Dexcom G4 CONTINUOUS GLUCOSE MONITORING SYSTEM USER’S GUI DE
Dexcom G4 CONTINUOUS GLUCOSE MONITORING SYSTEM
IMPORTANT CONTACTS AND NUMBERS Dexcom Website: www.dexcom.com Your Transmitter ID: Your Receiver ID: Your Healthcare Professional: Nearest Hospital: Other Notes: © 2013 Dexcom, Inc. All rights reserved. Dexcom, Dexcom G4, Dexcom Studio, SEVEN, Stay Between the Lines and The Glucose Sensor Company are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries.
DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM Dexcom G4 Receiver Dexcom G4 Sensor Dexcom G4 Transmitter SYSTEM CONTENTS: Reorder only the Dexcom G4 System components listed below: • sensor • transmitter • receiver • receiver USB charging/download cable • charger - MT21255 • adapter plugs - MT21561 • receiver case • user’s guide • quick start guide • tutorial CD •D excom Studio software (optional) HELPFUL HINT: Sensors are sold separately.
INTRODUCTION When you use the system, you will see continuous sensor glucose readings updated every 5 minutes for up to 7 days. These readings will help you detect trends and patterns in your glucose levels. The system includes the sensor, the transmitter, and the receiver. The sensor is a disposable unit that you insert under the skin of your abdomen (belly) to continuously monitor your glucose levels for up to 7 days.
INDICATIONS FOR USE The Dexcom G4 Continuous Glucose Monitoring System is a glucosemonitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for use by patients at home and in healthcare facilities and requires a prescription (United States). The Dexcom G4 System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
WARNINGS • Do not use the Dexcom G4 CGM System until after you have been trained or viewed the training materials included with your CGM system. • The blood glucose value from your blood glucose meter should be used for treatment decisions, such as how much insulin you should take. The Dexcom G4 System does not replace a blood glucose meter. Blood glucose values may differ from sensor glucose readings.
• Avoid areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. • Avoid injecting insulin or placing an insulin pump infusion set within 7.62 cm of the sensor in case the insulin affects the sensor glucose readings. •T he sensor is sterile in its unopened, undamaged package. Do not use any sensor if its sterile package has been previously damaged or opened.
table of contents DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM: SYSTEM KIT CONTENTS INTRODUCTION INDICATIONS FOR USE IMPORTANT USER INFORMATION 5 6 7 7 CHAPTER 1: THE DEXCOM G4 SYSTEM BASICS 1.1 Sensor Overview 1.2 Transmitter Overview 1.3 Receiver Overview 1.4 Charging Your Receiver Battery 1.4.1 Charging Your Receiver Battery from an AC Power Outlet 1.4.2 C harging Your Receiver Battery from a Windows Compatible Computer. 1.4.
CHAPTER 4: CALIBRATING YOUR DEXCOM G4 SYSTEM 4.1 Calibration Overview 4.2 How to Calibrate 4.3 Startup Calibration 4.4 12 Hour Calibration Update 4.5 Other Reasons You May Need to Calibrate 47 49 50 53 53 54 CHAPTER 5: S ENSOR GLUCOSE READINGS AND TRENDS 5.1 Sensor Glucose Readings 5.2 Rate of Change Arrows 5.3 Glucose Status Area Symbols 55 58 60 62 CHAPTER 6: ALERTS, ALARMS AND ALERT PROFILES 6.1 Setting Your Alerts 6.1.1 Default Alert/Alarm Settings 6.1.2 Glucose Alerts 6.1.3 High Glucose Alert 6.
CHAPTER 8: COMPLETING A SENSOR SESSION 8.1 Automatic Sensor Shut-off 8.2 Removing a Sensor 8.3 Transmitter Removal 91 94 95 95 CHAPTER 9: TROUBLESHOOTING 9.1 Sensor Insertion Troubleshooting 9.2 Calibration Troubleshooting 9.2.1 Types of Calibration Prompts 9.2.2 Status Area Symbols During Calibration Prompts 9.3 Calibration Error Troubleshooting 9.4 System Glucose Error 9.5 Sensor Inaccuracies 9.6 Sensor Shut-off Troubleshooting 9.6.1 Early Sensor Shut-off - Sensor Failure 9.6.
chapter one THE DEXCOM G4 SYSTEM BASICS Dexcom G4 User’s Guide | 13
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1.1 SENSOR OVERVIEW The sensor is placed under the skin of your belly and continuously measures your glucose levels. The sensor and transmitter (once snapped in) remain on your belly for the entire sensor session, up to 7 days. Plunger Safety lock Applicator barrel (contains small introducer needle and sensor) Transmitter Latch Collar Sensor pod Release Tab 1.2 TRANSMITTER OVERVIEW The transmitter wirelessly sends your glucose information to the receiver.
1 1.3 RECEIVER OVERVIEW The receiver is a small hand-held device that shows your sensor glucose readings, direction and rate of change arrow and trend graph. The international standard unit of measurement used for glucose testing systems (i.e., blood glucose meters) is mmol/L (millimoles per liter). The transmission range from the transmitter to the receiver is up to 6 meters. Your receiver is rated IP22, which means that it offers some protection from rain drops.
There are five receiver buttons to move you through the display screens that control setup and operation and allow you to change your receiver settings. The screens display sensor glucose readings, trend graphs and trend arrows. Your receiver and transmitter are wirelessly paired together to communicate securely and only with each other. You will need a commercially available blood glucose meter to use with your system.
