Dexcom AW00096-07 G6 Personal CGM System Instructions

June 9, 2024
Dexcom

AW00096-07 G6 Personal CGM System

USER GUIDE
Welcome Home screen overview Alerts Treatment decisions Starting a new sensor Appendices
Instructions For Use

Table of Contents
Chapter 1 Welcome! 3 1.1 Get started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Chapter 2 Dexcom ONE safety statements 5 Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Important user information. . . . . . . . . . . . . . . . . . . . 5 Contraindication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Start up safety statements . . . . . . . . . . . . . . . . . . . . . 8 System/hardware/software safety statements. . . . 8 Transmitter safety statements. . . . . . . . . . . . . . . . . 11 Display device safety statements . . . . . . . . . . . . . . 12
Chapter 3 Display device screens 15 3.1 Home screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 3.2 Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 3.3 Screen issues. . . . . . . . . . . . . . . . . . . . . . . . . . . .22
Chapter 4 Alerts 23 4.1 Low and high alerts . . . . . . . . . . . . . . . . . . . . . .24 4.2 Turn on alerts . . . . . . . . . . . . . . . . . . . . . . . . . . .25
Chapter 5 Treatment decisions 29 5.1 When to use your BG meter instead of your Dexcom ONE. . . . . . . . . . . . . . . . . . . . . . . . . . . .29 5.2 When to watch and wait . . . . . . . . . . . . . . . . . . 31 5.3 How to use the trend arrows . . . . . . . . . . . . . .32 5.4 Treat with professional advice . . . . . . . . . . . . .32 5.5 Practice making treatment decisions . . . . . . .32 5.6 Additional treatment help . . . . . . . . . . . . . . . .35
Chapter 6 Starting a new sensor session 37 6.1 Remove your sensor . . . . . . . . . . . . . . . . . . . . . 37 6.2 Reuse your transmitter . . . . . . . . . . . . . . . . . . .38
Appendix A Troubleshooting 40 A.1 Accuracy ­ sensor readings do not match blood glucose meter value . . . . . . . . . 40 A.2 Accuracy ­ sensor readings do not match symptoms . . . . . . . . . . . . . . . . . . . . . . . . 41 A.3 Adhesive patch . . . . . . . . . . . . . . . . . . . . . . . . . . 41 A.4 App shuts off . . . . . . . . . . . . . . . . . . . . . . . . . . . .43 A.5 Cannot hear alerts . . . . . . . . . . . . . . . . . . . . . .43 A.6 Common alerts . . . . . . . . . . . . . . . . . . . . . . . . .44 A.7 End sensor session early . . . . . . . . . . . . . . . . . .48 A.8 Gap in graph . . . . . . . . . . . . . . . . . . . . . . . . . . . .49 A.9 Technical support . . . . . . . . . . . . . . . . . . . . . . .49 A.10 Recharge receiver . . . . . . . . . . . . . . . . . . . . . .50 A.11 Water and Dexcom ONE . . . . . . . . . . . . . . . . .50
Appendix B Dexcom Clarity 51

Dexcom ONE User Guide

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Appendix C Taking care of your Dexcom ONE 52
C.1 Dexcom ONE storage and maintenance . . . .52 C.2 System disposal . . . . . . . . . . . . . . . . . . . . . . . . .53
Appendix D Packaging Symbols 54
Appendix E Risks and Benefits 57 E.1 Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 E.2 Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59
Appendix F Dexcom ONE Warranty 61 F.1 Dexcom receiver limited warranty . . . . . . . . . 61 F.2 Dexcom sensor limited warranty . . . . . . . . . . .63 F.3 Dexcom transmitter limited warranty . . . . . . .64
Appendix G Technical information 67 G.1 Device performance characteristics summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .67 G.2 Product specifications . . . . . . . . . . . . . . . . . . .68 G.3 Radio regulations compliance. . . . . . . . . . . . . 75
Appendix H Professional use instructions 76 H.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76 H.2 Prepare Dexcom ONE for patient . . . . . . . . . . 76 H.3 Explain to patient what Dexcom ONE is and how it works . . . . . . . . . . . . . . . . . . . . . . . .79 H.4 Set up Dexcom ONE with patient . . . . . . . . .79 H.5 Follow up with patient . . . . . . . . . . . . . . . . . . 80 H.6 Next steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Appendix I Glossary 82
Index 86

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Dexcom ONE User Guide

Chapter 1
Welcome!
Congratulations on making the Dexcom ONE Continuous Glucose Monitoring (CGM) System (Dexcom ONE) part of your life!
1.1 Get started
To set up your Dexcom ONE, follow instructions in the Start Here guide or the Dexcom ONE video tutorials available at dexcom.com.

This booklet, the Dexcom ONE User Guide, introduces you to the home screen, shows you how to turn on alerts and customize your alert sounds, guides you through making treatment decisions, and shows you how to start a new sensor session.
Images in this guide are representational. Your materials may look different.
Optional receiver may not be available in all regions.

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Welcome!

Critical safety notices
Dexcom ONE alerts
No glucose alerts unless you turn them on.
· Turn on alerts during setup to get glucose and system alerts when sensor warmup is over.
Dexcom ONE alerts will NOT override your smartphone’s settings.
· You will NOT hear high or low glucose alerts if your phone is set to silent (sound is turned off)
· You will hear alerts ONLY when your smartphone’s sound is turned on.
· Check your smartphone’s settings or you may miss an alert.
Dexcom ONE alerts will NOT override your receiver settings.
· If your receiver is set to vibrate, you will not hear high or low glucose alerts.
· Turn on receiver sound to hear alerts.

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Dexcom ONE User Guide

Welcome!

Chapter 2
Dexcom ONE safety
statements
Indications for use
The Dexcom ONE Continuous Glucose Monitoring System (Dexcom ONE) is a glucose monitoring system indicated for persons, including pregnant women, ages 2 years and older. Dexcom ONE is designed to replace fingerstick blood glucose (BG) testing for diabetes treatment decisions.
Interpretation of Dexcom ONE results should be based on the glucose trends and several sequential readings over time. Dexcom ONE also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
Dexcom ONE is intended for use by patients at home and in healthcare facilities.
Important user information
Please review the product instructions before using Dexcom ONE. Indications, contraindications, warnings, precautions, and other important user information can be found in the product instructions that are included with Dexcom ONE. You and your healthcare professional must discuss how you should use the information displayed on Dexcom ONE to help manage your diabetes. Getting familiar with the system could take days, weeks, or even months. The product instructions contain important information on troubleshooting Dexcom ONE and on the performance characteristics of the system.
Contraindication
· No MRI/CT/diathermy ­ MR unsafe MR
Do not wear any component of Dexcom ONE during magnetic resonance imaging (MRI), computed tomography (CT) scan, or highfrequency electrical heat (diathermy) treatment.

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Dexcom ONE safety statements

Dexcom ONE has not been tested in those situations. The magnetic fields and heat could damage the components of Dexcom ONE, which may cause it to display inaccurate CGM sensor glucose readings (Dexcom ONE readings) or may prevent alerts. Without Dexcom ONE readings or alert notifications, you might miss a severe low or high glucose event.
Warnings
· Read user materials
Before you use your Dexcom ONE, carefully read the materials included with it. If you do not, you might:
· Not use Dexcom ONE correctly
· Not understand Dexcom ONE information
· Affect how well it works
· Do not ignore low/high symptoms
Do not ignore how you feel. If your glucose alerts and Dexcom ONE readings do not match what you are feeling, use your blood glucose meter (BG meter) to make diabetes treatment decisions or, if needed, seek immediate medical attention.
When in doubt, get your BG meter out.
· No number, no arrow, no CGM treatment decision
If your Dexcom ONE does not show a number or arrow, or your Dexcom ONE readings do not match your symptoms, use your BG meter to make diabetes treatment decisions.
No number, no arrow, no treatment decision. When in doubt, get your BG meter out.
· Do not use if…
Do not use Dexcom ONE if you are on dialysis, or critically ill. It is not known how different conditions or medications common to these populations may affect performance of the system. Dexcom ONE readings may be inaccurate in these populations.

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Dexcom ONE User Guide

Dexcom ONE safety statements

· Take Healthcare Professional Advice
Has your healthcare professional given you selfmonitoring tasks? You should keep doing them. Having Followers does not replace medical advice.
Follow Dexcom ONE instructions. If you do not, you could have a severe low or high glucose event.

Precaution
· Avoid sunscreen and insect repellent
Some skin care products, such as sunscreens and insect repellents, can make the plastic used in your Dexcom ONE crack. Before using your Dexcom ONE, make sure there are no cracks in your transmitter and transmitter holder. If you find a crack, please contact Technical Support at dexcom.com, or contact your local Dexcom representative. Do not allow these skin care products to contact your Dexcom ONE. After using skin care products, wash your hands before touching your Dexcom ONE. If any skin care products get on your Dexcom ONE, immediately wipe with a clean cloth.
· Hydroxyurea precaution
If you are taking hydroxyurea, your Dexcom ONE readings may be falsely elevated and result in missed hypoglycemia alerts or errors in diabetes management decisions. The level of inaccuracy depends on the amount of hydroxyurea in your body. Use your BG meter.
· Going through security check point
When wearing your Dexcom ONE, ask for hand-wanding or full-body pat-down and visual inspection instead of going through the Advanced Imaging Technology (AIT) body scanner (also called a millimeter wave scanner) or putting any part of the Dexcom ONE system in the baggage x-ray machine.
You can wear Dexcom ONE for the walk-through metal detector. If you do, use your BG meter for treatment decisions until you leave the security area.
Because we have not tested every x-ray and scanner, we do not know if they damage Dexcom ONE.

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Dexcom ONE safety statements

Not sure what kind of machine it is? Be safe ­ request either hand-wanding or full-body patdown.
Start up safety statements
Warnings
· Use BG meter during startup
When you start a new sensor, you will not get any Dexcom ONE readings or alerts until you enter your sensor code. Use your BG meter to make treatment decisions during the 2-hour sensor warmup period.
Precautions
· Use correct sensor code
When you start a new sensor, you must enter a code into your display device to use Dexcom ONE. Each sensor has its own code printed on the back of the adhesive patch. Do not use a code from a different sensor or make up a code. If you do not enter the correct code, your sensor will not work as well and could be inaccurate.
System/hardware/software safety statements
Warnings
· Sensor wire breaks off or detaches
Do not ignore broken or detached sensor wires. A sensor wire could remain under your skin. If this happens, please contact Technical Support at dexcom.com, or contact your local Dexcom representative.
If a sensor wire breaks off under your skin and you cannot see it, do not try to remove it. Contact your Healthcare Professional as soon as possible. Also seek professional medical help if you have symptoms of infection or inflammation ­ redness, swelling, or pain ­ at the insertion site.

