Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.
USER’S GUIDE DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM RECEIVER WITH ShareTM IMPORTANT CONTACTS AND NUMBERS Dexcom® Website: www.dexcom.com Your Transmitter ID: Your Receiver ID: Your Healthcare Professional: Nearest Hospital: © 2015 Dexcom, Inc. All rights reserved. Covered by patents www.dexcom.com/patents Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom Share, Dexcom Share2, Dexcom STUDIO, and SEVEN are either registered trademarks or trademarks of Dexcom, Inc.
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM table of contents GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 CHAPTER 1: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION 11 1.1 1.2 1.3 1.4 1.5 1.6 System Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUP 43 5.1 Setting Up the Receiver and Pairing with Your Transmitter . . . . . . 45 5.2 The Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 5.2.1 Getting to the Settings Menu ������������������������������������������������� 47 5.2.2 Setting Your Receiver Time and Date ����������������������������������� 47 5.2.3 Entering Your Transmitter ID . . . . . . . . . . . . . . . . . . . . . . . . . 48 5.2.
8.3 Glucose Status Area Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 CHAPTER 9: ALERTS, ALARM & PROFILES 91 9.1 Setting Your Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 9.1.1 Default Alert/Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . . 93 9.1.2 Glucose Alerts and Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 9.1.2.1 High Glucose Alert . . . . . . . . . . . . . . . . . . . . . . . . . 96 9.1.
1 12.2 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 12.3 Product Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 CHAPTER 13: TROUBLESHOOTING 131 CHAPTER 14: TECHNICAL INFORMATION 149 CHAPTER 15: CHAPTER 16: CHAPTER 17: CHAPTER 18: 191 195 203 207 13.1 Sensor Insertion Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 13.2 Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . .
GLOSSARY Alternative Site This is when you take a blood glucose value on your meter BG Testing 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.
GLOSSARY (continued from page before) 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.
GLOSSARY (continued from page before) Profiles Sound pattern and volume level settings for your alerts. Range The distance between the receiver and transmitter. Keep the two devices within 20 feet of each other without obstruction to get glucose information on your receiver. Re-Alert A re-alert happens after the first alert is not confirmed. Receiver The small device that collects your glucose information from the sensor/transmitter.
GLOSSARY (continued from page before) System Reading A sensor glucose reading shown on your receiver. This reading is in mg/dL units and is updated every 5 minutes. Transmitter The Dexcom G4 PLATINUM System part that snaps into the sensor pod and 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.
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1 chapter one DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION Dexcom G4 PLATINUM User’s Guide | 11
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CHAPTER 1: DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION Dexcom G4 PLATINUM Receiver with Share Dexcom G4 PLATINUM Transmitter Dexcom G4 PLATINUM Sensor 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.
1 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.
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.
1 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.
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.
1 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. Display screen UP button Speaker USB port cover RIGHT button LEFT button DOWN button SELECT button USB port Receiver buttons: • Press the UP and DOWN buttons to scroll through trend graph screens, highlight menu items, or set values.
2 chapter two INDICATIONS FOR USE AND SAFETY STATEMENT Dexcom G4 PLATINUM User’s Guide | 19
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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.
2 2.3 CONTRAINDICATIONS • Remove the Dexcom G4 PLATINUM Sensor, MR 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.
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.
2 •S ensor 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.
to measure glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high blood glucose value. •A void 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.
2 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.
• 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.
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3 chapter three RISKS AND BENEFITS Dexcom G4 PLATINUM User’s Guide | 29
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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.
3 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 professional and call Dexcom’s Technical Support. Sensor breakage may cause some anxiety, but it is not a significant medical risk. 3.
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.
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4 chapter four CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU Dexcom G4 PLATINUM User’s Guide | 35
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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. Low battery prompt Charge the receiver battery using one of these options: • Section 4.1.1: an AC power outlet • Section 4.1.
4 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.
5. T he battery charging screen will show on the receiver. Battery charging screen 6. After a few seconds the trend graph will show with the battery charging symbol ( in the upper left corner. ) Battery charging symbol in upper left corner of trend graph 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.
4 4. A fter a few seconds, the trend graph screen will show the battery charging symbol in the upper left corner. Battery charging symbol in upper left corner of trend graph 4.1.3 KNOWING YOUR RECEIVER IS CHARGED s the battery charges, the battery charging symbol fills in. A When the battery is fully charged, the battery charging symbol is completely shaded. Fully Charged Start Battery charging symbol fills in as battery charges 4.
2 Receiver Main Menu Options (continued from page before) Menu User’s Guide Reference Purpose 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 Profiles Profiles allow you to customize the sound and volume of alerts and alarm.
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5 chapter five DEXCOM G4 PLATINUM SYSTEM SETUP Dexcom G4 PLATINUM User’s Guide | 43
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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. R emove the transmitter from its packaging. Wait 10 minutes for the transmitter to turn on before setting up the receiver. 2.
5 (3) Press the SELECT button after you enter the last number or letter 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. S et 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.
