USER’S GUIDE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM ® IMPORTANT CONTACTS AND NUMBERS Dexcom® Website: www.dexcom.com Your Transmitter ID: Your Receiver ID: Your Healthcare Professional: Nearest Hospital: © 2013 Dexcom, Inc. All rights reserved. Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom Studio, SEVEN, Stay Between the Lines and Dexcom Makes Sense are either registered trademarks or trademarks of Dexcom, Inc. in the United States and/or other countries.
DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM table of contents GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 CHAPTER 1: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION 9 1.1 1.2 1.3 1.4 1.5 System Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sensor Overview . .
CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUP 39 5.1 Setting Up the Receiver and Pairing with Your Transmitter . . . . . 41 5.2 The Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 5.2.1 Getting to the Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . 43 5.2.2 Setting Your Receiver Time and Date ���������������������������������43 5.2.3 Entering Your Transmitter ID �����������������������������������������������44 5.
CHAPTER 9: ALERTS, ALARM & PROFILES 87 9.1 Setting Your Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 9.1.1 Default Alert/Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . 89 9.1.2 Glucose Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 9.1.2.1 High Glucose Alert . . . . . . . . . . . . . . . . . . . . . . . . 92 9.1.2.2 Low Glucose Alert . . . . . . . . . . . . . . . . . . . . . . . . . 92 9.1.2.
1 12.3 Product Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124 CHAPTER 13: TROUBLESHOOTING 125 CHAPTER 14: TECHNICAL INFORMATION 141 CHAPTER 15: USER ASSISTANCE 177 CHAPTER 16: WARRANTY 181 CHAPTER 17: TRAVEL INFORMATION 189 CHAPTER 18: APPENDIX 193 13.1 Sensor Insertion Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 127 13.2 Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 128 13.2.
GLOSSARY Alternative Site BG Testing This is when you take a blood glucose value on your meter using a blood sample from an area on your body other than your fingertip. Do not use alternative site testing to calibrate your receiver. Applicator A disposable piece that comes attached to the sensor pod and inserts the sensor under the skin. There is a needle inside the applicator that you remove after you insert the sensor. BG Meter Blood glucose meter.
GLOSSARY (continued from page before) Hypoglycemia Low blood glucose. Same as “low.” The default low alert in your receiver is set to 80 mg/dL. Consult your health care provider to determine the appropriate hypoglycemic setting for you. Hyperglycemia High blood glucose. Same as “high.” The default high alert in your receiver is set to 200 mg/dL. Consult your health care provider to determine the appropriate hyperglycemic setting for you.
GLOSSARY (continued from page before) RF Radio-frequency transmission used to send glucose information from the transmitter to the receiver. Safety Lock The safety lock keeps the needle inside the applicator before you are ready to insert the sensor. It also helps you snap the transmitter out of the sensor pod after your sensor session ends. Sensor The Dexcom G4 PLATINUM System part that includes an applicator and wire.
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CHAPTER 1: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION Dexcom G4 PLATINUM Receiver Dexcom G4 PLATINUM Transmitter Dexcom G4 PLATINUM Sensor 1.1 SYSTEM CONTENTS: • sensor • transmitter • receiver • receiver USB charging/download cable • AC power adapter - MT21255 • receiver case • user’s guide • quick start guide • training checklist • tutorial disc • Dexcom Studio software (available for download online at www. dexcom.com) Sensors are sold separately.
1 PRECAUTION The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmitter and Receiver. Different generations will not connect with each other and will not work. Also, make sure to use the correct version of Dexcom Studio with your system. 1.2 INTRODUCTION When you use the system, you will see continuous sensor glucose readings updated every 5 minutes for up to 7 days. These readings will help you notice trends and patterns in your glucose levels.
1.3 SENSOR OVERVIEW The sensor is the piece that comes in a sterile, sealed sensor pouch. The sensor is made up of an applicator, a sensor pod, and a sensor wire. You remove the applicator after insertion. The sensor pod stays on your belly for the entire sensor session, up to 7 days. The pod is made of plastic and an adhesive patch. The sensor wire is thin and flexible, and inserts just under the skin of your belly.
1 1.4 TRANSMITTER OVERVIEW The transmitter is the gray, plastic “chip” that snaps into your sensor pod. The transmitter (including sensor pod) is about 1.5 inches long, 0.9 inches wide and 0.5 inches thick. Once snapped into the sensor pod, the transmitter wirelessly sends your glucose information to the receiver. The transmitter and sensor are water resistant when properly connected. Do not throw away your transmitter. It is reusable.
1.5 RECEIVER OVERVIEW The receiver is the small hand-held device that looks like a cell phone. It is about 4 inches long, 1.8 inches wide and 0.5 inches thick. It shows your sensor glucose readings, trend graph, direction and rate of change arrow. Do not spill fluids on the receiver or drop the receiver into fluids. Keep the micro USB port door closed to help prevent fluid and dust from getting inside the receiver.
1 Your receiver and transmitter wirelessly pair together to communicate securely and only with each other. You will need a commercially available blood glucose meter to use with your system. See Section 14 for Product Specifications. UP button RIGHT button SELECT button LEFT DOWN button button Receiver buttons: • Press the UP and DOWN buttons to scroll through trend screens, highlight menu items, or set values. • Press the SELECT button to turn the receiver on or select the highlighted option.
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CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT 2.1 INDICATIONS FOR USE The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The system is intended for single patient use and requires a prescription. The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
2 2.3 CONTRAINDICATIONS • Remove the Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.
measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range, so you do not miss a low or high blood glucose value. • Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. • Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it.
2 glucose readings to be inaccurate, and you might miss a low or high blood glucose value. 2.5 PRECAUTIONS • Before opening the sensor package, wash your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor. • Before inserting the sensor, clean the skin with a topical antimicrobial solution, such as isopropyl alcohol, and allow to dry. This may help prevent infection.
carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value. • Do not calibrate if your blood glucose is changing at a significant rate, typically more than 2 mg/dL per minute.
2 USB port, the receiver could become damaged and stop displaying readings or providing alerts, and you might miss a low or high blood glucose value. • Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration.
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CHAPTER 3: RISKS AND BENEFITS 3.1 RISKS There are some known risks with using real-time CGM. You will not get sensor glucose alerts when the alert function is turned off, your transmitter and receiver are out of range, or when your receiver is not showing sensor glucose readings. You might not notice alerts if you are unable to hear them or feel the vibration. Sometimes your sensor glucose reading may be slightly different than your blood glucose meter.
3 events happen, you might feel discomfort in the area the sensor is inserted. There is a remote chance that a sensor fragment could remain under your skin if the sensor breaks while you are wearing it. This did not happen in the clinical study for the Dexcom G4 PLATINUM System. If you think a sensor has broken under your skin, contact your healthcare provider and call Dexcom’s Technical Support. Sensor breakage may cause some anxiety, but it is not a significant medical risk. 3.
Real-time CGM can help improve diabetes control (lower A1c values, reducing glycemic variability and time spent in low and high blood glucose ranges)1, 2 , 3 which can help reduce diabetes related complications.4, 5 These benefits can be seen especially with using real-time CGM at least 6 days per week2 and can be sustained over time.6 In some cases, patients perceived an increase in their quality of life and peace of mind when using real-time CGM as well as reporting a high satisfaction with CGM.
