Dexcom G5 mobile User Manual

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User Guide
CONTINUOUS GLUCOSE
MONITORING SYSTEM
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IMPORTANT CONTACTS AND NUMBERS
Dexcom Website: dexcom.com
Transmitter Serial Number (SN): ___________________________________________
Receiver SN: _________________________________________________________
Nearest Hospital: ______________________________________________________
Your Local Dexcom Representative: ________________________________________
Other Notes: _________________________________________________________
___________________________________________________________________
___________________________________________________________________
IMPORTANT USER INFORMATION
Failure to use the Dexcom G5 Mobile CGM System and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from your Dexcom G5 Mobile CGM System do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.
Please review the product instructions before using the Dexcom G5 Mobile CGM System. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Dexcom G5 Mobile CGM System. Discuss with your healthcare professional how you should use the information displayed on the Dexcom G5 Mobile System to help manage your diabetes. The product instructions contain important information on troubleshooting the Dexcom G5 Mobile CGM System and on the performance characteristics of the system.
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Dexcom G5 Mobile System User Guide
Table of Contents
Part 1: Getting Started
Chapter 1 - Beginning Your Dexcom G5™ Mobile Continuous Glucose Monitoring (CGM) System Journey 5
1.1 Introduction ............................... 5
1.2 Self-Paced Resources .................... 6
Chapter 2 - Indications for Use and Safety Statement 9
2.1 Introduction ...............................9
2.2 Important User Information ............... 9
2.3 Overview of Safety Statements ..........10
Part 2: Let Us G5™! The Basics
Chapter 3 - What Is the Dexcom G5 Mobile CGM System? 21
3.1 System Description ......................21
3.2 The Dexcom G5 Mobile CGM System ...21
3.3 What is New to the Dexcom G5 Mobile
CGM System? ............................23
3.4 System Information ......................24
3.5 System Components .....................24
3.6 Smart Device Overview ..................33
Chapter 4 - Set up Your Display Devices 35
4.1 Introduction ..............................35
4.2 Why Different Monitoring Methods? .....35
4.3 Dexcom G5 Mobile App ..................36
4.4 Dexcom G5 Mobile Receiver .............47
Chapter 5 - Starting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session 53
5.1 Overview .................................53
5.2 Prepping for Sensor Insertion ............54
5.3 Choosing Your Insertion Site ............. 57
5.4 Inserting Your Sensor ....................58
5.5 Attaching Your Transmitter ..............62
5.6 Loose Sensor Pod ........................64
5.7 Starting Your Sensor Session ............65
5.8 Receiver
Bluetooth
®
Tips ................69
5.9 Sensor Session Warmup .................72
Chapter 6 - Calibration 75
6.1 Introduction ..............................75
6.2 Calibration Overview .....................76
6.3 When to Calibrate ........................77
6.4 Calibration Prompts ......................78
6.5 Preparing for Calibration .................82
6.6 Ready? Set? Calibrate! ...................82
6.7 Calibration Errors.........................88
Chapter 7 - Ending Your Sensor Session and Transmitter Session 91
7.1 Introduction ..............................91
7.2 Ending Your Sensor Session .............91
7.3 Remove Sensor Pod and Transmitter .. 105
7.4 End of Transmitter Battery ............. 107
Part 3: Next Steps - Getting the Most out of Your Dexcom
®
CGM
Chapter 8 - Home Screen, Rate of Change Arrows, and Errors 115
8.1 Introduction to Home Screens ......... 115
8.2 Overview of Home Screen ............. 115
8.3 Rate of Change Arrows ................ 126
8.4 Error Messages ........................ 127
Chapter 9 - Daily Events Affect Your Glucose Trends and Patterns 133
9.1 Introduction ............................ 133
9.2 What is an Event? ...................... 133
9.3 Entering Events ......................... 142
9.4 Viewing Events ......................... 150
Chapter 10 - Sensor Glucose Alarm and Alerts 153
10.1 Introduction ............................ 153
10.2 What are Alarm and Alerts? ........... 154
Table of Contents
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Dexcom G5 Mobile System User Guide
2Table of Contents
10.3 Reading Alarm and Alerts .............. 155
10.4 App: Alarm/Alert Recommended
Settings ................................. 161
10.5 Receiver: Default Beeps and
Vibrations ............................... 162
10.6 Clearing Alarm/Alerts .................. 166
Chapter 11 - On the Go With G5: Customizing Your Alarm/Alerts 169
11.1 Introduction ............................ 169
11.2 Changing App Alarm and Alerts ....... 170
11.3 Changing Receiver Alarm and Alerts .. 181
Chapter 12 - Using Dexcom G5 Mobile CGM System for Treatment Decisions 189
12.1 Introduction ............................ 189
12.2 Importance of Dexcom G5 Mobile CGM System Information for Treatment
Decisions ............................... 190
12.3 Making Treatment Decisions .......... 192
12.4 Creating Personal Guidelines .......... 203
12.5 Do’s and Do Not’s of CGM Treatment
Decisions ............................... 206
12.6 You Decide! ............................. 207
Part 4: Everything Else G5
Chapter 13 - Warranty: The Fine Print 215
13.1 Introduction ............................ 215
13.2 Receiver Warranty Information ........ 215
13.3 Transmitter Warranty Information ..... 217
Chapter 14 - Taking Care of Your Dexcom G5 Mobile CGM System 219
14.1 Introduction ............................ 219
14.2 Basic Maintenance ..................... 220
14.3 Cleaning and Disinfecting the System . 224
14.4 Storage ................................. 226
14.5 Checking App and Receiver
Information ............................. 227
14.6 System Disposal ....................... 228
Chapter 15 - Technical Information 229
15.1 Device Performance Characteristics .. 229
15.2 Product Specifications ................. 229
Chapter 16 - Troubleshooting 239
16.1 Introduction ............................ 239
16.2 Troubleshooting ........................ 240
Chapter 19 - Package Label Symbols 251
17.1 Symbols on Package Labels ........... 251
Part 5
Glossary 255
Index 259
Page 5
• Beginning Your Dexcom G5 Mobile Journey
• Indications for Use and Safety Statement
GETTING STARTED
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Dexcom G5 Mobile System User Guide
Beginning Your Dexcom G5™ Mobile Continuous Glucose Monitoring (CGM) System Journey
1.1 Introduction
Welcome to the Dexcom G5 Mobile family! We are excited you chose us to partner with you in your journey to manage your diabetes. As
a continuous glucose monitoring (CGM) device, the Dexcom G5 Mobile CGM System allows you to break free from constant fingersticks. But how do you use the Dexcom G5 Mobile CGM System? What are its features? Do you need to avoid anything? Can you dose off of your CGM?
Where do you even begin? This chapter is the first step to answering these and many other questions. After this chapter, you will be able to:
• Describe different training resources
• Locate tutorials about using a real-time CGM in your diabetes management
• Find Dexcom G5 Mobile System’s step-by-step instructions
• Recall how to use the User Guide
We have numerous resources available to help you to get the most out of your Dexcom G5 Mobile CGM System.
First Things First - Learning How to Learn
Knowing about the Dexcom G5 Mobile CGM System is your first step in creating a successful CGM experience. Before using it, learn about it.
You have numerous self-paced resources, helping you get to know the Dexcom G5 Mobile CGM System:
Chapter 1
Getting Started:
Beginning Your Dexcom G5™ Mobile Continuous Glucose Monitoring (CGM) System Journey
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5™ Mobile Continuous Glucose Monitoring (CGM) System Journey
1. Tutorials
2. Quick Start Guide
3. User Guide
No matter which resource you select, make sure you review them prior to using your new CGM system.
1.2 Self-Paced Resources
Tutorials
Along with step-by-step instructions, our tutorials illustrate how real-time CGM can assist in your daily diabetes management. The following is a list of tutorials and how to access them.
First Steps with Your Dexcom CGM
Designed for those who have never used a Dexcom CGM. This tutorial covers what to expect in your first week and includes links to step-by-step videos on how to insert your sensor, calibrations, ending a sensor session, etc.
Next Steps with Your Dexcom CGM
Just finished First Steps or already familiar with how a CGM can benefit you? This tutorial covers looking at trends and introduces some advanced features including our reporting tools.
Offline Tutorials
You do not need to be tied to the Internet to view our instructional tutorials, they are available offline.
Accessing Offline Tutorials:
• USB Card ○ In the receiver package
Paper Based G5 Mobile Resources
Quick Start Guide (QSG)
The DexcomG5 Mobile CGM System Quick Start Guide compliments the tutorials by proving the same step-by-step instructions in a booklet form or within the app.
One of the great things about the QSG is you can use it in conjunction with the videos, taking notes as you go!
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Dexcom G5 Mobile System User Guide
Beginning Your Dexcom G5™ Mobile Continuous Glucose Monitoring (CGM) System Journey
Accessing the QSG:
• Receiver package ○ Booklet
Both the tutorials and the QSG give you brief look at the Dexcom G5 Mobile CGM System. But what if you want more detailed information?
User Guide
Your Dexcom G5 Mobile CGM System reference book! This user guide gives you the most extensive overview of the system detailing features,
important safety information and so much more. The Dexcom G5 Mobile System User Guide is grouped into five separate parts:
Part 1:
Getting Started
1. Learning How to Learn About the Dexcom G5 Mobile CGM System
2. Indications for Use and Safety Statement
Part 2:
Let Us G5! The Basics
1. Introduction to the Dexcom G5 Mobile CGM System
2. Choose and Set Up Your Display Device(s)
3. Initiating a Sensor Session: Inserting the Sensor & Transmitter
4. Calibration
5. End a Sensor Session
Part 3:
Next Steps! Getting the Most out of Your Dexcom G5 Mobile CGM System
Once you are up and running, how you can maximize the Dexcom G5 Mobile CGM System features:
1. Reading Trend Graph Screens and Recognizing Trends
2. Events
3. Alarm and Alerts
4. Sounds for Alarm, Alerts and System Messages
5. How to Access Historical Glucose Trend Reports
6. Treatment Decisions
Part 4:
You Take Care of Your G5, and It Takes Care of You!
Dexcom G5 Mobile CGM System Maintenance:
1. Warranty
2. System Maintenance
3. Technical Information
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Dexcom G5 Mobile System User’s Guide
Beginning Your Dexcom G5™ Mobile Continuous Glucose Monitoring (CGM) System Journey
4. Troubleshooting
5. Package Label Symbols
Part 5
1. Glossary
2. Index
How to Use Your User Guide
All chapters in the DexcomG5 Mobile CGM System User Guide are laid out the same way: The beginning of each chapter lists what you will be able to do after you have finished,
followed by the chapter’s content. At the end, there is a recap of what was covered and what to expect in the next chapter.
