Dexcom G4 Platinum User Manual
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Dexcom G4 Platinum User Manual

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CONTINUOUS GLUCOSE
MONITORING SYSTEM
Receiver with Share
TM
USER'S GUIDE

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Summary of Contents for Dexcom G4 Platinum

  • Page 1 CONTINUOUS GLUCOSE MONITORING SYSTEM Receiver with Share USER’S GUIDE...

  • Page 3: Glucose Monitoring System

    Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom Share, Dexcom STUDIO, and SEVEN 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.

  • Page 4: Table Of Contents

    4.2 Receiver Menu Options ....... . 40 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 5 6.10 Temporary Receiver Shutdown ......68 6.11 The Dexcom G4 PLATINUM (Pediatric) System and Water . . . 69...
  • Page 6 10.1.6 Health ........122 10.2 Dexcom STUDIO Software ......123 CHAPTER 11: ENDING A SENSOR SESSION 11.1 Automatic Sensor Shut-Off .
  • Page 7 Appendix II: Index........224 Appendix III: Symbols Used in Labeling..... . 229 Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 8: Glossary

    (Do not use alternative site testing for calibration). Continuous Glucose Monitoring. Product that may be sold in the United States. Commercially Available A setting that is selected automatically, unless you choose Default another option. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 9 GLOSSARY (continued from page before) The sensor, transmitter, and receiver. Dexcom G4 PLATINUM (Pediatric) System Secondary notification system to the Dexcom G4 PLATINUM Dexcom System. For more information, please refer to the Dexcom Share System ™ Share User Manual. Different symbols show on the trend graph instead of a sensor...
  • Page 10 Something that blocks the wireless path between the Obstruction transmitter and receiver. There are many types of things that could come between the transmitter and receiver, and Dexcom could not test them all. “Without obstruction” means that we have not tested whether items blocking the transmitter or receiver could affect the transmission range.
  • Page 11 A sensor glucose reading shown on your receiver. This reading System is in mg/dL units and is updated every 5 minutes. Reading The Dexcom G4 PLATINUM (Pediatric) System part that snaps Transmitter into the sensor pod and wirelessly sends glucose information to your receiver.
  • Page 12 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 13: Chapter 1: Dexcom G4 Platinum (Pediatric) Continuous Glucose Monitoring (Cgm) System Description

    DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 14 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 15: System Contents

    • 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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 16: Introduction

    Please review the tutorial on the disc and discuss with your healthcare professional to decide if the Dexcom G4 PLATINUM (Pediatric) 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.

  • Page 17: Sensor Overview

    You discard the sensor at the end of the session. See Chapter 14 for Product Specifications. Plunger Safety lock Applicator barrel (contains small introducer Collar needle and sensor) Transmitter latch Sensor pod Release tab Adhesive patch Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 18: Transmitter Overview

    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. See Chapter 14 for Product Specifications. Transmitter Transmitter Low Battery screen Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 19: Receiver Overview

    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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 20: Share Overview

    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. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 21: Chapter 2: Indications For Use And Safety Statement

    INDICATIONS FOR USE AND SAFETY STATEMENT Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 22 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 23: Chapter 2: Indications For Use And Safety

    The Dexcom G4 PLATINUM (Pediatric) System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions.

  • Page 24: Contraindications

    2.4 WARNINGS • Do not use the Dexcom G4 PLATINUM (Pediatric) CGM System until you have thoroughly reviewed the training materials. Incorrect use might lead you to misunderstand the CGM information or affect system accuracy.
  • Page 25 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— Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 26 (low blood glucose) or hyperglycemia (high blood glucose) events. • Do not use the Dexcom G4 PLATINUM (Pediatric) System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system.

  • Page 27: Precautions

    Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better. • Avoid using the same spot repeatedly for sensor insertion. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 28 (low blood glucose) or hyperglycemia (high blood glucose) events. • 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 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 29 (high blood glucose) events. • 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 Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 30: Caution

    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 (Pediatric) System to sale by or on order of a physician.

  • Page 31: Chapter 3: Risks And Benefits

    RISKS AND BENEFITS Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 32 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 33: Risks

    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 Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 34: Benefits

    There is a low chance of this happening. In the clinical study for the Dexcom G4 PLATINUM (Pediatric) 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.
  • Page 35 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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 36 6-year study. Diabetes Res Clin Pract. 1995; 28:103-117. J DRF 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. JDRF CGM Study Group. Quality-of-Life Measures in Children and Adults With Type 1 Diabetes. Diabetes Care 2010; 33: 2175-2177. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 37: Chapter 4: Charging Your Receiver And The Receiver Main Menu

    CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 38 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 39: Charging Your Receiver Battery

    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.

