Home

User Guide

1. To change value Press Up Down Arrows to change value at 10 mg dL increments Press Selectto save and close These steps are enough to get you going now you can start your sensor session Summary Now You Can e Create a Dexcom username and password e Download the Dexcom G5 Mobile App Dexcom G5 Mobile System User Guide Set up Your Display Devices 67 e Set app up with the recommended settings e Successfully set up your Dexcom G5 Mobile Receiver What s Next Now you have completed setting up your app and or the receiver your next step is starting a sensor session No matter what monitoring method you choose starting a sensor session is the same Inserting the sensor Inserting the transmitter Pairing the transmitter to your device Two hour sensor warmup Initial calibrations OAN Dexcom G5 Mobile System User Guide Set up Your Display Devices 68 Chapter 6 Let s G5 The Basics Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 6 1 Overview Now that your display devices are set up you re ready to begin a sensor session If this is your first time inserting a sensor you may want to watch the Dexcom G5 Mobile sensor insertion video to get a better understanding of the process The Dexcom G5 Mobile sensor insertion video is available by three ways 1 Through the App 2 USB card in your Dexcom G5 Mobile Receiver package 3 On
2. PRECAUTION Don t Never prevent communication between transmitter and display devices Do Keep smart device and receiver within 20 feet of transmitter and away from obstructions Why If your transmitter display device s are more than 20 feet apart or are separated by an obstruction they might not communicate Types of obstruction differ and not all types have been tested Obstructions can include water walls metal etc Water e g swimming surfing bathing etc can severely limit communication range Consequences Missing severe low or high Alarm or Alerts Dexcom G5 Mobile System User Guide Troubleshooting 286 18 3 Troubleshooting No Alarm Alerts Smart Device In App What you see vows an lt Notifications Dexcom Show on Lock Semon Grow serna on Yw oct soven end in Mette stom Certa whan Aia occ eened bom fe wet erom AFIT STYLE WHEN UAIL OCRED JOE Receiver High Alert a Level 200 mg dl Not receiving Alerts Continued on next page Dexcom G5 Mobile System User Guide What you do See Chapter 11 Check Alarm Alerts sound and or vibrations for notifications are on Check your smart device is not on mute if applicable Troubleshooting 287 Sensor Glucose Readings What you see BG Meter Smart Device In App Receiver Problem Sensor readings and BG meter glucose values
3. ceeeeee ee 191 12 2 Safety Statement 08 192 12 3 Changing App Alarm and Alerts 192 12 4 Changing Receiver Alarm and Alerts 204 Part 4 Everything Else G5 Chapter 13 Warranty The Fine Print 215 13 1 Introduction ceeeeeees 215 13 2 Receiver Warranty Information 215 13 3 Transmitter Warranty Information 217 13 4 Dexcom s Obligations Under the Limited Warranty ececeeeeeeeee ee ea es 219 Chapter 14 How to Take Care of Your Dexcom G5 Mobile CGM System 221 14 1 Introduction cccee eee ees 221 14 2 Basic Maintenance 08 222 Dexcom G5 Mobile System User Guide 14 3 Storage eenen 226 14 4 Checking App and Receiver Information 0ceeeeeeeeees 227 14 5 System Disposal 008 228 Chapter 15 On the Go With Dexcom G5 Mobile CGM System Getting Through Security 229 15 1 Introduction ccecceeeee ees 229 15 2 Going Through Security 229 Chapter 16 Need Help You re Not Alone 233 16 1 Dexcom Technical Support 233 16 2 Patient Care Team 00000 234 16 3 Sales Support Team 0 085 235 16 4 Corporate ccccceeeeeeeeeee ees 235 Chapter 17 Technical Information 237 17 1 Device Performance Characteristics 237 17 2 Product Specifications 275 17 3 FCC Requirements 4 283 Ch
4. Alarm Alert Sound Profiles Profile name Notification description Vibration only Vibrate Only sound is your receiver vibrating Vibrate is not available for the Alarm Lower volume beeps Medium volume beeps Default Profile Normal No beeps Attentive e Rising melody for High and Rising Alerts e Dropping melody for Low and Falling Alerts Medium volume beeps Urgent low Alarm only Repeats fixed low alarm every 5 seconds until sensor glucose reading rises above 55 mg dL or is confirmed HypoRepeat Sample Profile setting before selecting After choosing your sound profile changing it is just a few steps away Change your Profile throughout the day depending on what lays ahead In a meeting Select Vibrate Going to a ball game after work Select Attentive The next table shows how to change a sound Profile then sample how it sounds Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts N O on Customizing Sound Profiles Receiver Step What you see What it means What you do Go to Main Menu Press Select Main Menu Ph Trend Graph Second Main Menu ae y rofiles on secon D Start Sensor screen screen U Enters Press Down Arrow Main Menu W Enter BG Profiles adjusts volume dy Profiles _ of Alarm Alerts Stop at Profiles Press Select Events Profiles t gt Vibrate ai Soft sf Normal Press Up
5. Home Screen Rate of Change Arrows and Errors 139 Continued from previous page App Portrait App Landscape What it means Sensor Glucose Reading Range Shows between 40 400 mg dL Within Glucose Range and Alert Levels 1 Yellow Bar High Alert level 2 Gray Background Within range 3 Red Bar Low Alert level Continued on next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 140 Continued from previous page App Portrait App Landscape What it means Trend Graph Timeframe Default is most recent 3 hours Turn smart device to Landscape mode for most recent 1 3 6 12 and 24 hour readings Receiver Home Screen Unlike your smart device screens the receiver s screen is not interactive all prompts are for information only To make changes or enter data in the receiver press Select and go to the Main Menu The receiver s home screen has two main sections 1 Status Bar a Status Bar reflects glucose trends readings status of receiver s system e g battery level 2 Glucose Information Trend Graph a Reflects sensor glucose readings and trends This section will get you familiar with the receiver s home screen In other chapters you ll see how to use the navigation wheel to enter data or make system changes Dexcom G5 Mobile System User Guide Home Screen
