “LOW” in the Receiver Status Box. When the G4-Global Receiver determines that the glucose level is above 400 mg/dL, it displays “HIGH” in the Receiver Status Box. The ability of the G4-Global Receiver to accurately report these occurrences is assessed by looking at the actual blood glucose concentrations (as determined by the YSI analyzer) when “LOW” or “HIGH” are reported.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
130 | Continuous Glucose Monitoring System• On 19 occasions, the G4-Global Receiver indicated the glucose reading was less than 40 mg/dL and displayed “LOW”. Of these, the YSI blood glucose readings were never below 40 mg/dL and ranged between 43 mg/dL up to 141 mg/dL.• On 39 occasions, the G4-Global Receiver indicated the glucose reading was greater than 400 mg/dL and displayed “HIGH”. Of these, the paired YSI glucose reading was also above 400 mg/dL twelve (12) times. When the G4-Global Receiver read more than 400 mg/dL, the range of the YSI blood glucose readings at that time was 264-438 mg/dL.LOW AND HIGH GLUCOSE ALERTSThe ability of the G4-Global Receiver to detect high and low glucose levels (concentrations) is assessed by comparing G4-Global Receiver results to YSI results at low and high blood glucose levels and determining if the alert may have sounded. The G4-Global Receiver and YSI readings were compared by pairing the G4-Global Receiver reading that occurred approximately 5 minutes after the YSI reading was collected. There were 1,827 pairs of paired G4-Global Receiver and YSI results evaluated. We suggest that you ask your doctor what Alert settings would be best for you.The Low Glucose AlertEstimates of how well the adjustable Low Glucose Alert performs are presented in the table on the next page. For example, the data in the table shows that if you set the Low Glucose Alert to 70 mg/dL, the G4-Global Receiver will alert you of a blood glucose measurement of 70 mg/dL or lower 57% of the time within 5 minutes of reaching that blood glucose level (True Alert Rate). The table also shows that at the same Alert setting (70 mg/dL), the Low Alert may not alert you 44% of the time (“Missed Alert Rate***”) within 5 minutes of the blood glucose reading. Also at the 70 mg/dL alert level, 46% of the time the G4-Global Receiver may falsely alert you that your glucose level is at or less than 70 mg/dL when your actual blood glucose level is above 70 mg/dL.If you set the Low Glucose Alert to 90 mg/dL, the G4-Global Receiver should alert you 73% of the time within 5 minutes of when your glucose levels are at or below 90 mg/dL. The table also shows that at the same Alert setting (90 mg/dL), the Low Alert may not alert you within ~5 minutes of the low blood glucose event 27% of the time (“Missed Alert Rate***”).11Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 131Also at the 90 mg/dL alert level, 25% of the time the G4-Global Receiver may falsely alert you that your glucose level is at or less than 90 mg/dL when your actual blood glucose reading is above 90 mg/dL at that time.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
132 | Continuous Glucose Monitoring SystemTable 2. Hypoglycemic Alert EvaluationG4-Global Receiver Alert LevelTrue Alert Rate* False Alert Rate** Missed Alert Rate***60 mg/dL 59 % 61 % 41%70 mg/dL 57% 46 % 44 %80 mg/dL 64 % 29 % 36 %90 mg/dL 73 % 25 % 27 % * True Alert Rate is the % of time when the blood glucose level was at or below the alert setting and the alert sounded. ** False Alert Rate is the % of time when the device alarmed but the blood glucose level was above the alert setting.*** Missed Alert Rate is the % of time when the device failed to alarm when the blood glucose level was at or below the alert setting.11The High Glucose AlertEstimates of how well the adjustable High Glucose Alert performs are presented in the table below. For example, if you set the High Glucose Alert to 200 mg/dL, the G4-Global Receiver should alert you 81% of the time within 5 minutes when your blood glucose levels rise above 200 mg/dL (True Alert). Additionally, 7% of the time when the alert sounds, the glucose level may actually be below 200 mg/dL (False Alert) at this time.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 133Table 3. Hyperglycemic Alert EvaluationAlert Setting True Alert Rate* False Alert Rate** Missed Alert Rate***140 mg/dL 92 % 6 % 8 %180 mg/dL 84 % 6 % 16 %200 mg/dL 82 % 7 % 18 %220 mg/dL 80 % 8 % 20 %240 mg/dL 77 % 8 % 23 %300 mg/dL 59 % 27 % 41 % * True Alert Rate is the % of time when the blood glucose level was at or above the alert setting and the alert sounded. ** False Alert Rate is the % of time when the device alarmed but the blood glucose level was below the alert setting.*** Missed Alert Rate is the % of time when the device failed to alarm when the blood glucose level was at or above the alert setting.Performance of High and Low Glucose Alerts at night comparing the G4-Global Receiver to YSI data has not been established with the G4-Global Receiver Sensor. During use of the G4-Global Receiver at home, the High Alert was set to 200 mg/dL and the Low Alert was set to 80 mg/dL. Subjects were asked to take a fi ngerstick each time a high or low glucose alert sounded. The G4-Global Receiver and Meter readings were compared by pairing the G4-Global Receiver reading that occurred on average 5 minutes after the fi ngerstick meter reading was taken during home use. Analysis of the home use data showed that when the G4-Global Receiver was above 200 mg/dL, 77% of the OneTouch Ultra meter readings were above 200 mg/dL (True High Alert). When the G4-Global Receiver read below 80 mg/dL, 73% of the time the OneTouch Ultra readings were below 80 mg/dL (True Low Alerts). The G4-Global Receiver notifi ed the subject that their glucose levels were falsely below the Low Alert level 27% of the time and notifi ed the subject that their glucose levels were falsely above the High Alert level 23% of the time.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