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CHAPTER 4: CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU 4.1 CHARGING YOUR RECEIVER BATTERY The receiver battery is rechargeable and will last about 3 days with normal use before you need to charge it. Your battery life depends on how often you press your receiver buttons or get alerts. The receiver will tell you when the battery charge is low. Low Battery prompt Charge the receiver battery using one of these options: • Section 4.1.1: an AC power outlet • Section 4.1.
4 Charge your receiver battery before each sensor insertion. Periodically check your battery level to make sure it has enough charge. If your battery drains, it will keep the time and date for 3 days without being charged. After 3 days, the receiver will prompt you to reset the time and date (see Chapter 5, Section 5.2, The Settings Menu). When the receiver is used in a healthcare facility, charging must take place away from the patient.
5. T he battery charging screen will show on the receiver. Battery Charging screen 6. A fter a few seconds the trend graph will show with the battery charging symbol ( in the upper left corner. ) Battery charging symbol in upper left corner of trend graph 4.1.2 CHARGING YOUR RECEIVER BATTERY FROM A WINDOWS COMPATIBLE COMPUTER You must install the Dexcom Studio software to charge your receiver from a computer. Please see the Dexcom Studio installation card for driver installation instructions. 1.
4 4. After a few seconds, the trend graph screen will show the battery charging symbol in the upper left corner. Battery charging symbol in upper left corner of trend graph 4.1.3 KNOWING YOUR RECEIVER IS CHARGED s the battery charges, the battery charging symbol fills in. When the A battery is fully charged, the battery charging symbol is completely shaded. Fully Charged Start Battery charging symbol fills in as battery charges 4.
2 Receiver Main Menu Options (continued from page before) Menu User’s Guide Reference Purpose Start Sensor To start a new sensor session. •T his option only shows if you have entered a transmitter ID and you are not in the middle of a sensor session Chapter 6 Enter BG To enter your blood glucose values for calibration. Chapter 7 Profiles Profiles allow you to customize the sound and volume of alerts and alarm.
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CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUP This chapter helps you when you first set up your Continuous Glucose Monitoring System. Read this chapter before you start. 5.1 SETTING UP THE RECEIVER AND PAIRING WITH YOUR TRANSMITTER The Setup Wizard guides you through setup the first time you turn on your receiver. 1. R emove the transmitter from its packaging. Wait 10 minutes for the transmitter to turn on before setting up the receiver. 2.
5 Your transmitter ID is a unique code with 5 numbers and/or letters found in the following locations: • On the transmitter box label • On the bottom of the transmitter c. S et your low and high glucose alert values. Your low and high glucose alerts are pre-set to 80 mg/dL and 200 mg/dL but can be changed. Setting Low Alert screen Setting High Alert screen (1) P ress the UP or DOWN button to select your alert level.
5.2 THE SETTINGS MENU The Settings menu lets you change the time, date or transmitter ID. The Setup Wizard only works the first time you turn on your receiver, but you can always use the Settings menu. 5.2.1 GETTING TO THE SETTINGS MENU 1. P ress the SELECT button to turn on the receiver. The 3-hour trend graph shows. 2. Press the SELECT button to see the Main Menu. 3. F rom the Main Menu, press the UP or DOWN button to scroll to “Settings” and press the SELECT button.
5 4. Press the RIGHT button to move to the next value. The date format is YYYY/MM/DD. 5. Press the SELECT button after choosing AM or PM. You will return to the Settings menu. Time/Date setting screen, year highlighted You might need to reset the receiver’s time and date if the rechargeable battery drains. If this happens, the receiver will alert you and automatically take you to the time/date setting screen. 5.2.
2. Start with the first number or letter (do not enter “SN”): a. Press the UP or DOWN button to show the correct number or letter. b. Press the RIGHT button to move to the next value and repeat step a. c. Continue repeating steps a and b to enter the whole transmitter ID. d. Press the SELECT button after you enter the last number or letter. You will return to the Settings menu.
5 3. Scroll down to see all of the Device Info: • Insertion Time • Last Calibration • Transmitter Battery • Transmitter ID • Serial Number • Part Number • Part Revision Device Info screen • Software Number • Software Revision 4. Press the LEFT button to return to the Settings menu. 5.4 TRANSMITTER AND RECEIVER COMMUNICATION When you are in a sensor session, you can check that the receiver and transmitter are communicating.
PRECAUTION The transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc. Types of obstruction differ and have not been tested.
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CHAPTER 6: INSERTING A SENSOR AND STARTING A SENSOR SESSION You need a sensor, a transmitter, and a receiver to use your Dexcom G4 PLATINUM Continuous Glucose Monitoring System. You also need a blood glucose meter and test strips for calibration. The blood glucose meter and test strips are not provided in the Dexcom G4 PLATINUM System. The sensor continuously measures and displays your sensor glucose readings for up to 7 days.
6 6.1 BEFORE YOU START • Make sure the correct transmitter ID has been entered into your receiver (see Chapter 5, Section 5.2, The Settings Menu). You do not need to re-enter the transmitter ID each time you start a sensor session. • Check the expiration date on the sensor package label. The format is YYYY-MM-DD. Insert sensors on or before the end of the expiration date calendar day.
Review the sensor applicator picture before using a new sensor. Plunger Safety Lock Applicator Barrel (with small introducer needle and sensor) Collar Transmitter Latch Sensor Pod Release Tab Adhesive Patch 6.2 REMOVING THE SENSOR FROM ITS PACKAGING PRECAUTION Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection. • Wash your hands thoroughly, and dry them. • Carefully remove the sensor from its packaging.
6 6.3 CHOOSING AN INSERTION SITE PRECAUTION • Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high blood glucose value. • Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor.
6.4 PLACING THE SENSOR WARNING Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value. 1.
6 3. P lace the sensor horizontally, NOT vertically, on your skin. 4. Move your fingers around the adhesive patch to secure the tape to your skin. 5. H old the applicator, and pull the safety lock straight out away from the applicator, in the direction of the arrows in the picture. Step 3 and 4. Adhere the sensor on the skin Step 5. Remove the safety lock 6. S ave the safety lock to help you remove the transmitter at the end of your sensor session.
3. P lace your thumb on the white plunger. Push the plunger down completely, making sure it is flush against the applicator barrel. You should hear 2 clicks. This inserts the needle and sensor under your skin. When you are pushing down on the plunger, do not pull back on the collar. “2 CLICKS” Steps 1-3. Push down the plunger - insert the needle and sensor 4. Keep pinching up on your skin with one hand. With your other hand, place two fingers under the collar.
6 • Make sure the transmitter latch is down (against your body) before squeezing the tabs to remove the applicator barrel. • Squeeze the center of the ribbed part of the release tabs. • While squeezing the tabs, rock the applicator barrel forward and out away from your body. If you have any problems with insertion, save the sensor and applicator and contact Dexcom Technical Support (see Chapter 15, User Assistance). 6.
place. The transmitter should lie flat in the sensor pod. • Make sure you hear 2 clicks when you snap the transmitter in place. If it is not fully snapped in, this may lead to a poor connection and let fluids to get under the transmitter. This can lead to inaccurate sensor glucose readings. d. R elease your pinch on the adhesive edge at this time. e.