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. P ress 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.
5 2. P ress 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. P ress the RIGHT button to move to the next value. The date format is YYYY/MM/DD. Time/Date setting screen, year highlighted 5. P ress 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.
1. F rom the Settings menu, press the UP or DOWN button to scroll to “Transmitter ID” and press the SELECT button. Settings menu, Transmitter ID highlighted 2. Start with the first number or letter (do not enter “SN”): a. P ress the UP or DOWN button to show the correct number or letter. b. P ress the RIGHT or SELECT button to move to the next value and repeat step a. c. C ontinue repeating steps a and b to enter the whole transmitter ID. Transmitter ID setting screen, first digit highlighted d.
5 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. F rom the Settings menu, press the UP or DOWN button to scroll to “Device Info.” 2. P ress the SELECT button. Information about your sensor session and system will show. Settings menu, Device Info highlighted 3.
CONTRAINDICATION 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.
5 Press the SELECT, LEFT or RIGHT button to see the trend graph. This antenna symbol shows that the transmitter and receiver are communicating. Antenna symbol appears in upper left of trend graph shows the This out of range symbol transmitter and receiver are not communicating.
6 chapter six INSERTING A SENSOR AND STARTING A SENSOR SESSION Dexcom G4 PLATINUM User’s Guide | 53
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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.
6 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.
Plunger Safety lock Applicator barrel (contains small introducer needle and sensor) Collar Transmitter latch Sensor pod Release tab Adhesive patch 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.
6 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. •A void injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor.
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.
6 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. Step 3 and 4. Adhere the sensor on the skin 5. H old the applicator, and pull the safety lock straight out away from the applicator, in the direction of the arrows in the picture. Step 5. Remove the safety lock 6. Save the safety lock to help you remove the transmitter at the end of your sensor session.
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. “2 CLICKS” Steps 1-3. Push down the plunger - insert the needle and sensor 4.
6 • 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.
Transmitter latch c. W ith your other hand, pull the transmitter latch up and forward, Transmitter installed over the transmitter, to snap it into place. The transmitter should lie flat in the sensor pod. Side view of transmitter in • M ake sure you hear 2 clicks sensor pod 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.
6 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 Main Menu, your menu screen, you can continue your Start Sensor highlighted current session or stop the session (refer to Chapter 13, Section 13.6, Sensor Shut-Off Troubleshooting). 4.
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. 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.
6 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™, Smith & Nephew IV3000®, 3M™ tape) for extra support. If you use tape, only tape over the white adhesive patch on all sides for even support.
2. Confirm that you want to shut down your receiver. a. I f you want to shut down, press the LEFT button to highlight “OK,” and then press the SELECT button. b. I f you want to cancel the shutdown, press the SELECT button (with “Cancel” highlighted) to return to the Main Menu. Shutdown screen, OK highlighted 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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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.
7 Example Minimum Calibration Schedule During Seven-Day Sensor Session 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.
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. •M ake sure either a sensor glucose reading or calibration needed symbol shows at the top of the trend graph before calibrating. •Y our 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.
7 PRECAUTION o not calibrate if your blood glucose is changing at a D 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.
1. W ash 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. •C arefully 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. U se the UP or DOWN button to scroll until you highlight “Enter BG.
7 7. C onfirm that the blood glucose value you entered is correct. Entering incorrect values may affect the sensor accuracy. a. P ress the SELECT button if the blood glucose value displayed is correct. b. I f the blood glucose value shown is incorrect, press the RIGHT button Enter BG screen, to highlight “Cancel” then press the OK highlighted to confirm SELECT button to return to the Enter BG screen. Repeat the steps to enter the correct blood glucose value. c.
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 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.
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. Calibration prompt These screens show calibration errors (see Chapter 13, Section 13.3, Calibration Error Troubleshooting).
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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.
8 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.
•E ach “dot” on the trend graph is a sensor glucose reading reported every 5 minutes. • The trend graph shows the current time. •T he 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. •T he gray zone highlights your target glucose range, based on your high and low glucose alert settings.
8 Which Trend Graph Do You See? (Scroll up from the 3-hour graph to reach the 1-hour graph) 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.
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. Trend graph reading LOW Trend graph reading HIGH 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.
8 Trend Arrows (continued from page before) 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.
top of the trend graph, the trend arrows will not show. I f 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.
8 Status Symbols (continued from page before) Glucose Reading Error Out of Range Wait 15 Minutes Calibration Error Wait 1 Hour Calibration Error Wait 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).
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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.
9 Default Alert/Alarm Settings (continued from page before) 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? Low Glucose Alarm Your most recent sensor glucose reading is at or below 55 mg/dL. On Vibrates 4 times and then vibrates/beeps 4 times every 5 minutes until confirmed or your glucose value goes above 55 mg/dL.
Default Alert/Alarm Settings (continued from page before) 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? 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.