  • Page 40: Charging Your Receiver Battery From An Ac Power Outlet

    When the receiver is used in a healthcare facility, charging must take place away from the patient. WARNING Do not use the Dexcom G4 PLATINUM (Pediatric) System in critically ill patients. It is not known how different conditions or medications common to the critically ill population may affect the performance of the system.

  • Page 41: Charging Your Receiver Battery From A Windows Compatible

    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.

  • Page 42: Knowing Your Receiver Is Charged

    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: Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 43 To change the settings for high and low alerts. Chapter 9 High/Low To change the time, date and transmitter ID; to turn on the Share feature; to look up your Dexcom G4 Settings PLATINUM (Pediatric) System hardware and software Chapter 5 version numbers;...
  • Page 44 See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts, for a list of screens that may show on the receiver. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 45: Chapter 5: Dexcom G4 Platinum (Pediatric) System Setup

    DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM SETUP Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 46 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 47: Setting Up The Receiver And Pairing With Your Transmitter

    Time/Date setting screen b. Enter your transmitter ID. (1) Press the DOWN button to enter your transmitter ID. (2) Press the RIGHT SELECT button to move to the next space. Transmitter ID setting screen Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 48 Setup Wizard see Section 5.2, The Settings Menu. The Setup Wizard is now complete. To start using your Dexcom G4 PLATINUM (Pediatric) CGM System you must insert a sensor (see Chapter 6, Inserting a Sensor and Starting a Sensor Session).

  • Page 49: The Settings Menu

    Settings menu Settings highlighted 5.2.2 SETTING YOUR RECEIVER TIME AND DATE 1. From the Settings menu, press the DOWN button to scroll to “Time/Date,” and press the SELECT button. Settings menu, Time/Date highlighted Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 50: Entering Your Transmitter Id

    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: Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 51: Turning On Share On Your Receiver

    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 Dexcom G4 PLATINUM (Pediatric) Receiver with Share.

  • Page 52: Checking Information About Your Dexcom G4 Platinum (Pediatric) System

    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. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 53 Tomograph (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...
  • Page 54 Antenna symbol appears in upper left of trend graph This out of range symbol shows the transmitter and receiver are not communicating. Out of range symbol appears in upper right of trend graph Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 55: Chapter 6: Inserting A Sensor And Starting Asensor Session

    INSERTING A SENSOR AND STARTING A SENSOR SESSION Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 56 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 57 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 (Pediatric) 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 (Pediatric) System.

  • Page 58: Before You Start

    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 severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 59: Removing The Sensor From Its Packaging

    • The applicator is for single use and is disposable. • The safety lock prevents you from releasing the needle accidentally before you are ready. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 60: Choosing An Insertion Site

    No other sensor insertion sites have been tested and we do not know how well the sensor will work in other sites. Front of body, sensor site option A Back of body, sensor site option B Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 61 • Make sure there are no traces of lotions, perfumes or medications on the skin where you place the sensor. For more help on ideal sensor insertion sites for you, contact your healthcare professional. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 62: Placing The Sensor

    6.4 PLACING THE SENSOR WARNINGS • Do not use the Dexcom G4 PLATINUM (Pediatric) System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM (Pediatric) System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions.
  • Page 63 5. Hold 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 Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 64: Sensor Insertion

    Removal, with or without the safety lock. NOTE: Contact your healthcare professional for specific questions regarding the use of medical tape, barrier wipes and/or other adhesives as it relates to your use of Dexcom CGM. 6.5 SENSOR INSERTION You are ready to insert the sensor after you place the applicator on your skin and remove the safety lock.

  • Page 65: Transmitter Attachment

    • 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.
  • Page 66 Release your pinch on the adhesive edge at this time. e. M ake 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. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 67: Starting A Sensor Session

    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 Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 68 Chapter 13, Section 13.10, Out of appear in upper left of Range/No Antenna. trend graph 8. 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. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 69: Sensor Startup Period

    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). Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 70: Taping The Sensor Pod

    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 (Pediatric) 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.