6 current session or stop the session (refer to Chapter 13, Section 13.6, Sensor Shut-off Troubleshooting). 4. Press the SELECT button to confirm the start of a new sensor session. The start sensor “thinking” screen lets you know your sensor 2-hour startup has begun. 5. Y our receiver returns to the 3-hour trend graph. 6. C heck your receiver 10 minutes after starting your sensor session to make sure your receiver and transmitter are communicating.
The countdown symbol fills in over time to show that you are getting closer to the first calibration time. You will not get sensor glucose readings, alerts and alarm during the countdown. Start [0-24] minutes [24-48] minutes [48-72] minutes [72-96] minutes Ready for calibration Countdown symbol fills in during sensor startup If you see the out of range symbol at the top of the screen during the 2-hour startup, review the following troubleshooting tips.
6 Do not tape under the sensor pod or leave any substance on the skin where you insert the sensor. The right way to use tape for extra support 6.10 TEMPORARY RECEIVER SHUTDOWN There may be times when you want to shut down your receiver temporarily. Shutdown stops all communication between the transmitter and receiver and turns the receiver off. You will not receive sensor glucose readings or any alerts or alarm while the receiver is shut down, but your current sensor session will continue.
To turn the receiver back on and resume communication with the transmitter, press the SELECT button. It may take up to 20 seconds for the display to turn back on. Remember that your alerts and low glucose alarm will not work when the receiver is shut down. Shutting down the receiver does not extend the sensor life beyond 7 days. Your sensor session will stop 7 days after you started the sensor session. 6.
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CHAPTER 7: CALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEM You must calibrate Dexcom G4 PLATINUM System sensor glucose readings to your blood glucose meter. CONTRAINDICATION Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person. 7.
7 Example Minimum Calibration Schedule During Seven-Day Sensor Session PRECAUTION Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration.
7.2 HOW TO CALIBRATE You must enter the exact blood glucose value from your meter for each calibration. Blood glucose values must be between 40-400 mg/dL and must have been taken within the past 5 minutes. • Make sure either a sensor glucose reading or a blood drop symbol shows at the top of the trend graph before calibrating. • Your sensor can be calibrated if your meter glucose is 40 mg/dL or above. For safety reasons, if your blood glucose is low, first treat your low blood sugar.
7 PRECAUTION To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value. Only use blood glucose values between 40-400 mg/dL for calibration.
a. W hen the receiver does not have a recent sensor glucose reading the default is 120 mg/dL. b. I f there has been a sensor glucose reading in the past 15 minutes, the “Enter BG” screen shows your current sensor glucose reading. Do not use the current sensor glucose reading for calibration. Use only blood glucose values from your meter. Enter BG screen, default is 120 mg/dL 6. U se the UP or DOWN button to scroll until you see the correct blood glucose value, and then press the SELECT button. 7.
7 PRECAUTION To calibrate the system, enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values from more than 5 minutes before entry might affect sensor performance, and you might miss a low or high blood glucose value. 7.3 STARTUP CALIBRATION Two hours after you start the sensor session (see Chapter 6, Section 6.
7.4 12-HOUR CALIBRATION UPDATE Calibrate your system at least every 12 hours after your first calibration (2-hour startup calibration) to make sure your sensor glucose readings remain accurate and close to your blood glucose meter values. You can enter blood glucose values earlier than 12 hours if you want. If you have not entered any blood glucose values in the past 12 hours, the receiver will ask you to enter a blood glucose value to update its calibration. WARNING Calibrate at least once every 12 hours.
7 When you see this calibration prompt it means it is time to calibrate with a single blood glucose value. Take 1 blood glucose measurement with your meter, and enter the blood glucose into the receiver. If this screen reappears soon, see Chapter 13, Section 13.2.1, Types of Calibration Prompts. Calibration prompt These screens show calibration errors (see Chapter 13, Section 13.3, Calibration Error Troubleshooting).
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CHAPTER 8: SENSOR GLUCOSE READINGS AND TRENDS This chapter teaches you how to view your sensor glucose readings and trend information. The trend graph provides additional information that your blood glucose meter does not. It shows your current glucose value, the direction it is changing and how fast it is changing. The trend graph can also show you where your glucose has been over time.
8 WARNING Do not use the Dexcom G4 PLATINUM System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could lead to low or high blood glucose value. 8.
• Each “dot” on the trend graph is a sensor glucose reading reported every 5 minutes. • The trend graph shows the current time. • The status area shows needed calibration updates, calibration errors and sensor glucose reading issues. • Your high alert setting shows as a yellow line across the trend graph. • Your low alert setting shows as a red line across the trend graph. • The gray zone highlights your target glucose range, based on your high and low glucose alert settings.
8 Which Trend Graph Do You See? (Scroll up from the 3-hour graph to reach the 1-hour graph) 1-Hour Trend Graph: The 1-hour trend graph shows your current glucose reading and the last 1 hour of sensor glucose readings. 3-Hour Trend Graph: The 3-hour trend graph shows your current glucose reading and the last 3 hours of sensor glucose readings.
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. Trend graph reading LOW Trend graph reading HIGH 8.2 RATE OF CHANGE ARROWS Your rate of change arrows add detail about the direction and speed of glucose change over the last 15-20 minutes. The trend arrows show to the right of your current glucose reading.
8 This table shows the different trend arrows your receiver displays: Trend Arrows Constant: Your glucose is steady (not increasing/decreasing more than 1 mg/dL each minute). Your glucose could increase or decrease by up to 15 mg/dL in 15 minutes. Slowly rising: Your glucose is rising 1-2 mg/dL each minute. If it continued rising at this rate, your glucose could increase up to 30 mg/dL in 15 minutes. Rising: Your glucose is rising 2-3 mg/dL each minute.
Trend arrows do not show when there are glucose data gaps (see Chapter 13, Section 13.4, System Glucose Error). If the glucose reading error symbol , the wait symbol , the out of range symbol , or the blood drop symbol show at the top of the trend graph, the trend arrows will not show. I f the trend arrow is missing, but you are concerned that your blood glucose level may be rising or falling, take a blood glucose measurement test on your blood glucose meter.
8 8.3 GLUCOSE STATUS AREA SYMBOLS The “status area” at the top of the trend graph may show any of the status symbols below during your sensor session. You will not get sensor glucose readings during the time a status symbol shows except during the regular 12-hour calibration prompt. Status Symbols Calibration Needed Additional Calibration Needed Glucose Reading Error Out of Range This symbol means you need to enter a calibration.
Status Symbols (continued from page before) Wait 15 Minutes Calibration Error Wait 1 Hour Calibration Error Wait This symbol means the sensor cannot calibrate right now. If you see this screen, enter at least one more calibration blood glucose value after about 10-15 minutes. If the sensor still cannot calibrate after that, the sensor needs to be removed and a new sensor needs to be inserted. This symbol means the sensor is not calibrating correctly.
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CHAPTER 9: ALERTS, ALARM & PROFILES This chapter teaches you about your Dexcom G4 PLATINUM CGM System’s many alerts and alarms and how to set them. 9.1 SETTING YOUR ALERTS 9.1.1 DEFAULT ALERT/ALARM SETTINGS The following alerts and alarms are preset on your receiver.
9 Default Alert/Alarm Settings (continued from page before) What will I see on the receiver screen? What does this mean? What How will is the the receiver default notify me? setting? Will the receiver re-notify me? Fixed Low Alarm On Your most recent sensor glucose reading is at or below 55 mg/dL Vibrates 4 times, then vibrates/beeps 4 times every five minutes until confirmed or your glucose value goes above 55 mg/dL.