134 | Continuous Glucose Monitoring System11AccuracyAccuracy between matched pairs was also estimated by calculating the percent difference between the G4-Global Receiver reading and the YSI reading. The G4-Global Receiver and YSI readings were compared by pairing the G4-Global Receiver reading that fell approximately 5 minutes after the YSI reading was collected. For example, if the YSI reading is 100 mg/dL and the G4-Global Receiver reading is 90 mg/dL, a 10% difference between the G4-Global Receiver and the YSI Laboratory machine is reported. In the above example the G4-Global Receiver reading is less than the YSI reading and so the percent difference reading is negative. The mean percent difference is the average of all of the positive and negative percent differences between the two devices compared and, therefore, tells you if the G4-Global Receiver on average reads higher or lower than the YSI at each glucose range. Another estimate used to tell you the accuracy of the G4-Global Receiver is the absolute percent difference. The absolute percent difference tells you the overall percent difference or “distance” between the G4-Global Receiver and YSI readings, but does not tell you if the G4-Global Receiver is reading on average higher or lower than the YSI laboratory standard. The mean absolute percent difference is the average “distance” (regardless if positive or negative) between G4-Global Receiver readings and YSI readings. These accuracy measures are summarized in Table 4 below and are based on 1,827 paired glucose measurements:Table 4. G4-Global Receiver and YSI Blood Glucose Accuracy by Glucose ConcentrationGlucose Range (mg/dL)Number of Paired ReadingsMean Percent DifferenceMedian Percent DifferenceMean Absolute Percent DifferenceMedian Absolute Percent DifferenceOverall (40-400 mg/dL)1827 -1% -3% 16% 13%40-80 277 13% 12% 25% 20%81-180 801 -1% -2% 15% 13%181-300 563 -6% -7% 13% 12%301-400 186 -9% -9% 13% 10%Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 135Table 4 shows that the G4-Global Receiver, on average, reads 13% higher than the YSI at glucose levels of 40-80 mg/dL and reads 9% lower, on average, than the YSI at glucose concentrations of 301-400 mg/dL (Mean Percent Difference). The G4-Global Receiver reads, on average, 25% different than the YSI at glucose levels of 40-80 mg/dL and, on average, 13% different than the YSI readings at glucose levels of 301-400 mg/dL (Mean Absolute Percent Difference). The Median Percent Difference shows that 50% of the time the G4-Global Receiver reads approximately 3% less than the YSI System and the Median Absolute Difference shows that 50% of the time the G4-Global Receiver reads about 13% different then YSI blood glucose readings taken within 5 minutes.Table 5. Clarke Error Grid AnalysisThe Clarke Error Grid was used to determine if G4-Global Receiver results are “clinically accurate.” The Clarke Error Grid divides a correlation plot into 5 zones, which are described in the table below.Zone DescriptionA Clinically Accurate, would lead to correct treatment decisionsB Would lead to benign decisions or no treatment C Would lead to overcorrection of normal glucose levelsD Would lead to failure to be aware of and treatment of high or low glucose levelsE Would lead to inaccurate and “dangerous” treatment decisionsResults in zones A and B are considered “clinically acceptable”, in which you would most likely make accurate treatment decisions or decide not to do treatment with the readings provided, while results in zones C, D, and E can lead to dangerous treatment errors. The Clarke Error Grid zones are labeled on a correlation plot in Figure 1. Each YSI result (on the horizontal axis) is matched up with its corresponding G4-Global Receiver result (on the vertical axis). A point is recorded where the two readings intersect. These results are based on 1,827 paired data points recorded.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
136 | Continuous Glucose Monitoring SystemYYY YSI Reading ••• G4-Global Receiver Glucose ReadingYYY YSI Reading ••• G4-Global Receiver Glucose Reading11Figure 1. Clarke Error Grid, G4-Global Receiver Results Compared to YSI ResultsPoint Error Grid Regions for All SiteThe percentage of G4-Global Receiver results in the above graph are presented in Table 6 on the next page according to the percentage of points falling within each zone (A-E). Results are further broken down (stratifi ed) according to the range of glucose concentration.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 137YYY YSI Reading •••G4-Global Receiver Glucose ReadingTable 6. Clarke Error Grid Analysis, Stratifi ed by YSI Glucose ConcentrationsGlucose Range (mg/dl)Total YSI – G4-Global Receiver PairsA%B%C%D%E%40-400 1,827 73%23%0%4%0%40-80 277 57% 22% 0% 21% 0%81-180 801 73% 27% 0% N/A* N/A*181-300 563 81% 17% 0% 2% 0%301-400 186 75% 23% N/A* 2% 0%* N/A means that the Clarke Error Grid does not consider the possibility of these zones in that glucose range.Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
