G4-Global Continuous Glucose Monitoring System CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.
G4-Global Continuous Glucose Monitoring System
IMPORTANT CONTACTS AND NUMBERS DexCom Website: www.DexCom.com Your Transmitter ID Number: Your Transmitter Expiration Date: Your Receiver ID: Your Healthcare Professional: Nearest Hospital: Other Notes: © 2010 DexCom, Inc. All rights reserved.
G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM G4-Global Receiver G4-Global Sensor and Applicator G4-Global Transmitter G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM KIT CONTENTS: • Transmitter • Receiver Case • Receiver • User’s Guide • DexCom Studio® Accessory Software • Quick Start Guide • Receiver Charging Cable NOTE: Sensors are sold separately. Commercially distributed blood glucose meter required for use. Make sure to use the correct version of DexCom Studio® with your G4-Global System.
DexCom would like to thank you for purchasing the G4-Global Continuous Glucose Monitoring System (G4-Global System)! When you use the G4-Global System, you will see real-time continuous glucose readings every 5 minutes for up to 7 days. These readings will help you detect trends and patterns in your glucose levels. Glucose trends let you see where your glucose levels have been, which direction your levels are headed, and how fast they may be rising or falling.
INDICATION FOR USE The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The G4-Global System is intended for use by patients at home and in health care facilities. The device is for prescription use only.
WARNINGS • This device is not designed to replace a blood glucose meter. The G4-Global System must be used with a blood glucose meter. • Treatment decisions should not be based solely on results from the G4-Global System. You must confirm results with fingerstick readings from a blood glucose meter before making therapeutic adjustments. • Symptoms related to low or high blood glucose levels should not be ignored.
• The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened. • The Sensor has currently only been tested in adult persons with type 1 and type 2 diabetes. The device has not been tested in children or adolescents, pregnant women, or persons on dialysis. CAUTION U.S. federal law restricts the sale of the G4-Global System to sale by or on order of a physician.
table of contents G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM: SYSTEM KIT CONTENTS INTRODUCTION: INDICATION FOR USE IMPORTANT SAFETY INFORMATION 5 6 7 7 CHAPTER 1: THE G4-GLOBAL SYSTEM BASICS 1.1 Sensor Overview 1.2 Transmitter Overview 1.3 Receiver Overview 1.4 Moving Through the Receiver Screens 13 15 16 17 19 CHAPTER 2: G4-GLOBAL SYSTEM SET UP 2.1 The Set Up Wizard 2.2 Turning the Receiver On 2.3 Setting the Time and Date 2.4 Entering Your Transmitter ID 2.5 Changing Your High and Low Alerts 2.
4.3 Startup Calibration 4.4 Calibration Update 4.5 Re-Calibration 50 51 52 CHAPTER 5: CONTINUOUS GLUCOSE READINGS, TRENDS, ALERTS AND ALARM 5.1 Glucose Readings 5.2 Glucose Trends 5.3 Glucose Alerts and Low Glucose ALARM 5.3.1 High Glucose Alert 5.3.2 Low Glucose Alert 5.3.3 Low Glucose ALARM 5.3.4 Rise and Fall Glucose rate Alerts 5.4 Glucose Status Area on Trend Graphs 5.4.1 Glucose Status Area Symbols 5.4.2 Missing Glucose Readings 5.4.3 System Glucose Errors 5.4.4 Out of range/No Antenna 5.
CHAPTER 8: ADVANCED FEATURES - BEYOND THE BASICS 8.1 Activating Advanced Features 8.2 Diabetes Events 8.2.1 Selecting an Event 8.2.2 Setting the Date and Time for an Event 8.2.3 Carbohydrates 8.2.4 Insulin 8.2.5 Exercise 8.2.6 Health 8.3 DexCom Studio® Software 8.4 Rise and Fall Glucose Rate Alerts 8.5 Setting Other Alerts 8.6 Setting the Out of Range Alert 8.7 Setting a Snooze Time for Your High and Low Glucose Alerts 95 97 98 98 99 99 100 101 102 103 103 105 106 108 CHAPTER 9: TROUBLESHOOTING 9.
chapter one on THE G4-GLOBAL SYSTEM BASICS
1.1 SENSOR OVERVIEW The Sensor is the System component that continuously measures your glucose levels. You will use a blood glucose meter to calibrate your glucose readings measured by the Sensor. The Transmitter collects the Sensor readings and sends them to the Receiver using wireless, radio frequency (RF) technology. This happens every 5 minutes for up to 7 days. The Sensor unit has an Applicator (needle, sensor, plastic housing), Sensor Probe, and Sensor Pod.
1 1.2 TRANSMITTER OVERVIEW The Transmitter wirelessly sends your glucose information from the Sensor to the Receiver. Once you insert the Sensor, you will snap the Transmitter into the Sensor Pod using the Transmitter Latch. The same Transmitter is used when you change Sensors. The Transmitter battery will last about 6 months. As the Transmitter nears the end of its battery life, it can sometimes lose communication with the Receiver.
1.3 RECEIVER OVERVIEW The Receiver looks like a small MP3 player and shows your Sensor-measured glucose information. The G4-Global Receiver only shows glucose readings in the milligrams per deciliter (mg/dL) unit of measure. In the United States, mg/dL is the standard unit used for glucose testing systems (i.e., blood glucose meters). Please check with your Diabetes Management Team if you have questions about the unit of measure displayed on your Receiver.
1 There are 5 Receiver buttons to move you through the display screens that control setup and operation. The screens display glucose readings and trend graphs (“Trend Graphs”) and allow you to change your Receiver settings (“Menu Screens”). You program your Receiver with a specific Transmitter ID Number so your Receiver and Transmitter can talk with each other. Each time you insert a new Sensor, you will need to notify the Receiver (see Chapter 3, Section 3.8).
1.4 MOVING THROUGH THE RECEIVER SCREENS 1. Turn the Receiver on by pressing the SELECT button. 2. The 3-Hour Trend Graph will appear. a. The default screen is the 3-Hour Trend Graph, but you may view glucose information for shorter or longer periods by pressing the TOP or BOTTOM TOGGLE button to see the 1-Hour, 6-Hour, 12-Hour, and 24-Hour Trend Graphs. 3. From any Trend Graph, press the SELECT button to display the Main Menu.
1 4. More information on Main Menu options can be found in the sections listed below: Menu Purpose User’s Guide Reference Trend Graph To display the Trend Graphs. • The 3-Hour Trend Graph is the default screen displayed whenever you turn the Receiver on. Chapter 1 Start Sensor To start a new Sensor session. • This option only appears if a Transmitter ID has been entered and you are not in the middle of a Sensor session.
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chapter pter two G4-GLOBAL LOBAL SYSTE SYSTEM SETUP
This chapter will help you set up your G4-Global System. You will want to read this chapter before you insert and start a new Sensor session. 2.1 THE SETUP WIZARD The Receiver Setup Wizard will guide you through the first-time setup of your G4-Global system. Before setting up your Receiver, remove the Transmitter from the box. NOTE: In order to save battery life, the Transmitter is stored in a tray with a small magnet attached. This prevents the Transmitter from turning on until it is removed from the tray.