Default Alert/Alarm Settings (continued from page before) What will I see on the receiver screen? What does this mean? What is the default setting? How will Will the the receiver receiver notify me? re-notify me? Rise/Fall Alert Double Arrow Your glucose is rising/falling at or above a rate of 3 mg/dL/min (at least 45 mg/dL in 15 minutes). Off The alert will not notify you. You must change the settings to receive this alert.
9 9.1.2.1 HIGH GLUCOSE ALERT When your sensor glucose readings are at or above your high alert level, this screen shows your high glucose alert level. Your receiver vibrates and/or beeps depending on your profile setting (see Chapter 9, Section 9.3, Alert Profiles). This level shows as a yellow line on the trend graph. The receiver continues to alert until you press the SELECT button to clear the alert or until your sensor glucose readings drop below your high glucose alert level.
9.1.2.3 LOW GLUCOSE ALARM The Dexcom G4 PLATINUM System also has a fixed low alarm at 55 mg/dL. This is different than your low glucose alert. You cannot change or turn off this alarm or its re-alarm settings. • The receiver displays the low glucose alarm screen. • Re-alarm: The receiver automatically alerts again 30 minutes after you press the SELECT button to clear it, if your sensor glucose readings are still at or below 55 mg/dL.
9 9.1.4 HIGH AND LOW GLUCOSE ALERTS The steps for setting both the high alert and the low alert are the same. The following steps show you how to change your high and low alert settings. 1. F rom the alerts menu, press the UP or DOWN button to select “High Alert” or “Low Alert” and press the SELECT button. Alerts menu, High Alert highlighted 2. H ighlight “On/Off,” and then press the SELECT button to set this option. A check mark shows next to the current setting. 3.
5. To change this number, press the SELECT button, and then press the UP or DOWN button to select your high glucose alert level. • Your high glucose alert value can be set between 120 and 400 mg/dL in 10 mg/dL steps. High Alert setting screen, 200 mg/dL selected • Your low glucose alert value can be set between 60 and 100 mg/dL in 5 mg/dL steps. 6. P ress the SELECT button to confirm your alert level. 7. Press the LEFT button to return to the alerts menu when you finish. 9.
9 9.2.1 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTS The snooze feature lets you delay your high and low glucose re-alerts. You have the option to set a snooze time for every 15 minutes for up to 5 hours. 1. P ress the UP or DOWN button to highlight “High Snooze” or “Low Snooze,” and press the SELECT button. Advanced menu, High Snooze highlighted 2. P ress the UP or DOWN button to select the amount of time (in 15 minute steps) between the first alert and re-alerts.
If you set your fall rate to 2 mg/dL per minute and your sensor glucose readings fall at this rate or faster, the “FALLING single arrow” screen shows, and the receiver vibrates or beeps in line with your profile settings. Fall alert If you set your rise rate to 3 mg/dL per minute and your sensor glucose readings rise at this rate or faster, the “RISING double arrow” screen shows, and the receiver vibrates or beeps in line with your profile settings.
9 3. P ress the UP or DOWN button to choose “On” or “Off.” Then, press the SELECT button to select “On” or “Off.” Fall Rate menu, On selected 4. Press the LEFT button to go back to the last screen. Highlight “Level” and then press the SELECT button. Fall Rate menu, Level highlighted 5. Choose “2 mg/dL/min” (2 mg/dL or more per minute) or “3 mg/dL/min” (3 mg/dL or more per minute). Press the SELECT button. 6. Press the LEFT button to return to the alerts menu when you finish.
The out of range symbol in the upper right corner of the trend graph and the out of range alert screen show when the transmitter and receiver are not communicating. The amount of time out of range shows on the out of range alert screen. It will continue to re-alert until they are back in range. Out of Range alert screen 1. Press the UP or DOWN button to choose “Out of Range,” and press the SELECT button. Advanced menu, Out of Range highlighted 2. Press the UP or DOWN button to choose “On/Off.
9 4. Press the UP or DOWN button to choose the amount of time out of range after which the receiver will alert. Press the SELECT button. 5. Press the LEFT button to return to the alerts menu when you finish. Out of Range setting screen, 20 minutes selected 9.3 ALERT PROFILES The Dexcom G4 PLATINUM System lets you set profiles to choose the way you want your alerts to act. This feature is found under the Profiles option on the Main Menu.
The soft, normal, attentive and hyporepeat profiles have the following alert sequence: • The first alert is vibrate only. • If the alert is not confirmed in five minutes, the system vibrates and beeps. • If the alert is not confirmed in five more minutes, the system vibrates and beeps louder. This continues at the same volume every five minutes until confirmed.
9 “HypoRepeat” profile: very similar to the normal profile, but it continuously repeats the fixed low alarm every 5 seconds until your sensor glucose reading rises above 55 mg/dL or is confirmed. This profile can be helpful if you want extra alerts for severe low sensor glucose readings. The “Try It” feature is found under the profiles menu and lets you to hear an example of each alert and alarm. 9.3.
ALERT PROFILE DETAILS (continued from page before) PROFILE TYPE VIBRATE 1 long Out of Range Alert vibrate SOFT NORMAL ATTENTIVE HYPOREPEAT 1 long vibrate + 1 low beep 1 long vibrate + 1 medium beep 1 long vibrate 1 long vibrate + + 3 short 1 medium beep repeating melodies Fixed Low 4 short vibrates +4 medium tone beeps 4 short vibrates +4 medium tone beeps 4 short vibrates +4 medium tone beeps 4 short vibrates + 2 long descending melodies + pause + 4 low beeps 4 short vibrates + 4 low beeps +
9 2. Press the SELECT button to see the Main Menu. 3. Press the UP or DOWN button to scroll to “Profiles,” and press the SELECT button. The Profiles menu will show. Main Menu, Profiles highlighted 4. Press the UP or DOWN button to scroll to the profile you want to set, and press the SELECT button. 5. Press the LEFT button to return to the Main Menu when you finish.
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CHAPTER 10: EVENTS The Events feature lets you record information that may help you and your healthcare professionals better understand your glucose patterns and trends. You can enter details about carbohydrates, insulin, exercise, and health issues. You can view these events with your trends and patterns using the Dexcom Studio software. 10.1 EVENTS Event markers can be downloaded and viewed in the Dexcom Studio software but cannot be viewed on your receiver. 10.1.1 SELECTING AN EVENT 1.
10 4. Press the UP or DOWN button to choose the event you want: “Carbs,” “Insulin,” “Exercise” or “Health.” Press the SELECT button. Events menu, Carbs highlighted 10.1.2 SETTING THE DATE AND TIME FOR AN EVENT When you enter an event, you must check that the date and time for that event are correct. The default is the current date and time stored in the receiver. The date format is YYYY/MM/DD.
4. P ress the SELECT button to confirm the entry. Carbs setting screen, OK highlighted 10.1.3 CARBOHYDRATES The Carbs event lets you enter the amount of carbohydrates you have taken, up to 250 grams. 1. F rom the Events menu press the UP or DOWN button to choose “Carbs,” and press the SELECT button. Events menu, Carbs highlighted 2. P ress the UP or DOWN button to enter your carb amount (0-250 grams), and press the SELECT button.
