Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.
USER’S GUIDE DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM RECEIVER WITH ShareTM IMPORTANT CONTACTS AND NUMBERS Dexcom® Website: www.dexcom.com Your Transmitter ID: Your Receiver ID: Your Healthcare Professional: Nearest Hospital: © 2015 Dexcom, Inc. All rights reserved. Covered by patents www.dexcom.com/patents Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom Share, Dexcom STUDIO, and SEVEN are either registered trademarks or trademarks of Dexcom, Inc.
DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM table of contents GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 CHAPTER 1: DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION 11 1.1 1.2 1.3 1.4 1.5 1.6 System Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Sensor Overview . . . . . .
CHAPTER 5: DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM SETUP 43 5.1 Setting Up the Receiver and Pairing with Your Transmitter . . . . . 45 5.2 The Settings Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 5.2.1 Getting to the Settings Menu ��������������������������������������������� 47 5.2.2 Setting Your Receiver Time and Date ������������������������������� 47 5.2.3 Entering Your Transmitter ID �����������������������������������������������48 5.2.
8.3 Glucose Status Area Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 CHAPTER 9: ALERTS, ALARM & PROFILES . . . . . . . 95 9.1 Setting Your Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 9.1.1 Default Alert/Alarm Settings . . . . . . . . . . . . . . . . . . . . . . . . 97 9.1.2 Glucose Alerts and Alarm . . . . . . . . . . . . . . . . . . . . . . . . . 100 9.1.2.1 High Glucose Alert . . . . . . . . . . . . . . . . . . . . . . . 101 9.1.2.
1 12.2 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 12.3 Product Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134 CHAPTER 13: TROUBLESHOOTING 135 CHAPTER 14: TECHNICAL INFORMATION 153 CHAPTER 15: CHAPTER 16: CHAPTER 17: CHAPTER 18: 193 197 205 209 13.1 Sensor Insertion Troubleshooting . . . . . . . . . . . . . . . . . . . . . . 13.2 Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . .
GLOSSARY Alternative Site This is when you take a blood glucose value on your meter BG Testing using a blood sample from an area on your body other than your fingertip. Do not use alternative site testing to calibrate your receiver. Applicator A disposable piece that comes attached to the sensor pod and inserts the sensor under the skin. There is a needle inside the applicator that you remove after you insert the sensor. BG Meter Blood glucose meter.
GLOSSARY (continued from page before) Dexcom G4 PLATINUM (Pediatric) System The sensor, transmitter, and receiver. Dexcom Share™ System Secondary notification system to the Dexcom G4 PLATINUM System. For more information, please refer to the Dexcom Share User Manual. Glucose Data Gaps Different symbols show on the trend graph instead of a sensor glucose reading to let you know that the receiver cannot provide a reading. Glucose Trends Trends let you see the pattern of your glucose levels.
GLOSSARY (continued from page before) Obstruction Something that blocks the wireless path between the transmitter and receiver. There are many types of things that could come between the transmitter and receiver, and Dexcom could not test them all. “Without obstruction” means that we have not tested whether items blocking the transmitter or receiver could affect the transmission range. Profiles Sound pattern and volume level settings for your alerts.
GLOSSARY (continued from page before) Sensor The Dexcom G4 PLATINUM (Pediatric) System part that includes an applicator and wire. The applicator inserts the wire under your skin, and the wire measures glucose levels in your tissue fluid. Sensor Pod The small plastic base of the sensor attached to your skin that holds the transmitter in place. Snoozing The option to delay your alert for a set amount of time. A snooze time can be set for high and low glucose re-alerts.
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1 chapter one DEXCOM G4 PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 11
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CHAPTER 1: DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION Dexcom G4 PLATINUM (Pediatric) Receiver with Share Dexcom G4 PLATINUM Transmitter Dexcom G4 PLATINUM Sensor 1.1 SYSTEM CONTENTS: • sensor • transmitter • receiver • receiver USB charging/download cable • AC power adapter - MT21255 • receiver case • user’s guide • quick start guide • training checklist • tutorial disc • Dexcom STUDIO™ software (available for download online at www.dexcom.
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 skin 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 your skin. It is attached to the sensor pod, and is made of silver and platinum metal with polymer membranes.
1 1.4 TRANSMITTER OVERVIEW The transmitter is the gray, plastic “chip” that snaps into your sensor pod. The 9438-01 transmitter (including sensor pod) is 1.5 inches long, 0.9 inches wide and 0.5 inches thick. The 9438-05 transmitter (including sensor pod) is 1.5 inches long, 0.9 inches wide and 0.4 inches thick. Once snapped into the sensor pod, the transmitter wirelessly sends your glucose information to the receiver. The transmitter and sensor are water resistant when properly connected.
1.5 RECEIVER OVERVIEW The receiver is the small hand-held device that looks like a cell phone. It is about 4 inches long, 1.8 inches wide and 0.5 inches thick. It shows your sensor glucose readings, trend graph, direction and rate of change arrow. Do not spill fluids on the receiver or drop the receiver into fluids. Keep the micro USB port door closed to help prevent fluid and dust from getting inside the receiver.
1 Your receiver and transmitter wirelessly pair together to communicate securely and only with each other. You will need a commercially available blood glucose meter to use with your system. See Section 14 for Product Specifications. Display screen UP button Speaker USB port cover RIGHT button LEFT button DOWN button SELECT button USB port Receiver buttons: • Press the UP and DOWN buttons to scroll through trend graph screens, highlight menu items, or set values.
2 chapter two INDICATIONS FOR USE AND SAFETY STATEMENT Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 19
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CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT 2.1 INDICATIONS FOR USE The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons ages 2 to 17 years with diabetes. The system is intended for single patient use and requires a prescription.
2 2.3 CONTRAINDICATIONS • Remove the Dexcom G4 PLATINUM Sensor, MR Transmitter, and Receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the device into the MR environment. The Dexcom G4 PLATINUM (Pediatric) System has not been tested during MRI or CT scans or with diathermy treatment.
glucose readings. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. • Do not ignore symptoms of high and low glucose. If your sensor glucose alerts and readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range.
2 at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200 24 hours a day, 7 days a week. • Do not use the Dexcom G4 PLATINUM (Pediatric) System in pregnant women or persons on dialysis. The system is not approved for use in pregnant women or persons on dialysis and has not been evaluated in these populations.
hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. • Do not use your transmitter or receiver if it is damaged/cracked. This could create an electrical safety hazard or malfunction, which might cause electrical shocks. • Store the sensor at temperatures between 36° F - 77° F for the length of the sensor’s shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in a freezer.
2 Rotate your sensor placement sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation. • 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.
the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during significant rise or fall of blood glucose may affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. • The system accuracy may be affected when your glucose is changing at a significant rate (e.g.
2 represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor accuracy and result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. • 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.