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Dexcom ONE User Guide

Dexcom ONE safety statements

· Where to insert: abdomen, back of arms, or buttocks?
All patients can use their abdomen or back of upper arms. Patients 2 to 17 years old can also choose their upper buttocks. Look for a place on your abdomen, back of upper arms, or upper buttocks where you have some padding.
The sensor is not tested or approved for other sites. Talk to your Healthcare Professional about the best site for you.
Ages 2-17 years: Insert in your abdomen, back of upper arms, or upper buttocks
Ages 18 and older: Insert in your abdomen or back of upper arms.

Ages 2-17
Can insert in upper buttocks

Anyone age 2 or older
Can use abdomen or back of upper arm

· Where to store
You can store your sensors at room temperature or in your refrigerator ­ as long as it is between 2°C and 30°C. Do not store sensors in the freezer.
Precautions
· Do not start sensor past use by date
You can start a new sensor on or before its Use By date. This gives you full wear.
Starting a sensor past its Use By date may cause incorrect results.

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Dexcom ONE safety statements

The Use By date is in YYYY-MM-DD (Year-Month-Day) format on the sensor package label, next to the hourglass symbol.
· Check package
Do not use sensor if its sterile package has been damaged or opened, because it might cause an infection.
· Clean and dry skin
Clean and dry your hands and your insertion site before inserting your sensor.
Wash your hands with soap and water, not gel cleaners, and then dry them before opening the sensor package. If your hands are dirty when you insert the sensor, you may get germs on the insertion site and get an infection.
Clean your insertion site with alcohol wipes to prevent infections. Do not insert the sensor until your skin is dry. If your insertion site is not clean and completely dry, you run the risk of infection or the transmitter holder not sticking well.
Make sure you do not have insect repellent, sunscreen, perfume, or lotion on your skin.
· Where to insert: things to check
Keep the safety guard on until you put the Dexcom ONE applicator against your skin. If you remove the safety guard first, you may hurt yourself by accidentally pushing the button that inserts the sensor before you mean to.
Change your insertion site with each sensor. Using the same site too often might not allow the skin to heal, causing scarring or skin irritation.
Sensor placement is important. Choose a site:
· At least 8 cm from insulin pump infusion set or injection site
· Away from waistband, scarring, tattoos, irritation, and bones
· Unlikely to be bumped, pushed, or laid on while sleeping

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Dexcom ONE User Guide

Dexcom ONE safety statements

· Use correct transmitter and sensor
Dexcom ONE components are not compatible with any previous Dexcom products. Do not mix transmitters, receivers, and sensors from different generations.
Transmitter safety statements
Warnings
· Inspect
Do not use a damaged or cracked transmitter. A damaged transmitter could cause injuries from electrical shocks and may make Dexcom ONE not work correctly.
· Use as directed
The transmitter is small and may pose a choking hazard. Do not put it in your mouth or let children hold it without adult supervision.
Precautions
· Reuse transmitter ­ do not throw away
When ending a session, do not throw away the transmitter. The transmitter is reusable until Dexcom ONE notifies you that the transmitter battery is about to expire.
For Healthcare Professionals: Please see cleaning and disinfection instructions in Professional Use Instructions.
· Do not start transmitter past use by date
You can start a new transmitter on or before its Use By date to get full use.
Starting a transmitter past its Use By date may cause incorrect results.
The Use By date is in YYYY-MM-DD (Year-Month-Day) format on the transmitter package label, next to the hourglass symbol.

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Dexcom ONE safety statements

Display device safety statements

Warnings
· Check settings
· Optional alerts: You will be prompted to turn on the optional alerts when setting up your Dexcom ONE system. You must turn them on to get glucose and system alerts. Follow the instructions and safety warnings in this user guide to make sure you receive alerts on your display device.
No glucose alerts unless you turn them on. Turn alerts on during setup to get glucose and system alerts when sensor warmup is over. Dexcom ONE alerts will NOT override your display device settings. You will NOT hear high or low glucose alerts if your display device is set to silent (sound is off). Check your display device settings, or you may miss an alert.
· Smartphone volume/sound: Make sure your smartphone volume is turned up, not muted and speaker works. If your smartphone is on mute, “Total Silence,” or “Do Not Disturb” modes, you will not receive any alerts related to Dexcom ONE.
· Receiver volume/sound (optional display device): Test your receiver speaker and vibrations regularly.
To make sure the speaker and vibrations work, plug in the receiver to charge. The Speaker Test screen appears for a few seconds. Follow the directions on the screen to test the speaker and vibrations. If it doesn’t beep and vibrate, Contact Technical Support at dexcom.com or your local Dexcom representative, and use your app or BG meter until the receiver is fixed.
· Bluetooth®: When using Bluetooth headphones, speakers, etc., your alerts may sound on your display device or on the smartphone accessory. Each accessory is different. Test yours so you know where you will hear your alerts.

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Dexcom ONE User Guide

Dexcom ONE safety statements

· Notifications (smartphone): Make sure your smartphone settings allow Dexcom app notifications to show on your lock screen. This will allow you to see notifications without unlocking your phone. During Dexcom ONE setup, enable Dexcom app notifications or you will not get alerts.
· Battery: Keep the battery of your display device charged to avoid missing Dexcom ONE data.
· Compatibility (smartphone): Before upgrading your smartphone or its operating system, check dexcom.com/compatibility. Automatic updates of the app or your phone operating system can change settings or shut down the app. Always update manually and verify correct device settings afterward.
· Time (smartphone): Let the date and time on your smartphone automatically update when you travel across time zones or switch between standard and daylight-saving times. Do not manually change your smartphone time, because it can make the time on the trend screen wrong and the app may stop displaying data.
· Do not use receiver if damaged (receiver is an optional display device): Do not use a receiver that is damaged or cracked. A damaged receiver could cause injuries from electrical shocks and may make the Dexcom ONE System not work correctly.
Follow Dexcom ONE instructions. If you do not, you could have a severe low or high glucose event.
Tips
· Use Dexcom ONE receiver: If you use the Dexcom receiver, be sure to use the one that comes with your Dexcom ONE system. Receivers from previous generations won’t work with the Dexcom ONE system.

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Dexcom ONE safety statements

Precautions
· Keep transmitter close to display device:
Keep your transmitter and display device within 6 meters with no obstacles (like walls or metal) between them. Otherwise, they might not be able to communicate. If water is between your transmitter and the display device ­ for example, if you are showering or swimming ­ keep them closer to each other. The range is reduced because Bluetooth does not work as well through water.
· Keep receiver clean and dry (receiver is an optional display device): Do not submerge your receiver in water and do not get dirt or water in the USB port. That could damage it.
· Get alerts on display device you use
You will be prompted to turn on the optional alerts when setting up your Dexcom ONE system. You must turn them on to get glucose and system alerts.
No glucose alerts unless you turn them on. Turn alerts on during setup to get glucose and system alerts when sensor warmup is over. Dexcom ONE alerts will NOT override your phone’s settings. You will NOT hear high or low glucose alerts if your phone is set to silent (sound is off). Check your phone’s settings, or you may miss an alert.
· Is it on?
If the display device is turned off (shut down), it will not show Dexcom ONE readings or alerts. Make sure your display device is turned on.
· Check smartphone accessory devices
When using smartphone accessory devices (such as headphones or Bluetooth speakers), keep in mind you may get your alerts on only one device or accessory, not all. After connecting any smartphone accessory devices, make sure that your smartphone settings allow you to continue receiving alerts.

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Dexcom ONE User Guide

Dexcom ONE safety statements

Chapter 3
Display device screens
This chapter describes the Dexcom ONE glucose information and navigation features on your display device.
3.1 Home screen
You spend most of your time on the home screen. It shows your sensor readings (readings) and glucose trend information. In the app, the home screen is called the Glucose screen. Access it by tapping the Glucose icon in the navigation menu.
Overview
The home screens have 3 main sections:
1. Sensor reading (number) and trend arrow
2. Trend graph
3. Navigation menu or Menu
App home screen

Sensor

8.5

reading

mmol/L

Trend arrow

Trend graph

3 Hours 6 12 24

22 18 14.0 10

9:00

10:00

11:00

3.9 2
Now

Glucose

Reports

Settings

Navigation menu

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Display device screens

Receiver home screen

Sensor reading
Trend graph

10:30

50%

8.3 mmol/L 22

14.0

8:00 9:00 3 Hours

3.9 2
10:00 Now
Menu

Trend arrow
Menu Navigation

Sensor readings

The number at the top of your home screen is your current sensor reading. It updates every 5 minutes.

App

Receiver

8.5
mmol/L

8.5 mmol/L

If alerts are OFF, the app background and receiver text will always be white.
When you turn on your:
· Low Alert: Color changes to red when your glucose goes too low.
· High Alert: Color changes to yellow when your glucose goes too high.

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Display device screens

Trend arrow
Trend arrows help you predict where your glucose will be in the next 30 minutes. Use them to be proactive in managing your diabetes.
App Receiver What it means
Steady Changing up to: · 0.06 mmol/L each
minute · 1.8 mmol/L in 30
minutes
Slowly rising or falling Changing: · Between
0.06­0.1 mmol/L each minute · Up to 3.4 mmol/L in 30 minutes
Rising or falling Changing: · Between
0.1­0.2 mmol/L each minute · Up to 5 mmol/L in 30 minutes
Rapidly rising or falling Changing more than: · 0.2 mmol/L each
minute · 5 mmol/L in 30
minutes
No arrow Cannot determine trend. Use BG meter to make treatment decisions.

