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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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.
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.
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 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.
• 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.
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.
• 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.
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.
• 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.
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.
• 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.
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.
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.
Receiver home screen 10:30 50% Sensor reading Trend arrow 8.3 mmol/L 22 14.0 Trend graph 3.9 2 8:00 9:00 10:00 Now 3 Hours Menu Menu Navigation Sensor readings The number at the top of your home screen is your current sensor reading. It updates every 5 minutes. App 8.5 mmol/L Receiver 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.
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 0.06–0.1 mmol/L each minute • Up to 3.4 mmol/L in 30 minutes Rising or falling Changing: • Between 0.1–0.2 mmol/L each minute • Up to 5 mmol/L in 30 minutes Rapidly rising or falling Changing more than: • 0.
Trend graph The trend graph displays current and past readings and shows your alert levels when alerts are turned on. App Hours Shown 3 Hours 6 12 24 22 High Alert Level (when alert is on) Low Alert Level (when alert is on) Alert settings 18 14.0 10 3.9 2 9:00 10:00 11:00 Current Sensor Reading Now Past sensor readings Receiver Past Sensor Readings High Alert Level (when alert is on) Low Alert Level (when alert is on) Hours shown 22 14.0 3.
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.
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. 10:30 50% Menu Reports Settings Information Help Replace Sensor Stop Sensor Session Power Off Back Scroll up Go back Select Scroll down • Reports: Get your summary glucose information for a specific period. • Settings: Edit alerts, change settings, customize sounds, and more.
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.
3.3 Screen issues Sometimes the number is missing, or you are not getting readings. Display What it means App LOW Sensor reading is below 2.2 mmol/L. Receiver LOW App HIGH Sensor reading is above 22.2 mmol/L. Receiver HIGH App 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.
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.
4.1 Low and high alerts What You See What It Means App Low Glucose Alert (Low Alert) Low Glucose Lets you know your Dexcom ONE sensor reading is below your Low Alert level. 3.8 mmol/L • Turn on your Low Alert during setup. Receiver 10:30 50% Low Glucose Alert 3.8 • Change it in receiver by going to Menu > Settings > Alerts. mmol/L OK App Lets you know when your Dexcom ONE sensor reading is above your High Alert level. 18.5 mmol/L • Turn on your High Alert during setup.
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.
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.
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.
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 10:30 50% Snooze 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.
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.
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 What it means App HIGH No number Receiver HIGH App 8.5 mmol/L Receiver No arrow 8.
Display What it means App 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.
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.
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 later you are sitting down for breakfast. • Number and Arrow: You have both. You see: 7.
Situation Solution An hour later: Think about: You watched and waited. • Insulin: The insulin you took with breakfast has you back in your target range. You see: 9.1 What you should do: mmol/L • Nothing. No treatment needed. Mid-morning: Think about: You are about to have a midmorning snack. • No number and No arrow: You have neither. Notice the gap in Dexcom ONE readings. You see: 3 Hours 6 12 24 22 18 14 10 6 2 9:00 10:00 11:00 • Error Message: You are not getting Dexcom ONE readings.
Situation Solution Mid-afternoon: Think about: It is 3 hours after lunch. • Number and no arrow: You do not have an arrow. You see: What you should do: 12.4 mmol/L • Use your BG meter for treatment decisions. Early Evening: Think about: Just before dinner, you feel a little shaky and sweaty. • Symptoms and Dexcom ONE reading: Your symptoms do not match your Dexcom ONE sensor readings. You see: 6.8 mmol/L What you should do: • Thoroughly wash your hands and take a fingerstick.
• 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.
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.
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. 4 Throw out adhesive patch according to your local guidelines for disposal of bloodcontacting 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.
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.
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.
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.
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.
A.6 Common alerts Issue Brief sensor issue App Receiver 10:30 No Alerts 50% Brief Sensor Issue Don’t remove sensor. Temporary issue. Wait up to 3 hours. Brief Sensor Issue Don’t remove sensor. Temporary issue. OK 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.