6. Limited Warranty for the period starting from the shipment date and continuing for a year following the shipment date Warranty Period Dexcom G5 Mobile Receiver 1 year from shipment date NOTE If you received this Receiver as a replacement for an in warranty Receiver the Limited Warranty for the original Receiver shall continue for the Warranty Period on the original Receiver but the replacement is not subject to any other warranty What s Not Covered This Limited Warranty is based on the Purchaser properly using the CGM system in accordance with the documentation provided by Dexcom You are not permitted to use the CGM system otherwise You understand that misusing the CGM system improperly accessing it or the information it processes and transmits jailbreaking your CGM system or cell phone and taking other unauthorized actions may put you at risk cause the CGM system to malfunction is not permitted and voids your Limited Warranty Dexcom G5 Mobile System User Guide N s Sz Warranty The Fine Print This Limited Warranty does not cover 1 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 2 Equipment with the ID number removed or made illegible 3 All surfaces and other externally exposed parts that are scratched or damaged due to normal use 4 Malfunctions
7. Continued from previous page Device What you see What it means Session Stopped Smart Device Lock Screen Sensor session has stopped Smart Device App In App e No sensor glucose readings e Prompts for new session Receiver e Straight line r o i Receiver No sensor glucose readings Sound Vibration Prompts In case you can t look at your screen both the smart device and receiver provide beep vibration prompts to remind you your sensor session will end in 30 minutes it has just ended or if your sensor failed and you need to start a new session Remember if your smart device is on Silent or Do Not Disturb you won t get any sound prompts For more information on setting your sound vibration prompts please see Chapter 9 Smart Device Your smart device prompts you with a triple beep If not cleared you receive the triple beep twice five minutes apart Receiver The receiver alerts you with an initial vibration prompts If not cleared you receive a vibrate beep twice five minutes apart Once a sensor session has expired you are ready to start your new session If you re not sure what to do the app will provide instructions or you can refer to the Quick Start Guide online tutorials or go to Chapter 6 in the User Guide Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 116 Ending Your Sensor Session Early For personal reasons you may want to
8. Table 2 B Number and Percentage of YSI Values When CGM Readings are LOW or HIGH Pediatric YSI mg dL CGM Readings CGM YSI 1 SUEY Pairs lt 70 lt 80 Original Cumulative Percent LOW Cumulative Percent YSI mg dL CGM Eel laters CGM YSI Pairs Study gt 280 Original Cumulative Percent HIGH n Software 505 Cumulative Percent Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Agreement When CGM Reads LOW or HIGH The System reports glucose readings between 40 and 400 mg dL When the System determines the glucose reading is below 40 mg dL it displays LOW in the Receiver Status Box When the Dexcom G5 Mobile System determines that the glucose level is above 400 mg dL it displays HIGH in the Receiver Status Box Because the System does not display glucose values below 40 mg dL or above 400 mg dL the comparisons to the actual blood glucose levels as determined by the YSI analyzer when CGM is classified as LOW or HIGH are included separately in Table 2 A and 2 B The tables include the numbers and the cumulative percentages when YSI values were less than certain glucose levels for LOW and when YSI values were greater than certain glucose levels for HIGH Dexcom G5 Mobile System User Guide Tec
9. 14 1 Introduction There are not a lot of moving parts in the Dexcom G5 Mobile CGM System so maintenance is relatively simple keep it clean keep display device s dry and protected use accessory parts like the USB cable etc given to you with the system and store according to each piece s labeling instructions This chapter only covers Dexcom parts sensor transmitter and receiver Follow the manufacturer s instructions when caring for your smart device After this chapter you will be able to 1 Demonstrate proper maintenance a Sensor b Transmitter c Receiver d Charge receiver battery 2 Determine what accessories you may use 3 Identify the best storage methods a Sensor b Transmitter c Receiver 4 How to safely dispose of a Sensor b Transmitter c Receiver Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System 221 14 2 Basic Maintenance Sensor 1 Keep in sterile package until ready for use 2 Check package label for expiration date a Expiration date format is YYYY MM DD year month day format b Don t use if sensor has expired i May provide inaccurate sensor glucose readings ii May be unsterile Transmitter 1 Keep in box until ready for use a Check transmitter and don t use if damaged 2 Transmitter is reusable however only by the same person a Never share transmitter with anyone 3 Between uses clean outside of the transmitter with d
10. CONTRAINDICATION Don t Never take any medications containing acetaminophen during your sensor session Why Taking medications with acetaminophen such as Tylenol or Excedrin Extra Strength while wearing sensor may falsely raise sensor glucose readings Level of inaccuracy depends on 1 Amount of acetaminophen active in your body 2 May be different for each person Consequences Without correct readings you might miss a severe low event WARNING Don t Never use the Dexcom G5 Mobile CGM System sensor glucose readings for treatment decisions Do Only use BG values from your BG meter for treatment decisions e g how much insulin to take Why Since they measure your glucose from different body fluids sensor glucose readings can be different from your meter s blood glucose values Consequences Using sensor glucose readings for treatment decisions could result in you missing a severe low or high event Dexcom G5 Mobile System User Guide Calibration 93 WARNING Do Calibrate at least once every 12 hours Why Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings Consequences Missing severe low hypoglycemia or high hyperglycemia Alarm or Alerts PRECAUTION Do Look at trend arrows before calibrating Trend arrows help you determine if you can calibrate now or should wait Don t Never calibrate if your blood glucose is changing at a signific
11. Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 127 Continued from previous page What you see What it means Smart Device Lock Screen Your transmitter battery is low The transmitter wit stop working In about tw weers if you havent aeacy please onder new Smart Device berainiter In App Battery will expire in two weeks Order a new transmitter 25 Low Battery Order New Transmitter Days Left 14 Receiver Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 128 Continued from previous page Device What you see What it means Smart Device Lock Screen Your current transmitter will stop working in about one week This is the last sensor Session with your current transmitter Smart Device if you naven t aoady In App Battery will expire in one week Order a new transmitter Receiver Order New Transmitter To make sure you have a transmitter that s ready for a new sensor session you may want to reorder a new one at store dexcom com by calling Customer Service See Section 16 1 or through the channels you used before at your first low battery prompt Sound Vibration Prompts In case you can t look at your screen both the smart device and receiver provide beep vibration prompts to t
12. These smart devices have not been tested with this equipment Exposure to these types of equipment could heat and damage the smart devices so that they are unable to send or receive glucose information Warnings Dosing decisions should not be made based on this device The user should follow instructions on the continuous glucose monitoring system This device is not intended to replace self monitoring practices advised by a physician Dexcom Share does not work alone Dexcom Share does not replace the Dexcom G5 Mobile System and requires Share to be turned On to communicate glucose information to the Follower You cannot use Dexcom Share to make treatment decisions such as how much insulin to take Dexcom Share does not replace a blood glucose meter Always use the values from a blood glucose meter for treatment decisions Blood glucose values may differ from the sensor glucose information Using the sensor glucose information for treatment decisions could lead to low or high blood glucose values Dexcom G5 Mobile System User Guide Sharing Is Caring Precautions Do not use Dexcom Share as the main source of CGM glucose trend information Use the Dexcom G5 Mobile Receiver as the main device to track sensor glucose information notifications and alarms At times the patient will be unable to share data using Dexcom Share and the Follower might miss helping the patient in the event of low or high blood glucose values Do
13. s look at how to enter Events in a smart device then in the receiver When using Dexcom Share you can allow your Followers see your Event entries For more Dexcom Share information please see Part 5 Enter Events Smart Device In the Dexcom G5 Mobile App Events are just a tap away The Event icon a running man is on the app s home screen s task bar in portrait mode remember you don t have the task bar in landscape Entering Events for Carbs Insulin Exercise and Health s categories follow the same steps If you can enter a Carb Event you can enter an Insulin Event To enter Events we ll use the above scenario The following table shows how to enter Carb drive thru lunch and Stress traffic jam Events Entering Events Dexcom G5 Mobile App Step What you see What you do Enter Carb Event se Tap Running Man Continued on next page Dexcom G5 Mobile System User Guide N Daily Events Affect Your Glucose Trends and Patterns 16 Continued from previous page Enter Carb Event insan O ky Exercise O Heaith Tap Carbs Carbs Event Add up all carb grams from lunch Enter 85 using keypad Tap Done Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 163 Continued from previous page Enter Carb Event Tap Event Time Scroll and select date and time
14. s screen per snack or meal reflects last number UP to 250 grams entered Receiver Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 155 Continued from previous page Device What you see What it means Insulin insulin Event Smart Device In App Receiver s screen reflects last number entered Receiver Continued on next page Dexcom G5 Mobile System User Guide What you do Enter insulin units for each dose up to 250 units Can t enter type of insulin only dosage Daily Events Affect Your Glucose Trends and Patterns 156 Continued from previous page Device What you see What it means What you do Exercise lt Exercise intensity Light Smart Device Select each In App exercise s intensity level and duration Enter intensity and duration Lae Type of exercise Cancel isn t an option Defaulted at 30 minutes Exercise Type Receiver Medium gt Heavy Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 157 DIA Health Smart Device In App Continued from previous page What you see lt Health Event tines Stes Feel High Feel Low Cycie Akohol Receiver Stress
15. t getting your CGM Alarm Alerts you run the risk of not knowing you are having a severe glucose low or high Some hardware issues preventing Alarm Alerts e Alert function is turned off e Transmitter and display device is out of range e Receiver or smart device isn t showing sensor glucose readings e Receiver or smart device battery is dead e Unable to hear Alarm Alerts or feel vibration e App not running in the background e Smart device is in Do Not Disturb See Troubleshooting or recommended settings in Chapter 11 for more information Sensor Glucose Reading Different From Meter s The sensor glucose reading can be different than your meter s BG value If the sensor s glucose reading is higher than your meter s BG value you may miss a Low Alert As an example your last sensor s glucose reading was 82 mg dL whereas your BG value shows 78 mg dL If your Low Alert is set at 80 mg dL you won t receive an Alert because the sensor glucose reading is 82 mg dL Dexcom G5 Mobile System User Guide Risks and Benefits 29 If you re not receiving an Alarm Alert and not taking fingerstick measurements you may be unaware of low or high glucose levels Sensor Insertion Risks Inserting the sensor and wearing the adhesive patch might cause infection bleeding pain or skin irritations e g redness swelling bruising itching scarring or skin discoloration The chance of this happening is low The Dexcom G5 Mobile C