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Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
2.1 Introduction
We want the Dexcom G5 Mobile CGM System to be a valuable tool in your diabetes management. Like any system, there are steps to take to get the most out of it. As excited as you are about getting started, did you know if you just took a medication with paracetamol/acetaminophen maybe you should wait? Did you know taking paracetamol/acetaminophen is contraindicated?
In this chapter, you will learn about some key areas that might prevent you from having the best CGM experience, or, if you are not careful, might even harm you or the system. You will even learn what a contraindication is!
2.2 Important User Information
Each part of your system has instructions including indications, contraindications, warnings, precautions, and other important user information. Please review the instructions for each part of the system in this user guide before using any of the Dexcom G5 Mobile CGM System.
This chapter is important to read. It helps you use the Dexcom G5 Mobile CGM System safely and covers:
• What is a Safety Statement? ○ Telling the difference between an indication and a contraindication ○ Explaining why warnings are so important ○ Defining precautions
• Safety Statement Overview
Let us start with definitions, and then review the Safety Statements broken down into the system’s components.
Safety Statement
A Safety Statement is a brief statement of the Dexcom G5 Mobile CGM System’s indications, relevant warnings, precautions, or its contraindications (when to avoid using it). The Safety
Chapter 2
Getting Started:
Indications for Use and Safety Statement
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Dexcom G5 Mobile System User Guide
10Indications for Use and Safety Statement
Statements are meant to keep you and the system safe while using the Dexcom G5 Mobile CGM System:
1) Indications How, for what purposes, and under what circumstances you should use the Dexcom G5
Mobile CGM System. Indications let you know who should use the Dexcom G5 Mobile CGM System and when. Indications are the who, what, and why of the Dexcom G5 Mobile CGM System
2) Contraindications Contraindications let you know when
not
to use the Dexcom G5 Mobile CGM System. If used during these situations, you may hurt yourself or the system, and the risk of use clearly outweighs the benefit.
3) Warning Important hazard information: Describes serious or life threatening circumstances to stay
away from while using the Dexcom G5 Mobile CGM System, their consequences, and how to avoid danger.
4) Precaution
Special steps you need to take while using the Dexcom G5 Mobile CGM System, preventing
minor or moderate injury to either you or the system.
2.3 Overview of Safety Statements
This section provides a review of all of the Safety Statements outlining the type of Safety Statement, an action, a statement of potential harm, and consequences. Here you will learn what indications and contraindications are and what to do to keep you safe and the system in proper working order.
Indications for Use
The Dexcom G5 Mobile Continuous Glucose Monitoring System is a glucose monitoring system indicated for the management of diabetes in persons age 2 years and older. The Dexcom G5 Mobile CGM System is designed to replace fingerstick blood glucose testing for diabetes treatment decisions.
Interpretation of the Dexcom G5 Mobile CGM System results should be based on the glucose trends and several sequential readings over time. The Dexcom G5 Mobile CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
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Indications for Use and Safety Statement
The Dexcom G5 Mobile CGM System is intended for use by patients at home and in healthcare facilities.
Important User Information
Failure to use the Dexcom G5 Mobile CGM System and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in you missing a severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) occurrence and/or making a treatment decision that may result in injury. If your glucose alerts and readings from your Dexcom G5 Mobile CGM System do not match your symptoms or expectations, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions. Seek medical attention when appropriate.
Please review the product instructions before using the Dexcom G5 Mobile CGM System. Indications, contraindications, warnings, precautions, cautions, and other important user information can be found in the product instructions that are included with, or accompany, the Dexcom G5 Mobile CGM System. Discuss with your healthcare professional how you should use the information displayed on the Dexcom G5 Mobile CGM System to help manage your diabetes. The product instructions contain important information on troubleshooting the Dexcom G5 Mobile CGM System and on the performance characteristics of the system.
Contraindications
MRI/CT/ Diathermy
Remove the Dexcom G5 Mobile CGM System sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment.
The Dexcom G5 Mobile CGM System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the components of the Dexcom G5 Mobile CGM System, which may cause it to display inaccurate blood glucose readings or may prevent alerts.
Medications
Taking medications with paracetamol/acetaminophen while wearing the Dexcom G5 Mobile CGM System may inaccurately raise the glucose readings generated by the Dexcom G5 Mobile CGM System. The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person. Do not rely on continuous glucose
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Dexcom G5 Mobile System User Guide
12Indications for Use and Safety Statement
monitoring (CGM) data produced by the Dexcom G5 Mobile CGM System if you have recently taken paracetamol/acetaminophen.
Warnings
Sensor Fractures
Do not ignore sensor fractures. Sensors may fracture or detach from the sensor pod on rare occasions. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have symptoms of infection or inflammation—redness, swelling or pain—at the insertion site. If you experience a broken sensor, please report this to your local Dexcom representative.
Do Not Use Damaged Goods
If the Dexcom G5 Mobile CGM System Receiver or G5 Mobile Transmitter is damaged or cracked, do not use it. This could create an electrical safety hazard causing possible electrical shocks resulting in injury. In addition, a damaged or cracked G5 Mobile Receiver or G5 Mobile Transmitter may cause the Dexcom G5 Mobile CGM System not to function properly.
Choking
Do not allow young children to hold the sensor or transmitter without adult supervision. The sensor and transmitter include small parts that may pose a choking hazard.
The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Review Training Materials
Thoroughly review the training materials included with your Dexcom G5 Mobile
CGM System before use. Incorrect use of the Dexcom G5 Mobile CGM System could lead you to misunderstand information produced by the system or might affect the system’s performance.
Diabetes Treatment Decisions
If your Dexcom G5 Mobile CGM System does not display a sensor glucose reading or if
you are getting inconsistent readings, use a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions.
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Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Do Not Ignore Low/High Symptoms
Do not ignore symptoms of low or high glucose. If your glucose alerts and readings do
not match your symptoms or expectations, you should obtain a fingerstick blood glucose value from your blood glucose meter to make diabetes treatment decisions or seek immediate medical attention.
Who Should Not Use
The Dexcom G5 Mobile CGM System was not evaluated or approved for the following
persons:
• Pregnant women
• Persons on dialysis
The Dexcom G5 Mobile CGM System’s accuracy has not been tested in people within
these groups and the system’s glucose readings may be inaccurate.
Calibrate on Schedule
Calibrate the Dexcom G5 Mobile CGM System at least once every 12 hours. The Dexcom
G5 Mobile CGM System needs to be calibrated in order to provide accurate readings. Do not use the Dexcom G5 Mobile CGM System for diabetes treatment decisions unless you have followed the prompts from the device and calibrated every 12 hours after the initial calibration.
Placement
Do not insert the sensor component of the Dexcom G5 Mobile CGM System in a site
other than the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17 years). The placement and insertion of the sensor component of the Dexcom G5 Mobile CGM System is not approved for other sites. If placed in other areas, the Dexcom G5 Mobile CGM System may not function properly.
Initial Calibration: Data/Alarm/Alert
Do not expect sensor glucose readings or alarms/alerts from the Dexcom G5 Mobile
CGM System until after the 2-hour startup. The Dexcom G5 Mobile CGM System will NOT provide any sensor glucose readings or alarms/alerts until after the 2-hour startup
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Dexcom G5 Mobile System User Guide
14Indications for Use and Safety Statement
ends AND you complete the startup calibration. Use fingerstick glucose values from your blood glucose meter during the 2-hour startup.
The following warnings may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Sensor Storage
Store the sensor at temperatures between 2° C-25° C for the length of the sensor’s
shelf life. You may store the sensor in the refrigerator if it is within this temperature range. The sensor should not be stored in the freezer.
Storing the sensor improperly might cause the sensor glucose readings to be inaccurate.
Smart Device Settings
Your smart device’s internal settings override any Dexcom G5 Mobile App setting. To receive Alarm or Alerts you must:
• Make sure the notifications for the G5 Mobile App are turned on in the setting’s menu of your smart device
• Check that the G5 Mobile App hasn’t been shut down by your smart device
• In order for the G5 Mobile App to function properly, you must turn on
Bluetooth
®
on
your smart device
• The Do Not Disturb feature on your smart device (if available) must be turned off
• Restart the G5 Mobile App after your smart device is restarted
• Set the volume on your smart device at a level you can hear
• Do not close the G5 Mobile App; always run the app in the background
If the settings on your smart device are incorrect your Dexcom G5 Mobile CGM System
may not function properly.
The Dexcom G5 Mobile CGM System Alarm/Alert vibrations are not any different from
other vibrating apps on your smart device. Medical device apps, like the Dexcom G5 Mobile CGM System App, do not have any special priorities over your smart device’s features. You cannot determine if a vibration is a notification from your Dexcom G5 Mobile CGM System App or another app. The only way to know is to look at the screen.
Missed an Alarm or Alert?
An Alarm or Alert from the Dexcom G5 Mobile CGM System App cannot be heard
through your smart device’s speakers if headphones are plugged in.
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Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
Make sure you unplug your headphones when you are done using them, otherwise you
might not hear an Alarm or Alert from the Dexcom G5 Mobile CGM System.
Precautions
Sensor Package
Do not use the G5 Mobile Sensor if its sterile package has been damaged or opened. Using a non-sterile sensor might cause infection.
Clean and Dry Before Using
Do not open the sensor package until you have washed your hands with soap and water, and let them dry. You may contaminate the insertion site and suffer an infection if you have dirty hands while inserting the sensor.
Do not insert the sensor until you have cleaned the skin near the insertion site with a topical antimicrobial solution, such as isopropyl alcohol, and allowed the skin to dry. Inserting into unclean skin might lead to infection. Do not insert the sensor until the cleaned area is dry so the sensor adhesive will stick better.
Reusable: Do Not Throw Away
Do not discard your transmitter. It is reusable. The same transmitter is used for each session until you have reached the end of the transmitter’s battery life.
The following precaution may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Be Accurate, Be Quick
To calibrate the system, enter the exact blood glucose value displayed on your
blood glucose meter within five minutes of a carefully performed fingerstick glucose measurement.
Do not enter the Dexcom G5 Mobile CGM System’s sensor glucose readings for
calibration. Entering incorrect blood glucose values, blood glucose values obtained more than 5 minutes before entry, or sensor glucose readings might affect sensor performance.
