Dexcom G4 PLATINUM User Manual
  1. Manuals
  2. Brands
  3. Dexcom Manuals
  4. Blood Glucose Meter
  5. G4 Platinum
  6. User manual
Dexcom G4 PLATINUM User Manual

Dexcom G4 PLATINUM User Manual

Continuous glucose monitoring system
Hide thumbs Also See for G4 PLATINUM:
Table of Contents

Advertisement

Quick Links

Download this manual See also: User Manual
USER'S GUIDE
®
DEXCOM G4
PLATINUM
CONTINUOUS GLUCOSE MONITORING SYSTEM
IMPORTANT CONTACTS AND NUMBERS
®
www.dexcom.com
Dexcom
Website:
Your Transmitter ID:
Your Receiver ID:
Your Healthcare Professional:
Nearest Hospital:
© 2014 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. All other product or company names that may be mentioned in this publication are
tradenames, trademarks or registered trademarks of their respective owners.
1

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the G4 PLATINUM and is the answer not in the manual?

Questions and answers

Related Manuals for Dexcom G4 PLATINUM

Summary of Contents for Dexcom G4 PLATINUM

  • Page 1 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. All other product or company names that may be mentioned in this publication are...

  • Page 2: Table Of Contents

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM table of contents [Page numbering will be updated after professional layout] GLOSSARY CHAPTER 1: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION System Contents Introduction Sensor Overview Transmitter Overview Receiver Overview Share Overview...
  • Page 3 Starting a Sensor Session Sensor Startup Period Taping the Sensor Pod 6.10 Temporary Receiver Shutdown 6.11 The Dexcom G4 PLATINUM System and Water CHAPTER 7: CALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEM Calibration Overview How to Calibrate Startup Calibration 12-Hour Calibration Update...
  • Page 4 Dexcom Studio Software CHAPTER 11: ENDING A SENSOR SESSION 11.1 Automatic Sensor Shut-Off 11.2 Removing a Sensor 11.3 Transmitter Removal CHAPTER 12: TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM 12.1 Maintenance 12.2 Storage 12.3 Product Disposal CHAPTER 13: TROUBLESHOOTING 13.1...
  • Page 5 CHAPTER 18: APPENDIX Appendix I, Receiver Alerts, Alarm and Prompt Appendix II, Index Appendix III, Symbols Used in Labeling...

  • Page 6: [Page Numbering Will Be Updated After Professional Layout] Glossary

    Default The sensor, transmitter, and receiver. Dexcom G4 PLATINUM System Secondary notification system to the Dexcom G4 PLATINUM System. For more Dexcom Share information, please refer to the Dexcom Share User Manual. System Different symbols show on the trend graph instead of a sensor glucose reading to Glucose Data Gaps let you know that the receiver cannot provide a reading.
  • Page 7 It also helps you snap the transmitter out of the sensor pod after your sensor session ends. The Dexcom G4 PLATINUM System part that includes an applicator and wire. The Sensor applicator inserts the wire under your skin, and the wire measures glucose levels in your tissue fluid.
  • Page 8 wirelessly sends glucose information to your receiver. A series of numbers and/or letters that you enter into your receiver to let it Transmitter ID communicate with the transmitter. The small, disposable piece that snaps the transmitter into the sensor pod. It is Transmitter Latch removed after the transmitter is snapped in.

  • Page 9: Chapter 1: Dexcom G4 Platinum Continuous Glucose Monitoring (Cgm) System Description

    • Dexcom Studio software (available for download online at www.dexcom.com) Sensors are sold separately. Commercially distributed blood glucose (BG) meter required for use. PRECAUTION The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible ® ® with the SEVEN /SEVEN PLUS Transmitter and Receiver.

  • Page 10: Sensor Overview

    System Tutorial is a good training option for you. The tutorial disc can only be used with your computer and cannot be used in DVD players. The tutorial is also found on the Dexcom website – www.dexcom.com. 1.3 SENSOR OVERVIEW The sensor is the piece that comes in a sterile, sealed sensor pouch.

  • Page 11: Receiver Overview

    See Chapter 14 for Product Specifications. 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.