10 4. Press the LEFT or RIGHT button to choose either “OK” to confirm or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. Carbs setting screen, OK highlighted 10.1.4 INSULIN The Insulin event lets you enter the amount of insulin you have taken, up to 250 units. You can only enter an insulin amount, not the type of insulin. 1. F rom the Events menu press the UP or DOWN button to choose “Insulin,” and press the SELECT button.
3. C heck that the date and time for this entry are correct. Press the SELECT button to confirm. 4. P ress the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. Insulin setting screen, OK highlighted 10.1.5 EXERCISE The exercise event lets you enter intensity (light, medium, or heavy) and duration (up to 360 minutes). 1.
10 3. P ress the UP or DOWN button to enter your exercise duration (0-360 minutes), and press the SELECT button. • The number that shows on this screen is the default amount of 30 minutes. 4. Check that the date and time for this entry are correct. Press the SELECT button to confirm. Exercise setting screen, 30 minutes selected 5. P ress the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button.
2. P ress the UP or DOWN button to choose your health event, and press the SELECT button. Health menu, Illness highlighted 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm. 4. Press the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. Health setting screen, OK highlighted 10.
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CHAPTER 11: ENDING A SENSOR SESSION PRECAUTION Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life. Your sensor gives you sensor glucose readings for up to seven days. The performance of a sensor has not been tested beyond seven days. Information for the end of a sensor session: • Do not remove the transmitter from the sensor pod while the pod is attached to your skin.
11 30-minute Replace Sensor Replace Sensor end of session You can set these alerts with the profiles setting (see Chapter 9, Section 9.3.2, Alert Profile Details, “All Other Alerts”). After the 6-hour, 2-hour, and 30-minute reminders, you continue to receive sensor glucose readings. Press SELECT to clear these screens. You must remove your sensor after the Replace Sensor Now screen (00:00:00) shows. Sensor glucose readings do not show on the receiver after your sensor session ends.
When you remove the sensor, make sure to pull out the sensor pod while the transmitter is still attached. Gently peel up the sensor pod adhesive patch from your skin. This will pull out your sensor. 11.3 TRANSMITTER REMOVAL PRECAUTION Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life. Do not remove the transmitter while the sensor pod is still attached to the body.
11 Method 2 Use your fingers to spread out the tabs at the back of the sensor pod (end closest to the sensor pod tab wings). The transmitter will “pop” out of the sensor pod.
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Chapter 12: TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM 12.1 MAINTENANCE Transmitter • Wipe the outside of the transmitter with a damp cloth or isopropyl alcohol wipe between uses. • Keep the transmitter protected when not in use. Receiver • Do not spill fluid on the receiver or submerge the receiver in liquid. • Keep the receiver in its carrying case or otherwise protected. • Charge the receiver when the battery gets low.
12 • Store at temperatures between 36° F - 77° F. Storing outside this temperature may result in reduced sensor response to glucose and may cause inaccurate CGM readings. You may store your sensors in the refrigerator if it is within this temperature range. Sensors should not be stored in a freezer. • Store at humidity levels between 15% - 85% relative humidity. Transmitter • Keep the transmitter protected when not in use. • Store at temperatures between 32° F - 113° F.
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Chapter 13: TROUBLESHOOTING This chapter provides helpful tips and instructions to fix issues you may have while using your Dexcom G4 PLATINUM CGM System. If any of the troubleshooting steps in this chapter do not fix your issue, contact Dexcom Technical Support (see Chapter 15, User Assistance). 13.1 SENSOR INSERTION TROUBLESHOOTING Sensor insertion difficulties • I am having trouble taking out the safety lock: -M ake sure to pull the safety lock straight out away from your body.
13 • I am not able to remove the transmitter latch: -H old the sensor pod with one hand and twist the transmitter latch with the other hand to remove it. - Do not try to snap it straight off. Sensor pod is not sticking long enough -M ake sure your skin is clean, clear of any cream or lotion, and completely dry before you insert the sensor. -S have your skin before you insert the sensor if hair is preventing the sensor pod from sticking.
• See Chapter 7, Calibrating Your Dexcom G4 PLATINUM System, for further information. 13.2.1 TYPES OF CALIBRATION PROMPTS This section describes the three blood drop symbols. The next section describes what to do when you see one of these symbols. Startup calibration prompt This prompt means the receiver’s 2-hour startup period is complete. You need to enter two blood glucose values to calibrate the system.
13 13.2.2 WHAT TO DO FOR CALIBRATION PROMPTS 1. When you see a calibration prompt, press the SELECT button to clear the prompt. 2. Check the status area at the top of the screen. a. I f the startup calibration symbol shows, take 2 more blood glucose values and enter them into your receiver. b. I f the additional startup calibration symbol shows, take 1 more blood glucose value and enter it into your receiver. Prompt in status area c.
If you see this screen, wait at least 1 hour and then enter 1 more calibration blood glucose value. Wait 15 minutes. If this error screen still shows, enter 1 more blood glucose value. Wait another 15 minutes. If this error screen still shows, the sensor needs to be replaced. Wait 1 hour calibration error screen 13.4 SYSTEM GLUCOSE ERROR The system may tell you that it cannot provide a sensor glucose reading.
13 • Make sure nothing is rubbing the sensor pod (i.e. clothing, seat belts, etc.). • Make sure you selected a good insertion site (see Chapter 6, Section 6.3, Choosing an Insertion Site). • Make sure your insertion site is clean and dry before sensor insertion. • Wipe the bottom of the transmitter with a damp cloth or isopropyl alcohol wipe. Place the transmitter on a clean, dry cloth and air dry for 2-3 minutes. 13.
If the difference between your sensor glucose reading and blood glucose value is greater than 20% of the blood glucose value for sensor readings > 80 mg/dL or greater than 20 points for sensor readings < 80 mg/dL, wash your hands and take another blood glucose measurement.
13 • Make sure you have not taken any medications containing acetaminophen (such as Tylenol to ensure you are getting accurate blood glucose values for calibration. 13.6 SENSOR SHUT-OFF TROUBLESHOOTING In some cases your sensor session may stop or need to be stopped before the end of a full 7-day period. You must remove your sensor. 13.6.1 EARLY SENSOR SHUT-OFF – SENSOR FAILURE The receiver may detect issues with your sensor where it cannot determine your glucose reading.
13.6.2 MANUAL SENSOR SHUT-OFF – “STOP SENSOR” There may be times that you will want to stop your sensor session before the end of the seven days. Some of these times may include removing the sensor early due to: • Calibration issues that cannot be resolved • icon that does not resolve • Sensor adhesion issues • Lifestyle needs When you are in an active sensor session, you will see the “Stop Sensor” option but not the “Start Sensor” option on the main menu.
13 3. The stop sensor thinking screen will show to let you know the sensor session is stopping. Stop Sensor screen “thinking” 4. Once the session has stopped, a red stoplight symbol ( ) shows in the upper right of the trend graph. Trend graph with red stoplight in upper right 13.7 BATTERY AND CHARGER TROUBLESHOOTING Only use the Dexcom cable and battery charger to charge your receiver.