138 | Continuous Glucose Monitoring System11The Continuous Error Grid was also used to determine if the G4-Global Receiver results are “clinically acceptable.” The Continuous Error Grid looks at how closely the G4-Global Receiver readings match to the YSI Analyzer and also how closely the G4-Global Receiver glucose rate of change (how fast the glucose rises or falls) compares to the actual blood glucose rate of change measured by the YSI. The data is evaluated in 3 zones: clinically accurate readings, benign errors, and clinically inaccurate readings. See the table below for the G4-Global Receiver accuracy by glucose range. There were 1,827 paired points evaluated.Table 7. Continuous Error Grid Combined Point and Rate Rating TableHypoglycemia(YSI<= 70 mg/dL)(8% of the data)Euglycemia(70< YSI <=180 mg/dL)(51% of the data)Hyperglycemia(YSI >180 mg/dL)(41% of the data)Accurate Readings 61% 97% 94%Benign Errors 1% 2% 2%Inaccurate Readings 39% 1% 5%Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 139Calibrations StabilityThe G4-Global Receiver must be calibrated every 12 hours. To demonstrate performance of the G4-Global Receiver over a 12-hour calibration period, 71 Sensors were evaluated to verify that performance remains consistent over the 12-hour calibration period. G4-Global Receivers were evaluated in 3-hour increments after calibration. Performance was estimated at each 3-hour interval and stratifi ed by glucose concentrations by calculating the percentage of G4-Global Receiver readings within 20%, 30% and greater than 40% of the YSI readings. See the table below.Table 8. Percentage of G4-Global Receiver readings within 20%, 30% and 40% of the YSI Laboratory reading with data stratifi ed in 3-hour increments after calibration across days 1, 4 and 7.Time from Calibration and YSI G l u c o s e R a n g e (40-400 mg/dL)Number of Paired Readings % of Readings within 20% of YSI% of Readings within 30% of YSI% of Readings within 40% of YSI0-3 hours 1031 77% 91% 96%3-6 hours 345 75% 91% 96%6-9 hours 235 71% 88% 94%9-12 hours 187 77% 88% 91%Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
140 | Continuous Glucose Monitoring System11Sensor StabilitySensors can be worn for up to 7 days. To verify that sensors perform consistently over the 7-day period, 71 Sensors were evaluated across the 7-day wear period. Performance was estimated by calculating the percentage of G4-Global Receiver readings within 20%, 30% and >40% of the YSI readings at the beginning (Day 1), middle (Day 4) and end (Day 7) of the G4-Global Receiver lifecycle. Results are shown in the table below.Precision of G4-Global Receiver System ReadingsIn the same study, 18 of the subjects wore two G4-Global Receiver’. This was done to look at how similarly two G4-Global Receiver’ on the same person function (Sensor Precision). Precision was evaluated by comparing the glucose readings from the two G4-Global Receiver’ worn on the same subject at the same time. Results showed that G4-Global Receiver readings from the two sensors generally agreed with each other within 15%.Table 9. G4-Global Receiver System Sensor Stability (Accuracy Over Time)Day of Wear (40-400 mg/dL) Number of Paired Readings % of Readings within 20% of YSI% of Readings within 30% of YSI% of Readings within 40% of YSIDay 1 637 77% 91% 3%Day 4 635 80% 94% 3%Day 7 533 70% 86% 8%Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 141Sensor LifeDuring the trial there were no Sensor insertion problems and Sensors may be worn for up to 7 days (168 hours). To estimate how long a G4-Global Receiver Sensor will work over 7 days, the 71 Sensors were evaluated to determine how many Days (hours) of readings each Sensor provided. Table 10, below, displays how long you can expect a Sensor to last after insertion. For example, 89% of the sensors lasted more than 6 and up to the full 7 days (144-168 hours).There were 6 Sensors that did not last at least 6 days or more than 144 hours. Five (5) of those sensors became non-functional due to an Early Sensor Shut-off, and 1 Sensor ended before 6 days because the subject bumped the Sensor and it fell off.Table 10. Estimated G4-Global Receiver Sensor LifeNumber of Days of Use (Hours) Percentage of Sensors1 (24 hours) 1%2 (48 hours) 1%3 (72 hours) 6%4 (96 hours) 0%5 (120 hours) 0%6 (144 hours) 3%7 (168 hours) 89%Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
142 | Continuous Glucose Monitoring System11Number of Readings ProvidedThe G4-Global Receiver is capable of providing a reading up to every 5 minutes, or up to 288 readings per day. For a variety of reasons, this does not always happen. Sometimes sensors cannot provide readings after calibration and readings are “skipped” (see Chapter 5). Table 11, below, estimates the number of readings you can expect to receive from the G4-Global Receiver over the entire 7-day period. For example, 87% of G4-Global Receiver devices provided between 1,557 and 1,992 readings (or at least 76% of the expected number of readings).Approximately 7% of readings were lost because the Transmitter and Receiver were not communicating. Approximately 1% of the time the G4-Global Receiver required additional calibration readings to start displaying glucose readings again. Over 7 days of