9 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 When your sensor glucose readings are at or above your high alert level, this screen shows your high glucose alert level. Your receiver vibrates and/or beeps depending on your profile setting (see Chapter 9, Section 9.3, Alert Profiles). This level shows as a yellow line on the trend graph.
the alert (to change your snooze settings see Chapter 9, Section 9.2, Advanced Alerts). Low glucose alert setting 9.1.2.3 LOW GLUCOSE ALARM The Dexcom G4 PLATINUM System also has a fixed low alarm at 55 mg/dL. This is different than your low glucose alert. You cannot change or turn off this alarm or its re-alarm settings. •T he receiver displays the low glucose alarm screen.
9 1. P ress the SELECT button to turn on the receiver. The 3-hour trend graph shows. Trend graph 2. P ress 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. Main Menu, Alerts highlighted Alerts menu, High Alert highlighted 9.1.4 HIGH AND LOW GLUCOSE ALERTS The steps for setting both the high alert and the low alert are the same.
1. F rom the alerts menu, press the UP or DOWN button to select “High Alert” or “Low Alert” and press the SELECT button. Alerts menu, High Alert highlighted 2. H ighlight “On/Off,” and then press the SELECT button to set this option. A check mark shows next to the current setting. High Alert menu, On/Off highlighted, On selected 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.
9 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. High Alert setting screen, 200 mg/dL selected 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.
9.2.1 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTS The snooze feature lets you delay your high and low glucose re-alerts. You have the option to set a snooze time for every 15 minutes for up to 5 hours. 1. P ress the UP or DOWN button to highlight “High Snooze” or “Low Snooze” and press the SELECT button. Advanced menu, High Snooze highlighted 2. P ress the UP or DOWN button to select the amount of time (in 15 minute steps) between the first alert and re-alerts. Press the SELECT button.
9 If you set your fall rate to 2 mg/dL per minute and your sensor glucose readings fall at this rate or faster, the “FALLING single arrow” screen shows, and the receiver vibrates or beeps in line with your profile settings. Fall alert If you set your rise rate to 3 mg/dL per minute and your sensor glucose readings rise at this rate or faster, the “RISING double arrow” screen shows, and the receiver vibrates or beeps in line with your profile settings.
3. Press the UP or DOWN button to choose “On” or “Off.” Then, press the SELECT button to select “On” or “Off.” Fall Rate menu, On selected 4. P ress the LEFT button to go back to the last screen. Highlight “Level” and then press the SELECT button. Fall Rate menu, Level highlighted 5. C hoose “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. Fall Rate menu, 2 mg/dL/min selected 6.
9 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. Out of Range alert screen 1. P ress the UP or DOWN button to choose “Out of Range,” and press the SELECT button. Advanced menu, Out of Range highlighted 2.
4. P ress the UP or DOWN button to choose the amount of time out of range after which the receiver will alert. Press the SELECT button. Out of Range setting screen, 30 minutes selected 5. P ress the LEFT button to return to the Alerts menu when you finish. 9.3 ALERT PROFILES The Dexcom G4 PLATINUM System lets you set profiles to choose the way you want your alerts to act. This feature is found under the Profiles option on the Main Menu.
9 The soft, normal, attentive and HypoRepeat profiles have the following alert sequence: • The first alert is vibrate only. • If the alert is not confirmed in five minutes, the system vibrates and beeps. • If the alert is not confirmed in five more minutes, the system vibrates and beeps louder. This continues at the same volume every five minutes until confirmed.
ALERT PROFILE OPTIONS (continued from page before) “HypoRepeat” profile: very similar to the normal profile, but it continuously repeats the fixed low alarm every 5 seconds until the sensor glucose reading rises above 55 mg/dL or is confirmed. This profile is only applicable if the receiver is used in real-time mode and can be helpful if you want extra alerts for severe low sensor glucose readings. The “Try It” feature is found under the Profiles menu and lets you to hear an example of each alert and alarm.
9 ALERT PROFILE DETAILS (continued from page before) VIBRATE SOFT NORMAL ATTENTIVE HYPOREPEAT 3 short vibrates + 3 low beeps 3 short vibrates + 3 medium beeps 3 short vibrates + 2 short descending melodies 3 short vibrates + 3 medium beeps 1 long vibrate + 1 low beep 1 long vibrate + 1 medium beep 1 long vibrate 1 long vibrate + + 3 short 1 medium beep repeating melodies PROFILE TYPE Fall Alert 3 short vibrates 1 long Out of Range Alert vibrate Fixed Low 4 short vibrates +4 medium tone beeps
1. P ress the SELECT button to turn on the receiver. The 3-hour trend graph will show. Trend graph 2. P ress the SELECT button to see the Main Menu. 3. Press the UP or DOWN button to scroll to “Profiles,” and press the SELECT button. The Profiles menu will show. Main Menu, Profiles highlighted 4. P ress the UP or DOWN button to scroll to the profile you want to set, and press the SELECT button. Profiles menu, Vibrate highlighted 5.
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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.