  • Page 12: Share Overview

    RIGHT 1.6 SHARE OVERVIEW ™ Dexcom Share remote monitoring system lets one person, the Sharer, transfer Dexcom G4 PLATINUM Continuous Glucose Monitoring information to another person, the Follower. Learn more about Dexcom Share by reading the Dexcom Share User Manual.

  • Page 13: Chapter 2: Indications For Use And Safety Statement

    • 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...

  • Page 14: Precautions

    Technical Support department at 1.877.339.2664 or 1.858.200.0200. • The Dexcom G4 PLATINUM System is not approved for use in children or adolescents, pregnant women or persons on dialysis. • It is not known how different conditions or medications common to the critically ill population may affect the performance of the system.
  • Page 15 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. The insulin might affect sensor performance, and you might miss a low or high blood glucose value.

  • Page 16: Caution

    Also make sure to use the correct version of Dexcom Studio with your system. 2.6 CAUTION U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM System to sale by or on order of a physician.

  • Page 17: Chapter 3: Risks And Benefits

    (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 System, only slight redness and swelling occurred in a few patients. If any of these events happen, you might feel discomfort in the area the sensor is inserted.
  • Page 18 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.

  • Page 19: Chapter 4: Charging Your Receiver And The Receiver Main Menu

    (www.dexcom.com) or the Dexcom Studio Software User’s Guide.) Only use the Dexcom battery charger provided in the receiver kit. Do not use any other battery charger. Charge only from a USB port on your computer or the AC power adapter. Do not use an external USB hub.

  • Page 20: Charging Your Receiver Battery From A Windows Compatible Computer

    4.1.2 CHARGING YOUR RECEIVER BATTERY FROM A WINDOWS COMPATIBLE COMPUTER You must install the Dexcom Studio software to charge your receiver from a computer. Please see the Dexcom Studio installation card for driver installation instructions. 1. Plug the included USB cable into your computer.

  • Page 21: Knowing Your Receiver Is Charged

    4. After a few seconds, the trend graph screen will show the battery charging symbol in the upper left corner. 4.1.3 KNOWING YOUR RECEIVER IS CHARGED As the battery charges, the battery charging symbol fills in. When the battery is fully charged, the battery charging symbol is completely shaded.
  • Page 22 To change the settings for high and low alerts. Chapter 9 High/Low To change the time, date and transmitter ID; to turn on the Share feature; to look up your Dexcom G4 PLATINUM System hardware Chapter 5 Settings and software version numbers; to view transmitter battery status, last calibration value and sensor insertion time.

  • Page 23: Chapter 5: Dexcom G4 Platinum System Setup

    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.

  • Page 24: The Settings Menu

    • If you need to change the time, date or transmitter ID after you complete the Setup Wizard see Section 5.2, The Settings Menu. The Setup Wizard is now complete. To start using your Dexcom G4 PLATINUM CGM System you must insert a sensor (see Chapter 6, Inserting a Sensor and Starting a Sensor Session).

  • Page 25: Entering Your Transmitter Id

    • On the transmitter box label • On the bottom of the transmitter If you cannot find your transmitter ID, please contact Dexcom Technical Support (see Chapter 15, User Assistance). You can only set your transmitter ID when you are not in a sensor session. During a sensor session, “Transmitter ID”...

  • Page 26: Turning On Share On Your Receiver

    5.2.4 TURNING ON SHARE ON YOUR RECEIVER Please see the Pairing Receiver section in Chapter Two of your Dexcom Share User Manual to learn how to turn on the Share feature on your Receiver with Share.

  • Page 27: Transmitter And Receiver Communication

    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.
  • Page 28 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.

  • Page 29: Chapter 6: Inserting A Sensor And Starting Asensor Session

    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.

  • Page 30: Removing The Sensor From Its Packaging

    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. Look closely at the sensor to make sure it is not damaged. •...

  • Page 31: Placing 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.

  • Page 32: Sensor Insertion

    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. 6.5 SENSOR INSERTION You are ready to insert the sensor after you place the applicator on your belly and remove the safety lock.

  • Page 33: Transmitter Attachment

    • 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).

  • Page 34: Starting A Sensor Session

    • 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.