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Display device screens

Trend graph
The trend graph displays current and past readings and shows your alert levels when alerts are turned on.
App

Hours Shown
High Alert Level (when alert is on)
Low Alert Level (when alert is on)

3 Hours 6 12 24

22 18 14.0 10

9:00

10:00

11:00

3.9 2
Now

Alert settings
Current Sensor Reading

Past sensor readings

Receiver

High Alert Level (when alert is on)
Low Alert Level (when alert is on)
Hours shown

Past Sensor Readings

22

14.0

8:00 9:00 3 Hours

3.9 2 10:00 Now
Menu

Current Sensor Reading
Menu

· Current and past sensor readings: The larger dot on the right is your current reading. The smaller dots to the left are your past readings.
· High and Low Alert levels: When alerts are on, they appear as lines on your trend graph. Low is red. High is yellow.
· Target range: The gray box shows the fixed target range of 3.9-10.0 mmol/L, the international consensus for the recommended target range.

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Dexcom ONE User Guide

Display device screens

App only
· Hours shown: To show readings over the past 3, 6, 12, or 24 hours, tap a number at the top.
· Alert settings: Turn on alerts or adjust an alert setting by tapping the More menu (3 dots).

Receiver only
· Hours shown: To show readings over the past 3, 6, 12, or 24 hours, use the up and down navigation buttons.
· Menu: Access the Menu by pressing the round Select button.

App navigation menu

You can access other features in the app using the icons in the navigation menu.

Icon

Description

Glucose: Your home screen

Reports: Shows your glucose information for a specific period, including average glucose and average time in range.
Settings: Edit alerts, change settings, customize sounds, and more.

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Display device screens

Receiver navigation menu
From the home screen, press the Select button to access the Menu. This gets you to other features. Use the navigation buttons to move around the receiver. The receiver screens show you where to press.

Scroll up Go back

10:30

50%

Menu

Reports

Settings

Information

Help

Replace Sensor

Stop Sensor Session

Power Off

Back

Select Scroll down

· Reports: Get your summary glucose information for a specific period.
· Settings: Edit alerts, change settings, customize sounds, and more. (More in Chapter 4: Alerts.)
· Information: Find out how much time you have left in your sensor. You can also test the speaker.
· Replace sensor and stop sensor session: Stop this sensor and start a new one. (More in Chapter 6: Starting a new sensor.)
· Power off: Turn off the receiver. No readings or alerts when powered off.

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Dexcom ONE User Guide

Display device screens

3.2 Reports
Using your navigation menu, access glucose reports that summarize your glucose data for a specific period. To access your reports in the:
· App: Tap the Reports icon in the navigation menu.
· Receiver: From the home screen, go to Menu > Reports to choose a report.
Available information:
· Average Glucose: The average of all the readings in the selected date range.
· GMI: (Glucose Management Indicator) Approximates your A1C level based on your average glucose from at least 12 days of CGM data.
· Time in Range: Percentage of time that glucose levels are in Low, Target, and High ranges based on international consensus for target range.

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Display device screens

3.3 Screen issues
Sometimes the number is missing, or you are not getting readings.

Display App

What it means

LOW
Receiver
LOW

Sensor reading is below 2.2 mmol/L.

App

HIGH
Receiver
HIGH
App

Sensor reading is above 22.2 mmol/L.

Signal Loss
Always keep phone within 6 meters of transmitter. Wait up to 30 minutes.
Help

Receiver

10:30

50%

Signal Loss
Always keep receiver within 6 meters of transmitter.
Wait up to 30 minutes.

System alerts show system issues not related to your glucose, but they tell you that you are NOT getting readings or alerts. (More in Appendix A: Troubleshooting.)

OK

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Display device screens

Chapter 4
Alerts
Turning on alerts can help you stay in your target range. They are an important tool when making treatment decisions with Dexcom ONE. Talk to your healthcare professional about the best Low Alert and High Alert settings for you.
When alerts are turned on, you will hear them or feel them vibrate when your glucose is too high or too low, or when your readings are temporarily unavailable.
Critical safety notices
Dexcom ONE alerts
No glucose alerts unless you turn them on.
· Turn on alerts during setup to get glucose and system alerts when sensor warmup is over.
Dexcom ONE alerts will NOT override your smartphone’s settings.
· You will NOT hear high or low glucose alerts if your smartphone is set to silent (sound is turned off).
· You will hear alerts ONLY when your smartphone sound is on.
· Check your smartphone’s settings or you may miss an alert.
Dexcom ONE alerts will NOT override your receiver settings.
· If your receiver is set to vibrate, you will not hear high or low glucose alerts.
· Turn on receiver sound to hear alerts.

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Alerts

4.1 Low and high alerts

What You See App
Low Glucose
3.8
mmol/L

Receiver

10:30

50%

Low Glucose Alert
3.8 mmol/L

OK
App
High Glucose
18.5 mmol/L

Receiver

10:30

50%

High Glucose Alert
18.5 mmol/L

OK

What It Means
Low Glucose Alert (Low Alert)
Lets you know your Dexcom ONE sensor reading is below your Low Alert level.
· Turn on your Low Alert during setup.
· Change it in the app by going to Settings > Alerts.
· Change it in receiver by going to Menu > Settings > Alerts.
· You can choose your alert level and tone.
High Glucose Alert (High Alert)
Lets you know when your Dexcom ONE sensor reading is above your High Alert level.
· Turn on your High Alert during setup.
· Change it in the app by going to Settings > Alerts.
· Change it in receiver by going to Menu > Settings > Alerts.
· You can choose your alert level and tone.

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Dexcom ONE User Guide

Alerts

4.2 Turn on alerts
Dexcom ONE gives you the option of turning on alerts when you set up your system. You just follow the prompts on your screen. You can also turn on or change your alerts after setup.
App
1. Go to Settings > Alerts.
2. Tap the alert you want to set.
3. Follow the screen prompts.

Settings

Alerts

Low

Off

High

Off

Signal Loss

Off

Brief Sensor Issue

Off

Technical Alerts

On

Dexcom ONE alerts will not override your phone settings.
You will NOT hear or feel alerts if your phone is set to silent.

Glucose

Reports

Settings

You can also turn on or adjust your Low Alert and High Alert by tapping the More icon in the top-right corner of your trend graph.

iOS

Android

App alert settings
· Dexcom ONE alerts will NOT override your smartphone’s settings. You will NOT hear high or low glucose alerts if your smartphone is set to silent (sound is off). Check your smartphone’s settings, or you may miss an alert.
· Alert vibrations feel the same as notifications you get from other apps on your smartphone. The only way to know if it is from Dexcom ONE is to look at your smartphone.

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Alerts

Receiver 1. Go to Menu > Settings > Alerts. 2. Select the alert you want to set. 3. Follow the screen prompts.

10:30

50%

Alerts

Low Off

High Off

Signal Loss Off

Brief Sensor Issue Off

Back

Receiver alert settings
· Dexcom ONE alerts will NOT override your receiver settings.
· If your receiver is set to vibrate, you will NOT hear high or low glucose alerts.
· Check your receiver sound settings: Go to Menu > Settings > Alert Sounds.
· Turn on receiver sound to hear alerts.

Customizing alert sounds
App Tap Tone in an alert menu to choose a different sound for that alert.

Alerts

Low Alert

Low
Alerts you when your sensor reading is at or below the set level. It’s the red line on the glucose graph.

Level

3.9 mmol/L

Tone

Low (Default)

Dexcom ONE alerts will not override your phone settings.
You will NOT hear or feel alerts if your phone is set to silent.

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Alerts

Receiver To choose different alert sounds on your receiver: 1. Go to Menu > Settings > Alert Sounds. 2. Select a sound style, such as Soft Tones.

10:30

50%

Alert Sounds

Choose how you want your alerts to notify you. All alerts will notify you this way.

Vibrate Only

Soft Tones

Normal Tones

Melodies

Back

Use alerts to achieve goals
You should talk with your healthcare professional to customize your alerts to help you achieve your goals. For example, are you worried about insulin stacking–taking doses too close together?
To use your Dexcom ONE as a tool to avoid insulin stacking, your healthcare professional should advise you to turn on the Snooze feature in your High Alert setting. That way, you can choose how long you want to wait before getting another High Alert after you confirm the first one. The alert will repeat at the interval you choose until your Dexcom ONE readings are back in your target range. This reminds you to check your readings later to make sure your glucose values have come down.

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Alerts

The screens below show Snooze Alerts set at 2 hours. If your Dexcom ONE readings remain high for 2 hours after your first High Alert, you will get another alert. This lets you know you might want to take more insulin. If 2 hours pass and you are in your target range, your High Alert will not repeat.

App

Receiver

Cancel

Save

Snooze
After you acknowledge your first alert, it repeats if your sensor reading stays high for this long. Select a repeat time between 15 minutes and 4 hours.

2 hours
1 2
3

00 min
05 10
15

10:30

50%

Snooze
After you acknowledge your first alert, it repeats if your sensor reading stays high for this long.

2 : 00
MM

Back

Next

If your sensor readings tend to be high after meals, your healthcare professional may advise you to delay your first High Alert to give your insulin a chance to work. You can set the Delay 1st Alert and select the length of the delay in the High Alert setting.
Changes you make to alerts in your app are not reflected in your receiver and vice versa. If you want the alerts to be the same, you need to make changes to both devices.

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Alerts

Chapter 5
Treatment decisions
With Dexcom ONE, you can make treatment decisions without using your blood glucose (BG) meter (BG meter). However, you should keep using your BG meter to make treatment decisions until you know how Dexcom ONE works for you.
Sometimes you must use your BG meter instead of Dexcom ONE. And other times it is best not to treat, just watch and wait.
Work with your healthcare professional to put together a plan for making treatment decisions. Always use your healthcare professional’s instructions to treat.
You can keep using your BG meter until you are familiar with your CGM.
Both your BG meter and your CGM give you a number. They measure glucose from different sources (blood and interstitial fluid), so those numbers may be different. And, if you took a lab test at the same time, the lab result may give you a third number. The lab result is considered the most accurate number.
5.1 When to use your BG meter instead of your Dexcom ONE
We do not recommend continuous glucose monitoring for people who cannot or will not:
· Use their BG meter to test their blood glucose if their symptoms do not match their Dexcom ONE readings.
· Keep in touch with their healthcare professional about diabetes management.

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Treatment decisions

Rely on your BG meter for treatment decisions when:
· Dexcom ONE is missing a number, an arrow, or both.
Examples: Use your BG meter if you see any of these.

Display App

What it means

HIGH
Receiver
HIGH
App

No number

8.5
mmol/L
Receiver
8.5 mmol/L

No arrow

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Treatment decisions

Display App

What it means

Signal Loss
Always keep phone within 6 meters of transmitter. Wait up to 30 minutes.
Help

Receiver

10:30

50%

No number or arrow

Signal Loss
Always keep receiver within 6 meters of transmitter.
Wait up to 30 minutes.

