Dexcom 9433 Users Manual

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G4-Global Continuous

Glucose Monitoring System

CAUTION: Investigational device. Limited by Federal

(or United States) law to investigational use.

SER’S GUID

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G4-Global Continuous

Glucose Monitoring System

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IMPORTANT CONTA CTS AND NUMBERS

DexCom Website: www.DexCom.com Your Transmitter ID Number: Your Transmitter Expiration Date: Your Receiver ID: Y our Healthcare Pr ofessional : Nearest Hospital:

Other Notes:

DexComTM, STS®, SEVEN®, DexCom DM®, DexCom Studio® Software, GVITM, OpenChoiceTM, Take Control – Live Uninterrupted®, Live Uninterrupted®, Between the LinesTM, SENSYNCTM, Stay Between the Lines®, DexCom Glucose Sensing™, Glucose Sensor Company™ and Dex™ are trademarks of DexCom, Inc. All other trademarks and copyrights are the property of their respective owners.

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G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM

G4-Global Receiver

G4-Global Sensor and Applicator

G4-Global Transmitter

G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM KIT CONTENTS:

•

Transmitter

•

Receiver

•

DexCom Studio

•

Receiver Charging Cable

Accessory Software

•

Receiver Case

•

User’s Guide

•

Quick Start Guide

NOTE: Sensors are sold separately. Commercially distributed blood glucose meter required for use. Make sure to use the correct version of DexCom

Studio

with your G4-Global System. The G4-Global Sensor works with the G4-Global family of products. The G4-Global Sensor, Transmitter and Receiver are not backwards compatible with the SEVEN/SEVEN

PLUS

T ransmitter and Receiver.

The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes.

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DexCom would like to thank you for purchasing the G4-Global Continuous Glucose Monitoring System (G4-Global System)! When you use the G4-Global System, you will see real-time continuous glucose readings every 5 minutes for up to 7 days. These readings will help you detect trends and patterns in your glucose levels. Glucose trends let you see where your glucose levels have been, which direction your levels are headed, and how fast they may be rising or falling.

The G4-Global System is made up of three technologies that all work together: the Sensor, the Transmitter, and the Receiver. The Sensor is a disposable unit that you insert into your abdomen (belly) to continuously monitor your glucose levels for up to 7 days. The Transmitter is a reusable device that snaps into the Sensor Pod. Your Transmitter will wirelessly send your Sensor-measured glucose information to your Receiver. The Receiver is a hand-held device that receives and displays your glucose information every 5 minutes.

The Receiver displays your current glucose reading and shows your glucose trend information from the past 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour periods. You will also see adjustable High and Low Glucose Alerts, and a Low Glucose ALARM to tell you when you are outside of your target glucose levels. Rise and Fall (Rate of Change) Alerts will let you know when your glucose levels are changing fast.

You can use any FDA-cleared blood glucose meter for calibration on the G4-Global System.

This User’s Guide describes how to use your G4-Global System from start to ﬁ nish of a continuous glucose monitoring session. Important safety information, warnings, precautions, cautions, and contraindications of the G4-Global System are described in the next few pages and throughout this guide. Be sure to read this entire User’s Guide before beginning a continuous glucose monitoring session.

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INDICATION FOR USE

The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The G4-Global System is intended for use by patients at home and in health care facilities. The device is for prescription use only.

The G4-Global Continuous Glucose Monitoring System is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The G4-Global Continuous Glucose Monitoring System aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of the G4-Global System results should be based on the trends and patterns seen with several sequential readings over time.

IMPORTANT SAFETY INFORMATION

Read this entire guide before using your G4-Global Continuous Glucose Monitoring System. If you do not understand something or have any questions, please ask your Diabetes Management Team or another health care provider. Contraindications, warnings, precautions, cautions, and other important safety information can be found in this section and in boxes throughout your G4-Global System User’s Guide. The T roubleshooting section (Chapter 9) contains important information on troubleshooting your G4-Global System. The T echnical Information section (Chapter 11, Section 11.2) provides information on the performance characteristics of the device.

CONTRAINDICATIONS

•

The G4-Global System must be removed prior to Magnetic Resonance Imaging (MRI).

•

Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device.

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WARNINGS

•

This device is not designed to replace a blood glucose meter. The G4-Global System must be used with a blood glucose meter.

•

T reatment decisions should not be based solely on results from the G4-Global System. You must conﬁ rm results with ﬁ ngerstick readings from a blood glucose meter before making therapeutic adjustments.

•

Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, use ﬁ ngerstick readings from your blood glucose meter to check the G4-Global System results.

•

You should update the G4-Global System calibration every 12 hours at a minimum. The performance of the G4-Global System when calibrated less frequently than every 12 hours has not been studied.

• 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 inﬂ ammation—redness, swelling or pain—at the insertion site. If you experience a broken Sensor, please report this to our Technical Support department.

• The G4-Global System is not approved for use in children or adolescents,

pregnant women or persons on dialysis.

• The safety and effectiveness of the G4-Global System has not been evaluated

for Sensor Probe insertion sites other than the skin of the abdomen.

PRECAUTIONS

•

Always wash hands with soap and water before opening the Sensor package. After opening the package, avoid touching the adhesive area.

•

Before inserting the Sensor, always clean the skin at the Sensor insertion location with a topical antimicrobial solution, such as isopropyl alcohol. Do not apply the Sensor until the cleaned area is dry .

•

Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing, accessories, or subjected to rigorous m ovement durin g exercise.

•

Avoid injecting insulin or placing an insulin pump infusion set within 3 inches (7.62 centimeters ) of the Sensor .

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•

The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.

•

The Sensor has currently only been tested in adult persons with type 1 and type 2 diabetes. The device has not been tested in children or adolescents, pregnant women, or persons on dialysis.

CAUTION

U.S. federal law restricts the sale of the G4-Global System to sale by or on order of a physician.

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able of co

G4-GLOBAL CONTINUOUS GLUCOSE MONITORING SYSTEM:

SYSTEM KIT CONTENTS 5

INTRODUCT ION : 6

INDICATION FOR USE 7 IMPORTANT SAFETY INFORMATION 7

CHAPTER 1: THE G4-GLOBAL SYSTEM BASICS 13

1.1 Sensor Overview 15

1.2 Transmitter Overview 16

1.3 Receiver Overview 17

1.4 Moving Through the Receiver Screens 19

CHAPTER 2: G4-GLOBAL SYSTEM SET UP 23

2. 1 The Set Up Wizard 25

2.2 Turning the Receiver On 26

2.3 Setting the Time and Date 27

2.4 Entering Your T ransmitter ID 28

2.5 Changing Your High and Low Alerts 29

2.6 Charging Your Receiver Battery 31

CHAPTER 3: USING A SENSOR 33

3. 1 Before You Start 35

3.2 Removing the Sensor From Its Packaging 37

3.3 Choosing an Insertion Site 37

3.4 Placing the Sensor 38

3.5 Sensor Insertion 39

3.6 Transmitter Attachment 40

3.7 Starting a Sensor Session 42

3.8 Transmitter and Receiver Communication 42

3.9 Sensor Startup Period 44

3. 10 The G4-Global System and Water 44

3. 11 Taping the Sensor Pod 44

CHAPTER 4: CALIBRATING YOUR G4-GLOBAL SYSTEM 45

4.1 Calibration Overview 47

4.2 How to Calibrate 48

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4.3 Startup Calibration 50

4.4 Calibration Update 51

4.5 Re-Calibration 52

CHAPTER 5: CONTINUOUS GLUCOSE READINGS, 55

TRENDS, ALERTS AND ALARM

5. 1 Glucose Readings 58

5.2 Glucose Trends 61

5.3 Glucose Alerts and Low Glucose ALARM 62

5.3.1 High Glucose Alert 63

5.3.2 Low Glucose Alert 64

5.3.3 Low Glucose ALARM 65

5.3.4 Rise and Fall Glucose rate Alerts 65

5.4 Glucose Status Area on Trend Graphs 67

5.4.1 Glucose Status Area Symbols 67

5.4.2 Missing Glucose Readings 68

5.4.3 System Glucose Errors 69

5.4.4 Out of range/No Antenna 70

5.5 Temporary Sensor Shut Down 71

CHAPTER 6: COMPLETING YOUR CONTINUOUS GLUCOSE

MONITORING SESSION 73

6. 1 Removing a Sensor 75

6.2 Automatic Sensor Shut-Off 76

6.3 Early Sensor Shut-Off 77

6.3.1 Early Shut-Off – Sensor Failure 77

6.3.2 Manual Sensor Shut-Off – “Stop Sensor” 77

6.4 Transmitter Removal 79

CHAPTER 7: BASIC SETTINGS 81

7.1 The Settings Menu 83

7.1.1 Getting to the Settings Menu 83

7.1.2 Setting Your Receiver Date and Time 83

7.1.3 Entering Your Transmitter ID 84

7.1.4 Checking Information About Your Receiver 86

7.2 Setting Your Alerts 87

7.2.1 F actory Alert Settings 87

7.2.2 Getting to the Alerts Menu 89

7.2.3 Setting Glucose Alerts 89

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CHAPTER 8: ADVANCED FEA TURES - BEYOND THE BASICS 95

8. 1 Activating Advanced Features 97

8.2 Diabetes Events 98

8.2.1 Selecting an Event 98

8.2.2 Setting the Date and Time for an Event 99

8.2.3 Carbohydrates 99

8.2.4 Insulin 100

8.2.5 Exercise 101

8.2.6 Health 102

8.3 DexCom Studio

Software 103

8.4 Rise and Fall Glucose Rate Alerts 103

8.5 Setting Other Alerts 105

8.6 Setting the Out of Range Alert 106

8.7 Setting a Snooze Time for Your High and Low Glucose Alerts 108

CHAPTER 9: TROUBLESHOOTING 109

9.1 Sensor Insertion Troubleshooting 1 11

9.2 Calibration Troubleshooting 1 12

9.2.1 Blood Drop Prompts 112

9.2.1. 1 Types of Blood Drop Prompts 112

9.2.1.2 Status Area Symbols During Blood Drop Prompts 114

9.3 Sensor Failed Troubleshooting 115

9.4 Calibration Error Troubleshooting 116

9.5 Receiver and Cables Troubleshooting 117

9.6 Receiver and Transmitter Communication Troubleshooting 1 18

CHAPTER 10: TAKING CARE OF YOUR G4-GLOBAL SYSTEM 119

10.1 Maintenance 121

10.2 Storage 122

10.3 Cleaning and Disinfecting 122

CHAPTER 11: STUDY RESULTS 125

1 1.1 Pivotal Study Results 127 1 1.2 Product Speciﬁ cations 145 1 1.3 FCC Requirements 154

CHAPTER 12: APPENDIX 155

Appendix I, Other Alerts 157 Appendix II, Receiver Screens and Prompts 160 Glossary 164 Symbols Used in Labeling 166 Index 168

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THE G4-GLOBAL SYSTEM BASICS

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1.1 SENSOR OVERVIEW

The Sensor is the System component that continuously measures your glucose levels. You will use a blood glucose meter to calibrate your glucose readings measured by the Sensor. The T ransmitter collects the Sensor readings and sends them to the Receiver using wireless, radio frequency (RF) technology. This happens every 5 minutes for up to 7 days.