  • Page 35: Sensor Startup Period

    4. Press the button to confirm the start of a new sensor session. The Start Sensor “thinking” SELECT screen lets you know your sensor 2-hour startup has begun. 5. Your receiver returns to the 3-hour trend graph. 6. Check your receiver 10 minutes after starting your sensor session to make sure your receiver and transmitter are communicating.

  • Page 36: Taping The Sensor Pod

    At the end of the 2-hour startup period the receiver lets you know it is time to calibrate your sensor. Chapter 7, Calibrating Your Dexcom G4 PLATINUM System, tells you how to calibrate your sensor. 6.9 TAPING THE SENSOR POD The sensor pod should stay on your skin using its own adhesive.

  • Page 37: The Dexcom G4 Platinum System And Water

    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. 6.11 THE DEXCOM G4 PLATINUM SYSTEM AND WATER Your sensor is water resistant when showering, bathing or swimming if the transmitter is fully snapped in.

  • Page 38: Chapter 7: Calibrating Your Dexcom G4 Platinum System

    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.

  • Page 39: How To Calibrate

    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.
  • Page 40 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.

  • Page 41: Startup Calibration

    7. Confirm that the blood glucose value you entered is correct. Entering incorrect values may affect the sensor accuracy. a. Press the button if the blood glucose value displayed is correct. SELECT b. If the blood glucose value shown is incorrect, press the button to highlight “Cancel”...

  • Page 42: 12-Hour Calibration Update

    1. When you see this screen, press the button to clear it. SELECT a. The startup calibration symbol will stay at the top of the trend graph until you calibrate. b. The system will re-alert you every 15 minutes until you enter the blood glucose values. c.
  • Page 43 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.

  • Page 44: Chapter 8: Sensor Glucose Readings And Trends

    Therefore, readings from your blood glucose meter and sensor may not match. The greatest benefit you get from using your Dexcom G4 PLATINUM System will come from the trending information. It is important that you focus on the trends and rate of change on your...
  • Page 45 • 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. •...
  • Page 46 1-Hour Trend Graph: The 1-hour trend graph shows your current sensor glucose reading and the last 1 hour of sensor glucose readings. 3-Hour Trend Graph: The 3-hour trend graph shows your current sensor glucose reading and the last 3 hours of sensor glucose readings. (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.

  • Page 47: Rate Of Change Arrows

    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.

  • Page 48: Glucose Status Area Symbols

    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. If it continued falling at this rate, your glucose could decrease up to 45 mg/dL in 15 minutes.
  • Page 49 This symbol means you need to enter a calibration. This prompt will show when it is time for your 12-hour calibration update or any other time an additional calibration is needed (see Chapter 7, Section 7.2, How to Calibrate). Calibration Needed This symbol means you need to enter one more blood glucose value in order to calibrate the system and start getting sensor glucose readings.

  • Page 50: Chapter 9: Alerts, Alarm & Profiles

    CHAPTER 9: ALERTS, ALARM & PROFILES This chapter teaches you about your Dexcom G4 PLATINUM CGM System’s many alerts and alarm how to set them. 9.1 SETTING YOUR ALERTS 9.1.1 DEFAULT ALERT/ALARM SETTINGS The following alerts and alarm are preset on your receiver.

  • Page 51: Glucose Alerts & Alarm

    9.1.2 GLUCOSE ALERTS AND ALARM The Dexcom G4 PLATINUM System lets you create personal settings for how you want the receiver to tell you what is going on. The low and high glucose alerts tell you when your sensor glucose readings are outside your target glucose range.

  • Page 52: Low Glucose Alert

    (to change your snooze settings see Chapter 9, Section 9.2, Advanced Alerts). 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.

  • Page 53: Getting To The Alerts Menu

    • Re-alarm: The receiver automatically alerts again 30 minutes after you press the button to clear SELECT 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.

  • Page 54: Advanced Alerts

    3. Press the button to return to the last screen. LEFT 4. Press the button to highlight “Level.” The number that shows is your current high glucose alert DOWN level. 5. To change this number, press the button, and then press the button to select SELECT DOWN...

  • Page 55: Setting A Snooze Time For Your High And Low Glucose Alerts

    4. From the Alerts menu, press the button to select “Advanced,” and press the DOWN SELECT button. 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.
  • Page 56 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. These steps show how to change your rise or fall rate alert settings.