1 1.4 CHARGING YOUR RECEIVER BATTERY The receiver battery is rechargeable. The rechargeable battery will typically last about 3 days before you need to charge it with the charging cable provided. Your battery life depends on how often you interact with your receiver. The receiver will alert you when the battery charge is low.
To remove the plug from the AC power adapter place both thumbs on the bottom of the plug and push up until the plug pops out of the adapter. To recharge your battery, follow the instructions below: 1. P lug the included USB cable into the AC power adapter. 2. Plug the AC power adapter into an AC power outlet. 3. S lide open the USB port cover on the side of the receiver to access the port 4. P lug the micro USB end of the cable into the receiver USB port.
1 1.4.2 CHARGING YOUR RECEIVER BATTERY FROM A WINDOWS COMPATIBLE COMPUTER The Dexcom Studio software must be installed to charge your receiver from a computer. 1. Plug the included USB cable into your computer. 2. Plug other end of the USB cable into the receiver. 3. The battery charging screen will appear on the receiver. 4. After a few seconds the trend graph will reappear with the battery charging symbol shown in the upper left corner.
1.4.3 KNOWING YOUR RECEIVER IS CHARGED 1. As the battery charges, the battery symbol will begin to fill in. The battery is fully charged when battery symbol is completely shaded. Start Fully Charged 2. After the charge is complete, remove the cable from the receiver and the wall outlet or computer USB port. HELPFUL HINTS: •C harge your receiver battery before each sensor insertion. Periodically check your battery level to make sure it has enough charge.
1 ore information on main menu options can be found in the sections listed M 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 5 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. Chapter 3 Enter BG To enter your blood glucose values for calibration.
chapter two DEXCOM G4 SYSTEM SETUP Dexcom G4 User’s Guide | 23
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This chapter will help you when you first set up your Dexcom G4 Continuous Glucose Monitoring System. Read this chapter before you start. 2.1 THE SETUP WIZARD 1. B efore setting up the receiver remove the transmitter from its packaging. It takes 10 minutes for the transmitter to turn on after it is removed from its packaging. 2. Make sure your receiver is fully charged (see Chapter 1, Section 1.4, Charging Your Receiver Battery). 3. Turn your receiver on by pressing the SELECT button on the receiver.
2 c. Set the time and date. The date format is YYYY/MM/DD. • Press the UP or DOWN button to enter the current date and time. • Press the RIGHT button (show icon) to move to the next section. • Press the SELECT button to confirm changes to time and date. d. Enter your transmitter ID. • Press the UP or DOWN button to enter your transmitter ID. • Press the SELECT button to confirm entry of transmitter ID.
e. S et your low and high glucose alert values. Your low and high glucose alerts are pre-set to 4.4 mmol/L and 11.1 mmol/L, but can be changed to meet your needs. •P ress the UP or DOWN button to select your desired alert value. Changes can be made in increments of 0.1 mmol/L. • Press the SELECT button to confirm your preferred alert value. The Setup Wizard is now complete.
2 2.2 THE SETTINGS MENU The settings menu shows you how to change the time, date or transmitter ID after you have already completed the Setup Wizard. 2.2.1 GETTING TO THE SETTINGS MENU 1. P ress 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. F rom the main menu, press the UP or DOWN button to scroll to “Settings” and press the SELECT button. The settings menu will appear. 2.2.
HELPFUL HINT: • You might need to reset the receiver’s time and date if the rechargeable battery is drained. If this happens, you will be alerted and automatically taken to the time/date setting screen. 2.2.3 ENTERING YOUR TRANSMITTER ID Any time you switch to a new transmitter and/or receiver (as a replacement to the transmitter and/or receiver that came in your kit) you must enter the transmitter ID into your receiver.
2 2.2.4 SETTING YOUR RECEIVER TIME FORMAT To set your receiver time format (24-hour or AM/PM) follow the steps below. 1. F rom the Settings menu, press the UP or DOWN button to scroll to “Time Format” and press the SELECT button. 2. P ress the UP or DOWN button to scroll and highlight your desired time format. 3. P ress the SELECT button to set the highlighted time format. You will return to the settings menu. 2.2.
2.3 CHECKING INFORMATION ABOUT YOUR DEXCOM G4 SYSTEM You can check your receiver for information about your CGM at any time. 1. F rom the Settings menu, press the UP or DOWN button to scroll to “Device Info” and press the SELECT button. 2. Information about your sensor session and system will appear.
2 2.4 TRANSMITTER AND RECEIVER COMMUNICATION The Dexcom G4 Sensor, Transmitter, and Receiver must be removed prior to Magnetic Resonance Imaging (MRI), CT scan, or diathermy treatment. The Dexcom G4 System has not been tested during MRI, CT scans or with diathermy treatment, and it is unknown if there are safety or performance issues. The transmission range from the transmitter to the receiver is up to 6 meters without obstruction.
chapter three INSERTING A SENSOR AND STARTING A SENSOR SESSION Dexcom G4 User’s Guide | 33
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To use your Dexcom G4 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 sensor glucose readings for up to 7 days. The following sections will show you how to insert the sensor and start a new continuous glucose monitoring session. Please review the tutorial on the CD in your kit.
3 r Make sure you are using your blood glucose meter per the manufacturer’s instructions to ensure you are getting accurate blood glucose values for calibration. r Clean the bottom of the transmitter with a wrung-out, slightly water-dampened cloth or isopropyl alcohol wipe. Place the transmitter on a clean, dry cloth and air dry for 2-3 minutes. r Make sure your blood glucose meter and receiver date and time match. Sensors should be stored at temperatures between 2° C - 25° C.