use, on average, subjects experienced 3 periods of time where the Receiver could not display glucose readings and displayed “???” instead. These periods lasted on average for 1 hour. A small percentage of subjects (<10%) experienced a period of missing glucose readings (or “???”) for more than 4 hours. However, per the Sensor Life data above, 89% of the Sensors were able to “recover” from these periods of signal problems and begin displaying continuous glucose readings again.Table 11. Number of Readings Provided by Each Sensor Over 7-Days% of Total Possible Readings ProvidedTotal Readings Provided % of G4-Global Receiver Devices Providing that number of readings0-25% 261 1%26-50% 521-782 7%51-75% 1005-1477 4%76-100% 1557-1992 87%Section 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 143Time-Elapsed PlotsExamples of G4-Global Receiver Continuous Glucose Monitoring System overlaid with the corresponding YSI readings over time are presented on the next page. The horizontal axis represents time, with the matching G4-Global Receiver and YSI readings plotted above the point in time when the measurements were taken. The circles (•) on the graph represent the G4-Global Receiver data. The “Y” represents the YSI reading.There are three Figures presented. Figure 2 is an example of when the G4-Global Receiver performed well, Figure 3 represents a period when the G4-Global Receiver performed in an average manner, and Figure 4 represents when the G4-Global Receiver performed poorly.Figure 2. Example of “Good” G4-Global Receiver PerformanceSection 11.1Placeholder for G4-Global Receiver Pivotal Study Results
144 | Continuous Glucose Monitoring System11Figure 3. Example of “ Average” G4-Global Receiver PerformanceFigure 4. Example of “Poor” G4-Global Receiver PerformanceSection 11.1Placeholder for G4-Global Receiver Pivotal Study Results
G4-Global System User’s Guide | 14511.2 PRODUCT SPECIFICATIONSSensorGlucose Range 40-400 mg/dL (2.2 – 22.2 mmol/L)Sensor Life Up to 7 daysCalibration FDA-cleared blood glucose meterCalibration Range 40-400 mg/dL (2.2 – 22.2 mmol/L)Operational Conditions Humidity: Maximum 95 % Relative Storage Condition Temperature: 2°-25° C (36°-77° F) Moisture Protection IPX 5: water resistance to jetting waterIPX 8: temporary submersion to a depth of 8 feet (2.44 meters) for 24 hoursSterilization Sterile by radiation
146 | Continuous Glucose Monitoring SystemTransmitterDimensions (including Sensor Pod)Length: 1.5 inches (3.8 cm)Width: 0.9 inches (2.3 cm)Thickness: 0.5 inches (1.3 cm)Weight (including Sensor Pod) 0.4 ounces (10 grams)Communication Range 20 ft (6m)Frequency Range 2.425 - 2.477 GHzPower Supply Silver Oxide BatteriesOperational Conditions Temperature: 10°- 42° C (50°- 108° F)Humidity: Maximum 95% RelativeStorage Conditions Temperature: 0°- 45° C (32°- 113° F) Limited Warranty 6 monthsMoisture Protection IPX 5: water resistance to jetting waterIPX 8: temporary submersion to a depth of 8 feet (2.44 meters) for 24 hoursProtection Against Electrical Shock Type B Applied Part11
G4-Global System User’s Guide | 147PARAMETER PERFORMANCE CHARACTERISTICSFrequency Allocation 2.4 GHz ISM BandTX/RX Frequencies2.424 999 877 GHz2.449 993 677 GHz2.474 737 539 GHz2.477 236 919 GHzBandwidth 270.833 kHzMaximum Output Power 1.25 mW EIRPModulation Minimum Shift KeyData Rate 49.987 Kbits/SecTotal Packet 224 bitsTransmit Duty Cycle 4.48 ms every 5 minutes at each of the four TX frequencies.Data Detection Range 20 ft (6m)Average Number of Collisions due to Coexistence. 20 DexCom Transmitters within 20 feet over a 24 hr period (288 transmissions each) Total of 2 collisions, if collision occurs, no glucose value is received
148 | Continuous Glucose Monitoring SystemGuidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe Transmitter is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Transmitter should assure that it is used in such an environmentImmunity Test IEC 60601 Test Level Transmitter Compliance LevelElectromagnetic Environment GuidanceElectromagnetic Environment Guidance Electrostatic Discharge (ESD) IEC 61000-4-2± 6 kV Contact± 8 kV Air± 6 kV Contact± 8 kV AirFloors should be wood, concrete or ceramic tile. If fl oors are covered with synthetic material, the relative humidity should be at least 30 %Electrical Fast Transient /burstIEC 61000-4-4± 2 kV for power supply lines± 1 kV for input/output linesNot Applicable-Battery OperatedSurgeIEC 61000-4-5± 1 kV differential mode± 2 kV common modeNot Applicable-Battery OperatedVoltage Dips, Short Interruptions and Voltage Variations on Power Supply Input LinesIEC 61000-4-11< 5 % UT (>95 % dip in UT) for 0.5 cycle40 % UT (60 % dip in UT) for 5 cycles70 % UT (30 % dip in UT) for 25 cycles< 5% UT (>95% dip in UT) for 5 secNot Applicable-Battery OperatedPower Frequency(50/60 Hz) Magnetic FieldIEC 61000-4-83 A/m 3 A/m Power Frequency magnetic fi elds should be at levels characteristic of a typical location in a typical commercial or hospital environment11
G4-Global System User’s Guide | 149ReceiverReading Frequency Every 5 minutesDimensions Length: 4.5 inches (11.4 cm)Width: 2.3 inches (5.8 cm)Thickness: 0.85 inches (2.2 cm)Weight 4.0 ounces (113.39 g)Communication Range 20 ft (6m)Memory Storage 30 days of user data,7 days of tech supportRe-Chargeable Battery Use 3 to 5 daysCharging Time 3 hours wall outlet,5 hours USBStorage/Operating Conditions Temperature: 0°- 45° C(32°- 113° F)Humidity: 10-95 %Relative Operating Pressure 10.2 to 21.8 psiMoisture Protection NoneLimited Warranty 1 year