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Dexcom G5 Mobile System User Guide
16Indications for Use and Safety Statement
The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Treatment Decisions
Make diabetes treatment decisions based on the combination of the sensor glucose
reading, trend arrow, trend graph, and/or actionable alerts generated by the Dexcom G5 Mobile CGM System.
Expiration Date
Do not use Dexcom G5 Mobile CGM Sensors that are beyond their expiration date.
Before inserting a sensor, confirm the expiration date listed on the package label in the following format: YYYY-MM-DD.
Do not use sensors that are beyond their expiration date because the sensor glucose
readings might not be accurate.
Sensor Placement
Avoid using the same spot repeatedly for sensor insertion. Rotate your sensor placement
sites, and do not use the same site for two sensor sessions in a row. Using the same site might cause scarring or skin irritation.
Avoid inserting the sensor in areas that are likely to be bumped, pushed or compressed
or areas of skin with scarring, tattoos, or irritation as these are not ideal sites to measure glucose. Insertion in these areas might affect sensor accuracy.
Avoid injecting insulin or placing an insulin pump infusion set within 7.5 cm of the
sensor. The insulin might affect sensor performance.
Use Correct Transmitter, Receiver, and Sensor
Different generations of Dexcom continuous glucose monitoring system transmitters and
receivers are not interchangeable with each other.
The Dexcom G5 Mobile CGM System’s transmitter and receiver are not compatible with
the Dexcom G4® PLATINUM CGM System’s transmitter and receiver. The Dexcom G5 Mobile CGM System will not work if you mix transmitter and receiver components from different generations.
You can use either a Dexcom G4 PLATINUM Sensor or Dexcom G5 Mobile/G4 PLATINUM
Sensor with your Dexcom G5 Mobile CGM System.
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Dexcom G5 Mobile System User Guide
Indications for Use and Safety Statement
The following precautions may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
Communication Range
Avoid separating the transmitter and receiver by more than 6 meters. The transmission
range from the transmitter to the receiver is up to 6 meters without obstruction. Wireless communication does not work well through water so the range is much less if you are in a pool, bathtub, or on a water bed, etc.
Types of obstruction differ and have not been tested. If your transmitter and receiver
are farther than 6 meters apart or are separated by an obstruction, they might not communicate or the communication distance may be shorter.
Setting Alarm/Alert Notifications
When using both a receiver and a smart device with your Dexcom G5 Mobile CGM
System, you must set your settings separately in each. If you set up one device and then use another, you might not get an Alarm or Alert.
Is It On?
If the receiver or smart device is turned off (Shut Down), it will not display sensor data,
information, Alarm or Alerts generated by the Dexcom G5 Mobile CGM System. Make sure the Display Devices are turned on; otherwise you will not get sensor glucose readings or Alarm or Alerts.
Keep Receiver Dry
Keep the USB port cover on the receiver closed whenever the USB cable is not attached.
Do not submerge the receiver in water.
If water gets into the USB port, the receiver could become damaged and stop displaying
readings or providing alerts.
No Alternative Site Testing
Do not use alternative blood glucose site testing (blood from your palm or forearm, etc.)
for calibration. Alternative site blood glucose values may be different than those taken from a fingerstick blood glucose value and may not represent the timeliest blood glucose value. Use a blood glucose value taken only from a fingerstick for calibration. Alternative site blood glucose values might affect the Dexcom G5 Mobile CGM System’s accuracy.
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Dexcom G5 Mobile System User Guide
18Indications for Use and Safety Statement
The following precaution may result in the consequence of missing severe hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that results in injury:
When Not To Calibrate
Do not calibrate if your blood glucose is changing at a significant rate, typically more
than 0.11 mmol/L per minute. Do not calibrate when your receiver screen is showing the rising or falling single arrow or double arrow, which indicates that your blood glucose is rapidly rising or falling. Calibrating during rapid rise or fall of blood glucose may affect sensor accuracy.
Summary
Now You Can:
• Define a Safety Statement ○ Explain the difference between an indication and a contraindication ○ Describe the importance of warnings ○ Describe what a precaution is
• Provide an overview of Safety Statements
What Is Next?
In our next chapter, gives you a high overview of the Dexcom’s G5 Mobile CGM System.
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• Introduction to the Dexcom G5 Mobile CGM System
• Initial Set-Up
• Starting a Sensor Session: Inserting the Sensor & Transmitter
• Calibration
• Ending a Sensor Session
LET US G5! THE BASICS
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Dexcom G5 Mobile System User Guide
What is the Dexcom G5 Mobile CGM System?
3.1 System Description
Now it is time to get an overview of the Dexcom’s G5 Mobile CGM System. After this chapter, you will be able to:
• Explain the Dexcom G5 Mobile CGM System
• Describe options to view trends
• Locate your historical readings
• Recognize system components
• Explain each part’s function
3.2 The Dexcom G5 Mobile CGM System
CGM
The Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System is a medical device you use to track your glucose trends and monitor the speed and direction of your glucose changes. You continually see your sensor glucose readings, updated every five minutes for up to 7 days, without the bother of taking constant fingerstick measurements.
Your sensor glucose readings are measured by a single use sensor inserted under your belly’s (if between the ages of 2 and 17, belly or upper buttocks) skin. A reusable transmitter sends your data to your display device once every five minutes.
The Dexcom G5 Mobile CGM System provides personalized trend alerts, prompting you to proactively react when your glucose levels are getting too low, or too high. Dexcom provides web-based reports reflecting your glucose trends and patterns. Share the reports with your healthcare professional when developing your diabetes management treatment plans.
Options to View Your Trends
The Dexcom G5 Mobile CGM System transmitter works with a number of display devices giving you flexibility to use what is best for you, your situation, or your lifestyle:
Chapter 3
Let Us G5! The Basics:
What Is the Dexcom G5 Mobile CGM System?
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Dexcom G5 Mobile System User Guide
22What is the Dexcom G5 Mobile CGM System?
• Dexcom G5 Mobile Receiver
• Dexcom G5 Mobile App on your smart device
While the system works with different smart devices, they are not interchangeable during a sensor session. Before starting one, select which smart device you want to use and stick with it throughout your session. You cannot use multiple smart devices at the same time, but you can combine the receiver with a smart device during a session.
The Dexcom G5 Mobile CGM System is the first CGM system where a smart device acts as a receiver. For a list of current devices and operating systems go to:
dexcom.com/g5mobile/compatibility
Chapter 4 covers how to set up your smart device with the Dexcom G5 Mobile App. The primary difference between the Dexcom G5 Receiver and Dexcom G5 App is not the
information they give you, but how that information is presented. The following are some of the shared CGM data and system information features.
Tracking Real Time CGM Data
The receiver and app give you the ability to track your glucose trends in a number of different ways. Each device’s home screen opens to your glucose trend screen.
View Glucose Levels
The receiver and app share many of the same glucose monitoring features. Your glucose values are color coded to highlight what zone you are in, allowing you, at a glance, to see what your levels are.
Color coded glucose levels:
• Red - Low
• Grey - Within your normal range
• Yellow - High
Trend Arrows
Glucose levels are not just about the numbers. The Dexcom G5 Mobile CGM System includes trend arrows so you know the speed and direction of your glucose, allowing you to proactively react before your glucose gets too high or too low.
Alarm/Alerts
Being warned when your glucose value is too high or too low, falling or rising too quickly, or if it is trending towards a severe low or high is very important. Warnings in the form of Alerts
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or an Alarm help you avoid getting too low or high. Alarm and Alert notifications help keep you aware of your glucose trends and are made up of a combination of sounds, vibrations, and screens.
There are a number of Alerts, but only one Alarm: when your glucose level dips below 3.05 mmol/L. Some customization options are available and are part of the setup process for the receiver and smart device.
In Chapter 10, you can learn more about the Alarm and Alerts feature, and in Chapter 11, how to customize them.
Viewing Your Glucose Values
The Dexcom G5 Mobile CGM System allows you to see your last 1-3-6-12-24 hours of your sensor glucose readings. On the receiver, from the home screen, press
Up/Down Arrows
to
view. On a smart device, hold upright in
portrait
mode, and see the most recent three hours,
turn sideways to
landscape
to view your glucose levels over the last 1-3-6-12-24 hours.
Go to Chapter 8 to learn more about viewing your glucose trends.
3.3 What Is New to the Dexcom G5 Mobile CGM System?
Dexcom’s G5 Mobile CGM System has features not found in our previous generations. They include:
• Ability to make treatment decisions based on your sensor glucose readings
• Dexcom G5 Mobile App for your smart device
• Updates to the Dexcom G5 Mobile Receiver screens
• Dexcom Share™ in the Dexcom G5 Mobile App
Treatment Decisions
New to the Dexcom G5 Mobile CGM System is the ability to use the sensor glucose readings to make treatment decisions, including insulin doses.
To make a treatment decision, you need to know what your glucose readings are now, where they are heading, along with what you have eaten, your stress levels, when you last exercised, etc. With the Dexcom G5 Mobile CGM System’s trend graphs and Alarm/Alerts feature, you can determine the speed and direction of your glucose changes and determine if you should dose without taking a fingerstick, eat carbs, or do nothing.
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For more information on how to use your sensor readings combined with your trend arrows, trend graphs, Alarm/Alerts to make your treatment decision, go to Chapter 12.
Use your BG meter values as a backup when your CGM data does not reflect how you feel or if you have sensor reading gaps.
Share Your Data
Through secure wireless connections, Dexcom Share allows remote viewing of your sensor glucose readings, trends, and data by your loved ones from a smart device. Activate Dexcom Share by tapping on the app’s Share icon, follow a few simple steps, then invite up to five people to connect with you.
After downloading the Dexcom Follow™ App, they become your Follower. As a Follower, they can watch your sensor glucose readings, trends, and receive Alarm/Alerts when your glucose is low or high.
You determine what your Follower can see. Based on what you allow, your Followers can receive your Alarm or Alerts, and view your trends. Followers can pick and choose, or turn off, the data they receive, including the Alarm/Alerts, trends, and messages. The Share feature in the Dexcom G5 Mobile App is different than the Dexcom Share App used with previous Dexcom CGM systems.
For more information about Share or Follow, please see the Share/Follow user manual.
3.4 System Information
The receiver and app also keep you informed on the system’s status. Technical notifications provide information about your sensor session and about the system’s hardware. Each chapter provides a table of the prompts, system, and error messages applicable to its subject. As an example, the calibration chapter will review all calibration messages you may see.
Now you know what the Dexcom G5 Mobile CGM System does and what is new, let us open your Dexcom G5 Mobile CGM System packages, see what is inside, and review each item.