The Sensor unit has an Applicator (needle, sensor, plastic housing), Sensor Probe, and Sensor Pod. The Applicator includes a Safety Lock/Transmitter Key to keep the needle in place until you are ready to insert. After taking off the Safety Lock, you will insert the Sensor Probe just beneath the skin (subcutaneous tissue) of your belly using a small needle inside the Applicator. The needle is inserted just under the skin at an angle and carries the Sensor Probe with it. After you insert the needle and Sensor Probe, you will pull the needle back into the Applicator. This leaves the Sensor Probe behind to continuously measure your glucose levels. The Applicator, with the needle inside, is pulled off from the Sensor Pod and should be thrown away. Save the Safety Lock/Transmitter Key because you can use it to remove the T ransmitter at the end of a continuous monitoring session.

The Sensor Probe lies underneath your skin at an angle and continuously measures your glucose levels for up to 7 days. The Sensor Pod and Transmitter (once snapped in) remain on your belly for the entire Sensor session. The Sensor insertion site is similar to an insulin pump infusion site.

Safety Lock/

Transmitter Release

Sensor Pod

Collar

Plunger

Applicator (needle/sensor probe inside)

Transmitter Latch

Release Tab

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1.2 TRANSMITTER OVERVIEW

The Transmitter wirelessly sends your glucose information from the Sensor to the Receiver. Once you insert the Sensor, you will snap the Transmitter into the Sensor Pod using the Transmitter Latch. The same T ransmitter is used when you change Sensors.

The Transmitter battery will last about 6 months. As the Transmitter nears the end of its battery life, it can sometimes lose communication with the Receiver. This can happen even if the Receiver and Sensor/ T ransmitter are within 20 feet (6 meters) of each other. The Transmitter (Low Battery) screen will ﬁ rst appear when there are about 2 weeks of battery life remaining. Press any Receiver button to clear the ALARM. This ALARM will reappear every day for 2 weeks, or until the T ransmitter is replaced. Once the Transmitter battery has drained, you will need to replace the Transmitter because it can no longer communicate (talk) to the Receiver. Y ou can easily set up a new Transmitter to talk with your Receiver (see Chapter 2, Section 2.4 ).

HELPFUL HIN TS:

• Y our Transmitter is re-used for many Sensor uses.

• If you see the Out of Range Symbol T rend Graph, your Transmitter and Receiver are no longer talking. This can happen even when your Sensor/Transmitter and Receiver are within 20 feet (6 meters) of each other.

• The Receiver and Transmitter are designed and tested to withstand common electromagnetic interference, including airport security systems.

in the upper right corner of the

Install Transmitter

in Sensor Pod

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Transmitter Installed

Remove

Transmitter Latch

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1.3 RECEIVER OVERVIEW

The Receiver looks like a small MP3 player and shows your Sensor-measured glucose information. The G4-Global Receiver only shows glucose readings in the milligrams per deciliter (mg/dL) unit of measure. In the United States, mg/dL is the standard unit used for glucose testing systems (i.e., blood glucose meters). Please check with your Diabetes Management Team if you have questions about the unit of measure displayed on your Receiver.

Keep the Receiver within 20 feet (6 meters) of the Sensor/Transmitter at all times for your G4-Global System to work best. Good places to keep the Receiver are on your belt in the Receiver case provided or in your pocket.

Most recent 5-minute

glucose reading

Trend Arrow

Time

High Glucose Alert Setting

Low Glucose Alert Setting

Trend Graph Hours

Plot of most recent glucose reading

EXAMPLE: 3-Hour Trend Graph Screen

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There are 5 Receiver buttons to move you through the display screens that control setup and operation. The screens display glucose readings and trend graphs (“Trend Graphs”) and allow you to change your Receiver settings (“Menu Screens”). You program your Receiver with a speciﬁ c Transmitter ID Number so your Receiver and Transmitter can talk with each other. Each time you insert a new Sensor, you will need to notify the Receiver (see Chapter 3, Section 3.8).

Each Sensor must be “calibrated” before glucose readings are displayed on the Receiver. T o calibrate, you manually enter ﬁ ngerstick readings (see Chapter 4, Section 4.1 ) from any FDA-cleared meter.

UP TOGGLE button

RIGHT TOGGLE button

SELECT button

LEFT

TOGGLE

button

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DOWN TOGGLE button

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1.4 MOVING THROUGH THE RECEIVER SCREENS

1. Turn the Receiver on by pressing the SELECT button.

2. The 3-Hour Trend Graph will appear. a. The default screen is the 3-Hour Trend Graph,

but you may view glucose information for shorter or longer periods by pressing the or

BOTTOM TOGGLE button to see the 1-Hour,

6-Hour, 12-Hour, and 24-Hour Trend Graphs.

TOP

3. From any Trend Graph, press the

NOTE: Main Menu options take up more than one screen, and certain options only appear at certain times.

a. Press the TOP or BOTTOM TOGGLE button to scroll through and highlight

different Menu options.

b. Press the

then enter that Menu.

c. Press the

SELECT button when the option you want is highlighted. Y ou will

LEFT TOGGLE button to return to the previous Menu.

SELECT button to display the Main Menu.

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4. More information on Main Menu options can be found in the sections listed below:

Menu Purpose User’s Guide

Reference

Trend Graph

Start Sensor

Enter BG To enter your ﬁ ngerstick blood glucose readings

Events To enter personal information about meals, insulin,

Alerts, High/low

Alerts, Rise/Fall rate, Other, and Out of Range

Settings To change the time, date and Transmitter ID number,

Shutdown To temporarily turn off all communications between

Stop Sensor

To display the Trend Graphs.

• The 3-Hour Trend Graph is the default screen displayed whenever you turn the Receiver on.

To start a new Sensor session.

• This option only appears if a Transmitter ID has been entered and you are not in the middle of a Sensor session.

for calibration.

exercise, and health status. To change the settings for notiﬁ cations of High and

Low Alerts from your Receiver. To change the settings for notiﬁ cations of Rise/Fall

Rate (Rate of Change) Alerts, Other Alerts and Out of Range Alerts.

to look up your G4-Global System hardware and software version numbers, to view Transmitter battery status, last calibration value, Sensor insertion time, and to enable Advanced features.

your Sensor, Transmitter and Receiver. To end a Sensor session early .

• This option only appears when you are in the middle of a Sensor session.

Chapter 1

Chapter 3

Chapter 4

Chapter 8

Chapters 2 and 7

Chapter 8

Chapters 2 and 7

Chapter 5

Chapter 6

See Appendix I, “Other Alerts”, for a list of prompt screens that may appear on the Receiver during use.

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LOBAL SYSTE

G4-GLOBAL SYSTEM SETUP

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This chapter will help you set up your G4-Global System. You will want to read this chapter before you insert and start a new Sensor session.

2.1 THE SETUP WIZARD

The Receiver Setup Wizard will guide you through the ﬁ rst-time setup of your G4-Global system.

Before setting up your Receiver, remove the Transmitter from the box.

NOTE: In order to save battery life, the Transmitter is stored in a tray with a small magnet attached. This prevents the Transmitter from turning on until it is removed from the tray . The Transmitter will turn on 10 minutes after being removed from the tray .

1. Turn your Receiver on by pressing the button on the Receiver. When you turn the Receiver on for the ﬁ rst time, the Setup Wizard will help you get started by prompting you to enter the following setup information:

2. Set the Time and Date

3. Enter your Transmitter ID

Your Transmitter ID can be found in any of the following locations:

- On the Transmitter card located inside your

Global System Kit

- On the outside of the Transmitter box label

- Engraved on the back of the Transmitter itself

If you have difﬁ culty locating your T ransmitter ID, please contact DexCom Technical Support.

SELECT

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4. Set your Low and High Glucose Alert Levels

The Setup Wizard is now completed. You will now need to insert a Sensor and start a Sensor session to begin a continuous glucose monitoring session (see Chapter 3).

NOTE:

• When using the Setup Wizard, the Low and High Glucose Alerts are already turned on and are set to vibrate and beep. Only the Low Alert and High Alert “levels” can be adjusted in the Setup Wizard. To make other changes, see Section 2.5.

• See Sections 2.3, 2.4 and 2.5 and Chapter 7 for more information on setting the time and date, entering Transmitter ID, and Low and High Glucose Alerts from the Main Menu.

2.2 TURNING THE RECEIVER ON

1. Press the SELECT button to turn the Receiver on. The 3-Hour Trend Graph will appear.

2. Press the

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SELECT button to display the Main Menu.

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2.3 SETTING THE TIME AND DATE

1. From the Main Menu, press the TOP or BOTTOM TOGGLE button to scroll to “Settings” and press the the

SELECT button.

2. Check that the current date and time are correctly set in the Receiver. Press the button to highlight each value in the date and time. Then, press the button to make any adjustments, and then press the

RIGHT TOGGLE button to move to the next

value. After choosing AM or PM, press the button. You will return to the Settings menu.

