Page 1 CONTINUOUS GLUCOSE MONITORING SYSTEM USER’S GUIDE Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.com LBL-012206 Rev 04 MT22434...
Page 2: Glucose Monitoring System
Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G4 PLATINUM Professional, Dexcom STUDIO, and SEVEN 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.
Page 3: Table Of Contents
4.2 Receiver Menu Options ....... . . 47 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 4 6.10 Temporary Receiver Shutdown ......77 6.11 The Dexcom G4 PLATINUM Professional System and Water . . 78...
Page 5 10.1.6 Health ........132 10.2 Dexcom STUDIO Software and Blinded Mode ... . . 133 10.2.1 Activating the Blinded Mode/Clinical Feature .
Page 6 11.3 Transmitter Removal ........144 CHAPTER 12: TAKING CARE OF THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM 12.1 Receiving the Transmitter and Receiver from Each User .
Page 7 Appendix II, Index ........251 Appendix III, Symbols Used in Labeling ..... . . 256 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 8: Glossary
There is a needle inside the applicator that you remove after you insert the sensor. When the Dexcom G4 PLATINUM Receiver is set to hide Blinded Mode sensor glucose readings and glucose trend information. The receiver records glucose information that can be downloaded and reviewed later with the Dexcom STUDIO software.
Page 9 Something that blocks the path between the transmitter and Obstruction 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.
Page 10 It also helps you snap the transmitter out of the sensor pod after the sensor session ends. The Dexcom G4 PLATINUM Professional System part that Sensor includes an applicator and wire. The applicator inserts the wire under the skin, and the wire measures glucose levels in tissue fluid.
Page 11 A sensor glucose reading shown on the receiver. This reading System is in mg/dL units and is updated every 5 minutes. Reading The Dexcom G4 PLATINUM Professional System part that Transmitter snaps into the sensor pod and wirelessly sends glucose information to the receiver.
Page 12: Chapter 1: Dexcom G4 Platinum Professional Continuous Glucose Monitoring (Cgm) System Description
DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION Dexcom G4 PLATINUM Professional System User’s Guide...
Page 13 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 14: System Contents
• 2 quick start guides (real-time and blinded use) • site training checklist • receiver shield pack containing receiver shield, square seals, triangle seal and acoustic spacer • Dexcom STUDIO software CD bundle ™ Dexcom G4 PLATINUM Professional System User’s Guide...
Page 15: Introduction
The Dexcom G4 PLATINUM Professional System includes the Dexcom G4 PLATINUM Sensor, the Dexcom G4 PLATINUM Transmitter, and the Dexcom G4 PLATINUM Receiver with a receiver shield. The sensor is a disposable unit that you insert under the skin of the abdomen (belly) to continuously monitor glucose levels for up to 7 days.
Page 16: Sensor Overview
You discard the sensor at the end of the session. See Chapter 14 for Product Specifications. Plunger Safety lock Applicator barrel (contains small introducer Collar needle and sensor) Transmitter latch Sensor pod Release tab Adhesive patch Dexcom G4 PLATINUM Professional System User’s Guide...
Page 17: Transmitter Overview
The transmitter battery will last at least 6 months. Once you see the transmitter low battery screen, replace the transmitter as soon as possible. The transmitter battery may drain as quickly as one week after this alert appears. See Chapter 14 for Product Specifications. Transmitter Transmitter Low Battery screen Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 18: Receiver Overview
See Chapter 10 for instructions on erasing patient data from the receiver. NOTE: In the Dexcom STUDIO software, select the “Prompt to reset receiver after every download” option under the Options - Healthcare Professional setting. This feature will remind the healthcare professional to erase the receiver data after each use.
Page 19 Trend graph hours EXAMPLE: 3-Hour Trend Graph Screen When used in real-time mode, the trend graph screen on the receiver shows the sensor glucose readings, trend graph, direction and rate of change arrow. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 20 The 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 the system. See Section 14 for Product Specifications. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 21: Receiver Shield Overview
1.6 RECEIVER SHIELD OVERVIEW The Dexcom G4 PLATINUM Professional System requires the use of the receiver shield and its components to help protect the receiver from contamination. The receiver shield pack includes the receiver shield, 3 square seals, 1 triangle seal and 1 acoustic spacer.
Page 22 The acoustic spacer is used to ensure the alert and alarm sounds are still audible when the receiver shield is over the receiver. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 23 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 24 INDICATIONS FOR USE AND SAFETY STATEMENT Dexcom G4 PLATINUM Professional System User’s Guide...
Page 25 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 26: Chapter 2: Indications For Use And Safety
The Dexcom G4 PLATINUM Professional System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions.
Page 27: Contraindications
2.4 WARNINGS • Thoroughly review the training materials included with your CGM system before using the Dexcom G4 PLATINUM Professional CGM System. Incorrect use might lead to you misunderstanding the information provided by your system, or might affect system performance, and you might miss a low or high blood glucose value.
Page 28 • Do not use the Dexcom G4 PLATINUM Professional System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM Professional System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions.
Page 29 • Sensor placement and insertion is not approved for sites other than the belly (abdomen). • Do not expect alerts from the Dexcom G4 PLATINUM Professional System until after the 2-hour startup. You will NOT get any sensor glucose readings or alerts until after the 2-hour startup ends AND you complete the startup calibration.
Page 30: Precautions
• Low/high glucose alerts and the 55 mg/dL low glucose alarm are all disabled when using the Dexcom G4 PLATINUM Professional System in blinded mode and will not alert you when the glucose is low or high. Check blood glucose meter if there are any signs or symptoms of low or high glucose.
Page 31 Do not calibrate when your receiver screen is showing the rising single arrow or double arrow, which indicates that your blood glucose is rising 2-3 mg/dL/min or more than 3 mg/dL/min. Also, do not calibrate when your receiver Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 32 Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor performance, and you might miss a low or high blood glucose value. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 33 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. • If all 3 square seals have been used before the end of the session, return the receiver to the healthcare professional office. Do not charge the receiver if you cannot seal it.
Page 34: Caution
2.6 CAUTION U.S. (Federal) law restricts the sale of the Dexcom G4 PLATINUM Professional System to sale by or on order of a physician.
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Page 36: Chapter 3: Risks And Benefits
RISKS AND BENEFITS Dexcom G4 PLATINUM Professional System User’s Guide...
Page 37 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 38: Risks
When the CGM system is used in blinded mode, the sensor glucose readings are not displayed, only recorded for review when downloaded later by the Dexcom STUDIO software. Using the system in blinded mode might cause you to expect glucose alerts, but you will not receive high...
Page 39: Benefits
This did not happen in the clinical study for the Dexcom G4 PLATINUM System. If you think a sensor has broken under your skin, contact your healthcare professional and call Dexcom’s Technical Support.
