Dexcom 9495 Wireless glucose monitor User Manual

Dexcom, Inc. Wireless glucose monitor Users Manual

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1 USER’S GUIDE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM IMPORTANT CONTACTS AND NUMBERS Dexcom® Website: www.dexcom.com Your Transmitter ID: Your Receiver ID: Your Healthcare Professional: Nearest Hospital: © 2014 Dexcom, Inc. All rights reserved. Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom Studio, SEVEN, Stay Between the Lines and Dexcom Makes Sense are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries. All other product or company names that may be mentioned in this publication are tradenames, trademarks or registered trademarks of their respective owners.

2 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM table of contents [Page numbering will be updated after professional layout] GLOSSARY 6 CHAPTER 1: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION 9 1.1 System Contents 11 1.2 Introduction 12 1.3 Sensor Overview 13 1.4 Transmitter Overview 14 1.5 Receiver Overview 15 1.6 Share Overview CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT 17 2.1 INDICATIONS FOR USE 19 2.2 IMPORTANT USER INFORMATION 19 2.3 CONTRAINDICATIONS 20 2.4 WARNINGS 20 2.5 PRECAUTIONS 22 2.6 CAUTION 24 CHAPTER 3: RISKS AND BENEFITS 25 3.1 Risks 27 3.2 Benefits 28 CHAPTER 4: CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU 31 4.1 Charging Your Receiver Battery 33 4.1.1 Charging Your Receiver Battery from an AC Power Outlet 34 4.1.2 Charging Your Receiver Battery from a Windows Compatible Computer 35 4.1.3 Knowing Your Receiver is Charged 36 4.2 Receiver Menu Options 36 CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUP 39 5.1 Setting Up the Receiver and Pairing with Your Transmitter 41 5.2 The Settings Menu 43 5.2.1 Getting to the Settings Menu 43 5.2.2 Setting Your Receiver Time and Date 43 5.2.3 Entering Your Transmitter ID 5.2.4 Turning On Share On Your Receiver 44 5.3 Checking Information About Your Dexcom G4 PLATINUM System 45 5.4 Transmitter and Receiver Communication 46

4 10.1.1 Selecting an Event 107 10.1.2 Setting the Date and Time for an Event 108 10.1.3 Carbohydrates 109 10.1.4 Insulin 110 10.1.5 Exercise 111 10.1.6 Health 112 10.2 Dexcom Studio Software 113 CHAPTER 11: ENDING A SENSOR SESSION 115 11.1 Automatic Sensor Shut-Off 117 11.2 Removing a Sensor 118 11.3 Transmitter Removal 119 CHAPTER 12: TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM 121 12.1 Maintenance 123 12.2 Storage 123 12.3 Product Disposal 124 CHAPTER 13: TROUBLESHOOTING 125 13.1 Sensor Insertion Troubleshooting 127 13.2 Calibration Troubleshooting 128 13.2.1 Types Of Calibration Prompts 129 13.2.2 What To Do For Calibration Prompts 130 13.3 Calibration Error Troubleshooting 130 13.4 System Glucose Error 131 13.5 Sensor Inaccuracies 132 13.6 Sensor Shut-Off Troubleshooting 134 13.6.1 Early Sensor Shut-Off - Sensor Failure 134 13.6.2 Manual Sensor Shut-Off - “Stop Sensor” 135 13.7 Share Pairing Error Troubleshooting 136 13.8 Battery and Charger Troubleshooting 136 13.9 Receiver and Transmitter Communication Troubleshooting 137 13.9.1 System Recovery Check 137 13.9.2 Receiver Error Code 137 13.9.3 Low Transmitter Battery 138 13.9.4 Transmitter Failed Error Code 138 13.10 Out of Range/No Antenna 138 13.11 Alerts Are Not Working 139 CHAPTER 14: TECHNICAL INFORMATION 141 14.1 Device Performance Characteristics 143 14.2 Product Specifications 162 14.3 FCC Requirements 175 CHAPTER 15: USER ASSISTANCE 177 CHAPTER 16: WARRANTY 181 CHAPTER 17: TRAVEL INFORMATION 189

5 CHAPTER 18: APPENDIX 193 Appendix I, Receiver Alerts, Alarm and Prompt 195 Appendix II, Index 204 Appendix III, Symbols Used in Labeling 209

6 GLOSSARY Alternative Site BG Testing This is when you take a blood glucose value on your meter using a blood sample from an area on your body other than your fingertip. Do not use alternative site testing to calibrate your receiver. Applicator A disposable piece that comes attached to the sensor pod and inserts the sensor under the skin. There is a needle inside the applicator that you remove after you insert the sensor. BG Meter Blood glucose meter. A device used to measure how much glucose is in the blood. You can use any commercially available meter for testing your blood glucose. BG Value Blood glucose value. The measurement of glucose in the blood. A blood glucose value taken with your commercially available blood glucose meter. Bluetooth Bluetooth® wireless technology allows devices to wirelessly communicate with each other. In this case, communication between the Receiver and your iPhone / iPod touch device. Calibration When you enter blood glucose values from a blood glucose meter into the receiver. Calibrations are needed for your receiver to show continuous sensor glucose readings and trend information. (Do not use alternative site testing for calibration). CGM Continuous Glucose Monitoring.Commercially Available Product that may be sold in the United States.Default A setting that is selected automatically, unless you choose another option.Dexcom G4 PLATINUM System The sensor, transmitter, and receiver.Dexcom Share System Secondary notification system to the Dexcom G4 PLATINUM System. For more information, please refer to the Dexcom Share User Manual. Glucose Data Gaps Different symbols show on the trend graph instead of a sensor glucose reading to let you know that the receiver cannot provide a reading. Glucose Trends Trends let you see the pattern of your glucose levels. The trend graph shows where your glucose levels have been during the time shown on the screen and where your glucose levels are now. Hypoglycemia Low blood glucose. Same as “low.” The default low alert in your receiver is set to 80 mg/dL. Consult your healthcare provider to determine the appropriate hypoglycemic setting for you. Hyperglycemia High blood glucose. Same as “high.” The default high alert in your receiver is set to 200 mg/dL. Consult your healthcare provider to determine the appropriate hyperglycemic setting for you.

8 wirelessly sends glucose information to your receiver.Transmitter ID A series of numbers and/or letters that you enter into your receiver to let it communicate with the transmitter. Transmitter Latch The small, disposable piece 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 show how fast your glucose levels are changing. There are 7 different arrows that show when your glucose speed and direction change.

9 CHAPTER 1: DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION 1.1 SYSTEM CONTENTS: • sensor • transmitter • receiver • receiver USB charging/download cable • AC power adapter - MT21255 • receiver case • user’s guide • quick start guide • training checklist • tutorial disc • Dexcom Studio® software (available for download online at www.dexcom.com) Sensors are sold separately. Commercially distributed blood glucose (BG) meter required for use. PRECAUTION The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN®/SEVEN® PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also, make sure to use the correct version of Dexcom Studio with your system. 1.2 INTRODUCTION When you use the system, you will see continuous sensor glucose readings updated every 5 minutes for up to 7 days. These readings will help you notice trends and patterns in your glucose levels. The system includes the sensor, the transmitter, and the receiver. The sensor is a disposable unit that you insert under the skin of your abdomen (belly) to continuously monitor your glucose levels for up to 7 days. The transmitter is a reusable device that wirelessly sends your sensor’s glucose information to your receiver. The receiver is a hand-held device that receives and displays your glucose information.