OK
In other words, no number, no arrow, no CGM treatment decision.
· Your Dexcom ONE readings do not match your symptoms.
Example: you do not feel right but your readings show your glucose is in target range. Wash your hands thoroughly and use your BG meter. If the BG meter value matches your symptoms, use the BG meter value to treat.
5.2 When to watch and wait
There are times when you should not treat at all, just watch and wait.
Stacking insulin: Do not stack insulin by taking doses too close together. Wait at least 2 hours between doses so you do not accidentally force your glucose down too low. Sometimes, it is best to watch and wait.

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Treatment decisions

5.3 How to use the trend arrows
Talk to your healthcare provider about using the trend arrows to determine how much insulin to take.
Up arrow: Consider taking a little more insulin when your glucose is rising
Down arrow: Consider taking a little less insulin than usual when your glucose is falling
5.4 Treat with professional advice
Talk to your healthcare provider about: · Using Dexcom ONE to manage your glucose · Setting alert levels · Comparing BG meter values and sensor
readings · Fingerstick best practices
5.5 Practice making treatment decisions
Use the examples below to practice making treatment decisions. Discuss them with your healthcare professional and review: · When you need to use your BG meter · How you can use your Dexcom ONE · When to watch and wait instead of treat You can keep using your BG meter until you are familiar with your CGM.

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Situation

Solution

Early morning: Think about:

Your Low Alert wakes you up.

· Number and Arrow: You have both.

You see: 4.4
mmol/L

· Number: Your glucose is low ­ 4.4 mmol/L.
· Slowly Falling Arrow: Glucose is falling up to 3.4 mmol/L in 30 minutes.

What you should do:

· Use your Dexcom ONE to treat as you normally would.

Breakfast time: Think about:

Ninety minutes

· Number and Arrow:

later you are sitting You have both.

down for breakfast. · Up Arrow: Glucose is

You see:

rising up to 5 mmol/L

in 30 minutes.

7.3

What you should do:

mmol/L

· Use your Dexcom ONE

to treat. Take your

normal dose and,

because of the up

arrow, a little more.

After breakfast: Think about:

Thirty minutes after · Insulin: You took

dosing to cover

insulin less than an

breakfast, you get

hour ago. It takes time

a High Alert.

to work.

You see:

What you should do:

· Nothing. Watch and

12.4 mmol/L

wait to avoid stacking insulin. Do not treat

for at least another

hour and a half.

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Treatment decisions

Situation An hour later: You watched and waited. You see:
9.1
mmol/L

Mid-morning:
You are about to have a midmorning snack.
You see:

3 Hours 6 12 24

9:00

10:00

11:00

22 18 14 10 6 2 Now

Lunch time: Three hours later, you are about to dose for lunch. You see:
6.1
mmol/L

Solution
Think about:
· Insulin: The insulin you took with breakfast has you back in your target range.
What you should do:
· Nothing. No treatment needed.
Think about:
· No number and No arrow: You have neither. Notice the gap in Dexcom ONE readings.
· Error Message: You are not getting Dexcom ONE readings.
What you should do:
· Use your BG meter for treatment decisions.
Think about:
· Number and Arrow: You have both.
· Down arrow: Your glucose is falling up to 5 mmol/L in 30 minutes.
What you should do:
· Use your Dexcom ONE to treat. Because of the down arrow, take a little less.

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Treatment decisions

Situation Mid-afternoon: It is 3 hours after lunch. You see:
12.4 mmol/L

Solution
Think about:
· Number and no arrow: You do not have an arrow.
What you should do:
· Use your BG meter for treatment decisions.

Early Evening: Just before dinner, you feel a little shaky and sweaty. You see:
6.8
mmol/L

Think about:
· Symptoms and Dexcom ONE reading: Your symptoms do not match your Dexcom ONE sensor readings.
What you should do:
· Thoroughly wash your hands and take a fingerstick. If your BG meter value matches your symptoms, use it for treatment decisions.

5.6 Additional treatment help
Talk to your healthcare professional about: · Using Dexcom ONE to manage your diabetes · Setting High and Low alert levels · Comparing BG meter values and sensor
readings · Fingersticking best practices
Online video tutorials
Access online video tutorials at dexcom.com. You can view videos on the following topics: · Sensor accuracy · Getting started and setting up the app · Inserting your sensor and attaching the
transmitter

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Treatment decisions

· How to replace your sensor
· Traveling with your Dexcom CGM
We also have training available online to support your continuous glucose monitoring (CGM) learning experience.

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Chapter 6
Starting a new sensor
session
Each sensor session lasts 10 days.
Settings show when your current session ends. Your Dexcom ONE alerts you when you have 24 hours left in your session, then 6 hours, 2 hours, and finally, 30 minutes.
A final alert lets you know your session has ended. When you get that alert, follow the steps in this chapter to remove your current sensor and start a new one.
To start a new session before the sensor expires completely, follow the instructions in Appendix A: Troubleshooting.
Remember, after your sensor session has ended, you will not get any sensor readings. To resume getting sensor readings, follow the steps below to remove the old sensor, then insert a new one, and complete the sensor warmup.

6.1 Remove your sensor
Follow these steps to: · Take your sensor off your body. · Remove your transmitter from the holder.

Dexcom ONE lets you know when to replace sensor.

App

Receiver

Sensor Expired

No Alerts

1

Remove Sensor Now

No readings or alerts until you start a new

sensor.

OK Sensor Removal Instructions

10:30

50%

Sensor Expired
Remove sensor now.
No readings or alerts until you start a new sensor.

Start New Sensor Dismiss

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Starting a new sensor session

Peel off patch from the edge. Remove the sensor, transmitter holder, and transmitter. 2
Break transmitter holder at the notches.
3
Slide transmitter out. Keep transmitter to use with next sensor. Throw out adhesive patch according to your local guidelines for disposal of blood4 contacting components.

6.2 Reuse your transmitter
Your transmitter lasts 3 months. Reuse it for multiple sensor sessions. Dexcom ONE tells you when your transmitter will need to be replaced, starting 3 weeks before. If it is your only transmitter, visit dexcom.com or contact your local Dexcom representative to order another.
When the transmitter has less than one sensor session of battery life left, you will not be able to use it to start a new sensor session.

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Starting a new sensor session

APPENDIX
Troubleshooting Dexcom Clarity Taking care of your Dexcom ONE Packaging symbols Warranty Technical information Professional use instructions Glossary

Appendix A
Troubleshooting
This appendix has brief instructions for the most common questions. They are listed in alphabetical order, as shown below: A.1 Accuracy ­ sensor readings do not match blood glucose meter value A.2 Accuracy ­ sensor readings do not match symptoms A.3 Adhesive patch A.4 App shuts off A.5 Cannot hear alerts A.6 Common alerts · Brief sensor issue · Pairing unsuccessful · Signal loss alert · Transmitter battery low and last session alerts · Transmitter failed A.7 End sensor session early A.8 Gap in graph A.9 Technical support A.10 Recharge receiver A.11 Water and Dexcom ONE For full troubleshooting information, go to the frequently asked questions section on the Dexcom website (dexcom.com).
A.1 Accuracy ­ sensor readings do not match blood glucose meter value
Different body fluids give different numbers: · BG meter measures glucose from blood. · Dexcom ONE sensor measures glucose from
interstitial fluid.

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A.2 Accuracy ­ sensor readings do not match symptoms
If your readings do not match your symptoms: · Wash your hands with soap and water. Dry
them. Then take a fingerstick with your BG meter. If your BG meter value matches your symptoms, use it to make treatment decisions.
A.3 Adhesive patch
Issue
Applicator will not come off

Solution

1. Gently peel off adhesive patch with applicator attached.
2. Check insertion site to make sure the sensor is not left in the skin.
3. Do not reuse applicator.
4. Contact Technical Support at dexcom.com, or contact your local Dexcom representative.

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Troubleshooting

Issue Adhesive patch peeling off body

Solution
After your sensor is inserted, you can reduce peeling by:
· Putting Overpatch or medical tape (such as Blenderm) over the adhesive patch. Do not cover transmitter. Avoid open wounds.
· To order Overpatch, contact Technical Support at dexcom.com, or contact your local Dexcom representative.

Overpatch

Medical Tape

For your next sensor session, you can prevent

peeling before inserting your sensor by:

· Making sure your skin is clean and dry before inserting sensor.

· Using adhesive products (such as Mastisol®, SkinTacTM) under patch. Avoid spot where needle inserts.

· Thoroughly rubbing patch onto skin.

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Troubleshooting

Issue
Skin irritation around sensor site
Solution
Some people are sensitive to the sensor adhesive. If you have significant skin irritation, such as itching, burning and/or rashes at the site of the adhesive patch, contact your health care professional.
A.4 App shuts off
If your app shuts itself off, it may be because the smart device’s memory or storage is full. To fix this, close open apps that are not in use and delete files you do not use.
A.5 Cannot hear alerts
1. No glucose alerts unless you turn them on. If you did not turn on alerts during setup, turn them on now.
· App: Go to Settings > Alerts
· Receiver: Go to Menu > Settings > Alerts
2. Dexcom ONE alerts will NOT override your smart device’s settings.
· App: You will NOT hear high or low glucose alerts if your phone is set to silent (sound is off) or vibrate.
· Receiver: If your receiver is set to vibrate, you will not hear high or low glucose alerts. Turn on receiver sound to hear alerts: Menu > Settings > Alert Sounds.
3. If alerts are turned on, and your smartphone is set to sound, verify that the app, Bluetooth, volume, and notifications are on.
4. Go to Chapter 2 for suggested smartphone settings. Go to your smartphone product instructions to test the speaker.

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Troubleshooting

A.6 Common alerts

Issue Brief sensor issue App
No Alerts Brief Sensor Issue Don’t remove sensor. Temporary issue. Wait up to 3 hours.
OK

Receiver

10:30

50%

Brief Sensor Issue
Don’t remove sensor. Temporary issue.
Wait up to 3 hours.

OK
Sensor is temporarily unable to measure glucose.
Solution
1. Check transmitter; is it snapped into transmitter holder?
2. Wait up to 3 hours while the Dexcom ONE fixes itself.
3. If not corrected after 3 hours, contact Technical Support at dexcom.com, or contact your local Dexcom representative.
No alerts or sensor readings until fixed. Use your BG meter for treatment decisions.
Tap or select OK to clear the alert, then to go Help on the home screen for more information.