Page 40 Blinded CGM can also allow for assessment of the true diurnal glucose patterns as it relates to basal management adjustment and lifestyle choices of diet and exercise. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 41 6-year study. Diabetes Res Clin Pract. 1995; 28:103-117. J DRF CGM Study Group. Sustained Benefit of Continuous Glucose Monitoring on A1c, Glucose Profiles, and Hypoglycemia in Adults With Type 1 Diabetes, Diabetes Care 2009; 32: 2047-2049. JDRF CGM Study Group. Quality-of-Life Measures in Children and Adults With Type 1 Diabetes. Diabetes Care 2010; 33: 2175-2177. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 42: Chapter 4: Charging The Receiver And The Receiver Main Menu
CHARGING THE RECEIVER AND THE RECEIVER MAIN MENU Dexcom G4 PLATINUM Professional System User’s Guide...
Page 43 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 44: Charging The Receiver Battery
Dexcom website (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 the computer or the AC power adapter.
Page 45: Charging The Receiver Battery From An Ac Power Outlet
3. Plug the AC power adapter into an AC power outlet. 4. Make sure the USB door is open so you can reach the port easily. If it is closed, press down firmly with a thumb USB port cover when sliding open the USB port cover. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 46: Charging The Receiver Battery From A Windows Compatible
4.1.2 CHARGING THE RECEIVER BATTERY FROM A WINDOWS COMPATIBLE COMPUTER You must install the Dexcom STUDIO software to charge the receiver from a computer. Please see the Dexcom STUDIO Installation Card for driver installation instructions. This charging option should be used by the healthcare professional only.
Page 47: Knowing The Receiver Is Charged
4.1.3 KNOWING THE RECEIVER IS CHARGED A s the battery charges, the battery charging symbol fills in. When the battery is fully charged, the battery charging symbol is completely shaded. Fully Charged Start Battery charging symbol fills in as battery charges After the receiver is fully charged: Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 48: Receiver Menu Options
This table explains the purpose of each option. These menu options can be seen in both real-time and blinded modes. More information on Main Menu options can be found in the chapters listed: Dexcom G4 PLATINUM Professional System User’s Guide...
Page 49 See Chapter 18, Appendix I, Receiver Alerts, Alarm and Prompts, for a list of screens that may show on the receiver. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 50: Chapter 5: Dexcom G4 Platinum Professional System Initial Setup
DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM INITIAL SETUP Dexcom G4 PLATINUM Professional System User’s Guide...
Page 51 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 52: Setting Up The Receiver And Pairing With The Transmitter
(2) Press the RIGHT SELECT button to move to the next section. (3) Press the SELECT button to confirm time and date. Time/Date setting screen b. Enter the transmitter ID. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 53 NOTE: Even though alerts and alarm for low or high glucose levels are inactive in blinded mode, you must set the low and high alert levels as part of the Setup Wizard process in order to proceed. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 54: The Settings Menu
Setup Wizard see Section 5.2, The Settings Menu. The Setup Wizard is now complete. To start using the Dexcom G4 PLATINUM Professional CGM System you must insert a sensor (see Chapter 6, Inserting a Sensor and Starting a Sensor Session).
Page 55: Setting The Receiver Time And Date
4. Press the RIGHT button to move to the next value. Time/Date setting screen, The date format is YYYY/MM/DD. year highlighted 5. Press the SELECT button after choosing Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 56: Entering The Transmitter Id
To enter the transmitter ID follow these steps: 1. From the Settings menu, press the DOWN button to scroll to “Transmitter ID” and press the SELECT button. Settings menu, Transmitter ID highlighted 2. S tart with the first number or letter (do not enter “SN”): Dexcom G4 PLATINUM Professional System User’s Guide...
Page 57: Checking Information About The Dexcom G4 Platinum Professional System
Settings menu, 3. Scroll down to see all of the Device Info: Device Info highlighted • Insertion Time • Last Calibration • Transmitter Battery Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 58: Transmitter And Receiver Communication
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 Professional System has not been tested during MRI or CT scans or with diathermy treatment.
Page 59 This out of range symbol shows the transmitter and receiver are not communicating. See Chapter 13 for troubleshooting instructions if the out of range symbol appears. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 60: Using The Receiver Shield And Preparing The Receiver For Multiple Patient Use
The spacer allows the receiver speaker to work properly when the shield is in place. If the spacer moves and the receiver speaker volume is low, you might miss alerts or alarms. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 61 Dexcom Technical Support. The shield helps protect the user and healthcare professionals from contamination and allows the receiver to function properly. The Dexcom G4 PLATINUM Receiver is protected by a receiver shield when used with multiple patients. Acoustic spacer Triangle seal...
Page 62 Opening back of receiver 2. Note location of USB opening on receiver shield. Stretch receiver shield over receiver. USB opening lined up with USB port Stretch receiver shield over receiver Dexcom G4 PLATINUM Professional System User’s Guide...
Page 63 If a patient returns a receiver because the spacer is torn, damaged or defective, discard the shield, seal and spacer and replace with a new shield, seal and spacer. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 64: Chapter 6: Inserting A Sensor And Starting Asensor Session
INSERTING A SENSOR AND STARTING A SENSOR SESSION Dexcom G4 PLATINUM Professional System User’s Guide...
Page 65 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 66 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 Professional System. The sensor continuously measures and displays the sensor glucose readings for up to 7 days when in real-time mode.
Page 67: Before You Start
The sensor should not be stored in a freezer. Storing the sensor improperly might cause the sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 68: Removing The Sensor From Its Packaging
• The applicator is for single use and is disposable. • The safety lock prevents you from releasing the needle accidentally before you are ready. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 69: Choosing An Insertion Site
• Make sure there are no traces of lotions, perfumes or medications on the area. Clean the skin with isopropyl alcohol to remove these products from the skin. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 70: Placing The Sensor
6.4 PLACING THE SENSOR WARNING Do not use the Dexcom G4 PLATINUM Professional System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM Professional System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions.
Page 71: Sensor Insertion
1. P lace the fingers of one hand at the edge of the white adhesive (at the opposite side of the sensor from the transmitter latch). You may pinch up on the skin using this hand. Do not pinch up in the middle section of the plastic base. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 72 5. Squeeze the center of the ribbed release tabs on the sides of the sensor pod to remove the applicator barrel. Only the sensor pod will be left on the body. Step 5. Release the applicator barrel Dexcom G4 PLATINUM Professional System User’s Guide...
Page 73: Transmitter Attachment
• While squeezing the tabs, rock the applicator barrel forward and out away from the body. If you have any problems with insertion, save the sensor and applicator and contact Dexcom Technical Support (see Chapter 15, User Assistance). 6.6 TRANSMITTER ATTACHMENT You must snap the transmitter into the sensor pod after you insert the sensor.
Page 74: Starting A Sensor Session
6.7 STARTING A SENSOR SESSION Follow the steps below to tell the receiver that you inserted a new sensor. 1. Press the SELECT button to turn on the receiver. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 75 If the out of range symbol shows in the upper right corner of the trend graph, see Chapter 13, Section 13.9, Out of Range/No Antenna. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 76: Sensor Startup Period