16. Approximately five minutes after entering your second BG meter value your display device s will start providing sensor glucose readings and glucose level trends While each display device may have different ways of presenting sensor glucose readings and trends the meanings are the same Fingerstick measurements entered into one device will be available in the other approximately ten minutes after entering data Dexcom G5 Mobile System User Guide Calibration 107 Summary Now You Can e Calibration Overview o Define calibration o Explain the importance of calibration o Identify steps to ensure a successful calibration e Recognize the steps required to take an accurate blood glucose levels o Identify the best blood glucose site for calibrations o Prepare finger for fingerstick measurement e Determine if you should should not calibrate o Recognize when you can enter BG meter values o Recognize when should not enter the BG meter values o Determine if you need to calibrate outside of the normal calibration guides e Initiate startup calibration e Perform maintenance calibrations e Correctly enter your fingerstick measurement o Dexcom G5 Mobile App o Dexcom G5 Mobile Receiver e Identify calibration errors What s Next In the next chapter you ll learn how to end a typical seven day sensor session what to do if you need to end your sensor session early along with removing the transmitter and determining if you need to replace
17. Default Beep and Vibrations 184 Rise Rate Fall Rate 181 182 Rise Rate Fall Rate Repeat Signal Loss 177 What are 176 C Calibration 92 Entering into app 101 Entering into your receiver 104 Errors 106 Preparing for 100 Prompts 96 98 99 What is it 92 When to Calibrate 95 Why is Calibrating important 92 CGM System Basic Maintenance 222 Different Monitoring Methods 50 Disposal 228 Overview 42 Storage 226 Dexcom G5 Mobile System User Guide Categories 154 Definition 153 Events 153 Entering App 162 Receiver 168 Viewing 170 G Glucose Information Rate of Change Arrows 145 Trend Screen 138 144 Rate of Change Arrows 139 144 145 Receiver Home Screen 141 Initial set up 64 Overview 45 S Safety Statement Contraindications 19 Indications 18 Precautions 21 23 24 25 27 Warnings 20 21 22 24 26 Sensor Insertion Choosing site 75 Sensor Session Attaching transmitter 80 Definition 8 Ending 110 Ending Early Index App 119 Receiver 121 Notes Ending Seven Day 111 Inserting sensor 76 Prepping for Sensor Insertion 72 Preventing Sensor Failures 123 Receiver Starting a Session 84 Remove Sensor Pod and Transmitter 124 Starting a 69 Starting with app 83 Sensor Session Warmup Warmup 90 Signal Loss Alert Signal Loss 183 187 208 Sound Vibration Prompts 116 System Components 39 T Technical I
18. Dexcom G5 Mobile System User Guide Troubleshooting 293 Calibration Error What you see Problem What you do System will See Chapter 7 not accept Wait until your glucose is calibration if between 40 400 mg dL outside of the Calibrate only when your BG 40 400 mg dL meter values are between range 40 400 mg dL See Chapter 7 Smart Wait 15 minutes Device a In App System didn t Enter 1 caliration accept recent If error screen still appears calibration see enter 1 more BG meter Sensor Glucose Value Readings Wait 15 minutes troubleshooting if I di for a possible no sensor glucose readings reason appear on the display the sensor needs to be replaced No sensor Call Technical Support to Receiver glucose readings report error see Section Enter BG in 15min will be displayed 16 1 until error is BG Meter resolved App Follow same instructions Tap question mark to get more information Continued on next page Dexcom G5 Mobile System User Guide Troubleshooting 294 Continued from previous page Device What you see Problem What you do See Chapter 7 Wait 15 minutes Enter 1 BG meter value Wait 15 more minutes T If error screen still appears System didn t enter 1 more BG meter accept recent value calibration Wait 15 minutes If no sensor glucose readings appear on the display the sensor needs to be replaced Call Technical Su
19. In the previous chapter you received a high level overview of the Dexcom G5 Mobile CGM System and learned you can monitor your glucose levels with different display devices Now it s time to set up your Dexcom G5 Mobile App and your receiver After this chapter you will be able to e Create a Dexcom username and password e Download the Dexcom G5 Mobile App e Set up the Dexcom G5 Mobile App with the recommended settings e Successfully set up your Dexcom G5 Mobile Receiver 5 2 Safety Statement If you ve used the Dexcom G4 PLATINUM CGM System you might still have its transmitter or receiver While you can use the sensors across the different generations look for the Dexcom G5 Mobile G4 PLATINUM Sensor package you can t mix the transmitter or receiver between the two systems PRECAUTION Don t Never mix Dexcom G5 Mobile s Transmitter or Receiver with Dexcom G4 PLATINUM s Transmitter or Receiver Why The Dexcom G5 Mobile CGM System s Transmitter and Receiver are not compatible with the Dexcom G4 PLATINUM CGM System s Transmitter and Receiver The Dexcom G5 Mobile CGM System won t work if you mix Receiver and Transmitter components from different generations Consequences Missing a severe low hypoglycemia or high hyperglycemia event Dexcom G5 Mobile System User Guide Set up Your Display Devices 49 5 3 Why Different Monitoring Methods Your convenience By offering two separate monitoring
20. Mean Median Absolute Absolute Percent Percent Number Mean Median Study of Paired Percent Percent CGM YSI Difference Difference mg dL Difference Difference Original Software 505 Overall Original Software 505 Original Software 505 Original Software 505 Original Software 505 40 60 61 80 81 180 181 300 Original Software 505 301 350 Original Software 505 351 400 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 For CGM lt 80 mg dL the difference and absolute difference in mg dL are included instead of percent differences Accuracy Relative to YSI Accuracy between matched pairs was also estimated by calculating the percent difference between the System reading and the YSI value For example if the YSI value is 100 mg dL and the System reading is 90 mg dL a 10 difference between the System and the YSI is reported The System and YSI values were compared by pairing the System reading that fell immediately after the YSI value was collected Dexcom G5 Mobile System User Guide Technical Information 251 In the example above the System reading is less than the YSI value so the percent difference reading is negative The mean percent difference is the average of all positive and negative percent differences between the two devic