  • Page 71: The Dexcom G4 Platinum (Pediatric) System And Water

    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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 72 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 73: Chapter 7: Calibrating Your Dexcom G4

    CALIBRATING YOUR DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 74 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 75: Calibration Overview

    CHAPTER 7: CALIBRATING YOUR DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM You must calibrate Dexcom G4 PLATINUM (Pediatric) 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.
  • Page 76 Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor accuracy and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 77: How To Calibrate

    12 hours might cause sensor glucose readings to be inaccurate and glucose alerts to become unreliable. This could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 78 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: Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 79 Use only blood default is 120 mg/dL glucose values from your meter. 6. Use the DOWN button to scroll until you see the correct blood glucose value, and then press the SELECT button. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 80 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. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 81: Startup Calibration

    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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 82: 12-Hour Calibration Update

    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. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 83: Other Reasons You May Need To Calibrate

    Chapter 13, Section 13.2.1, Types of Calibration prompt Calibration Prompts. These screens show calibration errors (see Chapter 13, Section 13.3, Calibration Error Troubleshooting). Wait 15 minutes Wait 1 hour calibration error screen calibration error screen Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 84 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 85: Chapter 8: Sensor Glucose Readings And Trends

    SENSOR GLUCOSE READINGS AND TRENDS Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 86 10 3 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 87 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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 88: Sensor Glucose Readings

    The greatest benefit you get from using your Dexcom G4 PLATINUM (Pediatric) 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.
  • Page 89 • 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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 90 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. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 91 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 Trend graph reading LOW reading HIGH Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 92: Rate Of Change Arrows

    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. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 93 If the trend arrow is missing, but you are glucose data gaps concerned that your blood glucose level may be rising or falling, take a blood glucose measurement test on your blood glucose meter. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 94: Glucose Status Area Symbols

    Additional This symbol means you need to enter one more blood glucose value in Startup order to calibrate the system and start getting sensor glucose readings. Calibration Needed (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 95 You should wait about 30 minutes for more prompts. Do not enter any blood Wait glucose values when you see this symbol. Status symbols show in the upper right of your trend graph. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 96 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 97: Chapter 9: Alerts, Alarm & Profiles

    ALERTS, ALARM & PROFILES Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 98 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 99: Setting Your Alerts

    CHAPTER 9: ALERTS, ALARM & PROFILES This chapter teaches you about your Dexcom G4 PLATINUM (Pediatric) 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.
  • Page 100 The alert will Out of Range Alert not notify you. You must The transmitter change the and receiver settings to are not receive this communicating alert. to each other. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 101 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. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 102: Glucose Alerts And Alarm

    CGM. Do not rely solely on CGM alerts to detect low glucose. The Dexcom G4 PLATINUM (Pediatric) 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.

  • Page 103: High Glucose Alert

    CGM alerts to detect low glucose. When your sensor glucose readings are at or below your low alert level, this screen shows your low glucose alert level. Your receiver vibrates and/or beeps depending on your profile setting. This level shows as a red line on the trend graph. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 104: Low Glucose Alarm

    • The receiver displays the low glucose alarm screen. • Re-alarm: The receiver automatically alerts again 30 minutes after you press the SELECT Low glucose alarm Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 105: Getting To The Alerts Menu

    The following steps show you how to change your high and low alert settings. 1. From the Alerts menu, press the DOWN button to select “High Alert” or “Low Alert” and press the SELECT button. Alerts menu, Low Alert highlighted Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 106 120 and 400 mg/dL in 10 mg/dL steps. Low Alert setting screen, • Your low glucose alert value can be set between 60 and 100 mg/dL in 5 80 mg/dL selected mg/dL steps. 6. Press the SELECT button to confirm your alert level. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 107: Advanced Alerts

    7. This screen appears when you set the low alert to remind you that your Dexcom G4 PLATINUM (Pediatric) System may not detect all low glucose events. Check with your blood glucose meter when or if you have signs and symptoms of low glucose. Press the...