The trend graph shows a 2-hour countdown symbol in the upper right corner. Countdown symbol appears Counddown symbol appears in upper right of trend graph in upper right of trend graph in real-time mode in blinded mode Dexcom G4 PLATINUM Professional System User’s Guide...
Page 77: Taping The Sensor Pod
Support (see Chapter 15, User Assistance). At the end of the 2-hour startup period the receiver lets you know it is time to calibrate the sensor. Chapter 7, Calibrating the Dexcom G4 PLATINUM Professional System, tells you how to calibrate the sensor.
Page 78: Temporary Receiver Shutdown
“OK,” and then press the SELECT button. b. If you want to cancel the shutdown, Shutdown screen, press the SELECT button (with “Cancel” OK highlighted highlighted) to return to the Main Menu. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 79: The Dexcom G4 Platinum Professional System And Water
Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub or water bed. If the receiver gets wet, make sure the speaker and vibrate mode are still working. You can do this using the Try It option in the profiles menu. See Chapter 9, Section 9.3, Alert Profiles. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 80: Platinum Professional System
CALIBRATING THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM Dexcom G4 PLATINUM Professional System User’s Guide...
Page 81 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 82: Chapter 7: Calibrating The Dexcom G4
CHAPTER 7: CALIBRATING THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM In both real-time and blinded modes, you must calibrate Dexcom G4 PLATINUM Professional System sensor glucose readings to the blood glucose meter. CONTRAINDICATION Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings.
Page 83 Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect sensor performance, and you might miss a low or high blood glucose value. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 84: How To Calibrate
Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 85 You must wait until the blood glucose is in this range to calibrate. These steps show you how to enter the blood glucose values for calibration in both real-time and blinded modes: Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 86 Use only blood glucose values from the meter. 6. Use the DOWN button to scroll until you see the correct blood glucose value, and then press the SELECT button. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 87 A sensor glucose reading appears on the receiver right away, and sensor glucose readings are updated every 5 minutes. If readings do not appear immediately, see Chapter 13, Section 13.2, Calibration Troubleshooting. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 88: Startup Calibration
“- - -” in status area by showing “- - -” in the status area of the receiver screen. 1. T he receiver will alert you based on the alert profile setting chosen. When you see this screen, press the SELECT button to clear it. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 89: 12-Hour Calibration Update
Calibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 90: Other Reasons You May Need To Calibrate
If this screen reappears soon, see Chapter 13, Section 13.2.1, Types of Calibration Calibration prompt Prompts. These screens show calibration errors (see Chapter 13, Section 13.3, Calibration Error Troubleshooting). Dexcom G4 PLATINUM Professional System User’s Guide...
Page 91 Wait 1 hour Wait 15 minutes calibration error screen calibration error screen Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 92: Chapter 8: Viewing Sensor Glucose Readings And Trends In Real-Time Mode
VIEWING SENSOR GLUCOSE READINGS AND TRENDS IN REAL-TIME MODE Dexcom G4 PLATINUM Professional System User’s Guide...
Page 93 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 94 The greatest benefit you get from using the Dexcom G4 PLATINUM Professional System used in real-time mode will come from the trending information. It is important that you focus on the trends and rate of change on the receiver, rather than the exact sensor glucose reading.
Page 95: Sensor Glucose Readings In Real-Time Mode
WARNING Do not use the Dexcom G4 PLATINUM Professional System for treatment decisions, such as how much insulin you should take. The Dexcom G4 PLATINUM Professional System does not replace a blood glucose meter. Always use the values from your blood glucose meter for treatment decisions.
Page 96 If the sensor glucose reading is less than 40 mg/dL the receiver will read “LOW”; if the sensor glucose reading is greater than 400 mg/dL, the receiver will read “HIGH.” Dexcom G4 PLATINUM Professional System User’s Guide...
Page 97 (Scroll down from the 3-hour graph to reach the 6-hour graph) 6-Hour Trend Graph: The 6-hour trend graph shows the current sensor glucose reading and the last 6 hours of sensor glucose readings. (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 98: Rate Of Change Arrows In Real-Time Mode
Trend graph reading LOW reading HIGH 8.2 RATE OF CHANGE ARROWS IN REAL-TIME MODE The rate of change arrows add detail about the direction and speed of glucose change over the last 15-20 minutes. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 99 Slowly falling: The glucose is falling 1-2 mg/dL each minute. If it continued falling at this rate, the glucose could decrease up to 30 mg/dL in 15 minutes. (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 100 If the trend arrow is missing, but you are in upper right and concerned that the blood glucose level may glucose data gaps be rising or falling, take a blood glucose measurement test on the blood glucose meter. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 101: Glucose Status Area Symbols In Both Real-Time And Blinded
Additional This symbol means you need to enter one more blood glucose value in Startup order to calibrate the system and start getting sensor glucose readings. Calibration Needed (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 102 You should wait about 30 minutes for more prompts. Do not enter any blood Wait glucose values when you see this symbol. Status symbols show in the upper right of the trend graph. Dexcom G4 PLATINUM Professional System User’s Guide...
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Page 104: Chapter 9: Alerts, Alarm & Profiles
ALERTS, ALARM & PROFILES Dexcom G4 PLATINUM Professional System User’s Guide...
Page 105 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 106: Setting The Alerts In Real-Time Mode
CHAPTER 9: ALERTS, ALARM & PROFILES This chapter teaches you about the Dexcom G4 PLATINUM Professional CGM System’s many alerts and alarm and how to set them. 9.1 SETTING THE ALERTS IN REAL-TIME MODE WARNING Low/high glucose alerts and the 55 mg/dL low glucose...
Page 107 5 minutes until until the blood reading is at or confirmed or the glucose value below 55 mg/dL glucose value comes back goes above 55 into range. mg/dL. (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 108 Double Arrow You must The glucose is change the rising/falling at or settings to above a rate of receive this 3 mg/dL/min (at alert. least 45 mg/dL in 15 minutes). Dexcom G4 PLATINUM Professional System User’s Guide...
Page 109: Glucose Alerts And Alarm In Real-Time Mode
9.1.2 GLUCOSE ALERTS AND ALARM IN REAL-TIME MODE The Dexcom G4 PLATINUM Professional System lets you create personal settings for how you want the receiver to tell you what is going on if the receiver is used in real-time mode. The low and high glucose alerts tell you when the sensor glucose readings are outside the target glucose range.
Page 110: Low Glucose Alert In Real-Time Mode
Low glucose alert setting 9.1.2.3 LOW GLUCOSE ALARM IN REAL-TIME MODE The Dexcom G4 PLATINUM Professional System also has a fixed low alarm at 55 mg/dL. This is different than the low glucose alert. You cannot change or turn off this alarm or its re-alarm settings. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 111: Getting To The Alerts Menu For Both Real-Time And Blinded
SELECT button to turn on the receiver. The 3-hour trend graph shows. Trend graph in Trend graph in real-time mode blinded mode 2. Press the SELECT button to see the Main Menu. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 112: Changing The High And Low Glucose Alerts
GLUCOSE ALERTS WARNING Low/high glucose alerts and the 55 mg/dL low glucose alarm are all disabled when using the Dexcom G4 PLATINUM Professional System in blinded mode and will not alert you when the glucose is low or high. Check blood glucose meter if there are any signs or symptoms of low or high glucose.