SELECT button. Next, scroll to “Time/Date” and press

RIGHT TOGGLE

TOP or BOTTOM TOGGLE

SELECT

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2.4 ENTERING YOUR TRANSMITTER ID

Before you can use your G4-Global System, you must enter the Transmitter ID into the Receiver. The Transmitter ID is a series of 2 letters and 5 numbers on the back of the Transmitter. Entering the ID will begin the unique wireless radio frequency (RF) communication between the Transmitter and Receiver. To enter the T ransmitter ID, perform the following steps:

1. From the Main Menu, press the “Settings” and press the press the

NOTE: You can only enter your T ransmitter ID when you are not in a Sensor session. During a Sensor session, “Transmitter ID” will not appear as an option on the Settings menu.

2. Starting with the ﬁ rst value, press the TOP or adjustment, and then press the button to move to the next value. After entering the 5th number, press the return to the Settings menu.

Your Transmitter ID can be found in any of the following locations:

- On the Transmitter card located inside your Global System Kit

- On the outside of the Transmitter box label

- Engraved on the back of the Transmitter itself

If you have difﬁ culty locating your T ransmitter ID, please contact DexCom Technical Support.

SELECT button.

BOTTOM TOGGLE button to make any

SELECT button. You will

TOP or BOTTOM TOGGLE button to scroll to

SELECT button. Next, scroll to “Transmitter ID” and

RIGHT TOGGLE

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2.5 CHANGING YOUR HIGH AND LOW ALERTS

High Alerts and Low Alerts provide information about your glucose levels and trends. See Chapter 5, Section 5.3 for more information. You can turn the High Alert and/or Low Alert on or off, and choose how the Alerts are delivered (vibrate and beep, or vibrate only). You can also select the glucose value the Receiver will use to trigger a High or Low Alert.

NOTE: The High and Low Alerts are already turned on when you turn the Receiver on for the ﬁ rst time during Setup Wizard.

The options for setting both a High Alert and a Low Alert are the same. The following steps will show you how to change your High Alert settings.

1. From the Main Menu, press the to “Alerts” and press the Alert” and press the

SELECT button.

TOP or BOTTOM TOGGLE button to scroll

SELECT button. Next, scroll to “High Alert” or “Low

2. On the High Alert menu (example), press the or

BOTTOM TOGGLE button to choose the “On/

Off” option. The High Alert is currently set to “On”. If you do not want to receive this type of Alert press the

SELECT button to choose “Off”.

TOP

Example-High Alert menu

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3. Next, on the High Alert menu (example), press the

TOP or BOTTOM TOGGLE button to choose

“Type” and press the SELECT button. Then, choose “Vibrate Then Beep” or “Vibrate Only” as your Alert delivery option, and press the

SELECT button.

- V ibrate Then Beep (vibrate, then a vibrate and a beep every 5 minutes)

° High Alert Beep (a series of tones in ascending order, followed by a few

steady high tones)

° Low Alert Beep (a series of tones in descending order, followed by a few

steady low tones)

- Vibrate Only (vibrate every 5 minutes)

NOTE: Alerts can be acknowledged by pressing any button on the Receiver.

4. Next, on the High Alert menu (example), press

the

TOP or BOTTOM TOGGLE button to choose

“Level” and press the SELECT button. Press the

TOP or BOTTOM TOGGLE button to enter

your Alert value (120 to 400 mg/dL in 10 mg/dL increments for a High Alert and 60 to 100 mg/dL in 5 mg/dL increments for a Low Alert). The starting value that ﬁ rst appears on this screen is the default value of 200 mg/dL (High Alert) and 80 mg/dL (Low Alert), or the values you set in the Setup Wizard.

You have the option to set a snooze time to re-alert you (see Chapter 8, Section

8.7, Setting a Snooze Time for Your High and Low Alerts).

Example-High Alert

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2.6 CHARGING YOUR RECEIVER BATTERY

The Receiver battery is rechargeable like a cellular phone. The rechargeable battery will last for about 3-5 days before you need to charge it with the Receiver Charging Cable. Your rechargeable battery life depends on how often you turn your Receiver on, your Alert settings, and how often you enter Event information using the Events feature. The Receiver will tell you when the battery charge is low.

The Receiver Battery may be charged using one of the following options:

• Receiver charging cable for wall charging (cable included with kit)

• PC cable for computer charging (cable available separately) It takes about 3 hours to fully charge an empty battery with the wall charger, and

about 5 hours when the Receiver is connected to a computer. To recharge your battery, follow the instructions below:

1. Open the connection port cover on the right side of the Receiver. Plug the Receiver end of the Receiver charging or PC cable into the connection port on the Receiver.

2. Plug the other end of the cable to the wall outlet or to the USB port on your computer, depending on the cable you are using.

3. The Battery Charging screen will appear on the Receiver.

Low Battery

4. After a few seconds the Trend Graph will reappear with the Battery Charging Symbol

shown in the

upper left corner next to the Antenna Symbol .

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Battery Charging

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5. As the battery charges, the Battery Symbol will begin to ﬁ ll in (green). When the battery is fully charged, the Battery Symbol will be completely ﬁ lled in.

Start Fully Charged

6. After the charge is complete, remove the cable from the Receiver and the wall outlet or computer USB port.

HELPFUL HINTS:

• Charge your Receiver battery before each Sensor insertion. Periodically check your battery level to make sure it has enough charge.

• If your battery drains and is not charged for about 6 months, the backup battery might also drain. When this happens, you will need to reset your Receiver time and date (see Section 2.3).

• Only use the DexCom battery charger provided in the Starter Kit. Do not use any other battery charger.

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USING A SENSOR

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To use your G4-Global Continuous Glucose Monitoring System you will need a Sensor, a Transmitter, and a Receiver . You will also need a blood glucose meter and test strips for calibration. Once inserted and calibrated, the Sensor will continuously measure and display your glucose readings for up to 7 days (167 hours after the 1-hour Startup period). The following sections will show you how to insert the Sensor and start a new continuous glucose monitoring session.

3.1 BEFORE YOU START

Wash your hands thoroughly.



Make sure you charge your Receiver completely . See Chapter 2, Section 2.6



for directions.

Check that the date and time are correct on the Receiver.



If this is a new Transmitter, make sure the correct Transmitter ID Number has



been entered into your Receiver (See Chapter 2, Section 2.4).

Check the expiration date on the Sensor, before you start, to make sure you



are not using an expired Sensor. The expiration date format is YYYY-MM-DD.

Quality check (“QC”) your blood glucose meter per the manufacturer’s



instructions to make sure it is providing you the best readings for calibration (e.g., check the code number and use the control solution if applicable).

Clean the bottom of the Transmitter with a damp cloth or alcohol wipe, and



dry before you start a new Sensor session.

Make sure your blood glucose meter and Receiver date and time match.



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REVIEW THE SENSOR APPLICATOR

Review the Sensor Applicator picture below before using a new Sensor.

Plunger

Safety Lock/

Transmitter Release

Collar

Sensor Pod

Applicator (needle/sensor probe inside)

Transmitter Latch

Release Tab

HELPFUL HIN T: Always check the expiration date on the Sensor

packaging before opening the Sensor for use. Never use expired Sensors. The expiration date fo rmat is YYYY-MM-DD.

The G4-Global Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes.

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3.2 REMOVING THE SENSOR FROM ITS PACKAGING

The Sensor is sterile in its unopened, undamaged package. Do not use any Sensor if its sterile package has been previously damaged or opened.

•

Carefully remove the Sensor from its packaging. Look closely at the Sensor to make sure it is not damaged.

•

The Applicator is a single use, disposable unit. The Safety Lock prevents you from accidentally releasing the needle before you are ready .

3.3 CHOOSING AN INSERTION SITE

Establish a rotation schedule for choosing each new Sensor location. Avoid Sensor locations that are constrained by clothing, accessories, or subjected to rigorous movement during exercise.

Avoid injecting insulin or placing an insulin pump infusion set within 3 inches (7.62 centimeters) of the Sensor.

Choose a site on a fatty area of your belly to place the Sensor. You can choose a site above or below your belt line. The best areas to insert your Sensor are usually ﬂ at, “pinchable,” and free from where rubbing can occur (i.e., pant line, seatbelts).

•

Avoid areas with scarring, tattoos, or rough patches of skin from your insulin injections or pump.

•

Choose an area that is at least 3 inches (7.62 centimeters) from where you plan to inject insulin or from where your pump infusion site is located.

•

Avoid using the same spot repeatedly for Sensor insertion. Never use the same site for 2 Sensor sessions in a row.

•

You may need to shave the area where you plan to put the Sensor so that the adhesive patch sticks securely .

•

Make sure there are no traces of lotions, perfumes or medications on the area. Clean the area ﬁ rst with an alcohol swab. Make sure the area is clean and completely dry before you insert the Sensor.

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3.4 PLACING THE SENSOR

1. After you have cleaned your skin, remove the adhesive backing from the Sensor Pod. Hold the Sensor by the plastic Applicator and try not to touch the sticky adhesive patch.

2. Place the Sensor on the area. You can place the Sensor ﬂ at facing to the left or right of your belly button. Make sure the Sensor is placed in the same direction shown in the picture below. You should not place the Sensor pointing in the up or down direction.

Remove the Adhesive backing Adhere the Sensor on the skin

3. After placing the Sensor, press ﬁ rmly on and around the outside of the adhesive patch to make sure it is ﬂ at.

a. Pressing the patch to remove any wrinkles should help it stick better. b. Press ﬁ rmly over the entire patch area.

4. Hold on to the Applicator. Then pull the Safety Lock/Transmitter Key straight out away from the applicator, in the direction the arrow shows below.

Remove the Safety Lock/Transmitter Key

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HELPFUL HIN T: The Safety Lock also serves as the Transmitter Key that is used later for Transmitter removal. Keep this piece to help you remove the T ransmitter at the end of a continuous glucose monitoring session. When your glucose monitoring session is over, follow the steps in Chapter 6, Section 6.4 to remove the Transmitter.

3.5 SENSOR INSERTION

Once you have placed the Applicator on your belly and removed the Safety Lock (see Section 3.4), you are ready to insert the Sensor. Follow these 4 steps to successfully insert your Sensor.

1. Hold down the Pod with one hand. With your other hand, place two ﬁ ngers above the collar on the barrel of the Applicator.

2. Place your thumb on the plunger. Push the plunger down completely. This action inserts the needle and Sensor Probe under your skin.