3 chapter three RISKS AND BENEFITS Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 29
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CHAPTER 3: RISKS AND BENEFITS 3.1 RISKS WARNINGS • In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decision. • In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose. There are some known risks with using real-time CGM.
3 high blood glucose levels. If this happens, and your blood glucose levels are very high or low, there is a remote chance you might need medical help. Inserting the sensor and wearing the adhesive patch might cause infection, bleeding, pain or skin irritations (redness, swelling, bruising, itching, scarring or skin discoloration). There is a low chance of this happening. In the clinical study for the Dexcom G4 PLATINUM (Pediatric) System, only slight redness and swelling occurred in a few patients.
Alerts and the low alarm tell you when your glucose is outside of your target glucose range and may help you avoid low and high blood sugar. Rise and fall glucose alerts can also provide benefit by alerting you when your glucose is rapidly going down or up. This way you can be alerted to this information before you are too high or too low and take action to avoid it. Real-time CGM can help increase time in your target glucose range without increasing your time in the low or high glucose range.
1 arg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L. G Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006; 29:44-50. 2 J DRF CGM Study Group. Continuous Glucose Monitoring and Intensive Treatment of Type 1 Diabetes. NEJM 2008;359:1464-76. 3 attelino. Effect of continuous glucose monitoring of hypoglycemia in B type 1 diabetes. Diabetes Care 2011; 34(4): 795-800.
4 chapter four CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 35
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CHAPTER 4: CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU 4.1 CHARGING YOUR RECEIVER BATTERY The receiver battery is rechargeable and will last about 3 days with normal use before you need to charge it. Your battery life depends on how often you press your receiver buttons or get alerts. The receiver will tell you when the battery charge is low. Low battery prompt Charge the receiver battery using one of these options: • Section 4.1.1: an AC power outlet • Section 4.1.
4 Charge your receiver battery before each sensor insertion. Periodically check your battery level to make sure it has enough charge. If your battery drains, it will keep the time and date for 3 days without being charged. After 3 days, the receiver will prompt you to reset the time and date (see Chapter 5, Section 5.2, The Settings Menu). When the receiver is used in a healthcare facility, charging must take place away from the patient.
4. P lug the micro USB end of the cable into the receiver USB port. Keep the USB port cover on the receiver closed whenever the USB cable is not attached. 5. T he battery charging screen will show on the receiver. Battery charging screen 6. After a few seconds the trend graph will show with the battery charging symbol ( in the upper left corner. ) Battery charging symbol in upper left corner of trend graph 4.1.
4 3. The battery charging screen shows on the receiver. Battery charging screen 4. A fter a few seconds, the trend graph screen will show the battery charging symbol in the upper left corner. Battery charging symbol in upper left corner of trend graph 4.1.3 KNOWING YOUR RECEIVER IS CHARGED s the battery charges, the battery charging symbol fills in. A When the battery is fully charged, the battery charging symbol is completely shaded.
2 Receiver Main Menu Options Menu User’s Guide Reference Purpose Trend Graph To show the trend graphs. •T he 3-hour trend graph is the default screen whenever you turn on the receiver. Chapter 8 Start Sensor To start a new sensor session. • This option only shows if you have entered a transmitter ID and you are not in the middle of a sensor session Chapter 6 Enter BG To enter your blood glucose values for calibration.
Receiver Main Menu Options (continued from page before) Menu Stop Sensor Purpose To end a sensor session early. • This option only shows when you are in the middle of a sensor session. You will not get sensor glucose readings, and you must dispose of your sensor if you stop the session. User’s Guide Reference Chapter 13 See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts, for a list of screens that may show on the receiver.
5 chapter five DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM SETUP Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 43
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CHAPTER 5: DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM SETUP This chapter helps you when you first set up your Continuous Glucose Monitoring system. Read this chapter before you start. 5.1 SETTING UP THE RECEIVER AND PAIRING WITH YOUR TRANSMITTER The Setup Wizard guides you through setup the first time you turn on your receiver. 1. R emove the transmitter from its packaging. Wait 10 minutes for the transmitter to turn on before setting up the receiver. 2.
5 (3) Press the SELECT button after you enter the last number or letter to confirm the transmitter ID. Your transmitter ID is a unique code with 5 numbers and/or letters found in the following locations: • On the transmitter box label • On the bottom of the transmitter c. S et your low and high glucose alert values. Your low and high glucose alerts are pre-set to 80 mg/dL and 200 mg/dL but can be changed.
5.2 THE SETTINGS MENU The Settings menu lets you change the time, date or transmitter ID. The Setup Wizard only works the first time you turn on your receiver, but you can always use the Settings menu. 5.2.1 GETTING TO THE SETTINGS MENU 1. P ress the SELECT button to turn on the receiver. The 3-hour trend graph shows. 2. Press the SELECT button to see the Main Menu. 3. From the Main Menu, press the UP or DOWN button to scroll to “Settings” and press the SELECT button.
5 2. P ress the RIGHT button to highlight each value in the date and time. 3. Press the UP or DOWN button to make any changes. 4. P ress the RIGHT button to move to the next value. The date format is YYYY/MM/DD. Time/Date setting screen, year highlighted 5. P ress the SELECT button after choosing “AM” or “PM.” You will return to the Settings menu. You might need to reset the receiver’s time and date if the rechargeable battery drains.
1. F rom the Settings menu, press the UP or DOWN button to scroll to “Transmitter ID” and press the SELECT button. Settings menu, Transmitter ID highlighted 2. Start with the first number or letter (do not enter “SN”): a. P ress the UP or DOWN button to show the correct number or letter. b. P ress the RIGHT or SELECT button to move to the next value and repeat step a. c. C ontinue repeating steps a and b to enter the whole transmitter ID. d.
5 5.3 CHECKING INFORMATION ABOUT YOUR DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM You can check your receiver for information about your CGM system at any time. 1. F rom the Settings menu, press the UP or DOWN button to scroll to “Device Info.” 2. P ress the SELECT button. Information about your sensor session and system will show. Settings menu, Device Info highlighted 3.
CONTRAINDICATION Remove the Dexcom G4 PLATINUM Sensor, MR Transmitter, and Receiver before Magnetic Resonance Imaging (MRI), Computed Tomograph (CT) scan, or diathermy treatment. The device is MR Unsafe. Do not bring any portion of the device into the MR environment. The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment.
5 Press the SELECT, LEFT or RIGHT button to see the trend graph. This antenna symbol shows that the transmitter and receiver are communicating. Antenna symbol appears in upper left of trend graph This out of range symbol shows the transmitter and receiver are not communicating.