10 4. P ress the UP or DOWN button to choose the event you want: “Carbs,” “Insulin,” “Exercise” or “Health.” Press the SELECT button. Events menu, Carbs highlighted 10.1.2 SETTING THE DATE AND TIME FOR AN EVENT 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.
4. P ress the SELECT button to confirm the entry. Carbs setting screen, OK highlighted 10.1.3 CARBOHYDRATES The Carbs event lets you enter the amount of carbohydrates you have taken, up to 250 grams. 1. F rom the Events menu press the UP or DOWN button to choose “Carbs,” and press the SELECT button. Events menu, Carbs highlighted 2. P ress the UP or DOWN button to enter your carb amount (0-250 grams), and press the SELECT button.
10 4. P ress 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. Carbs setting screen, OK highlighted 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. F rom the Events menu press the UP or DOWN button to choose “Insulin,” and press the SELECT button.
4. P ress 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. Insulin setting screen, OK highlighted 10.1.5 EXERCISE The Exercise event lets you enter intensity (light, medium, or heavy) and duration (up to 360 minutes). 1. F rom the Events menu press the UP or DOWN button to choose “Exercise,” and press the SELECT button. Events menu, Exercise highlighted 2.
10 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. Exercise setting screen, 30 minutes selected 4. C heck that the date and time for this entry are correct. Press the SELECT button to confirm. 5. P ress 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.
2. Press the UP or DOWN button to choose your health event, and press the SELECT button. Health menu, Illness highlighted 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm. 4. P ress 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. Health setting screen, OK highlighted 10.
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CHAPTER 11: ENDING A SENSOR SESSION PRECAUTION 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. Your sensor gives you sensor glucose readings for up to seven days. The performance of a sensor has not been tested beyond seven days. Information for the end of a sensor session: •D o not remove the transmitter from the sensor pod while the pod is attached to your skin.
11 6-hour Replace Sensor 2-hour Replace Sensor 30-minute Replace Sensor Replace Sensor end of session You can set these alerts with the profiles setting (see Chapter 9, Section 9.3.2, Alert Profile Details, “All Other Alerts”). After the 6-hour, 2-hour, and 30-minute reminders, you continue to receive sensor glucose readings. Press SELECT to clear these screens. You must remove your sensor after the Replace Sensor Now screen (00:00:00) shows.
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.
11 11.3 TRANSMITTER REMOVAL PRECAUTION 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. Do not remove the transmitter while the sensor pod is still attached to the body. After the sensor pod is off your body, you must remove the transmitter to reuse it. Use either of these two transmitter removal methods: Method 1 The safety lock that you removed from the applicator (see Chapter 6, Section 6.
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CHAPTER 12: TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM 12.1 MAINTENANCE Transmitter •W ipe the outside of the transmitter with a damp cloth or isopropyl alcohol wipe between uses. •K eep the transmitter protected when not in use. Receiver • Do not spill fluid on the receiver or submerge the receiver in liquid. •K eep the receiver in its carrying case or otherwise protected. • Charge the receiver when the battery gets low.
12 format is YYYY-MM-DD. Insert sensors on or before the end of the calendar day printed on the sensor package label. • Store at temperatures between 36° F - 77° F. Storing outside this temperature may result in reduced sensor response to glucose and may cause inaccurate CGM readings. You may store your sensors in the refrigerator if it is within this temperature range. Sensors should not be stored in a freezer. • Store at humidity levels between 15% - 85% relative humidity.
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CHAPTER 13: TROUBLESHOOTING This chapter provides helpful tips and instructions to fix issues you may have while using your Dexcom G4 PLATINUM CGM System. If any of the troubleshooting steps in this chapter do not fix your issue, contact Dexcom Technical Support (see Chapter 15, User Assistance). 13.1 SENSOR INSERTION TROUBLESHOOTING Sensor insertion difficulties • I am having trouble taking out the safety lock: - M ake sure to pull the safety lock straight out away from your body.
13 • I am not able to remove the transmitter latch: - Hold the sensor pod with one hand and twist the transmitter latch with the other hand to remove it. - Do not try to snap it straight off. Sensor pod is not sticking long enough - Make sure your skin is clean, clear of any cream or lotion, and completely dry before you insert the sensor. - Shave your skin before you insert the sensor if hair is preventing the sensor pod from sticking.
•S ee Chapter 7, Calibrating Your Dexcom G4 PLATINUM System, for further information. 13.2.1 TYPES OF CALIBRATION PROMPTS This section describes the three calibration symbols. The next section describes what to do when you see one of these symbols. Startup calibration prompt This prompt means the receiver’s 2-hour startup period is complete. You need to enter two blood glucose values to calibrate the system.
13 13.2.2 WHAT TO DO FOR CALIBRATION PROMPTS 1. W hen you see a calibration prompt, press the SELECT button to clear the prompt. 2. C heck the status area at the top of the screen. a. I f the startup calibration symbol shows, take 2 more blood glucose values and enter them into your receiver. b. I f the additional startup calibration symbol shows, take 1 more blood glucose value and enter it into your receiver. Prompt in status area c.