10 Please read this user’s guide closely. It describes how to use your system. In addition, Dexcom has a self-guided training tutorial for the Dexcom G4 PLATINUM CGM System. Some people have found this to be an effective method of product training. Please review the tutorial on the disc and discuss with your healthcare professional to decide if the Dexcom G4 PLATINUM System Tutorial is a good training option for you. The tutorial disc can only be used with your computer and cannot be used in DVD players. The tutorial is also found on the Dexcom website – www.dexcom.com. 1.3 SENSOR OVERVIEW The sensor is the piece that comes in a sterile, sealed sensor pouch. The sensor is made up of an applicator, a sensor pod, and a sensor wire. You remove the applicator after insertion. The sensor pod stays on your belly for the entire sensor session, up to 7 days. The pod is made of plastic and an adhesive patch. The sensor wire is thin and flexible, and inserts just under the skin of your belly. It is attached to the sensor pod, and is made of silver and platinum metal with polymer membranes. You discard the sensor at the end of the session. See Chapter 14 for Product Specifications. 1.4 TRANSMITTER OVERVIEW The transmitter is the gray, plastic “chip” that snaps into your sensor pod. The 9438-01 transmitter (including sensor pod) is 1.5 inches long, 0.9 inches wide and 0.5 inches thick. The 9438-05 transmitter (including sensor pod) is 1.5 inches long, 0.9 inches wide and 0.4 inches thick. Once snapped into the sensor pod, the transmitter wirelessly sends your glucose information to the receiver. The transmitter and sensor are water resistant when properly connected. Do not throw away your transmitter. It is reusable. The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water, so the range is much less if you are in a pool, bathtub or water bed. The transmitter battery will last at least 6 months. Once you see the transmitter low battery screen, replace the transmitter as soon as possible. Your transmitter battery may drain as quickly as one week after this alert appears.

11 See Chapter 14 for Product Specifications. 1.5 RECEIVER OVERVIEW The receiver is the small hand-held device that looks like a cell phone. It is about 4 inches long, 1.8 inches wide and 0.5 inches thick. It shows your sensor glucose readings, trend graph, direction and rate of change arrow. Do not spill fluids on the receiver or drop the receiver into fluids. Keep the micro USB port door closed to help prevent fluid and dust from getting inside the receiver. The trend graph screen on your receiver shows your sensor glucose readings, trend graph, direction and rate of change arrow. There are five receiver buttons to move you through the screens. The trend graph screens show sensor glucose readings, trend graphs and trend arrows. The receiver menu screens let you change your receiver settings. Your receiver and transmitter wirelessly pair together to communicate securely and only with each other. You will need a commercially available blood glucose meter to use with your system. See Section 14 for Product Specifications.

12 Receiver buttons: • Press the UP and DOWN buttons to scroll through trend screens, highlight menu items, or set values. • Press the SELECT button to turn the receiver on or select the highlighted option. • Press the LEFT button to go back to the last item or screen. • Press the RIGHT button to highlight the next item. 1.6 SHARE OVERVIEW Dexcom Share™ remote monitoring system lets one person, the Sharer, transfer Dexcom G4 PLATINUM Continuous Glucose Monitoring information to another person, the Follower. Learn more about Dexcom Share by reading the Dexcom Share User Manual.

13 CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT 2.1 INDICATIONS FOR USE The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription. The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The Dexcom G4 PLATINUM System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the Dexcom G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time. 2.2 IMPORTANT USER INFORMATION Please review your product instructions before using your continuous glucose monitoring system. Contraindications, warnings, precautions, cautions, and other important user information can be found in your product instructions. Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes. Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device. 2.3 CONTRAINDICATIONS Remove the Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the device into the MR environment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value. • Taking medications with acetaminophen (such as Tylenol®) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person. 2.4 WARNINGS • Thoroughly review the training materials included with your CGM system before using the Dexcom G4 PLATINUM CGM System. Incorrect use might lead to you misunderstanding the information provided by your system, or might affect system performance, and you might miss a low or high blood glucose value. • Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a

$14 blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value. • Do not ignore symptoms of high and low glucose. If your sensor glucose readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range, so you do not miss a low or high blood glucose value. • Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. • 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 inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200. • The Dexcom G4 PLATINUM System is not approved for use in children or adolescents, pregnant women or persons on dialysis. • It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Therefore, the use of this system in the critically ill population is not recommended. • Sensor placement and insertion is not approved for sites other than the belly (abdomen). • If your transmitter or receiver case is damaged/cracked, do not use it. This could create an electrical safety hazard or malfunction, which might cause electrical shocks. • Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. 2.5 PRECAUTIONS • Before opening the sensor package, wash your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor. • Before inserting the sensor, clean the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allow to dry. This may help prevent infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better. • Change the site where you place the sensor with each insertion. Using the same site too often might not allow the skin to heal, and might cause scarring or skin irritation. • Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure$

15 glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high blood glucose value. • Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor. The insulin might affect sensor performance, and you might miss a low or high blood glucose value. • Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection. • To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value. • Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising single arrow or double arrow, which indicates that your blood glucose is rising 2-3 mg/dL/min or more than 3 mg/dL/min. Also, do not calibrate when your receiver screen is showing the falling single arrow or double arrow, which indicates that your blood glucose is falling 2-3 mg/dL/min or more than 3 mg/dL/min. Calibrating during significant rise or fall of blood glucose may affect accuracy of sensor glucose readings. • The system accuracy may be affected when your glucose is changing at a significant rate (e.g., 2-3 mg/dL/min or more than 3 mg/dL each minute), such as during exercise or after a meal. • The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and you might miss a low or high blood glucose value. • Keep the USB port cover on the receiver closed whenever the USB cable is not attached. If water gets into the USB port, the receiver could become damaged and stop displaying readings or providing alerts, and you might miss a low or high blood glucose value. • Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor performance, and you might miss a low or high blood glucose value. • Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.

16 • The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also make sure to use the correct version of Dexcom Studio with your system. 2.6 CAUTION U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM System to sale by or on order of a physician.

17 CHAPTER 3: RISKS AND BENEFITS 3.1 RISKS There are some known risks with using real-time CGM. You will not get sensor glucose alerts when the alert function is turned off, your transmitter and receiver are out of range, or when your receiver is not showing sensor glucose readings. You might not notice alerts if you are unable to hear them or feel the vibration. Sometimes your sensor glucose reading may be slightly different than your blood glucose meter. For example, your blood glucose meter may show a blood glucose value of 78 mg/dL, but your sensor glucose reading may show as 82 mg/dL. If your low alert is set at 80 mg/dL, your system will not alert for a low glucose at this time because 82 mg/dL is still above your low alert setting. In most cases, the sensor glucose readings will move in the right direction and will alert you of a high or low shortly after. If you do not get an alert for any reason, and you do not take frequent blood glucose measurements with your blood glucose meter, you might not be aware of low or high blood glucose levels. If this happens, and your blood glucose levels are very high or low, there is a remote chance you might need medical help. Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration). There is a low chance of this happening. In the clinical study for the Dexcom G4 PLATINUM System, only slight redness and swelling occurred in a few patients. If any of these events happen, you might feel discomfort in the area the sensor is inserted. There is a remote chance that a sensor fragment could remain under your skin if the sensor breaks while you are wearing it. This did not happen in the clinical study for the Dexcom G4 PLATINUM System. If you think a sensor has broken under your skin, contact your healthcare provider and call Dexcom’s Technical Support. Sensor breakage may cause some anxiety, but it is not a significant medical risk. 3.2 BENEFITS Real-time CGM provides benefits beyond the information you get from a blood glucose meter. It provides glucose readings every five minutes for up to seven days to help you detect trends and patterns in your glucose levels. This trend information can help you see where your glucose is now as well as where your glucose may be heading and how fast you may be getting there. Understanding your glucose trends may help you take action to help avoid high or low glucose values.