Page 113 A check mark shows next to the current setting. High Alert menu, On/Off highlighted, On selected High Alert menu, On selected 3. Press the LEFT button to return to the last screen. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 114: Advanced Alerts
1. Press the SELECT button to turn on the receiver. 2. Press the SELECT button to enter the Main Menu. 3. Press the DOWN button to highlight “Alerts,” and press the SELECT button. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 115: Setting A Snooze Time For The High And Low Glucose Alerts
(in 15 minute steps) between the first alert and re-alerts. Press SELECT button. • If you set the amount of time to zero there will be no re-alerts. High Alert setting screen, 15 minutes selected 3. Press the LEFT button to return to the Alerts menu when you finish. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 116: In Real-Time Mode
These steps show how to change the rise or fall rate alert settings. 1. Press the DOWN button to choose “Rise Rate” or “Fall Rate,” and press the SELECT button. Alerts menu, Fall Rate highlighted Dexcom G4 PLATINUM Professional System User’s Guide...
Page 117 Fall Rate menu, Level highlighted 5. Choose “2 mg/dL/min” (2 mg/dL or more per minute) or “3 mg/dL/min” (3 mg/dL or more per minute). Press the SELECT button. Fall Rate menu, 2 mg/dL/min selected Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 118: Setting The Out Of Range Alert For Both Real-Time And Blinded Modes
“On/Off.” Then, press the SELECT button to select “On.” If you do not want to get out of range alert press the SELECT button again to choose “Off.” Out of Range menu, On/Off highlighted Dexcom G4 PLATINUM Professional System User’s Guide...
Page 119: Alert Profiles
The Dexcom G4 PLATINUM Professional System lets you set profiles to choose the way you want the alerts to act. This feature is found under the Profiles option on the Main Menu. You can set the profile to the sound pattern and volume that fits the user’s needs. The profile options are: Main Menu, 1. Vibrate Profiles highlighted 2. Soft 3. Normal 4. Attentive 5. HypoRepeat NOTE: For each profile option, the first alert is vibration only. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 120: Alert Profile Options
55 mg/dL the system repeats the alert sequence in 30 minutes. Press the SELECT button to confirm any alert. 9.3.1 ALERT PROFILE OPTIONS Vibrate profile: when you want to silence the receiver and be alerted by vibration. The only exception to this is the fixed low alarm at 55 mg/dL in real-time mode, which alerts you as a vibration first, followed by beeps 5 minutes later if not confirmed. (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 121: Alert Profile Details
2 long vibrates High Alert vibrates vibrates vibrates + vibrates + + 2 medium In Real-Time + 2 low 2 medium ascending beeps Mode Only beeps beeps melody (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 122 + 1 vibrate + vibrate + + 1 medium Range Alert low beep 1 medium 3 short beep In Both beep repeating Real-Time melodies and Blinded Modes (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 123 30-minute replace sensor and replace sensor now. These steps show you how to select the profile you want. 1. Press the SELECT button to turn on the receiver. The 3-hour trend graph will show. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 124 “Profiles,” and press the SELECT button. The Profiles menu will show Main Menu, 4. Press the DOWN button to scroll to Profiles highlighted the profile you want to set, and press the SELECT button. 5. Press the LEFT button to return to the Main Menu when you finish. Profiles menu, Vibrate highlighted Dexcom G4 PLATINUM Professional System User’s Guide...
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Page 126: Chapter 10: Events, Dexcom Studio ™ Software And Blinded Mode
EVENTS, DEXCOM STUDIO SOFTWARE AND BLINDED MODE Dexcom G4 PLATINUM Professional System User’s Guide...
Page 127 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 128: Events
Dexcom STUDIO software. 10.1 EVENTS Event markers can be downloaded and viewed in the Dexcom STUDIO software but cannot be viewed on the receiver. 10.1.1 SELECTING AN EVENT 1. Press the SELECT button to turn on the receiver.
Page 129: Setting The Date And Time For An Event
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 the receiver. To change the date and time for an event: Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 130: Carbohydrates
The Carbs event lets you enter the amount of carbohydrates you have taken, up to 250 grams. 1. From the events menu press the DOWN button to choose “Carbs,” and press SELECT button. Events menu, Carbs highlighted Dexcom G4 PLATINUM Professional System User’s Guide...
Page 131: Insulin
250 units. You can only enter an insulin amount, not the type of insulin. 1. From the Events menu press the DOWN button to choose “Insulin,” and press SELECT button. Events menu, Insulin highlighted Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 132: Exercise
The Exercise event lets you enter intensity (light, medium, or heavy) and duration (up to 360 minutes). 1. From the Events menu press the DOWN button to choose “Exercise,” and press the SELECT button. Events menu, Exercise highlighted Dexcom G4 PLATINUM Professional System User’s Guide...
Page 133: Health
You will return to the Events menu. Exercise setting screen, OK highlighted 10.1.6 HEALTH The Health event lets you enter episodes of illness, stress, high symptoms, low symptoms, cycle (menstrual) or alcohol consumption. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 134: Dexcom Studio Software And Blinded Mode
Health setting screen, OK highlighted 10.2 DEXCOM STUDIO SOFTWARE AND BLINDED MODE The Dexcom STUDIO software is optional. This software lets you view trends, track patterns and create custom charts to display the glucose trends. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 135: Activating The Blinded Mode/Clinical Feature
Dexcom STUDIO software. Healthcare professionals must obtain an authorization code from Dexcom to be able to access this feature. The act of blinding turns on this feature, and unblinding returns the receiver to its normal functions. To obtain a healthcare professional authorization code, please contact Dexcom Technical Support.
Page 136 Features” from the drop down menu. Activate Clinical Features highlighted 2. Dexcom STUDIO software prompts you to contact Dexcom Technical Support and provide them with the Activation Request Key that appears in the Activate Clinical Features pop-up window. Contact Dexcom Technical Support at 1.877.339.2664 or via e-mail at technicalsupport@dexcom.com and provide them your name, your...
Page 137: Blinding The Receiver
If you change the current blind/unblind setting, an updated group of receiver settings will automatically be downloaded to the software. Some of the downloaded settings may affect the charts/reports currently being displayed in the software. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 138: Downloading The Receiver
The software will first try to assign the new receiver download to an existing patient record (using this same receiver). If it does not find a match, the Edit Patient pop-up window will appear where you can create a new patient record for this download. See the Dexcom STUDIO Software User’s Guide, Section 5, Patient Management, for editing patient record information. 10.2.4 RESETTING THE RECEIVER FOR...
Page 139 Internet time and date, and set the prior transmitter ID and blind/unblind settings back into the receiver. This is the preferred setting when you are using the Dexcom G4 PLATINUM Professional System for multiple patient use.
Page 140: Chapter 11: Ending A Sensor Session
ENDING A SENSOR SESSION Dexcom G4 PLATINUM Professional System User’s Guide...
Page 141 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 142: Automatic Sensor Shut-Off In Both Real-Time And Blinded
The receiver tells you how much time you have left until the sensor session is complete. The Replace Sensor screen shows at 6 hours, 2 hours and 30 minutes before the 7-day sensor session ends. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 143 (i.e., the healthcare professional will tell you Trend graph with if you should remove the sensor yourself or red stoplight in upper right return to the healthcare professional’s office to remove the sensor). Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 144: Removing A Sensor