21. Smart Device In App Continued from previous page What you see Receiver What it means Wait up to three hours while the system autocorrects Check transmitter is it properly inserted into sensor pod Make sure you haven t taken acetaminophen If not corrected after 3 hours e Contact Dexcom Technical Support Smart Device Lock Screen Smart Device In App Receiver Dexcom G5 Mobile System User Guide Wait up to three hours while the system autocorrects Check transmitter is it properly inserted into sensor pod Make sure you haven t taken acetaminophen If not corrected after 3 hours e Contact Dexcom Technical Support Ending Your Sensor Session and Transmitter Session 119 The Dexcom G5 Mobile CGM System knows when a typical seven day sensor session is over automatically ending the session in each display device However if you need to end the session early you need to let the system know by manually stopping the sensor session While the end result is the same ending a sensor session the steps differ between the app and receiver If you re using both no need to stop the sensor session in each the other display will see the session has stopped Let s first look at how to end a sensor session in the app then the receiver App Ending a Sensor Session Early Step What you see What it means What you do Access Main Menu Tap Main Menu i
22. User Guide Your Dexcom G5 Mobile CGM System reference book This user guide gives you the most extensive overview of the system detailing features important safety information and so much more To download an ebook of the user guide or request a printed user guide visit dexcom com guides The Dexcom G5 Mobile User Guide is grouped into six separate parts Part 1 Getting Started 1 Glossary 2 Getting Started a Learning how to learn about the Dexcom G5 Mobile CGM System b Registering at dexcom com 3 Indications for Use and Safety Statement 4 Risks and Benefits Part 2 Let s G5 The Basics Introduction to the Dexcom G5 Mobile CGM System Choose and Set up Your Display Device s Initiating a Sensor Session Inserting the Sensor amp Transmitter Calibration Enda Sensor Session orwonh Dexcom G5 Mobile System User Guide Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey 11 Part 3 Next Steps Getting the Most out of Your Dexcom G5 Mobile CGM System Once you are up and running how you can maximize the Dexcom G5 Mobile features 1 Reading Trend Graph Screens and Recognizing Trends 2 Events 3 Alarm and Alerts 4 Sounds for Alarm Alerts and System Messages Part 4 You Take Care of Your G5 and It Takes Care of You Warranty Dexcom G5 Mobile CGM System Maintenance Travel Tips Customer Service Contacts Technical Information Troubleshooting Packa
23. and states Purchaser 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 will be enforced to the maximum extent permitted by law 13 3 Transmitter Warranty Information Dexcom G5 Mobile Transmitter Limited Warranty What s Covered and for How Long Dexcom Inc Dexcom provides a limited warranty to the original purchaser that the Dexcom G5 Mobile Transmitter is free from defects in material and workmanship under normal use for the period commencing on the date of first use by the original purchaser the Date of First Use and expiring three 3 months thereafter provided that the Date of First use occurs within five 5 months of the date of shipment or disbursement of the transmitter to the original purchaser Dexcom G5 Mobile System User Guide Warranty The Fine Print 217 NOTE If you received this Transmitter as a replacement for an in warranty Transmitter the Limited Warranty for the original Transmitter shall continue for the Warranty Period on the original Transmitter but the replacement is not subject to any other warranty What s Not Covered This Limited Warranty is based on the Purchaser properly using the CGM system in a timely manner and in accordance with the documentation provided by Dexcom You are
24. enter data etc 2 Glucose Information a Reflects sensor glucose readings and trends Status and Task Bar Glucose Information Figure 6 App Home Screen on Mobile Device Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 135 Status and Task Bar App AEG Status Bar Information Only Task Bar Complete Ta Status Bar Main Menu What it means Displays signal strength time Bluetooth and battery level Changes are made using smart device settings not in the app May look different depending on your smart device carrier Goes to other options What you do Time Check smart device and receiver show same time Bluetooth Check Bluetooth is on Battery App can use up battery Check you are charged Tap Main Menu icon to access e Alerts e Settings e Help e Start Stop Sensor Dexcom G5 Mobile System User Guide BG Meter with red circle and number BG Meter without red circle Calibration Prompt No need to calibrate Continued on next page Tap icon and enter fingerstick BG value see Chapter 7 Do nothing Home Screen Rate of Change Arrows and Errors 136 Continued from p Task Bar Complete Tasks evious page Enter different events capturing activities affecting your glucose Tap icon to enter data for e Carbs e I
25. instrument is referred to as the YSI In the Original Pediatric Study subjects glucose levels were not intentionally manipulated during this study in the Software 505 Pediatric Study subjects ages 13 17 had their glucose levels intentionally manipulated during the clinic session Readings from the System were reported every 5 minutes and paired with YSI values collected every 15 minutes in order to characterize how well the System readings agreed with laboratory standard blood glucose results The remainder of the study took place at home and the System performance was also paired with the comparative meter results referred to as the SMBG Dexcom G5 Mobile System User Guide Technical Information 239 Table 1 A System Agreement to YSI within CGM Glucose Ranges Adult Percent Greater than 40 40 YSI CGM Number Percent Percent Percent Glucose Within Within Within Range Study 15 15 20 20 30 30 mg dL YSI YSI YSI Original Software 505 Overall Original Software 505 40 60 Original Software 505 61 80 Original Software 505 81 180 Original Software 505 Original Software 505 181 300 301 350 Original Software 505 351 400 1CGM readings are within 40 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User