18 Alerts and the low alarm tell you when your glucose is outside of your target glucose range and may help you avoid low and high blood sugar. Rise and fall glucose alerts can also provide benefit by alerting you when your glucose is rapidly going down or up. This way you can be alerted to this information before you are too high or too low and take action to avoid it. Real-time CGM can help increase time in your target glucose range without increasing your time in the low or high glucose range.1 Real-time CGM can help improve diabetes control (lower A1c values, reducing glycemic variability and time spent in low and high blood glucose ranges)1, 2 , 3 which can help reduce diabetes related complications.4, 5 These benefits can be seen especially with using real-time CGM at least 6 days per week2 and can be sustained over time.6 In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM as well as reporting a high satisfaction with CGM.7 1 Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006; 29:44-50. 2 JDRF CGM Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. NEJM 2008;359:1464-76. 3 Battelino. Effect of continuous glucose monitoring of hypoglycemia in type 1 diabetes. Diabetes Care 2011; 34(4): 795-800. 4 The Diabetes Control and Complications Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus. N Eng J Med. 1993; 329:997-1036. 5 Ohkubo Y, Kishikawa H, Araki E, et al. Intensive insulin therapy prevents progression of diabetic microvascular complications in Japanese patients with non-insulin dependent diabetes mellitus: a randomized prospective 6-year study. Diabetes Res Clin Pract. 1995; 28:103-117. 6 JDRF CGM Study Group. Sustained Benefit of Continuous Glucose Monitoring on A1c, Glucose Profiles, and Hypoglycemia in Adults With Type 1 Diabetes, Diabetes Care 2009; 32: 2047-2049. 7 JDRF CGM Study Group. Quality-of-Life Measures in Children and Adults With Type 1 Diabetes. Diabetes Care 2010; 33: 2175-2177.

19 CHAPTER 4: CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU 4.1 CHARGING YOUR RECEIVER BATTERY The receiver battery is rechargeable and will last about 3 days with normal use before you need to charge it. Your battery life depends on how often you press your receiver buttons or get alerts. The receiver will tell you when the battery charge is low. Charge the receiver battery using one of these options: • Section 4.1.1: an AC power outlet • Section 4.1.2: a personal computer with Windows® operating system (to charge your receiver from your PC, Dexcom Studio must be installed. For system requirements and more information, see the Dexcom website (www.dexcom.com) or the Dexcom Studio Software User’s Guide.) Only use the Dexcom battery charger provided in the receiver kit. Do not use any other battery charger. Charge only from a USB port on your computer or the AC power adapter. Do not use an external USB hub. An external USB hub may not provide enough power to charge the receiver. Fully charging an empty battery takes about 3 hours with the wall charger and about 5 hours with a computer. The battery does not need to be drained to charge fully. You may use the receiver while it is charging with an AC power outlet or PC. Charge your receiver battery before each sensor insertion. Periodically check your battery level to make sure it has enough charge. If your battery drains, it will keep the time and date for 3 days without being charged. After 3 days, the receiver will prompt you to reset the time and date (see Chapter 5, Section 5.2, The Settings Menu). When the receiver is used in a healthcare facility, charging must take place away from the patient. WARNING It is not known how different conditions or medications common to the critically ill population may affect the performance of the system. Therefore, the use of this system in the critically ill population is not recommended. 4.1.1 CHARGING YOUR RECEIVER BATTERY FROM AN AC POWER OUTLET To recharge your battery:

20 1. Plug the included USB cable into the AC power adapter. 2. Plug the AC power adapter into an AC power outlet. 3. Slide open the USB port cover on the side of the receiver to reach the port. Press down firmly with your thumb when sliding open the USB port cover. 4. Plug the micro USB end of the cable into the receiver USB port. Keep the USB port cover on the receiver closed whenever the USB cable is not attached. 5. The battery charging screen will show on the receiver. 6. After a few seconds the trend graph will show with the battery charging symbol ( ) in the upper left corner. 4.1.2 CHARGING YOUR RECEIVER BATTERY FROM A WINDOWS COMPATIBLE COMPUTER You must install the Dexcom Studio software to charge your receiver from a computer. Please see the Dexcom Studio installation card for driver installation instructions. 1. Plug the included USB cable into your computer. 2. Plug the other end of the USB cable into the receiver. 3. The battery charging screen shows on the receiver.

21 4. After a few seconds, the trend graph screen will show the battery charging symbol in the upper left corner. 4.1.3 KNOWING YOUR RECEIVER IS CHARGED As the battery charges, the battery charging symbol fills in. When the battery is fully charged, the battery charging symbol is completely shaded. 4.2 RECEIVER MENU OPTIONS The receiver’s Main Menu lets you scroll through important menu options. This table explains the purpose of each option. More information on Main Menu options can be found in the chapters listed: Receiver Main Menu Options Menu Purpose User’s Guide Reference Trend Graph To show the trend graphs. • The 3-hour trend graph is the default screen whenever you turn on the receiver. Chapter 8 Start Sensor To start a new sensor session. • This option only shows if you have entered a transmitter ID and you are not in the middle of a sensor session Chapter 6 Enter BG To enter your blood glucose values for calibration. Chapter 7

22 Profiles Profiles allow you to customize the sound and volume of alerts and alarm. Chapter 9 Events To enter personal information about meals, insulin, exercise, and health status. Chapter 10 Alerts, High/Low To change the settings for high and low alerts. Chapter 9 Settings To change the time, date and transmitter ID; to turn on the Share feature; to look up your Dexcom G4 PLATINUM System hardware and software version numbers; to view transmitter battery status, last calibration value and sensor insertion time. Chapter 5 Shutdown To temporarily turn off all communication between your transmitter and receiver during a sensor session. You will not get sensor glucose readings, and it will not extend the life of your sensor. Chapter 6 Stop Sensor To end a sensor session early. • This option only shows when you are in the middle of a sensor session. You will not get sensor glucose readings, and you must dispose of your sensor if you stop the session. Chapter 13 See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts, for a list of screens that may show on the receiver.

23 CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUP This chapter helps you when you first set up your Continuous Glucose Monitoring system. Read this chapter before you start. 5.1 SETTING UP THE RECEIVER AND PAIRING WITH YOUR TRANSMITTER The Setup Wizard guides you through setup the first time you turn on your receiver. 1. Remove the transmitter from its packaging. Wait 10 minutes for the transmitter to turn on before setting up the receiver. 2. Make sure your receiver is fully charged (see Chapter 4, Section 4.1, Charging Your Receiver Battery). 3. Press the SELECT button on the receiver to turn it on. The Setup Wizard will guide you to enter the following setup information: a. Set the time and date. The date format is YYYY/MM/DD. (1) Press the UP or DOWN button to enter the current date and time. (2) Press the RIGHT or SELECT button to move to the next section. (3) Press the SELECT button to confirm time and date. b. Enter your transmitter ID. (1) Press the UP or DOWN button to enter your transmitter ID. (2) Press the RIGHT or SELECT button to move to the next space. (3) Press the SELECT button to confirm the transmitter ID. Your transmitter ID is a unique code with 5 numbers and/or letters found in the following locations: • On the transmitter box label • On the bottom of the transmitter c. Set your low and high glucose alert values. Your low and high glucose alerts are pre-set to 80 mg/dL and 200 mg/dL but can be changed.