Issue Pairing unsuccessful App Receiver Pairing Unsuccessful Done 10:30 50% Pairing Unsuccessful Try Pairing Again 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.
Issue Signal loss App Receiver 10:30 No Alerts 50% Signal Loss Always keep phone within 6 meters of transmitter. Wait up to 30 minutes. Signal Loss Always keep receiver within 6 meters of transmitter. OK 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.
Issue Transmitter battery low and last session alerts App Receiver Transmitter Battery Low 10:30 50% 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 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.
Issue Transmitter failed App Receiver 10:30 Transmitter Failed 50% No Alerts Transmitter Failed Remove Sensor Now No readings or alerts. Replace the old and pair a new transmitter with a new sensor. Remove sensor and transmitter now. Pair a new transmitter with a new sensor. OK Sensor Removal Instructions 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.
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 22 18 14 10 6 2 9:00 10:00 11:00 Now A.
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.
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.
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.
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.
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.
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.
Temperature Limit Type BF Applied Part Use By Date 56 Dexcom ONE User Guide 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.
Using Dexcom ONE for treatment decisions You can use your Dexcom ONE for treatment decisions in all but a few situations.
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.
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.
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.
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.
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.
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.
• 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.
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.
Appendix G Technical information G.1 Device performance characteristics summary When LOWER is better Adults Performance metrics* Pediatrics Overall Accuracy Mean ARD% (MARD), 2.22–22.22 mmol/L 9.8% (% average absolute error versus reference across all glucose levels) Day 1: 8.6% Day 1: 10.5% Day 2: 8.7% Days 4–5: 10.7% 7.7% Accuracy Over Time Mean ARD% (MARD), 2.22–22.22 mmol/L Day 7: 10.6% Day 2: 7.8% Days 4–5: 7.2% Day 7: 6.2% Day 10: 7.1% Day 10: 10.
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.
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 charging time Nonrechargeable Approximately 3 hours Temperature: 10°C–42°C Temperature: 0°C–40°C Humidity: 10%–95% RH Temperature: 0°C–45°C Humidity: 10%–90% RH Temperature: 0°C–40°C Humidity: 10%–95% RH -396 meters to 4,206 me
Transmitter and receiver product specifications Ingress protection Protection against electrical shock Alarm audible output TX/RX frequencies Transmitter Receiver IP28: Protection against insertion of large objects and immersion in water for up to 2.4 meters for 24 hours IP54: Protected from ingress of dust; Protected from splashing water in any direction Type BF applied part No applied parts N/A 50dBA at 1 meter 2.402–2.480 GHz Bandwidth 1.07 MHz 1.39 MHz Maximum output power 1.
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.
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 100–240 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.
Immunity test Transmitter compliance level 0% 230V for 0.
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.
• 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 Group 1, Class B CISPR 11 Radio frequency emissions Aircraft Use Meets FAA RTCA /DO160 edition G Section 21, Category M for in-cabin use. G.3 Radio regulations compliance Hereby, Dexcom, Inc.
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.
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.
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.
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.
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.
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.
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) 82 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.
A situation where Dexcom ONE should not be used because it Contraindication may be harmful to you. The risk of use outweighs the benefit. A manufacturer’s preset option Default for a device setting. Approximates your A1C level GMI (Glucose based on your average glucose Management from at least 12 days of CGM Indicator) data. High BG. Same as “high” or high blood sugar. Hyperglycemia is characterized by an excess of glucose in the bloodstream.
The International Electrotechnical Commission (IEC) is a nonprofit, nongovernmental, international organization created to produce safety standards for electronics. IP 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 app message that appears on the screen of a smart device. Notification Notification may also include a sound or vibration, depending on the smart device settings. Special care to be exercised by you or your healthcare Precaution professional for the safe and effective use of Dexcom ONE. A statement of the intended Safety uses of Dexcom ONE and Statement relevant warnings, precautions, and contraindications. The glucose concentration Sensor Reading measured in the interstitial fluid.
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 Profes
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 Dexcom ONE User Guide Glossary 87
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