150 | Continuous Glucose Monitoring SystemImmunity Test IEC 60601 Test Level Receiver Compliance LevelElectromagnetic Environment GuidanceElectromagnetic Environment Guidance Electrostatic Discharge (ESD) IEC 61000-4-2± 6 kV Contact± 8 kV Air± 6 kV Contact± 8 kV AirFloors should be wood, concrete or ceramic tile. If fl oors are covered with synthetic material, the relative humidity should be at least 30%Electrical Fast Transient /burstIEC 61000-4-4± 2 kV for power supply lines± 1 kV for input/output lines± 2 kV for power supply lines± 1 kV for input/output linesMain power quality should be that of a typical commercial or hospital environmentSurgeIEC 61000-4-5± 1 kV differential mode± 2 kV common mode± 1 kV differential mode± 2 kV common modeMain power quality should be that of a typical commercial or hospital environmentVoltage Dips, Short Interruptions and Voltage Variations on Power Supply Input LinesIEC 61000-4-11< 5 % UT(>95 % dip in UT) for 0.5 cycle40 % UT (60 % dip in UT) for 5 cycles70 % UT (30 % dip in UT) for 25 cycles< 5% UT (>95% dip in UT) for 5 sec< 5 % UT (>95 % dip in UT) for 0.5 cycle40 % UT (60 % dip in UT) for 5 cycles70 % UT (30 % dip in UT) for 25 cycles< 5% UT (>95% dip in UT) for 5 secMain power quality should be that of a typical commercial or hospital environment11Guidance and Manufacturer’s Declaration- Electromagnetic ImmunityThe Receiver is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Receiver should assure that it is used in such an environment.
G4-Global System User’s Guide | 151Immunity Test IEC 60601 Test Level Receiver Compliance LevelElectromagnetic Environment GuidancePower Frequency(50/60 Hz) Magnetic FieldIEC 61000-4-83 A/m 3 A/m Power Frequency magnetic fi elds should be at levels characteristic of a typical location in a typical commercial or hospital environmentNote: UT is the a.c. main voltage prior to application of the test levelGuidance and Manufacturer’s Declaration- Electromagnetic ImmunityThe Receiver is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Receiver should assure that it is used in such an environment.Electromagnetic Environment GuidancePortable and mobile RF communications equipment should be used no closer to any part of the Receiver, including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.Recommended Separation Distanced =1.2 P1/2d = 1.2 P1/2 80 MHz to 800 MHzd = 2.3 P1/2 800 MHz to 2.5 GHzNote 1: At 80 MHz and 800 MHz, the higher frequency range appliesNote 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects and people
152 | Continuous Glucose Monitoring Systema. Field strengths from fi xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fi xed RF transmitters, an electromagnetic site survey should be considered. If the measure fi eld strength in the location in which the Receiver is used exceeds the applicable RG compliance level above, the Receiver should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary such as reorienting or relocating the Receiver.b. Over the frequency range 150 KHz to 80 MHz, fi eld strengths should be less than 3 V/m.11Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment GuidanceConducted RFIEC 61000- 4-63 Vrms150 k Hz to 80 MHz3 V Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).RadiatedRFIEC 61000-4-33 V/m80 MHz to 2.5 GHz3 V/m Field strengths from fi xed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with following symbol: Note 1: At 80 MHz and 800 MHz, the higher frequency range appliesNote 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects and people
G4-Global System User’s Guide | 153Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and ReceiverThe Receiver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Receiver can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Receiver as recommended below, according to the maximum output power of the communications equipment.Rated maximumOutput Power of Transmitter (W) Separation DistanceAccording to Frequency of Transmitter (m)150 kHz to 80 MHzd = 1.2 P1/280 MHz to 800 MHzd = 1.2 P1/2800 MHz to 2.5 GHzd = 2.3 P1/20.010.1110100 0.120.381.23.8120.120.381.23.8120.230.732.37.323For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture.Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refl ection from structures, objects and people.* There is a separate USB cable and USB power supply.Charging Cable*AC Input 110-240 V, 50-60 Hz Length 6.6 FT (2 M)
154 | Continuous Glucose Monitoring System1111.3 FCC REQUIREMENTSThe Transmitter covered by this User’s Guide has been certifi ed under FCC ID: PH29433Although the Transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from the Transmitter will be free from interference.Compliance Statement (Part 15.19)This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation.Warning (Part 15.21)Changes or modifi cations not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.FCC Interference Statement (Part 15.105 (b)This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures: - Reorient or relocate the receiving antenna. - Increase the separation between the equipment and receiver. - Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. - Consult the dealer or an experienced radio/TV technician for help.This portable transmitter with its antenna complies with FCC/IC RF exposure limits for general population / uncontrolled exposure.