  • Page 108: Rise And Fall Glucose Rate Alerts

    Selecting the 2 mg/dL level setting instead of the 3 mg/dL level setting will reduce the missed alerts but may cause more false alerts. It is important you discuss your alert settings with your healthcare professional. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 109 DOWN button to choose “Rise Rate” or “Fall Rate,” and press the SELECT button. Advanced menu, Fall Rate highlighted 2. Highlight “On/Off” and then press the SELECT button. Fall Rate menu, On/Off highlighted Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 110: Setting The Out Of Range Alert

    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. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 111 SELECT button again to choose “Off.” Out of Range menu, On/Off highlighted 3. Press the DOWN button to choose “Time,” and press the SELECT button. Out of Range menu, Time highlighted Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 112: Alert Profiles

    When you choose your profile setting this setting applies to all alerts, alarm and prompts. Within each profile setting, each alert has its own unique sound pattern, tone and volume level. This lets you to easily identify each alert and alarm and its meaning. The fixed low alarm at 55 mg/dL cannot be turned off or adjusted. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 113: Alert Profile Options

    55 mg/dL your system repeats the alert sequence in 30 minutes. Press the SELECT button to confirm any alert. 9.3.1 ALERT PROFILE OPTIONS Vibrate profile: when you want to silence the receiver and be alerted by vibration. The only exception to this is the fixed low alarm at 55 mg/dL, which alerts you as a vibration first, followed by beeps 5 minutes later if not confirmed. Soft profile: when you need your alert to be less noticeable. This profile sets all the alerts and alarm to lower volume beeps. Normal profile: the default profile when you receive your system. This profile sets all alerts and alarm to higher volume beeps. Attentive profile: when you need your alert to be the most noticeable. This profile sets all the alerts and alarm to loud and highly distinctive melodies. (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 114: Alert Profile Details

    3 short 3 short Fall Alert vibrates vibrates vibrates + vibrates vibrates + 3 + 3 low 3 medium + 2 short medium beeps beeps beeps descending melodies (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 115 + 1 short 1 medium beep Alerts + 1 low 1 medium melody beep beep These steps show you how to select the profile you want. 1. Press the SELECT button to turn on the receiver. The 3-hour trend graph will show. Trend graph Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 116 3. Press the DOWN button to scroll to “Profiles,” and press the SELECT button. The Profiles menu will show. Main Menu, Profiles highlighted 4. Press the DOWN button to scroll to the profile you want to set, and press the SELECT button. Profiles menu, Vibrate highlighted 5. Press the LEFT button to return to the Main Menu when you finish. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 117 EVENTS Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 118 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 119: Events

    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.

  • Page 120: Setting The Date And Time For An Event

    RIGHT button to move to the next value. 3. Press the SELECT button after choosing Carbs setting screen, “AM” or “PM.” minutes highlighted Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 121: Carbohydrates

    50 grams. Carbs setting screen, 50 grams selected 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 122: Insulin

    10 units. Insulin setting screen, 10 units highlighted 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 123: Exercise

    “Exercise,” and press the SELECT button. Events menu, Exercise highlighted 2. Press the DOWN button to choose your exercise intensity level, and press the SELECT button. Exercise Type menu, Light highlighted Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 124: 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 DOWN button to choose “Health,” and press SELECT button. Events menu, Health highlighted Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 125: Dexcom Studio Software

    Health setting screen, OK highlighted 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.
  • Page 126 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 127: Chapter 11: Ending A Sensor Session

    ENDING A SENSOR SESSION Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 128 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 129: Automatic Sensor Shut-Off

    The receiver tells you how much time you have left until your sensor session is complete. The Replace Sensor screen shows at 6 hours, 2 hours and 30 minutes before your 7-day sensor session ends. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 130: Removing A Sensor

    You must remove your sensor and insert a new sensor. Trend graph with red stoplight in upper right 11.2 REMOVING A SENSOR Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 131 1. Gently peel up the sensor pod adhesive patch from your skin. This will pull out your sensor. Peel up the sensor pod Keep the transmitter adhesive patch in the sensor pod Completely remove the adhesive patch Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 132: Transmitter Removal

    Safety lock Transmitter with safety lock snapped in Method 2 Use your fingers to spread out the tabs at the back of the sensor pod (end closest to the sensor pod tab wings). The transmitter will “pop” out of the sensor pod. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 133: Chapter 12: Taking Care Of Your Dexcom G4

    TAKING CARE OF YOUR DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 134 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 135: Maintenance

    Use of non-Dexcom supplied parts may affect safety and performance. There is no repair service available for your Dexcom G4 PLATINUM (Pediatric) CGM System. If you experience problems with your system contact Dexcom Technical Support (see Chapter 15, User Assistance).