6 chapter six INSERTING A SENSOR AND STARTING A SENSOR SESSION Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 53
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CHAPTER 6: INSERTING A SENSOR AND STARTING A SENSOR SESSION You need a sensor, a transmitter, and a receiver to use your Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System. You also need a blood glucose meter and test strips for calibration. The blood glucose meter and test strips are not provided in the Dexcom G4 PLATINUM (Pediatric) System. 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 (contains small introducer needle and sensor) Collar Transmitter latch Sensor pod Release tab Adhesive patch 6.2 REMOVING THE SENSOR FROM ITS PACKAGING PRECAUTION Do not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor might cause infection. • Wash your hands thoroughly, and dry them. • Carefully remove the sensor from its packaging.
6 6.3 CHOOSING AN INSERTION SITE PRECAUTIONS • 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 accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. • Avoid injecting insulin or placing an insulin pump infusion set within 3 inches of the sensor.
The ideal sensor insertion site for you may be based on your body type, activity, sensitivities, and other personal and physical traits. You can choose a site above or below your belt line. The best areas to insert your sensor are usually flat and “pinchable.” Avoid sensor insertion where something may rub or press against the sensor.
6 6.4 PLACING THE SENSOR WARNINGS • Do not use the Dexcom G4 PLATINUM (Pediatric) System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM (Pediatric) System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions. Blood glucose values may differ from sensor glucose readings.
NOTE: Skin preparation or adhesive products (Mastisol®, Skin Tac™) are optional. If you use an optional skin preparation or adhesive product, place it on the skin in a “doughnut” shape where you will place the sensor adhesive patch. Insert the sensor through the clean skin at the center of the doughnut where it is free of skin preparation or adhesive products. Let dry (skin may feel slightly sticky). 2.
6 6. Save the safety lock to help you remove the transmitter at the end of your sensor session. The safety lock can be used for transmitter removal but is not required. When your glucose monitoring session is over, follow the steps in Chapter 11, Section 11.3, Transmitter Removal, with or without the safety lock. NOTE: Contact your healthcare professional for specific questions regarding the use of medical tape, barrier wipes and/or other adhesives as it relates to your use of Dexcom CGM. 6.
4. K eep pinching up on your skin with one hand. With your other hand, place two fingers under the collar. Keep your thumb lightly on top of the white plunger, and pull the collar back towards your thumb until you hear 2 clicks or cannot pull back any more. This leaves the sensor under your skin and removes the needle from your body. “ 2 CLICKS” Step 4. Pull back the collar - retract the needle 5.
6 Do not to touch the metal circles on the bottom of the transmitter with your skin. Do not to scratch the bottom of the transmitter as scratches may compromise the waterproof seal. 2. P lace the transmitter in the sensor pod (with the flat side down, and the narrower side away from the transmitter latch). Install transmitter in sensor pod 3. Snap in the transmitter: a. W ith one hand, you may want to pinch up on your skin at the front edge of the white adhesive. b.
4. H old the sides of your sensor pod with one hand. Remove the transmitter latch with your other hand by quickly twisting off the latch away from your body. Twist transmitter latch up or down 5. Do not remove the transmitter from the sensor pod while the pod is attached to your skin. 6.
6 current session or stop the session (refer to Chapter 13, Section 13.6, Sensor Shut-off Troubleshooting). 4. P ress 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. Start Sensor “thinking“ screen 5. A fter you start your sensor session, this screen appears as a reminder of the differences in CGM performance between two different clinical studies in adults and pediatrics.
6.8 SENSOR STARTUP PERIOD The sensor needs a 2-hour startup period to adjust to being under the skin. Your trend graph shows a 2-hour countdown symbol in the upper right corner. 1. Press SELECT during the startup period to turn the on receiver display and see this symbol. The countdown symbol fills in over time to show that you are getting closer to the first calibration time. You will not get sensor glucose readings, alerts and alarm during the countdown.
6 At the end of the 2-hour startup period the receiver lets you know it is time to calibrate your sensor. Chapter 7, Calibrating Your Dexcom G4 PLATINUM (Pediatric) System, tells you how to calibrate your sensor. 6.9 TAPING THE SENSOR POD The sensor pod should stay on your skin using its own adhesive. But, if the patch is peeling up, you can use medical tape (such as Blenderm™, Tegaderm™, Smith & Nephew IV3000®, 3M™ tape) for extra support.
2. Confirm that you want to shut down your receiver. a. I f you want to shut down, press the LEFT button to highlight “OK,” and then press the SELECT button. b. I f you want to cancel the shutdown, press the SELECT button (with “Cancel” highlighted) to return to the Main Menu. Shutdown screen, OK highlighted To turn the receiver back on and resume communication with the transmitter, press the SELECT button. It may take up to 20 seconds for the display to turn back on.
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CHAPTER 7: CALIBRATING YOUR DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM You must calibrate Dexcom G4 PLATINUM (Pediatric) System sensor glucose readings to your blood glucose meter. CONTRAINDICATION Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person. 7.
7 Example Minimum Calibration Schedule During Seven-Day Sensor Session PRECAUTION Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration.
7.2 HOW TO CALIBRATE You must enter the exact blood glucose value from your meter for each calibration. Blood glucose values must be between 40-400 mg/dL and must have been taken within the past 5 minutes. •M ake sure either a sensor glucose reading or a calibration needed symbol shows at the top of the trend graph before calibrating. •Y our sensor can be calibrated if your meter glucose is 40 mg/dL or above. For safety reasons, if your blood glucose is low, first treat your low blood sugar.
7 PRECAUTION o not calibrate if your blood glucose is changing at a D significant rate, typically more than 2 mg/dL per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during significant rise or fall of blood glucose may affect sensor accuracy and could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events.
1. W ash and dry your hands, make sure your glucose test strips are not expired and have been stored properly, and make sure your meter is properly coded (if required). 2. Take a blood glucose measurement using your meter. •C arefully apply the blood sample to the test strip following your meter or test strip instructions. 3. From any trend graph, press the SELECT button to see the Main Menu. 4. U se the UP or DOWN button to scroll until you highlight “Enter BG.
7 7. C onfirm that the blood glucose value you entered is correct. Entering incorrect values may affect the sensor accuracy. a. P ress the SELECT button if the blood glucose value displayed is correct. b. I f the blood glucose value shown is Enter BG screen, incorrect, press the RIGHT button OK highlighted to confirm to highlight “Cancel” then press the SELECT button to return to the Enter BG screen. Repeat the steps to enter the correct blood glucose value. c.
PRECAUTION To calibrate the system, do enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement. Do not enter sensor glucose readings for calibration.
7 2. T ake 2 separate blood glucose measurements with your meter, and enter the blood glucose values into the receiver (see Chapter 7, Section 7.2, How to Calibrate). 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.
7.5 OTHER REASONS YOU MAY NEED TO CALIBRATE You may need to calibrate when your system did not accept the last calibration or your blood glucose value is very different from the sensor glucose reading. 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.