2 4. Set your Low and High Glucose Alert Levels The Setup Wizard is now completed. You will now need to insert a Sensor and start a Sensor session to begin a continuous glucose monitoring session (see Chapter 3). NOTE: • When using the Setup Wizard, the Low and High Glucose Alerts are already turned on and are set to vibrate and beep. Only the Low Alert and High Alert “levels” can be adjusted in the Setup Wizard. To make other changes, see Section 2.5. • See Sections 2.3, 2.4 and 2.
2.3 SETTING THE TIME AND DATE 1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the SELECT button. Next, scroll to “Time/Date” and press the SELECT button. 2. Check that the current date and time are correctly set in the Receiver. Press the RIGHT TOGGLE button to highlight each value in the date and time. Then, press the TOP or BOTTOM TOGGLE button to make any adjustments, and then press the RIGHT TOGGLE button to move to the next value.
2 2.4 ENTERING YOUR TRANSMITTER ID Before you can use your G4-Global System, you must enter the Transmitter ID into the Receiver. The Transmitter ID is a series of 2 letters and 5 numbers on the back of the Transmitter. Entering the ID will begin the unique wireless radio frequency (RF) communication between the Transmitter and Receiver. To enter the Transmitter ID, perform the following steps: 1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the SELECT button.
2.5 CHANGING YOUR HIGH AND LOW ALERTS High Alerts and Low Alerts provide information about your glucose levels and trends. See Chapter 5, Section 5.3 for more information. You can turn the High Alert and/or Low Alert on or off, and choose how the Alerts are delivered (vibrate and beep, or vibrate only). You can also select the glucose value the Receiver will use to trigger a High or Low Alert.
2 3. Next, on the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your Alert delivery option, and press the SELECT button.
2.6 CHARGING YOUR RECEIVER BATTERY The Receiver battery is rechargeable like a cellular phone. The rechargeable battery will last for about 3-5 days before you need to charge it with the Receiver Charging Cable. Your rechargeable battery life depends on how often you turn your Receiver on, your Alert settings, and how often you enter Event information using the Events feature. The Receiver will tell you when the battery charge is low.
2 5. As the battery charges, the Battery Symbol will begin to fill in (green). When the battery is fully charged, the Battery Symbol will be completely filled in. Start Fully Charged 6. After the charge is complete, remove the cable from the Receiver and the wall outlet or computer USB port. HELPFUL HINTS: • Charge your Receiver battery before each Sensor insertion. Periodically check your battery level to make sure it has enough charge.
chapter three e USING A SENSOR
To use your G4-Global Continuous Glucose Monitoring System you will need a Sensor, a Transmitter, and a Receiver. You will also need a blood glucose meter and test strips for calibration. Once inserted and calibrated, the Sensor will continuously measure and display your glucose readings for up to 7 days (167 hours after the 1-hour Startup period). The following sections will show you how to insert the Sensor and start a new continuous glucose monitoring session. 3.
3 REVIEW THE SENSOR APPLICATOR Review the Sensor Applicator picture below before using a new Sensor. Plunger Safety Lock/ Transmitter Release Collar Applicator (needle/sensor probe inside) Transmitter Latch Sensor Pod Release Tab HELPFUL HINT: Always check the expiration date on the Sensor packaging before opening the Sensor for use. Never use expired Sensors. The expiration date format is YYYY-MM-DD.
3.2 REMOVING THE SENSOR FROM ITS PACKAGING The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened. • Carefully remove the Sensor from its packaging. Look closely at the Sensor to make sure it is not damaged. • The Applicator is a single use, disposable unit. The Safety Lock prevents you from accidentally releasing the needle before you are ready. 3.
3 3.4 PLACING THE SENSOR 1. After you have cleaned your skin, remove the adhesive backing from the Sensor Pod. Hold the Sensor by the plastic Applicator and try not to touch the sticky adhesive patch. 2. Place the Sensor on the area. You can place the Sensor flat facing to the left or right of your belly button. Make sure the Sensor is placed in the same direction shown in the picture below. You should not place the Sensor pointing in the up or down direction.
HELPFUL HINT: The Safety Lock also serves as the Transmitter Key that is used later for Transmitter removal. Keep this piece to help you remove the Transmitter at the end of a continuous glucose monitoring session. When your glucose monitoring session is over, follow the steps in Chapter 6, Section 6.4 to remove the Transmitter. 3.5 SENSOR INSERTION Once you have placed the Applicator on your belly and removed the Safety Lock (see Section 3.4), you are ready to insert the Sensor.
3 4. Squeeze the ribbed release tabs on the sides of the Sensor Pod to remove the Applicator. When you squeeze the front release tabs, the back tabs will widen, allowing you to pull off the Applicator. After this step, only the Sensor Pod will be left on your body. a. Make sure the Transmitter Latch is down (against your body) to remove the Applicator. Release the Applicator 5. The used Applicator can be thrown in the trash.
5. Remove the Transmitter Latch by holding the end of the Latch and quickly twisting off the Latch away from your body. Install Transmitter in Sensor Pod Transmitter Installed Remove Transmitter Latch Transmitter Latch HELPFUL HINTS: • Make sure you hear 2 clicks when you snap the Transmitter in place (see Step 3). This helps ensure your device is water resistant (see Section 3.10). • Make sure that you have entered the correct Transmitter ID into your Receiver. See Chapter 2, Section 2.
3 3.7 STARTING A SENSOR SESSION After you have checked that your Transmitter and Receiver are talking, you need to tell the Receiver that you have inserted a new Sensor. To tell the Receiver that you have inserted a new Sensor, follow the steps below. 1. Press the SELECT button to turn the Receiver on. 2. From any Trend Graph, press the SELECT button to display the Main Menu. 3. Press the TOP or BOTTOM TOGGLE button to scroll until you highlight “Start Sensor.” 4.
Keep your Receiver within 20 feet (6 meters) of the Sensor/Transmitter for best communication. To check that the Receiver and Transmitter are talking, press the SELECT, LEFT or RIGHT TOGGLE button to see the Trend Graph. Note the difference between the two Antenna Symbols below: This Antenna Symbol shows that the Transmitter and Receiver are talking. This Out of Range Symbol shows the Transmitter and Receiver are not talking.
3 3.9 SENSOR STARTUP PERIOD The Sensor needs a 1-hour Startup period. This is so the Sensor can get used to its new insertion site. During the Startup period, check every so often to make sure the Antenna Symbol is in the upper left corner of the Trend Graph. Also make sure your Receiver battery is fully charged. When you press the SELECT button during the Startup period to turn the Receiver display on, your Trend Graph will include a 1-hour Countdown Symbol in the upper right hand corner.
chapter four CALIBRATING YOUR G4-GLOBAL SYSTEM
The G4-Global System requires you to “calibrate” the Sensor glucose readings to your blood glucose meter. The purpose of calibration is to convert the measurement of glucose by the Sensor into a reading similar to the one provided by your meter. CONTRAINDICATION: Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device. 4.1 CALIBRATION OVERVIEW When calibrating, you need to manually enter your fingerstick readings into the Receiver.