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. • Wash your hands thoroughly and dry them. •C arefully remove the sensor from its packaging. Look closely at the sensor to make sure it is not damaged. •T he 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 The Dexcom G4 System is a glucose-monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. 1. C lean the area first with an alcohol wipe. Make sure the area is clean and completely dry before you insert the sensor. 2. U sing the white tabs on the adhesive backing, remove the adhesive backing from the sensor pod one half at a time. Hold the sensor by the applicator barrel and try not to touch the sticky adhesive patch.
HELPFUL HINT: • The safety lock can be 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 8, Section 8.3, Transmitter Removal. 3.5 SENSOR INSERTION Once you have placed the applicator on your belly and removed the safety lock, you are ready to insert the sensor. To insert your sensor follow the steps below: 1.
3 4. To remove the applicator barrel, squeeze the ribbed release tabs on the sides of the sensor pod (when you squeeze the front part of the release tabs, the back part of the tabs will widen, allowing you to pull off the applicator barrel.) After this step, only the sensor pod will be left on your body. •M ake sure the transmitter latch is down (against your body) to remove the applicator barrel.
3. W ith one hand, you may want to pinch up on your skin at the front edge of the white adhesive. a. Place one finger on the transmitter to keep it in place while securing the transmitter into the sensor pod. Transmitter latch b. Pull the transmitter latch over the transmitter to snap the transmitter into place. The transmitter should lie flat in the sensor pod. You should hear 2 “clicks.” If you do not hear 2 “clicks,” the transmitter might not be fully snapped in.
3 3.7 STARTING A SENSOR SESSION Follow the steps below to tell the receiver that you have inserted a new sensor. 1. Press the SELECT button to turn the receiver on. 2. F rom any trend graph, press the SELECT button to display the main menu. 3. P ress the Up or DOWN button to scroll until you highlight “Start Sensor.” 4. P ress the SELECT button to confirm the start of a new sensor session.
3.8 SENSOR STARTUP PERIOD The sensor needs a 2-hour startup period to adjust to being under the skin. When you press the SELECT button during the startup period to turn the receiver display on, your trend graph will include a 2-hour countdown symbol in the upper right hand corner. Over time, the countdown symbol will fill to indicate that you are getting closer to initial calibration time. See the pictures below for an example of what this looks like.
3 3.9 TAPING THE SENSOR POD The sensor pod should stay securely attached to your skin using its own adhesive. But, if the patch is peeling up, you can use medical tape (such as Blenderm, Tegaderm, IV 3000, 3M tape) for extra support. If you use tape, only tape over the white adhesive patch on all sides for even support. Do not tape over the transmitter or any of the plastic parts of the sensor pod. Do not tape under the sensor pod or leave any substance on the skin where you insert the sensor. 3.
HELPFUL HINTS: •R emember that your alerts and low glucose alarm will not work when the receiver is shut down. •S hutting down the receiver does not extend the sensor life beyond 7 days. Your sensor session will stop 7 days after you started the sensor session. 3.11 THE DEXCOM G4 SYSTEM AND WATER Your sensor is water resistant when showering, bathing, or swimming if the transmitter is fully snapped in. The sensor has been tested to be water resistant when submerged for up to 2.
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chapter four CALIBRATING YOUR DEXCOM G4 SYSTEM Dexcom G4 User’s Guide | 47
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The Dexcom G4 System requires you to calibrate the sensor glucose readings to your blood glucose meter. Taking acetaminophen (paracetamol) containing products (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen (paracetamol) active in your body. 4.1 CALIBRATION OVERVIEW There are important times when you must calibrate: 1. Initial startup: 2 hours after you insert your sensor 2.
4 HELPFUL HINTS: •D o not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration as alternate site blood glucose values may be different than those obtained from a fingerstick blood glucose value. Use a blood glucose value obtained only from a blood glucose meter for calibration. • I n order to obtain accurate sensor glucose readings proper calibration is required using accurate blood glucose values. 4.
HELPFUL HINT: • “ Enter BG” will be the second main menu option when you are in the middle of a sensor session. a. W hen the receiver does not have a recent sensor glucose reading the default is 6.7 mmol/L. b. I f there has been a sensor glucose reading in the past 15 minutes, the “Enter BG” screen will display your current sensor glucose reading as your starting point. Do not use the current sensor glucose reading for calibration. Use only blood glucose values from your meter. c.
4 8. F or startup calibration, repeat these steps for the second blood glucose value. 9. A sensor glucose reading will appear on the receiver right away, and sensor glucose readings will be updated every 5 minutes. 10. I f readings do not appear immediately, see Chapter 9, Section 9.2, Calibration Troubleshooting. HELPFUL HINTS: •B efore calibration make sure a sensor glucose reading or a blood drop symbol is displayed at the top of the trend graph.
4.3 STARTUP CALIBRATION Two hours after you start the sensor session (see Chapter 3, Section 3.7, Starting a Sensor Session) the receiver will tell you that you need to calibrate by displaying the startup calibration prompt. This prompt means you need to calibrate with 2 separate blood glucose values from your meter. You will not see sensor glucose readings until the receiver accepts the blood glucose values. Startup calibration prompt 1.
4 1. W hen you see this calibration prompt it means it is time to calibrate with a single blood glucose value. You can clear the prompt by pushing the SELECT button. The system will re-alert you every 15 minutes until the receiver accepts the blood glucose value. 2. Take 1 blood glucose measurement with your meter Calibration prompt and enter the blood glucose value into the receiver. If this screen reappears shortly after you have entered a new blood glucose value see Chapter 9, Section 9.
chapter five SENSOR GLUCOSE READINGS AND TRENDS Dexcom G4 User’s Guide | 55
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This chapter will teach you how to view your sensor glucose readings and trend information. The trend graph will provide additional information that your blood glucose meter does not. It shows your current glucose value, the direction it is changing and how fast it is changing. The trend graph can also show you where your glucose has been over time. Taking acetaminophen (paracetamol) containing products (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings.