26. 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 Transmitter W Continued on next page Dexcom G5 Mobile System User Guide Technical Information 281 Continued from previous page Separation Distance According to Frequency of Transmitter m Rated Maximum Output Power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Transmitter 0N d 1 2P d 1 2P d 2 3P 0 38 0 38 0 73 1 2 1 2 2 3 3 8 3 8 7 3 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in feet can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacture NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people USB Charging Download Cable Specifications Part Number MT20655 Input Output 5V DC 1A Type USB A to USB micro B Length 3 feet The power supply charger can be connected to the USB charging download cable for charging using an AC power outlet Misuse of the USB cable can present a strangulation risk Isolation of system is by unplugging charger from wall Power Supply Charger Specifications Part Number
27. 5 Minutes Vibrates beeps 2x s every 5 minutes until cleared Trend screen will continue to reflect Alert until sensor glucose readings go below Alert level Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 185 Rise Rate Fall Rate Alerts What you see Beeps and vibration RISING Initial Default Alert None Off After Setting Change Vibrates 2x s 2 sounds After 5 Minutes RISING a 4 Vibrates beeps 2x s every 5 minutes until cleared FALLING Initial Default Alert None Off After Setting Change Vibrates 3x s FALLING After 5 Minutes Vibrates beeps 3x s every 5 minutes until cleared or sensor glucose reading drops below Alert level Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 186 Low Repeat High Repeat What you see Beeps and vibration Initial Default Alert None Off After Setting Change Vibrates 3x s After 5 Minutes Vibrates beeps 3x s every 5 minutes until cleared Will re alert if sensor glucose readings drop at or below 55 mg dL Initial Default Alert None Off After Setting Change Vibrates 2x s After 5 Minutes Vibrates beeps 2x s every 5 minutes until cleared Beeps and vibration Initial Default Alert On After Setting Change Vibrates 1x Signal Loss After 5 Minutes for 11 53 48 Vibrates beeps 1x every 5 min
28. 6 Receiver Default Beeps and Vibrations The Dexcom G5 Mobile Receiver s Alarm Alerts are vibrations and a beep or a series of beeps based on the Alarm or Alert Beeps and vibrations are preprogrammed into the receiver and unlike the smart device the volume can t be changed In Chapter 12 you ll learn how to adjust the volume and intensity of your Alarm Alerts The following is a table of the receiver s default beep and vibration patterns If you clear the Alert s initial vibration you won t get any beeps or sounds unless you ve turned on the Repeat Alert In the next section you ll learn how to clear the Alarm Alerts Urgent Low Glucose Alarm What you see Beeps and vibration Initial Default Alert Vibrates 4x s URGENT LOW After 5 Minutes Vibrates beeps 4x s every 5 minutes until cleared or sensor 53z gt glucose readings go above Alarm level After 30 Minutes After clearing Alarm continues to notify if sensor glucose readings remain at or below Alarm level Dexcom G5 Mobile System User Guide a oO Sensor Glucose Alarm and Alerts Low High Glucose Alerts What you see Beeps and vibration Initial Default Alert Vibrates 3x s After 5 Minutes Vibrates beeps 3x s every 5 minutes until cleared Trend screen will continue to reflect Alert until sensor glucose readings go above Alert level Initial Default Alert Vibrates 2x s After
29. DONA Welcome Dexcom Share allows you the Sharer to send your inforrnation to another person the Follower For complete information soe your User Gude Dexcom G5 Mobile System User Guide Dexcom Share Welcome Screen Continued on next page Read screen Tap Next when done Sharing Is Caring 315 Continued from previous page What you see What it means What you do Internet Sarera toso ithe Fone wt Pod tom h To share your glucose information you must have internat Wi Fi or cell phone Message about Internet Tap Next data plan 7 access IMPORTANT Ii Internet access ts tumed OFF or unavailable your Follower will not receive your glucose information To make sure you are sharing How to know you are you must see BOTH a colored logo and a glucose value sharing your data oQ t you are not sharing the logo will turn gray with a red badge Continued on next page Dexcom G5 Mobile System User Guide Sharing Is Caring 316 Continued from previous page Step What you see Sharing There will be times when your Follower cannot see your glucose information An exampie Follower is in tremore area with no intemet access Your Dexcorn GS Mobile should always be the primary source of glucose information Dexcom G5 Mobile System User Guide What it means How to know your Follower is not getting y
30. Down Arrow Press Up Down Arrow Choose sound Profile Stop at desired Profile Press Select Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 206 Continued from previous page Step What you see What it means What you do Sample sound rt Press Down Arrow z Stop at Try It af Attentive Selected Profile check pasy Press Select to have the 3 marked af HypoRepeat sound play GI Tyit Exit Profiles Press Left Arrow Profiles Repeat steps 2 5 to change Profile Repeat as needed To Exit Press Left Arrow to Main Menu Profiles allow you to change your Alarm and Alerts tones The Alerts menu gives you options for personalizing your glucose level Alerts repeating Alerts turning your Rising Falling Alerts on and turning on your Signal Loss Alert Alerts Main Menu Low High Alert option lets you adjust your low high glucose Alert level mg dL Advanced gives you options to turn on Low High Repeat Rise Fall Alerts and Signal Loss Alert Low High Repeat In the previous chapter you learned clearing an Alert stops it from repeating If you want to continue to be re alerted until your glucose levels are back in your target range turn on the Repeat option Rise Fall Rate Your trend screen provides visual cues letting you know your sensor glucose readings are falling or rising rapidly Dexcom