  • Page 136: Product Disposal

    • Store at humidity levels between 10% - 95% relative humidity. 12.3 PRODUCT DISPOSAL Consult your local waste management authorities for instructions to dispose of devices containing electronic waste (transmitter and receiver) and blood contacting parts (sensor and applicator). Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 137: Chapter 13: Troubleshooting

    TROUBLESHOOTING Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 138 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 139: Sensor Insertion Troubleshooting

    CHAPTER 13: TROUBLESHOOTING This chapter provides helpful tips and instructions to fix issues you may have while using your Dexcom G4 PLATINUM (Pediatric) 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 •...

  • Page 140: Calibration Troubleshooting

    (if required). Carefully apply the blood sample to the test strip following the instructions that came with your meter or test strips. • Make sure you have not taken any medications containing acetaminophen (such as Tylenol). Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 141: Types Of Calibration Prompts

    • See Chapter 7, Calibrating Your Dexcom G4 PLATINUM (Pediatric) 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.

  • Page 142: What To Do For Calibration Prompts

    15 minutes. If this error screen still shows, the sensor needs to be replaced. This screen also means you recently entered a calibration blood glucose value and the sensor is having trouble calibrating. If you press the Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 143: System Glucose Error

    Technical Support (see Chapter 15, User Assistance). If you see these system glucose error symbols often, follow these troubleshooting tips before inserting another sensor: • Make sure your sensor is not expired. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 144: Sensor Inaccuracies

    Inaccuracies are usually related to your sensor only and not your receiver or transmitter. Your sensor glucose readings are meant to be used for trending purposes only. Your blood glucose meter and sensor measure your glucose from two different types of body fluids: blood and interstitial fluid. Therefore, your readings from your blood glucose meter readings and sensor may not match. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 145 5 minutes before entry, or sensor glucose readings might affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 146 (if required). Carefully apply the blood sample to the test strip following the instructions provided with your meter or test strips. • Make sure you are using your blood glucose meter following the Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 147: Sensor Shut-Off Troubleshooting

    • Make sure you have selected a good insertion site (see Chapter 6, Section 6.3, Choosing an Insertion Site). • Make sure your insertion site is clean and dry prior to sensor insertion. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 148: Manual Sensor Shut-Off - "Stop Sensor

    7 day period. 1. To end your sensor session, select “Stop Sensor” from the Main Menu. 2. Press the SELECT button with “OK” highlighted to confirm. Stop Sensor screen, OK highlighted Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 149: Share Pairing Error Troubleshooting

    For more information on how to Share unsuccessful troubleshoot your Dexcom Share System, refer pairing prompt to the Dexcom Share User Manual. If you are not using the Share feature, you should leave Share turned “Off.” Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 150: Battery And Charger Troubleshooting

    13.8 BATTERY AND CHARGER TROUBLESHOOTING Only use the Dexcom cable and battery charger to charge your receiver. A full charge can take up to 5 hours and will last about 3 days, depending on how often you turn on your receiver, use the alerts, and enter events.

  • Page 151: Receiver Error Code

    Replace your Transmitter Low Battery transmitter as soon as possible after you see screen this screen. Contact Dexcom Sales Support (see Chapter 15, User Assistance) to order a new transmitter. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 152: Transmitter Failed

    20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 153: Alerts Are Not Working

    ID. “Transmitter ID” will not appear as an option on the Settings menu during a sensor session. If you are still having trouble getting system readings, contact Dexcom Technical Support (see Chapter 15, User Assistance). 13.11 ALERTS ARE NOT WORKING 1.
  • Page 154 If your receiver gets wet or is dropped, make sure the speaker and vibrations still work. You can do this with the Try It option in the Profiles menu (see Chapter 9, Section 9.3.1, Alert Profile Options). Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 155: Chapter 14: Technical Information

    TECHNICAL INFORMATION Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 156 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 157: Device Performance Characteristics