5 5.1 Sensor Glucose Readings Press the select button to wake up the receiver screen. You will see the home screen, which is the 3-hour trend graph. The 3-hour trend graph will show the following: Most recent 5-minute Battery status glucose reading Trend arrow Status area Antenna High glucose alert setting Glucose value Glucose target range Low glucose alert setting Current time • Each “dot” on the trend graph is a sensor glucose reading reported every 5 minutes.
You can view your past glucose information through the 1, 3, 6, 12, and 24 hour trend graphs by pressing the UP or DOWN button. • Your system only reports glucose information between 2.2-22.2 mmol/L. Your trend graph will show a flat line or dots at 22.2 or 2.2 mmol/L when your glucose is outside this range.
5 (Scroll down from the 12-hour graph to reach the 24-hour graph) 24-Hour Trend Graph: The 24-hour trend graph shows your current glucose reading and the last 24 hours of sensor glucose readings. The receiver displays “LOW” when the most recent glucose reading is less than 2.2 mmol/L and “HIGH” when the most recent glucose reading is greater than 22.2 mmol/L. 5.2 RATE OF CHANGE ARROWS Your rate of change arrows add detail about the direction and speed your glucose is changing.
This table shows the different trend arrows your receiver will display: Constant: Your glucose is steady (not increasing/decreasing more than 0.06 mmol/L each minute). Your glucose could increase or decrease by up to 0.8 mmol/L in 15 minutes. Slowly rising: Your glucose is rising 0.06-0.11 mmol/L each minute. If it continued rising at this rate, your glucose could increase up to 1.7 mmol/L in 15 minutes. Rising: Your glucose is rising 0.11-0.17 mmol/L each minute.
5 HELPFUL HINTS: • Trend arrows do not appear when there are glucose data gaps (see Chapter 9, Section 9.4, System Glucose Error). If the glucose reading error symbol , the wait symbol , the out of range symbol , or the blood drop symbol appear at the top of the trend graph, the trend arrows will not appear. • I f the trend arrow is missing, but you are concerned that your blood glucose level may be rising or falling, take a blood glucose measurement test on your blood glucose meter.
Glucose Reading Error Out of Range 15 Minute Calibration Error 1 Hour Calibration Error Wait This icon means the receiver does not understand the sensor signal temporarily. This icon is related to the sensor only. You should wait for more prompts and do not enter any blood glucose values when you see this symbol. This icon means the receiver and sensor/transmitter are not communicating. Make sure the receiver and sensor/transmitter are within 6 meters of each other (see Chapter 1, Section 1.
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chapter six ALERTS, ALARMS AND ALERT PROFILES Dexcom G4 User’s Guide | 65
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This chapter will teach you about your Dexcom G4 CGM System’s many alerts and alarms and how to customize them. 6.1 SETTING YOUR ALERTS 6.1.1 DEFAULT ALERT/ALARM SETTINGS When you receive your Dexcom G4 CGM System the following alerts and alarms are preset on your receiver (see table below).
6 What will I see on the receiver screen? What does this mean? What is the default setting? How will the receiver notify me? Will the receiver re-notify me? Out of Range Alert The Sensor/Transmitter and Receiver are not communicating to each other. Off Off No Rise/Fall Alert Single Arrow Your glucose is rising/falling at or above a rate of 0.11 mmol/L/min (at least 1.7 mmol/dL in 15 minutes). Off Off No Rise/Fall Alert Double Arrow Your glucose is rising/falling at or above a rate of 0.
6.1.2 GLUCOSE ALERTS The Dexcom G4 System lets you create your own personal settings for how you want the receiver to tell you what is going on. The low and high glucose alerts will tell you when your sensor glucose readings are outside your target glucose range. Rise and fall (rate of change) alerts let you know when your glucose levels are changing fast (see Chapter 6, Section 6.2, Advanced Alerts).
6 6.1.4 LOW GLUCOSE ALERT When your sensor glucose readings are at or below your low alert level, this screen will appear with your low glucose alert value displayed. Your receiver will vibrate and/or beep depending on your profile setting. When you set the low glucose alert, this level is indicated by a red line on the trend graph. Low glucose alert set at 4.
6.1.5 LOW GLUCOSE ALARM The Dexcom G4 System also has a fixed low alarm set at 3.1 mmol/L. 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. • For the low glucose alarm the receiver will display the screen to the right. • Re-alarm: The receiver will automatically notify you again in 30 minutes after you press the SELECT button to clear it, if your sensor glucose readings are still at or below 3.1 mmol/L.
6 6.1.7 HIGH AND LOW GLUCOSE ALERTS HELPFUL HINT: • The steps for setting both the high alert and the low alert are the same. The following steps show you how to change your high and low alert settings. 1. F rom the alerts menu, press the UP or DOWN button to select “High Alert” or “Low Alert” and press the SELECT button. 2. P ress the UP or DOWN button to highlight “On/Off” then press the SELECT button to set this option. A check mark will appear next to the current setting. 3.
HELPFUL HINT: • Alerts must be acknowledged by pressing the SELECT button on the receiver. 6.2 ADVANCED ALERTS In addition to your high and low alerts and alarm, the high and low snooze, rise and fall rate and out of range alerts may be set. For any of these advanced alerts follow the steps below. 1. T urn the receiver on by pressing the SELECT button. 2. Press the SELECT button to enter the main menu. 3. P ress the UP or DOWN button to highlight “Alerts” and press the SELECT button. 4.