1. Connect the receiver to the charger before resetting. 2. Insert the end of a paperclip into the small circular hole on the back of the receiver and push down. The receiver will vibrate and show the thinking screen. 3. Charge your receiver. 4. You may need to reset the time and date (see Chapter 4, Section 4.1, Charging Your Receiver Battery and Chapter 5, Section 5.2, The Settings Menu). 13.8 RECEIVER AND TRANSMITTER COMMUNICATION TROUBLESHOOTING 13.8.
13 13.8.3 TRANSMITTER LOW BATTERY This screen shows when the transmitter nears the end of its battery life (see Chapter 1, Section 1.4, Transmitter Overview). It will first show when there is about 1 week of battery life left. When the transmitter battery drains low enough, the transmitter and receiver will stop communicating. Replace Transmitter Low Battery your transmitter as soon as possible after screen you see this screen.
This screen means your receiver and transmitter are not communicating and you are not getting sensor glucose readings. • Your receiver and transmitter only communicate when you are in an active sensor session. • Each time you start a new sensor session, wait 10 minutes for your receiver and transmitter to start communicating. Out of Range screen • You may sometimes experience loss of communication for 10 minutes at a time. This is normal.
13 3. Remember, the first alert is vibrate only. See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts sequence tables for how the alerts, alarm and prompts work. If your receiver gets wet or is dropped, make sure the speakers and vibrations still work. You can do this with the Try It option in the profiles menu (see Chapter 9, Section 9.3.1, Alert Profile Options).
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16 CHAPTER 14: TECHNICAL INFORMATION 14.1 DEVICE PERFORMANCE CHARACTERISTICS NOTE: We recommend that you review the information in this chapter with your healthcare provider to understand how well the Dexcom G4 PLATINUM System performs. The Dexcom G4 PLATINUM System (the System) uses a glucose sensor to continuously measure and monitor your glucose levels.
14 average of 2 fingersticks per day (approximately once every 12 hours). All subjects were evaluated in a controlled clinic environment on Day 1, Day 4, and Day 7 of the 7-day wear period. While using the System in the clinic, participants had their blood glucose measured every 15 minutes with a reliable laboratory method, the Yellow Springs Instrument 2300 STAT Plus™ Glucose Analyzer. This instrument is referred to as the “YSI.
16 Table 1-A. System Agreement to YSI within CGM Glucose Ranges CGM Glucose Range mg/dL (mmol/L) Number of paired CGM-YSI Percent within 40/40% YSI Percent Greater than 40/40% YSI Overall 9152 71% 82% 92% 97% 3% 40-60 (2.2-3.3) 512 67% 78% 88% 94% 6% 61-80 (3.4-4.4) 781 73% 85% 94% 98% 2% 81-180 (4.5-10.0) 3853 67% 78% 91% 97% 3% 181-300 (10.1-16.7) 2784 72% 84% 93% 96% 4% 301-350 (16.7-19.4) 775 82% 91% 97% 98% 2% 351-400 (19.4-22.
14 Table 1-B. System Agreement to YSI within YSI Glucose Ranges YSI Glucose Range mg/dL (mmol/L) Number of paired CGM-YSI Percent within 40/40% YSI Percent Greater than 40/40% YSI Overall 9152 71% 82% 92% 97% 3% < 40 (2.2) 22 59% 73% 86% 100% 0% 40-60 (2.2-3.3) 461 75% 87% 94% 98% 2% 61-80 (3.4-4.4) 890 69% 81% 94% 98% 2% 81-180 (4.5-10.0) 3892 65% 76% 88% 95% 5% 181-300 (10.1-16.7) 2644 74% 85% 94% 97% 3% 301-350 (16.7-19.
16 20% of YSI values, i.e. 80 to 120 mg/dL (4.5-6.7 mmol/L), 76% of the time. During the clinical study, the reference YSI values outside of the System measurable range were collected. Among these samples, on 22 occasions, when the actual blood glucose concentrations (as determined by the YSI analyzer) were lower than 40 mg/dL (2.2 mmol/L), 73% of the paired CGM glucose readings were within 20 mg/dL (1.1 mmol/L) of the YSI values, and 86% of the paired CGM glucose readings were within 30 mg/dL (1.
14 Table 2. Number and Percentage of YSI Values When CGM Readings are ‘Low’ or ‘High’ YSI mg/dL (mmol/L) CGM Readings ‘LOW’ CGM-YSI pairs < 55 (3.1) < 60 (3.3) < 70 (3.9) < 80 (4.4) > 80 (4.4) Total n 66 18 39 19 13 155 Cumulative Percent 42% 54% 79% 92% 8% YSI mg/dL (mmol/L) CGM Readings ‘HIGH’ CGM-YSI pairs > 340 (18.9) > 320 (17.8) > 280 (15.6) > 240 (13.3) < 240 (13.
16 Table 3. Concurrence of CGM Readings and YSI Values CGM mg/dL (mmol/L) YSI mg/dL (mmol/L) Percent of matched pairs in each YSI glucose range for each Sensor glucose range Number of Paired CGM-YSI < 40 (<2.2) 40-60 (2.23.3) 61-80 (3.44.4) 81120 (4.56.7) 121160 (6.78.9) 161200 (8.911.1) 201250 (11.113.9) 251300 (13.916.7) 301350 (16.719.4) 351400 (19.422.2) > 400 (>22.2) < 40 (< 2.2) 6% 48% 37% 7% 1% 0% 0% 0% 0% 0% 0% 155 40-60 (2.2-3.
14 Accuracy Accuracy between matched pairs was also estimated by calculating the percent difference between the System reading and the YSI value. For example, if the YSI value is 100 mg/dL (5.6 mmol/L) and the System reading is 90 mg/dL (5.0 mmol/L), a 10% difference between the System and the YSI is reported. The System and YSI values were compared by pairing the System reading that fell immediately after the YSI value was collected.
Table 4-A. System Difference to YSI within CGM Glucose Ranges Number of Paired CGM-YSI Mean Percent Difference (%) Median Percent Difference (%) Mean Absolute Percent Difference (%) Median Absolute Percent Difference (%) Overall 9152 2.9 1.7 13.3 9.8 *40-60 (2.2-3.3) 512 -10.0 (-0.6) -8.2 (-5.2) 13.5 (0.8) 9.7 (0.5) *61-80 (3.4-4.4) 781 -2.4 (-0.1) -0.4 (-0.0) 11.4 (0.6) 8.6 (0.5) 81-180 (4.5-10.0) 3853 4.8 3.0 13.8 9.8 181-300 (10.1-16.7) 2784 2.1 0.0 11.9 9.
14 the reference at CGM reading within 351-400 mg/dL (Mean Absolute Percent Difference, i.e. 19.4-22.2 mmol/L). Table 4-B. System Difference to YSI within YSI Glucose Ranges YSI Glucose Ranges mg/dL (mmol/L) Number of paired CGM-YSI Mean Percent Difference (%) Median Percent Difference (%) Mean Absolute Percent Difference (%) Median Absolute Percent Difference (%) Overall 9152 2.9 1.7 13.3 9.8 *< 40 (2.2) 22 14.4 (0.8) 12.9 (0.7) 14.4 (0.8) 12.9 (0.7) *40-60 (2.2-3.3) 461 7.3 (0.4) 6.