4 4.2 HOW TO CALIBRATE For Calibration, you must enter the exact fingerstick reading from your meter. Readings must be between 40-400 mg/dL and must have been taken within the past 5 minutes. Entering incorrect fingerstick readings, or fingerstick readings that occurred more than 5 minutes ago, will affect device performance. The steps below show you how to enter your fingerstick readings for calibration: 1. Take a fingerstick reading using your meter. 2.
5. To enter the fingerstick reading taken from your meter, press the TOP or BOTTOM TOGGLE button until you find the correct reading and then press the SELECT button. a. Pressing the TOP or BOTTOM TOGGLE button lets you scroll by 1 mg/dL. To scroll faster, hold down the TOP or BOTTOM TOGGLE button. 6. Confirm that the fingerstick reading you entered is correct. a. If the fingerstick reading displayed is correct, press the LEFT TOGGLE button to highlight “OK” and then press the SELECT button. b.
4 HELPFUL HINTS: • Make sure a glucose reading is displayed at the top of the Trend Graph, or a Blood Drop Symbol is displayed in the top right corner of the Trend Graph, before calibration. • Only fingerstick readings between 40-400 mg/dL can be used for calibration. If 1 or more of your readings entered was outside of this range, the Receiver will not calibrate. You will have to wait to until your blood glucose is in this range to calibrate.
HELPFUL HINTS: • If your readings are less than 40 mg/dL or greater than 400 mg/dL, you should determine if you should treat yourself first, and then calibrate when it is convenient for you. • If you choose to clear the Double Blood Drop Prompt and calibrate later, the Blood Drop Symbol will appear in the top right corner of the Trend Graph. • Once you clear the Double Blood Drop Prompt, it will reappear every 15 minutes until you successfully calibrate.
4 1. If you see the Single Blood Drop Prompt shown to the right, clear this display by pressing any Receiver button. The Single Blood Drop Prompt will not go away until you press a button. Single Blood Drop Prompt 2. Take a fingerstick reading at this time. Enter this reading in the Receiver to update calibration. 3. This screen will appear every 15 minutes until you enter a new fingerstick reading that is accepted for calibration. 4.
You should take another fingerstick reading and enter it into the Receiver. 1. Your System should calibrate immediately. 2. After successful Re-calibration the System will display glucose readings, trends and provide Alerts/Low Glucose ALARM again. HELPFUL HINT: Refer to Section 8.4, “Error Code Troubleshooting,” if you see the “15 Minute Calibration Error Screen” or the “1 Hour Calibration Error Screen” on your Receiver during calibration.
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chapter five CONTINUOUS GLUCOSE READINGS, TREN TRENDS, ALERTS AND ALARM
This chapter will teach you how to view your G4-Global System continuous glucose readings and trend information. Once you have successfully calibrated, the G4-Global Receiver will display your glucose readings every 5 minutes. This will tell you how your glucose levels are changing. You must update G4-Global System calibration every 12 hours at a minimum. The performance of the System when calibrated less frequently than every 12 hours has not been studied.
5 The G4-Global System also lets you enter information about your meals, insulin, exercise, and health. That way you and your Diabetes Management Team can view a bigger picture of your diabetes management plan. Your Diabetes Management Team can transfer this information to the DexCom Studio® Accessory Software to see how you are doing over a long period of time. Treatment decisions should not be based solely on results from the G4-Global System.
• The G4-Global System reports glucose readings from 40-400 mg/dL and updates glucose readings every 5 minutes. The glucose reading is in milligrams per deciliter (mg/dL) units. The Receiver displays “LOW” when the most recent glucose reading is less than 40 mg/dL, and “HIGH” when the most recent glucose reading is greater than 400 mg/dL. “Low” Less than 40 mg/dL “High” Greater than 400 mg/dL • Each “dot” on the Trend Graph is a glucose reading. • Every Trend Graph shows the current time.
5 (Scroll up from the 3-Hour Graph to reach the 1-Hour Graph) 1-Hour Trend Graph: The 1-Hour (1 Hr) Trend Graph shows your current glucose reading and the last 1 hour of glucose readings. 3-Hour Trend Graph: The 3-Hour (3 Hr) Trend Graph shows your current glucose reading and the last 3 hours of glucose readings (this is your default Trend Graph screen).
5.2 GLUCOSE TRENDS In addition to your current glucose reading and Trend Graphs, Trend (Rate of Change) Arrows may appear to show you how your glucose readings are changing. The Trend Arrows appear to the right of your current glucose reading.
5 HELPFUL HINTS: • Trend Arrows do not appear when there is Missing Glucose Information (see Section 5.4). If the Symbol, the Wait Symbol , the Out of Range Symbol , or the Blood Drop Symbol appears in the upper right corner, the Trend Arrows will not appear. • If the Trend Arrow is missing, but you are concerned that your blood glucose level may be rising or falling, take a fingerstick test on your blood glucose meter to check your readings. 5.
5.3.1 HIGH GLUCOSE ALERT When your G4-Global System readings are at or above your High Alert level, the screen shown to the right will appear. You can also set the Receiver to beep and vibrate when this screen appears (see Chapter 2, Section 2.5). The default level is set at 200 mg/dL, but you can adjust this value. High Glucose Alert set at 200 mg/dL When you set the High Glucose Alert, the level is indicated by the top of the gray zone on the Trend Graphs.
5 5.3.2 LOW GLUCOSE ALERT When your G4-Global System readings are at or below your Low Alert level, the screen shown to the right will appear. You can also set the Receiver to beep and vibrate when this screen appears (see Chapter 2, Section 2.5). The default level is set at 80 mg/dL, but you can adjust this value. Low Glucose Alert set at 80 mg/dL When you set the Low Glucose Alert, the level is indicated by the bottom of the gray zone on the Trend Graphs.
5.3.3 LOW GLUCOSE ALARM The G4-Global System also has an automatic Low Glucose ALARM set at 55 mg/dL. This ALARM is a feature in addition to your personal Low and High glucose Alerts. You cannot change or turn off this ALARM or its Re-ALARM settings. • When your glucose reading is at or below 55 mg/dL the Receiver will notify you with 3 ALARMS (each 5 minutes apart) that beep/vibrate as follows: - 1st ALARM: Vibrate - 2nd ALARM: Vibrate, then a series of rapid descending tones followed by 3 constant tones.
5 You can set the Fall Rate (how fast you are going down) to one of two different Fall Rate levels, or choose to turn this feature off. Depending on your selection, you will be notified if your glucose level is falling 2 mg/dL or more each minute, or 3 mg/dL or more each minute. If your glucose reading rises or falls at or above/below the Alert setting you chose, the Receiver will display an Alert. You can also set the Alert to vibrate or beep (see Chapter 8, Section 8.4).
5.4 GLUCOSE STATUS AREA ON TREND GRAPHS This device is not designed to replace a blood glucose meter. When there is Missing Glucose Information, rely on fingerstick readings from your blood glucose meter. Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, confirm them with fingerstick readings from your blood glucose meter. 5.4.