SELECT button to clear the screen, this symbol status area. shows in the If you see this screen, wait at least 1 hour and then enter 1 more calibration blood glucose value. Wait 15 minutes. If this error screen still shows, enter 1 more blood glucose value. Wait another 15 minutes. If this error screen still shows, the sensor needs to be replaced. Wait 1 hour calibration error screen 13.4 SYSTEM GLUCOSE ERROR The system may tell you that it cannot provide a sensor glucose reading.
13 • Make sure your sensor pod is not dislodged or peeling up. • Make sure your transmitter is snapped in completely. • Make sure nothing is rubbing the sensor pod (i.e. clothing, seat belts, etc.). • Make sure you selected a good insertion site (see Chapter 6, Section 6.3, Choosing an Insertion Site). • Make sure your insertion site is clean and dry before sensor insertion. • Wipe the bottom of the transmitter with a damp cloth or isopropyl alcohol wipe.
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.
13 glucose to calibrate. Do not switch your meter in the middle of a sensor session. Blood glucose meter and strip accuracy vary between blood glucose meter brands. • Before taking a blood glucose measurement for calibration, wash your hands, make sure your glucose test strips have been stored properly and are not expired and make sure that your meter is properly coded (if required). Carefully apply the blood sample to the test strip following the instructions provided with your meter or test strips.
• Make sure your transmitter is snapped in. • Make sure your sensor pod is not dislodged or peeling up. •M ake sure nothing is rubbing the sensor pod (i.e. clothing, seat belts, etc.). •M ake sure you have selected a good insertion site (see Chapter 6, Section 6.3, Choosing an Insertion Site). •M ake sure your insertion site is clean and dry prior to sensor insertion. 13.6.
13 2. P ress the SELECT button with “OK” highlighted to confirm. Stop Sensor screen, OK highlighted 3. The Stop Sensor “thinking” screen will show to let you know the sensor session is stopping. Stop Sensor “thinking” screen 4. O nce the session has stopped, a red stoplight symbol ( ) shows in the upper right of the trend graph. Trend graph with red stoplight in upper right 13.
This screen means you recently turned Share “On,” and your receiver is having trouble connecting with your iPhone® or iPod touch®. If you press the “OK” button to clear this screen, you will be taken back to the Share menu and Share will be turned “Off.” Turn Share “On” to try pairing again. For more information on how to troubleshoot your Dexcom Share System, refer to the Dexcom Share User Manual.
13 3. Charge your receiver. 4. Y ou may need to reset the time and date (see Chapter 4, Section 4.1, Charging Your Receiver Battery and Chapter 5, Section 5.2, The Settings Menu). 13.9 RECEIVER AND TRANSMITTER COMMUNICATION TROUBLESHOOTING 13.9.1 SYSTEM RECOVERY CHECK This screen means the system found an error that it was able to fix. Press the SELECT button to clear this display, and continue your sensor session. System Check screen 13.9.
13.9.3 TRANSMITTER LOW BATTERY This screen shows when the transmitter nears the end of its battery life (see Chapter 1, Section 1.4, Transmitter Overview). It will first show when there is about 1 week of battery life left. When the transmitter battery drains low enough, the transmitter and receiver will stop communicating. Replace your transmitter as soon as possible after you see this screen.
13 PRECAUTION (continued from page before) 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. This screen means your receiver and transmitter are not communicating and you are not getting sensor glucose readings. • Your receiver and transmitter only communicate when you are in an active sensor session.
13.11 ALERTS ARE NOT WORKING 1. M ake sure you have not turned off the sound and/or vibrations for the alerts. Chapter 9, Section 9.1, Setting Your Alerts explains how to change these alert options. 2. C heck that you have turned on and set the level for your advanced alerts (see Chapter 9, Section 9.2, Advanced Alerts). 3. Remember, the first alert is vibrate only. See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts sequence tables for how the alerts, alarm and prompts work.
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16 CHAPTER 14: TECHNICAL INFORMATION 14.1 DEVICE PERFORMANCE CHARACTERISTICS NOTE: We recommend that you review the information in this chapter with your healthcare provider to understand how well the Dexcom G4 PLATINUM System performs. The Dexcom G4 PLATINUM System (the System) uses a glucose sensor to continuously measure and monitor your glucose levels.
14 and required insulin or oral medication to manage their diabetes. In the Original Study, 83% of subjects had Type 1 diabetes, and 17% of subjects had Type 2 diabetes. In the Software 505 Study, 86% of subjects had Type 1 diabetes, and 14% of subjects had Type 2 diabetes. Both studies included subjects greater than 18 years of age. Subjects in both studies used the System for seven days.
16 You can check your receiver for information about your CGM system at any time. 1. F rom the Settings menu, press the UP or DOWN button to scroll to “Device Info.” 2. P ress the SELECT button. Information about your sensor session and system will show. Settings menu, Device Info highlighted 3. Scroll down to see: • Serial Number • Part Number • Part Revision • Software Number Device Info screen • Software Revision 4.