hapter twelveAPPENDIXchapter twelve
G4-Global System User’s Guide | 157APPENDIX I, OTHER ALERTSThis table describes the Other Alerts, how to clear them and when you will be re-alerted by the Receiver.Screen Alert Title Description Re-Alert Clearing Alerts Re-Alert After ClearLow Battery The Receiver battery is low. Charge your Receiver as soon as possible when you see the Low Battery Alert.2 times in the next 10 minutesPress any Receiver buttonEvery 60 minutesSingle Blood Drop PromptThe Receiver needs a calibration fi ngerstick reading. Take a fi ngerstick reading and enter it into the Receiver.None Press any Receiver buttonEvery 15 minutesDouble Blood Drop PromptYou must enter two additional fi ngerstick readings for Startup Calibration.Every 5 minutesPress any Receiver buttonEvery 15 minutesAdditional Blood Drop PromptYou must enter one additional fi ngerstick reading for Startup Calibration. Every 5 minutesPress any Receiver buttonEvery 15 minutes
158 | Continuous Glucose Monitoring System12Screen Alert Title Description Re-Alert Clearing Alerts Re-Alert After ClearWait 15 minutes to calibrateThe Sensor is not calibrating properly (see Section 8.4, “Error Code Troubleshooting for instructions on what to do is you see this screen).Every 5 minutesPress any Receiver buttonEvery 15 minutes until you fi x the problem, or your glucose level changes enough to fi x the problem itselfWait 1 Hour to calibrateSensor ExpirationYour Sensor session will soon expire, and you will need to change your Sensor soon. There will be no sound when the 6-hour and 2-hour screens display. The 30-minute screen will be set to your “Other Alert” options.None for 6-hour and 2-hour.2 times in the next 10 minutes for 30-minutePress any Receiver buttonNoneSensor ExpirationThe Sensor session is complete. You should change your Sensor at this time.2 times in the next 10 minutesPress any Receiver buttonNone
G4-Global System User’s Guide | 159Screen Alert Title Description Re-Alert Clearing Alerts Re-Alert After ClearSensor FailedThe Sensor is not working properly (see Section 8.3, “Sensor Failed Troubleshooting”).2 times in the next 10 minutesPress any Receiver buttonNoneReceiver ErrorThere is a problem with the Receiver. Write down the code on the screen, and contact DexCom.None. The Receiver will beep and vibrate for 5 seconds and then will be silent.Cannot clear alertNoneSystem RecoveryThere was a problem with the Receiver, but it was able to fi x itself. Every 5 minutesPress any Receiver buttonNoneTime Loss The Receiver backup battery has drained, and you will need to reset the Receiver time and date. The Time Loss Alert automatically takes you to the Time/Date Setting screen.None Enter the time and dateNone
160 | Continuous Glucose Monitoring SystemAPPENDIX II, RECEIVER SCREENS & PROMPTSThe following prompt screens may appear on the Receiver during use:DOUBLE BLOOD DROP PROMPT: Appears about 1 hour after you insert a new Sensor, and tells you that you need to take 2 fi ngerstick readings on your meter and enter them for calibration.DOUBLE BLOOD DROP PROMPT, (1 CHECKED): This tells you that only 1 fi ngerstick reading has been successfully entered. You need to take at least 1 more fi ngerstick reading on your meter and enter it for calibration.SINGLE BLOOD DROP PROMPT: This screen appears during Calibration Update or Re-Calibration. This means it is time for you to take a fi ngerstick reading on your meter and enter it into the Receiver. Only enter fi ngerstick readings if the Single Blood Drop Symbol or your current glucose reading is displayed on the Trend Graph. Do not enter any fi ngerstick readings if , or appear in the upper right corner of the Trend Graph.RECEIVER LOW BATTERY NOTIFICATION: Your Receiver battery is running low and needs to be recharged. Charge the battery as soon as possible.ENTER BG PROCESSING SCREEN: The meter reading that you entered is being processed for calibration by the Receiver.HIGH GLUCOSE ALERT: Your glucose reading is at or above the High Glucose Alert level you set.LOW GLUCOSE ALERT: Your glucose reading is at or below the Low Glucose Alert level you set.12
G4-Global System User’s Guide | 161LOW GLUCOSE ALARM: Your System reading is at or below the factory Low Glucose ALARM level (55 mg/dL). You cannot change this ALARM level.RISE ALERTS: Either the Rise Alert or Rapid Rise Alert may appear, depending on the Rise Alert level you set.Rise Alert: Your glucose levels are rising at 2 mg/dL per minute or more.ORRapid Rise Alert: Your glucose levels are rising fast at 3 mg/dL per minute or more.FALL ALERTS: Either the Fall Alert or the Rapid Fall Alert may appear, depending on the Fall Rate Alert level you set.Fall Alert: Your glucose levels are falling at 2 mg/dL per minute or more.ORRapid Fall Alert: Your glucose levels are falling fast at 3 mg/dL per minute or more.OUT OF RANGE ALERT: The Transmitter and Receiver are not talking and you will not receive glucose readings.SENSOR FAILED SCREEN: The Sensor is not working. You will need to replace the Sensor at this time.TIME/DATE LOSS ALERT: The Receiver backup battery is drained, so you need to reset the Receiver time and date. The Time Loss Alert will automatically take you to the Time/Date Setting Screen.If you were in the middle of a Sensor Session, this Alert will end your session. You must recharge the Receiver battery. Then, you must set the correct date and time and start a new session.