5 15 Minute Calibration Error 1 Hour Calibration Error Wait Means the Sensor cannot calibrate right now. If you see this screen, enter at least 1 more calibration fingerstick reading after about 10-15 minutes. If the Sensor still cannot calibrate using this additional fingerstick reading, the Sensor needs to be replaced. (See Chapter 8, Section 8.4.) Means the Sensor is not calibrating properly. If you see this screen, wait about one hour and then enter at least 1 more fingerstick reading.
5.4.3 SYSTEM GLUCOSE ERRORS Sometimes the G4-Global System may tell you that it cannot provide a glucose reading. When this occurs you will see 3 question marks ( ) in the Status Area. Check the placement of your Sensor to make sure it is still sticking securely to your skin. Also make sure nothing is rubbing the Sensor Pod (i.e. clothing, seat belts, etc.). No Glucose Data Check to see if the Transmitter is snapped in on both sides.
5 5.4.4 OUT OF RANGE/NO ANTENNA • When you see the Out of Range Symbol in the Status Area, this means the Receiver has “missed” the last glucose reading sent by the Transmitter. • If you see this Symbol, make sure the Receiver is within 20 feet (6 meters) of the Sensor/Transmitter. If not, move the Receiver closer and wait at least 5 minutes. • Once you have moved the Receiver closer and waited 5-10 minutes, the Out of Range Symbol in the Status Area should disappear.
5.5 TEMPORARY SENSOR SHUT DOWN There may be times when you want to temporarily shut down your Receiver. Shutdown will stop all communication between the Transmitter and Receiver, and will turn the Receiver off. You will not receive glucose readings or any Alerts/ Low Glucose ALARMs while the Receiver is shut down, but your current Sensor session will remain in progress. Follow these steps to shut down your Receiver: 1. From the Main Menu, scroll to and highlight “Shutdown”. Press the SELECT button. 2.
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chapter hapter six COMPLETING YOUR CONTINUOUS GLUCOSE MONITORING SESSION
At the end of your Sensor session (or wear period), you will need to remove the Sensor. Gently peel up the adhesive patch from your skin (this will pull out your Sensor Probe). Then remove the Transmitter from the Sensor and keep it for your next continuous glucose monitoring session (see Section 6.4). 6.1 REMOVING A SENSOR Your Sensor session will end on time when the Sensor expires (after 7 days).
6 6.2 AUTOMATIC SENSOR SHUT-OFF The Receiver will tell you how much time you have remaining until your G4-Global Sensor session is complete. The Sensor Expiration screen will appear at 6 hours, 2 hours and 30 minutes before your 7-day session ends. You can to set the Receiver to vibrate and/or beep with these displays if you choose (see Chapter 8, Section 8.5). After the 6-hour, 2-hour, and 30-minute reminders, you will still continue to receive glucose readings.
6.3 EARLY SENSOR SHUT-OFF In some cases your Sensor session may end before you have completed a full 7-day period. You should review Chapter 11, Section 11.2 in this User’s Guide to determine how often you should expect this to happen. Examples of why this may occur are described below. 6.3.1 EARLY SHUT-OFF – SENSOR FAILURE During a session the Receiver may detect a series of issues with your Sensor signal where it can no longer determine your glucose reading (see Chapter 9, Section 9.3).
6 The Stop Sensor processing screen will appear to let you know the Sensor session is stopping. Once the session has stopped, a Red Stoplight Symbol will appear in the upper right corner of the Trend Graph. HELPFUL HINTS: • If you removed your Sensor before stopping the Sensor session on the Receiver, the Sensor Failed screen will appear automatically. You must press SELECT before inserting a new Sensor. Look closely at the Sensor to make sure it is not damaged.
6.4 TRANSMITTER REMOVAL When you are ready to remove the Sensor, make sure to pull out the Sensor Pod with the Transmitter still inside. Once the Sensor Pod is off your body, you will need to remove the Transmitter. To do this you can use either of the two methods below: Method 1 The Safety Lock/Transmitter Key once removed from the Applicator (see Chapter 3, Section 3.5) can be used as a tool to remove the Transmitter. 1. Place the Sensor Pod on a table. 2. Hold the rounded edge of the Transmitter Key. 3.
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chapterr seven sev BASIC SETTINGS
7.1 THE SETTINGS MENU 7.1.1 GETTING TO THE SETTINGS MENU 1. Press any button to turn on the Receiver. The 3-Hour Trend Graph will appear. 2. Press the SELECT button to display the Main Menu. 3. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the SELECT button. The Settings menu will appear. 7.1.2 SETTING YOUR RECEIVER TIME AND DATE 1. From the Settings menu, press the TOP or BOTTOM TOGGLE button to scroll to “Time/Date” and press the SELECT button. 2.
7 HELPFUL HINTS: • The date in the Receiver is set at the factory to Pacific Standard Time (PST). • Make sure to set the correct date and time on your Receiver. • When setting values for the time or date, press and hold the TOP or BOTTOM TOGGLE button to scroll through the fields more quickly. • You might need to reset the Receiver’s time and date if the rechargeable battery is drained. If this happens, the Time Loss Alert will automatically take you to the Time/Date Setting Screen. 7.1.
2. Starting with the first number (do not enter the first 2 letters), press the TOP or BOTTOM TOGGLE button to make any adjustment and then press the RIGHT TOGGLE button to move to the next value. After entering the 5th number, press the SELECT button. You will return to the Settings menu.
7 7.1.4 CHECKING INFORMATION ABOUT YOUR RECEIVER At any time you can check your Receiver for information about your G4-Global System. 1. From the Settings menu, press the TOP or BOTTOM TOGGLE button to scroll to “Device Info” and press the SELECT button. 2. Information about your Sensor session and System will appear. Scroll down to see all the information. Press the LEFT TOGGLE button to return to the Settings menu.
7.2 SETTING YOUR ALERTS 7.2.1 FACTORY ALERT SETTINGS The G4-Global System is shipped from the factory with the following “default” settings for Alerts. (See the table below.
7 Screen Alert Type Default Setting Default Prompt Vibrate/Beep Default Re-alert Setting Fall Alert Off Disabled (None) None (no Re-alerts after pressing any Receiver button to clear) Other Alerts (See Chapter 11, Appendix 1 for a detailed list of all “Other Alerts.”) On Vibe then Beep (vibrate first, then medium beep tone) Depends on the Alert Type (See Chapter 12, Appendix 1) Out of Range Alert Off Disabled (None) Continues to Re-alert you until you come back into range.
7.2.2 GETTING TO THE ALERTS MENU 1. Press the SELECT button to turn on the Receiver. The 3-Hour Trend Graph will appear. 2. Press the SELECT button to display the Main Menu. 3. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Alerts” and press the SELECT button. The Alerts menu will appear. 7.2.3 SETTING GLUCOSE ALERTS The High Alert, Low Alert, Rise Rate Alert, and Fall Rate Alert (see Chapter 5) provide information about your glucose levels and trends.