24 (1) Press the UP or DOWN button to select your alert level. The low alert can be changed in steps of 5 mg/dL and the high alert can be changed in steps of 10 mg/dL. (2) Press the SELECT button to confirm your alert level. • You can also change your alert levels in the Alerts menu. • The unit of measure (mg/dL) is not adjustable. • If you need to change the time, date or transmitter ID after you complete the Setup Wizard see Section 5.2, The Settings Menu. The Setup Wizard is now complete. To start using your Dexcom G4 PLATINUM CGM System you must insert a sensor (see Chapter 6, Inserting a Sensor and Starting a Sensor Session). 5.2 THE SETTINGS MENU The Settings menu lets you change the time, date or transmitter ID. The Setup Wizard only works the first time you turn on your receiver, but you can always use the Settings menu. 5.2.1 GETTING TO THE SETTINGS MENU 1. Press the SELECT button to turn on the receiver. The 3-hour trend graph shows. 2. Press the SELECT button to see the Main Menu. 3. From the Main Menu, press the UP or DOWN button to scroll to “Settings” and press the SELECT button. The Settings menu shows: 5.2.2 SETTING YOUR RECEIVER TIME AND DATE 1. From the Settings menu, press the UP or DOWN button to scroll to “Time/Date,” and press the SELECT button.

25 2. Press the RIGHT or SELECT button to highlight each value in the date and time. 3. Press the UP or DOWN button to make any changes. 4. Press the RIGHT button to move to the next value. The date format is YYYY/MM/DD. 5. Press the SELECT button after choosing “AM” or “PM.” You will return to the Settings menu. You might need to reset the receiver’s time and date if the rechargeable battery drains. If this happens, the receiver will alert you and automatically take you to the Time/Date setting screen. 5.2.3 ENTERING YOUR TRANSMITTER ID Any time you switch to a new transmitter and/or receiver you must enter the transmitter ID into your receiver. The transmitter ID is a series of 5 numbers and/or letters that can be found in the following locations: • On the transmitter box label • On the bottom of the transmitter If you cannot find your transmitter ID, please contact Dexcom Technical Support (see Chapter 15, User Assistance). You can only set your transmitter ID when you are not in a sensor session. During a sensor session, “Transmitter ID” will not be an option on the Settings menu. To enter the transmitter ID follow these steps: 1. From the Settings menu, press the UP or DOWN button to scroll to “Transmitter ID” and press the SELECT button.

26 2. Start with the first number or letter (do not enter “SN”): a. Press the UP or DOWN button to show the correct number or letter. b. Press the RIGHT button to move to the next value and repeat step a. c. Continue repeating steps a and b to enter the whole transmitter ID. d. Press the SELECT button after you enter the last number or letter. You will return to the Settings menu. NOTE: The “Transmitter ID” menu option is marked with an antenna symbol as a graphical flag; it does not tell you whether the transmitter and receiver are communicating. The “Transmitter ID” menu option only shows when you are not in a sensor session. See Section 5.4 for the antenna symbol that shows whether the transmitter and receiver are communicating. 5.2.4 TURNING ON SHARE ON YOUR RECEIVER Please see the Pairing Receiver section in Chapter Two of your Dexcom Share User Manual to learn how to turn on the Share feature on your Receiver with Share. 5.3 CHECKING INFORMATION ABOUT YOUR DEXCOM G4 PLATINUM SYSTEM You can check your receiver for information about your CGM system at any time. 1. From the Settings menu, press the UP or DOWN button to scroll to “Device Info.”

27 2. Press the SELECT button. Information about your sensor session and system will show. 3. Scroll down to see all of the Device Info: • Insertion Time • Last Calibration • Transmitter Battery • Transmitter ID • Serial Number • Part Number • Part Revision • Software Number • Software Revision 4. Press the LEFT button to return to the Settings menu. 5.4 TRANSMITTER AND RECEIVER COMMUNICATION When you are in a sensor session, you can check that the receiver and transmitter are communicating. CONTRAINDICATION Remove the Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.

28 PRECAUTION The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested. If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and you might miss a low or high blood glucose value. Press the SELECT, LEFT or RIGHT button to see the trend graph. This antenna symbol shows that the transmitter and receiver are communicating. This out of range symbol shows the transmitter and receiver are not communicating.

$29 CHAPTER 6: INSERTING A SENSOR AND STARTING A SENSOR SESSION You need a sensor, a transmitter, and a receiver to use your Dexcom G4 PLATINUM Continuous Glucose Monitoring System. You also need a blood glucose meter and test strips for calibration. The blood glucose meter and test strips are not provided in the Dexcom G4 PLATINUM System. The sensor continuously measures and displays your sensor glucose readings for up to 7 days. The following sections will show you how to insert the sensor and start a new continuous glucose monitoring session. Please review the tutorial on the disc in your kit. The tutorial is also available online at www.dexcom.com. WARNING 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 inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200. For patients undergoing an MRI with a retained wire broken off from a Dexcom G4 PLATINUM Sensor, in-vitro MRI testing did not detect any safety hazards. There was no significant migration or heating of the wire and imaging artifacts were limited to the area around the wire. 6.1 BEFORE YOU START • Make sure the correct transmitter ID has been entered into your receiver (see Chapter 5, Section 5.2, The Settings Menu). You do not need to re-enter the transmitter ID each time you start a sensor session. • Check the expiration date on the sensor package label. The format is YYYY-MM-DD. Insert sensors on or before the end of the expiration date calendar day. • Follow your blood glucose meter’s manufacturer’s instructions to make sure you are getting accurate blood glucose values for calibration. • Wipe the bottom of the transmitter with a damp cloth or isopropyl alcohol wipe. Place the transmitter on a clean, dry cloth, and air dry for 2-3 minutes. • Make sure your blood glucose meter and receiver date and time match. WARNING Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. Review the sensor applicator picture before using a new sensor.$

30 6.2 REMOVING THE SENSOR FROM ITS PACKAGING PRECAUTION Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection. • Wash your hands thoroughly, and dry them. • Carefully remove the sensor from its packaging. Look closely at the sensor to make sure it is not damaged. • The applicator is for single use and is disposable. • The safety lock prevents you from releasing the needle accidentally before you are ready. 6.3 CHOOSING AN INSERTION SITE PRECAUTION • Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high blood glucose value. • Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor. The insulin might affect sensor performance, and you might miss a low or high blood glucose value. Review the tutorial disc for more help to learn how to insert your sensor. Choose a site on 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 flat, “pinchable,” and free from where rubbing can occur, such as along the waist band and seat belt strap. • Choose an area at least 3 inches from your insulin pump infusion set or injection site.

31 • 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 the adhesive patch sticks securely. • Make sure there are no traces of lotions, perfumes or medications on the area. 6.4 PLACING THE SENSOR WARNING Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value. 1. Clean your skin at the sensor placement site with an alcohol wipe. Make sure the area is clean and completely dry before you insert the sensor. 2. Remove the adhesive backing from the sensor pod one half at a time, using the white tabs on the backing. Hold the sensor by the applicator barrel, and try not to touch the sticky adhesive patch. 3. Place the sensor horizontally, NOT vertically, on your skin. 4. Move your fingers around the adhesive patch to secure the tape to your skin. 5. Hold the applicator, and pull the safety lock straight out away from the applicator, in the direction of the arrows in the picture.