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8 chapter eight SENSOR GLUCOSE READINGS AND TRENDS Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 83
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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 The greatest benefit you get from using your Dexcom G4 PLATINUM (Pediatric) System will come from the trending information. It is important that you focus on the trends and rate of change on your receiver, rather than the exact sensor glucose reading. If you have trouble reading your receiver in bright sunlight, find a shady spot. WARNING Do not use the Dexcom G4 PLATINUM (Pediatric) System for treatment decisions, such as how much insulin you should take.
Most recent 5-minute sensor glucose reading Battery Status area Trend arrow Antenna Plot of most recent sensor glucose readings High glucose alert setting Glucose values Glucose target range Low glucose alert setting Current time Trend graph hours EXAMPLE: 3-Hour Trend Graph Screen •E ach “dot” on the trend graph is a sensor glucose reading reported every 5 minutes. • The trend graph shows the current time.
8 • The dots on your trend graph change colors based on your high and low alert settings. You can view your past glucose information on the 1, 3, 6, 12, and 24 hour trend graphs by pressing the UP or DOWN button. • Your system only reports glucose information between 40-400 mg/dL. Your trend graph shows a flat line or dots at 400 or 40 mg/dL when your glucose is outside this range.
Which Trend Graph Do You See? (continued from page before) (Scroll down from the 3-hour graph to reach the 6-hour graph) 6-Hour Trend Graph: The 6-hour trend graph shows your current sensor glucose reading and the last 6 hours of sensor glucose readings. (Scroll down from the 6-hour graph to reach the 12-hour graph) 12-Hour Trend Graph: The 12-hour trend graph shows your current sensor glucose reading and the last 12 hours of sensor glucose readings.
8 8.2 RATE OF CHANGE ARROWS Your rate of change arrows add detail about the direction and speed of glucose change over the last 15-20 minutes. The trend arrows show to the right of your current sensor glucose reading. Do not overreact to the rate of change arrows. Consider recent insulin dosing, activity, food intake, your overall trend graph and your blood glucose value before taking action.
Trend Arrows (continued from page before) Rapidly rising: Your glucose is rising more than 3 mg/dL each minute. If it continued rising at this rate, your glucose could increase more than 45 mg/dL in 15 minutes. Slowly falling: Your glucose is falling 1-2 mg/dL each minute. If it continued falling at this rate, your glucose could decrease up to 30 mg/dL in 15 minutes. Falling: Your glucose is falling 2-3 mg/dL each minute.
8 WARNING Do not ignore symptoms of high and low glucose. If your sensor glucose alerts and readings do not match your symptoms, measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range. Solely relying on the sensor glucose alerts and readings for treatment decisions could result in you missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) events. 8.
Status Symbols (continued from page before) Glucose Reading Error This symbol means the receiver does not understand the sensor signal but is likely to recover. This symbol is related to the sensor only. You should wait for more prompts and do not enter any blood glucose values when you see this symbol (see Chapter 13, Section 13.4, System Glucose Error for more information). Out of Range This symbol means the receiver and sensor/transmitter are not communicating.
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CHAPTER 9: ALERTS, ALARM & PROFILES This chapter teaches you about your Dexcom G4 PLATINUM (Pediatric) CGM System’s many alerts and alarm and how to set them. 9.1 SETTING YOUR ALERTS 9.1.1 DEFAULT ALERT/ALARM SETTINGS The following alerts and alarm are preset on your receiver.
9 Default Alert/Alarm Settings (continued from page before) What will I see on the receiver screen? What does this mean? What is the default setting? How will the receiver notify me? Will the receiver re-notify me? Low Glucose Alert Your most recent sensor glucose reading is at or below the low alert setting. On at 80 mg/dL Vibrates 3 times and then vibrates/beeps 3 times every 5 minutes until confirmed or your glucose value goes above the alert level.
Default Alert/Alarm Settings (continued from page before) What will I see on the receiver screen? What does this mean? What is the default setting? How will the receiver notify me? Will the receiver re-notify me? Rise/Fall Alert Single Arrow Your glucose is rising/falling at or above a rate of 2 mg/dL/min (at least 30 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 GLUCOSE ALERTS AND ALARM WARNINGS • In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decision. • In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.
alerts but may cause more false alerts. It is important you discuss your alert settings with your healthcare professional. 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.
9 The receiver continues to alert until you press the SELECT button to clear the alert or until your sensor glucose readings rise above your low glucose alert level. You can have the receiver re-alert after clearing the alert (to change your snooze settings see Chapter 9, Section 9.2, Advanced Alerts). Low glucose alert set at 80 mg/dL Low glucose alert setting 9.1.2.3 LOW GLUCOSE ALARM WARNING In a pediatric clinical study, a significant number of low glucose events were not detected by CGM.
button to clear it, if your sensor glucose readings are still at or below 55 mg/dL. • Your receiver does not alert if you have a sensor glucose reading outside your target range and you calibrated in the last 5 minutes. • The receiver alerts if your sensor glucose reading stays outside your target range after five minutes. 9.1.3 GETTING TO THE ALERTS 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.
9 2. H ighlight “On/Off,” and then press the SELECT button to set this option. A check mark shows next to the current setting. Low Alert menu, On/Off highlighted, On selected 3. Press the LEFT button to return to the last screen. 4. P ress the DOWN button to highlight “Level.” The number that shows is your current glucose alert level. Low Alert menu, Level highlighted 5. T o change this number, press the SELECT button, and then press the UP or DOWN button to select your glucose alert level.
7. T his screen appears when you set the low alert to remind you that your Dexcom G4 PLATINUM (Pediatric) System may not detect all low glucose events. Check with your blood glucose meter when or if you have signs and symptoms of low glucose. Press the SELECT button to confirm you have read and understand this message. Low Alert warning screen 8. You will return to the Alerts menu when you finish. 9.
9 1. P ress the UP or DOWN button to highlight “High Snooze” or “Low Snooze” and press the SELECT button. Advanced menu, High Snooze highlighted 2. P ress the UP or DOWN button to select the amount of time (in 15 minute steps) between the first alert and re-alerts. Press the SELECT button. • If you set the amount of time to zero there will be no re-alerts. 3. Press the LEFT button to return to the Alerts menu when you finish. High Alert setting screen, 15 minutes selected 9.2.
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. Press the UP or DOWN button to choose “On” or “Off.” Then, press the SELECT button to select “On” or “Off.” Fall Rate menu, On selected 4. P ress the LEFT button to go back to the last screen. Highlight “Level” and then press the SELECT button. Fall Rate menu, Level highlighted 5. C hoose “2 mg/dL/min” (2 mg/dL or more per minute) or “3 mg/dL/min” (3 mg/dL or more per minute). Press the SELECT button. Fall Rate menu, 2 mg/dL/min selected 6.