  • Page 57: Setting The Out Of Range Alert

    4. Press the button to go back to the last screen. Highlight “Level” and then press the LEFT SELECT button. 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 button.

  • Page 58: Alert Profiles

    1. Press the button to choose “Out of Range,” and press the button. DOWN SELECT 2. Press the button to choose “On/Off.” Then, press the button to select “On.” If DOWN SELECT you do not want to get out of range alerts press the button again to choose “Off.”...

  • Page 59: Alert Profile Options

    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. You can set your profile to the sound pattern and volume that fits your needs.

  • Page 60: Alert Profile Details

    Normal profile: the default profile when you receive your system. This profile sets all alerts and alarms to higher volume beeps. Attentive profile: when you need your alert to be the most noticeable. This profile sets all the alerts and alarm to loud and highly distinctive melodies. “HypoRepeat”...
  • Page 61 vibrates vibrates + 4 + 4 medium + 2 long + 4 low beeps + 4 medium medium tone tone beeps descending + pause + tone beeps beeps melodies + repeat pause + 4 low sequence beeps 1 long vibrate 1 long vibrate 1 long vibrate 1 long vibrate +...

  • Page 62: Software

    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.

  • Page 63: Carbohydrates

    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. If you change the date or time for any event, it only applies to that event and will not change the current date and time in your receiver.

  • Page 64: Insulin

    3. Check that the date and time for this entry are correct. Press the button to confirm. SELECT 4. Press the button to choose either “OK” to confirm or “Cancel” to discard this entry, and LEFT RIGHT then press the button.

  • Page 65: Exercise

    4. Press the button to choose either “OK” to confirm this entry or “Cancel” to discard this LEFT RIGHT entry, and then press the button. You will return to the Events menu. SELECT 10.1.5 EXERCISE The exercise event lets you enter intensity (light, medium, or heavy) and duration (up to 360 minutes). 1.

  • Page 66: Health

    4. Check that the date and time for this entry are correct. Press the button to confirm. SELECT 5. Press the button to choose either “OK” to confirm this entry or “Cancel” to discard this LEFT RIGHT entry, and then press the button.

  • Page 67: Dexcom Studio Software

    10.2 DEXCOM STUDIO SOFTWARE The Dexcom Studio software is optional. This software lets you view trends, track patterns and create custom charts to display your glucose trends. You can change the date ranges to view long- or short-term patterns and trends. You can use data from current and older downloads and save or print files for you and your healthcare professionals to review.

  • Page 68: Chapter 11: Ending A Sensor Session

    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.

  • Page 69: Removing A Sensor

    11.2 REMOVING A SENSOR 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.
  • Page 70 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.

  • Page 71: Chapter 12: Taking Care Of Your Dexcom G4

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

  • Page 72: Product Disposal

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

  • Page 73: Chapter 13: Troubleshooting

    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).

  • Page 74: Types Of Calibration Prompts

    • Make sure you have not taken any medications containing acetaminophen (such as Tylenol). • See Chapter 7, Calibrating Your Dexcom G4 PLATINUM System, for further information. 13.2.1 TYPES OF CALIBRATION PROMPTS This section describes the three calibration symbols. The next section describes what to do when you see one of these symbols.

  • Page 75: What To Do For Calibration Prompts

    The receiver shows this prompt screen every 15 minutes until the receiver accepts the blood glucose value. 13.2.2 WHAT TO DO FOR CALIBRATION PROMPTS 1. When you see a calibration prompt, press the button to clear the prompt. SELECT 2. Check the status area at the top of the screen. a.

  • Page 76: System Glucose Error

    If you see this screen, wait 15 minutes and then enter 1 more calibration blood glucose value. Wait 15 more 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. This screen also means you recently entered a calibration blood glucose value and the sensor is having trouble calibrating.

  • Page 77: Sensor Inaccuracies

    Often, the system can correct the problem and continue providing sensor glucose readings. If it has been at least 3 hours since your last sensor glucose reading, contact Technical Support (see Chapter 15, User Assistance). If you see these system glucose error icons often, follow these troubleshooting tips before inserting another sensor: •...