3.5 System Components
Package
The Dexcom G5 Mobile CGM System comes to you in a number of boxes; after opening keep the packaging until you are no longer using its contents.
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Sensor
Sensor package
Single use sensor(s) Sold separately. Comes in a sterile tray or pouch.
IMPORTANT USER INFORMATION
Please review your user’s guide instructions before using your continuous glucose monitoring system. Indications, contraindications, warnings, precautions, and other important user information can be found in your user’s guide. Note: If you need another copy of your user’s guide, it is available for download at www.dexcom.com or by contacting your local distributor.
TÄRKEITÄ KÄYTTÄJÄTIETOJA
Tutustu käyttäjän ohjekirjaan, ennen kuin käytät jatkuvatoimista glukoosin seurantajärjestelmää. Ohjekirjasta löytyy käyttöaiheita, vasta-aihe ita, varoituksia, varotoimia ja muita tärkeitä käyttäjätietoja. Huomautus: Jos tarvitset toisen käyttäjän ohjekirjan, voit ladata sen sivustolta www.dexcom.com tai ottaa yhteyttä paikalliseen jälleenmyyjään.
INFORMATIONS IMPORTANTES POUR L’UTILISATEUR
Veuillez lire les instructions fournies dans le guide de l’utilisateur avant de commencer à utiliser votre système de contrôle continu du glucose. Le guide de l’utilisateur contient des indications, contre-indications, avertissements, précautions et autres informations importantes destinées à l’utilisateur. Remarque : Si vous avez besoin d’un exemplaire supplémentaire du guide de l’utilisateur, celui-ci est disponible en téléchargement sur le site www.dexcom.com ou auprès de votre distributeur local.
WICHTIGE BENUTZERINFORMATIONEN
Bitte lesen Sie sich die Bedienungsanleitung durch, bevor Sie das System zur kontinuierlichen Glukoseüberwachung verwenden. Anzeigen, Gegenanzeigen, Warnungen, Vorsichtsmaßnahmen
und andere wichtige Benutzerinformationen nden
DŮLEŽITÉ INFORMACE PRO UŽIVATELE
Před použitím systému kontinuálního monitorování glykémie si pozorně projděte pokyny v uživatelské příručce. Najdete v ní indikace, kontraindikace,
  
      
    .   
                  : . 
       
     www.dexcom.com
. 
AR
FI
FR
D
E
C
S
EN
Insert
Transmitter
Transmitter package
Reusable transmitter
(Continued on next page)
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(Continued from previous page)
Receiver
Receiver package
Chargeable Receiver
Receiver’s USB charging and download cable
AC power wall charger
Adapters for wall outlet
(Continued on next page)
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(Continued from previous page)
Receiver
User Guide
Quick Start Guide
Training Tutorial USB Card
Overview of System Components
This section is meant as a quick overview of each part, specifics for each are found in following chapters. For detailed product specifications and technical information, please go to Chapter 15.
The Dexcom G5 Mobile CGM System is comprised of three key parts:
1. Single use sensor
2. Reusable transmitter
3. Display devices:
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28What is the Dexcom G5 Mobile CGM System?
a. Rechargeable receiver b. Dexcom G5 Mobile App
i. Downloaded to your smart device
Dexcom G5 Mobile CGM System optional: Dexcom Share
Sensor Overview
For your safety, the sensor is packaged in a sterile sealed pouch or tray, containing an applicator, sensor pod, and sensor wire. When you first open the package, your sensor looks like one item, however it is actually three: sensor applicator barrel, sensor pod, and sensor wire.
The applicator barrel helps you insert the sensor wire inside the sensor pod under your skin. After inserting the sensor wire, remove the applicator barrel. The sensor wire is in the sensor pod stays, with the pod attached to your skin by adhesive.
The sensor wire is made of silver and platinum with polymer membranes. Once inserted, the thin and flexible wire measures your glucose levels in the fluid between your cells (interstitial fluid) for up to seven days.
Figure 1. Dexcom G5 Mobile Sensor Applicator and Pod
Safety Lock
Collar
Sensor Pod
Adhesive Patch
Release Tab
Transmitter Latch
Applicator Barrel
(contains small
introducer needle
and sensor)
Plunger
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This section is meant as a quick overview. More information on using and inserting the applicator, sensor, and sensor wire can be found in Chapter 5.
Applicator and Sensor Pod
What it is called What it does
Applicator
Applicator Barrel
Contains small insertion needle and sensor wire. Inserts sensor wire under the skin. Disposable, for single use only. Removed after insertion.
Safety Lock
Keeps all moving parts in place before insertion. Prevents accidental sensor insertion. Tool to remove transmitter after sensor session. Put in transmitter box after removal to use later.
Collar Collar removes insertion needle.
Plunger Inserts sensor wire into your body.
Transmitter Latch Securely snaps transmitter into sensor pod.
Sensor Pod
Sensor Pod
Holds transmitter and sensor wire. Water resistant when transmitter is properly installed. Discarded after sensor session.
Adhesive Patch Keeps sensor pod attached to your skin.
Sensor Wire
Wire measures glucose levels in fluid in between your cells. Attached to sensor pod. Discarded with pod after session.
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Transmitter Overview
NOTE: Pictures are representational only, your transmitter may look different. Snapping into the sensor pod, the gray plastic transmitter wirelessly sends your glucose
information to your display devices—receiver and/or smart device. If you have a new transmitter, open the package when you are ready to use it.
The transmitter:
1. Is reusable a. Do not discard after sensor session. b. Only for you, do not share transmitter.
2. Is water resistant
3. Can transmit data to your display devices for up to six meters a. Range is less if you are in or under water.
4. Battery lasts approximately three months a. Receiver or smart device prompts you when battery is running low.
5. Serial number on back
More transmitter features and insertion information is in Chapter 4 and 5. Now you are familiar with sensor and transmitter, let us review the Dexcom G5
Mobile Receiver.
Dexcom G5 Mobile Receiver
Your receiver, along with your smart device, shows your sensor glucose readings, trend graphs, trend arrows and alerts you when your glucose is too high or too low or if there is something you should be aware of or need to do.
The receiver’s small size helps make it low key and discreet. See Chapter 13 for charging your receiver’s battery.
Figure 2. Dexcom G5 Mobile Transmitter Front and Back
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The receiver is neither water resistant nor waterproof and can get damaged if moisture gets inside, so keep it away from any liquids and very high humidity. Keeping the micro USB port closed helps prevent damaging fluids and dust from getting inside the receiver. If your receiver does get wet, test it to make sure the speaker and vibrations still work (see Section 11.3).
If you want to use the receiver along with a smart device, you need to set them up separately.
Remember, you cannot use a combination of smart devices during a sensor session; select just one.
Receiver Overview
What you see What it is called What it does
Receiver
Provides data about your glucose trends via screen display, sounds and vibration.
Micro USB Port
Plug
USB cable
into
port
for
recharging.
USB Port Door
Close
USB port door
after removing
USB cable
to keep receiver clean
and dry.
Micro USB Cable
Plugs into
receiver
and wall charger
to charge battery See Chapter 13 for instructions
on how to charge your receiver’s battery.
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(Continued from previous page)
What you see What it is called What it does
AC Power Adapter Plugs
The AC power adapter comes with interchangeable plugs.
Install the appropriate plug for your wall outlet.
Wall Charger
Charges receiver once plugged into wall outlet.
Display Screen
Shows sensor glucose readings, trend graphs and arrows, Alarm/Alerts, sensor session status.
Change settings on Menu screen.
Speaker
Allows you to hear your Alarm/Alerts sounds.
Navigation Wheel
Arrows and button to help you navigate through the receiver’s menu options and choose features.
Select Button Press to select menu option.
(Continued on next page)
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(Continued from previous page)
What you see What it is called What it does
Left Arrow
Press to go back to last item/screen or home screen.
Right Arrow Press to highlight next item.
Up/Down Arrows
Press to scroll up or down to select menu items or set values.
Press to scroll back and forth beyond from the 3 hour trend graph to the 1-6-12-24 views.
3.6 Smart Device Overview
The Dexcom G5 Mobile App was created to work with your smart device, giving you even more options in monitoring your glucose trends and patterns. The app is similar to all other apps.
This User Guide is not meant to show you how to use your smart device. Please contact your smart device support or read your smart device’s user guide for assistance.
Summary
Now You Can:
• Explain the Dexcom G5 Mobile CGM System
• Describe options to view trends
• Locate your historical readings
• Recognize system components
• Explain each part’s function
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Next Steps
Your next step in getting started with the Dexcom G5 Mobile CGM System is selecting how to continuously receive your sensor glucose readings: Dexcom G5 Mobile App, the Dexcom G5 Mobile Receiver or a combination.
Our next chapter helps you set up both!
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Set up Your Display Devices
4.1 Introduction
In the previous chapter, you received a high level overview of the Dexcom G5 Mobile CGM System and learned you can monitor your glucose levels with different display devices. Now it is time to set up your Dexcom G5 Mobile App and your receiver.
After this chapter, you will be able to:
• Create a Dexcom username and password
• Download the Dexcom G5 Mobile App
• Set up the Dexcom G5 Mobile App with the recommended settings
• Successfully set up your Dexcom G5 Mobile Receiver
4.2 Why Different Monitoring Methods?
Your convenience! By offering two separate monitoring systems, the app or receiver, you can choose to monitor
your glucose levels in the handiest method at that moment. Smart device ran out of memory? Use your receiver! If you forgot your receiver at home use your smart device! Battery died on your smart device? Your receiver has you covered!
With the exception of Dexcom Share, the primary difference between the two monitoring systems is not the data itself, but how it is presented.
The next section walks you through the initial set up for the app. To set up the receiver, go to Section 4.4. If you want to use both the mobile app and the receiver, you need to set each up individually.
Once you have completed the initial setup, you are one step closer to beginning your sensor session!
Chapter 4
Let Us G5! The Basics:
Set up Your Display Devices
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36Set up Your Display Devices
4.3 Dexcom G5 Mobile App
Before starting your first sensor session, pick the smart device you want to use. As mentioned in the previous chapter, you can use the receiver with one smart device during a session; however, you cannot use multiple smart devices during the same session.
While your smart device can have the app installed, part of your initial set up is entering the transmitter’s serial number (SN). If by accident you enter the SN into more than one smart device, the system warns you and you will not be able to complete the set up process.