The out of range symbol in the upper right corner of the trend graph and the Out of Range alert screen show when the transmitter and receiver are not communicating. The amount of time out of range shows on the Out of Range alert screen. It will continue to re-alert until they are back in range. Out of Range alert screen 1. P ress the UP or DOWN button to choose “Out of Range,” and press the SELECT button. Advanced menu, Out of Range highlighted 2. P ress the UP or DOWN button to choose “On/Off.
9 4. P ress the UP or DOWN button to choose the amount of time out of range after which the receiver will alert. Press the SELECT button. Out of Range setting screen, 30 minutes selected 5. P ress the LEFT button to return to the Alerts menu when you finish. 9.3 ALERT PROFILES The Dexcom G4 PLATINUM (Pediatric) 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 ALERT PROFILE OPTIONS (continued from page before) “HypoRepeat” profile: very similar to the normal profile, but it continuously repeats the fixed low alarm every 5 seconds until 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 hear an example of each alert and alarm. 9.3.
ALERT PROFILE DETAILS (continued from page before) 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 PROFILE TYPE 1 long Out of Range Alert vibrate 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. P ress the SELECT button to see the Main Menu. 3. Press the UP or DOWN button to scroll to “Profiles,” and press the SELECT button. The Profiles menu will show. Main Menu, Profiles highlighted 4. P ress the UP or DOWN button to scroll to the profile you want to set, and press the SELECT button. Profiles menu, Vibrate highlighted 5. P ress 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. P ress the UP or DOWN button to choose the event you want: “Carbs,” “Insulin,” “Exercise” or “Health.” Press the SELECT button. Events menu, Carbs highlighted 10.1.2 SETTING THE DATE AND TIME FOR AN EVENT When you enter an event, you must check that the date and time for that event are correct. The default is the current date and time stored in the receiver. The date format is YYYY/MM/DD.
4. P ress the SELECT button to confirm the entry. Carbs setting screen, OK highlighted 10.1.3 CARBOHYDRATES The Carbs event lets you enter the amount of carbohydrates you have taken, up to 250 grams. 1. F rom the Events menu press the UP or DOWN button to choose “Carbs,” and press the SELECT button. Events menu, Carbs highlighted 2. P ress the UP or DOWN button to enter your carb amount (0-250 grams), and press the SELECT button.
10 4. P ress the LEFT or RIGHT button to choose either “OK” to confirm or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. Carbs setting screen, OK highlighted 10.1.4 INSULIN The Insulin event lets you enter the amount of insulin you have taken, up to 250 units. You can only enter an insulin amount, not the type of insulin. 1. F rom the Events menu press the UP or DOWN button to choose “Insulin,” and press the SELECT button.
4. P ress the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button. You will return to the Events menu. Insulin setting screen, OK highlighted 10.1.5 EXERCISE The Exercise event lets you enter intensity (light, medium, or heavy) and duration (up to 360 minutes). 1. F rom the Events menu press the UP or DOWN button to choose “Exercise,” and press the SELECT button. Events menu, Exercise highlighted 2.
10 3. Press the UP or DOWN button to enter your exercise duration (0-360 minutes), and press the SELECT button. • The number that shows on this screen is the default amount of 30 minutes. Exercise setting screen, 30 minutes selected 4. C heck that the date and time for this entry are correct. Press the SELECT button to confirm. 5. P ress the LEFT or RIGHT button to choose either “OK” to confirm this entry or “Cancel” to discard this entry, and then press the SELECT button.
2. Press the UP or DOWN button to choose your health event, and press the SELECT button. Health menu, Illness highlighted 3. Check that the date and time for this entry are correct. Press the SELECT button to confirm. 4. 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 10.2 DEXCOM STUDIO SOFTWARE The Dexcom STUDIO software is optional.
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CHAPTER 11: ENDING A SENSOR SESSION PRECAUTION Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life. Your sensor gives you sensor glucose readings for up to seven days. The performance of a sensor has not been tested beyond seven days. Information for the end of a sensor session: •D o not remove the transmitter from the sensor pod while the pod is attached to your skin.
11 6-hour Replace Sensor 2-hour Replace Sensor 30-minute Replace Sensor Replace Sensor end of session You can set these alerts with the profiles setting (see Chapter 9, Section 9.3.2, Alert Profile Details, “All Other Alerts”). After the 6-hour, 2-hour, and 30-minute reminders, you continue to receive sensor glucose readings. Press SELECT to clear these screens. You must remove your sensor after the Replace Sensor Now screen (00:00:00) shows.
WARNING Do not ignore sensor fractures. Sensors may fracture on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to our Technical Support department at 1.877.339.2664 or 1.858.200.0200 24 hours a day, 7 days a week.
11 11.3 TRANSMITTER REMOVAL PRECAUTION Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter battery life. Do not remove the transmitter while the sensor pod is still attached to the body. After the sensor pod is off your body, you must remove the transmitter to reuse it. Use either of these two transmitter removal methods: Method 1 The safety lock that you removed from the applicator (see Chapter 6, Section 6.
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CHAPTER 12: TAKING CARE OF YOUR DEXCOM G4 PLATINUM (PEDIATRIC) SYSTEM 12.1 MAINTENANCE Transmitter •W ipe the outside of the transmitter with a damp cloth or isopropyl alcohol wipe between uses. •K eep the transmitter protected when not in use. Receiver • Do not spill fluid on the receiver or submerge the receiver in liquid. •K eep the receiver in its carrying case or otherwise protected. • Charge the receiver when the battery gets low.
12 calendar day printed on the sensor package label. • Store at temperatures between 36° F - 77° F. Storing outside this temperature may result in reduced sensor response to glucose and may cause inaccurate CGM readings. You may store your sensors in the refrigerator if it is within this temperature range. Sensors should not be stored in a freezer. • Store at humidity levels between 15% - 85% relative humidity. Transmitter • Keep the transmitter protected when not in use.
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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 (Pediatric) CGM System. If any of the troubleshooting steps in this chapter do not fix your issue, contact Dexcom Technical Support (see Chapter 15, User Assistance). 13.1 SENSOR INSERTION TROUBLESHOOTING Sensor insertion difficulties • I am having trouble taking out the safety lock: -M ake sure to pull the safety lock straight out away from your body.
13 • I am not able to remove the transmitter latch: - Hold the sensor pod with one hand and twist the transmitter latch with the other hand to remove it. - Do not try to snap it straight off. Sensor pod is not sticking long enough - Make sure your skin is clean, clear of any cream or lotion, and completely dry before you insert the sensor. - Shave your skin before you insert the sensor if hair is preventing the sensor pod from sticking.
•S ee Chapter 7, Calibrating Your Dexcom G4 PLATINUM (Pediatric) System, for further information. 13.2.1 TYPES OF CALIBRATION PROMPTS This section describes the three calibration symbols. The next section describes what to do when you see one of these symbols. Startup calibration prompt This prompt means the receiver’s 2-hour startup period is complete. You need to enter two blood glucose values to calibrate the system.