When you are pushing down on the plunger, do not pull back on the collar.

“CLICK”

Push down the plunger – Insert the Needle and Sensor Probe

3. To remove the needle, keep holding the Sensor Pod with one hand. With your other hand, place two ﬁ ngers under the collar . Then pull the collar back towards your thumb. Stop when you hear 2 “clicks” or cannot pull back any more. This step pulls the needle back into the Applicator and keeps the Sensor Probe under your skin.

a. Remember to do this in the correct order:

push plunger down, then pull collar up.

“ 2 CLICKS”

Pull back the collar - Retract

the Needle

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4. Squeeze the ribbed release tabs on the sides of the Sensor Pod to remove the Applicator. When you squeeze the front release tabs, the back tabs will widen, allowing you to pull off the Applicator. After this step, only the Sensor Pod will be left on your body .

a. Make sure the Transmitter Latch is

down (against your body) to remove the Applicator.

5. The used Applicator can be thrown in the trash.

If you have any problems with insertion, save the Sensor and Applicator and contact DexCom.

3.6 TRANSMITTER ATTACHMENT

The Transmitter wirelessly sends your Sensor glucose information to the Receiver. Once you have inserted your Sensor, you will need to snap the Transmitter into the Sensor Pod. Follow the steps below to attach your Transmitter .

1. Clean and dry the bottom of the Transmitter with a damp cloth or an alcohol wipe before every use.

a. Be careful not to touch the metal circles on the bottom of the Transmitter.

2. Place the Transmitter in the Sensor Pod with the ﬂ at side facing down.

3. Pull the Transmitter Latch over the Transmitter to snap the Transmitter into place. The Transmitter should lie ﬂ at in the Sensor Pod. You should hear 2 “clicks.”

a. If you do not hear 2 clicks, the Transmitter might not be fully snapped in.

4. Make sure both sides of the Transmitter are secure inside the Sensor Pod.

a. Do this by sliding your ﬁ rst and second ﬁ ngers under the edge of the

Sensor Pod (with your ﬁ ngernails against your skin under the Latch). b. Place your thumb on top of the Transmitter. c. Then squeeze together to make sure the Transmitter has been snapped in.

Release the Applicator

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5. Remove the Transmitter Latch by holding the end of the Latch and quickly twisting off the Latch away from your body.

Install Transmitter

in Sensor Pod

Transmitter Installed

Transmitter Latch

Remove

Transmitter Latch

HELPFUL HIN TS:

• Make sure you hear 2 clicks when you snap the Transmitter in place (see Step 3). This helps ensure your device is water resistant (see Section 3.10).

• Make sure that you have entered the correct Transmitter ID into your Receiver. See Chapter 2, Section 2.4 for instructions on how to enter the Transmitter ID into your Receiver.

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3.7 STARTING A SENSOR SESSION

After you have checked that your Transmitter and Receiver are talking, you need to tell the Receiver that you have inserted a new Sensor.

To tell the Receiver that you have inserted a new Sensor, follow the steps below.

1. Press the

2. From any Trend Graph, press the

3. Press the scroll until you highlight “Start Sensor.”

SELECT button to turn the Receiver on.

SELECT button to display the Main Menu.

TOP or BOTTOM TOGGLE button to

4. Press the new Sensor session. The Start Sensor Processing screen will appear to let you know your Sensor session has begun.

5. Your Receiver will then return to the 3-Hour Trend Graph.

HELPFUL HIN TS:

• The Start Sensor menu option will now disappear from the Main Menu. The option will only appear again after an active Sensor session ends.

• Each time you insert a new Sensor and press SELECT to start a new Sensor session, you will start a new 1-hour Startup period.

SELECT button to conﬁ rm the start of a

3.8 TRANSMITTER AND RECEIVER COMMUNICATION

CONTRAINDICA TION: The G4-Global System must be removed prior to Magnetic Resonance Imaging (MRI).

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Keep your Receiver within 20 feet (6 meters) of the Sensor/Transmitter for best communication. To check that the Receiver and Transmitter are talking, press the

SELECT, LEFT or RIGHT TOGGLE button to see the Trend Graph.

Note the difference between the two Antenna Symbols below:

This Antenna Symbol shows that the Transmitter

and Receiver are talking.

This Out of Range Symbol shows the

Transmitter and Receiver are not talking. If you see the Out of Range Symbol in the

upper right corner of the screen, then review the following troubleshooting tips.

•

Is the Receiver within 20 feet (6 meters) of your Sensor/Transmitter? If the Receiver is not close enough, then move it within 20 feet (6 meters) of the Sensor/Transmitter. Check in 5-10 minutes to see if the Antenna Symbol appears and the Out of Range symbol

•

If the Receiver and Sensor/Transmitter are still not talking, then check to make

disappears.

sure the correct Transmitter ID Number is entered into your Receiver (see Chapter 2, Section 2.4).

•

If the correct Transmitter ID has been entered into your Receiver and the Receiver and Transmitter are still not talking, then contact DexCom.

HELPFUL HIN TS:

The Transmitter and Receiver may lose communication at the following times:

• When they are near metallic objects.

• While you are lying on a water bed.

• When you are using an electric blanket.

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3.9 SENSOR STARTUP PERIOD

The Sensor needs a 1-hour Startup period. This is so the Sensor can get used to its new insertion site. During the Startup period, check every so often to make sure the Antenna Symbol make sure your Receiver battery is fully charged.

When you press the Startup period to turn the Receiver display on, your Trend Graph will include a 1-hour Countdown Symbol

Over time, the Countdown Symbol indicate that you are getting closer to initial calibration time. See the pictures below for an example of what this looks like.

in the upper right hand corner.

SELECT button during the

is in the upper left corner of the Trend Graph. Also

will ﬁ ll to

[0-12] [12-24] [36-48]

Start

At the end of the 1-hour Startup period the Receiver will let you know that it is time to calibrate your Sensor. Chapter 4 tells you how to calibrate your Sensor.

[24-36]

Ready for calibration

3.10 THE G4-GLOBAL SYSTEM AND WATER

Your Sensor (including the installed Transmitter) is water resistant when showering, bathing, or swimming. The Sensor has been tested to be water resistant when submerged for up to 3 feet (0.9 meters) for a maximum of 30 minutes. For added protection you can use a shower cover. The Receiver is not water resistant. Do not get your Receiver wet at any time.

3.11 TAPING THE SENSOR POD

The Sensor Pod should stay securely attached using its own adhesive. But, if the patch is peeling up, you can use medical tape (such as Blenderm support. If you use tape, only tape over the white adhesive patch on all sides for even support. Do not tape over the Transmitter or any of the plastic parts of the Sensor Pod. Do not tape under the Sensor Pod or leave any substance on the skin where you insert the Needle.

44 | Continuous Glucose Monitoring System

) for extra

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CALIBRATING YOUR G4-GLOBAL SYSTEM

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The G4-Global System requires you to “calibrate” the Sensor glucose readings to your blood glucose meter. The purpose of calibration is to convert the measurement of glucose by the Sensor into a reading similar to the one provided by your meter.

CONTRAINDICATION: Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device.

4.1 CALIBRATION OVERVIEW

When calibrating, you need to manually enter your ﬁ ngerstick readings into the Receiver. You can use any FDA-cleared blood glucose meter.

You will need to perform three types of calibration on your Receiver:

1. Startup Calibration 2. Calibration Update 3. Re-calibration Startup Calibration happens at the end of the 1-hour Startup Period and takes 2

ﬁ ngerstick readings. Calibration Update is a calibration that must be performed every 12 hours (about 1 ﬁ ngerstick reading, 2 times per day). The Receiver will remind you when these calibrations are needed. Re-calibration may be required if one of the ﬁ ngerstick readings entered for Startup Calibration or Calibration Update is not accepted by the Receiver.

The sections in this Chapter tell you how to calibrate your system. The sections also describe Startup Calibration, Calibration Update, and how to Re-calibrate in more detail.

HELPFUL HIN T: Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.) for calibration. You must take your blood glucose readings from your ﬁ ngertips only for calibration.

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4.2 HOW TO CALIBRATE

For Calibration, you must enter the exact ﬁ ngerstick reading from your meter . Readings must be between 40-400 mg/dL and must have been taken within the past 5 minutes. Entering incorrect ﬁ ngerstick readings, or ﬁ ngerstick readings that occurred more than 5 minutes ago, will affect device performance.

The steps below show you how to enter your ﬁ ngerstick readings for calibration:

1. Take a ﬁ ngerstick reading using your meter.

2. From any Trend Graph, press the

3. Use the until you highlight “Enter BG.”

NOTE: “Enter BG” will be the second Main Menu option when you are not in the middle of a Sensor session.

TOP or BOTTOM TOGGLE button to scroll

SELECT button to display the Main Menu.

4. Press the You will see a screen with a blood drop and a number in mg/dL units.

a. During initial calibration the Receiver will

b. If there has been a glucose reading in the past

48 | Continuous Glucose Monitoring System

SELECT button to choose this option.

default to the reading of 120 mg/dL as your starting point.

15 minutes, the Enter BG screen will display your current continuous glucose reading as your starting point. Do not use the continuous glucose reading for calibration. Use only ﬁ ngerstick readings from your meter.

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5. To enter the ﬁ ngerstick reading taken from your meter, press the TOP or

BOTTOM TOGGLE button until you ﬁ nd the correct reading and then press

the SELECT button.

a. Pressing the

1 mg/dL. To scroll faster, hold down the

TOP or BOTTOM TOGGLE button lets you scroll by

TOP or BOTTOM TOGGLE button.

6. Conﬁ rm that the ﬁ ngerstick reading you entered is correct.

a. If the ﬁ ngerstick reading displayed is correct,

press the “OK” and then press the

LEFT TOGGLE button to highlight

SELECT button.

b. If the ﬁ ngerstick reading displayed is incorrect,

press the

SELECT button (with “Cancel”

highlighted) to return to the Enter BG screen. Repeat the steps for re-entering the correct reading.

c. If you do not press any button, the Receiver will “time out” and no

ﬁ ngerstick reading will be entered.

7. The Enter BG Processing screen will appear to let you know the ﬁ ngerstick reading is being processed for calibration.