7 High and Low Glucose Alerts NOTE: The options for setting both a High Alert and a Low Alert are the same. The following steps will show you how to change your High Alert Settings. 1. From the Alerts menu, press the TOP or BOTTOM TOGGLE button to select “High Alert” or “Low Alert” and press the SELECT button. 2. On the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “On/Off”. The High Alert is currently set to “On”.
4. Next, on the High Alert menu (example), press the TOP or BOTTOM TOGGLE button to choose “Level” and press the SELECT button. Press the TOP or BOTTOM TOGGLE button to enter your Alert value (120 to 400 mg/dL in 10 mg/dL increments for a High Alert and 60 to 100 mg/dL in 5 mg/dL increments for a Low Alert). The starting value that first appears on this screen is the default value of 200 mg/dL (High Alert) and 80 mg/dL (Low Alert), or the values you set in the Setup Wizard.
7 Rise and Fall Rate Alerts NOTE: • The options for setting both a Rise Rate Alert and a Fall Rate Alert are the same. • To use the Rise and Fall Rate Alerts feature, Advanced Features must be turned on. (See Chapter 8, Section 8.1.) The following steps will show you how to change your Fall Rate Alert settings. 1. From the Alerts menu, press the TOP or BOTTOM TOGGLE button to select “Rise Rate” or “Fall Rate” and press the SELECT button. 2.
4. Next, on the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “Level” and press the SELECT button. Then, choose whether the alerts should be delivered when your glucose levels are falling either “2 mg/dL/min” (2 mg/dL or more per minute), or “3 mg/dL/min” (3 mg/dL or more per minute). Press the SELECT button. Example-Fall Rate When finished, press the LEFT TOGGLE button to return to the Alerts menu.
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chapter eight ADVANCED FEATURES S BEYOND THE BASICS S
Advanced features allows you to do the following: • Enter events related to your carbohydrate consumption, insulin usage, exercise and overall health. Event information can be downloaded to a PC along with your glucose readings and viewed using the DexCom Studio® Accessory Software.
8 8.2 DIABETES EVENTS With the G4-Global System you can enter meal, insulin, physical activity, and health information. This information can help you and your Diabetes Management Team review your glucose trends and patterns and may help you make better decisions about your diabetes management plan. These events can be downloaded to a PC along with your glucose readings and reviewed later with the DexCom Studio® Accessory Software. 8.2.
8.2.2 SETTING THE DATE AND TIME FOR AN EVENT When you enter an event you will be prompted to check that the date and time for that event are correct. The default date and time for events you enter is the current date and time stored in the Receiver. 1. To change the date and time for an event, press the RIGHT TOGGLE button to highlight each value in the date and time. Then, press the TOP or BOTTOM TOGGLE button to make any adjustments and then press the RIGHT TOGGLE button to move to the next value.
8 4. Check that the date and time for this entry are correct. 5. Confirm the entry. Press the LEFT or RIGHT TOGGLE button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and press the SELECT button. You will return to the Events menu. 8.2.4 INSULIN The Insulin Event lets you enter the amount of insulin you have taken, up to 250 units for any particular date and time. You can only enter an insulin amount, not the type of insulin taken. 1.
8.2.5 EXERCISE The Exercise Event lets you enter the intensity (Light, Medium, or Heavy) and duration (up to 360 minutes), for any particular date and time. 1. Press the TOP or BOTTOM TOGGLE button to choose “Exercise” and press the SELECT button. 2. Press the TOP or BOTTOM TOGGLE button to enter your exercise intensity level, and press the SELECT button. 3. Press the TOP or BOTTOM TOGGLE button to enter your exercise duration (0-360 minutes), and press the SELECT button.
8 8.2.6 HEALTH The Health Event lets you enter episodes of Illness, Stress, High Symptoms, Low Symptoms, Cycle (menstrual) or Alcohol consumption, for any particular date and time. 1. Press the TOP or BOTTOM TOGGLE button to choose “Health” and press the SELECT button. 2. Press the TOP or BOTTOM TOGGLE button to enter your health event, and press the SELECT button. 3. Check that the date and time for this entry are correct. 4. Confirm the entry.
8.3 DEXCOM STUDIO SOFTWARE The DexCom Studio® Accessory Software comes with your G4-Global System. This software allows you to view trends and track patterns and create customizable charts to display your glucose trends. Change the date ranges to view long- or short-term patterns and trends. Plus, you can use data from current and previous G4-Global System downloads and save or print files that you can take to your next doctor visit. For system requirements refer to the DexCom website (www.dexcom.com).
8 2. On the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “On/Off”. Then, press the SELECT button to select “On”. If you do not want to receive this type of Rate Alert press the SELECT button to choose “Off”. Example-Fall Rate menu 3. Next, on the Fall Rate menu (example), press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option and press the SELECT button.
NOTE: When you choose “2 mg/dL/min” for your Rise or Fall Rate Alert, one arrow will appear on the screen when you receive the Alert. Two arrows (meaning Rapid) will appear when you select “3 mg/dL/min” for your Rise or Fall Rate Alert. Example-Fall Alert Example-Rapid Rise Alert 8.5 SETTING OTHER ALERTS The G4-Global System provides many other notifications. See Chapter 12, Appendix I for a complete list of these “Other Alerts.
8 3. Press the TOP or BOTTOM TOGGLE button to change “Vibrate Then Beep” to “Vibrate Only” or “Silent” option and press the SELECT button. When finished, press the LEFT TOGGLE button to return to the Alerts menu. 8.6 SETTING THE OUT OF RANGE ALERT The Out of Range Alert lets you know when the Sensor/Transmitter and Receiver are not talking to each other. Typically, you should keep the Sensor/ Transmitter and Receiver within 20 feet (6 meters) of each other.
2. On the Out of Range menu, press the TOP or BOTTOM TOGGLE button to choose “On/Off”. Then, press the SELECT button to select “On”. If you do not want to receive Out of Range Alerts press the SELECT button to choose “Off”. 3. Next, on the Out of Range menu, press the TOP or BOTTOM TOGGLE button to choose “Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option and press the SELECT button. 4.
8 8.7 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTS You have the option to set a snooze time (every 15 minutes up to 5 hours) in between High and Low glucose Re-alerts. NOTE: To set a snooze time for your High and Low Alerts, Advanced Features must be turned on. TOGGLE button to choose “Snooze” and press the SELECT button. Example-High Alert 2. Press the TOP or BOTTOM TOGGLE button to select the amount of time (in 15 minute increments) in between the first Alert and Re-alerts.
chapter nine TROUBLESHOOTING
9.1 SENSOR INSERTION TROUBLESHOOTING Sensor Insertion Difficulties • I am having trouble taking out the Safety Lock/Transmitter Key: - Make sure to pull straight out using the arrows on the Safety Lock as a guide. - Do not wiggle back and forth. • I am not able to pull the Collar up: - Make sure the plunger is completely pressed down before pulling the collar up. - When pulling the Collar up you should hear 2 clicks. - Try using more force when pulling the collar up.