13 13.2.2 WHAT TO DO FOR CALIBRATION PROMPTS 1. W hen you see a calibration prompt, press the SELECT button to clear the prompt. 2. C heck the status area at the top of the screen. a. I f the startup calibration symbol shows, take 2 more blood glucose values and enter them into your receiver. b. I f the additional startup calibration symbol shows, take 1 more blood glucose value and enter it into your receiver. Prompt in status area c.
SELECT button to clear the screen, this symbol status area. shows in the If you see this screen, wait at least 1 hour and then enter 1 more calibration blood glucose value. Wait 15 minutes. If this error screen still shows, enter 1 more blood glucose value. Wait another 15 minutes. If this error screen still shows, the sensor needs to be replaced. Wait 1 hour calibration error screen 13.4 SYSTEM GLUCOSE ERROR The system may tell you that it cannot provide a sensor glucose reading.
13 • Make sure your sensor pod is not dislodged or peeling up. • Make sure your transmitter is snapped in completely. • Make sure nothing is rubbing the sensor pod (i.e. clothing, seat belts, etc.). • Make sure you selected a good insertion site No glucose data ( (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.
WARNINGS • In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decision. • In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose. • Do calibrate at least once every 12 hours.
13 If the difference between your sensor glucose reading and blood glucose value is greater than 20% of the blood glucose value for sensor glucose readings > 80 mg/dL or greater than 20 points for sensor glucose readings < 80 mg/dL, wash your hands and take another blood glucose measurement.
manufacturer’s instructions to get accurate blood glucose values for calibration. •M ake 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.
13 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 • symbol 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.
3. The Stop Sensor “thinking” screen will show to let you know the sensor session is stopping. Stop Sensor “thinking” screen 4. O nce the session has stopped, a red stoplight symbol ( ) shows in the upper right of the trend graph. Trend graph with red stoplight in upper right 13.7 SHARE PAIRING ERROR TROUBLESHOOTING This screen means you recently turned Share “On,” and your receiver is having trouble connecting with your iPhone® or iPod touch®.
13 13.8 BATTERY AND CHARGER TROUBLESHOOTING Only use the Dexcom cable and battery charger to charge your receiver. A full charge can take up to 5 hours and will last about 3 days, depending on how often you turn on your receiver, use the alerts, and enter events. If your receiver does not show the battery charging symbol when plugged into the charger, make sure that both ends of the USB cable are fully inserted into the receiver port and wall charger or computer.
This screen means the system found an error that it was able to fix. Press the SELECT button to clear this display, and continue your sensor session. System Check screen 13.9.2 RECEIVER ERROR CODE This screen shows an error code that means the receiver may not be working properly. Write down the error code and contact Dexcom Technical Support (see Chapter 15, User Assistance). Continue to check your blood glucose value using your blood glucose meter.
13 13.9.4 TRANSMITTER FAILED This screen means that the transmitter is not working. If you get this alert during a sensor session, your sensor session automatically stops. Contact Dexcom Technical Support (see Chapter 15, User Assistance). Continue to check your blood glucose value using your blood glucose meter. Transmitter Failed screen 13.10 OUT OF RANGE/NO ANTENNA PRECAUTION Avoid separating the transmitter and receiver by more than 20 feet.
This screen means your receiver and transmitter are not communicating and you are not getting sensor glucose readings. •Y our receiver and transmitter only communicate when you are in an active sensor session. •E ach time you start a new sensor session, wait 10 minutes for your receiver and transmitter to start communicating. Out of Range alert screen •Y ou may sometimes experience loss of communication for 10 minutes at a time. This is normal.
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 speaker and vibrations still work. You can do this with the Try It option in the Profiles menu (see Chapter 9, Section 9.3.1, Alert Profile Options).
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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 professional to understand how well the Dexcom G4 PLATINUM (Pediatric) System performs. The Dexcom G4 PLATINUM (Pediatric) System (the System) uses a glucose sensor to continuously measure and monitor your glucose levels.
14 study (72 patients, age 18 and older). Subjects used the System for seven days. All subjects wore 2 sensors. Sensors were calibrated approximately once every 12 hours, using the self-monitoring blood glucose (SMBG) meter values obtained from a LifeScan® OneTouch® Verio® IQ meter. The adult clinical study used the LifeScan® OneTouch® Ultra® 2 meter. All subjects were evaluated in a controlled clinic environment on Day 1, Day 4 or Day 7 of the 7 day wear period.
16 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL (2.2 mmol/L) or 40% or greater than 40 mg/dL (2.2 mmol/L) or 40% were then calculated in Table 1-A (pediatric study) and Table 1-B (adult study). Table 1-A. System Agreement to YSI within CGM Glucose Ranges (Pediatric Study) CGM Glucose Range mg/dL (mmol/L) Number of paired CGM-YSI Percent within 40/40% YSI Percent Greater than 40/40% YSI Overall 2922 55% 68% 85% 93% 7% 40-60 (2.2-3.3) 19 63% 74% 79% 79% 21% 61-80 (3.4-4.
14 Table 1-B. System Agreement to YSI within CGM Glucose Ranges (Adult Study) 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.
16 Status Box. When the Dexcom G4 PLATINUM (Pediatric) System determines that the glucose level is above 400 mg/dL (22.2 mmol/L), it displays “HIGH” in the Receiver Status Box. Because the System does not display glucose values below 40 mg/dL (2.2 mmol/L) or above 400 mg/dL (22.2 mmol/L), the comparisons to the actual blood glucose concentrations (as determined by the YSI analyzer) when CGM is classified as “LOW” or “HIGH” are included separately in Tables 2-A (pediatric study) and 2-B (adult study).
14 Table 2-B. Number and Percentage of YSI Values When CGM Readings are ‘Low’ or ‘High’9 (Adult Study) 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 64 82 122 142 13 155 Cumulative Percent 41% 53% 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-A. Concurrence of CGM Readings and YSI Values (Pediatric Study) YSI mg/dL (mmol/L) Sensor mg/dL (mmol/L) 40< 40 60 (2.2) (2.23.3) 61-80 (3.44.4) 81120 (4.56.7) 121160 (6.78.9) 161200 (8.911.1) 201- 251- 301250 300 350 (11.1- (13.9- (16.713.9) 16.7) 19.4) 351400 (19.422.2) > 400 Total (>22.2) < 40 (2.2) 0% 0% 0% 54% 31% 15% 0% 0% 0% 0% 0% 13 40-60 (2.2-3.3) 0% 21% 58% 16% 5% 0% 0% 0% 0% 0% 0% 19 61-80 (3.4-4.