1. Gently peel up the sensor pod adhesive patch from the skin. This will pull out the sensor. Peel up the sensor pod Keep the transmitter adhesive patch in the sensor pod Completely remove the adhesive patch Dexcom G4 PLATINUM Professional System User’s Guide...
Page 145: Transmitter Removal
Section 6.4, Placing the Sensor), can be used as a tool to remove the transmitter. 1. Place the sensor pod/transmitter on a flat surface. 2. Hold the rounded edge of the safety lock. 3. Make sure the jagged edge of the safety lock is facing down, with the arrow pointing up, as shown: Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 146 Safety lock Transmitter with safety lock snapped in Method 2 Use the fingers to spread out the tabs at the back of the sensor pod (end closest to the sensor pod tab wings). The transmitter will “pop” out of the sensor pod. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 147 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 148: Chapter 12: Taking Care Of The Dexcom G4
TAKING CARE OF THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM Dexcom G4 PLATINUM Professional System User’s Guide...
Page 149 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 150: Receiving The Transmitter And Receiver From Each User
CHAPTER 12: TAKING CARE OF THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM 12.1 RECEIVING THE TRANSMITTER AND RECEIVER FROM EACH USER Before touching the transmitter and receiver used by a patient, make sure the healthcare professional wears personal protective equipment as appropriate (gloves, protective goggles, lab coat, etc.).
Page 151 Step 7. Peel back shield 8. Hold the edge of the shield that is still on the receiver, just above a clean surface. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 152 If a defect or malfunction of the shield is suspected, the healthcare professional should retain the shield and contact Dexcom Technical Support. b. If there is no evidence of defect or malfunction, discard the shield.
Page 153: Cleaning And Disinfection Of The Transmitter
12.3 CLEANING AND DISINFECTION OF THE TRANSMITTER Dexcom validated 52 cleaning and disinfection cycles. This represents one cleaning and one disinfection cycle per week over twelve months of use, which exceeds the expected transmitter battery life of six months and meets the warranty time of the receiver.
Page 154 Step 3. Transmitter with contact side down on absorbent wipe 4. Hold the Clorox Healthcare Bleach Germicidal Cleaner spray bottle 6-8 inches from unit, and dispense two sprays onto the top surface. Step 4. Spray transmitter Dexcom G4 PLATINUM Professional System User’s Guide...
Page 155 8. Place the transmitter in the Clorox Healthcare Bleach Germicidal Cleaner spray solution for one minute. Step 8. Place transmitter in solution 9. R emove the transmitter and rinse it under flowing tap water for ten seconds. 10. Wipe the transmitter with a cloth until it is completely dry. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 156 Dispatch Hospital Cleaner Bleach Germicidal Disinfectant Towels Cleaner with Bleach Low-lint wipes Water Components to disinfect the transmitter Disinfecting the Transmitter 1. Wear clean gloves and goggles. Step 1. Wear gloves and goggles Dexcom G4 PLATINUM Professional System User’s Guide...
Page 157 Bleach to use a clean side for a fourth back and forth wipe. 10. Keep track to be sure you wiped four times back and forth for a total of eight passes and that all transmitter surfaces are covered with disinfectant. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 158 After cleaning and disinfection, remove and discard gloves, and wash hands thoroughly with soap and water. Clorox Healthcare Bleach Germicidal Cleaner (EPA registration number 56392-7) and Dispatch Hospital Cleaner Disinfectant Towels with Bleach Dexcom G4 PLATINUM Professional System User’s Guide...
Page 159 Company ® at www.cloroxprofessional.com. Stop using the transmitter and contact Dexcom Technical Support if signs of deterioration are noted. Signs of deterioration include corrosion or discoloration on the metal transmitter contacts, pitting of the transmitter’s gray epoxy surface, reduced legibility of the text on the bottom of the transmitter, or any other visual changes to the transmitter.
Page 160: Using The Receiver Shield
Use caution when handling products worn or handled by another person. Wear personal protective equipment as appropriate (gloves, protective goggles, lab coat, etc.). Use only legally marketed Dexcom G4 PLATINUM Professional Receiver Shields (manufactured by Seal Shield specifically for the use ™...
Page 161: Maintenance
• Keep the transmitter protected when not in use. Receiver • D o not spill fluid on the receiver or submerge the receiver in liquid. • Keep the receiver protected. • Charge the receiver when the battery gets low, optimally before each new patient use. Accessories Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 162: Storage
Use of non-Dexcom supplied parts may affect safety and performance. There is no repair service available for the Dexcom G4 PLATINUM Professional CGM System. If you experience problems with the system contact Dexcom Technical Support (see Chapter 15, User Assistance).
Page 163: Product Disposal
• Store at humidity levels between 10% - 95% relative humidity. 12.7 PRODUCT DISPOSAL Consult the local waste management authorities for instructions to dispose of devices containing electronic waste (transmitter and receiver) and blood contacting parts (sensor and applicator). Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 164: Chapter 13: Troubleshooting
TROUBLESHOOTING Dexcom G4 PLATINUM Professional System User’s Guide...
Page 165 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 166: Sensor Insertion Troubleshooting
CHAPTER 13: TROUBLESHOOTING This chapter provides helpful tips and instructions to fix issues you may have while using the Dexcom G4 PLATINUM Professional CGM System. If any of the troubleshooting steps in this chapter do not fix the issue, contact Dexcom Technical Support (see Chapter 15, User Assistance). 13.1 SENSOR INSERTION TROUBLESHOOTING Sensor insertion difficulties •...
Page 167: Calibration Troubleshooting
Carefully apply the blood sample to the test strip following the instructions that came with the meter or test strips. • Make sure you have not taken any medications containing acetaminophen (such as Tylenol). Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 168: Types Of Calibration Prompts
• See Chapter 7, Calibrating the Dexcom G4 PLATINUM Professional 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 169: What To Do For Calibration Prompts
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. If you press the Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 170: System Glucose Error
(see Chapter 8, Section 8.3, Glucose Status Area Symbols in Both Real-Time and Blinded Modes). No glucose data ( No glucose data ( in real-time mode in blinded mode Dexcom G4 PLATINUM Professional System User’s Guide...
Page 171: Sensor Inaccuracies In Real-Time Mode
Inaccuracies are usually related to the sensor only and not the receiver or transmitter. The sensor glucose readings are meant to be used for trending purposes only. The blood glucose meter and sensor measure the glucose from two different types of body fluids: blood and interstitial Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 172 The sensor glucose reading will correct over the next 15 minutes. If you see differences between the sensor glucose readings and blood glucose values outside of this acceptable range, follow the troubleshooting tips below before inserting another sensor: Dexcom G4 PLATINUM Professional System User’s Guide...
Page 173: Sensor Shut-Off Troubleshooting
13.6 SENSOR SHUT-OFF TROUBLESHOOTING In some cases the sensor session may stop or need to be stopped before the end of a full 7-day period. You must remove the sensor and contact your healthcare professional. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 174: Early Sensor Shut-Off - Sensor Failure
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 Dexcom G4 PLATINUM Professional System User’s Guide...
Page 175 Stop Sensor “thinking” screen 4. Once the session has stopped, a red stoplight symbol ( ) shows in the upper right of the trend graph. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 176: Battery And Charger Troubleshooting