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Troubleshooting

Issue Pairing unsuccessful App

Pairing Unsuccessful

Done

Pairing Unsuccessful Try Pairing Again

Receiver

10:30

50%

Pairing Unsuccessful
Check troubleshooting tips and try pairing again.
Try Pairing Again Troubleshooting Tips Edit Transmitter SN

Dexcom ONE did not pair.
Solution
1. Make sure transmitter is snapped into transmitter holder.
2. Check the transmitter serial number (SN) and try again.
3. If you did not do the following when pairing, pair again, and do them:
· Accept the Bluetooth Pairing Request.
· Stay within 6 meters of the display device.
4. Do not use an expired transmitter.
5. Replace your sensor, attach the transmitter again, and pair. If you need a replacement, contact Technical Support at dexcom.com, or contact your local Dexcom representative.
No alerts or sensor readings until fixed. Use your BG meter for treatment decisions.

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Troubleshooting

Issue Signal loss App
No Alerts Signal Loss Always keep phone within 6 meters of transmitter. Wait up to 30 minutes.
OK

Receiver

10:30

50%

Signal Loss
Always keep receiver within 6 meters of transmitter.
Wait up to 30 minutes.

OK
Display device and transmitter are not communicating.
Solution
Try each of these tips and wait 10 minutes to see if Bluetooth reconnects:
1. Be sure your transmitter and display device are within 6 meters of each other. If you are in water, keep device closer than 6 meters.
2. Turn Bluetooth off and on.
3. Restart display device. Reopen Dexcom ONE app if using your smartphone.
4. If these tips do not solve the problem, contact Technical Support at dexcom.com, or contact your local Dexcom representative.
No alerts or sensor readings until fixed. Use your BG meter for treatment decisions.

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Troubleshooting

Issue
Transmitter battery low and last session alerts

App

Receiver

Transmitter Battery Low Your transmitter will expire in about 3 weeks.
Do not replace your current transmitter with a new one yet. Wait until the system tells you to replace it.
If you haven’t already, please order a new transmitter.
OK

10:30

50%

Transmitter Battery Low
Your transmitter will expire in about 3 weeks.
Do not replace your current transmitter with a new one yet. Wait until the system tells you
to replace it.
If you haven’t already, please order a new transmitter.
OK

Transmitter battery expiring.
Solution Order new transmitter. When your transmitter battery is about to expire, Dexcom ONE tells you when it: · Has 3 weeks left · Has 2 weeks left · Has 1 more session · Is too low for another session · Is critically low and must be replaced
immediately

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Troubleshooting

Issue Transmitter failed App
Transmitter Failed No Alerts Remove Sensor Now Replace the old and pair a new transmitter with a new sensor.
OK Sensor Removal Instructions

Receiver

10:30

50%

Transmitter Failed
No readings or alerts.
Remove sensor and transmitter now. Pair a new
transmitter with a new sensor.
Pair New Transmitter
Dismiss

Transmitter not working. Sensor session automatically stops.
Solution
To report this issue and get a replacement, contact Technical Support at dexcom.com, or contact your local Dexcom representative. No alerts or sensor readings until replaced. Use your BG meter for treatment decisions.

A.7 End sensor session early
You might want to end your sensor session early. Once you stop your sensor session, you will not be able to restart it.

App

Tap Settings

1

Glucose

Reports

Settings

Tap Stop Sensor Session Remove the sensor and transmitter. Go to 2 Chapter 6 for more information.
REPLACE SENSOR STOP SENSOR SESSION

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Receiver

1 Go to Menu
Select Stop Sensor Session
Remove the sensor and transmitter. Go to Chapter 6 for more information.

10:30

50%

Menu

2

Reports

Settings

Information

Help

Replace Sensor

Stop Sensor Session

Power Off

Back

A.8 Gap in graph
Your graph may show a gap if you are not getting readings. When readings resume, Dexcom ONE can fill in up to 3 hours of missed readings.

3 Hours 6 12 24

9:00

10:00

11:00

22 18 14 10 6 2 Now

A.9 Technical support
For help with the Dexcom ONE CGM system, contact Technical Support at dexcom.com, or contact your local Dexcom representative.
Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which you are established.

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Troubleshooting

A.10 Recharge receiver
Issue Your receiver needs to be charged when: · Battery icon shows low charge · Receiver won’t turn on
Solution Use the Dexcom supplied charger. Full charge may take up to 3 hours.
A.11 Water and Dexcom ONE
Once snapped into place, the transmitter is water resistant. Swim, shower, take a bath: no need to worry about water and your Dexcom ONE ­ just leave your display device in a dry area. If you are in water, your display device needs to be closer than 6 meters to get sensor readings.

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Troubleshooting

Appendix B
Dexcom Clarity
Dexcom Clarity software is an important part of your Dexcom CGM system.
Dexcom Clarity is an important part of your CGM system, providing a holistic view of your diabetes management by highlighting glucose patterns, trends, and statistics. It can help you identify glucose patterns and, with your healthcare provider, determine the potential causes of those patterns.
Get reports on the web at dexcom.com/clarityapp and on the go using the Dexcom Clarity app. Just log in with your Dexcom information. When you also use the Dexcom CGM app, you automatically and continuously send your glucose data to your Dexcom Clarity account (internet connection required).
With a sharing code provided by your clinic, you can authorize your clinic to have continuous access to your data during visits or anytime you might need assistance.
If you only use the receiver, upload your data to Clarity at least once every six months.
To get started, either:
· Share using Dexcom Clarity app:
· Log into the Dexcom Clarity app with your Dexcom login
· Tap Profile > Authorize Sharing and follow the instructions on the screen
· Or share using the Dexcom Clarity website:
· Log into Dexcom Clarity online at dexcom.com/clarityapp
· Follow the instructions on the screen

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Dexcom Clarity

Appendix C
Taking care of your Dexcom ONE
C.1 Dexcom ONE storage and maintenance
Sensor
· Keep in its sterile packaging until you are ready to use it.
· Store at temperatures between 2°C and 30°C.
Transmitter
· Keep in box until ready for use. Check transmitter and do not use if damaged.
· Store at temperatures between 0°C and 45°C. · Store between 10% and 95% relative humidity.
Receiver
· Keep battery charged. Only use Dexcom USB charging/download cable.
· When carrying the receiver in your purse or pocket consider using a screen protector that doesn’t interfere with the information displayed. Protect it from metal items and pointed objects.
· Don’t get sunscreen or insect repellent on it. · Update the date/time on the receiver when
needed. · Clean when dirty or at least once a month.
Disinfect when needed to avoid crosscontamination.
To clean 1. Use one of these cleaners:
· Damp cloth with liquid hand soap and water · Bleach wipes · Ammonium wipes

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Taking care of yourDexcom ONE

2. Wipe
· Using moderate pressure, wipe the receiver all over, 3 times up-and-down and 3 times side-to-side, to remove all dirt or soil
3. Let air dry
To disinfect
1. Repeat cleaning instructions using a new bleach or ammonium wipe.
2. Wipe receiver until completely wet. Use wipe to keep receiver wet for 2 minutes.
3. Let air dry.
Tips
· Don’t get water or other fluids inside the receiver through openings like the USB port
· Don’t use anything abrasive on the receiver
· If the receiver has a screen protector, remove it before cleaning and disinfecting
· Using alcohol wipes to clean the receiver hasn’t been tested
Use correct transmitter and sensor
· Dexcom ONE components are not compatible with any previous Dexcom products. Do not mix transmitters, receivers, and sensors from different generations.
C.2 System disposal
Different regions have different requirements for disposing of electronics (transmitter) and parts that have come in contact with blood or other bodily fluids (sensor). Follow your area’s local waste management requirements.

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Taking care of yourDexcom ONE

Appendix D
Packaging symbols
Symbols are on the Dexcom ONE packaging. They show proper and safe use of the Dexcom ONE. For symbol descriptions, refer to the table below.
Some of these symbols may not have meaning in your region and are listed for informational purposes only. This table shows what each symbol means:
~ Alternating Current

EC REP

Authorized Representative in the European Community

Batch/Lot Number

Bluetooth is on; device pairing is enabled

REF Catalog Number

Caution, Consult Instructions for Use

Class II Equipment

Consult Instructions for Use

Date of Manufacture

Direct Current

Do Not Reuse

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Packaging symbols

Do Not Use if Package is Damaged
For Indoor Use Only Waste Electrical and Electronic Equipment (WEEE) ­ Follow local requirements for proper disposal Humidity Limitation
Input Degrees of Ingress Protection Provided by Enclosure Objects > 12.5 mm diameter; immersion in water Keep Away from Heat
Keep Dry
Manufacturer
CE Marking of Conformity
MR MR (Magnetic Resonance) Unsafe
PN Part Number
SN Serial Number
STERILE R Sterilized Using Irradiation

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Packaging symbols

Temperature Limit Type BF Applied Part Use By Date

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Packaging symbols

Appendix E
Risks and benefits
When using any medical device, there are risks and benefits. In this appendix, you’ll learn what they are.
E.1 Risks
The risks with using Dexcom ONE are:
· Not getting your alerts
· Using Dexcom ONE to make treatment decisions when you should not
· Sensor insertion issues
· Adhesive reactions
· Sensor wire remains under the skin
Not getting alerts
Check your display device if you aren’t getting alerts:
· Battery charged
· App on
· Alerts on
· Volume up
· Speaker and vibrations work
· In range within 6 meters
· No System errors, such as Brief Sensor Issue or Signal Loss
· Warmup and after session ends: You will NOT get alerts or Dexcom ONE readings during the 2-hour Dexcom ONE warmup or after a sensor session ends.
· App Bluetooth on
Make sure your smartphone settings follow Dexcom’s recommended settings.
Go to Appendix A: Troubleshooting and the recommended settings in Chapter 2 for more information.