Suggested Smart Device Settings
Bluetooth
is designed wireless communication between devices (unlike Wi-Fi®, which wirelessly connects devices to the Internet). Your transmitter communicates to your app via
Bluetooth
®
Smart! Before beginning, make sure your smart device’s
Bluetooth
is
available and turned on.
• While checking your
Bluetooth
settings, check to see
Silent
and
Do Not Disturb
are off. Your app does not override these settings; if you have them on, you will
miss Alarm/Alerts
• After verifying all your settings are correct, there is one more thing to check. Make sure your smart device’s
Volume
is loud enough for you to hear any Alarm/Alerts
• Verify your Dexcom Alarm/Alerts have been prioritized
• For information on how to set the above settings, see your smart device’s user guide. Once you have verified your smart device’s settings are right, the next step is installing the Dexcom G5 Mobile App
• The app needs to be open and running in the background. This may drain your smart device’s battery; make sure you check its battery is charged
• Do not change your smart device’s time because it can make the time on the trend screen wrong and the app may stop displaying data
If your smart device is broken or lost, use receiver until it is fixed or replaced.
Dexcom G5 Mobile App Installation
Installing the app is easy! Simply download the Dexcom G5 Mobile App from your smart device’s store. However, if your smart device has been jailbroken, do not install the app.
For information on how to install an app, see your smart device’s user guide.
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Initial Dexcom G5 Mobile App Setup
Setting up your app is easy! You will need your Dexcom account
username
and
password
,
along with your
transmitter
box. Once inside, simply follow the set up wizard instructions. The set up wizard walks you through safety information, recommended settings, entering transmitter SN, setting your high/low glucose levels, and receiving CGM notifications.
Your initial set up will require a Dexcom username and password. You can create them by tapping
Sign Up
within the app, or by going to dexcom.com. But what if you are unclear about a step? The Dexcom App has prompts allowing you to get more information. If you are unsure of
something during your initial set up process, look at the screen for additional information prompt. Informational prompts include, but are not limited to:
I don’t understand, Learn More,
or Question Mark
. Tap your
informational prompt
to get more information.
To close out of the information prompt, tap the X in the upper right hand corner.
Initial App Setup
Step What you see What you do
Introductory Screens
1
Tap
Dexcom G5 Mobile App
icon to open app.
(Continued on next page)
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(Continued from previous page)
Introductory Screens
2
Swipe through introductory screens or tap
Log In
.
3
Enter existing username and password OR Need a Dexcom username and password? Tap
Sign Up
.
Complete
Username/Password
fields.
Tap
Login
once.
(Continued on next page)
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Introductory Screens
4
Tap
Let’s Get Started
.
5
The next screens are the Terms of Use, safety warnings, contraindications, and the recommended settings.
Once each screen is read, tap the
appropriate
answer
to move forward.
Tap
Full Safety Statement
or
I don’t understand
to
get more information.
(Continued on next page)
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(Continued from previous page)
Setting up Your App Alarm/Alerts and Basic Settings
6
Set your
Low Glucose Alert
.
Default is 4.44 mmol/L.
Scroll
to select another amount.
Tap
Save
to move forward.
Once set, you will receive an Alert notification if your glucose dips below your set amount.
7
Set your
High Glucose Alert
.
Default is 11.1 mmol/L.
Scroll to select another amount. Tap
Save
to move forward.
Once set, you will receive an Alert notification if your glucose rises above your set amount.
(Continued on next page)
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Setting up Your App Alarm/Alerts and Basic Settings
8a
Make sure you get your Alarm/Alerts notifications. Tap the
appropriate response
to move forward and
set your notifications.
8b
Tap OK to receive Alarm/Alerts notifications.
(Continued on next page)
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(Continued from previous page)
Setting up Your App Alarm/Alerts and Basic Settings
9
The next screens provide suggestions for device volume,
Do Not Disturb
, and other basic settings.
Tap
appropriate answer
to move forward.
Connecting/Pairing Transmitter With App
10
Tap
Next
.
(Continued on next page)
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Connecting/Pairing Transmitter With App
11
Verify
Bluetooth
is on.
The app will check to see if
Bluetooth
is turned
“on.”
12a
Get your
Transmitter
box.
Tap
Take Photo
.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
12b
Turn
transmitter box
upside down on a flat surface
with barcode(s) facing up. Center longest
barcode
within green brackets.
NOTE: Picture is representational and may not reflect exactly the back of transmitter box.
12c
Check mark confirms successful transmitter SN scan.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
13a
If unable to use app’s scanning device: Tap
Enter transmitter SN by hand
.
13b
Use keyboard to enter transmitter SN. Confirm correct SN. Tap
Save
.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter With App
14
Insert sensor and attach transmitter following video’s instructions.
See Chapter 5 for more information.
15
Wait up to 30 minutes for smart device and transmitter to connect.
(Continued on next page)
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(Continued from previous page)
Connecting/Pairing Transmitter with App
16
At prompt, Tap
Pair
to pair app with smart device.
17
Tap the
Sensor warmup
circle to start your two
hour sensor warmup. When you see the sensor warmup timer, your initial
set up is complete. Congratulations!
If you have any issues setting up the Dexcom G5 Mobile App, contact your local Dexcom representative.
If you are having problems with your smart device, contact your smart device’s support line. After completing your initial app set up, set up the receiver or go to Chapter 6 to start your
initial sensor session.
4.4 Dexcom G5 Mobile Receiver
In the previous chapter, you learned about the receiver’s components. The following is a refresher to help in your initial set up.
Display Screen:
• Trend screen
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• Menu selection screen
Navigation Wheel:
• Select ○ Button in the middle of the navigation wheel
▪ Center button does not say “Select”
○ Press to
▪ Turn on receiver ▪ Select options/features ▪ Accept changes ▪ Move forward through menus/features
• Up/Down ○ Scroll through trend screens ○ Highlight menu items ○ Change values
• Left ○ Go back to last item or screen
• Right ○ Go to next item or screen
Initial Setup of the Dexcom G5 Mobile Receiver
Press
Select
to turn receiver on.
The first screen you see is the startup screen with ascending green bars. Once complete, a set up wizard guides you through the initial set ups steps. Do not be alarmed if your receiver buzzes or makes other sounds during this process.
After your initial setup is complete, you will not see the setup wizard again. Your settings can always be adjusted using menu options.
How you complete your initial set up differs between the receiver and your smart device; however, the data is the same.
Setup Wizard Prompts:
• Language
• Time/Date
• Transmitter Serial Number ○ Back of transmitter ○ Back of transmitter’s box
• Setting Low Alert
• Setting High Alert
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Before starting a session, you may want to check the receiver’s battery level. If it less than half, go to Chapter 14, for charging instructions.
Initial Receiver Set up
Step What you see What you do
Initial Screens
1
Press
Select
to turn receiver on.
2
Wait.
Language
3
Select language. Press
Up/Down Arrow
to choose desired language.
Press
Select
button to set the highlighted language.
Time/Date
4a
Set time format. Time formats available are 24 Hour or AM/PM
(12-hour).
Press
Up/Down Arrow
to choose desired time
format.
Press
Select
button to confirm changes to time
format.
(Continued on next page)
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(Continued from previous page)
Time/Date
4b
Press
Up/Down Arrow
to change year.
Press
Right Arrow
to move forward.
Press
Up/Down Arrow
to change month.
Press
Right Arrow
.
Press
Up/Down Arrow
to change day.
Press
Right Arrow
to move to time.
NOTE: Format is YYYY/MM/DD
4c
Press
Up/Down Arrow
to change hour.
Press
Right
Arrow.
Press
Up/Down Arrow
to change minutes.
(Optional for AM/PM) Press
Right
Arrow.
(Optional for AM/PM) Press
Up/Down Arrow
.
Press
Select
to save and close.
NOTE: After initial set up, if battery is drained, receiver will vibrate once and you will need to reset date and time.
Transmitter
5a
Turn
transmitter box
upside down to locate SN
number. NOTE: This picture is representational only,
transmitter SN may be placed in a different location.
5b
If transmitter package is not available:
• SN is on transmitter’s back
NOTE: Picture is representational only, your transmitter may look different
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Set up Your Display Devices
(Continued from previous page)
Transmitter
5c
Press
Up/Down Arrows
to select and enter
transmitter SN. Press
Right Arrow
to move to next digit.
Press
Select
to save and close.
Setting Low Alert
6a
System default is at 4.4 mmol/L. Press
Select
to save at present levels and close.
6b
To change value: Press
Up/Down Arrows
to change value at 0.1
mmol/L increments. Press
Select
to save and close.
Setting High Alert
7a
System default is at 11.1 mmol/L. Press
Select
to save at present levels and close.
7b
To change value: Press
Up/Down Arrows
to change value at 0.1
mmol/L increments. Press
Select
to save and close.
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These steps are enough to get you going; now you can start your sensor session!
Summary
Now You Can:
• Create a Dexcom username and password
• Download the Dexcom G5 Mobile App
• Set app up with the recommended settings
• Successfully set up your Dexcom G5 Mobile Receiver
What Is Next?
Now you have completed setting up your app and/or the receiver, your next step is starting a sensor session.
No matter what monitoring method you choose, starting a sensor session is the same:
1. Inserting the sensor.
2. Inserting the transmitter.
3. Pairing the transmitter to your device.
4. Two hour sensor warmup.
5. Initial calibrations.
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5.1 Overview
Now that your display devices are set up, you are ready to begin a sensor session. If this is your first time inserting a sensor, you may want to watch the Dexcom G5 Mobile sensor insertion video to get a better understanding of the process.
The Dexcom G5 Mobile sensor insertion video is available by two ways:
1. Through the App
2. USB card in your Dexcom G5 Mobile Receiver package
After inserting the sensor, start the sensor warmup on your smart device and receiver. The sensor warmup takes approximately two hours; during this time your body is getting used to the new sensor, allowing for more accurate sensor glucose readings. Once the two hour sensor warmup has passed, you enter two back-to-back fingerstick measurements to calibrate the sensor’s glucose readings with your fingerstick measurements (Calibration is covered in the next chapter).
Make sure you give yourself enough time to finish the startup session. Remember your smart device’s
Bluetooth
needs to pair with transmitter, adding up to 30 minutes. Good news is you don not need to sit around waiting: as long as you have your display device near, you can go about your day running errands, gardening, personalizing the Dexcom G5 Mobile settings, whatever you choose during that time frame.
Keep your display device(s) handy during the warmup period—it shows how much time has passed, notifying you with beeps and an icon when your sensor session is ready for its initial calibrations.