32 6. Save the safety lock to help you remove the transmitter at the end of your sensor session. The safety lock can be used for transmitter removal but is not required. When your glucose monitoring session is over, follow the steps in Chapter 11, Section 11.3, Transmitter Removal, with or without the safety lock. 6.5 SENSOR INSERTION You are ready to insert the sensor after you place the applicator on your belly and remove the safety lock. To insert your sensor follow these steps: 1. Place the fingers of one hand at the edge of the white adhesive (at the opposite side of the sensor from the transmitter latch). You may pinch up on your skin using this hand. Do not pinch up in the middle section of the plastic base. 2. While still pinching, use your other hand to place two fingers above the collar on the applicator barrel so they are resting above the collar. 3. Place your thumb on the white plunger. Push the plunger down completely, making sure it is flush against the applicator barrel. You should hear 2 clicks. This inserts the needle and sensor under your skin. When you are pushing down on the plunger, do not pull back on the collar. 4. Keep pinching up on your skin with one hand. With your other hand, place two fingers under the collar. Keep your thumb lightly on top of the white plunger, and pull the collar back towards your thumb until you hear 2 clicks or cannot pull back any more. This leaves the sensor under your skin and removes the needle from your body.

33 5. Squeeze the center of the ribbed release tabs on the sides of the sensor pod to remove the applicator barrel. Only the sensor pod will be left on your body. • Make sure the transmitter latch is down (against your body) before squeezing the tabs to remove the applicator barrel. • Squeeze the center of the ribbed part of the release tabs. • While squeezing the tabs, rock the applicator barrel forward and out away from your body. If you have any problems with insertion, save the sensor and applicator and contact Dexcom Technical Support (see Chapter 15, User Assistance). 6.6 TRANSMITTER ATTACHMENT You must snap the transmitter into the sensor pod after you insert your sensor. Follow these steps to attach your transmitter. 1. Wipe and dry the bottom of the transmitter with a damp cloth or an alcohol wipe before every use. Do not to touch the metal circles on the bottom of the transmitter with your skin. Do not to scratch the bottom of the transmitter as scratches may compromise the waterproof seal. 2. Place the transmitter in the sensor pod (with the flat side down, and the narrower side away from the transmitter latch). 3. Snap in the transmitter: a. With one hand, you may want to pinch up on your skin at the front edge of the white adhesive. b. Place one finger on the transmitter to keep it in place. c. With your other hand, pull the transmitter latch up and forward, over the transmitter, to snap it into place. The transmitter should lie flat in the sensor pod.

34 • Make sure you hear 2 clicks when you snap the transmitter in place. If it is not fully snapped in, this may lead to a poor connection and let fluids to get under the transmitter. This can lead to inaccurate sensor glucose readings. d. Release your pinch on the adhesive edge at this time. e. Make sure the transmitter is secure by sliding your fingers under each long side of the sensor pod and pressing down on the transmitter with your thumb of the same hand, like you are pinching it. 4. Hold the sides of your sensor pod with one hand. Remove the transmitter latch with your other hand by quickly twisting off the latch away from your body. 5. Do not remove the transmitter from the sensor pod while the pod is attached to your skin. 6.7 STARTING A SENSOR SESSION Follow the steps below to tell the receiver that you inserted a new sensor. 1. Press the SELECT button to turn on the receiver. 2. From any trend graph, press the SELECT button to see the Main Menu. 3. Press the DOWN button to highlight “Start Sensor.” • The “Start Sensor” menu option will disappear from the main menu after you select it. The option will only come back after an active sensor session ends. If you do not see the “Start Sensor” option on your menu screen, you can continue your current session or stop the session (refer to Chapter 13, Section 13.6, Sensor Shut-off Troubleshooting).

35 4. Press the SELECT button to confirm the start of a new sensor session. The Start Sensor “thinking” screen lets you know your sensor 2-hour startup has begun. 5. Your receiver returns to the 3-hour trend graph. 6. Check your receiver 10 minutes after starting your sensor session to make sure your receiver and transmitter are communicating. The antenna symbol should be in the upper left corner of trend graph. If the out of range symbol shows in the upper right corner of the trend graph, see Chapter 13, Section 13.9, Out of Range/No Antenna. 7. You will not get sensor glucose readings or alerts until your 2-hour startup period ends and you complete your first calibrations. See Chapter 7, Section 7.3, Startup Calibration. 6.8 SENSOR STARTUP PERIOD The sensor needs a 2-hour startup period to adjust to being under the skin. Your trend graph shows a 2-hour countdown symbol in the upper right corner. 1. Press SELECT during the startup period to turn the on receiver display and see this symbol.

36 The countdown symbol fills in over time to show that you are getting closer to the first calibration time. You will not get sensor glucose readings, alerts and alarm during the countdown. If you see the out of range symbol at the top of the screen during the 2-hour startup, review the following troubleshooting tips: • Make sure your receiver and transmitter are within 20 feet of each other without obstruction. Check in 10 minutes to see if the antenna symbol shows in the upper left corner of the receiver screen. • If the receiver and transmitter are still not communicating, check the device information screen to make sure the correct transmitter ID is entered into your receiver (see Chapter 5, Section 5.2, The Settings Menu). • If the correct transmitter ID is in your receiver and the receiver and transmitter are still not communicating, contact Dexcom Technical Support (see Chapter 15, User Assistance). At the end of the 2-hour startup period the receiver lets you know it is time to calibrate your sensor. Chapter 7, Calibrating Your Dexcom G4 PLATINUM System, tells you how to calibrate your sensor. 6.9 TAPING THE SENSOR POD The sensor pod should stay on your skin using its own adhesive. But, if the patch is peeling up, you can use medical tape (such as Blenderm, Tegaderm, IV 3000, 3M tape) 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 sensor. 6.10 TEMPORARY RECEIVER SHUTDOWN There may be times when you want to shut down your receiver temporarily. Shutdown stops all communication between the transmitter and receiver and turns the receiver off. You will not receive sensor glucose readings or any alerts or alarm while the receiver is shut down, but your current sensor session will continue. Follow these steps to shut down your receiver: 1. From the Main Menu, scroll to highlight “Shutdown.” Press the SELECT button.

37 2. Confirm that you want to shut down your receiver. a. If you want to shut down, press the LEFT 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. 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. Remember that your alerts and low glucose alarm will not work when the receiver is shut down. Shutting down the receiver does not extend the sensor life beyond 7 days. Your sensor session will stop 7 days after you started the sensor session. 6.11 THE DEXCOM G4 PLATINUM SYSTEM AND WATER Your sensor is water resistant when showering, bathing or swimming if the transmitter is fully snapped in. The sensor has been tested to be water resistant when submerged for up to 8 feet and up to 24 hours. Keep the receiver dry. Do not spill fluids on it or drop it into fluids. Keep the micro USB port cover closed to help prevent fluid from getting inside the receiver. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub or water bed. If your receiver gets wet, make sure the speaker and vibrate mode are still working. You can do this using the Try It option in the Profiles menu. See Chapter 9, Section 9.3, Alert Profiles.

38 CHAPTER 7: CALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEM You must calibrate Dexcom G4 PLATINUM System sensor glucose readings to your blood glucose meter. CONTRAINDICATION Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person. 7.1 CALIBRATION OVERVIEW Your receiver needs calibrations to display continuous sensor glucose readings and trend information. There are important times when you must calibrate: 1. 2-hour startup: 2 hours after you insert your sensor 2. 12 hour update: every 12 hours after the 2-hour startup calibration 3. More information needed or other reasons When calibrating, you must enter your blood glucose values into the receiver by hand. You can use any commercially available blood glucose meter. You must calibrate with accurate blood glucose meter values to get accurate sensor glucose readings. On the first day of your sensor session, you must enter 2 blood glucose values into your receiver. You must enter 1 blood glucose value calibration 12 hours after your startup calibration. You must enter 1 blood glucose value every 12 hours. The receiver will remind you when it needs these calibrations. You may be prompted to enter additional blood glucose values as needed.