8. For Startup Calibration, repeat these steps for the second ﬁ ngerstick reading.

9. A glucose reading will appear on the Receiver right away, and glucose

readings will be updated every 5 minutes.

10. If readings do not appear immediately, see Chapter 9, Section 9.2.

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HELPFUL HIN TS:

• Make sure a glucose reading is displayed at the top of the Trend Graph, or a Blood Drop Symbol Graph, before calibration.

• Only ﬁ ngerstick readings between 40-400 mg/dL can be used for calibration. If 1 or more of your readings entered was outside of this range, the Receiver will not calibrate. You will have to wait to until your blood glucose is in this range to calibrate.

• Always make sure the Antenna Symbol corner of the Trend Graph before you enter ﬁ ngerstick readings for calibration.

• You should always use the same meter you routinely use to measure your blood glucose to calibrate. Do not switch your meter in the middle of Sensor session.

4.3 STARTUP CALIBRATION

One (1) hour after you start the Sensor session (see Chapter 3, Section 3.7) the Receiver will tell you that you need to calibrate. The Receiver will show the Double Blood Drop Prompt. If your Alerts are set to the factory default settings, the Receiver will also vibrate and beep to tell you it is ready for calibration.

1. You can also set your Receiver to vibrate only (see Chapter 8, Section 8.5).

2. When you see this screen, press any Receiver button to clear the display.

3. Take 2 ﬁ ngerstick readings with your meter and enter them into the Receiver (see Section 4.2).

is displayed in the top right corner of the Trend

is displayed in the upper left

Double Blood Drop Prompt

NOTE: Your ﬁ ngerstick readings must be between 40 mg/dL and 400

mg/dL for calibration. The Receiver cannot use ﬁ ngerstick readings outside of this range for calibration.

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HELPFUL HIN TS:

• If your readings are less than 40 mg/dL or greater than 400 mg/dL, you should determine if you should treat yourself ﬁ rst, and then calibrate when it is convenient for you.

• If you choose to clear the Double Blood Drop Prompt and calibrate later, the Blood Drop Symbol the Trend Graph.

• Once you clear the Double Blood Drop Prompt, it will reappear every 15 minutes until you successfully calibrate.

• Always make sure the Antenna Symbol corner before you calibrate.

will appear in the top right corner of

is visible in the upper left

4.4 CALIBRATION UPDATE

Calibration Update is required every 12 hours to make sure your Sensor readings remain accurate and are close to your blood glucose meter readings. You can enter any ﬁ ngerstick readings you take during a Sensor session. If you have not entered any ﬁ ngerstick readings in the past 12 hours, the Receiver will ask you for a ﬁ ngerstick reading to update its calibration. The steps below show you how to enter this calibration.

You must update G4-Global System calibration every 12 hours at a minimum. The performance of the System when calibrated less frequently than every 12 hours has not been studied.

You must enter the exact ﬁ ngerstick reading that your blood glucose meter displays. Enter all ﬁ ngerstick readings for calibration within 5 minutes. Entering incorrect ﬁ ngerstick readings, or ﬁ ngerstick readings that occurred more than 5 minutes ago, will affect device performance.

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1. If you see the Single Blood Drop Prompt shown to the right, clear this display by pressing any Receiver button. The Single Blood Drop Prompt will not go away until you press a button.

Single Blood Drop Prompt

2. Take a ﬁ ngerstick reading at this time. Enter this reading in the Receiver to update calibration.

3. This screen will appear every 15 minutes until you enter a new ﬁ ngerstick reading that is accepted for calibration.

4. If this screen reappears shortly after you have entered a new ﬁ ngerstick reading, review Chapter 5, Section 5.4.

4.5 RE-CALIBRATION

When you enter a ﬁ ngerstick reading for 12-Hour Update Calibration (Section 4.3), the System checks how well it is functioning compared to the blood glucose meter. During each Calibration Update attempt, the System may tell you that another ﬁ ngerstick reading is needed. This Re-calibration can also be prompted during Startup Calibration. The Single Blood Drop Prompt will appear (shown to the right).

You can clear this Screen by pressing any Receiver button. The display will return to the Trend Graph. A Blood Drop Symbol the Trend Graph screen.

This Blood Drop Symbol needs at least one more ﬁ ngerstick reading. You will not see glucose readings or trends, or get Alerts/Low Glucose ALARM when the Blood Drop Symbol still displayed.

will appear on the top right of

tells you that the System

Single Blood Drop Prompt

No glucose data

Awaiting Fingerstick

Reading (Blood Drop)

Symbol

52 | Continuous Glucose Monitoring System

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You should take another ﬁ ngerstick reading and enter it into the Receiver.

1. Your System should calibrate immediately.

2. After successful Re-calibration the System will display glucose readings, trends and provide Alerts/Low Glucose ALARM again.

HELPFUL HINT: Refer to Section 8.4, “Error Code Troubleshooting,” if you see the “15 Minute Calibration Error Screen” or the “1 Hour Calibration Error Screen” on your Receiver during calibration.

15 Minute Calibration

Error screen

1 Hour Calibration

Error screen

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54 | Continuous Glucose Monitoring System

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hapter

ﬁ

TREN

CONTINUOUS GLUCOSE READINGS,

TRENDS, ALERTS AND ALARM

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This chapter will teach you how to view your G4-Global System continuous glucose readings and trend information. Once you have successfully calibrated, the G4-Global Receiver will display your glucose readings every 5 minutes. This will tell you how your glucose levels are changing.

You must update G4-Global System calibration every 12 hours at a minimum. The performance of the System when calibrated less frequently than every 12 hours has not been studied. Use of acetaminophen-containing medications while the Sensor is inserted may affect the performance of the device.

Your blood glucose meter only gives your blood glucose level at one point in time (like a still picture). However, the G4-Global System Trend Graphs and Trend (Rate of Change) Arrows will help you understand the direction your glucose level is moving (like a video camera).

The G4-Global Sensor sits in the ﬂ uid under your skin, not in your blood. The Sensor calculates a glucose reading from this ﬂ uid when you calibrate your System. So, the glucose reading you see on your Receiver may be about 5-10 minutes behind the ﬁ ngerstick reading you get from your meter . If your meter reading is above 80 mg/dL, the G4-Global System readings can be 10 – 20% different from your meter readings. If your meter reading is below 80 mg/dL, the G4-Global System readings can be up to 20 mg/dL different from your meter readings.

It is important that you focus on the trends and rate of change on your Receiver, rather than the exact glucose reading. The Trend Graphs and Arrows will help you determine how fast your glucose level is rising or falling. Chapter 1 1, Section 1 1.2 tells you how closely your G4-Global System readings will be to a laboratory analyzer in the doctor’s ofﬁ ce.

Glucose Alerts and the Low Glucose ALARM are designed to help you stay within your target glucose zones. Your Low and High Glucose Alerts, and Rise and Fall (Rate of Change) Alerts can tell you when you fall outside of your target glucose range. Your Alerts are personal tools that you can set (see Chapter 2, Section 2.5), and are determined by you and your Diabetes Management Team. Your Low Glucose ALARM can tell you when your glucose levels may be reaching potentially dangerous low levels.

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The G4-Global System also lets you enter information about your meals, insulin, exercise, and health. That way you and your Diabetes Management Team can view a bigger picture of your diabetes management plan. Your Diabetes Management Team can transfer this information to the DexCom Studio Accessory Software to see how you are doing over a long period of time.

Treatment decisions should not be based solely on results from the G4-Global System. You must conﬁ rm System readings with a ﬁ ngerstick reading on a blood glucose meter before making therapeutic adjustments.

You must update G4-Global System calibration every 12 hours at a minimum. The performance of the System when calibrated less frequently than every 12 hours has not been studied.

5.1 GLUCOSE READINGS

Press any button on the Receiver to display the 3-Hour Trend Graph. This is the default screen whenever you turn your Receiver on. The following information will appear:

Most recent 5-minute

glucose reading

Time

Trend Arrow

High Glucose Alert Setting

Low Glucose Alert Setting

Trend Graph Hours

EXAMPLE: 3-Hour Trend Graph Screen

58 | Continuous Glucose Monitoring System

Plot of most recent glucose reading

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•

The G4-Global System reports glucose readings from 40-400 mg/dL and updates glucose readings every 5 minutes.

The glucose reading

is in milligrams per

deciliter (mg/dL) units.

The Receiver displays “LOW” when the most recent glucose reading is less than 40 mg/dL, and “HIGH” when the most recent glucose reading is greater than 400 mg/dL.

“Low”

Less than 40 mg/dL

•

Each “dot” on the Trend Graph is a glucose reading.

•

Every Trend Graph shows the current time.

•

The gray zone on the Trend Graphs indicates the area in between the High

Greater than 400 mg/dL

“High”

Alert and Low Alert settings (see Chapter 2, Section 2.5 to change these settings).

You can see Trend Graphs of your glucose information from the past 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour periods by pressing the

TOGGLE

button on your Receiver. Trend Graphs show you where your glucose

TOP or BOTTOM

levels have been and where your glucose levels are headed.

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(Scroll up from the 3-Hour Graph to reach the 1-Hour Graph)

1-Hour Trend Graph: The 1-Hour (1 Hr) Trend Graph shows your current glucose reading and the last 1 hour of glucose readings.

3-Hour Trend Graph: The 3-Hour (3 Hr) Trend Graph shows your current glucose reading and the last 3 hours of glucose readings (this is your default Trend Graph screen).

(Scroll down from the 3-Hour Graph to reach the 6-Hour Graph)

6-Hour Trend Graph: The 6-Hour (6 Hr) Trend Graph shows your current glucose reading and the last 6 hours of glucose readings.

(Scroll down from the 6-Hour Graph to reach the 12-Hour Graph)

12-Hour Trend Graph: The 12-Hour (12 Hr) Trend Graph shows your current glucose reading and the last 12 hours of glucose readings.

(Scroll down from the 12-Hour Graph to reach the 24-Hour Graph)

24-Hour Trend Graph: The 24-Hour (24 Hr) Trend Graph shows your current glucose reading and the last 24 hours of glucose readings.

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5.2 GLUCOSE TRENDS

In addition to your current glucose reading and Trend Graphs, Trend (Rate of Change) Arrows may appear to show you how your glucose readings are changing.