After this chapter you will be able to:
• Identify sensor applicator features
• Properly prepare for sensor insertion
• Choose the best location to insert your sensor
• Correctly insert your sensor
Chapter 5
Let Us G5! The Basics:
Starting a Sensor Session: Inserting Sensor, Transmitter, and Starting Your Session
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• Prepare transmitter for placement
• Correctly attach transmitter to sensor
• Outline what happens during the sensor warmup
• Identify countdown icon
5.2 Prepping for Sensor Insertion
Before inserting a sensor, make sure you have everything you need. Some items are included in the Dexcom G5 Mobile CGM System’s packages, others are not.
Items Included in Your Dexcom G5 Mobile Packages
For sensor insertion, you need the sensor and transmitter.
Sensor Applicator
Inside Sensor Box
What you see What it is
Sterilized sensor pouch with important label information. Check
expiration date
.
Do not use if it is past the expiration date.
Single use sensor applicator.
Knowing what each applicator piece does helps you successfully insert your sensor. Chapter 3 gave you overview of the sensor applicator.
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The following table reviews the sensor applicator components in order of use.
Order of Use Name What it does
1 Sensor Pouch
Sterilized for your protection. Open to remove applicator and sensor.
2 Adhesive Patch
Holds the sensor/transmitter in place on your skin.
3 Safety Lock
Prevents plunger from inserting sensor until you are ready.
4
Plunger
Inserts sensor wire into your body.
5 Applicator Barrel
Contains small insertion needle and sensor wire.
Disposable, for single use only.
6 Collar
Collar removes insertion needle. Helps remove applicator barrel once sensor
wire is inserted.
(Continued on next page)
Figure 3. Dexcom G5 Mobile Sensor Applicator and Pod
3. Safety Lock
6. Collar
7. Sensor Pod
2. Adhesive Patch
9. Release Tab
8. Transmitter Latch
5. Applicator
Barrel (contains
small introducer
needle and sensor)
4. Plunger
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(Continued from previous page)
Order of Use Name What it does
7 Sensor Pod
Holds sensor wire in place under skin. Holds transmitter.
8 Transmitter Latch Locks transmitter into sensor pod.
9 Release Tab
Allows you to remove applicator barrel from sensor pod.
Transmitter
Transmitter Box
What you see What it is
Bottom of box with important label information. Keep box until transmitter battery dies. NOTE: Picture is representative only, your transmitter box
may look different.
Reusable transmitter. NOTE: Picture is representative only, your transmitter may
look different.
In the previous chapter, you entered your transmitter SN into your display devices and made sure your smart device and/or receiver connected with the transmitter. You will not be able to start a sensor session if your transmitter is not paired with your receiver and/or smart device.
Not included in packages:
1. Alcohol wipes
2.
Your
blood glucose meter
3.
Your
test strips
Before starting, check your blood glucose meter; make sure it is in good working order following manufacturer’s directions and the meter’s date and time match your display device’s date and time.
Make sure test strips have not expired and work with your meter.
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Before removing the sensor applicator out of its sterile pouch, determine the best place to insert your sensor.
5.3 Choosing Your Insertion Site
Choose a place on your belly (or if user is between the ages of 2 and 17, also the upper buttocks) to insert the sensor; the site should be either above or below your belt line. The best areas are usually flat, “pinchable,” and free from where rubbing can occur (along the waist band, seat belt strap or where you lay when sleeping).
For more help on ideal sensor insertion sites, contact your healthcare professional.
Insertion Sites
Location Where it is
Front of body (belly area) for ages 2 years and above
If user is between the ages of 2 years and 17: Back of body (Upper buttocks)
Do:
• Remove the sensor and applicator from its sterile package only at time of use
• Place at least 8 cm from your insulin pump infusion set or injection site
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• Shave the area so the adhesive patch sticks securely (if needed)
• Make sure area is clean and free of lotions, perfumes, medications
Do Not:
• Use same site repeatedly for sensor insertion
• Use same site for 2 sensor sessions in a row
• Use sites where bones are close to the surface of your skin (e.g., ribs or hip bones)
If you have concerns about the sensor pod not sticking, before inserting your sensor, you can make the sensor site stickier to help ensure the sensor pod does not peel
Optional Site Preparation
Use optional skin adhesives (Mastisol™, SkinTac™) as part of your insertion site preparation to help keep your sensor pod attached. Apply the skin adhesive after you selected and cleaned your insertion site. Use circular motions and create an oval, making sure you do not get any skin adhesive in the middle. Let the oval dry based on skin adhesive manufacturer’s instructions. Once dry, your skin may feel slightly sticky.
See Step 3 in the next table for directions. NOTE: Contact your healthcare professional for specific questions regarding the use of
medical tape, barrier wipes and/or other adhesives as it relates to your use of Dexcom CGM.
5.4 Inserting Your Sensor
You have collected all of the needed items to begin a sensor session, viewed the tutorials, reviewed the sensor applicator and prepped the sensor pod site. You are now ready to insert your sensor!
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Step Picture What you do
Preparation
1
Wash and dry your hands.
2
Clean
insertion site
with alcohol wipe.
Let dry.
3
Optional Step: Skin Adhesive Create an
oval
on the skin
• Do not get any skin adhesive inside the circle
• Let skin adhesive dry
• Insert sensor on clean skin at the center of the circle
4
Check
pouch
: Is it damaged or already opened?
• If yes, do not use
Remove
sensor applicator
from sterile pouch.
Closely inspect
sensor
, check it has not been
damaged. Keep
sensor packaging
until sensor session is
complete.
(Continued on next page)
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(Continued from previous page)
Attaching Sensor Pod
5
Pull
adhesive backing tabs
.
Do not touch
sticky adhesive patch
.
6
Place
sensor
horizontally, not vertically, on skin.
Move fingers around
adhesive patch’s top
several
times to secure tape.
Inserting Sensor Wire
7
Hold
applicator barrel
.
Pull
safety lock
out.
8
Place fingers of one hand on edges of
adhesive patch
.
Pinch up your skin at the tips of the
white adhesive
.
(Continued on next page)
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(Continued from previous page)
Inserting Sensor Wire
9
Place two fingers directly
above
collar to steady
applicator barrel. Place thumb on the
white plunger
.
Push
plunger
completely down the applicator barrel. You should hear 2 clicks. NOTE: Finger placement is important for correct
insertion.
Removing Applicator Barrel and Collar
10
Move two fingers from
above
collar to
below
collar. Keeping your thumb as a base on the white plunger. Pull
collar
all the way back towards your thumb. You should hear 2 clicks. NOTE: Finger placement is important for correct
needle removal.
11
Hold
transmitter latch
down against your body.
Squeeze
ribbed release tabs
on the sides of sensor
pod.
(Continued on next page)
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(Continued from previous page)
Removing Applicator Barrel and Collar
12
Move
applicator barrel
forward and out, away from
your body. Follow local ordinances when disposing the applicator.
What is left?
1. Sensor pod
2. Transmitter latch
You have successfully inserted the sensor! At this point, you should have two items attached to your belly:
1. The sensor pod
2. The transmitter latch
Having problems?
If it is the first time inserting a sensor, you may have questions or need help. If you do, please contact your local Dexcom representative.
The next step is attaching your transmitter to the sensor pod.
5.5 Attaching Your Transmitter
Now that you have inserted your sensor, you need to attach your transmitter. Since the transmitter is reusable, you do not need a new one every time you start a sensor
session. Keep your current session’s transmitter box. The bottom label has important information you may need after you have inserted the transmitter. Once the transmitter has been attached, you cannot remove it until your session is over. Chapter 7 reviews when and how to remove your transmitter.
Before inserting your transmitter, check you entered the correct transmitter SN into your display device. Chapter 4 covers entering transmitter’s SN number.
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Step Picture What you do
1
Remove
transmitter
from box.
Keep box. Save
safety latch
from sensor applicator (helps
remove transmitter once sensor session is over). Get alcohol wipe.
2
Wipe
back of transmitter
with alcohol wipe.
Let dry for 2-3 minutes. Do not let the back of transmitter touch your skin. Do not scratch transmitter’s back, this can harm the
waterproof seal. Do not touch metal dots on transmitter’s bottom.
3
Flat side down. Slide
transmitter’s small end
under the sensor pod
lip located in front of pod’s ribbed tabs, away from
transmitter latch
.
4
Keep finger on
transmitter
holding it in place.
Push
transmitter latch
up and forward over the
transmitter’s wide end with your other hand. You should hear 2 clicks.
(Continued on next page)
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(Continued from previous page)
Step Picture What you do
5
Is transmitter secure?
Before removing transmitter latch, verify transmitter is securely in place.
Make sure none of the transmitters sides popped out of the sensor pod.
If not completely snapped in, you may have a bad connection and it will not be water tight.
6
Hold
sensor pod sides
with one hand.
Twist
latch
away from your body with other hand.
Remove
latch
.
Do not remove
transmitter
while sensor pod is
attached to skin.
You are almost done starting your sensor session! Inserting the sensor, attaching the transmitter, and the two hour sensor warmup are the
same regardless whether you use the receiver or app. The remaining steps vary from app to receiver:
1. Letting your device know you need to start the sensor warmup.
2. Following your warmup countdown.
5.6 Loose Sensor Pod
The sensor pod should stay on your skin using its own adhesive however, due to normal wear and tear, it may peel up.
If the patch peels up after insertion, use medical tape (such as Blenderm™, Tegaderm™, Smith & Nephew IV3000®, 3M™ tape) for extra support.
• Tape over white adhesive patch on all sides for even support
• Do not tape over the transmitter or any the sensor pod’s plastic parts
• Do not tape under sensor pod
• Do not leave any substance on the skin where you insert the sensor
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5.7 Starting Your Sensor Session
If you choose to use both the receiver and the app, each system requires individual set ups (see Chapter 4).
After pairing the transmitter to your device(s), inserting your sensor, and attaching the transmitter to the sensor pod, your next step is telling your device(s) you want to start a sensor session. Transmitters are reusable; pairing is required only when using a new transmitter.
During the warmup period, neither device will provide any sensor glucose readings. Your sensor glucose readings begin after the two hour sensor warmup has passed and you entered the initial two calibration BG values into either the smart device or the receiver.
We will first review starting the sensor session for the app.
Dexcom App: Starting a Session
Step What you see What you do
1
Wait for
Successful Pairing
notification.
Tap
green checkmark
in black square.