16 Table 4-B is categorized within YSI glucose value ranges. For example, on average, CGM reads 7.3 mg/dL (0.4 mmol/L) higher than the reference at YSI glucose levels of 40-60 mg/dL (2.2-3.3 mmol/L) and reads 3.6 mg/dL (0.2 mmol/L) higher than the reference at YSI glucose level of 61-80 mg/dL (Mean Difference, i.e. 3.4-4.4 mmol/L), 9.8% different than the reference at YSI glucose values of 301-350 mg/dL (Mean Absolute Percent Difference, i.e. 16.7-19.4 mmol/L), and 8.
14 Hypoglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the % of time the device alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the device alarmed. The False Alert Rate is the % of time the device alarmed when the blood glucose level was above the alert setting within 15 minutes before or after the device alarmed. For example, if you set the Low Glucose Alert to 70 mg/dL (3.
16 The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Table 6. Table 6. Hyperglycemic Alert Evaluation Hyperglycemic Alert Level mg/dL (mmol/L) True Alert Rate False Alert Rate Hyperglycemia Detection Rate Hyperglycemia Missed Detection Rate 120 (6.7) 95% 5% 98% 2% 140 (7.8) 94% 6% 97% 3% 180 (10.0) 92% 8% 97% 3% 200 (11.1) 92% 8% 97% 3% 220 (12.2) 91% 9% 95% 5% 240 (13.3) 91% 9% 94% 6% 300 (16.
14 Hyperglycemia Detection Rate The Detection Rate shows how often the device recognizes and alerts you to an episode of hyperglycemia or how often it misses such an event. The Hyperglycemia Detection Rate is the % of time the blood glucose level was at or above the alert setting and the device alarmed within 15 minutes before or after the blood glucose was at or above the alert settings.
Table 7.
14 Table 8. Sensor Stability (Accuracy over Time) Day of Wear Number of paired CGM-YSI Mean Absolute Percent Differences (%) Median Absolute Percent Differences (%) Percent within 15/15% YSI Percent within 20/20% YSI Percent within 30/30% YSI Percent within 40/40% YSI Percent greater than 40/40% YSI Day 1 3023 16.7% 13.2% 59% 71% 86% 94% 6% Day 4 3108 11.4% 8.2% 77% 87% 95% 98% 2% Day 7 3021 11.9% 8.9% 76% 87% 95% 98% 2% NOTE: CGM readings are within 40 to 400 mg/dL (2.
provided between 1,811 and 1,992 valid glucose readings (or more than 76% of the expected number of readings). Adjusted within each system wear-day, the System provided an average of 97% of all expected glucose readings (288) as seen in Table 10. Table 9. Number of Readings Provided by Each Sensor Over 7-Days % of Total Possible Readings Provided Total Readings Provided (Min-Max) % of Systems Providing that Number of Readings 0-25% 167-491 1.9% 26-50% 719-914 3.7% 51-75% 1267-1267 0.
14 able 11. System Agreement to SMBG Within CGM T Glucose Ranges CGM Glucose Ranges mg/dL (mmol/L) Percent Percent Percent within within within 15/15% 20/20% 30/30% CGM-SMBG SMBG SMBG SMBG Number of paired Percent within 40/40% SMBG Percent greater than 40/40% SMBG Overall 7508 69% 81% 94% 98% 2% 40-60 (2.2-3.3) 731 75% 84% 92% 96% 4% 61-80 (3.4-4.4) 968 78% 86% 95% 99% 1% 81-180 (4.5-10.0) 3141 65% 78% 93% 98% 2% 181-300 (10.1-16.
example, if the CGM reads 100 mg/dL, it is between 81-180 mg/dL (4.510.0 mmol/L) range, you can expect the CGM readings to be within 20% of the SMBG values 78% time. Table 12. System Difference to SMBG within CGM Glucose Ranges CGM Glucose Ranges mg/dL (mmol/L) Mean Median Mean Median Number of Absolute Absolute Percent Percent Paired Percent Percent Difference Difference CGM-SMBG Difference Difference (%) (%) (%) (%) Overall 7508 -0.4 -1.4 14.0 11.0 *40-60 (2.2-3.3) 731 -9.3 (-0.5) -8.0 (-0.
14 or less than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 11.0% or less different than SMBG values (Table 12). Adverse Events No serious adverse events or device-related serious adverse events occurred during the study. Mild skin irritation, such as erythema or edema, occurred in low frequency around adhesive area. No infection, bruising, or bleeding occurred at the sensor needle insertion area or the adhesive area. 14.
14 Transmitter Product Specifications (continued from page before) Power Supply Silver oxide batteries (not replaceable) Operational Conditions Temperature: 50° F - 108° F Storage Conditions Temperature: 32° F - 113° F Humidity: 10% - 95% RH Operating Altitude -500 to 12000 feet Limited Warranty 6 months Moisture Protection IP28: t emporary submersion Protection Against Electrical Shock Type BF applied part Humidity: 10% - 95% RH Transmitter Performance Characteristics PARAMETER PERFORMANCE
14 Transmitter Performance Characteristics (continued from page before) PARAMETER PERFORMANCE CHARACTERISTICS Transmit Duty Cycle 4.48 ms every 5 minutes at each of the four TX frequencies. Data Detection Range 20 feet The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is safe for use on U.S. commercial airlines. The Dexcom G4 PLATINUM Transmitter is an M-PED with emission levels that meet RTCA/DO160, Section 21, Category M.
Transmitter Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Transmitter Compliance Level Electromagnetic Environment Guidance with synthetic material, the relative humidity should be at least 30% Electrical Fast ± 2 kV for power supply lines Transient / burst Not applicable IEC 61000-4-4 ± 1 kV for input/output lines Battery operated Surge ± 1 kV line(s) to line(s) Not applicable IEC 61000-4-5 Voltage Dips, Short Interruptions and Voltage V
14 Transmitter Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Transmitter Compliance Level Electromagnetic Environment Guidance Power Frequency 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 3 A/m (50/60 Hz) Magnetic Field IEC 61000-4-8 NOTE: UT is the a.c. mains voltage prior to application of the test level.
Receiver Product Specifications (continued from page before) Communication Range 20 feet Memory Storage 30 days of glucose data, 7 days of tech support data Re-Chargeable Battery Use 3 days Charging Time 3 hours wall outlet, 5 hours powered USB Storage/Operating Conditions Temperature: 32° F - 113° F Humidity: 10% - 95% RH Operating Altitude -500 to 12000 feet Moisture Protection IP22: vertically falling drops Limited Warranty 1 year Control Classification Class II equipment Guidance and M
14 Receiver Electromagnetic Immunity Specifications Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge (ESD) ± 6 kV Contact ± 6 kV Contact ± 8 kV Air ± 8 kV Air Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Receiver Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Receiver Compliance Level IEC 61000-4-11 70% UT (30% dip in UT) for 25 cycles 70% UT (30% dip in UT) for 25 cycles 85% UT (15% dip in UT) for 5 sec 85% UT (15% dip in UT) for 5 sec IEC 60601-1-11 Electromagnetic Environment Guidance < 5% UT < 5% UT (> 95% dip in UT) (> 95% dip in UT) for 5 sec for 5 sec Power Frequency (50/60 Hz) Magnetic Field IEC 61000-4-8 3 A/m 3 A/m Power freque
14 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Dexcom G4 PLATINUM System is intended for use in the electromagnetic environment specified below. The customer or the user of the Dexcom G4 PLATINUM System should ensure that it is used in such an environment.
System Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb.