162 | Continuous Glucose Monitoring SystemOUT OF RANGE/NO ANTENNA: The Receiver and Transmitter are not talking and your glucose readings have not been sent to the Receiver in the last 5 minutes. If you see this screen (with no Antenna Symbol in the upper left hand corner) you should make sure the Receiver and Transmitter are within 20 feet (6m) of each other. See Chapter 8 for Troubleshooting.UNKNOWN SENSOR GLUCOSE READINGS: appears in the upper right corner of the Trend Graph. The Sensor is sending glucose readings that the Receiver does not understand.15 MINUTE CALIBRATION ERROR: The Sensor cannot calibrate. If you see this screen, enter at least 1 more fi ngerstick reading for calibration after about 10-15 minutes. If no glucose readings appear on the Receiver, the Sensor needs to be replaced.1 HOUR CALIBRATION ERROR: The Sensor is not calibrating correctly. If you see this screen, wait approximately 1 hour and then enter at least 1 more fi ngerstick reading for calibration. If no glucose readings appear up on the Receiver, the Sensor needs to be replaced.WAIT: The Single Hourglass Symbol in the upper right hand corner means the Receiver has detected a potential problem with the Sensor signal. You should wait about 30 minutes for more prompts. Do not enter any fi ngerstick readings for calibration when you see this symbol.ERROR CODE: The Receiver may not be working correctly. If you see this code, write the code down for troubleshooting and use your meter to check your blood glucose readings.SYSTEM RECOVERY: The Receiver discovered an error that it was able to fi x itself. Press any Receiver button to clear this display. Your Sensor session will continue.6-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor session will end in 6 hours.12
G4-Global System User’s Guide | 1632-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor session will end in 2 hours.30-MINUTE SENSOR EXPIRATION NOTIFICATION: Your Sensor session will end in 30 minutes.0-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor session has ended. Once you clear the Alert, your Receiver will be notifi ed that the Sensor has been removed. You should clear this notifi cation by pressing any Receiver button, then remove your Sensor at this time.
164 | Continuous Glucose Monitoring SystemGLOSSARYThe following list of terms will help you while reading though this guide:Alternative Site Testing (BG) This is when you obtain a glucose reading on your meter using a blood sample from an area on your body other than your fi ngertip. Do not use alternative site testing for entering blood glucose readings into the G4-Global Receiver.Applicator A disposable component piece that comes attached to the Sensor Pod, and inserts the Sensor Probe under the skin. There is a needle inside the Applicator that you remove once you have inserted the Sensor Probe.BG meter Blood Glucose meter. You can use any FDA-cleared meter for obtaining fi ngerstick readings to enter into your G4-Global Receiver. BG reading Blood Glucose reading. A fi ngerstick blood glucose reading taken with your FDA-cleared blood glucose meter.Calibration This is when you enter fi ngerstick readings from a blood glucose meter into the G4-Global Receiver. Calibrations are needed for your G4-Global Receiver to display continuous glucose readings and trend information. (Do not use alternative site testing for calibration.)Default A setting that is selected automatically unless another option is chosen.FDA-cleared System The product has met the U.S. Food and Drug Administration’s standards and may be sold legally in the United States.G4-Global System The Sensor, Transmitter, and Receiver.G4-Global Reading A glucose reading shown on your Receiver. This reading is given in mg/dL units and is updated every 5 minutes. Glucose Data Gaps This can happen when the Receiver does not display a glucose reading that is sent from the Transmitter. A symbol will appear instead of a glucose reading to let you know that the Receiver cannot display a reading.Glucose Trends Trends let you see the pattern of your glucose levels; you can see where your glucose levels have been and where your glucose levels are headed. The G4-Global Receiver displays fi ve glucose Trend Graphs: the 1-Hour, 3-Hour, 6-Hour, 12-Hour, and 24-Hour Graphs. Each Trend Graph shows glucose trends over the amount of time shown on the screen.12
G4-Global System User’s Guide | 165mg/dL Milligrams per deciliter. The standard unit of measure for glucose readings in the United States.Range The distance between the Receiver and Transmitter. Keep the 2 devices within 20 feet (6 meters) from each other to get glucose information on your ReceiverRise and Fall (Rate of Change) AlertsAlerts based on how fast your glucose levels rise/fall, and by how much.Receiver An MP3-like device, which collects your glucose information from the Sensor/Transmitter. Your results are displayed on the Receiver screen as a glucose reading (mg/dL) and as a trend.RF Radio-Frequency transmission used to send glucose information from the Transmitter to the Receiver.Safety Lock/Transmitter Key The Safety Lock keeps the needle inside the Applicator before you are ready to insert the Sensor Probe. It also helps you snap the Transmitter out of the Sensor Pod after your Sensor session has ended.Sensor The G4-Global System component that is inserted under the skin to continuously measure your glucose levels.Sensor Pod The small base of the Sensor attached to your belly that holds the Transmitter in place. The Sensor Pod and Transmitter are all that remain on your skin during each Sensor use.Sensor Probe The part of the Sensor that is inserted under your skin with the Applicator. It measures the glucose levels in your surrounding tissue fl uid.Startup Period The 1-hour “startup” period after you tell the Receiver you have inserted a new Sensor (glucose readings cannot be provided during this time).Transmitter The G4-Global System component that snaps into the Sensor Pod and wirelessly sends glucose information to your Receiver.Transmitter ID Transmitter ID Number that is entered into your Receiver to enable it to talk to the Transmitter.