9 9.2 CALIBRATION TROUBLESHOOTING Prompts may appear during or shortly after you try to calibrate your System. Review the following troubleshooting tips so that your calibration is successful.
Additional Startup Blood Drop Prompt The Additional Startup Blood Drop Prompt (with 1 checked) means you need 1 more fingerstick reading for Startup Calibration. This screen will appear and the Receiver will make a medium tone and vibrate once (if set to “Vibe then beep”). The Receiver will continue to show the Additional Startup Blood Drop Prompt screen every 15 minutes until the fingerstick reading is successfully entered into the Receiver.
9 9.2.1.2 STATUS AREA SYMBOLS DURING BLOOD DROP PROMPTS If you are prompted repeatedly by the Double Blood Drop screen, Additional Startup Blood Drop screen (1 checked), or the Single Blood Drop screen, make sure you first check the Status Area on your Receiver before you take another fingerstick reading. Then follow the steps below: 1. Clear the prompt from the Screen by pressing any button on the Receiver. 2. Check the Status Area in the upper right corner of your Receiver.
e. If the Out of Range Symbol is displayed, do not take any more fingerstick readings for calibration at this time. Move the Receiver and Transmitter so that they are within 20 feet (6 meters) of each other and wait at least 5 minutes. 1. Make sure your Transmitter ID is entered into the Receiver (see Chapter 2, Section 2.4) 2. Make sure your Transmitter is fully snapped in If you are still having problems with communication review Chapter 5, Section 5.4.4.
9 During use your System may detect problems that make your Sensor unable to calculate glucose readings (see Chapter 5, Section 5.4.3). At this time the Sensor session will stop automatically and the following screen will appear. Sensor Failed Screen 9.4 CALIBRATION ERROR TROUBLESHOOTING The screen to the right means your Sensor cannot calibrate. If you see this screen, enter at least 1 more calibration fingerstick reading after about 10-15 minutes.
Note any code that may appear on the screen, and contact DexCom Technical Support at 1-888-SEVENGO (738-3646). Continue to check blood glucose readings using your meter. System Recovery Check This screen indicates that the System discovered an error that it was able to fix itself. Press any button on the Receiver to clear this display, and your continuous monitoring session will continue. System Recovery Check Screen 9.5 RECEIVER AND CABLES TROUBLESHOOTING Battery and Charging Difficulties 1.
9 Alerts Not Working 1. Make sure you have not disabled the sound and/or vibrations for the Alerts. Chapter 2, Section 2.5 explains how to change these Alert options. 2. Check to be sure that Advanced Features is turned on. If not, you will not receive Rise and Fall Rate Alerts. 3. Remember “Vibe then Beep” will vibrate during the first alert and then will beep during the re-alert. If you do not hear a sound during the first alert, this is normal. 9.
chapter ten chapt TAKING CARE OF YOUR G4-GLOBAL G4-G SYSTEM
10.1 MAINTENANCE The G4-Global Receiver requires minimal maintenance. Keep the following tips in mind: Sensor and Transmitter • Insert the Sensor only as directed. • Snap the Transmitter completely into the Sensor Pod in the correct alignment. • Calibrate the G4-Global Receiver every 12 hours as directed. • Do not wear the Sensor/Transmitter in water deeper than 3 feet and do not wear the Sensor/Transmitter in water for over 30 minutes. • Remove the Sensor and Transmitter as directed.
10 10.2 STORAGE Sensor • Keep the Sensor in its sterile packaging until you are ready to use it. • Do not insert Sensors past the expiration date printed on the Sensor packaging. • Storage Temperature should be 36°-77° F (2°-25° C) for the length of its shelf life. You may store your Sensors in the refrigerator if it is within this temperature range. Transmitter • Keep the Transmitter clean and protected when not in use. • Transmitter Warranty is 6 months.
NOTE: • Always clean the Receiver and Transmitter after each use. • Do NOT use bleach or acetone to clean the Receiver and Transmitter. For Single-Patient Use Cleaning 1. Use an alcohol wipe, or equivalent to clean the outside of the Receiver and Transmitter. Avoid using wipes that contain adhesive properties. (e.g. Smith + Nephew IV Prep™). NOTE: Do NOT get the DexCom Receiver wet.
10 Cleaning 6. Use an alcohol wipe, or equivalent, to clean the outside of the Receiver and Transmitter. Avoid using wipes that contain adhesive properties (e.g. Smith + Nephew IV Prep™). NOTE: Do NOT get the DexCom Receiver wet. Ensure the wipe is slightly damp, but not wet enough to leave drops of liquid on the Receiver surface (particularly the openings and buttons). 7. Verify that any signs of bodily fluids have been wiped away. The presence of bodily fluids is rare. 8.
chapter apter eleve eleven STUDY RESULTS
11.1 DEVICE PERFORMANCE CHARACTERISTICS Section 11.1 The G4-Global Receiver uses a glucose Sensor toPivotal continuously measure and Placeholder for G4-Global Receiver Study Results monitor your glucose levels. The Sensor is “calibrated” using your OneTouch® Ultra® blood glucose meter (Auto Upload) or a FDA-cleared blood glucose meter (using the OpenChoiceTM feature). Once calibrated, the G4-Global Receiver reports glucose readings up to every 5 minutes.
11 Clinical Study Results Section 11.1 ToPlaceholder evaluate performance of the G4-Global Receiver, 53 participants were for G4-Global Receiver Pivotal Study Results enrolled in a clinical study conducted at 3 clinics. All participants had Type 1 or Type 2 diabetes mellitus, and required insulin to manage their diabetes. About 81% of participants had Type 1 diabetes and about 19% had Type 2 diabetes. Subjects ranged in age from 23 to 72 years old.
The agreement of the G4-GlobalSection Receiver 11.1 to blood glucose levels was assessed by calculating the percentage of G4-Global Receiver readings that Placeholder for G4-Global Receiver Pivotal StudyFor Results were within 20%, 30%, and greater than 40% of the YSI readings. readings less than or equal to 80 mg/dL the difference in mg/dL between the two glucose readings was calculated. For readings greater than 80 mg/dL the percent difference (%) from the YSI reading was calculated.
11 • On 19 occasions, the G4-Global Receiver11.1 indicated the glucose reading was Section less than 40 mg/dL and displayed “LOW”. Of these, the YSI blood glucose Placeholder forbelow G4-Global Results readings were never 40 mg/dLReceiver and rangedPivotal betweenStudy 43 mg/dL up to 141 mg/dL. • On 39 occasions, the G4-Global Receiver indicated the glucose reading was greater than 400 mg/dL and displayed “HIGH”. Of these, the paired YSI glucose reading was also above 400 mg/dL twelve (12) times.
Also at the 90 mg/dL alert level, Section 25% of the11.1 time the G4-Global Receiver may falsely alert you that your glucose level is at or less than 90 mg/dL when your Placeholder forreading G4-Global actual blood glucose is aboveReceiver 90 mg/dL atPivotal that time.