  • Page 78: Sensor Shut-Off Troubleshooting

    • Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration as alternative site readings may be different than those from a blood glucose value. Use a blood glucose value only from your fingers for calibration. •...
  • Page 79 • 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. When you are not in an active sensor session, you will see the “Start Sensor”...

  • Page 80: Share Pairing Error Troubleshooting

    If you press the “Ok” button to clear this screen, you will be taken back to the Share menu and Share will be turned “Off.” Turn Share “On” to try pairing again. For more information on how to troubleshoot your Dexcom Share System, refer to the Dexcom Share User Manual. Share unsuccessful pairing prompt If you are not using the Share feature, you should leave Share turned “Off”.

  • Page 81: Receiver Error Code

    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 your transmitter as soon as possible after you see this screen. Contact Dexcom Sales Support (see Chapter 15, User Assistance) to order a new transmitter.

  • Page 82: Out Of Range/No Antenna

    ID. “Transmitter ID” will not appear as an option on the Settings menu during a sensor session. If you are still having trouble getting system readings, contact Dexcom Technical Support (see Chapter 15, User Assistance).
  • Page 83 1. Make sure you have not turned off the sound and/or vibrations for the alerts. Chapter 9, Section 9.1, Setting Your Alerts explains how to change these alert options. 2. Check that you have turned on and set the level for your advanced alerts (see Chapter 9, Section 9.2, Advanced Alerts).

  • Page 84: Chapter 14: Technical Information

    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. The sensor is “calibrated” using a commercially available blood glucose meter;...
  • Page 85 CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION CHECKING YOUR RECEIVER SOFTWARE VERSION...
  • Page 86 Table 1. System Agreement to YSI within CGM Glucose Ranges Percent Percent Percent Percent Number of within within within Greater than Glucose Study paired 15/15% 20/20% 30/30% 40/40% Range CGM-YSI (mg/dL) Original 9152 Overall Advanced 2263 Original 40-60 Advanced Original 61-80 Advanced Original...
  • Page 87 The System reports glucose readings between 40 and 400 mg/dL. When the System determines the glucose reading is below 40 mg/dL, it displays “LOW” in the Receiver Status Box. When the Dexcom G4 PLATINUM System determines that the glucose level is above 400 mg/dL, it displays “HIGH” in the Receiver Status Box.
  • Page 88 Table 3-A. Concurrence of CGM Readings and YSI Values (Original Study) YSI (mg/dL) Row percentage of matched pairs in each CGM glucose range (mg/dL) Number of < 40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 > 400 Paired CGM-YSI <...
  • Page 89 Table 3-B. Concurrence of CGM Readings and YSI Values (Advanced Study) YSI (mg/dL) Row percentage of matched pairs in each CGM glucose range (mg/dL) Number of < 40 40-60 61-80 81-120 121-160 161-200 201-250 251-300 301-350 351-400 > 400 Paired CGM-YSI <...
  • Page 90 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 and the System reading is 90 mg/dL, 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.
  • Page 91 Table 4. System Difference to YSI within CGM Glucose Ranges Mean Median Number of Median Glucose Receiver Mean Percent Absolute Absolute Paired CGM- Percent Ranges Software Difference Percent Percent Difference (mg/dL) Difference Difference Original 9152 2.9% 1.7% 13.3% 9.8% Overall Advanced 2263 2.5%...
  • Page 92 Low and High Glucose Alerts The ability of the System to detect high and low glucose levels is assessed by comparing System results to YSI results at low and high blood glucose levels and determining if the alert may have sounded. The System and YSI values were compared by pairing the System reading that occurred immediately after the YSI value was collected.
  • Page 93 Table 5. Hypoglycemic Alert Evaluation Hypoglycemic True False Hypoglycemia Receiver Hypoglycemia Alert Level Alert Alert Missed Detection Software Detection Rate (mg/dL) Rate Rate Rate Original Advanced Original Advanced Original Advanced Original Advanced Original Advanced Both sets of study data are presented and are labeled as (SW10050) or (SW10505).
  • Page 94 The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Table 6. Hyperglycemia 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 above the alert setting within 15 minutes before or after the device alarmed.
  • Page 95 Table 6. Hyperglycemic Alert Evaluation Hyperglycemic True False Hyperglycemia Hyperglycemia Alert Level Study Alert Alert Missed Detection Detection Rate (mg/dL) Rate Rate Rate Original Advanced 100% Original Advanced Original Advanced Original Advanced Original Advanced Original Advanced Original Advanced Both sets of study data are presented and are labeled as (SW10050) or (SW10505).
  • Page 96 Table 7. Percentage of System Readings within YSI Values with Data Stratified in 2-Hour Increments after Calibration Percent Percent Percent Percent Number of greater Time from within within within Study paired than Calibration 15/15% 20/20% 30/30% CGM-YSI 40/40% Original 1929 0-2 hours Advanced Original...
  • Page 97 Table 8. Sensor Stability (Accuracy over Time) Median Percent Percent Percent Percent Number of Mean Absolute Day of Absolute within within within greater Study paired CGM- Percent Wear Percent 15/15% 20/20% 30/30% than Differences Differences 40/40% YSI Original 3023 16.7% 13.2% Day 1 Advanced...
  • Page 98 Table 9. Number of Readings Provided by Each Sensor Over 7-Days Total Readings % of Total Possible % of Systems Providing that Study Provided (Min- Readings Provided Number of Readings Max) 167-491 Original 0-25% Advanced 719-914 Original 26-50% 856-856 Advanced 1267-1267 Original 51-75%...
  • Page 99 System provided an average of 98% of all expected glucose readings (288) as seen in Table Advanced Table 11. CGM System Agreement to SMBG within CGM Glucose Ranges Percent Percent Percent Percent Number of greater Glucose within within within Study paired than Ranges...
  • Page 100 range and you can expect the CGM readings to be within 20% of the SMBG values 78% of the time for the System and 85% time for the System. Original Advanced Table 12. CGM System Difference to SMBG within CGM Glucose Ranges Median Median Mean Absolute...