14 Table 1.
16 Agreement Relative to YSI Agreement between the System and blood glucose values is characterized using paired System and YSI values. The System and YSI results were compared by pairing the YSI blood glucose value to a System glucose reading that occurred immediately after the YSI was collected. The agreement of the System to blood glucose value was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and greater than 40% of the YSI values.
14 Table 2.
System does not display glucose values below 40 mg/dL or above 400 mg/dL, the comparisons to the actual blood glucose levels (as determined by the YSI analyzer) when CGM is classified as “LOW” or “HIGH” are included separately in Table 2. The table includes the numbers and the cumulative percentages when YSI values were less than certain glucose levels (for “LOW”), and when YSI values were greater than certain glucose levels (for “HIGH”).
14 Table 3-A.
Table 3-B.
14 Another estimate used to show the accuracy of the System is the absolute percent difference. The absolute percent difference tells you the percent difference or “distance” between the System and YSI values, but does not tell you whether the System 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 System readings and YSI values.
16 Table 4. System Difference to YSI within CGM Glucose Ranges CGM Glucose Ranges1 (mg/dL) Overall *40-60 *61-80 81-180 181-300 301-350 351-400 Number of Paired CGM-YSI Mean Percent Difference Median Percent Difference Mean Absolute Percent Difference Median Absolute Percent Difference Original 9152 2.9% 1.7% 13.3% 9.8% Software 505 2263 2.5% 2.4% 9.0% 7.0% Original 512 -10.0 -8.2 13.5 9.7 Software 505 120 -3.3 -2.1 6.9 4.8 Original 781 -2.4 -0.4 11.4 8.
14 Low and High Glucose Alerts The ability of the System to detect high and low glucose levels is assessed by comparing System results to YSI results at low and high blood glucose levels and determining if the alert may have sounded. The System and YSI values were compared by pairing the System reading that occurred immediately after the YSI value was collected. We suggest that you ask your doctor what alert settings would be best for you.
16 Table 5.
14 Table 6.
Hyperglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the % of time the device alarmed when the blood glucose level was at or above the alert setting within 15 minutes before or after the device alarmed. The False Alert Rate is the % of time the device alarmed when the blood glucose level was below the alert setting within 15 minutes before or after the device alarmed.
14 your alarm to sound 98% of the time and not to sound approximately 2% of time within the 15 minute period before or after your blood sugar goes above 200 mg/dL. Calibration Stability The System must be calibrated every 12 hours. To demonstrate performance of the System over a 12-hour calibration period, Systems were evaluated to verify that performance remains consistent over the 12-hour calibration period. Systems were evaluated in 2-hour increments after calibration.
Table 7.
14 Table 8. Sensor Stability (Accuracy over Time) Day of Wear1 Day 1 Day 4 Day 7 1 2 Study2 Number of paired CGM-YSI Mean Absolute Percent Differences Median Absolute Percent Differences Percent within 15/15% YSI Percent within 20/20% YSI Percent within 30/30% YSI Percent greater than 40/40% YSI Original 3023 16.7% 13.2% 59% 71% 86% 6% Software 505 680 10.7% 7.9% 77% 84% 96% 2% Original 3108 11.4% 8.2% 77% 87% 95% 2% Software 505 777 8.0% 6.
Precision of System Readings In the Original Study, 36 subjects wore two Systems. This was to look at how similarly two Systems function on the same subject (sensor precision). Precision was evaluated by comparing the glucose readings from the two Systems worn on the same subject at the same time. Results showed that System readings from the two sensors generally agreed with each other within 9% (absolute percent difference) with a 7% coefficient of variation.
14 Table 9.
14 Table 10.
14 Table 11.
Agreement and Accuracy Relative to SMBG During the study, agreement between the System and blood glucose values is also characterized using paired System and SMBG results. The System and SMBG values were compared by pairing the comparative SMBG value to a System glucose reading that occurred immediately after the SMBG was collected.
14 Table 12. CGM System Difference to SMBG within CGM Glucose Ranges CGM Glucose Ranges1 (mg/dL) Overall *40-60 *61-80 81-180 181-300 301-350 351-400 Study2 Mean Median Mean Median Absolute Absolute Number of Percent Percent Percent Percent Paired Difference Difference Difference Difference CGM-SMBG (%) (%) (%) (%) Original 7508 -0.4% -1.4% 14.0% 11.0% Software 505 2992 -2.6% -2.7% 11.3% 8.6% Original 731 -9.3 -8.0 11.7 8.0 Software 505 221 -10.3 -6.0 13.0 8.
Table 12 is categorized within CGM glucose ranges. Overall, the System in the Original Study reads, on average, 0.4% lower (Mean Percent Difference) than SMBG values and 14.0% absolute different (Mean Absolute Percent Difference) than the SMBG values. The Median Percent Difference shows that half of the time the System reads -1.4% or less than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 11.0% or less different than SMBG values.