6 6.2.1 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTS You have the option to set a snooze time, every 15 minutes for up to 5 hours, in between your high and low glucose re-alerts. 1. P ress the UP or DOWN button to choose “High Snooze” or “Low Snooze” and press the SELECT button. 2. P ress the UP or DOWN button to select the amount of time (in 15 minute increments) in between the first alert and re-alerts. Press the SELECT button.
6.2.2 RISE AND FALL GLUCOSE RATE ALERTS Rate alerts notify you when your glucose levels are rising (rise alert) or falling (fall alert), and by how much. You can choose whether your receiver alerts you when your sensor glucose value is either rising or falling 0.11 mmol/L or more per minute, or 0.17 mmol/L or more per minute. If you set your fall rate to 0.
6 The following steps show you how to change your rise or fall rate alert settings. 1. P ress the UP or DOWN button to choose “Rise Rate” or “Fall Rate” and press the SELECT button. 2. P ress the UP or DOWN button to highlight “On/Off,” then press the SELECT button. 3. P ress the UP or DOWN button to choose “On” or “Off.” Then, press the SELECT button to select “On” or “Off.” 4. P ress the LEFT button to go back to the previous screen.
HELPFUL HINT: • You confirm alerts by pressing the SELECT button on the receiver. 6.2.3 SETTING THE OUT OF RANGE ALERT The out of range alert lets you know when the sensor/transmitter and receiver are not communicating with each other. Typically, you should keep the sensor/ transmitter and receiver within 6 meters of each other. When the sensor/ transmitter and receiver are too far apart and are not communicating, you will not receive sensor glucose readings from the sensor.
6 4. P ress the UP or DOWN button to choose the elapsed time, after which the receiver will alert you and continue to re-alert you until you are back in range. Press the SELECT button. 5. W hen finished, press the LEFT button to return to the alerts menu. 6.3 ALERT PROFILES The Dexcom G4 System allows you to set profiles to choose the way you want your alerts to behave. This customizable feature is found under the Profiles option on the Main Menu shown to the right.
HELPFUL HINTS: •O n the first alert notification the receiver will vibrate only (no beep). Regardless of the specific alert profile you chose, if you confirm the initial vibrate alert, you will not receive an additional audible alert. • The fixed low alarm at 3.1 mmol/L cannot be turned off or adjusted. •F or the soft, normal, attentive and hyporepeat profiles the following alert sequence will occur: • The first alert is vibrate only.
6 6.3.1 ALERT PROFILE OPTIONS The vibrate profile can be used when you want to silence the receiver and be alerted by vibration. The only exception to this will be with the fixed low alarm at 3.1 mmol/L, which will alert you as a vibration first, followed by audible beeps 5 minutes later if not confirmed. The soft profile can be used when you need your alert to be discreet. This profile sets all the alerts and alarms to lower volume beeps, which is intended to be less noticeable by people around you.
6.3.
6 The following steps show you how to access and choose the profile you want to set. 1. P ress the SELECT button to turn on the receiver. The 3-hour trend graph will appear. 2. P ress the SELECT button to display the main menu. 3. F rom the main menu, press the UP or DOWN button to scroll to “Profiles” and press the SELECT button. The profiles menu will appear. 4. P ress the UP or DOWN button to scroll to the profile you want to set and press the SELECT button. 5.
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The Events feature allows you to record information about your diabetes management that may help you and your healthcare professionals better understand your glucose patterns and trends. You can enter details about carbohydrate intake, insulin intake, exercise, and issues related to your health. You can then view your trends and track your patterns using the Dexcom Studio software. 7.
7 4. P ress the UP or DOWN button to choose the event you want, “Carbs,” “Insulin,” “Exercise” or “Health” and press the SELECT button. 7.1.2 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. The date format is YYYY/MM/DD.
7.1.3 CARBOHYDRATES The carbs event lets you enter the amount of carbohydrates you have consumed, up to 250 grams. 1. F rom the events menu press the UP or DOWN button to choose “Carbs” and press the SELECT button. 2. P ress the UP or DOWN button to enter your carb amount (0-250 grams), and press the SELECT button. The number that first appears on this screen will be the last number you entered or the default amount of 50 grams. 3. C heck that the date and time for this entry are correct.
7 7.1.4 INSULIN The insulin event lets you enter the amount of insulin you have taken, up to 250 units. You can only enter an insulin amount, not the type of insulin taken. 1. F rom the events menu press the UP or DOWN button to choose “Insulin” and press the SELECT button. 2. P ress the UP or DOWN button to enter your insulin amount (0-250 units), and press the SELECT button. The number that first appears on this screen will be the last number you entered or the default amount of 10 units. 3.
7.1.5 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. F rom the events menu press the UP or DOWN button to choose “Exercise”, and press the SELECT button. 2. P ress the UP or DOWN button to choose your exercise intensity level, and press the SELECT button. 3. P ress the UP or DOWN button to enter your exercise duration (0-360 minutes), and press the SELECT button.
7 7.1.6 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. F rom the events menu press the UP or DOWN button to choose “Health,” and press the SELECT button. 2. P ress the UP or DOWN button to choose your health event, and press the SELECT button. 3. C heck that the date and time for this entry are correct. Press the SELECT button to confirm the entry. 4.
chapter eight COMPLETING A SENSOR SESSION
Your sensor will continue to give you sensor glucose readings for up to seven days. The performance of a sensor has not been tested beyond seven days. HELPFUL HINTS: • Do not remove the transmitter from the sensor pod while the pod is attached to your skin. • Do not dispose of your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life.