14 Table 3-B. Concurrence of CGM Readings and YSI Values (Adult Study) CGM mg/dL (mmol/L) YSI mg/dL (mmol/L) Percent of matched pairs in each YSI glucose range for each Sensor glucose range < 40 (<2.2) 40-60 61-80 (2.2- (3.43.3) 4.4) 81120 (4.56.7) 121- 161- 201- 251- 301- 351Number 160 200 250 300 350 400 > 400 of (6.7- (8.9- (11.1- (13.9- (16.7- (19.4- (>22.2) Paired 8.9) 11.1) 13.9) 16.7) 19.4) 22.2) CGM-YSI < 40 (< 2.2) 6% 48% 37% 7% 1% 0% 0% 0% 0% 0% 0% 155 40-60 (2.2-3.
Accuracy Relative to YSI 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 occurred immediately after the YSI sample was collected.
14 Table 4-A. System Difference to YSI within CGM Glucose Ranges (Pediatric Study) CGM 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 2922 13.5 11.6 17.4 13.5 *40-60 (2.2-3.3) 19 -18.1 -9.1 19.2 9.1 (-1.0) (-0.5) (1.1) (0.5) *61-80 (3.4-4.4) 76 -3.7 -2.3 13.4 10.6 (-0.2) (-0.1) (0.7) (0.6) 81-180 (4.5-10.0) 1155 11.9 9.7 17.
16 Table 4-B. System Difference to YSI within CGM Glucose Ranges (Adult Study) CGM 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 *40-60 (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 -0.4 11.4 8.6 (-0.1) (-0.0) (0.6) (0.5) 81-180 (4.5-10.0) 3853 4.8 3.0 13.8 9.
14 the System reading that occurred immediately after the YSI reading was collected. There were 9555 paired System and YSI results evaluated. We suggest that you ask your doctor what alert settings would be best for you. The Low Glucose Alert Estimates of how well the adjustable Low Glucose Alert performs are presented in Tables 5-A through 5-C.10 Table 5-A represents the alert evaluation within 15 minutes of the YSI reading for the pediatric study.
16 Table 5-B. Hypoglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult Study) Hypoglycemic Alert Level mg/dL (mmol/L) True Alert Rate False Alert Rate Hypoglycemia Detection Rate Hypoglycemia Missed Detection Rate 55 (3.1) 50% 50% 71% 29% 60 (3.3) 64% 36% 75% 25% 70 (3.9) 79% 21% 83% 17% 80 (4.4) 87% 13% 86% 14% 90 (5.0) 90% 10% 89% 11% Table 5-C.
14 glucose level was at or below the alert setting within 15 or 30 minutes before or after the device alarmed. The False Alert Rate is the percent of time the device alarmed when the blood glucose level was above the alert setting within 15 or 30 minutes before or after the device alarmed. For example, if you set the Low Glucose Alert to 70 mg/dL (3.
presented in Tables 6-A through 6-C.11 Table 6-A represents the alert evaluation within 15 minutes of the YSI reading for the pediatric study. It is a sub-set of the pediatric population—subjects age 6 to 17 years who had YSI measurements every 15 minutes. Table 6-B represents the alert evaluation within 15 minutes of the YSI reading for the adult study. Table 6-C represents the alert evaluation within 30 minutes of an SMBG reading for 2- to 5-year old subjects in the pediatric study. Table 6-A.
14 Table 6-B. Hyperglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After (Adult Study) 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 (16.7) 82% 18% 86% 14% Table 6-C.
Hyperglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the percent of time the device alarmed when the blood glucose level was at or above the alert setting within 15 or 30 minutes before or after the device alarmed. The False Alert Rate is the percent of time the device alarmed when the blood glucose level was below the alert setting within 15 or 30 minutes before or after the device alarmed.
14 Calibration Stability The System must be calibrated every 12 hours. To demonstrate performance of the System over a 12-hour calibration period, 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 15 mg/dL (0.9 mmol/L) or 15%, 20 mg/dL (1.
Sensor Stability Relative to YSI Sensors can be worn for up to 7 days. Performance was estimated by calculating the percentage of System readings within 15 mg/dL (0.9 mmol/L) or 15%, 20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30% , 40 mg/dL (2.2 mmol/L) or 40% 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.
14 a sensor will work over 7 days, 351 sensors were evaluated to determine how many days/hours of readings each sensor provided. Eighty-five percent (85%) of the sensors lasted until at least the start of Day 7 (145-168 hours). 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.
Agreement and Accuracy Relative to SMBG During the study, agreement between the System and blood glucose values is also characterized using paired System and SMBG results (Tables 11-12). The System and SMBG values were compared by pairing the comparative SMBG value to a System glucose reading that occurred immediately after the SMBG was collected.
14 Table 11 is categorized within CGM glucose ranges. For readings less than or equal to 80 mg/dL (4.4 mmol/L) the absolute difference in mg/dL (mmol/L) between the two glucose results was calculated. For values greater than 80 mg/dL (4.4 mmol/L) the absolute percent difference (%) from the SMBG values was calculated. The percentages of total readings within 15 mg/dL (0.8 mmol/L) or 15%, 20 mg/dL (1.1 mmol/L) or 20%, 30 mg/dL (1.7 mmol/L) or 30%, 40 mg/dL (2.2 mmol/L) or 40% or greater than 40 mg/dL (2.
Overall, the System reads, on average, 2.2% lower (Mean Percent Difference) than SMBG values and 15.3% absolute different (Mean Absolute Percent Difference) than the SMBG values. The Median Percent Difference shows that half of the time the System reads +0.9% or less than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 11.1% or less different than SMBG values (Table 12). Sensor Stability Relative to SMBG Sensors can be worn for up to 7 days.
14 occurred during the study. Mild skin irritation, such as erythema or edema, occurred in low frequency around the adhesive area. There were two examples of pain or discomfort during wear. No infection, bruising, or bleeding occurred at the sensor needle insertion area or the adhesive area. 14.
Transmitter Product Specifications (continued from page before) 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 Transmitter Performance Characteristics 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.
14 The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is safe for use on U.S. commercial airlines. The Dexcom G4 PLATINUM Transmitter is an M-PED with emission levels that meet RTCA/DO160, Section 21, Category M. Per FAA Advisory, Circular #91-21, 1B, dated 8/25/06, any M-PED that meets this standard in all modes may be used onboard the aircraft without any further testing by the operator.
Transmitter Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Transmitter Compliance Level Surge ± 1 kV line(s) to line(s) Not applicable IEC 61000-4-5 Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines ± 2 kV line(s) to earth < 5% UT (> 95% dip in UT) for 0.
14 Receiver Product Specifications (continued from page before) Reading Frequency Every 5 minutes Dimensions Length: 4.0 inches Width: 1.8 inches Thickness: 0 .5 inches Weight 2.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The receiver (P/N MT22608) is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the receiver should ensure that it is used in such an environment.
14 Receiver Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Receiver Compliance Level Voltage Dips, Short Interruptions and Voltage Variations on Power Supply Input Lines < 5% UT (> 95% dip in UT) for 0.5 cycle < 5% UT (> 95% dip in UT) for 0.