14 (footnotes continued page from page before) stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Electromagnetic Emissions Specifications (continued from page before) Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Class B The Dexcom G4 PLATINUM System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
14 Minimum Recommended Distance Between Transmitter and Receiver Rated maximum Output Power of Transmitter (W) Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz d = 1.2 P1/2 80 MHz to 800 MHz d = 1.2 P1/2 800 MHz to 2.5 GHz d = 2.3 P1/2 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.
Power Supply/Charger Specifications Dexcom P/N MT21255 Class II Input: AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100Vac DC Output: 5V DC, 1A (5.0 Watts) 14.3 FCC REQUIREMENTS The transmitter covered by this user’s guide has been certified under FCC ID: PH29433. 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.
14 and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation.
15 chapter fifteen USER ASSISTANCE Dexcom G4 PLATINUM User’s Guide | 177
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17 CHAPTER 15: USER ASSISTANCE Dexcom Website: www.dexcom.com Dexcom Address: 6340 Sequence Drive San Diego, CA 92121 TECHNICAL SUPPORT For Dexcom product questions and troubleshooting issues8. Dexcom Technical Support Phone Numbers: 1.877.339.2664 or 1.858.200.0200 (24 hours, 7 days a week) Dexcom Technical Support E-mail: TechSupport@dexcom.com Dexcom Technical Support Fax: 1.877.633.
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16 chapter sixteen WARRANTY Dexcom G4 PLATINUM User’s Guide | 181
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CHAPTER 16: WARRANTY Dexcom G4 PLATINUM System Limited Warranty 1. What is Covered and for How Long? Dexcom, Inc.
16 installation, maintenance, and service of products; or (g) equipment that has been disassembled; or (h) water damage to the receiver (receiver is not water resistant, do not get the receiver wet at any time). 3. What are Dexcom’s Obligations Under the Limited Warranty? During the Warranty Period, Dexcom will replace, at Dexcom’s sole option, without charge to purchaser, any defective Dexcom G4 PLATINUM Receiver.
INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, DEXCOM SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING IN ANY WAY OUT OF THE SALE, USE, MISUSE OR INABILITY TO USE ANY DEXCOM G4 PLATINUM SYSTEM.
16 Transmitter is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing upon the date of shipment and continuing for the following specified period of time after that date (“Warranty Period”): Dexcom G4 PLATINUM Transmitter: 6 Months NOTE: If you received this transmitter as a replacement for an in-warranty transmitter, any remaining warranty on the original transmitter shall transfer to this replacement transmitter, and this warranty page shall be voi
of which was included with your Dexcom G4 PLATINUM CGM System and may be found at www.dexcom.com. 3. What Are Dexcom’s Obligations Under The Limited Warranty? During the Warranty Period, Dexcom will replace, at Dexcom’s sole option, without charge to purchaser, any defective Dexcom G4 PLATINUM Transmitter.
16 PURPOSE, OR NON-INFRINGEMENT. EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, DEXCOM SHALL NOT BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, ARISING IN ANY WAY OUT OF THE SALE, USE, MISUSE OR INABILITY TO USE ANY DEXCOM G4 PLATINUM CGM SYSTEM. THIS LIMITATION SHALL APPLY EVEN IF DEXCOM OR ITS AGENT HAS BEEN ADVISED OF SUCH DAMAGES AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF THIS LIMITED REMEDY.
17 chapter seventeen TRAVEL INFORMATION Dexcom G4 PLATINUM User’s Guide | 189
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CHAPTER 17: TRAVEL INFORMATION It is safe for you to go through the metal detector or be “handwanded” while wearing your Dexcom sensor and transmitter. If you’re concerned or uncomfortable about going through the walk-through metal detector, the Transportation Security Administration (TSA) states that you should notify the Security Office that you’re wearing a continuous glucose monitor and would like a full-body pat-down and a visual inspection of your Dexcom Sensor and Transmitter instead.
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18 chapter eighteen APPENDIX Dexcom G4 PLATINUM User’s Guide | 193
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CHAPTER 18: APPENDIX APPENDIX I, RECEIVER ALERTS, ALARM AND PROMPTS The following tables describe the alarm, alerts and prompts and how the receiver notifies you. Prompt - Shows on screen only. Silent, no vibrate or beep. Alert - Notifies with vibrate and beep depending on your profile settings. Alarm - Low 55 - Notifies with vibrate and beep. Cannot be changed.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, What does this alert or mean? alarm? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Low glucose alert Your most recent sensor glucose reading is at or below the low alert setting. Vibrates three, times then vibrates/beeps three times every 5 minutes until confirmed or your glucose value goes above the alert level.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Unknown sensor prompt The sensor is sending sensor glucose readings that the receiver does not understand. You will not receive sensor glucose readings. Symbol in status area only.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Wait 15 minutes calibration error alert The sensor cannot calibrate. Wait 15 minutes then enter 1 more blood glucose value. Wait 15 more minutes. If error screen still appears enter 1 more blood glucose value. Wait 15 minutes.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? 12 hour calibration prompt The receiver needs a blood glucose value entered to calibrate. Prompt screen only. Yes, every 15 minutes. Calibration prompt The receiver needs a blood glucose value entered to calibrate.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Enter BG processing screen prompt The receiver is processing the blood glucose value you entered. Prompt screen only. N/A Rise alert Your glucose levels are rising at 2 mg/dL per minute or more.
20 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Rapid fall alert Your glucose levels are falling fast at 3 mg/dL per minute or more. 3 vibrates then 3 vibrates/3 beeps every 5 minutes (2 times) or until confirmed. No 6-hour sensor expiration prompt Your sensor session will end in 6 hours. Prompt screen only.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Sensor Failed alert The sensor is not working properly. 1 vibrate then vibrate/beep every 5 minutes (2 times). Yes, 2 re-alerts in the next 10 minutes for 30 minutes. Receiver error code alert Your receiver is not working properly.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Transmitter Low Battery alert Transmitter battery is low. Replace the transmitter as soon as possible. 1 vibrate then Yes, vibrate/beep once a every 5 minutes day. (2 times). Transmitter Failed alert The transmitter has failed. Replace the transmitter immediately.
18 APPENDIX II, INDEX A Alarm, Low Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 Glucose Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 Setting . . . . . . . . . . . . . . . . . . . . . . .
20 C Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67 Calibration Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 How to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Re-Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Start-up Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 M Maintenance, System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123 Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 R Radio-Frequency (RF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Charging your . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20 Failed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 Insertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .51 Insertion Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8,13 Removing from Package . . . . . . . . . . . . . . . . . . . . . . . .
18 ID Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Setting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8,58 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Pairing with receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDIX III, SYMBOLS USED IN LABELING The following symbols may be found on the sensor, transmitter, and receiver package labels. These symbols tell you about the proper and safe use of the Dexcom G4 PLATINUM CGM System. Some of these symbols may not have meaning in your region, and are listed for informational purposes only. This table shows what each symbol means.
18 19 Symbols (continued from page before) Manufacturer EC REP Two-Sided Humidity Limitation Non-ionizing Radiation European Union WEEE Directive 200666-EC Marking Certifies that the device meets the European Council Directive 93/42/EEC Electrical Equipment Designed Primarily for Indoor Use Input Authorized Representative in the European Community Do Not Use if Package is Damaged SB Ship By Date Keep Dry 210 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System