39 PRECAUTION Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor performance, and you might miss a low or high blood glucose value. 7.2 HOW TO CALIBRATE You must enter the exact blood glucose value from your meter for each calibration. Blood glucose values must be between 40-400 mg/dL and must have been taken within the past 5 minutes. • Make sure either a sensor glucose reading or a calibration needed symbol shows at the top of the trend graph before calibrating. • Your sensor can be calibrated if your meter glucose is 40 mg/dL or above. For safety reasons, if your blood glucose is low, first treat your low blood sugar. • Always make sure the antenna symbol is in the upper left corner of the trend graph before you enter blood glucose values for calibration. • Always use the same meter to calibrate that you routinely use to measure your blood glucose. Do not switch your meter in the middle of a sensor session. Blood glucose meter and strip accuracy vary between blood glucose meter brands. • The accuracy of the blood glucose meter value used for calibration may affect the accuracy of sensor glucose readings. WARNING Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. PRECAUTION Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising single arrow or double arrow, which indicates that your blood glucose is rising 2-3 mg/dL/min or more than 3 mg/dL/min. Also, do not calibrate when your receiver screen is showing the falling single arrow or double arrow, which indicates that your blood glucose is falling 2-3 mg/dL/min or more than 3 mg/dL/min. Calibrating during significant rise or fall of blood glucose may affect accuracy of sensor glucose readings.

40 PRECAUTION To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value. Only use blood glucose values between 40-400 mg/dL for calibration. If the blood glucose value you enter is outside of this range, the receiver will not calibrate. You must wait until your blood glucose is in this range to calibrate. These steps show you how to enter your blood glucose values for calibration: 1. Wash and dry your hands, make sure your glucose test strips are not expired and have been stored properly, and make sure your meter is properly coded (if required). 2. Take a blood glucose measurement using your meter. • Carefully apply the blood sample to the test strip following your meter or test strip instructions. 3. From any trend graph, press the SELECT button to see the Main Menu. 4. Use the UP or DOWN button to scroll until you highlight “Enter BG”. • “Enter BG” will be the second Main Menu option when you are in the middle of a sensor session. 5. 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. When the receiver does not have a recent sensor glucose reading the default is 120 mg/dL. b. If there has been a sensor glucose reading in the past 15 minutes, the Enter BG screen shows your current sensor glucose reading. Do not use the current sensor glucose reading for calibration. Use only blood glucose values from your meter. 6. Use the UP or DOWN button to scroll until you see the correct blood glucose value, and then press the SELECT button.

41 7. Confirm that the blood glucose value you entered is correct. Entering incorrect values may affect the sensor accuracy. a. Press the SELECT button if the blood glucose value displayed is correct. b. If the blood glucose value shown is incorrect, press the RIGHT button to highlight “Cancel” then press the SELECT button to return to the Enter BG screen. Repeat the steps to enter the correct blood glucose value. c. If you do not press the SELECT button, the receiver will “time out” and no blood glucose value will be recorded for calibration. 8. The Enter BG “thinking” screen lets you know the blood glucose value is being used for calibration. 9. For 2-hour startup calibration, repeat these steps for the second blood glucose value. A sensor glucose reading appears on the receiver right away, and sensor glucose readings are updated every 5 minutes. If readings do not appear immediately, see Chapter 13, Section 13.2, Calibration Troubleshooting. PRECAUTION To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value. 7.3 STARTUP CALIBRATION Two hours after you start the sensor session (see Chapter 6, Section 6.7, Starting a Sensor Session) the receiver tells you that you need to calibrate by showing the startup calibration prompt. This means you need to calibrate with 2 separate blood glucose values from your meter. You will not see sensor glucose readings until the receiver accepts the blood glucose values.

42 1. When you see this screen, press the SELECT button to clear it. a. The startup calibration symbol will stay at the top of the trend graph until you calibrate. b. The system will re-alert you every 15 minutes until you enter the blood glucose values. c. If you do not clear the prompt, the system will re-alert you every 5 minutes. 2. Take 2 separate blood glucose measurements with your meter, and enter the blood glucose values into the receiver (see Chapter 7, Section 7.2, How to Calibrate). 7.4 12-HOUR CALIBRATION UPDATE Calibrate your system at least every 12 hours after your first calibration (2-hour startup calibration) to make sure your sensor glucose readings remain accurate and close to your blood glucose meter values. You can enter blood glucose values earlier than 12 hours if you want. If you have not entered any blood glucose values in the past 12 hours, the receiver will ask you to enter a blood glucose value to update its calibration. WARNING Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. The following steps show you how to enter this calibration. 1. When you see this screen, press the SELECT button to clear it. a. The startup calibration needed symbol will stay at the top of the trend graph until you calibrate. b. The system will re-alert every 15 minutes until you enter the blood glucose values. 2. Take 1 blood glucose measurement with your meter, and enter the blood glucose value into the receiver. If this screen reappears soon, see Chapter 13, Section 13.2, Calibration Troubleshooting. 7.5 OTHER REASONS YOU MAY NEED TO CALIBRATE

43 You may need to calibrate when your system did not accept the last calibration or your blood glucose value is very different from the sensor glucose reading. When you see this calibration prompt it means it is time to calibrate with a single blood glucose value. Take 1 blood glucose measurement with your meter, and enter the blood glucose into the receiver. If this screen reappears soon, see Chapter 13, Section 13.2.1, Types of Calibration Prompts. These screens show calibration errors (see Chapter 13, Section 13.3, Calibration Error Troubleshooting).

44 CHAPTER 8: SENSOR GLUCOSE READINGS AND TRENDS This chapter teaches you how to view your sensor glucose readings and trend information. The trend graph provides additional information that your blood glucose meter does not. It shows your current glucose value, the direction it is changing and how fast it is changing. The trend graph can also show you where your glucose has been over time. CONTRAINDICATION Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person. Your blood glucose meter and sensor measure glucose from two different types of body fluids: blood and interstitial fluid. Therefore, readings from your blood glucose meter and sensor may not match. The greatest benefit you get from using your Dexcom G4 PLATINUM System will come from the trending information. It is important that you focus on the trends and rate of change on your receiver, rather than the exact sensor glucose reading. If you have trouble reading your receiver in bright sunlight, find a shady spot. WARNING Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value. 8.1 SENSOR GLUCOSE READINGS Press the SELECT button to wake up the receiver screen and see the home screen (the 3-hour trend graph). The 3-hour trend graph shows the following:

45 • Each “dot” on the trend graph is a sensor glucose reading reported every 5 minutes. • The trend graph shows the current time. • The status area shows needed calibration updates, calibration errors and sensor glucose reading issues. • Your high alert setting shows as a yellow line across the trend graph. • Your low alert setting shows as a red line across the trend graph. • The gray zone highlights your target glucose range, based on your high and low glucose alert settings. • Your current sensor glucose reading is red if it is low and yellow if it is high, based on your high and low glucose alert settings. • If your low glucose alert is not set and your glucose is 55 mg/dL or lower, your glucose value is red. • If your sensor glucose readings are in between your high and low glucose alert settings, the glucose value is white. • The dots on your trend graph change colors based on your high and low alert settings. You can view your past glucose information on the 1, 3, 6, 12, and 24 hour trend graphs by pressing the UP or DOWN button. • Your system only reports glucose information between 40-400 mg/dL. Your trend graph shows a flat line or dots at 400 or 40 mg/dL when your glucose is outside this range. Which Trend Graph Do You See? (Scroll up from the 3-hour graph to reach the 1-hour graph)

46 1-Hour Trend Graph: The 1-hour trend graph shows your current sensor glucose reading and the last 1 hour of sensor glucose readings. 3-Hour Trend Graph: The 3-hour trend graph shows your current sensor glucose reading and the last 3 hours of sensor glucose readings. (Scroll down from the 3-hour graph to reach the 6-hour graph) 6-Hour Trend Graph: The 6-hour trend graph shows your current sensor glucose reading and the last 6 hours of sensor glucose readings. (Scroll down from the 6-hour graph to reach the 12-hour graph) 12-Hour Trend Graph: The 12-hour trend graph shows your current sensor glucose reading and the last 12 hours of sensor glucose readings. (Scroll down from the 12-hour graph to reach the 24-hour graph) 24-Hour Trend Graph: The 24-hour trend graph shows your current sensor glucose reading and the last 24 hours of sensor glucose readings. The receiver displays “LOW” when the most recent sensor glucose reading is less than 40 mg/dL and “HIGH” when the most recent sensor glucose reading is greater than 400 mg/dL.