166 | Continuous Glucose Monitoring System12Transmitter Latch The small disposable component that snaps the Transmitter into the Sensor Pod. It is removed after the Transmitter is snapped in.Trend (Rate of Change) Arrows Arrows on Trend Graphs that indicate if and how fast your glucose levels are changing. The are 7 different arrows that show when your glucose speed and direction change. “ Use By” Date Lot NumberCaution Part Number, Catalog NumberDate of Manufacture Lower Limit of TemperatureDo Not Reuse Two-sided Temperature LimitsSerial Number Upper Limit of TemperatureSterilized by Radiation Keep DryDo Not Use if Package is Damaged Direct CurrentSYMBOLS USED IN LABELINGThe following symbols may be found on the Sensor, Transmitter, and Receiver package labels. These symbols tell you about the proper and safe use of the G4-Global System. This table shows what each symbol means.
G4-Global System User’s Guide | 167Water resistant to jetting water Type B Applied PartTemporary submersion to a depth of 8 feet (2.44 meters) for 24 hoursFollow Operating InstructionsManufacturer Authorized Representative in the European communityHumidity Limitation:: ADDITIONAL INFORMATIONReceiver INPUT: 5 VDC, 750 mARated supply voltage range: 100-240 VAC (AC supply)Phases and current: 0.3A (AC supply)Rated frequency range: 50-60 Hz (AC supply)
168 | Continuous Glucose Monitoring SystemAALARM, Low Glucose 65Alerts 62 Glucose Alerts 29, 62 High 29, 63, 90 Low 29, 64, 90 Snooze 108 Not Working 118 Other Alerts 105 Setting 29, 63, 64, 90, 92, 103 Rise and Fall 65, 92, 103 (Rate of Change) Setting Out of Range Alert 106 Alternative Site Testing (BG) 47Antenna Symbol 42 Missing 69Arrows, Trend (Rate of Change) 61, 105BBattery, Receiver 31 Charging 31 Troubleshooting 117Blood Glucose (BG) Meter 6, 7, 15, 47Blood Glucose (BG) Reading 15, 47CCable, Connection 31, 117Calibration 15, 45 Calibration Update 51 How to Calibrate 48 Re-Calibration 52 (Blood Drop in Status Area)Startup Calibration 50Troubleshooting 112Contact Information 4 DexCom Technical Support 4 DexCom Website 4Contents, G4-Global Receiver Continuous Glucose Monitoring System Kit 5DDexCom Studio Software 103EEvents, Diabetes 98 Carbohydrates 99 Exercise 101 Health 102 Insulin 100 Setting the Date and Time for an Event 99FFDA-cleared meter 6, 18, 47GGlucose Data Gaps 164Glucose Readings 58 High 63 Low 64 Missing 68Glucose Trends 61MMaintenance, System 121index
G4-Global System User’s Guide | 169RRadio-Frequency 15Range 69Receiver 17 Charging your 31 Overview 17 Screens, viewing 19 Settings 27SSafety Information 7 Caution 8 Contraindications 7 Indication for Use 6 Precautions 8Safety Lock (Transmitter Key) 15, 79Screens, Receiver 19 Prompts and Notifi cations 50, 52, 112 Trend Graphs 19, 58-60Sensor 5, 33 Applicator 5, 38 Automatic Shut-Off 76 Early Shut-Off 77 Expiration Date 35 Failed 77, 115 Insertion 39 Insertion Site 37 Overview 15 Pod 15, 36, 38 Probe 15 Removing the Sensor from Package 37 Sensor Failure 115 Starting a Session 43 Startup Period 44 Stop Sensor (Manual Sensor Shut-Off) 77 Temporary Shut Down 71, 117 Troubleshooting 111, 115Settings, Alerts 29, 87Settings, Receiver 25, 81 Date and Time 27, 83 Transmitter ID 28, 84Setup Wizard 25Specifi cations, Product 145Startup Period 44Status Area 66, 114 Gray Zone 59 Symbols Calibration Needed Glucose Reading 48, 52, 67, 157 Glucose Reading Error 67, 68 Out of Range 67, 69, 161 15 Minute Calibration Error 53, 67, 157 1 Hour Calibration Error 53, 67, 157Troubleshooting 111Storage, System 122Symbols, Labeling 166TTape 44, 111Transmitter 5 Attaching to Sensor 40 ID Number 25, 28, 84 Setting 25, 28, 84 Latch 15, 36 Overview 16 Removal 79 Safety-Lock/Transmitter Key 15, 79
170 | Continuous Glucose Monitoring SystemindexWWater Resistance 44, 122, 167
LBL-010797 Rev 01 MT21202 Stay Between the Lines® DexCom, INC6340 Sequence Drive,San Diego, CA 92121 USA+1.858.200.0200www.DexCom.com

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