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Risks and benefits

Using Dexcom ONE for treatment decisions
You can use your Dexcom ONE for treatment decisions in all but a few situations.
Situation: How you feel is inconsistent with your Dexcom ONE reading
Treatment Decision Tool: Take a fingerstick for a BG measurement and use the number to make a treatment decision
Situation: Your CGM display is missing Dexcom ONE reading (number) or arrow(s), or both
Treatment Decision Tool: Take a fingerstick for a BG measurement and use the number to make a treatment decision
Some users found accuracy between different sensors varied significantly. When you insert each sensor, pay attention to its accuracy before deciding to use it for treatment decisions.
For more information on how to make treatment decisions using your Dexcom ONE, go to Chapter 5.
Paracetamol/acetaminophen interfering substance risks
With the Dexcom ONE, you can take a standard or maximum paracetamol/acetaminophen dose of 1 gram (1,000mg) every 6 hours and still use the Dexcom ONE readings to make treatment decisions. Taking higher than the maximum dose of paracetamol/acetaminophen (e.g. > 1 gram every 6 hours in adults) may affect the Dexcom ONE readings and make them look higher than they really are.
Hydroxyurea interfering substance risks
Hydroxyurea, a medication used to treat some cancers or blood disorders, may falsely elevate your Dexcom ONE readings and result in missed hypoglycemia alerts or errors in diabetes management decisions. The level of inaccuracy depends on the amount of hydroxyurea in your body. Use your BG meter.

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Risks and benefits

Sensor insertion risks
Inserting the sensor can cause infection, bleeding, or pain. Some people are sensitive to the sensor adhesive. If you have significant skin irritation, such as itching, burning, and/or rashes at the site of the adhesive patch, contact your healthcare professional.
No sensor wires broke or detached in clinical studies; however, there is a remote chance a sensor wire could break or detach and remain under your skin. Sterile broken or detached sensor wires usually do not pose a significant medical risk. If a sensor wire breaks off or detaches, remains under your skin, and shows signs of infection or inflammation, contact your Healthcare Professional and Technical Support at dexcom.com, or contact your local Dexcom representative.
E.2 Benefits
Some benefits of using your Dexcom ONE are:
· Managing your diabetes
· Knowing where your glucose was and where it is going
· Getting immediate feedback on your lifestyle decisions
· Making treatment decisions using your Dexcom ONE
· Decreasing the pain and hassle from frequent blood glucose testing, sparing the fingertips
Knowing your trends
The Dexcom ONE not only sends you a glucose reading every 5 minutes but also provides overviews of your glucose trends and patterns. This lets you see the overall picture and how the foods you eat, medications you take, and exercise impact your glucose levels.

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Risks and benefits

Making treatment decisions using Dexcom ONE
You can use your Dexcom ONE reading and trend arrow to make treatment decisions. Go to Chapter 5 for more information. No fingersticks calibration is needed. This reduces the pain and burden of excessive fingersticks (Price and Walker, 2016) and potential errors due to inaccurate calibration (Wadwa, 2018).
Helping your diabetes management
The optional alerts features notify you when your glucose goes outside your target range. This lets you take action to prevent glucose from going too low or too high. Go to Chapter 4 for more information.
References
Aleppo, G (2017). Replace-BG: a randomized trial comparing continuous glucose monitoring with and without routine blood glucose monitoring in wellcontrolled adults with type 1 diabetes. Diabetes Care, 40(4), 538-545. doi: 10.2337/dc16-2482.
Price D, Walker T. The Rationale for Continuous Glucose Monitoring-based Diabetes Treatment Decisions and Non-adjunctive Continuous Glucose Monitoring Use. Eur Endocrinol. 2016;12(1):24-30. doi:10.17925/EE.2016.12.01.24

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Appendix F
Dexcom ONE warranty
Sometimes things happen. Dexcom has you covered!
This appendix covers our warranty information outlining what we cover and for how long.
F.1 Dexcom receiver limited warranty
What is covered and for how long?
Dexcom, Inc. or its local Dexcom affiliate (“Dexcom”) provides a limited warranty to the individual end user (“you” or “User”) that the Dexcom receiver (the “receiver”) is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing on the date of original purchase and expiring one (1) year thereafter, provided it is not modified, altered, or misused.
Note: If you received this receiver as a replacement for an in-limited- warranty receiver, the Limited Warranty for the replacement receiver shall continue for the remaining Limited Warranty Period on the original receiver, but the replacement is not subject to any other warranty.
System modifications are not permitted and void all warranties
This Limited Warranty is based on User properly using the continuous glucose monitoring system in accordance with the documentation provided by Dexcom. You are not permitted to use the continuous glucose monitoring system otherwise. Misusing the continuous glucose monitoring system, improperly accessing it or the information it processes and transmits, “jailbreaking” or “rooting” your continuous glucose monitoring system or smartphone, and taking other unauthorized actions may put you at risk, cause the continuous glucose monitoring system to malfunction, are not permitted, and void your Limited Warranty.

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What is not covered?
This Limited Warranty does not cover:
· Defects or damage resulting from accident, misuse, abuse, neglect, unusual physical, electrical or electromechanical stress, modification of any part of the product, or cosmetic damage.
· Equipment with the SN number removed or made illegible.
· All surfaces and other externally exposed parts that are scratched or damaged due to normal use.
· Malfunctions resulting from the use of the receiver in conjunction with accessories, ancillary products, and peripheral equipment, whether hardware or software, not furnished or approved by Dexcom.
· Defects or damage from improper testing, operation, maintenance, installation, or adjustment.
· Installation, maintenance, and service of products or services other than the CGM system (which may be subject to a separate limited warranty), whether provided by Dexcom or any other party; this includes your smartphone or smart device and your connection to the Internet.
· A receiver that has been taken apart physically or has had any of its software accessed in any unauthorized manner.
· Water damage to the receiver. Although the receiver is designed to withstand splashing, you should avoid getting the receiver wet.
Dexcom’s obligations under the limited warranty
During the Limited Warranty Period, Dexcom will replace, without charge to User, any defective receiver.
To obtain assistance regarding a defective receiver, contact Dexcom Technical Support at dexcom.com or contact your local Dexcom distributor.

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Limits on Dexcom’s limited warranty and liability obligations
The Limited Warranty described above is the exclusive limited warranty for the receiver, and in lieu of all other warranties, expressed or implied, either in fact or by operation of law, statutory or otherwise. Dexcom expressly excludes and disclaims all other warranties, express or implied, including without limitation any warranty of merchantability, fitness for a particular purpose, or non-infringement, except to the extent prohibited by applicable law.
Dexcom shall not be liable for any special, incidental, consequential, or indirect damages, however caused, and on any theory of liability, arising in any way out of the sale, use, misuse, or inability to use, any Dexcom ONE or any feature or service provided by Dexcom for use with the Dexcom ONE.
These limits on Dexcom’s warranty and liability obligations apply even if Dexcom, or its agent, has been advised of such damages and notwithstanding any failure of essential purpose of this Limited Warranty and the limited remedy provided by Dexcom.
This Limited Warranty is only provided to the original User and cannot be transferred to anyone else, and it states User’s exclusive remedy.
If any portion of this Limited Warranty is illegal or unenforceable by reason of any law, such partial illegality or enforceability shall not affect the enforceability of the remainder of this limited warranty. This limited warranty does not change or limit your rights under any warranty the User has from a seller or under mandatory applicable law.

F.2 Dexcom sensor limited warranty

What is covered and for how long?

To the extent allowed by law, the Dexcom ONE sensor is provided to you “as is.” Dexcom hereby disclaims all warranties (express, implied, and statutory) with respect to the sensor, including, but not limited to, the implied warranties of merchantability and fitness

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for a particular purpose. There are no warranties which extend beyond the description herein.
F.3 Dexcom transmitter limited warranty
What is covered and for how long?
Dexcom, Inc. or its local Dexcom affiliate (“Dexcom”) provides a limited warranty to the individual end user (“you” or “User”) that the Dexcom ONE transmitter (the “transmitter”) is free from defects in material and workmanship under normal use (“Limited Warranty”) for the period commencing on the date of the original purchase and expiring three (3) months thereafter.
Note: If you received this transmitter as a replacement for an in-warranty transmitter, the Limited Warranty for the replacement transmitter shall continue for the remaining Warranty Period on the original transmitter, but the replacement is not subject to any other warranty.
What is not covered?
This Limited Warranty is based on User properly using the continuous glucose monitoring system in a timely manner and in accordance with the documentation provided by Dexcom. You are not permitted to use the continuous glucose monitoring system otherwise. Misusing the continuous glucose monitoring system, improperly accessing it or the information it processes and transmits, “jailbreaking” or “rooting” your continuous glucose monitoring system or cell phone, and taking other unauthorized actions may put you at risk, cause the continuous glucose monitoring system to malfunction, are not permitted, and void your Limited Warranty
This Limited Warranty does not cover:
· Defects or damage resulting from accident, misuse, abuse, neglect, unusual physical, electrical or electromechanical stress, modification of any part of the product, or cosmetic damage.
· Equipment with the SN number removed or made illegible.

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· All surfaces and other externally exposed parts that are scratched or damaged due to normal use.
· Malfunctions resulting from the use of the transmitter in conjunction with accessories, ancillary products, and peripheral equipment, whether hardware or software, not furnished or approved by Dexcom.
· Defects or damage from improper testing, operation, maintenance, installation, or adjustment.
· Installation, maintenance, and service of products or services other than the continuous glucose monitoring system (which may be subject to a separate limited warranty), whether provided by Dexcom or any other party; this includes your cell phone or smart device and your connection to the Internet.
· A transmitter that has been taken apart physically or has had any of its software accessed in any unauthorized manner.
· Beyond specifications listed in the Dexcom ONE User Guide.
Dexcom’s obligations under the limited warranty
During the Warranty Period, Dexcom will replace, without charge to User, any defective transmitter. To obtain assistance regarding a defective transmitter, contact Dexcom at dexcom.com, or contact your local Dexcom representative.
Limits on Dexcom’s warranty and liability obligations
The Limited Warranty described above is the exclusive limited warranty for the transmitter, and in lieu of all other warranties, expressed or implied, either in fact or by operation of law, statutory or otherwise.
Dexcom expressly excludes and disclaims all other warranties, express or implied, including without limitation any warranty of merchantability, fitness for a particular purpose, or non-infringement, except to the extent prohibited by applicable law.