31. G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 207 Constantly looking at your screen may not be practical You can customize your Rise Fall Alert with vibrations or beeps letting you know when your glucose is rising or falling 2 mg dL min or 30 mg dL up or down in 15 minutes or rising or falling rapidly 3 or more mg dL min or 45 mg dL or more up or down in 15 minutes The default setting for Repeat and Rise Fall Rate is Off It s important you discuss your alert settings with your healthcare professional Signal Loss Signal Loss Alert tells you when your transmitter and receiver aren t communicating Set the Signal Loss and get alerted if your sensor glucose readings have stopped due to a signal loss anywhere from 20 to 200 minutes The default setting for Signal Loss is On Steps to Customize Receiver Alarm Alerts Using the same example from changing your app Alerts let s change the receiver s High Alert notification level from 200 mg dL to 190 mg dL repeating every 60 minutes Follow the same steps turning on the Rise Fall Alerts and adjusting your Low Alerts Customizing Alerts Receiver Step What you see What it means What you do Change High Alert Level Go to Main Menu Press Select Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts N O Change High Alert Level Continued from previous pag
32. Guide Set up Your Display Devices 56 Continued from previous page Setting up Your App Alarm Alerts and Basic Settings Do Not Disturb We recommend you check that Do Not Disturb is not enabled If you have Do Not Disturt enabled you will not receive Sudidle Of vibratory fucose mit The next screens provide suggestions for device volume Do Not Disturb and other basic settings Tap appropriate answer to move forward Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 57 Continued from previous page Connecting Pairing Transmitter With App Transmitter Your transmitter sends glucose information to your Phone The next few screens witi walk Tap Next you through how to connect your transmitter to your IPhone Bluetooth Verify Bluetooth is on Your transmitter and iPhone The app will check to see if Bluetooth is turned connect using Buetootr on Bluetooth on your iPhone needs to be on im order for the system to work Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 58 Continued from previous page Connecting Pairing Transmitter With App Take Photo of Barcode Using your Phone take a photo oe the barcode found on the tom of the transmitter box Get your Transmitter box Tap Take Photo Enter transs Turn transmitter
33. Hardware Error Device What you see Problem What you do See Chapter 4 Charge receiver using Won tturnon electrical outlet not Battery dead computer laptop Full charge may take up to five hours See Chapter 4 Reset receiver Connect receiver to charger Insert end of paper clip into small circular hole on receiver s back Push down on paper clip Receiver will vibrate Processing screen appears Charge receiver Receiver After full charge Receiver session Won t turn on Receiver Low See Chapter 4 Receiver Battery Charge receiver Continued on next page Dexcom G5 Mobile System User Guide N tO N Troubleshooting Continued from previous page Device What you see Problem What you do See Chapter 16 Write down error code Contact Dexcom Technical Corrupted Support see Section 16 1 Call Tech Support database Check BG value using BG Error ERRI17 meter Receiver Prompt Vibrates one time for four seconds and four beeps See Chapter 16 Do nothing System Check Receiver is able to continue J System to work and recover from an Recovery error Receiver Passed App Tap OK to clear Alert Receiver Press Select to clear Alert See Chapter 5 Go to smart device s Settings No Bluetooth Make sure Bluetooth is On If problem persists please contact device s manufacturer
34. High Symptoms What it means General well being Continued on next page Dexcom G5 Mobile System User Guide What you do Enter different health Events see following Health Events Menu table Daily Events Affect Your Glucose Trends and Patterns 158 Continued from previous page Device What you see What it means What you do Event Time O Bar O amp ime O Exercise O 4 Health Smart Device In App Event Time For each separate Event enter date time Event o oe O Ra Event time Health afe Receiver 2014 12 31 1230 PM As mentioned in the last table Health has a series of Events Tell the system how you are feeling if you had a drink if you re having low or high BG symptoms etc You select the Event no amounts are entered just date and time Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 159 Health Events Menu Device What you see What it means Health Main Menu lt Health Event Hines Stress Feel High Foei Low Smart Device 9 In App Ac ohot Use Health Main Menu to access selections Cancel K Receiver Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 160 Device Health Events Smart Device In App Continued from previous page What you see
35. Mobile CGM System does and what s new let s open your Dexcom G5 Mobile packages see what s inside and review each item 4 6 System Components Package The Dexcom G5 Mobile CGM System comes to you in a number of boxes after opening keep the packaging until you are no longer using its contents Sensor Sensor package Single use sensor s Continued on next page Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 39 Continued from previous page Transmitter Transmitter package Reusable transmitter Receiver Receiver package Receiver Receiver s USB charging and download cable AC power adapter Continued on next page Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 40 Continued from previous page Receiver Welcome Card Quick Start Guide Training Checklist attached to Quick Start Guide Training Tutorial USB Card Overview of System Components This section is meant as a quick overview of each part specifics for each are found in following chapters For detailed product specifications and technical information please go to Chapter 17 Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 41 The Dexcom G5 Mobile CGM System is comprised of four key parts 1 Single use sensor 2 Re
36. Sensor failures can happen when your display device doesn t receive your sensor s glucose readings While it is rare to have a sensor failure there are preventative steps you can take Help prevent sensor failures by checking Sensor hasn t expired Transmitter is snapped securely in sensor pod Sensor pod isn t dislodged or adhesive isn t peeling Nothing is rubbing against sensor pod e g seat belts etc You selected a good insertion site see Chapter 6 Insertion site is clean and dry before sensor insertion oor whrh Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 123 The app and receiver are ready for a new session However before you can start a new sensor session you need to end the current sensor session and remove the old sensor and transmitter 8 4 Remove Sensor Pod and Transmitter Remove Sensor Pod Think of the transmitter as being part of the sensor pod Do not remove the transmitter before removing the sensor pod from your body To remove the sensor pod 1 Gently peel sensor pod adhesive patch from skin a Sensor wire comes out with sensor pod 2 Separate the transmitter from the sensor pod 3 Discard the sensor pod following your local waste management regulations for disposing blood contacting parts sensor and applicator Remove Transmitter from Sensor Pod Remember your transmitter is reusable With a battery life of 90 days us