8 8.1 AUTOMATIC SENSOR SHUT-OFF The receiver will tell you how much time you have remaining until your sensor session is complete. The sensor expiration screen will appear at 6 hours, 2 hours and 30 minutes before your 7-day sensor session ends.
HELPFUL HINT: •G lucose level alerts and alarms will not function after the sensor session has ended. 8.2 REMOVING A SENSOR Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to your local distributor.
8 Removal arrow Sensor pod tab wings Safety lock (from applicator) Sensor pod with safety lock snapped in Sensor pod tabs 4. I nsert the jagged edges so that they “hug” the wide end of the transmitter in the sensor pod. Press the safety lock down until you cannot press down anymore, and the transmitter will “pop” out of the sensor pod. 5. R emove the transmitter, clean it (see Chapter 10, Section 10.1, Maintenance) and store it in a cool, dry place until your next glucose monitoring session.
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This chapter provides helpful tips and instructions to resolve issues you may experience while using your Dexcom G4 CGM System. HELPFUL HINT: • I f the troubleshooting steps in this chapter do not fix your issue, contact your local distributor. 9.1 SENSOR INSERTION TROUBLESHOOTING Sensor insertion difficulties • I am having trouble taking out the safety lock: - Make sure to pull the safety lock straight out away from your body. Use the arrows on the safety lock as a guide. - Do not wiggle back and forth.
9 Sensor pod is not sticking long enough • Make sure your skin is clear of any cream or lotion before you attach the sensor pod. • Clean the area first with an alcohol wipe. Make sure the area is clean and completely dry before you insert the sensor. Do not leave any substance on the skin where the needle inserts.
9.2.1 TYPES OF CALIBRATION PROMPTS This section describes the three blood drop symbols you will see. The next section describes what to do when you see one of these symbols. Startup calibration prompt This prompt means the receiver’s 2-hour startup period is complete. You need to enter two blood glucose values to calibrate the system and start receiving sensor glucose readings.
9 9.2.2 STATUS AREA SYMBOLS DURING CALIBRATION PROMPTS 1. C lear the prompt from the screen by pressing the SELECT button. 2. C heck the status area at the top of the screen. You will decide what to do based on the symbol shown in the status area: a. I f the startup calibration symbol is displayed: • Take 2 more blood glucose values and enter them into your receiver b.
If you see this screen, wait at least 1 hour and then enter 1 more calibration blood glucose value. Wait 15 minutes. If this error screen still appears enter 1 more blood glucose value. Wait another 15 minutes. If this error screen still appears, the sensor needs to be replaced. 9.4 SYSTEM GLUCOSE ERROR Sometimes the system may tell you that it can not provide a valid sensor glucose reading. When this occurs you will see either the glucose reading error icon or the wait icon in the status area.
9 9.5 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. Your sensor glucose readings may be inaccurate if you calibrate less than every 12 hours.
• You should always use the same meter you routinely use to measure your blood glucose to calibrate. Do not switch your meter in the middle of a sensor session. Blood glucose meter and strip accuracy may vary between blood glucose meter brands. • Prior to obtaining a blood glucose value to be used for calibration, wash your hands, make sure your glucose test strips are not expired and have been stored properly and that your meter is properly coded (if required).
9 9.6.1. EARLY SENSOR SHUT-OFF - SENSOR FAILURE During a sensor session the receiver may detect a series of issues with your sensor signal where it can no longer determine your glucose reading. At this time, the sensor session will end and show the screen to the right. If you see this screen it means your continuous glucose monitoring session has ended. Press the SELECT button to clear this screen. You will need to remove your sensor and insert a new sensor. 9.6.
1. To manually end your sensor session, select “Stop Sensor” from the main menu. 2. W ith “OK” highlighted, press the SELECT button to confirm that you want to stop the sensor session. 3. The stop sensor processing screen will appear to let you know the sensor session is stopping. 4. O nce the session has stopped, a red stoplight symbol ( ) will appear in the upper right corner of the trend graph.
9 9.7 BATTERY AND CHARGER TROUBLESHOOTING Only use the Dexcom cable and battery charger to charge your receiver. 1. R emember to charge your receiver battery as needed. The charge will last approximately 3 days, depending on how often you turn on your receiver, use the alerts, and enter events. 2. I f your receiver does not show the charging icon when plugged into the charger make sure that both ends of the USB cable are fully inserted into the receiver port and wall charger. 3.
9.8.3 LOW TRANSMITTER BATTERY This screen will appear once the transmitter nears the end of its battery life (see Chapter 1, Section 1.2, Transmitter Overview). When the transmitter battery is drained low enough the transmitter and receiver will stop communicating. Contact your local distributor to order a new transmitter. Your transmitter battery may drain as quickly as one week after this alert appears. 9.8.4 TRANSMITTER FAILED ERROR CODE This screen means that the transmitter is not working.
9 The transmission range from the transmitter to the receiver is up to 6 meters without obstruction. Wireless communication does not work well under water so the range is much less if you are in a pool, bathtub, water bed, etc. • Your transmitter ID must be entered correctly into your receiver to receive sensor glucose readings (see Chapter 2, Section 2.2, The Settings Menu). Make sure you have removed your sensor and stopped your sensor session before checking or changing your transmitter ID.
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10.1 MAINTENANCE Transmitter • Wipe the outside of the transmitter with a wrung-out, slightly water-dampened cloth or isopropyl alcohol wipe between uses. •K eep the transmitter clean and protected when not in use. Receiver • Do not spill fluid on the receiver or submerge the receiver in liquid. •K eep the receiver in its carrying case or otherwise protected. •C harge the receiver when the battery gets low.