The Trend Arrows appear to the right of your current glucose reading.

Trend Arrows appear

here

This table shows the different Trend Arrows your Receiver will display:

Constant: Your glucose is steady (not increasing/decreasing more than 1 mg/dL each minute)

Slowly rising: Your glucose is rising 1-2 mg/dL each minute

Rising: Your glucose is rising 2-3 mg/dL each minute

Rapidly rising: Your glucose is rising more than 3 mg/dL each minute

Slowly falling: Your glucose is falling 1- 2 mg/dL each minute

Falling: Your glucose is falling 2-3 mg/dL each minute

Rapidly falling: Your glucose is falling more than 3 mg/dL each minute

no arrow

No Rate of Change Information: The Receiver cannot always

calculate how fast your glucose is rising or falling

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HELPFUL HIN TS:

• Trend Arrows do not appear when there is Missing Glucose Information (see Section 5.4). If the

Symbol, the Wait Symbol , the Out

of Range Symbol

appears in the upper right corner, the Trend

Arrows will not appear .

• If the Trend Arrow is missing, but you are concerned that your blood glucose level may be rising or falling, take a ﬁ ngerstick test on your blood glucose meter to check your readings.

5.3 GLUCOSE ALERTS AND LOW GL UC OSE ALARM

The G4-Global System lets you create your own personal settings for how you want the Receiver to tell you what is going on. The Low and High Glucose Alerts will tell you when you fall outside of your target glucose range. Rise and Fall (Rate of Change) Alerts let you know when your glucose levels are changing fast (see Chapter 8, Section 8.4). The G4-Global System also features a non-adjustable Low Glucose ALARM that will tell you when your glucose levels may be reaching potentially dangerous low levels. In addition to the Alert screens that appear on your Receiver display , you can also set High and Low Glucose Alerts to notify you with vibrations and beeps. This feature can be helpful during times when you are not able to test your blood glucose on your meter (such as sleeping, driving, exercise, or long meetings).

, or the Blood Drop Symbol

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5.3.1 HIGH GLUCOSE ALERT

When your G4-Global System readings are at or above your High Alert level, the screen shown to the right will appear. You can also set the Receiver to beep and vibrate when this screen appears (see Chapter 2, Section 2.5). The default level is set at 200 mg/dL, but you can adjust this value.

When you set the High Glucose Alert, the level is indicated by the top of the gray zone on the Trend Graphs. (If the Low Glucose Alert is not set, the High Glucose Level is indicated by a horizontal gray line.)

The Receiver will continue to alert you until you press any Receiver button to clear the Alert, or until your glucose readings drop below your High Glucose Alert level. You can choose to have the Receiver re-alert you every 15, 30 minutes or 1, 2, 3, 4, or 5 hours after clearing the Alert, by changing your Snooze settings (see Chapter 8, Section 8.7). Snooze settings for the High Glucose Alert are only available if Advanced features is turned on (see Chapter 8, Section 8.1).

High Glucose Alert set

at 200 mg/dL

High Glucose

Alert Setting

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5.3.2 LOW GLUCOSE ALERT

When your G4-Global System readings are at or below your Low Alert level, the screen shown to the right will appear. You can also set the Receiver to beep and vibrate when this screen appears (see Chapter 2, Section 2.5). The default level is set at 80 mg/dL, but you can adjust this value.

When you set the Low Glucose Alert, the level is indicated by the bottom of the gray zone on the Trend Graphs. (if the High Glucose Alert is not set, the Low Glucose Level is indicated by a horizontal gray line.)

The Receiver will continue to alert you until you press any Receiver button, or until your glucose readings rise above your Low Glucose Alert level. You can choose to have the Receiver re-alert you every 15, 30 minutes or 1, 2, 3, 4, or 5 hours after clearing the Alert, by changing your Snooze settings (see Chapter 8, Section 8.7). Snooze settings for the Low Glucose Alert are only available if Advanced features is turned on (see Chapter 8, Section 8.1).

Low Glucose Alert set

at 80 mg/dL

Low Glucose

Alert Setting

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5.3.3 LOW GLUCOSE ALARM

The G4-Global System also has an automatic Low Glucose ALARM set at 55 mg/dL. This ALARM is a feature in addition to your personal Low and High glucose Alerts. You cannot change or turn off this ALARM or its Re-ALARM settings.

•

When your glucose reading is at or below 55 mg/dL the Receiver will notify you with 3 ALARMS (each 5 minutes apart) that beep/vibrate as follows:

- 1st ALARM: Vibrate

- 2nd ALARM: Vibrate, then a series of rapid descending tones followed by 3 constant tones. Series is repeated 3 times.

- 3rd ALARM: Vibrate, then a series of rapid descending tones followed by

3 constant tones. Series is repeated 3 times. (louder)

•

The Receiver will vibrate and beep every 5 minutes after the 3rd ALARM if your readings are still at or below 55 mg/dL, until you press any Receiver button to clear it.

•

For Low Glucose ALARMs the Receiver will display the screen to the right.

•

Re-ALARM: The Receiver will automatically notify you again in 30 minutes after you press any Receiver button to clear it, if your glucose readings are still at or below 55 mg/dL.

Low Glucose ALARM

5.3.4 RISE AND FALL GLUCOSE RATE ALERTS

You can activate these Alerts (see Chapter 8, Section

8.4), to have the Receiver tell you if your glucose

readings are rising or falling fast. You can set the Rise Rate (how fast you are going

up) to one of two different Rise Rate levels, or choose to turn this Alert off. Depending on your selection, you will be notiﬁ ed if your glucose level is rising 2 mg/dL or more each minute, or 3 mg/dL or more each minute.

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You can set the Fall Rate (how fast you are going down) to one of two different Fall Rate levels, or choose to turn this feature off. Depending on your selection, you will be notiﬁ ed if your glucose level is falling 2 mg/dL or more each minute, or 3 mg/dL or more each minute.

If your glucose reading rises or falls at or above/below the Alert setting you chose, the Receiver will display an Alert. You can also set the Alert to vibrate or beep (see Chapter 8, Section 8.4). Two examples are shown below:

If you set your Fall Rate to 2 mg/dL per minute and your glucose readings fall at this rate or faster, the FALLING Single Arrow screen will appear and vibrate/beep according to your settings.

Example-Fall Alert

If you set your Rise Rate to 3 mg/dL per minute and your glucose readings rise at this rate or faster, the RISING Double Arrow screen will appear and vibrate/beep according to your settings.

NOTE: To set Rise and Fall Glucose Rate Alerts,

Advanced features must be turned on (see Chapter 8, Section 8.1).

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Example-Rapid Rise Alert

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5.4 GLUCOSE STATUS AREA ON TREND GRAPHS

This device is not designed to replace a blood glucose meter. When there is Missing Glucose Information, rely on ﬁ ngerstick readings from your blood glucose meter.

Symptoms related to low or high blood glucose levels should not be ignored. If you have symptoms of low or high glucose, conﬁ rm them with ﬁ ngerstick readings from your blood glucose meter .

5.4.1 GLUCOSE STATUS AREA SYMBOLS

During your Sensor session the “Status Area” in the upper right hand corner of the Trend Graph may display any of the information below.

A blood drop means your System requires you to enter another ﬁ ngerstick reading. You may need to enter a ﬁ ngerstick reading for your

Calibration

Needed

Glucose Reading

Error

12-hour calibration, or the Receiver might need an additional ﬁ ngerstick reading to improve its calibration. (See Chapter 4, Section 4.2.)

Three question marks mean the Receiver does not understand the Sensor signal. You should wait for more prompts and do not enter any ﬁ ngerstick readings when you see this symbol. (See Section 5.4.3.)

RF Error

An antenna symbol with a line through it and a circle around it, means the Sensor/Transmitter and Receiver are out of range. Make sure the Receiver and Sensor/Transmitter are within 20 feet (6 meters) of each other. (See Section 5.4.4.)

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Means the Sensor cannot calibrate right now. If you see this screen, enter at least 1 more calibration ﬁ ngerstick reading after about

15 Minute

Calibration

Error

1 Hour

Calibration

Error

Wait

5.4.2 MISSING GLUCOSE READINGS

At certain times, a notiﬁ cation symbol may appear in the Status Area of the Trend Graph. These notiﬁ cations are helpful in troubleshooting why glucose readings do not appear on the Receiver. The table in the previous section shows the symbols that might appear in the Status Area.

Missing Glucose Information can happen when:

1. The System needs another ﬁ ngerstick reading for calibration because the Sensor readings do not match the recent ﬁ ngerstick reading you just entered.

2. The Receiver does not understand the Sensor signal.

3. The Sensor/Transmitter and Receiver are out of range. Make sure the Sensor/Transmitter and Receiver are within 20 feet (6 meters) of each other.

For calibration errors see Chapter 8. The following sections will tell you what happens when the Receiver does not understand the Sensor signal, and when your Sensor/Transmitter and Receiver are out of range. If your Receiver is not displaying glucose information, look at the Status Area on the Trend Graph.

10-15 minutes. If the Sensor still cannot calibrate using this additional ﬁ ngerstick reading, the Sensor needs to be replaced. (See Chapter 8, Section 8.4.)

Means the Sensor is not calibrating properly. If you see this screen, wait about one hour and then enter at least 1 more ﬁ ngerstick reading. If no readings display on the Receiver after this additional ﬁ ngerstick, the Sensor needs to be replaced.

The single hourglass means the Receiver has detected a potential problem with the Sensor signal. You should wait about 30 minutes for more prompts. Do not enter any ﬁ ngerstick readings when you see this symbol.

Status Area

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5.4.3 SYSTEM GLUCOSE ERRORS

Sometimes the G4-Global System may tell you that it cannot provide a glucose reading. When this occurs you will see 3 question marks ( Area.

Check the placement of your Sensor to make sure it is still sticking securely to your skin. Also make sure nothing is rubbing the Sensor Pod (i.e. clothing, seat belts, etc.).

Check to see if the Transmitter is snapped in on both sides. This error can happen when the G4-Global System detects problems with the glucose signal or Sensor insertion area. Chapter 9 tells you how often you might expect to see this error. Sometimes the G4-Global System can correct the problem and continue providing glucose readings. However, if it has been 3 hours since your last glucose reading appeared, contact Technical Support.