  • Page 101: Product Specifications

    Overall, the System in the study reads, on average, 2.6% lower (Mean Percent Difference) than Advanced SMBG values and 11.3% absolute different (Mean Absolute Percent Difference) than the SMBG values. The Median Percent Difference shows that half of the time the System reads lower in 2.7% or less than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 8.6% or less different than SMBG values.
  • Page 102 20 feet Data Detection Range 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. Per FAA Advisory, Circular #91-21, 1B, dated 8/25/06, any M-PED that meets this standard in all modes may be used onboard the aircraft without any further testing by the operator.
  • Page 103 relative humidity should be at least 30% ± 2 kV for power supply Not applicable Electrical Fast lines Transient /burst ± 1 kV for input/output Battery operated IEC 61000-4-4 lines ± 1 kV line(s) to line(s) Not applicable Surge ± 2 kV line(s) to earth Battery operated IEC 61000-4-5 <...
  • Page 104 MT21255 Power Supply 20 feet Communication Range 30 days of glucose data, Memory Storage 7 days of tech support data 3 days Re-Chargeable Battery Use 3 hours wall outlet, Charging Time 5 hours powered USB Charging Temperature Temperature: 32° F - 104° F Condition Temperature: 32°...
  • Page 105 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Dexcom G4 PLATINUM System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the Dexcom G4 PLATINUM System should ensure that it is used in such an environment.
  • Page 106 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions 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.
  • Page 107 Class B The Dexcom G4 PLATINUM System is RF emissions suitable for use in all establishments other than CISPR 11 domestic and those directly connected to the Not applicable Harmonic emissions public low-voltage power supply network that IEC 61000-3-2 supplies buildings used for domestic purposes.

  • Page 108: Fcc Requirements

    * The power supply/charger can be connected to the USB charging/download cable for charging using an AC power outlet. Power Supply/Charger Specifications MT21255 Dexcom P/N Class AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100Vac Input: 5V DC, 1A (5.0 Watts) DC Output: 14.3 FCC REQUIREMENTS...

  • Page 109: Chapter 15: User Assistance

    Dexcom Technical Support E-mail: TechSupport@dexcom.com Dexcom Technical Support Fax: 1.877.633.9266 SALES SUPPORT For help with first-time orders, re-orders, tracking shipments, and locating a Dexcom representative in your area. Dexcom Sales Support Phone Numbers: 1.877.339.2664 or 1.858.200.0200 Dexcom Sales Support E-mail: CustomerService@dexcom.com...