47 8.2 RATE OF CHANGE ARROWS Your rate of change arrows add detail about the direction and speed of glucose change over the last 15-20 minutes. The trend arrows show to the right of your current sensor glucose reading. Do not overreact to the rate of change arrows. Consider recent insulin dosing, activity, food intake, your overall trend graph and your blood glucose value before taking action. If there are missed communications between the sensor and receiver during the last 15-20 minutes, an arrow may not display. This table shows the different trend arrows your receiver displays: Trend Arrows Constant: Your glucose is steady (not increasing/decreasing more than 1 mg/dL each minute). Your glucose could increase or decrease by up to 15 mg/dL in 15 minutes. Slowly rising: Your glucose is rising 1-2 mg/dL each minute. If it continued rising at this rate, your glucose could increase up to 30 mg/dL in 15 minutes. Rising: Your glucose is rising 2-3 mg/dL each minute. If it continued rising at this rate, your glucose could increase up to 45 mg/dL in 15 minutes. Rapidly rising: Your glucose is rising more than 3 mg/dL each minute. If it continued rising at this rate, your glucose could increase more than 45 mg/dL in 15 minutes.

48 Slowly falling: Your glucose is falling 1-2 mg/dL each minute. If it continued falling at this rate, your glucose could decrease up to 30 mg/dL in 15 minutes. Falling: Your glucose is falling 2-3 mg/dL each minute. If it continued falling at this rate, your glucose could decrease up to 45 mg/dL in 15 minutes. Rapidly falling: Your glucose is falling more than 3 mg/dL each minute. If it continued falling at this rate, your glucose could decrease more than 45 mg/dL in 15 minutes. No arrow No rate of change information: The receiver cannot calculate how fast your glucose is rising or falling at this time. Trend arrows show to the right of your sensor glucose reading. They tell you more about your glucose’s speed and direction. Trend arrows do not show when there are glucose data gaps (see Chapter 13, Section 13.4, System Glucose Error). If the glucose reading error symbol , the wait symbol , the out of range symbol , or the calibration needed symbol show at the top of the trend graph, the trend arrows will not show.` If the trend arrow is missing, but you are concerned that your blood glucose level may be rising or falling, take a blood glucose measurement test on your blood glucose meter. WARNING Do not ignore symptoms of high and low glucose. If your sensor glucose readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range, so you do not miss a low or high blood glucose value. 8.3 GLUCOSE STATUS AREA SYMBOLS The “status area” at the top of the trend graph may show any of the status symbols below during your sensor session. You will not get sensor glucose readings during the time a status symbol shows except during the regular 12-hour calibration prompt. Status Symbols

49 Calibration Needed This symbol means you need to enter a calibration. This prompt will show when it is time for your 12-hour calibration update or any other time an additional calibration is needed (see Chapter 7, Section 7.2, How to Calibrate). Additional Calibration Needed This symbol means you need to enter one more blood glucose value in order to calibrate the system and start getting sensor glucose readings. Glucose Reading Error This symbol means the receiver does not understand the sensor signal but is likely to recover. This symbol is related to the sensor only. You should wait for more prompts and do not enter any blood glucose values when you see this symbol (see Chapter 13, Section 13.4, System Glucose Error for more information). Out of Range This symbol means the receiver and sensor/transmitter are not communicating. Make sure the receiver and sensor/transmitter are within 20 feet of each other without obstruction (see Chapter 1, Section 1.4, Transmitter Overview). Wait 15 Minutes Calibration Error This symbol means the sensor cannot calibrate right now. If you see this screen, enter at least one more calibration blood glucose value after about 10-15 minutes. If the sensor still cannot calibrate after that, the sensor needs to be removed and a new sensor needs to be inserted. Wait 1 Hour Calibration Error This symbol means the sensor is not calibrating correctly. If you see this screen, wait a minimum of one hour and then enter one more blood glucose value. If no readings display on the receiver after this, the sensor needs to be removed and a new sensor needs to be inserted. Wait This symbol means the receiver has detected a potential significant problem with the sensor signal and may result in a sensor failure. You should wait about 30 minutes for more prompts. Do not enter any blood glucose values when you see this symbol. Status symbols show in the upper right of your trend graph.

50 CHAPTER 9: ALERTS, ALARM & PROFILES This chapter teaches you about your Dexcom G4 PLATINUM CGM System’s many alerts and alarm and how to set them. 9.1 SETTING YOUR ALERTS 9.1.1 DEFAULT ALERT/ALARM SETTINGS The following alerts and alarm are preset on your receiver. Default Alert/Alarm Settings What will I see on the receiver screen? What does this mean? What is the default setting? How will the receiver notify me? Will the receiver re-notify me? High Glucose Alert Your most recent sensor glucose reading is at or above the high alert setting. On at 200 mg/dL Vibrates two times then vibrates/beeps two times every 5 minutes until confirmed or your glucose value drops below the alert level. No, unless you have turned on the high alert snooze feature. Low Glucose Alert Your most recent sensor glucose reading is at or below the low alert setting. On at 80 mg/dL Vibrates three times then vibrates/beeps three times every 5 minutes until confirmed or your glucose value goes above the alert level. No, unless you have turned on the low alert snooze feature. Low Glucose Alarm Your most recent sensor glucose reading is at or below 55 mg/dL On Vibrates 4 times, then vibrates/beeps 4 times every five minutes until confirmed or your glucose value goes above 55 mg/dL. Yes, every 30 minutes after each confirmation until your blood glucose value comes back into range.

51 Out of Range Alert The sensor/transmitter and receiver are not communicating to each other. Off The alert will not notify you. You must change the settings to receive this alert. No Rise/Fall Alert Single Arrow Your glucose is rising/falling at or above a rate of 2 mg/dL/min (at least 30 mg/dL in 15 minutes). Off The alert will not notify you. You must change the settings to receive this alert. No Rise/Fall Alert Double Arrow Your glucose is rising/falling at or above a rate of 3 mg/dL/min (at least 45 mg/dL in 15 minutes). Off The alert will not notify you. You must change the settings to receive this alert. No This table describes the receiver alerts and alarm and explains how the receiver will notify you in the default setting. Your receiver may alert you at other times you need to take action, such as low battery, failed sensor, etc. See Chapter 18, Appendix I, for a detailed list of these other alerts. 9.1.2 GLUCOSE ALERTS AND ALARM The Dexcom G4 PLATINUM System lets you create personal settings for how you want the receiver to tell you what is going on. The low and high glucose alerts tell you when your sensor glucose readings are outside your target glucose range. Rise and fall (rate of change) alerts let you know when your glucose levels are changing fast (see Chapter 9, Section 9.2, Advanced Alerts). The Dexcom G4 PLATINUM System also has a 55 mg/dL low glucose alarm that cannot be changed or turned off. This safety feature tells you your glucose level may be dangerously low. You can set high and low glucose alerts to vibrate and beep. This feature can help during sleeping, driving, exercising or during meetings. When you have both your high and low alerts turned on, a gray zone on your trend graph shows your target range. 9.1.2.1 HIGH GLUCOSE ALERT