System Electromagnetic Immunity Specifications Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000-4-6 (Receiver only) 3 Vrms 3 Vrms Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.5 GHz Portable and mobile RF communications equipment should be used no closer to any part of the receiver, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
14 System Electromagnetic Immunity Specifications (continued from page before) Immunity Test IEC 60601 Test Level Receiver Compliance Level Electromagnetic Environment Guidance the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
14 Electromagnetic Emissions Specifications (continued from page before) Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Class B The Dexcom G4 PLATINUM (Pediatric) System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Minimum Recommended Distance Between Transmitter and Receiver Rated Maximum Output Power of Transmitter (W) Separation Distance According to Frequency of Transmitter (m) 150 kHz to 80 MHz d = 1.2 P1/2 80 MHz to 800 MHz d = 1.2 P1/2 800 MHz to 2.5 GHz d = 2.3 P1/2 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.
14 * The power supply/charger can be connected to the USB charging/download cable for charging using an AC power outlet. Power Supply/Charger Specifications Dexcom P/N MT21255 Class II Input: AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100Vac DC Output: 5V DC, 1A (5.0 Watts) 14.3 FCC REQUIREMENTS The transmitter covered by this user’s guide has been certified under FCC ID: PH29433. The receiver has been certified under FCC ID: PH29495.
FCC Interference Statement (Part 15.105 (b)) This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.
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15 chapter fifteen USER ASSISTANCE Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 193
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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 issues11. 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 (Pediatric) System User’s Guide | 197
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CHAPTER 16: WARRANTY Dexcom G4 PLATINUM (Pediatric) System Limited Warranty 1. What is Covered and for How Long? Dexcom, Inc.
16 by Dexcom; (e) defects or damage from improper testing, operation, maintenance, installation or adjustment; (f) installation, maintenance, and service of products; or (g) equipment that has been disassembled; or (h) water damage to the receiver (receiver is not water resistant, do not get the receiver wet at any time). 3.
FACT OR BY OPERATION OF LAW, STATUTORY OR OTHERWISE, AND DEXCOM EXPRESSLY EXCLUDES AND DISCLAIMS ALL SUCH OTHER WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT.
16 Dexcom, Inc.
Dexcom G4 PLATINUM (Pediatric) CGM System User’s Guide, a copy of which was included with your Dexcom G4 PLATINUM (Pediatric) 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 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 (PEDIATRIC) CGM SYSTEM.
17 chapter seventeen TRAVEL INFORMATION Dexcom G4 PLATINUM (Pediatric) System User’s Guide | 205
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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 (Pediatric) System User’s Guide | 209
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CHAPTER 18: APPENDIX APPENDIX I: RECEIVER ALERTS, ALARM AND PROMPTS The following tables describe the alarm, alerts and prompts and how the receiver notifies you. Prompt - Shows on screen only. Silent, no vibrate or beep. Alert - Notifies with vibrate and beep depending on your profile settings. Alarm - Low 55 - Notifies with vibrate and beep. Cannot be changed.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? High glucose Your most alert recent sensor glucose reading is at or above the high alert setting. Vibrates 2 times and then vibrates/beeps 2 times every 5 minutes until confirmed or your glucose value drops below the alert level.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Low battery alert The receiver battery is low. Charge your receiver as soon as possible when you see this alert. Vibrates 1 time at 20% battery capacity left. Yes, at 10% battery capacity left.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Glucose The sensor Symbol in reading error is sending status area prompt sensor glucose only. readings that the receiver does not understand. You will not receive sensor glucose readings.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Wait prompt Symbol in The receiver status area has detected only. a potential problem with the sensor signal. You should wait about 30 minutes for more prompts. Do not enter any blood glucose values during this time. You will not receive sensor glucose readings.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Wait 15 minutes calibration error alert The sensor cannot calibrate. Wait 15 minutes then enter 1 more blood glucose value. Wait 15 more minutes. If error screen still appears enter 1 more blood glucose value. Wait 15 minutes.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Wait 1 hour calibration error alert The sensor cannot calibrate. Wait a minimum of 1 hour then enter 1 more blood glucose value for calibration. If no sensor glucose readings appear on the receiver, the sensor needs to be replaced.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Calibration prompt The receiver needs a blood glucose value entered to calibrate. Sensor glucose readings will not be displayed at this time. Vibrates 1 time and then vibrates/beeps every 5 minutes until confirmed. Yes, every 15 minutes.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Enter BG processing screen prompt The receiver is processing the blood glucose value you entered. Prompt screen only. N/A Rise alert Your glucose levels are rising at 2 mg/dL per minute or more.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Fall alert Your glucose levels are falling at 2 mg/dL per minute or more. Vibrates 3 No times and then vibrates/beeps 3 times every 5 minutes or until confirmed (2 repeats max). Rapid fall alert Your glucose levels are falling fast at 3 mg/dL per minute or more.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? 30-minute sensor expiration alert Your sensor session will end in 30 minutes. Vibrates 1 No time and then vibrates/beeps every 5 minutes (2 repeats max). End of session sensor expiration alert Your sensor session has ended.
18 Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Receiver error code alert Your receiver is not working properly. Record the error code and call Dexcom Technical Support. Vibrates 1 time No (4 seconds) + 4 beeps. System recovery check alert There was a system error and the receiver fixed it.
Receiver Alerts, Alarm and Prompts (continued from page before) What will I see on the receiver screen? Prompt, alert or alarm? What does this mean? How will the receiver notify me? (vibrate and/or beep) Will the receiver re-notify me? Transmitter failed alert The transmitter has failed. Replace the transmitter immediately. Vibrates 1 No time and then vibrates/beeps every 5 minutes (2 repeats max).
18 APPENDIX II: INDEX A Alarm, Low Glucose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102 Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Glucose Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 High . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Low . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101 Setting . . . . . . . . . . . . . . . . . . . . . . .
20 C Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73 Calibration Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 How to Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139 Re-Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80 Startup Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 M Maintenance, System . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133 Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 R Radio-Frequency (RF) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Charging your . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
20 Insertion Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Pod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 15 Removing from Package . . . . . . . . . . . . . . . . . . . . . . . . . 57 Sensor Failure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145 Starting a Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
18 Latch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9, 64 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Pairing with Receiver . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 Safety Lock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Removing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
APPENDIX III: SYMBOLS USED IN LABELING The following symbols may be found on the sensor, transmitter, and receiver package labels. These symbols tell you about the proper and safe use of the Dexcom G4 PLATINUM (Pediatric) 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 2006-66-EC Marking Certifies that the device meets the European Council Directive 93/42/EEC Electrical Equipment Designed Primarily for Indoor Use Input Do Not Use if Package is Damaged SB Keep Dry Bluetooth Authorized Representative in the European Community Ship By Date Prescription Required MR MR Unsafe 230 | Dexcom G4 PLATINUM (Pediatric) Conti
Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.