10 10.2 STORAGE Sensor •K eep the sensor in its sterile packaging until you are ready to use it. •D o not insert sensors past the Use By Date. The Use By Date format is YYYY-MM-DD. Sensors must be inserted on or before the end of the calendar day printed on the sensor package label. •S torage temperature should be 2° C - 25° C. You may store your sensors in the refrigerator if it is within this temperature range. Sensors should not be stored in a freezer.
6. Do not use wipes that contain adhesives (e.g. Smith + Nephew IV Prep). 7. Place the device on a clean, dry cloth and air dry for 2-3 minutes. Disinfection Disinfection removes and destroys microorganisms and pathogens from the surface of the device. Disinfect the receiver and transmitter periodically or whenever you suspect that blood or body fluid has come in contact with the surface of the device.
10 8. P lace the receiver screen side facing down on a clean, dry cloth and air dry for 60 minutes. 9. Place the transmitter on a clean, dry cloth and air dry for 2-3 minutes. 10. Remove gloves and dispose of gloves as biohazard waste. 11. Wash hands thoroughly. 10.4 PRODUCT DISPOSAL Consult your local waste management authorities for appropriate procedures for disposal of devices containing electronic waste (transmitter and receiver) or blood contacting components (sensor and applicator).
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11.1 PRODUCT SPECIFICATIONS Sensor Glucose Range 2.2 – 22.2 mmol/L Sensor Life Up to 7 days Calibration Commercially available blood glucose meter Calibration Range 2.2 – 22.2 mmol/L Storage Condition Temperature: 2° C - 25° C Humidity: 0% - 95% RH Sterilization Sterile by radiation Transmitter Dimensions (including sensor pod) Length: 3.8 cm Width: 2.3 cm Thickness: 1.
11 Transmitter PARAMETER PERFORMANCE CHARACTERISTICS TX/RX Frequencies 2.424 999 877 GHz 2.449 993 677 GHz 2.474 737 539 GHz 2.477 236 919 GHz Bandwidth 334.7 kHz Maximum Output Power 1.25 mW EIRP Modulation Minimum Shift Key Data Rate 49.987 Kbits/Sec Total Packet 224 bits Transmit Duty Cycle 4.48 ms every 5 minutes at each of the four TX frequencies.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The transmitter is intended for use in the electromagnetic environment specified below. The customer or the user of the transmitter should ensure that it is used in such an environment.
11 Receiver Reading Frequency Every 5 minutes Dimensions Length: 10.1 cm Width: 4.6 cm Thickness: 1.
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 ensure that it is used in such an environment.
11 Receiver 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. main voltage prior to application of the test level.
System Immunity Test Radiated RF IEC 61000-4-3 IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance 3 V/m 80 MHz to 2.5 GHz 3 V/m 80 MHz to 2.5 GHz Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with following symbol: a.
11 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The Dexcom G4 System is intended for use in the electromagnetic environment specified below. The customer or the user of the Dexcom G4 System should ensure that it is used in such an environment. Emissions Test RF Radiated emissions CISPR 11 RF Conducted emissions Compliance Group 1, Class B Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
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 Charging Cable* Dexcom P/N MT20655 Input/Output 5V DC, 1A Type USB A to USB micro B Length 0.9 m * There is a separate AC wall charger adapter that can be connected to the USB charging/download cable for charging using an AC power outlet. Power Supply/Charger Dexcom P/N MT21255 Class II Input: AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100Vac DC Output: 5V DC, 1A (5.
11.2 DEVICE PERFORMANCE CHARACTERISTICS HELPFUL HINT: •W e recommend that you review the information in this chapter with your healthcare provider to understand how well the Dexcom G4 System performs. The Dexcom G4 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 (OpenChoice), once calibrated, the System reports glucose readings up to every 5 minutes.
11 System readings agreed with laboratory standard blood glucose results. The remainder of the study took place at home, the System performance was also paired with the comparative Lifescan OneTouch Ultra2 meter results, and that is referred to as the ‘SMBG’. Agreement Agreement between the System and blood glucose values is characterized using paired System and YSI values.
In the example above the System reading is less than the YSI value, so the percent difference reading is negative. The mean percent difference is the average of all positive and negative percent differences between the two devices; it tells you if the System reads higher or lower on average than the YSI at each glucose range. Another estimate used to show the accuracy of the System is the absolute percent difference.
11 Overall, the System reads, on average, 8.2% different (Mean Percent Difference) than the YSI at glucose levels of 40-400 mg/dL (2.2-22.2 mmol/L) and, 14.1% absolute different (Mean Absolute Difference) than the YSI values at glucose levels of 40-400 mg/dL (2.2-22.2 mmol/L). The Median Percent Difference shows that 50% of the time the System reads approximately 8.7% more than the YSI blood glucose values and the Median Absolute Difference shows that 50% of the time the System reads about 12.
Figure 1. Clarke Error Grid, System Results Compared to YSI Results Summary Statistics (N,%) of System results in Figure 1 are presented in Table 4 according to the percentage of points falling within each zone (A-E). Table 4. Clarke Error Grid Analysis Glucose Range mg/dL (mmol/L) 40-400 (2.2-22.2) Total YSI-CGM Pairs A N (%) B N (%) C N (%) D N (%) E N (%) 1477 1151 (77.9) 285 (19.3) 0 (0.0) 41 (2.8) 0 (0.