14 14.2 PRODUCT SPECIFICATIONS Sensor Product Specifications Glucose Range 40 - 400 mg/dL Sensor Life Up to 7 days Calibration Commercially available blood glucose meter Calibration Range 40 - 400 mg/dL Storage Conditions Temperature: 36° F - 77° F Humidity: 15% - 85% RH Sterilization Sterile by radiation Transmitter Product Specifications Part Number 9438-01 9438-05 Dimensions (including sensor pod) Length: 1.5 inches Width: 0.9 inches Thickness: 0.5 inches Length: 1.5 inches Width: 0.
Transmitter Product Specifications (continued from page before) Moisture Protection IP28: temporary submersion Protection Against Electrical Shock Type BF applied part Transmitter Performance Characteristics Parameter Performance Characteristic TX/RX Frequencies 2.424 999 877 GHz 2.449 993 677 GHz 2.474 737 539 GHz 2.477 236 919 GHz Bandwidth 334.7 kHz Maximum Output Power 1.25 mW EIRP Modulation Minimum Shift Key Data Rate 49.987 Kbits/Sec Total Packet 224 bits Transmit Duty Cycle 4.
14 device can withstand exposure to common electrostatic (ESD) and electromagnetic interference (EMI). Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The transmitter (P/N 9438-01 and P/N 9438-05) is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment.
Transmitter Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Transmitter Compliance Level Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines < 5% UT (> 95% dip in UT) for 0.
14 Receiver Product Specifications Part Number MT22495 Reading Frequency Every 5 minutes Dimensions Length: 4.0 inches Width: 1.8 inches Thickness: 0 .5 inches Weight 2.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The receiver (P/N MT22495) is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the receiver should ensure that it is used in such an environment.
14 Receiver Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines < 5% UT (> 95% dip in UT) for 0.5 cycle < 5% UT (> 95% dip in UT) for 0.
System Electromagnetic Immunity Specifications Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000-4-6 (Receiver only) 3 Vrms 150 kHz to 80 MHz 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz 20 V/m 80 MHz to 2.
14 System Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb.
a. Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered.
14 Electromagnetic Emissions Specifications (continued from page before) Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Class B The Dexcom G4 PLATINUM System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Minimum Recommended Distance Between Transmitter and Receiver Rated Maximum Output Power of Transmitter (W) Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz d = 1.2 P1/2 80 MHz to 800 MHz d = 1.2 P1/2 800 MHz to 2.5 GHz d = 2.3 P1/2 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.
14 Power Supply/Charger Specifications Dexcom P/N MT21255 Class II Input: AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100Vac DC Output: 5V DC, 1A (5.0 Watts) 14.3 FCC REQUIREMENTS The transmitter covered by this user’s guide has been certified under FCC ID: PH29433. The receiver has been certified under FCC ID: PH29495.
14 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.
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17 CHAPTER 15: USER ASSISTANCE Dexcom Website: www.dexcom.com Dexcom Address: 6340 Sequence Drive San Diego, CA 92121 TECHNICAL SUPPORT For Dexcom product questions and troubleshooting issues8. Dexcom Technical Support Phone Numbers: 1.877.339.2664 or 1.858.200.0200 (24 hours, 7 days a week) Dexcom Technical Support E-mail: TechSupport@dexcom.com Dexcom Technical Support Fax: 1.877.633.
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CHAPTER 16: WARRANTY Dexcom G4 PLATINUM System Limited Warranty 1. What is Covered and for How Long? Dexcom, Inc.
16 operation, maintenance, installation or adjustment; (f) installation, maintenance, and service of products; or (g) equipment that has been disassembled; or (h) water damage to the receiver (receiver is not water resistant, do not get the receiver wet at any time). 3.
AND DISCLAIMS ALL SUCH OTHER WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, DEXCOM SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING IN ANY WAY OUT OF THE SALE, USE, MISUSE OR INABILITY TO USE ANY DEXCOM G4 PLATINUM SYSTEM.
16 the original purchaser that the Dexcom G4 PLATINUM Transmitter is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing upon the date of shipment and continuing for the following specified period of time after that date (“Warranty Period”): Dexcom G4 PLATINUM Transmitter: 6 Months NOTE: If you received this transmitter as a replacement for an in-warranty transmitter, any remaining warranty on the original transmitter shall transfer to this replaceme
of which was included with your Dexcom G4 PLATINUM CGM System and may be found at www.dexcom.com. 3. What Are Dexcom’s Obligations Under The Limited Warranty? During the Warranty Period, Dexcom will replace, at Dexcom’s sole option, without charge to purchaser, any defective Dexcom G4 PLATINUM Transmitter.
16 PURPOSE, OR NON-INFRINGEMENT. EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, DEXCOM SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING IN ANY WAY OUT OF THE SALE, USE, MISUSE OR INABILITY TO USE ANY DEXCOM G4 PLATINUM CGM SYSTEM. THIS LIMITATION SHALL APPLY EVEN IF DEXCOM OR ITS AGENT HAS BEEN ADVISED OF SUCH DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF THIS LIMITED REMEDY.