13.7 BATTERY AND CHARGER TROUBLESHOOTING Only use the Dexcom cable and battery charger to charge the receiver. A full charge can take up to 5 hours and will last about 3 days, depending on how often you turn on the receiver, use the alerts, and enter events.
Page 177: Receiver Error Code
Replace the transmitter Transmitter Low Battery as soon as possible after you see this screen screen. Contact Dexcom Sales Support (see Chapter 15, User Assistance) to order a new transmitter. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 178: Transmitter Failed Error Code
If your transmitter and receiver are farther than 20 feet apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter and you might miss a low or high blood glucose value. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 179 Out of Range alert screen If you are still having trouble getting system readings, contact Dexcom Technical Support (see Chapter 15, User Assistance). Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 180: Alerts Are Not Working
13.10 ALERTS ARE NOT WORKING WARNING Low/high glucose alerts and the 55 mg/dL low glucose alarm are all disabled when using the Dexcom G4 PLATINUM Professional System in blinded mode and will not alert you when the glucose is low or high. Check blood glucose meter if there are any signs or symptoms of low or high glucose.
Page 181 If a defect or malfunction is suspected, the healthcare professional should retain the shield and contact Dexcom Technical Support. The shield helps protect the user and healthcare professionals from contamination and allows the receiver to function properly.
Page 182: Chapter 14: Technical Information
TECHNICAL INFORMATION Dexcom G4 PLATINUM Professional System User’s Guide...
Page 183 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 184: Device Performance Characteristics
Dexcom G4 PLATINUM Professional System performs. The Dexcom G4 PLATINUM Professional System is the same as the Dexcom G4 PLATINUM System with the addition of the receiver shield. Therefore, the Dexcom G4 PLATINUM System clinical study is applicable to this system.
Page 185 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 and Table 1-B. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 186 CGM reading on your receiver, this table shows you how likely that reading matches your blood glucose level (measured by YSI in the study). For example, if your CGM reads 100 mg/dL (5.6 mmol/L), it is Dexcom G4 PLATINUM Professional System User’s Guide...
Page 187 Table 1-B is categorized within YSI reference value ranges. When you know your blood glucose level (measured by YSI in the study), this table shows how likely your CGM reading matches with your blood glucose Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 188 (2.2-22.2 mmol/L). When the System determines the glucose level is below 40 mg/dL (2.2 mmol/L), it displays “LOW” in the Receiver Status Box. When the Dexcom G4 PLATINUM System determines that the glucose level is above 400 mg/dL (22.2 mmol/L), it displays “HIGH”...
Page 189 Table 3 is categorized by each range of CGM glucose ranges. This table describes for each range of CGM glucose readings, what percentage of paired YSI values were in the same glucose range (shaded) or in Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 190 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 Dexcom G4 PLATINUM Professional System User’s Guide...
Page 191 Difference shows that half of the time the System reads 1.7% or less than the YSI blood glucose values and the Median Absolute Percent Difference shows that half of the time the System reads about 9.8% or less different than YSI blood glucose values. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 192 (0.1 mmol/L) lower than the reference at CGM glucose level of 61-80 mg/dL (Mean Difference, i.e. 3.4-4.4 mmol/L), 9.8% different than the reference at CGM glucose values of 301-350 mg/dL (Mean Absolute Percent Difference, i.e. 16.7-19.4 mmol/L), and 12.8% different than Dexcom G4 PLATINUM Professional System User’s Guide...
Page 193 * F or YSI ≤ 80 mg/dL (4.4 mmol/L), the differences in mg/dL (mmol/L) are included instead of percent differences (%). NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L), inclusive. Table 4-B is categorized within YSI glucose value ranges. For example, Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 194 Table 5. Hypoglycemic Alert Evaluation Hypoglycemic True False Hypoglycemia Hypoglycemia Missed Alert Level Alert Alert Detection Rate Detection Rate mg/dL (mmol/L) Rate Rate 55 (3.1) 60 (3.3) 70 (3.9) 80 (4.4) 90 (5.0) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 195: The High Glucose Alert
17% of time within the 15 minute period before or after your blood sugar goes below 70 mg/dL(3.9 mmol/L). The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Table 6. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 196 8% of the time within the 15 minute period before or after your alarm sounds. Hyperglycemia Detection Rate The Detection Rate shows how often the device recognizes and alerts you to an episode of hyperglycemia or how often it misses such an Dexcom G4 PLATINUM Professional System User’s Guide...
Page 197 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 in Table 7. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 198 (Day 1), middle (Day 4) and end (Day 7) of the System lifecycle. The average and median of the absolute percent differences are included in Table 8 showing consistent accuracy and sensor stability over the 7-day life of the sensor. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 199 288 readings per day. For a variety of reasons, the System may not display a glucose reading and readings are “skipped.” Table 9 estimates the number of readings you can expect to receive from Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 200 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. These results characterize the performance patients expect during real-time use of the system in Dexcom G4 PLATINUM Professional System User’s Guide...
Page 201 (%) 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% Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 202 NOTE: CGM readings are within 40 to 400 mg/dL (2.2-22.2 mmol/L), inclusive. Overall, the System reads, on average, 0.4% lower (Mean Percent Difference) than SMBG values and 14.0% absolute different (Mean Absolute Percent Difference) than the SMBG values. The Median Dexcom G4 PLATINUM Professional System User’s Guide...
Page 203: Product Specifications
Sterile by radiation Transmitter Product Specifications Part Number 9438-01 Dimensions Length: 1.5 inches (including Width: 0.9 inches sensor pod) Thickness: 0.5 inches Weight (including 0.4 ounces sensor pod) (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 204 1.25 mW EIRP Modulation Minimum Shift Key Data Rate 49.987 Kbits/Sec Total Packet 224 bits 4.48 ms every 5 minutes at each Transmit Duty Cycle of the four TX frequencies. Data Detection Range 20 feet Dexcom G4 PLATINUM Professional System User’s Guide...
Page 205 The Dexcom G4 PLATINUM Professional 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 206 Power Supply for 5 cycles Input Lines 70% U IEC 61000-4-11 (30% dip in U for 25 cycles < 5% U (> 95% dip in ) for 5 sec (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 207 5V DC, 1A Power Supply MT21255 Communication Range 20 feet 30 days of glucose data, Memory Storage 7 days of tech support data Re-Chargeable Battery Use 3 days (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 208 ± 8 kV Air ± 8 kV Air (ESD) or ceramic tile. If floors are covered IEC 61000-4-2 with synthetic material, the relative humidity should be at least 30%. (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 209 40% U Variations on or hospital (60% dip in U 40% U Power Supply environment. for 5 cycles (60% dip in U Input Lines for 5 cycles (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 210 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Dexcom G4 PLATINUM Professional System is intended for use in the electromagnetic environment specified in the next table. The customer or the user of the Dexcom G4 PLATINUM Professional System should ensure that it is used in such an environment.