(Continued on next page)
Figure 4. The Right Way to Use Tape for Extra Support
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(Continued from previous page)
Step What you see What you do
2
Tap
Sensor Warmup
circle to start your two hour
sensor warmup. NOTE: You will NOT get any sensor glucose
readings, Alarm/Alerts during your two hour sensor warmup period.
Use fingerstick glucose values from your blood glucose meter to make treatment decisions during this warmup period.
3
Wait. Screen provides countdown to sensor warmup. The
orange dashes darken as the countdown moves forward.
Keep
smart device
within six meters of transmitter
during the sensor warmup period.
4a
Locked screen
Initial calibration
prompt tells you when warmup is
complete. Chapter 6 covers calibrating.
(Continued on next page)
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(Continued from previous page)
Step What you see What you do
4b
Initial calibration
prompt tells you when warmup is
complete. Sensor warmup is complete. You are ready to calibrate!
Receiver: Starting a Session
Step What you see What you do
1 Press
Select
to turn on receiver.
2
From Trend Graph. Press
Select
to go to
Main Menu
.
(Continued on next page)
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68Starting a Sensor Session
(Continued from previous page)
Step What you see What you do
3
Press
Down Arrow
to highlight
Start Sensor
.
Press
Select
to start new sensor session.
NOTE: After sensor starts,
Start Sensor
option
disappears.
4
“
Start Sensor
” progress bar confirms two hour
sensor warmup. Keep your receiver within six meters during the
warmup period.
5
Receiver returns to the trend graph screen.
6
Make sure
receiver
and
transmitter
are
communicating. Check
receiver
10 minutes after starting for
Bluetooth
icon.
• Solid: Connected
• Blinking: Searching for connection
• No
Bluetooth
Icon: No connection
7
Wait.
Screen provides countdown of the two hour sensor warmup.
(Continued on next page)
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(Continued from previous page)
Step What you see What you do
8
Sensor warmup is complete. You are ready to calibrate!
5.8 Receiver
Bluetooth
Tips
Your transmitter and receiver begin communicating once you start a sensor session. After approximately 30 minutes, if the
Bluetooth
symbol is solid, and not blinking, your transmitter
and receiver are talking to each other.
• If blinking,
Bluetooth
is looking for your transmitter
○ Make sure your transmitter and receiver are within six meters of each other
If the
Bluetooth
icon is not on the receiver and the
Signal Loss
icon appears in the receiver’s
upper right corner of the status bar, they are not communicating.
No Communication Between Transmitter and Receiver
Step What you see What you do
1
Check correct transmitter SN is in receiver.
• SN is on the label on bottom of transmitter box
Press
Select
to go to
Main Menu
.
(Continued on next page)
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70Starting a Sensor Session
(Continued from previous page)
Step What you see What you do
2
Press
Down Arrow
to
Settings
.
Press
Select
.
3
Press
Down Arrow
to
Transmitter
.
Press
Select
.
4
Press
Select
.
5
Check correct transmitter SN is in receiver.
• SN is on the label on bottom of transmitter box
Compare SN in receiver to SN on transmitter box. If correct, contact your local Dexcom representative. Press
Select
to exit screen.
If Wrong SN Entered
6
Press
Left Arrow
twice to go to
Main Menu
.
(Continued on next page)
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(Continued from previous page)
If Wrong SN Entered
7
If sensor session has started, to correct transmitter SN, you must stop the sensor session.
Press
Down Arrow
to
Stop Sensor
.
Press
Select
.
8
Press
Select
to stop session.
9
Wait for sensor session to end.
10
From
Main Menu
:
Press
Down Arrow
to
Settings
.
Press
Select
.
11
Press
Down Arrow
to
Transmitter
.
Press
Select
.
(Continued on next page)
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(Continued from previous page)
If Wrong SN Entered
12
Highlight
Transmitter SN
.
Press
Select
.
13
Enter correct SN using
Up/Down Arrow
.
Press
Up/Down Arrow
to select and enter transmitter
SN. Press
Right Arrow
to move to next digit.
Press
Select
to save and close.
Press
Left Arrow
twice to return to Main Menu.
14
Start Sensor Session. Press
Up/Down Arrow
to highlight
Start Sensor
.
Press
Select
on
Start Sensor
.
5.9 Sensor Session Warmup
The sensor takes about two hours to adjust to your body. While you are in the sensor warmup period, you can customize your settings. Chapter 11, steps you through how to personalize your Dexcom G5 Mobile CGM System’s display devices.
Once the sensor warmup is complete, you are ready to enter your initial calibrations! The next chapter shows you how.
Summary
Now You Can:
• Identify sensor applicator features
• Properly prepare for sensor insertion
• Choose the best location to insert your sensor
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• Correctly insert your sensor
• Prepare transmitter for placement
• Properly attach transmitter to sensor
• Outline sensor warmup
• Identify countdown icon
What Is Next?
The next chapter guides you through the calibration steps.
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Calibration
6.1 Introduction
In the previous chapter, you learned how to insert your sensor, transmitter, and start a new sensor session. You are now ready to begin your last step before getting your sensor glucose readings: Calibration.
This chapter reviews not just your initial calibration, but also update calibrations required throughout your sensor session. After this chapter, you will be able to:
• Provide calibration overview ○ Define calibration ○ Explain the importance of calibration ○ Identify steps to ensure a successful calibration
• Recognize steps in taking accurate blood glucose measurement ○ Identify the correct blood glucose site for calibrations ○ Prepare finger for fingerstick measurement
• Determine if you should/should not calibrate ○ Recognize when you can enter fingerstick measurement for calibration ○ Recognize when you should not enter the fingerstick measurement for calibration ○ Determine if you need to calibrate outside of the normal calibration requirements
• Initiate startup calibration
• Perform update calibrations
• Correctly enter your fingerstick measurement ○ Dexcom G5 Mobile App ○ Dexcom G5 Mobile Receiver
• Identify calibration errors
Chapter 6
Let Us G5! The Basics:
Calibration
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6.2 Calibration Overview
What Is a Calibration?
As you learned earlier, the sensor glucose readings come from measuring the glucose fluids found between your cells (interstitial fluids). Although blood and interstitial fluids are similar, sensor glucose readings can be different between your fingerstick and your CGM. Calibration provides a comparison, or measurement, between your meter’s fingerstick measurement and the sensor’s glucose readings, allowing alignment between the sensor and meter.
Your BG meter ‘teaches’ the sensor your glucose values through calibration. Just like a clock can need adjusting – calibrations allow your CGM to adjust to your body.
Why Is Calibrating Important?
Calibrations are a must to make sure the CGM system is performing at its best. By calibrating when the system notifies you that a calibration is due, the Dexcom G5 Mobile
CGM System uses your meter’s BG value to make sure the sensor glucose readings remain accurate throughout your session.
How Do I Calibrate?
Take a fingerstick measurement from your meter, and simply enter the meter’s BG value into your display device. This chapter lets you know what precautions you need to take before taking your BG meter value, then entering your data. Up to now, you entered information such as Alerts, transmitter SN, etc., separately for the receiver and smart device. Calibration is different.
If you enter your meter’s BG value into your receiver, it takes about five minutes for your sensor glucose readings to begin. In approximately ten minutes, you can view the readings in the other display device.
How Often Do I Calibrate?
There are three primary “must do” calibration events, each with its own prompts:
1. Two initial calibrations once your warmup session is complete
2. Update calibrations done twice daily, once every 12 hours
3. When you are prompted
Do not enter your BG values in both devices, enter either into your app or the receiver. If you receive a calibration prompt outside of your scheduled calibration schedule, the system does
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Calibration
not accept your most recent calibration or your meter’s BG value is very different from the sensor’s glucose reading.
Do not worry about keeping track of the time between calibrations, the system will prompt you when you are ready for another.
6.3 When to Calibrate
Calibrating on a regular schedule aligns your sensor glucose readings with your meter’s BG values. Without calibrations, your sensor may be inaccurate, and as a result, so will your display device’s sensor glucose readings, Alerts, and prompts, etc.
There are important times when you
must
calibrate:
1. Initial or Start-Up Calibration: two hours after you insert your sensor.
2. 12 Hour Update: every 12 hours after two hour startup calibration.
3. When system prompts you.
With calibration prompts, your sensor and display device helps you keep your calibration schedule on track. If your BG values are not between 2.2-22.2 mmol/L, the system will not accept your calibration. Wait until you are within the 2.2-22.2 mmol/L range before entering your BG values.
Initial Calibration: Sensor Start-Up Completed
1. At prompts (see next table) enter two back-to-back fingerstick measurements into just
one device.
2. No need to do initial calibrations twice.
a. Calibration data flows between the receiver and your app. b. Five minute reporting delay between devices.
3. First maintenance calibration is 12 hours after your second initial calibration.
Update Calibration
1. Enter one fingerstick measurement every 12 hours.
2. Display devices provides calibration prompts.
3. You may be prompted to enter additional fingerstick measurements as needed.
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6.4 Calibration Prompts
Sensor Session Start-Up Calibration Prompts
Once your two hour sensor start-up is complete, your display device tells you it is time to enter the first of your two back-to-back start-up calibrations. Once the system has accepted your BG values, your sensor glucose readings begin. If you do not enter your BG values right away, the system reminds you every 15 minutes. Remember, only use your BG meter for calibrations, and never enter values from your CGM.
Figure 5. Example Minimum Calibration Schedule During
Seven-Day Sensor Session
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Calibration
Start-Up Calibration Prompts
Device What you see What it means What you do
First Calibration
Smart Device: Lock Screen
Sensor warmup is complete.
Ready for first of two initial calibrations.
Follow steps in Section 6.5 and 6.6.
Immediately prepare for next calibration.
Smart Device: In App
Receiver
(Continued on next page)
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(Continued from previous page)
Device What you see What it means What you do
Second Calibration
Smart Device: Lock Screen
Sensor accepted first calibration.
Ready for second BG meter value.
Repeat steps in Section 6.5 and 6.6
Next calibration in 12 hours.
Smart Device: In App
Receiver
Your sensor glucose readings begin in approximately five minutes once the device(s) accepts your calibrations.
Update Calibration Prompts
Once your start-up calibration is done, your update calibration schedule begins.
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Calibration
The steps to enter your update calibrations are the same as your initial calibration, including only entering values in one display device. The only difference is, with update calibrations, you enter your BG meter value just once.
Like the reminders you received with your initial calibration, if you do not enter your BG meter values right away, the system prompts you every 15 minutes.
Update Calibration Prompts
Device What you see What it means What you do
Smart Device: Lock Screen
Enter update calibration.