    Dexcom G4 PLATINUM (Pediatric) System performs. The Dexcom G4 PLATINUM (Pediatric) System (the System) uses a glucose sensor to continuously measure and monitor your glucose levels. The sensor is “calibrated” using a commercially available blood glucose meter;...
  • Page 158 For values greater than 80 mg/dL (4.4 mmol/L) the absolute percent difference (%) from the YSI values was calculated. The percentages of total readings within 15 mg/dL (0.8 mmol/L) or 15%, 20 mg/dL (1.1 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 159 20/20% 30/30% 40/40% mg/dL CGM-YSI 40/40% (mmol/L) Overall 2922 40-60 (2.2-3.3) 61-80 (3.4-4.4) 81-180 1155 (4.5-10.0) 181-300 1380 (10.1-16.7) 301-350 (16.7-19.4) 351-400 (19.4-22.2) NOTE: CGM readings are within 40-400 mg/dL (2.2-22.2 mmol/L), inclusive. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 160 Agreement When CGM Reads “LOW” or “HIGH” The System reports glucose concentrations between 40 and 400 mg/dL (2.2-22.2 mmol/L). When the System determines the glucose level is below 40 mg/dL (2.2 mmol/L), it displays “LOW” in the Receiver Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 161 Status Box. When the Dexcom G4 PLATINUM (Pediatric) System determines that the glucose level is above 400 mg/dL (22.2 mmol/L), it displays “HIGH” in the Receiver Status Box. Because the System does not display glucose values below 40 mg/dL (2.2 mmol/L) or above 400 mg/dL (22.2 mmol/L), the comparisons to the actual blood glucose...
  • Page 162 In the pediatric clinical study, the subject’s glucose levels were not intentionally manipulated during this study, so there are fewer data samples in the low and high glucose ranges than in the adult clinical study. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 163 < 40 (2.2) 40-60 (2.2-3.3) 61-80 (3.4-4.4) 81-120 (4.5-6.7) 121-160 (6.7-8.9) 161-200 (8.9-11.1) 201- 250 (11.1- 13.9) 251- 300 (13.9- 16.7) 301- 350 (16.7- 19.4) 351- 400 (19.4- 22.2) > 400 (> 22.2) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 164 60% 13% 1492 (6.7-8.9) 161-200 28% 53% 16% 1240 (8.9-11.1) 201- 250 1181 (11.1- 13.9) 251- 300 1018 (13.9- 16.7) 301- 350 (16.7- 19.4) 351- 400 (19.4- 22.2) > 400 (> 22.2) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 165 These accuracy measures in differences are based on 2922 paired glucose results and summarized in the following tables. Tables 4-A and Table 4-B represent the system difference within CGM glucose ranges from the pediatric and adults studies, respectively. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 166 19.4 15.9 (16.7-19.4) 351-400 18.5 15.5 19.1 15.5 (19.4-22.2) * F or CGM ≤ 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L) are included instead of percent differences (%). NOTE: CGM readings are within 40 to 400 mg/dL (2.2- 22.2 mmol/L), inclusive. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 167 (concentrations) 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 readings were compared by pairing Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 168 In the pediatric clinical study, the subject’s glucose levels were not intentionally manipulated, so there are fewer data samples in the low and high glucose ranges than in the adult clinical study. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 169 90 (5.0) 100 (5.6) Hypoglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the percent of time the device alarmed when the blood Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 170: The High Glucose Alert

    50% of the time (pediatric study) or 17% (adult study) of time within the 15 minute period before or after your blood sugar goes below 70 mg/dL (3.9 mmol/L). The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 171 300 (16.7) In the pediatric clinical study, the subject’s glucose levels were not intentionally manipulated, so there are fewer data samples in the low and high glucose ranges than in the adult clinical study. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 172 Hyperglycemic True False Hyperglycemia Hyperglycemia Alert Level Alert Alert Missed Detection Detection Rate mg/dL (mmol/L) Rate Rate Rate 120 (6.7) 140 (7.8) 180 (10.0) 200 (11.1) 220 (12.2) 240 (13.3) 300 (16.7) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 173 (pediatric study) or 97% of the time (adult study) and not to sound approximately 2% of the time (pediatric study) or 3% of time (adult study) within the 15 minute period before or after your blood sugar goes above 200 mg/dL (11.1 mmol/L). Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 174 15/15% 20/20% 30/30% 40/40% CGM-YSI 40/40% 0-2 hours 2-4 hours 4-6 hours 6-8 hours 8-10 hours 10-12 hours 12-14 hours NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L), inclusive. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 175 System readings from the two sensors generally agreed with each other within 10% (absolute percent difference) with a 7% coefficient of variation. Sensor Life Sensors may be worn for up to 7 days (168 hours). To estimate how long Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 176 86.2% Table 10. System Readings Within Wear Days (Pediatric Study) All Days Statistic Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7 (N = 108) Mean Median Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 177 SMBG SMBG SMBG Overall 16318 40-60 (2.2-3.3) 61-80 (3.4-4.4) 1340 81-180 7084 (4.5-10.0) 181-300 5627 (10.1-16.7) 301-350 1176 (16.7-19.4) 351-400 (19.4-22.2) NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L), inclusive. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 178 1176 14.2 10.4 (16.7-19.4) 351-400 12.7 10.2 16.1 11.9 (19.4-22.2) * F or CGM ≤ 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L) are included instead of percent differences (%). NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L), inclusive. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 179 Day 3 1977 15.2 11.0 Day 4 2830 14.0 10.9 Day 5 1768 15.4 10.7 Day 6 1704 14.3 Day 7 2675 12.4 Adverse Events No serious adverse events or device-related serious adverse events Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 180: Product Specifications