17 chapter seventeen TRAVEL INFORMATION Dexcom G4 PLATINUM User’s Guide | 203
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CHAPTER 17: TRAVEL INFORMATION It is safe for you to go through the metal detector or be “handwanded” while wearing your Dexcom sensor and transmitter. If you’re concerned or uncomfortable about going through the walk-through metal detector, the Transportation Security Administration (TSA) states that you should notify the Security Office that you’re wearing a continuous glucose monitor and would like a full-body pat-down and a visual inspection of your Dexcom Sensor and Transmitter instead.
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18 chapter eighteen APPENDIX Dexcom G4 PLATINUM User’s Guide | 207
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CHAPTER 18: APPENDIX APPENDIX I, RECEIVER ALERTS, ALARM AND PROMPTS The following tables describe the alarm, alerts and prompts and how the receiver notifies you. Prompt - Shows on screen only. Silent, no vibrate or beep. Alert - Notifies with vibrate and beep depending on your profile settings. Alarm - Low 55 - Notifies with vibrate and beep. Cannot be changed.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? High glucose Your most alert recent sensor glucose reading is at or above the high alert setting. Vibrates 2 times and then vibrates/beeps 2 times every 5 minutes until confirmed or your glucose value drops below the alert level.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Low battery alert The receiver battery is low. Charge your receiver as soon as possible when you see this alert. Vibrates 1 time at 20% battery capacity left. Yes, at 10% battery capacity left.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Unknown sensor prompt The sensor Symbol in is sending status area sensor glucose only. readings that the receiver does not understand. You will not receive sensor glucose readings.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Wait prompt Symbol in The receiver status area has detected only. a potential problem with the sensor signal. You should wait about 30 minutes for more prompts. Do not enter any blood glucose values during this time. You will not receive sensor glucose readings.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Wait 15 minutes calibration error alert The sensor cannot calibrate. Wait 15 minutes then enter 1 more blood glucose value. Wait 15 more minutes. If error screen still appears enter 1 more blood glucose value. Wait 15 minutes.
20 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Wait 1 hour calibration error alert The sensor cannot calibrate. Wait a minimum of 1 hour then enter 1 more blood glucose value for calibration. If no sensor glucose readings appear on the receiver, the sensor needs to be replaced.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Calibration prompt The receiver needs a blood glucose value entered to calibrate. Sensor glucose readings will not be displayed at this time. Vibrates 1 time and then vibrates/beeps every 5 minutes until confirmed. Yes, every 15 minutes.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Enter BG processing screen prompt The receiver is processing the blood glucose value you entered. Prompt screen only. N/A Rise alert Your glucose levels are rising at 2 mg/dL per minute or more.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Fall alert Your glucose levels are falling at 2 mg/dL per minute or more. Vibrates 3 times and then vibrates/beeps 3 times every 5 minutes or until confirmed (2 repeats max). No Rapid fall alert Your glucose levels are falling fast at 3 mg/dL per minute or more.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? 30-minute sensor expiration alert Your sensor session will end in 30 minutes. Vibrates 1 No time and then vibrates/beeps every 5 minutes (2 repeats max). End of session sensor expiration alert Your sensor session has ended.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Receiver error code alert Your receiver is not working properly. Record the error code and call Dexcom Technical Support. Vibrates 1 time No (4 seconds) + 4 beeps. System recovery check alert There was a system error and the receiver fixed it.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Transmitter Failed alert The transmitter has failed. Replace the transmitter immediately. Vibrates 1 No time and then vibrates/beeps every 5 minutes (2 repeats max).
18 APPENDIX II, INDEX A Alarm, Low Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Glucose Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 Setting . . . . . . . . . . . . . . . . . . . . .
20 C Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71 Calibration Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 How to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135 Re-Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Startup Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 M Maintenance, System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 R Radio-Frequency (RF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Charging your . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20 Insertion Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8, 15 Removing from Package . . . . . . . . . . . . . . . . . . . . . . . . . 57 Sensor Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 Starting a Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 63 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Pairing with Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126 Safety Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Removing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDIX III, SYMBOLS USED IN LABELING The 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 Dexcom G4 PLATINUM CGM System. Some of these symbols may not have meaning in your region, and are listed for informational purposes only. This table shows what each symbol means.
18 19 Symbols (continued from page before) Manufacturer EC REP Authorized Representative in the European Community Two-Sided Humidity Limitation Non-ionizing Radiation European Union WEEE Directive 2006-66-EC Marking Certifies that the device meets the European Council Directive 93/42/EEC Electrical Equipment Designed Primarily for Indoor Use Do Not Use if Package is Damaged Input SB Keep Dry Bluetooth Ship By Date Prescription Required MR MR Unsafe 228 | Dexcom G4 PLATINUM Continuous Gluco
Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.