HELPFUL HIN TS:

• If you see that you wait out this period of time. Do not calibrate your System during this time.

• When you see entering them does not help the System display more glucose readings. Any ﬁ ngerstick readings that you enter during System.

• Wait until you see a Single Blood Drop entering a calibration value into your Receiver.

in the Status Area of the Trend Graph, it is recommended

, taking ﬁ ngerstick readings with your meter and

) in the Status

in the Status Area before

No Glucose Data

will be ignored by the

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5.4.4 OUT OF RANGE/NO ANTENNA

•

When you see the Out of Range Symbol Receiver has “missed” the last glucose reading sent by the Transmitter.

• If you see this Symbol, make sure the Receiver is within 20 feet (6 meters) of the Sensor/Transmitter. If not, move the Receiver closer and wait at least 5 minutes.

•

Once you have moved the Receiver closer and waited 5-10 minutes, the Out of Range Symbol in the Status Area should disappear. The Antenna Symbol and you should receive a glucose reading.

•

If you are still having trouble receiving System readings because of this problem, contact DexCom Technical Support.

HELPFUL HIN TS:

• You can set an Out of Range Alert to notify you when the Receiver and Sensor/Transmitter are not talking (see Chapter 8, Section 8.6). You can also set the amount of time the Transmitter can be out of range before the Receiver alerts you.

• The Sensor/Transmitter and Receiver may lose communication during the following circumstances: while you are lying on a waterbed, while you are near other metallic objects, or when you are using an electric blanket.

should reappear in the upper left corner,

in the Status Area, this means the

No Glucose Data

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5.5 TEMPORARY SENSOR SHUT DOWN

There may be times when you want to temporarily shut down your Receiver. Shutdown will stop all communication between the Transmitter and Receiver, and will turn the Receiver off. You will not receive glucose readings or any Alerts/ Low Glucose ALARMs while the Receiver is shut down, but your current Sensor session will remain in progress. Follow these steps to shut down your Receiver:

1. From the Main Menu, scroll to and highlight “Shutdown”. Press the

2. Conﬁ rm that you want to shutdown your Receiver .

a. If you want to shutdown, press the

TOGGLE

the

b. If you want to cancel the shutdown, press the

SELECT button (with “Cancel” highlighted) to

return to the Main Menu.

3. To turn the Receiver back on and resume communication with the Transmitter, press the back on.

button to highlight “OK” and then press

SELECT button.

SELECT button. It may take up to 20 seconds for the display to turn

SELECT button.

LEFT

HELPFUL HIN TS:

• Remember that your Alerts and Low Glucose ALARM will not work when the Receiver is shut down.

• Your Sensor session will stop 7 days after you start the Sensor session. Shutting down the Receiver does not extend Sensor life beyond 7 days.

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COMPLETING YOUR CONTINUOUS

GLUCOSE MONITORING SESSION

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At the end of your Sensor session (or wear period), you will need to remove the Sensor. Gently peel up the adhesive patch from your skin (this will pull out your Sensor Probe). Then remove the Transmitter from the Sensor and keep it for your next continuous glucose monitoring session (see Section 6.4).

6.1 REMOVING A SENSOR

Your Sensor session will end on time when the Sensor expires (after 7 days). You can also choose to end the session early, or it might end early (less than 7 days) due to a Sensor failure.

Once your Sensor session has ended, glucose readings will no longer be shown on the Receiver. The Trend Graphs will indicate that the Sensor session has ended by displaying a red Stoplight Symbol in the upper right corner.

A Stop Sign indicates

that your Sensor

session has ended

HELPFUL HIN T: Remember to save your Transmitter after each Sensor

removal. The same Transmitter is used for each session until you have reached the end of the Transmitter battery life. The Sensor can be thrown in the trash.

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6.2 AUTOMATIC SENSOR SHUT-OFF

The Receiver will tell you how much time you have remaining until your G4-Global Sensor session is complete. The Sensor Expiration screen will appear at 6 hours, 2 hours and 30 minutes before your 7-day session ends.

You can to set the Receiver to vibrate and/or beep with these displays if you choose (see Chapter 8, Section 8.5). After the 6-hour, 2-hour, and 30-minute reminders, you will still continue to receive glucose readings. You can clear any of these screens by pressing any button on the Receiver. You must remove your Sensor after the ﬁ nal Sensor Expiration screen (00:00:00) appears.

6-hour Sensor Expiration

Notiﬁ cation

30-minute Sensor Expiration

Notiﬁ cation

2-hour Sensor Expiration

Notiﬁ cation

Sensor Expiration Notiﬁ cation

End of session

Once the Replace Sensor Now screen appears, press any button on the Receiver to clear this notiﬁ cation.

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6.3 EARLY SENSOR SHUT-OFF

In some cases your Sensor session may end before you have completed a full 7-day period. You should review Chapter 11, Section 11.2 in this User’s Guide to determine how often you should expect this to happen. Examples of why this may occur are described below.

6.3.1 EARLY SHUT-OFF – SENSOR F AILURE

During a session the Receiver may detect a series of issues with your Sensor signal where it can no longer determine your glucose reading (see Chapter 9, Section 9.3). At this time the CGM session will end and show the screen to the right.

If you see this screen then your continuous glucose monitoring session has ended. Press any button on the Receiver to clear this screen.

Sensor Failed Screen

6.3.2 MANUAL SENSOR SHUT-OFF – “STOP SENSOR”

To manually end your Sensor session, select “Stop Sensor” from the Main Menu. This option will only appear if you are in the middle of an active Sensor session (you have already started a Sensor session and the Sensor has not expired or failed). See Chapter 6, and Chapter 9, Section 9.3.

With “OK” highlighted, press the conﬁ rm that you want to stop the Sensor session.

SELECT button to

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The Stop Sensor processing screen will appear to let you know the Sensor session is stopping. Once the session has stopped, a Red Stoplight Symbol will appear in the upper right corner of the Trend Graph.

HELPFUL HIN TS:

• If you removed your Sensor before stopping the Sensor session on the Receiver, the Sensor Failed screen will appear automatically. You must press SELECT before inserting a new Sensor. Look closely at the Sensor to make sure it is not damaged.

• You cannot reverse the decision to stop a Sensor session after pressing the SELECT button. Press the LEFT TOGGLE button to return to the Main Menu if you do not want to stop the Sensor session.

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6.4 TRANSMITTER REMOV AL

When you are ready to remove the Sensor, make sure to pull out the Sensor Pod with the Transmitter still inside. Once the Sensor Pod is off your body, you will need to remove the Transmitter. T o do this you can use either of the two methods below:

Method 1

The Safety Lock/Transmitter Key once removed from the Applicator (see Chapter 3, Section 3.5) can be used as a tool to remove the Transmitter.

1. Place the Sensor Pod on a table.

2. Hold the rounded edge of the Transmitter Key.

3. Make sure the jagged edge of the Transmitter Key is facing down (the direction away from the removal arrow) as shown below:

Transmitter Key (from Applicator)

Sensor Pod with Transmitter Key snapped in

4. Insert the jagged edges so that they “hug” the Transmitter wings in the Sensor Pod. Press the Transmitter Key down until you cannot press down anymore, and the Transmitter wings will “pop” out of the Sensor Pod.

5. Remove the Transmitter and store it in a cool, dry place until your next glucose monitoring session.

Method 2

If you did not save the Transmitter Key, you can simply use your pointer ﬁ nger on each hand and spread out the tabs at the back of the Sensor Pod (end closest to the wings). The Transmitter wings will “pop” out of the Sensor Pod.

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BASIC SETTINGS

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7.1 THE SETTINGS MENU

7.1.1 GETTING TO THE SETTINGS MENU

1. Press any button to turn on the Receiver. The 3-Hour Trend Graph will

appear.

2. Press the

3. From the Main Menu, press the “Settings” and press the

SELECT button to display the Main Menu.

TOP or BOTTOM TOGGLE button to scroll to

SELECT button. The Settings menu will appear.

7.1.2 SETTING YOUR RECEIVER TIME AND DATE

1. From the Settings menu, press the TOP or

BOTTOM TOGGLE button to scroll to “Time/Date”

and press the

2. Check that the current date and time are correctly set in the Receiver. Press the button to highlight each value in the date and time. Then, press the to make any adjustments and then press the

RIGHT TOGGLE button to move to the next value.

After choosing AM or PM, press the button. You will return to the Settings menu.

SELECT button.

RIGHT TOGGLE

TOP or BOTTOM TOGGLE button

SELECT

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HELPFUL HINTS:

• The date in the Receiver is set at the factory to Paciﬁ c Standard Time (PST).

• Make sure to set the correct date and time on your Receiver.

• When setting values for the time or date, press and hold the TOP

BOTTOM TOGGLE button to scroll through the ﬁ elds more quickly.

• You might need to reset the Receiver’s time and date if the rechargeable battery is drained. If this happens, the Time Loss Alert will automatically take you to the Time/Date Setting Screen.

7.1.3 ENTERING YOUR TRANSMITTER ID

Any time you switch to a new Transmitter and/or Receiver (as a replacement to the Transmitter and Receiver that came in your kit) you must enter the T ransmitter ID into your Receiver. The Transmitter ID is a series of 2 letters and 5 numbers on the back of the Transmitter. Entering the ID will begin the unique wireless radio frequency (RF) communication between the Transmitter and Receiver.

NOTE: You can only set your Transmitter ID when you are not in a Sensor session. During a Sensor session, “Transmitter ID” will not appear as an option on the Settings menu.

T o enter the Transmitter ID, perform the following steps:

1. From the Settings menu, press the

BOTTOM TOGGLE button to scroll to “Transmitter

ID” and press the

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SELECT button.

TOP or

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2. Starting with the ﬁ rst number (do not enter the ﬁ rst 2 letters), press the

TOP or BOTTOM TOGGLE

button to make any adjustment and then press the

RIGHT TOGGLE button to move to the next value.

After entering the 5th number, press the

SELECT

button. You will return to the Settings menu.

Your Transmitter ID can be found in any of the following locations:

- On the Transmitter card located inside your G4-Global System Kit

- On the outside of the Transmitter box label

- Engraved on the back of the Transmitter itself If you have difﬁ culty locating your Transmitter ID, please contact DexCom

Technical Support.