    Weight (including 0.4 ounces 0.3 ounces sensor pod) Power Supply Silver oxide batteries (not replaceable) Operational Temperature: 50° F - 108° F Conditions Humidity: 10% - 95% RH (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 181 1.25 mW EIRP Modulation Minimum Shift Key Data Rate 49.987 Kbits/Sec Total Packet 224 bits 4.48 ms every 5 minutes at each Transmit Duty Cycle of the four TX frequencies. Data Detection Range 20 feet Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 182 The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is safe for use on U.S. commercial airlines. The Dexcom G4 PLATINUM Transmitter is an M-PED with emission levels that meet RTCA/DO160, Section 21, Category M. Per FAA Advisory, Circular #91-21, 1B, dated 8/25/06, any M-PED that meets this standard in all modes may be used onboard the aircraft without any further testing by the operator.
  • Page 183 IEC 61000-4-8 typical commercial or hospital environment. NOTE: U is the a.c. mains voltage prior to application of the test level. Receiver Product Specifications Part Number MT22608 (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 184 Temperature: 32° F - 113° F Conditions Humidity: 10% - 95% RH Operating Altitude -500 to 12000 feet Moisture Protection IP22: vertically falling drops Limited Warranty 1 year Control Classification Class II equipment Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 185 ± 1 kV line(s) to Mains power quality line(s) line(s) should be that of a IEC 61000-4-5 typical commercial ± 2 kV line(s) to Not applicable or hospital earth environment. (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 186 The Dexcom G4 PLATINUM (Pediatric) System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the Dexcom G4 PLATINUM (Pediatric) System should ensure that it is used in such an environment. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 187 = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 188 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 189: Electromagnetic Emissions

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Dexcom G4 PLATINUM (Pediatric) System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the Dexcom G4 PLATINUM (Pediatric) System should ensure that it is used in such an environment. Electromagnetic Emissions Specifications Emissions Test...
  • Page 190 Portable and mobile RF equipment include: baby monitors, Bluetooth wireless headsets, ® wireless routers, microwave ovens, laptops with internal wi-fi adapters, GSM cell phones, RFID scanners and hand-held security metal detector often used by security screeners. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 191 Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. USB Charging/Download Cable* Specifications Dexcom P/N MT20655 Input/Output 5V DC, 1A Type USB A to USB micro B Length 3 feet Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 192: Fcc Requirements

    1. This device may not cause harmful interference, and 2. This device must accept any interference received, including interference that may cause undesired operation. Warning (Part 15.21) Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 193 • Consult the dealer or an experienced radio/TV technician for help. This portable transmitter with its antenna complies with FCC/IC RF exposure limits for general population/uncontrolled exposure. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
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  • Page 195: Chapter 15: User Assistance

    USER ASSISTANCE Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 196 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 197 Dexcom representative in your area. Dexcom Sales Support Phone Numbers: 1.877.339.2664 or 1.858.200.0200 Dexcom Sales Support E-mail: CustomerService@dexcom.com Dexcom Sales Support Fax: 1.877.633.9266 Dexcom Technical Support does not offer medical advice. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
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  • Page 199: Chapter 16: Warranty