11 Section Table 2. Hypoglycemic Alert Evaluation 11.1 Placeholder for G4-Global Study Results G4-Global True Alert Receiver False Pivotal Alert Missed Alert Receiver Alert Level Rate* Rate** Rate*** 60 mg/dL 59 % 61 % 41% 70 mg/dL 57% 46 % 44 % 80 mg/dL 64 % 29 % 36 % 90 mg/dL 73 % 25 % 27 % * True Alert Rate is the % of time when the blood glucose level was at or below the alert setting and the alert sounded.
Section Table 3. Hyperglycemic Alert Evaluation 11.1 Placeholder for G4-Global Receiver Pivotal Study Results Missed Alert Alert Setting True Alert Rate* False Alert Rate** 140 mg/dL 92 % 6% 8% 180 mg/dL 84 % 6% 16 % 200 mg/dL 82 % 7% 18 % 220 mg/dL 80 % 8% 20 % 240 mg/dL 77 % 8% 23 % 300 mg/dL 59 % 27 % 41 % Rate*** * True Alert Rate is the % of time when the blood glucose level was at or above the alert setting and the alert sounded.
11 Section 11.1 Accuracy between for matched pairs wasReceiver also estimated by calculating the percent Placeholder G4-Global Pivotal Study Results Accuracy difference between the G4-Global Receiver reading and the YSI reading. The G4-Global Receiver and YSI readings were compared by pairing the G4-Global Receiver reading that fell approximately 5 minutes after the YSI reading was collected.
Section 11.1 reads 13% higher than the Table 4 shows that the G4-Global Receiver, on average, YSI at glucose levels of 40-80 mg/dL and reads 9% lower, on average, than the YSI at Placeholder for G4-Global Receiver Pivotal Study Results glucose concentrations of 301-400 mg/dL (Mean Percent Difference).
11 Figure 1. Section 11.1 Clarke Error Grid, G4-Global Receiver Results Compared to YSI Results Placeholder for G4-Global Receiver Pivotal Study Results Point Error Grid Regions for All Site The percentage of G4-Global Receiver results in the above graph are presented in Table 6 on the next page according to the percentage of points falling within each zone (A-E). Results are further broken down (stratified) according to the range of glucose concentration.
Section 11.1 Placeholder for G4-Global Receiver Pivotal Study Results YYY YSI Reading ••• G4-Global Receiver Glucose Reading Table 6.
11 The Continuous Error Grid was also used to11.1 determine if the G4-Global Receiver Section results are “clinically acceptable.” The Continuous Error Grid looks at how closely for G4-Global Receiver Study thePlaceholder G4-Global Receiver readings match to the YSI Pivotal Analyzer and alsoResults how closely the G4-Global Receiver glucose rate of change (how fast the glucose rises or falls) compares to the actual blood glucose rate of change measured by the YSI.
Calibrations Stability Section 11.1 The G4-Global Receiver must be calibrated every 12 hours. Study To demonstrate Placeholder for G4-Global Receiver Pivotal Results performance of the G4-Global Receiver over a 12-hour calibration period, 71 Sensors were evaluated to verify that performance remains consistent over the 12-hour calibration period. G4-Global Receivers were evaluated in 3-hour increments after calibration.
11 Sensor Stability Section 11.1 Sensors can be worn up to 7 days.Receiver To verify thatPivotal sensors Study perform Results consistently Placeholder forforG4-Global over the 7-day period, 71 Sensors were evaluated across the 7-day wear period. Performance was estimated by calculating the percentage of G4-Global Receiver readings within 20%, 30% and >40% of the YSI readings at the beginning (Day 1), middle (Day 4) and end (Day 7) of the G4-Global Receiver lifecycle. Results are shown in the table below.
Sensor Life Section 11.1 During the trial there no Sensor insertion problems andStudy SensorsResults may be Placeholder forwere G4-Global Receiver Pivotal worn for up to 7 days (168 hours). To estimate how long a G4-Global Receiver Sensor will work over 7 days, the 71 Sensors were evaluated to determine how many Days (hours) of readings each Sensor provided. Table 10, below, displays how long you can expect a Sensor to last after insertion.
11 Number of Readings Provided Section 11.1 The G4-Global Receiver is capable of Receiver providing a reading to everyResults 5 minutes, Placeholder for G4-Global PivotalupStudy or up to 288 readings per day. For a variety of reasons, this does not always happen. Sometimes sensors cannot provide readings after calibration and readings are “skipped” (see Chapter 5). Table 11, below, estimates the number of readings you can expect to receive from the G4-Global Receiver over the entire 7-day period.
Time-Elapsed Plots Section 11.1 Examples of G4-Global Receiver Continuous Glucose Monitoring System Placeholder for G4-Global Receiver Pivotal Study Results overlaid with the corresponding YSI readings over time are presented on the next page. The horizontal axis represents time, with the matching G4-Global Receiver and YSI readings plotted above the point in time when the measurements were taken. The circles (•) on the graph represent the G4-Global Receiver data. The “Y” represents the YSI reading.
11 Figure 3. Example of “ Average”Section G4-Global11.1 Receiver Performance Placeholder for G4-Global Receiver Pivotal Study Results Figure 4.
11.2 PRODUCT SPECIFICATIONS Sensor Glucose Range 40-400 mg/dL (2.2 – 22.2 mmol/L) Sensor Life Up to 7 days Calibration FDA-cleared blood glucose meter Calibration Range 40-400 mg/dL (2.2 – 22.2 mmol/L) Operational Conditions Humidity: Maximum 95 % Relative Storage Condition Temperature: 2°-25° C (36°-77° F) Moisture Protection IPX 5: water resistance to jetting water Sterilization Sterile by radiation IPX 8: temporary submersion to a depth of 8 feet (2.
11 Transmitter Dimensions (including Sensor Pod) Length: 1.5 inches (3.8 cm) Width: 0.9 inches (2.3 cm) Thickness: 0.5 inches (1.3 cm) Weight (including Sensor Pod) 0.4 ounces (10 grams) Communication Range 20 ft (6m) Frequency Range 2.425 - 2.
PARAMETER PERFORMANCE CHARACTERISTICS Frequency Allocation 2.4 GHz ISM Band TX/RX Frequencies 2.424 999 877 GHz 2.449 993 677 GHz 2.474 737 539 GHz 2.477 236 919 GHz Bandwidth 270.833 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 4.48 ms every 5 minutes at each of the four TX frequencies. Data Detection Range 20 ft (6m) Average Number of Collisions due to Coexistence.
11 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Transmitter is intended for use in the electromagnetic environment specified below.
Receiver Reading Frequency Every 5 minutes Dimensions Length: 4.5 inches (11.4 cm) Width: 2.3 inches (5.8 cm) Thickness: 0.85 inches (2.2 cm) Weight 4.0 ounces (113.39 g) Communication Range 20 ft (6m) Memory Storage 30 days of user data, 7 days of tech support Re-Chargeable Battery Use 3 to 5 days Charging Time 3 hours wall outlet, 5 hours USB Storage/Operating Conditions Temperature: 0°- 45° C (32°- 113° F) Humidity: 10-95 % Relative Operating Pressure 10.2 to 21.