11 Calibrations Stability The System must be calibrated every 12 hours. To demonstrate performance of the System over a 12-hour calibration period, 42 Sensors were evaluated to verify that performance remains consistent over the 12-hour calibration period. Systems were evaluated in 2-hour increments after calibration. Performance was estimated at each 2-hour interval and stratified by glucose concentrations by calculating the percentage of System readings within 20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.
Sensor Stability Sensors can be worn for up to 7 days. To verify sensors performance over time, 42 sensors were evaluated across the 7-day wear period. Performance was estimated by calculating the percentage of System readings within 20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30% and greater than 40 mg/dL (2.2 mmol/L) or 40% of the YSI values at the beginning (Day 1), middle (Day 4) and end (Day 7) of the System lifecycle.
11 Number of Readings Provided The System is capable of providing a reading up to every 5 minutes, or up to 288 readings per day. For a variety of reasons, the System may not display a glucose reading and readings are “skipped.” Table 7 estimates the number of readings you can expect to receive from the System over the entire 7-day period after calibration. For example, 93% of Systems provided between 1,707 and 1,992 valid glucose readings (or more than 76% of the expected number of readings).
Table 9. Percentage of CGM System Reading within Paired SMBG Results SMBG Glucose Ranges mg/dL (mmol/L) Number of Paired SMBG-CGM Readings Percent within 20% of SMBG* Percent within 30% of SMBG* Percent greater than 40% of SMBG* 40-400 (2.2-22.2) 2824 83% 95% 2% *40-60 (2.2-3.3) 64 91% 97% 2% *61-80 (3.4-4.4) 249 81% 95% 3% 81-180 (4.5-10.0) 1726 83% 94% 2% 181-300 (10.1-16.7) 727 85% 96% 1% 301-350 (16.8-19.4) 42 93% 100% 0% 351-400 (19.5-22.
11 Adverse Events There were no adverse events nor any device-related adverse event occurred during the study. There was no noticeable Erythema, Edema, Infection, Bruising or Bleeding occurred at the sensor needle insertion area and the adhesive area.
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.
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APPENDIX I, RECEIVER ALERTS, ALARM AND PROMPTS The following tables describe the alarm, alerts and prompts and how the receiver notifies you. Prompt - Shows on screen only. Silent, no vibrate or beep. Alert - Notifies with vibrate and beep depending on your profile settings. Alarm - Low 3.1 - Notifies with vibrate and beep. Cannot be changed.
12 What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Out of range alert The transmitter and receiver are not communicating and you will not receive sensor glucose readings. 1 vibrate then vibrate/beep every 5 minutes until the receiver and transmitter are back in range. No unless you have turned on the out of range alert.
What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? 1 hour calibration error alert The sensor cannot calibrate. Wait a minimum of 1 hour then enter 1 more blood glucose value for calibration. If no sensor glucose readings appear on the receiver, the sensor needs to be replaced. 1 vibrate then vibrate/beep every 5 minutes until confirmed.
12 What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Enter BG processing screen prompt The receiver is processing the blood glucose value you entered. Prompt screen only. N/A Rise alert Your glucose levels are rising at 0.11 mmol/L per minute or more. 2 vibrates then 2 vibrates/2 beeps every 5 minutes (2 times) or until confirmed.
What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? 6-hour sensor expiration prompt Your sensor session will end in 6 hours. Prompt screen only. N/A 2-hour sensor expiration prompt Your sensor session will end in 2 hours. Prompt screen only. N/A 30-minute sensor expiration alert Your sensor session will end in 30 minutes.
12 What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Receiver error alert Your receiver is not working properly. Record the error code and call your local distributor. 1 vibrate (4 seconds) + 4 beeps. No System check alert There was a system error and the receiver fixed it. 1 vibrate then vibrate/beep every 5 minutes until confirmed.
Important alerts and alarms that can be verified by the user: •O ut of Range Alert - You can test this alert by moving the receiver more than 6 meters away for 30 minutes or more •3 0-minute sensor expiration alert - You will see this alert in the normal course of using a sensor for seven days. •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 verified by the user.
12 GLOSSARY Alternative Site BG Testing This is when you obtain a blood glucose value on your meter using a blood sample from an area on your body other than your fingertip. Do not use alternative site testing for entering blood glucose values into the receiver. Applicator A disposable component piece that comes attached to the sensor pod and inserts the sensor under the skin. There is a needle inside the applicator barrel that you remove once you have inserted the sensor. BG Meter Blood glucose meter.
GLOSSARY (continued) Re-alert A re-alert occurs when the initial alert has not been confirmed. Receiver The small device which collects your glucose information from the sensor/transmitter. Your results are displayed on the receiver screen as a sensor glucose reading (mmol/L) and as a trend. Rise and Fall (Rate of Change) Alerts Alerts based on how fast your glucose levels rise/fall, and by how much.
12 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 CGM System. Some of these symbols may not have meaning in your region, and are listed for informational purposes only. This table shows what each symbol means.
Two-Sided Humidity Limitation European Union WEEE Directive 2006-66-EC Non-ionizing Radiation 0086 Electrical Equipment Designed Primarily for Indoor Use Input Marking Certifies that the device meets the European Council Directive 93/42/EEC Do Not Use if Package is Damaged SB Ship By Date Keep Dry Dexcom G4 User’s Guide | 153
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Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA +1.858.200.0200 www.dexcom.com Outside US: Contact your local distributor LBL-011277 Rev 05 MT21647 EC REP MediTech Strategic Consultants B.V. Maastrichterlaan 127-129 NL - 6291 EN Vaals Tel. +31.43.306.3320 Fax. +31.43.306.