  • Page 110: Chapter 16: Warranty

    1. What is Covered and for How Long? Dexcom, Inc. (“Dexcom”) provides a limited warranty to the original purchaser that the Dexcom G4 PLATINUM Receiver with Share is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing upon the date of shipment and continuing for the following specified period of time after that date (“Warranty Period”):...
  • Page 111 (g) equipment that has been disassembled, or (h) water damage to the transmitter beyond the specifications listed in the Dexcom G4 PLATINUM CGM System User’s Guide, a copy of which was included with your Dexcom G4 PLATINUM CGM System and may be found at www.dexcom.com.
  • Page 112 Dexcom G4 PLATINUM Transmitter, contact Dexcom Customer Support Department at 1.877.339.2664 or 1.858.200.0200. Upon receipt, Dexcom will promptly replace the defective product. If Dexcom determines that any product is not covered by this Limited Warranty, purchaser must pay all shipping charges for the return of such product.

  • Page 113: Chapter 17: Travel Information

    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.
  • Page 114 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.
  • Page 115 Out of Range The transmitter Vibrates 1 time and then No unless you alert and receiver are vibrates/beeps every 5 have turned on minutes until the receiver the out of range communicating and transmitter are back in alert. and you will not range.
  • Page 116 glucose readings appear on the receiver, the sensor needs to be replaced. Wait 1 hour The sensor Vibrates 1 time and then calibration cannot calibrate. vibrates/beeps every 5 error alert Wait a minimum minutes until confirmed. of 1 hour then enter 1 more blood glucose value for...
  • Page 117 calibration. Enter BG The receiver is Prompt screen only. processing processing the screen prompt blood glucose value you entered. Rise alert Your glucose Vibrates 2 times and then levels are rising vibrates/beeps 2 times at 2 mg/dL per every 5 minutes or until minute or more.
  • Page 118 Receiver error Your receiver is Vibrates 1 time (4 code alert not working seconds) + 4 beeps. properly. Record the error code and call Dexcom Technical Support. System There was a Vibrates 1 time and then recovery system error and...
  • Page 119 Important alerts that can be checked by the user: • Out of range alert - You can test this alert by moving the receiver more than 20 feet away for 30 minutes or more. • 30-minute sensor expiration alert - You will see this alert in the normal course of using a sensor for seven days.

  • Page 120: How To Calibrate

    APPENDIX II, INDEX Alarm, Low Glucose Alerts Glucose Alerts High Setting Not Working Out of Range Setting Profiles Setting Rise and Fall (Rate of Change) Setting Alternative Site Testing (BG) Antenna Symbol Missing Arrows, Trend (Rate of Change) Battery, Receiver Charging Troubleshooting Battery, Transmitter...
  • Page 121 Troubleshooting Contact Information, Dexcom Sales Support Technical Support Website Contents, Dexcom G4 PLATINUM CGM System Kit Device Information Dexcom Studio Software Events, Diabetes Carbohydrates Exercise Health Insulin Glucose Data Gaps Glucose Trends Maintenance, System Menu Options Radio-Frequency (RF) Range Receiver...
  • Page 122 Safety Information Caution Contraindications Important User Information Indications for Use Warnings Precautions Sensor Applicator 6, 13 Automatic Shut-Off Expiration Date Failed Insertion Insertion Site Overview 8, 13 Removing from Package Sensor Failure Starting a Session Start-up Period Stop Sensor (Manual Sensor Shut-Off) Troubleshooting Wire Settings, Alerts...
  • Page 123 Tape Transmitter Attaching to Sensor ID Number Setting Latch 8, 58 Overview Pairing with receiver Removal Safety-Lock Removing 56, 127 Using Trend screen, receiver Warranty Water Resistance...
  • Page 124 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.
  • Page 125 Do Not Use if Package is Primarily for Indoor Use Damaged Input Ship By Date Keep Dry MR Unsafe Bluetooth Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.com LBL012528 Rev X02 MT22690 Stay Between the Lines...

Table of Contents