If prompt does not go away:
• System did not accept calibration
• BG values are very different from sensor glucose readings
Follow steps in Sections 6.6 and
6.7.
Smart Device: In App
Receiver
Tap
message
to clear prompt on your smart device and to clear a prompt on your receiver,
press
Select
.
Sound/Vibration Prompts
In case you cannot look at your screen, both the smart device and receiver provide, with the exception of your regular 12 hour update calibration, beep/vibration prompts to let you know it is time to calibrate or if there was a system calibration error.
For more information on setting your sound/vibration prompts and how to clear them, please see Chapter 10.
Smart Device
Calibration prompts will alert you with a triple beep if your smart device is not on
Silent
or
Do
Not Disturb
.
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82Calibration
Receiver
The receiver alerts you with an initial vibration for calibration prompts. If not cleared, you receive a vibrate/beep every five minutes until confirmed.
6.5 Preparing for Calibration
Your sensor depends on you to help make its sensor glucose readings accurate. If you do not prepare properly for the calibration, your sensor may not provide you with the most accurate sensor glucose readings.
Eight Steps to Successful Calibration:
Do:
1. Wash and dry your hands before staking a fingerstick measurement.
2. Always use the same meter you routinely use to measure your blood glucose. a. Blood glucose meter and strip accuracy vary between meter brands. b. Switching within a session might cause sensor glucose readings to be less
accurate.
3. Follow meter’s instructions exactly when taking your fingerstick measurement.
4. Verify test strips are current and, if required, coded correctly with meter.
5. Check: Is
Bluetooth
active?
6. Use fingerstick BG values only. a. Other sites are not as accurate. b. Must enter within five minutes of taking BG meter value. c. Enter exact BG value from your meter for each calibration.
Do Not:
7. Do not take paracetamol/acetaminophen containing medication during your session. a. See your healthcare professional to better understand how long
paracetamol/acetaminophen is active in your body.
8. Do not calibrate if your BG values are under 2.2 mmol/L or over 22.2 mmol/L. a. If BG value is outside of this range, the system does not understand these values
and will not calibrate.
i. You must wait until your blood glucose is in the range to calibrate.
Be safe—if blood glucose is low, first treat low blood sugar, and then calibrate.
6.6 Ready? Set? Calibrate!
You have followed the eight steps, have a valid BG value from your meter, and your display device keeps alerting you: Calibrate! Calibrate! Calibrate!
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Calibration
Remember:
You do not have to take a fingerstick measurement for each display device when calibrating, once you enter the reading into one, data is sent to the other within five minutes.
Next are steps to enter your calibrations using the app, followed by the steps for entering your calibrations into the receiver.
Calibrate With Your Dexcom G5 Mobile App
Step What you see What you do Additional info
1 Tap
circle
.
Initial calibration: Enter two back-to-back meter BG value.
Update calibration: Enter one meter BG value.
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Step What you see What you do Additional Info
2
Enter meter’s
BG value
using number pad. Tap
Save
.
3
Verify value is correct. Tap
Save
. If not correct: Tap
Cancel
.
Reenter correct value.
Double check your numbers.
Entering wrong BG values can affect the sensor’s accuracy.
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Step What you see What you do Additional Info
4
Tap
circle
to enter your
second BG value. Follow steps 2-3 and
enter second reading.
5
Meter icon has no calibration prompt.
Calibration accepted.
Your calibration was successful.
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Step What you see What you do Additional Info
6
Wait for next calibration prompt in 12 hours.
Default Home Trend screen.
Calibration accepted.
Calibrate With Your Dexcom G5 Mobile Receiver
Step What you see What you do Additional Info
1
Press
Select
to turn on
receiver. Press
Select
again for
Main Menu.
You will not see calibration prompts when receiver screen is black.
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Step What you see What you do Additional Info
2
Press
Up/Down Arrow
.
Highlight
Enter BG
.
Press
Select
.
3
Press
Up/Down Arrow
to change numbers. Stop at meter’s BG
value. Press
Select
.
Sensor default reading is
6.7 mmol/L. If sensor glucose
reading is within the last 15 minutes, screen will show sensor’s actual reading.
4
Verify BG value is correct.
If correct: Press
Select
.
If Select is not pressed:
• Receiver times out
• BG level is not recorded
5
Verify BG value is correct.
If incorrect: Press
Right Arrow
to
Cancel. Press
Select
.
Reenter BG value.
Cancel and re-enter BG value.
Fingerstick measurement must be within five minute window.
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Step What you see What you do Additional Info
6 Wait.
“Thinking” screen. BG value is accepted.
7
Immediately take another meter reading.
Enter meter’s BG Value.
First calibration accepted.
Time for second calibration.
8
Wait for next calibration prompt in 12 hours.
Default Trend screen. Calibration(s) accepted.
6.7 Calibration Errors
Before or during your calibration process, your display device may show error prompts. If the prompts do not go away after 15 minutes, refer to Chapter 15, Troubleshooting.
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Device What you see What it means What you do
Smart Device: In App
Sensor cannot calibrate now.
Wait 10-15 minutes. Retake fingerstick
measurement at prompt.
Enter BG value.
Receiver
Smart Device: In App
System did not accept recent calibration.
Additional calibration needed immediately.
Calibrate. No sensor glucose
readings.
Receiver
Approximately five minutes after entering your second BG meter value, your display device(s) will start providing sensor glucose readings and glucose level trends. While each display device may have different ways of presenting sensor glucose readings and trends, the meanings are the same.
Fingerstick measurements entered into one device will be available in the other approximately ten minutes after entering data.
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Summary
Now You Can:
• Calibration Overview ○ Define calibration ○ Explain the importance of calibration ○ Identify steps to ensure a successful calibration
• Recognize the steps required to take an accurate blood glucose levels ○ Identify the best blood glucose site for calibrations ○ Prepare finger for fingerstick measurement
• Determine if you should/should not calibrate ○ Recognize when you can enter BG meter values ○ Recognize when should not enter the BG meter values ○ Determine if you need to calibrate outside of the normal calibration guides
• Initiate startup calibration
• Perform maintenance calibrations
• Correctly enter your fingerstick measurement ○ Dexcom G5 Mobile App ○ Dexcom G5 Mobile Receiver
• Identify calibration errors
What Is Next?
In the next chapter, you will learn how to end a typical seven day sensor session, what to do if you need to end your sensor session early, along with removing the transmitter and determining if you need to replace it.
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Ending Your Sensor Session and Transmitter Session
7.1 Introduction
Dexcom G5 Mobile Sensor Sessions last seven days. This chapter reviews what you should expect when your session is about to expire, removing the sensor and transmitter. It also covers how to determine if you need to end your session early.
After this chapter, you will be able to:
• Identify replace sensor prompts at the end of a seven day sensor session
• Recognize when you have to end a sensor session early
• Successfully end a sensor session early ○ Identify how you can prevent sensor session failures
• Remove your sensor pod with transmitter attached
• Separate transmitter from sensor pod
• Determine if transmitter can be used for another sensor session
To keep up with your glucose trends, it is important to begin a new sensor session as quickly as possible. After a sensor session ends, the sensor stops taking your sensor glucose readings. You will not get your trends, nor will you get any Alarm or Alerts.
7.2 Ending Your Sensor Session
There are different ways your session might end. The most common is your sensor’s typical seven day timeframe ended. The second is
ending the sensor session early. You may end a session early based on a personal decision, or on rare occasions, the receiver or app detects sensor issues and prompts you to end the session.
Let us review ending a normal session first, later in this chapter we will review the prompts for ending the session early.
Chapter 7
Let Us G5! The Basics:
Ending Your Sensor Session and Transmitter Session
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Ending Your Seven Day Sensor Session
Just like other prompts, your sensor session ending prompts need clearing:
• App ○ Tap
screen
• Receiver ○ Press
Select
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Ending Your Sensor Session and Transmitter Session
End of Seven Day Sensor Session Prompts
Ending Sensor Session Prompts
Device What you see What it means
At Six Hours
Smart Device: Lock Screen
Prompts begin when sensor session has only six hours left.
Clock will countdown until session has ended.
Continue to get sensor glucose readings.
Smart Device: In App
Receiver
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Device What you see What it means
At Two Hours
Smart Device: Lock Screen
Two hours remain on your current sensor session.
Continue to get sensor glucose readings.
Smart Device: In App
Receiver
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(Continued from previous page)
Device What you see What it means
At Thirty Minutes
Smart Device: Lock Screen
Thirty minutes remain. Continue to get sensor glucose readings.
Smart Device: In App
Receiver
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Device What you see What it means
Session Ended
Smart Device: Lock Screen
Session has ended.
App Tap screen’s “?” for steps to:
• Remove sensor
• Insert new sensor
Receiver Press
Select
to clear.
Smart Device: In App
Receiver
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Ending Your Sensor Session and Transmitter Session
(Continued from previous page)
Device What you see What it means
Session Stopped
Smart Device: Lock Screen
N/A
Sensor session has stopped.
App
• No sensor glucose readings
• Prompts for new session
Receiver
• Straight line ○ No sensor glucose readings
Smart Device: In App
Receiver
Sound/Vibration Prompts
In case you cannot look at your screen, both the smart device and receiver provide beep/vibration prompts to remind you your sensor session will end in 30 minutes, it has just ended, or if your sensor failed and you need to start a new session. Remember, if your smart device is turned on to Silent or Do Not Disturb, you will not get any sound prompts.
For more information on setting your sound/vibration prompts, please see Chapter 9.
Smart Device
Your smart device prompts you with a triple beep. If not cleared, you receive the triple beep twice, five minutes apart.
Receiver
The receiver alerts you with an initial vibration prompts. If not cleared, you receive a vibrate/beep twice, five minutes apart.
Once a sensor session has expired, you are ready to start your new session! If you are not sure what to do, the app will provide instructions, or you can refer to the Quick Start Guide, tutorials, or go to Chapter 5 in this User Guide.
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Ending Your Sensor Session Early
For personal reasons, you may want to force quit a sensor session early (for example, you are getting an MRI and need to remove sensor pod).
Or, occasionally the app or receiver may detect something is wrong with your sensor and let you know it is stopping the current session.
This may be caused by a number of reasons:
1. Unresolved calibration issues
2. Error symbol does not go away
3. Wait symbol does not go away
4. Sensor is coming out of the body (for example, the adhesive is peeling off)
You will receive error prompts leading to a new sensor session. If you see error prompts, always your local Dexcom representative.
When your display device has system errors, you may not receive any sensor glucose readings and you should not calibrate.
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