    WARRANTY Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 200 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 201 1. What is Covered and for How Long? Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser that the Dexcom G4 PLATINUM (Pediatric) Receiver with Share is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing upon the date of...
  • Page 202 Dexcom; (e) defects or damage from improper testing, 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).
  • Page 203 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 (PEDIATRIC) SYSTEM.
  • Page 204 Dexcom, Inc. (“Dexcom”) provides a limited warranty to 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”):...
  • Page 205 PLATINUM Transmitter, contact Dexcom Customer Support Department at 1.877.339.2664 or 1.858.200.0200. Upon receipt, Dexcom will promptly replace the defective product. If Dexcom determines that any product is not covered by this Limited Warranty, purchaser must pay all shipping charges for the return of such product.
  • Page 206 SHALL NOT AFFECT THE ENFORCEABILITY OF THE REMAINDER OF THIS LIMITED WARRANTY WHICH PURCHASER ACKNOWLEDGES IS AND WILL ALWAYS BE CONSTRUED TO BE LIMITED BY ITS TERMS OR AS LIMITED AS THE LAW PERMITS. Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 207: Chapter 17: Travel Information

    TRAVEL INFORMATION Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 208 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 209 The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is safe for use on U.S. commercial airlines. The Dexcom G4 PLATINUM Transmitter is an M-PED with emission levels that meet RTCA/DO160, Section 21, Category M. Per FAA Advisory, Circular #91-21, 1B, dated 8/25/06. Any M-PED that meets this standard in all modes may be used onboard the aircraft without any further testing by the operator.
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  • Page 211: Chapter 18: Appendix

    APPENDIX Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 212 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 213: Appendix I: Receiver Alerts, Alarm And Prompts

    4 times every confirmation or below 55 5 minutes until until your mg/dL. confirmed or blood your glucose glucose value goes value above 55 comes back mg/dL. into range. (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 214 5 minutes until snooze alert setting. confirmed or feature. your glucose value goes Chapter 9, above the alert Section 9.2, level. Advanced Alerts. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 215 5 the out of and you will minutes until range alert. not receive the receiver sensor glucose and transmitter readings. are back in range. (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 216 The sensor Symbol in reading error is sending status area prompt sensor glucose only. readings that the receiver does not understand. You will not receive sensor glucose readings. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 217 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. (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 218 1 more blood glucose value. Wait 15 minutes. If no sensor glucose readings appear on the receiver, the sensor needs to be replaced. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 219 12-hour The receiver Prompt screen Yes, every calibration needs a blood only. 15 minutes. prompt glucose value entered to calibrate. (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 220 Vibrates 1 Yes, every startup needs 1 time and then 15 minutes. calibration additional vibrates/beeps prompt blood glucose every 5 value to minutes until complete confirmed. startup calibration. (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 221 Vibrates 2 alert levels are times and then rising fast at vibrates/beeps 3 mg/dL per 2 times every 5 minute or minutes or until more. confirmed (2 repeats max). (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 222 Your sensor Prompt screen sensor session will only. expiration end in 6 hours. prompt 2-hour Your sensor Prompt screen sensor session will only. expiration end in 2 hours. alert (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 223 The sensor is Vibrates 1 Yes, 2 failed alert not working time and then re-alerts in properly. vibrates/beeps the next 10 every 5 minutes minutes for (2 repeats 30 minutes. max). (continued on next page) Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 224 Vibrates 1 Yes, once a low battery battery is low. time and then day. alert Replace the vibrates/beeps transmitter every 5 minutes as soon as (2 repeats possible. max). (continued on next page) Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 225 • 0-hour sensor expiration alert - You will see this alert in the normal course of using a sensor for seven days. Other alerts and alarms cannot be safely checked by the user. Dexcom G4 PLATINUM (Pediatric) System User’s Guide...

  • Page 226: Appendix Ii: Index

    Bluetooth ........6 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 227 Device Information ....... 50 Dexcom STUDIO Software ......123 Events, Diabetes .
  • Page 228 Insertion ........55 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 229 Setting ........48 Dexcom G4 PLATINUM (Pediatric) System User’s Guide...
  • Page 230 Water Resistance ....... . 69 Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...

  • Page 231: 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 (Pediatric) CGM System. Some of these symbols may not have meaning in your region, and are listed for informational purposes only.
  • Page 232 2006-66-EC European Council Directive 93/42/EEC Electrical Equipment Do Not Use if Package Designed Primarily for is Damaged Indoor Use Input Ship By Date Keep Dry Prescription Required Bluetooth MR Unsafe Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System...
  • Page 234 Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.com LBL012590 Rev 02 MT22734...

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