53 • Re-alarm: The receiver automatically alerts again 30 minutes after you press the SELECT button to clear it, if your sensor glucose readings are still at or below 55 mg/dL. • Your receiver does not alert if you have a sensor glucose reading outside your target range and you calibrated in the last 5 minutes. • The receiver alerts if your sensor glucose reading stays outside your target range after five minutes. 9.1.3 GETTING TO THE ALERTS MENU 1. Press the SELECT button to turn on the receiver. The 3-hour trend graph shows. 2. Press the SELECT button to see the Main Menu. 3. From the Main Menu, press the UP or DOWN button to scroll to “Alerts,” and press the SELECT button. The Alerts menu shows. 9.1.4 HIGH AND LOW GLUCOSE ALERTS The steps for setting both the high alert and the low alert are the same. The following steps show you how to change your high and low alert settings. 1. From the Alerts menu, press the UP or DOWN button to select “High Alert” or “Low Alert” and press the SELECT button. 2. Highlight “On/Off,” and then press the SELECT button to set this option. A check mark shows next to the current setting.

54 3. Press the LEFT button to return to the last screen. 4. Press the DOWN button to highlight “Level.” The number that shows is your current high glucose alert level. 5. To change this number, press the SELECT button, and then press the UP or DOWN button to select your high glucose alert level. • Your high glucose alert value can be set between 120 and 400 mg/dL in 10 mg/dL steps. • Your low glucose alert value can be set between 60 and 100 mg/dL in 5 mg/dL steps. 6. Press the SELECT button to confirm your alert level. 7. Press the LEFT button to return to the Alerts menu when you finish. 9.2 ADVANCED ALERTS Advanced alerts include the high and low snooze, rise and fall rate, and out of range alerts. All advanced alerts follow the following steps. 1. Press the SELECT button to turn on the receiver. 2. Press the SELECT button to enter the Main Menu. 3. Press the UP or DOWN button to highlight “Alerts,” and press the SELECT button.

57 4. Press the LEFT button to go back to the last screen. Highlight “Level” and then press the SELECT button. 5. Choose “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. 6. Press the LEFT button to return to the Alerts menu when you finish. 9.2.3 SETTING THE OUT OF RANGE ALERT The out of range alert lets you know when the transmitter and receiver are not communicating with each other. Keep the transmitter and receiver within 20 feet of each other without obstruction. When the transmitter and receiver are too far apart, you will not get sensor glucose readings. The out of range symbol in the upper right corner of the trend graph and the Out of Range alert screen show when the transmitter and receiver are not communicating. The amount of time Out of Range shows on the out of range alert screen. It will continue to re-alert until they are back in range.

58 1. Press the UP or DOWN button to choose “Out of Range,” and press the SELECT button. 2. Press the UP or DOWN button to choose “On/Off.” Then, press the SELECT button to select “On.” If you do not want to get out of range alerts press the SELECT button again to choose “Off.” 3. Press the UP or DOWN button to choose “Time,” and press the SELECT button. 4. Press the UP or DOWN button to choose the amount of time out of range after which the receiver will alert. Press the SELECT button. 5. Press the LEFT button to return to the Alerts menu when you finish. 9.3 ALERT PROFILES

62 CHAPTER 10: EVENTS The Events feature lets you record information that may help you and your healthcare professionals better understand your glucose patterns and trends. You can enter details about carbohydrates, insulin, exercise, and health issues. You can view these events with your trends and patterns using the Dexcom Studio software. 10.1 EVENTS Event markers can be downloaded and viewed in the Dexcom Studio software but cannot be viewed on your receiver. 10.1.1 SELECTING AN EVENT 1. Press the SELECT button to turn on the receiver. The 3-hour trend graph will show. 2. Press the SELECT button to see the Main Menu. 3. Press the UP or DOWN button to scroll to “Events,” and press the SELECT button. The Events menu will show. 4. Press the UP or DOWN button to choose the event you want: “Carbs,” “Insulin,” “Exercise” or “Health.” Press the SELECT button. 10.1.2 SETTING THE DATE AND TIME FOR AN EVENT

63 When you enter an event, you must check that the date and time for that event are correct. The default is the current date and time stored in the receiver. The date format is YYYY/MM/DD. 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. To change the date and time for an event: 1. Press the RIGHT button to highlight each value in the date and time. 2. Press the UP or DOWN button to make any changes, and then press the RIGHT button to move to the next value. 3. Press the SELECT button after choosing AM or PM. 4. Press the SELECT button to confirm the entry. 10.1.3 CARBOHYDRATES The Carbs event lets you enter the amount of carbohydrates you have taken, up to 250 grams. 1. From the Events menu press the UP or DOWN button to choose “Carbs,” and press the SELECT button. 2. Press the UP or DOWN button to enter your carb amount (0-250 grams), and press the SELECT button. • The number that shows on this screen is the last number you entered or the default amount of 50 grams.

64 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm. 4. Press the LEFT or RIGHT button to choose either “OK” to confirm or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. 10.1.4 INSULIN The Insulin event lets you enter the amount of insulin you have taken, up to 250 units. You can only enter an insulin amount, not the type of insulin. 1. From the Events menu press the UP or DOWN button to choose “Insulin,” and press the SELECT button. 2. Press the UP or DOWN button to enter your insulin amount (0-250 units), and press the SELECT button. • The number that shows on this screen is the last number you entered or the default amount of 10 units. 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm.

65 4. Press the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. 10.1.5 EXERCISE The exercise event lets you enter intensity (light, medium, or heavy) and duration (up to 360 minutes). 1. From the Events menu press the UP or DOWN button to choose “Exercise,” and press the SELECT button. 2. Press the UP or DOWN button to choose your exercise intensity level, and press the SELECT button. 3. Press the UP or DOWN button to enter your exercise duration (0-360 minutes), and press the SELECT button. • The number that shows on this screen is the default amount of 30 minutes.

66 4. Check that the date and time for this entry are correct. Press the SELECT button to confirm. 5. Press the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. 10.1.6 HEALTH The Health event lets you enter episodes of illness, stress, high symptoms, low symptoms, cycle (menstrual) or alcohol consumption. 1. From the Events menu press the UP or DOWN button to choose “Health,” and press the SELECT button. 2. Press the UP or DOWN button to choose your health event, and press the SELECT button. 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm. 4. Press the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu.

67 10.2 DEXCOM STUDIO SOFTWARE The Dexcom Studio software is optional. This software lets you view trends, track patterns and create custom charts to display your glucose trends. You can change the date ranges to view long- or short-term patterns and trends. You can use data from current and older downloads and save or print files for you and your healthcare professionals to review. For system requirements and more information, see the Dexcom website (www.dexcom.com) or the Dexcom Studio Software User’s Guide.

$69 11.2 REMOVING A SENSOR WARNING Do not ignore sensor fractures. Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200 24 hours a day, 7 days a week. When you remove the sensor, make sure to pull out the sensor pod while the transmitter is still attached. 1. Gently peel up the sensor pod adhesive patch from your skin. This will pull out your sensor. 11.3 TRANSMITTER REMOVAL$

Dexcom 9495 Wireless glucose monitor User Manual

Dexcom, Inc. Wireless glucose monitor Users Manual

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