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7.1.4 CHECKING INFORMA TION ABOUT YOUR RECEIVER

At any time you can check your Receiver for information about your G4-Global System.

1. From the Settings menu, press the

BOTTOM TOGGLE button to scroll to “Device Info”

and press the

2. Information about your Sensor session and System will appear. Scroll down

to see all the information. Press the Settings menu.

Device Info:

• Insertion Time • Part Number

• Last Calibration • Part Revision

• T ransmitter Battery • Software Version

• Transmitter ID • Software Revision

SELECT button.

TOP or

LEFT TOGGLE button to return to the

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7.2 SETTING YOUR ALERTS

7.2.1 FACTORY ALERT SETTINGS

The G4-Global System is shipped from the factory with the following “default” settings for Alerts. (See the table below.)

Screen Alert Type Default

Setting

High Alert On-

200 mg/dL

Low Alert On-

80 mg/dL

Rise Alert Off Disabled (None) None

Default Prompt Vibrate/Beep

Vibe then Beep (vibrate ﬁ rst, then 2 high beeps and vibrate)

Vibe then Beep (vibrate ﬁ rst, then 3 low beeps and vibrate)

Default Re-alert Setting

None (no Re-alerts after pressing any Receiver button to clear)

(no Re-alerts after pressing any Receiver button to clear)

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Screen Alert Type Default

Setting

Fall Alert Off Disabled (None) None

Other Alerts (See Chapter 11, Appendix 1 for a detailed list of all “Other Alerts.”)

Out of Range Alert

On Vibe then Beep

Off Disabled (None) Continues to

Default Prompt Vibrate/Beep

(vibrate ﬁ rst, then medium beep tone)

Default Re-alert Setting

(no Re-alerts after pressing any Receiver button to clear)

Depends on the Alert Type (See Chapter 12, Appendix 1)

Re-alert you until you come back into range.

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7.2.2 GETTING TO THE ALERTS MENU

1. Press the SELECT button to turn on the Receiver. The 3-Hour Trend Graph will appear.

2. Press the

3. From the Main Menu, press the

“Alerts” and press the

SELECT button to display the Main Menu.

TOP or BOTTOM TOGGLE button to scroll to

SELECT button. The Alerts menu will appear.

7.2.3 SETTING GLUCOSE ALERTS

The High Alert, Low Alert, Rise Rate Alert, and Fall Rate Alert (see Chapter 5) provide information about your glucose levels and trends. The following will show you how to change the High Alert, Low Alert, Rise Rate Alert, and Fall Rate Alert settings.

NOTE: To receive Rise Rate and Fall Rate Alerts, Advanced Features must be turned on (see Chapter 8, Section 8.1).

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High and Low Glucose Alerts

NOTE: The options for setting both a High Alert and a Low Alert are the

same.

The following steps will show you how to change your High Alert Settings.

1. From the Alerts menu, press the

TOGGLE

Alert” and press the

2. On the High Alert menu (example), press the

or The High Alert is currently set to “On”. If you do not want to receive this type of Alert press the

SELECT button to choose “Off”.

3. Next, on the High Alert menu (example), press

the “Type” and press the choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option, and press the button.

- V ibrate Then Beep (vibrate, then a vibrate and a

beep every 5 minutes)

° High Alert Beep (a series of tones in ascending order, followed by a few

° Low Alert Beep (a series of tones in descending order, followed by a few

- Vibrate Only (vibrate every 5 minutes)

NOTE: Alerts can be acknowledged by pressing any button on the Receiver.

button to select “High Alert” or “Low

SELECT button.

BOTTOM TOGGLE button to choose “On/Off”.

TOP or BOTTOM TOGGLE button to choose

SELECT button. Then,

steady high tones)

steady low tones)

TOP or BOTTOM

TOP

Example-High Alert menu

SELECT

Example-High Alert

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4. Next, on the High Alert menu (example), press the

TOP or BOTTOM TOGGLE button to choose

“Level” and press the SELECT button. Press the

TOP or BOTTOM TOGGLE button to enter

your Alert value (120 to 400 mg/dL in 10 mg/dL increments for a High Alert and 60 to 100 mg/dL in 5 mg/dL increments for a Low Alert). The starting value that ﬁ rst appears on this screen is

Example-High Alert

the default value of 200 mg/dL (High Alert) and 80 mg/dL (Low Alert), or the values you set in the Setup Wizard.

You have the option to set a snooze time to re-alert you (see Chapter 8, Section 8.7).

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Rise and Fall Rate Alerts

NOTE:

• The options for setting both a Rise Rate Alert and a Fall Rate Alert are the same.

• To use the Rise and Fall Rate Alerts feature, Advanced Features must be turned on. (See Chapter 8, Section 8.1.)

The following steps will show you how to change your Fall Rate Alert settings.

1. From the Alerts menu, press the “Rise Rate” or “Fall Rate” and press the

2. On the Fall Rate menu (example) , press the

BOTTOM TOGGLE button to choose “On/Off”.

Then, press the you do not want to receive this type of Rate Alert press the

3. Next, on the Fall Rate menu (example), press the

TOP or BOTTOM TOGGLE button to choose

“Type” and press the choose “Vibrate Then Beep” or “Vibrate Only” as your alert delivery option and press the button.

- V ibrate Then Beep (vibrate, then a vibrate and a beep every 5 minutes)

° Rise Rate Beep (a series of rapid ascending tones, repeated 3 times) ° Fall Rate Beep (a series of rapid descending tones, repeated 3 times)

- Vibrate Only (vibrate every 5 minutes)

SELECT button to select “On”. If

SELECT button to choose “Off”.

SELECT button. Then,

TOP or BOTTOM TOGGLE button to select

SELECT button.

TOP

Example-Fall Rate menu

SELECT

Example-Fall Rate

NOTE: Alerts can be acknowledged by pressing any button on the Receiver.

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4. Next, on the Fall Rate menu (example), press the

TOP or BOTTOM TOGGLE button to choose

“Level” and press the SELECT button. Then, choose whether the alerts should be delivered when your glucose levels are falling either “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.

When ﬁ nished, press the

LEFT TOGGLE button to return to the Alerts menu.

Example-Fall Rate

NOTE: When you choose “2 mg/dL/min” for your Rise or Fall Rate Alert,

one arrow will appear on the screen when you receive an Alert. Two arrows (meaning Rapid) will appear when you select “3 mg/dL/min” for your Rise or Fall Rate Alert.

Example-Fall Rate Alert

Example-Rapid Rise Alert

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ADVANCED FEATURES

BEYOND THE BASICS

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Advanced features allows you to do the following:

• Enter events related to your carbohydrate consumption, insulin usage, exercise and overall health. Event information can be downloaded to a PC along with your glucose readings and viewed using the DexCom Studio

Accessory Software.

• Expand and customize the Alerts feature so that the Receiver can:

- notify you when and how fast your glucose levels are rising or falling

- deliver other Alerts according to your preference

- notify you when your Sensor/Transmitter and Receiver are out of range

8.1 ACTIVATING ADVANCED FEATURES

T o use the Receiver’s Advanced features, the Advanced features setting must be turned on.

1. From the Main Menu, press the

to “Settings” and press the press the

SELECT button.

2. On the “Advanced” screen, press the

TOP or BOTTOM TOGGLE button to scroll

SELECT button. Next, scroll to “Advanced” and

SELECT

button to turn Advanced features On (or Off). Press the

LEFT TOGGLE button to return to the

Settings screen.

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8.2 DIABETES EVENTS

With the G4-Global System you can enter meal, insulin, physical activity, and health information. This information can help you and your Diabetes Management Team review your glucose trends and patterns and may help you make better decisions about your diabetes management plan. These events can be downloaded to a PC along with your glucose readings and reviewed later with the DexCom Studio

8.2.1 SEL E CTING AN EVENT

When Advanced features is turned on, “Events” will appear as an option on the Main Menu .

Accessory Software.

1. Press the choose “Events” and press the

From the Events menu you can choose “Carbs”, “Insulin”, “Exercise” or “Health”.

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TOP or BOTTOM TOGGLE button to

SELECT button.

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8.2.2 SETTING THE DATE AND TIME FOR AN EVENT

When you enter an event you will be prompted to check that the date and time for that event are correct. The default date and time for events you enter is the current date and time stored in the Receiver.

1. To change the date and time for an event, press the

RIGHT TOGGLE button to highlight each

value in the date and time. Then, press the

TOP or BOTTOM TOGGLE button to make any

adjustments and then press the button to move to the next value. After choosing AM or PM, press the advance to the Event conﬁ rmation screen.

NOTE: 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.

SELECT button. You will

RIGHT TOGGLE

8.2.3 CARBOHYDRAT ES

The Carbs Event lets you enter the amount of carbohydrates you have consumed, up to 250 grams for any particular date and time.

1. Press the choose “Carbs” and press the

2. Press the

enter your carb amount (0-250 grams), and press the on this screen will be the last number you entered or the default amount of 50 grams.

TOP or BOTTOM TOGGLE button to

SELECT button.

TOP or BOTTOM TOGGLE button to

SELECT button. The number that ﬁ rst appears

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4. Check that the date and time for this entry are correct.

5. Conﬁ rm the entry. Press the

TOGGLE button to choose either “OK” to conﬁ rm

this entry or “Cancel” to discard this entry, and press the Events menu.

SELECT button. You will return to the

LEFT or RIGHT

8.2.4 INSULIN

The Insulin Event lets you enter the amount of insulin you have taken, up to 250 units for any particular date and time. Y ou can only enter an insulin amount, not the type of insulin taken.

1. Press the

choose “Insulin” and press the

2. Press the enter your insulin amount (0-250 units), and press the on this screen will be the last number you entered or the default amount of 10 units.

TOP or BOTTOM TOGGLE button to

SELECT button.

TOP or BOTTOM TOGGLE button to

SELECT button. The number that ﬁ rst appears

3. Check that the date and time for this entry are correct.

4. Conﬁ rm the entry. Press the

TOGGLE button to choose either “OK” to conﬁ rm

this entry or “Cancel” to discard this entry, and press the Events menu.

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SELECT button. You will return to the

LEFT or RIGHT