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Dexcom shall not be liable for any special, incidental, consequential, or indirect damages, however caused, and on any theory of liability, arising in any way out of the sale, use, misuse, or inability to use, any Dexcom ONE or any feature or service provided by Dexcom for use with the Dexcom ONE.
These limits on Dexcom’s warranty and liability obligations apply even if Dexcom, or its agent, has been advised of such damages and notwithstanding any failure of essential purpose of this Limited Warranty and the limited remedy provided by Dexcom.
This Limited Warranty is only provided to the original User and cannot be transferred to anyone else, and it states User’s exclusive remedy. If any portion of this Limited Warranty is illegal or unenforceable by reason of any law, such partial illegality or enforceability shall not affect the enforceability of the remainder of this Limited Warranty. This Limited Warranty does not change or limit your rights under any warranty the User has from a seller or under mandatory applicable law.

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Appendix G
Technical information

G.1 Device performance characteristics summary

When LOWER is better

Adults Performance metrics* Pediatrics

9.8%

Overall Accuracy

Mean ARD% (MARD),

2.22­22.22 mmol/L

(% average absolute

7.7%

error versus reference

across all glucose

levels)

Day 1: 8.6%
Day 2: 8.7%
Days 4­5: 10.7%
Day 7: 10.6%
Day 10: 10.6%

Accuracy Over Time
Mean ARD% (MARD), 2.22­22.22 mmol/L

Day 1: 10.5%
Day 2: 7.8%
Days 4­5: 7.2%
Day 7: 6.2%
Day 10: 7.1%

When HIGHER is better

Adults Performance metrics* Pediatrics

92% [100%]

Clinical Accuracy
% of readings that were in the Clarke Error Grid (CEG) A Zone
[% CEG A+B Zone]

96% [99.8%]

  • Reference is YSI (Yellow Springs Laboratory Instrument)

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G.2 Product specifications
WARNING: Use of accessories other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm to any part of the Dexcom ONE CGM system including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
WARNING: Misuse of the USB cable can present a strangulation risk.
The device behaves normally while charging, however, do not hold the receiver while charging for over a minute as the device can get warm to the touch.
CAUTION: If you have difficulty reading your receiver in bright sunlight, you may need to seek a shady location.

Sensor product specifications Glucose range 2.2­22.2 mmol/L

Sensor useful life Up to 10 days

Storage and transport conditions
Sterilization

Temperature: 2°C­30°C Store sensors in a cool, dry place
Sterile by radiation

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Transmitter and receiver product specifications

Transmitter Receiver

Memory storage N/A

180 days of glucose data

Electrical safety Internally

class

Powered

Internally/ battery powered, re-chargeable; AC mains powered

Battery longevity (typical)

3 months

7 days

Battery

Non-

Approximately

charging time rechargeable 3 hours

Operational conditions
Storage and transport conditions
Operating altitude

Temperature: Temperature: 10°C­42°C 0°C­40°C

Humidity:

Humidity:

10%­95% RH 10%­90% RH

Temperature: Temperature: 0°C­45°C 0°C­40°C

Humidity:

Humidity:

10%­95% RH 10%­90% RH

-396 meters to 4,206 meters

-382 meters to 5,000 meters

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Transmitter and receiver product specifications

Transmitter Receiver

Ingress protection
Protection against electrical shock Alarm audible output TX/RX frequencies

IP28:

Protection IP54:

against

Protected

insertion

from ingress

of large

of dust;

objects and Protected

immersion in from splashing

water for up to water in any

2.4 meters for direction

24 hours

Type BF

No applied

applied part parts

N/A

50dBA at 1 meter

2.402­2.480 GHz

Bandwidth

1.07 MHz

1.39 MHz

Maximum output power
Modulation

1.0 mW EIRP 2.4 mW EIRP
Gaussian Frequency-Shift Keying

Data rate

1 Mbps

Data communication 6 meters range

The maximum surface temperature of Applied part = 43°C.
Essential performance
The Dexcom ONE system measures patients’ glucose sensor readings with specified accuracy under the stated operating conditions. The Essential Performance of the Dexcom ONE CGM system also

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includes reporting the corresponding measured glucose sensor readings and alerts on the display device.
Quality of service summary
Quality of Service for the Dexcom ONE System wireless communication using Bluetooth Low Energy is assured within the effective range of 6 meters, unobstructed, between the Dexcom ONE transmitter and paired display device at regular 5-minute intervals. If connection is lost between the transmitter and display device, upon reconnection any missed packets (up to 3 hours) will be transmitted from the transmitter to the display device. The Dexcom ONE CGM System is designed to only accept radio frequency (RF) communications from recognized and paired display devices.
Security measures
The Dexcom ONE System is designed to transmit data between the transmitter and designated display devices in accordance to the industry standard BLE protocols. It will not accept radio frequency (RF) communications using any other protocol, including Bluetooth classic communication protocols.
In addition to the security provided by the BLE connection, communication between the Dexcom ONE transmitter and the Dexcom ONE receiver and mobile application is protected by additional levels of security and safety mitigations using an encrypted and proprietary data format. This format embeds various methods to verify data integrity and to detect potential instances of data tampering. While the format is proprietary, industry standard encryption protocols (e.g., RSA and AES) are used in different parts of this proprietary data format.
Unless disabled, the Dexcom ONE mobile application regularly communicates with Dexcom Servers. Communication between the Dexcom ONE applications and Dexcom Servers is protected by a number of mechanisms, designed to safeguard against data corruption. This includes industry standard JWIT token based authentication and authorization. All such communication takes place exclusively over an encrypted data path using industry standard SSL format.

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USB charging/download cable specifications

Input/output 5 V DC, 1A

Type

USB A to USB micro B

Length

0.91 meters

Power supply/charger specifications

Class

II

Input

AC Input 100­240 Vac, 50/60Hz, 0.2A, 0.2A rms at 100 Vac

DC output

5V DC, 1A (5.0 Watts)

Electromagnetic immunity and emissions declaration and guidance
The transmitter and receiver are intended for use in the electromagnetic environment specified in the next table. The customer or the user of the transmitter should ensure that it is used in such an environment.

Immunity test
Electrostatic discharge (ESD) IEC 61000-4-2 Magnetic field (50Hz) IEC 61000-4-8 Electrical fast transient/burst IEC 61000-4-4
Surge IEC 61000-4-5

Transmitter Receiver

compliance compliance

level

level

± 8 kV Contact ± 15 kV Air

30 A/m N/A N/A

± 2 kV for power supply lines
± 0.5 kV, ± 1 kV line(s) to line(s)

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Immunity test

Transmitter Receiver

compliance compliance

level

level

0% 230V for 1 cycle

Voltage dips and interruptions IEC 61000-4-11 N/A
IEC 60601-1-11

0% 230V for 0.5 cycle at 8 phase angles
70% 230V (30% dip in 230V) for 25 cycles

0% 230V for 250 cycles

Conducted fields

disturbance

N/A

IEC 61000-4-6

6 Vrms
150 kHz to 80 MHz

Radiated fields disturbance
IEC 61000-4-3

10 V/m at 80 MHz to 2700 MHz (AM Modulation)

Radiated and conducted fields Meets RTCA/DO-160 edition G
Section20, Category T Aircraft use

Electromagnetic interference can still occur in the home health care environment as control over the EMC environment cannot be guaranteed. An interference event can be recognized by gaps in sensor readings or gross inaccuracies. The user is encouraged to try to mitigate these effects by one of the following measures:
· If the Dexcom ONE sensor reading does not match your symptoms or expectations take a fingerstick. Usually, the Dexcom ONE sensor reading is close to the BG meter value. Your Dexcom ONE is working normally if those two numbers are:
· Within 20% (if Dexcom ONE reading is 3.9 or more)
or
· Within 1.1 mmol/L (if Dexcom ONE reading is less than 3.9)

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For example, your Dexcom ONE is working normally in this situation:
· Dexcom ONE reading: 6.5
· Acceptable range (20%): 5.2 ­ 7.7 mmol/L
· BG meter value: 5.5
· Your Dexcom ONE may not be working normally when those two numbers are:
· More than 30% apart (if Dexcom ONE reading is 3.9 or more)
or
· More than 1.7 mmol/L apart (if the Dexcom ONE reading is less than 3.9)
In that case, use your BG meter value to make treatment decisions.
For example, your Dexcom ONE may not be working normally in this situation:
· Dexcom ONE reading: 6.5
· Acceptable range (30%): 4.6 ­ 8.4 mmol/L
· BG meter value: 9
Your Dexcom ONE may be working normally but is not aligned with your BG meter when those two number are:
· Between 21% and 30% apart (if Dexcom ONE reading is 3.9 or more)
or
· Between 1.2 mmol/L and 1.7 mmol/L apart (if Dexcom ONE reading is less than 3.9)
In that case, make treatment decisions on the number that matches your symptoms and expectations.
· If display device misses 20 minutes of sensor glucose data (4 readings), the Signal Loss error displays. To resolve, go to Appendix A: Troubleshooting.
· If display device shows the loading screen unexpectedly and does not display the trend screen within 3 minutes, contact Technical Support at dexcom.com, or contact your local Dexcom representative. For more information, go to Appendix A: Troubleshooting.

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· If your receiver does not work for 6 minutes, contact Technical Support at dexcom.com, or contact your local Dexcom representative.

Electromagnetic emissions specifications

Immunity test

Compliance

Radio frequency emissions
CISPR 11
Radio frequency emissions
Aircraft Use

Group 1, Class B
Meets FAA RTCA /DO160 edition G Section 21, Category M for in-cabin use.

G.3 Radio regulations compliance
Hereby, Dexcom, Inc. declares that the radio equipment type Dexcom ONE System is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: dexcom.com/doc.

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Appendix H
Professional use instructions
H.1 Introduction
Dexcom ONE supports multi-patient use. You just:
· Prepare Dexcom ONE for your patient
· Tell the patient what Dexcom ONE is and how it works
· Set up the system with the patient
· Follow up with the patient to share insights on their glucose trends, patterns, and statistics
This helps both of you manage their diabetes better. The following sections go through each step and give you resources to share with your patients as you guide them through a sensor session.
H.2 Prepare Dexcom ONE for patient
Decide whether the patient should be able to see their Dexcom ONE readings (unblinded). Will this motivate them to manage their diabetes better?
Whether the receiver is blinded or unblinded, all Dexcom ONE patients:
· Must carry their receiver to record data for later analysis
· Will get system alerts, such as Signal Loss and Brief Sensor Issue
The differences between blinded and unblinded are:
· Unblinded: Receiver shows patient’s sensor reading, trend arrow, graph, Low and High glucose alerts.
· Blinded: Receiver does not show any unblinded information. In addition, it does not show the Warmup Complete message.
Go to dexcom.com/clarityapp for more information (may not be available in all regions).