Page 211 10 V/m 3 V/m equation applicable to 80 MHz to the frequency of the 2.5 GHz transmitter. Recommended Separation Distance d = 1.2 √P 150 kHz to 80 MHz d = 1.2 √P 80 MHz to 800 MHz d = 2.3 √P 800 MHz to 2.5 GHz (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 212 NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 213: Electromagnetic Emissions
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Dexcom G4 PLATINUM Professional System is used exceeds the applicable RF compliance level above, the Dexcom G4 PLATINUM Professional System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Dexcom G4 PLATINUM Professional System.
Page 214 Portable and mobile RF equipment include: baby monitors, Bluetooth wireless headsets, wireless routers, microwave ovens, laptops with internal wi-fi adapters, GSM cell phones, RFID scanners and hand-held security metal detector often used by security screeners. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 215 5V DC, 1A Type USB A to USB micro B Length 3 feet * The power supply/charger can be connected to the USB charging/download cable for charging using an AC power outlet. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 216: Fcc Requirements
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 Dexcom G4 PLATINUM Professional System User’s Guide...
Page 217 • Consult the dealer or an experienced radio/TV technician for help. This portable transmitter with its antenna complies with FCC/IC RF exposure limits for general population/uncontrolled exposure. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 218: Chapter 15: User Assistance
USER ASSISTANCE Dexcom G4 PLATINUM Professional System User’s Guide...
Page 219 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 220 For Dexcom product questions and troubleshooting issues 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: 1.877.633.9266 Dexcom Technical Support does not offer medical advice. Dexcom G4 PLATINUM Professional System User’s Guide...
Page 221 SALES SUPPORT For help with first-time orders, re-orders, tracking shipments, and locating a Dexcom representative in your area. If, after using a Dexcom G4 PLATINUM Professional System, your patients would like to purchase a Dexcom CGM system for their personal use, please have them contact Dexcom Sales Support or their local Dexcom representative.
Page 222: Chapter 16: Warranty
WARRANTY Dexcom G4 PLATINUM Professional System User’s Guide...
Page 223 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 224 Dexcom G4 PLATINUM Professional System Limited 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 is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing...
Page 225 PLATINUM Receiver, call 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 226 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 PROFESSIONAL SYSTEM.
Page 227 Dexcom; (e) defects or damage from improper testing, operation, maintenance, installation or adjustment; (f) installation, maintenance, and service of products; (g)
Page 228 Dexcom G4 PLATINUM Professional CGM System User’s Guide, a copy of which was included with the Dexcom G4 PLATINUM Professional 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...
Page 229 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 PROFESSIONAL CGM SYSTEM.
Page 230 PLATINUM RECEIVER DUE TO MISUSE, AND IMPROPER INSTALLATION, CARE OR MAINTENANCE OF THE SHIELD. SEAL SHIELD’S LIMITED WARRANTY DOES NOT, UNDER ANY CIRCUMSTANCES, COVER THE DAMAGE, REPAIR, REPLACEMENT OR COST OF THE DEXCOM G4 PLATINUM RECEIVER OR DATA INSIDE. Dexcom G4 PLATINUM Professional System User’s Guide...
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Page 232: Chapter 17: Travel Information
TRAVEL INFORMATION Dexcom G4 PLATINUM Professional System User’s Guide...
Page 233 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 234 CHAPTER 17: TRAVEL INFORMATION It is safe for you to go through the metal detector or be “handwanded” while wearing the 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...
Page 235 PAGE INTENTIONALLY LEFT BLANK Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 236: Chapter 18: Appendix
APPENDIX Dexcom G4 PLATINUM Professional System User’s Guide...
Page 237 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 238: Appendix I, Receiver Alerts, Alarm And Prompts
5 minutes until until the confirmed or the blood glucose value glucose goes above 55 value mg/dL. comes back into range. In blinded mode: Disabled Disabled Disabled No display (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 239 5 minutes until snooze confirmed or feature. See the glucose Chapter 9, value goes Section 9.2, above the alert Advanced level. Alerts. In blinded mode: Disabled Disabled Disabled No display (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 240 5 minutes the out and you will not until the receiver of range receive sensor and transmitter alert under glucose readings. are back in the Alerts, range. Advanced menu option. (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 241 The sensor Symbol in status reading is sending area only. error sensor glucose prompt readings that the receiver does not understand. You will not be recording sensor glucose readings. (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 242 You should wait about 30 minutes for more prompts. Do not enter any blood glucose values during this time. You will not receive or record sensor glucose readings. (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 243 1 more blood glucose value. Wait 15 minutes. If no sensor glucose readings appear on the receiver, the sensor needs to be replaced. (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 244 In both real-time 12 hour The receiver Prompt screen Yes, and blinded modes: calibration needs a blood only. every 15 prompt glucose value minutes. entered to calibrate. (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 245 1 time and then every 15 calibration additional blood vibrates/beeps minutes. prompt glucose value to every 5 minutes complete startup until confirmed. calibration. (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 246 2 mg/dL per vibrates/beeps minute or more. 2 times every 5 minutes or until confirmed (2 repeats max). In blinded mode: Disabled Disabled Disabled No display (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 247 2 mg/dL per vibrates/beeps minute or more. 3 times every 5 minutes or until confirmed (2 repeats max). In blinded mode: Disabled Disabled Disabled No display (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 248 6 hours. prompt In both real-time 2-hour The sensor Prompt screen and blinded modes: sensor session will end only. expiration in 2 hours. alert (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 249 Yes, 2 and blinded modes: failed alert working properly. time and then re-alerts vibrates/beeps in the every 5 minutes next 10 (2 repeats max). minutes for 30 minutes. (continued on next page) Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 250 5 minutes until confirmed. In both real-time Backup battery Vibrates 1 time. and blinded modes: time/date has drained, prompt time/date need to be reset. (continued on next page) Dexcom G4 PLATINUM Professional System User’s Guide...
Page 251 • 0-hour sensor expiration alert - You will see this alert in the normal course of using a sensor for seven days. Other alerts and alarms cannot be safely checked by the user. Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 252: Appendix Ii, Index
Calibration ........81 Dexcom G4 PLATINUM Professional System User’s Guide...
Page 253 Device Information ....... 56 Dexcom STUDIO Software ......133 Events, Diabetes .
Page 254 Overview ........15 Dexcom G4 PLATINUM Professional System User’s Guide...
Page 255 Overview ........16 Pairing with Receiver ......55 Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System...
Page 256 Water Resistance ....... . .78 Dexcom G4 PLATINUM Professional System User’s Guide...
Page 257: 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 Professional CGM System. Some of these symbols may not have meaning in your region, and are listed for informational purposes only.
Page 258 Directive 93/42/EEC Electrical Equipment Do Not Use if Package Designed Primarily for is Damaged Indoor Use Input Ship By Date Keep Dry Prescription Required Not Made with Natural MR Unsafe LATEX Rubber Latex Dexcom G4 PLATINUM Professional System User’s Guide...
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This manual is also suitable for:

G4 platinum professional

Dexcom G4 Professional User Manual

Glucose Monitoring System

Glossary

Chapter 1: Dexcom G4 Platinum Professional Continuous Glucose Monitoring (Cgm) System Description

Chapter 2: Indications for Use and Safety

Statement

Chapter 3: Risks and Benefits

Chapter 4: Charging the Receiver and the Receiver Main Menu

Chapter 5: Dexcom G4 Platinum Professional System Initial Setup

Chapter 6: Inserting a Sensor and Starting Asensor Session

Platinum Professional System

Chapter 7: Calibrating the Dexcom G4

Chapter 8: Viewing Sensor Glucose Readings and Trends in Real-Time Mode

Chapter 9: Alerts, Alarm & Profiles

Chapter 10: Events, Dexcom Studio ™ Software and Blinded Mode

Chapter 11: Ending a Sensor Session

Chapter 12: Taking Care of the Dexcom G4

Platinum Professional System

Chapter 13: Troubleshooting

Chapter 14: Technical Information

Chapter 15: User Assistance

Chapter 16: Warranty

Chapter 17: Travel Information

Chapter 18: Appendix

Appendix I, Receiver Alerts, Alarm and Prompts

Appendix II, Index

Appendix III, Symbols Used in Labeling

Quick Links

Troubleshooting

Need help?

Questions and answers

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Summary of Contents for Dexcom G4 Professional

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Table of Contents