11 Guidance and Manufacturer’s Declaration- Electromagnetic Immunity The Receiver is intended for use in the electromagnetic environment specified below. The customer or the user of the Receiver should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance Power Frequency 3 A/m 3 A/m Power Frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment (50/60 Hz) Magnetic Field IEC 61000-4-8 Note: UT is the a.c.
11 Immunity Test Conducted RF IEC 61000- 4-6 Radiated RF IEC 61000-4-3 IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance 3 Vrms 150 k Hz to 80 MHz 3V Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). 3 V/m 80 MHz to 2.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and Receiver The Receiver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
11 11.3 FCC REQUIREMENTS The Transmitter covered by this User’s Guide has been certified under FCC ID: PH29433 Although the Transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from the Transmitter will be free from interference. Compliance Statement (Part 15.19) This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: 1.
chapter hapter twelve APPENDIX
APPENDIX I, OTHER ALERTS This table describes the Other Alerts, how to clear them and when you will be re-alerted by the Receiver. Screen Alert Title Description Re-Alert Clearing Alerts ReAlert After Clear Low Battery The Receiver battery is low. Charge your Receiver as soon as possible when you see the Low Battery Alert. 2 times in the next 10 minutes Press any Receiver button Every 60 minutes Single Blood Drop Prompt The Receiver needs a calibration fingerstick reading.
12 Screen Alert Title Description Re-Alert Clearing Alerts Re-Alert After Clear Wait 15 minutes to calibrate The Sensor is not calibrating properly (see Section 8.4, “Error Code Troubleshooting for instructions on what to do is you see this screen). Every 5 minutes Press any Receiver button Every 15 minutes until you fix the problem, or your glucose level changes enough to fix the problem itself Your Sensor session will soon expire, and you will need to change your Sensor soon.
Screen Alert Title Description Re-Alert Clearing Alerts ReAlert After Clear Sensor Failed The Sensor is not working properly (see Section 8.3, “Sensor Failed Troubleshooting”). 2 times in the next 10 minutes Press any Receiver button None Receiver Error There is a problem with the Receiver. Write down the code on the screen, and contact DexCom. None. The Receiver will beep and vibrate for 5 seconds and then will be silent.
12 APPENDIX II, RECEIVER SCREENS & PROMPTS The following prompt screens may appear on the Receiver during use: DOUBLE BLOOD DROP PROMPT: Appears about 1 hour after you insert a new Sensor, and tells you that you need to take 2 fingerstick readings on your meter and enter them for calibration. DOUBLE BLOOD DROP PROMPT, (1 CHECKED): This tells you that only 1 fingerstick reading has been successfully entered. You need to take at least 1 more fingerstick reading on your meter and enter it for calibration.
LOW GLUCOSE ALARM: Your System reading is at or below the factory Low Glucose ALARM level (55 mg/dL). You cannot change this ALARM level. RISE ALERTS: Either the Rise Alert or Rapid Rise Alert may appear, depending on the Rise Alert level you set. Rise Alert: Your glucose levels are rising at 2 mg/dL per minute or more. OR Rapid Rise Alert: Your glucose levels are rising fast at 3 mg/dL per minute or more.
12 OUT OF RANGE/NO ANTENNA: The Receiver and Transmitter are not talking and your glucose readings have not been sent to the Receiver in the last 5 minutes. If you see this screen (with no Antenna in the upper left hand corner) you should make sure the Symbol Receiver and Transmitter are within 20 feet (6m) of each other. See Chapter 8 for Troubleshooting. UNKNOWN SENSOR GLUCOSE READINGS: appears in the upper right corner of the Trend Graph.
2-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor session will end in 2 hours. 30-MINUTE SENSOR EXPIRATION NOTIFICATION: Your Sensor session will end in 30 minutes. 0-HOUR SENSOR EXPIRATION NOTIFICATION: Your Sensor session has ended. Once you clear the Alert, your Receiver will be notified that the Sensor has been removed. You should clear this notification by pressing any Receiver button, then remove your Sensor at this time.
12 GLOSSARY The following list of terms will help you while reading though this guide: Alternative Site Testing (BG) This is when you obtain a glucose reading on your meter using a blood sample from an area on your body other than your fingertip. Do not use alternative site testing for entering blood glucose readings into the G4-Global Receiver. Applicator A disposable component piece that comes attached to the Sensor Pod, and inserts the Sensor Probe under the skin.
mg/dL Milligrams per deciliter. The standard unit of measure for glucose readings in the United States. Range The distance between the Receiver and Transmitter. Keep the 2 devices within 20 feet (6 meters) from each other to get glucose information on your Receiver Rise and Fall (Rate of Change) Alerts Alerts based on how fast your glucose levels rise/fall, and by how much. Receiver An MP3-like device, which collects your glucose information from the Sensor/Transmitter.
12 Transmitter Latch The small disposable component that snaps the Transmitter into the Sensor Pod. It is removed after the Transmitter is snapped in. Trend (Rate of Change) Arrows Arrows on Trend Graphs that indicate if and how fast your glucose levels are changing. The are 7 different arrows that show when your glucose speed and direction change. SYMBOLS USED IN LABELING The following symbols may be found on the Sensor, Transmitter, and Receiver package labels.
Water resistant to jetting water Type B Applied Part Temporary submersion to a depth of 8 feet (2.44 meters) for 24 hours Follow Operating Instructions Manufacturer Authorized Representative in the European community Humidity Limitation :: ADDITIONAL INFORMATION Receiver INPUT: 5 VDC, 750 mA Rated supply voltage range: 100-240 VAC (AC supply) Phases and current: 0.
index A ALARM, Low Glucose 65 Alerts 62 Glucose Alerts 29, 62 High 29, 63, 90 Low 29, 64, 90 Snooze 108 Not Working 118 Other Alerts 105 Setting 29, 63, 64, 90, 92, 103 Rise and Fall 65, 92, 103 (Rate of Change) Setting Out of Range Alert 106 Alternative Site Testing (BG) 47 Antenna Symbol 42 Missing 69 Arrows, Trend (Rate of Change) 61, 105 B Battery, Receiver 31 Charging 31 Troubleshooting 117 Blood Glucose (BG) Meter 6, 7, 15, 47 Blood Glucose (BG) Reading 15, 47 C Cable, Connection 31, 117 Calibratio
R Radio-Frequency Range Receiver Charging your Overview Screens, viewing Settings 15 69 17 31 17 19 27 S Safety Information 7 Caution 8 Contraindications 7 Indication for Use 6 Precautions 8 Safety Lock (Transmitter Key) 15, 79 Screens, Receiver 19 Prompts and Notifications 50, 52, 112 Trend Graphs 19, 58-60 Sensor 5, 33 Applicator 5, 38 Automatic Shut-Off 76 Early Shut-Off 77 Expiration Date 35 Failed 77, 115 Insertion 39 Insertion Site 37 Overview 15 Pod 15, 36, 38 Probe 15 Removing the Sensor from Pack
index W Water Resistance 44, 122, 167 170 | Continuous Glucose Monitoring System
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