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Professional use instructions

Follow the instructions to clean and disinfect the receiver and transmitter between patients.
1. Prepare receiver
a. Charge and reset receiver:
· Resetting the receiver removes the previous patient’s data. To ensure patient privacy, reset the receiver after each use.
b. Clean and disinfect
· See instructions in the Storage and Maintenance section in Appendix C.
2. Clean transmitter
a. Prepare
· Protect: Wear clean gloves and goggles
· Prepare Soak: Put Clorox Healthcare® Bleach Germicidal Cleaner solution (Clorox) in a container deep enough to submerge the transmitter
b. Clean
· Rinse and Scrub: Rinse transmitter in cold tap water while brushing with a soft bristle brush until all visible soil is gone
· Soak and Scrub:
· Put transmitter in prepared soak for 3 minutes
· While immersed, scrub uneven areas (see green arrows) with a soft bristled brush or a pre-saturated bleach wipe

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c. Rinse and dry · Rinse: Remove from soak and rinse
transmitter under flowing cold tap water for 10 seconds · Dry: Wipe transmitter dry with cloth d. Inspect · Verify there is no visible soil. If there is, clean again. 3. Disinfect transmitter a. Prepare · Protect: Wear clean gloves and goggles · Prepare Soak and syringe: · Put CaviCide® solution (Cavicide) in a
container deep enough to submerge the transmitter · Fill syringe with about 30 mL of Cavicide b. Disinfect · Flush: · Focus on the uneven areas · Swirl in Cavicide for 10 seconds · Refill syringe · Scrub: · Saturate clean cloth or wipe with Cavicide · Wipe entire transmitter for at least 3 minutes or until all soil is removed · Focus on the uneven areas · Flush: · Focus on the uneven areas · Swirl in Cavicide for 10 seconds · Soak: · Put transmitter in prepared soak · Swirl it for 30 seconds · Then let it soak for another 3 minutes

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c. Rinse and dry
· Rinse: Remove from soak and rinse transmitter under flowing cold tap water for 10 seconds
· Dry: Wipe transmitter dry with cloth

H.3 Explain to patient what Dexcom ONE is and how it works
This table shows you what to explain to your patients and lets you know where you can find patient-centered information to help them understand.

Explain
What CGM is
Dexcom ONE Components

Show
Go to Start Here guide’s How It Works section
Go to Start Here guide’s Overview section

H.4 Set up Dexcom ONE with patient
Set up system with patients
With your patient, follow the setup instructions in Start Here to set up the app or receiver.
Be sure to enter the Sensor Code found on the applicator adhesive backing.

The setup instructions include inserting the sensor and attaching the transmitter.

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Additional set up with patients
Blinded
Explain why the patient is using blinded mode.
Unblinded
While setting up Dexcom ONE with your patient, create a personalized glucose target zone by setting low and high alerts appropriate for their A1C.
During the 2-hour sensor warmup, use the table below to explain how to interpret the information on Dexcom ONE.

Explain

Show

Introduce Home Screen
What are Alerts
Managing Diabetes with Dexcom ONE

Chapter 3: Display device screens in this guide
Chapter 4: Alerts
Chapter 5: Treatment decisions

Resource

Suggest your patient review the Dexcom website on their own to review the information you introduce

Let your patients who use

Dexcom Clarity App

the app know about Clarity’s trends, statistics, and patterns. Go to dexcom.com/clarityapp

for more information.

H.5 Follow up with patient
You can see a patient’s glucose data at any time during their sensor session at dexcom.com/clarityapp. Clarity identifies trends, patterns, and presents statistics. You can review this information with the patient to give them insights about how to better manage their diabetes.
At the end of the session, remove Dexcom ONE from the patient. Go to Chapter 6: Starting a new sensor session for more information.

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Professional use instructions

H.6 Next steps
Your patient may want to have their own Dexcom ONE. It is available for personal use. Direct them to dexcom.com for more information.
You are ready to use Dexcom ONE on another patient and introduce them to the benefits of Dexcom ONE.

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Appendix I
Glossary

A1C
Airplane Mode
Alternative Site Testing
Android
App or Application
App Store or Play Store Apple Watch Blood Glucose (BG) Meter Blood Glucose (BG) Value
Bluetooth
Continuous Glucose Monitoring (CGM)

Blood test used to diagnose type 1 or 2 diabetes and to gauge how well you are managing your diabetes. A1C reflects your average blood sugar level for the past 2 to 3 months.
A setting on a smart device where certain features are disabled to comply with airline regulations.
Using a blood sample from nonfingertip (alternate) sites such as the palm, forearm, or upper arm for meter values.
Operating system used for smart devices.
Software installed on a smart or mobile device.
The Dexcom ONE app is a display for continuous glucose monitoring.
Internet store for downloading applications to a smart device.
A smart watch for iPhone.
A medical device used to measure how much glucose is in the blood. Blood glucose value is the amount of glucose in the blood measured by a meter.
A technology that allows devices to communicate wirelessly with each other.
A sensor inserted under the skin checks glucose levels in interstitial fluid. A transmitter sends readings to a display device.

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Glossary

A situation where Dexcom ONE

Contraindication

should not be used because it may be harmful to you. The risk

of use outweighs the benefit.

Default

A manufacturer’s preset option for a device setting.

GMI (Glucose Management Indicator)

Approximates your A1C level based on your average glucose from at least 12 days of CGM data.

High BG. Same as “high” or high blood sugar. Hyperglycemia is characterized by an excess of glucose in the bloodstream.

Hyperglycemia

It is important to treat hyperglycemia. If left untreated, hyperglycemia can lead to serious complications. The default High Alert in Dexcom ONE is set to 11.1 mmol/L. Consult your healthcare professional to determine the appropriate hyperglycemia setting for you. Low BG. Same as “low” or low blood sugar. Hypoglycemia is characterized by a low level of glucose in the bloodstream.

Hypoglycemia Indications

It is important to treat hypoglycemia. If left untreated, hypoglycemia can lead to serious complications. The default Low Alert in Dexcom ONE is set to 4.4 mmol/L. Consult your healthcare professional to determine the appropriate hypoglycemia setting for you.
How, for what purposes, and under what circumstances you should use Dexcom ONE.

iOS

Operating system used for Apple smart devices.

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Glossary

IP
Jailbroken or Rooted mg/dL mmol/L

The International Electrotechnical Commission (IEC) is a nonprofit, nongovernmental, international organization created to produce safety standards for electronics.
One of the safety standards is the Ingress Protection (IP) Marking, which classifies and rates how protected an electronic device is against dust, water, accidental contact, etc.
IP ratings are numerical, with the number based on the conditions the electronic device encounters.
An IP22 rating lets you know your electronic device will not allow you to stick your fingers in it and will not get damaged or be unsafe during specific testing with water dripping down.
The removal of limitations and security measures set by the manufacturer on a smart device.
The removal poses a security risk and data may become vulnerable.
Do not install Dexcom ONE app on a jailbroken or rooted smart device. It may not work correctly.
Milligrams per deciliter. The standard unit of measure for BG readings in the United States.
Millimoles per litre. A unit of measure for BG values.

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Glossary

Notification

An app message that appears on the screen of a smart device. Notification may also include a sound or vibration, depending on the smart device settings.

Precaution

Special care to be exercised by you or your healthcare professional for the safe and effective use of Dexcom ONE.

Safety Statement

A statement of the intended uses of Dexcom ONE and relevant warnings, precautions, and contraindications.

The glucose concentration Sensor Reading measured in the interstitial
fluid.

Sensor Session

The period after inserting a new sensor. During this period, your Dexcom ONE reading shows on your display device(s) every 5 minutes.

Simultaneous Voice and Data

The ability to make a phone call and access the Internet on the same cellular connection at the same time.

An electronic device that

Smart or Mobile is cordless, mobile, and

Device

connected to the internet, such

as a smartphone or tablet.

Stacking Insulin

Taking a dose of insulin soon after your most recent dose. This can result in low blood sugar. Does not apply to taking insulin doses to cover what you just ate.

Warning

Describes serious and lifethreatening circumstances, the consequences, and how to avoid the hazard while using Dexcom ONE.

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Index
Accuracy Dexcom ONE Readings Do Not Match Blood Glucose Meter Value, 40 Dexcom ONE Readings Do Not Match Symptoms, 41
Adhesive Patch, 41 Alerts, 23
Brief Sensor Issue, 44 Signal Loss, 46 Transmitter Alerts, 47, 48 Turn On, 25 Alerts Will NOT Sound While Display Device is Muted/Silenced, 25 Brief Sensor Issue, 44 Cannot Hear Alerts, 43 Clarity, 51 End Sensor Session Early, 48 End Your Sensor Session, 37 Glossary, 82 Goals, 27 Graph Missing Readings, 49 Reading, 16 Home Screen, 15 Maintenance, 52 Professional Use, 76 Readings Do Not Match BG Meter Value, 40 Readings Do Not Match Symptoms, 41 Resources, 3, 40 Safety Statement, 5 Sensor Session End Early, 48 Set Up, 3

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Glossary

Signal Loss Alert, 46 Symbols, 54 Technical Information, 67 Transmitter Alert, 48 Transmitter Battery Low Alert, 47 Treatment Decisions, 29, 32 Trend Arrow, 15, 16, 32 Troubleshooting, 40 Use Meter Instead of Dexcom ONE, 29 Warranty, 61 Watch and Wait, 31 Water and the Dexcom ONE, 49

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© 2021 Dexcom, Inc. All rights reserved.
Covered by patents dexcom.com/patents.
Dexcom, Dexcom ONE, Dexcom Share, Share, and Dexcom Clarity are either registered trademarks or trademarks of Dexcom, Inc. in the United States and may be in other countries. Bluetooth is a registered trademark owned by Bluetooth SIG, Inc. Apple is a trademark of Apple Inc., registered in the U.S. and other countries. Android is a registered trademark owned by Alphabet Inc. All other marks are property of their respective owners.

Dexcom, Inc 6340 Sequence Drive San Diego, CA 92121 USA
+18582000200 dexcomcom
Outside US: Contact your local Dexcom representative
EC REP
MDSS GmbH Schiffgraben 41 30175 Hannover, Germany
AW00096-07 Rev 002 MT00096-07 Rev Date: 2022/07

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