37. Sent when active glucose sharing is stopped for any reason other than the Sharer turning Share Off o The Follower should contact the Sharer for more information about the data interruption The Follower Dashboard Figure 11 Follower Dashboard If you don t allow your Follower to see your Trend Graph they will only see your glucose reading and trend arrow Dexcom G5 Mobile System User Guide Sharing Is Caring How long ago the Sharer s glucose reading and trend arrow were last updated Sharer s picture Sharer s glucose reading and trend arrow Figure 12 Follower Information If you choose to have your Follower see your Trend Graph they see Sharer s name Notification settings Home icon Sharer s 4 Trend arrow glucose Time s7 6HR RHR ZHR reading duration setting of 3 6 12 or 24 hours Glucose range between high Trend graph and low alerts d 1 pete Figure 13 Follower Information With Trend Graph 20 8 Troubleshooting Dexcom Share Troubleshooting Troubleshooting Status See the Troubleshooting Status Issues portion of Section 20 6 Dexcom G5 Mobile System User Guide Sharing Is Caring 330 Sharing status X Oa e Sharing troubleshooting Figure 14 Sharing Status Troubleshooting Sharing Checklist To share you need to Make sure your smart device works with the Dexcom G5 Mobile App To see a list of supported
38. Software 505 1Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 258 Table 6 C Hyperglycemic Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After Pediatric Ages 2 5 Years Hyperglycemic Alert Level Study Hyperglycemia Hyperglycemia Missed Detection Rate mg dL Detection Rate Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Table 6 A 6 B and 6 C Table 6 A represents the hyperglycemic alert evaluation within 15 minutes of the YSI value in the adult studies Table 6 B represents the alert evaluation within 15 minutes of the YSI value for a subset of the pediatric population subjects age 6 to 17 years who had YSI measurements every 15 minutes Table 6 C represents the alert evaluation within 30 minutes of an SMBG reading for 2 to 5 year old subjects in the pediatric studies Hyperglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong The True Ale
39. What it means Sensor glucose reading at or above your high Alert level Shows most current sensor glucose reading Arrows reflect rate of change Can be set to repeat between 15 minutes to 4 hours Check BG meter to make treatment decisions Sensor Glucose Alarm and Alerts 180 Rise Rate Fall Rate Alerts Device Smart Device Lock Screen Smart Device In App What you see Rise Rate Alert Receiver RISING 4 RISING 44 Dexcom G5 Mobile System User Guide Continued on next page What it means Sensor glucose readings rising quickly Number of arrows shows how fast 2 mg dL min 3 mg dL min Check BG meter to make any treatment decisions Sensor Glucose Alarm and Alerts 181 DIA Smart Device Lock Screen Continued from previous page What you see Smart Device In App Fall Rate Alert kd Fall Rate Alert Receiver FALLING 4 FALLING 44 Dexcom G5 Mobile System User Guide What it means Sensor glucose readings falling quickly Number of arrows shows how fast 2 mg dL min 3 mg dL min Check BG meter to make any treatment decisions Sensor Glucose Alarm and Alerts 182 Signal Loss Alert Device What you see What it means Smart Device Lock Screen Smart Device Your receiver and transmitter are not In App communicating Y
40. applicator barrel You should hear 2 clicks NOTE Finger placement is important for correct insertion Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 78 Continued from previous page Removing Applicator Barrel and Collar Move two fingers from above collar to below collar Keeping your thumb as a base on the white plunger Pull collar all the way back towards your thumb You should hear 2 clicks NOTE Finger placement is important for correct needle removal Hold transmitter latch down against your body Squeeze ribbed release tabs on the sides of sensor pod Move applicator barrel forward and out away from your body Follow local ordinances when disposing the applicator What s left 1 Sensor pod 2 Transmitter latch You have successfully inserted the sensor At this point you should have two items attached 1 The sensor pod 2 The transmitter latch Having problems If it s the first time inserting a sensor you may have questions or need help If you do please contact your Dexcom G5 Mobile CGM System Technical Support team 24 7 at Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 79 e Toll free 1 877 339 2664 e Toll call 1 858 200 0200 The next step is attaching your transmitter to the se
41. box upside down on a flat surface with barcodes facing up Center longest barcode within green brackets Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 59 Continued from previous page Connecting Pairing Transmitter With App Take Photo of Barcode Check mark confirms successful transmitter SN scan lt Take Photo of Barcode Using your iPhone take a photo of the barcode found on the bottom of the transmitter box If unable to use app s scanning device Tap Enter transmitter SN by hand Enter tranuretter SN by hand Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 60 Continued from previous page Connecting Pairing Transmitter With App Enter Transmitter SN Use keyboard to enter transmitter SN Confirm correct SN Tap Save Sensor Transmitter insert your sensor Insert sensor and attach transmitter following video s instructions See Chapter 6 for more information Watch me video for instructions Skip Video Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 61 Continued from previous page Connecting Pairing Transmitter with App Wait up to 30 minutes for smart device and transmitter to connect It will take up to 30 minutes for your Pod touch to connect to your transmitt
42. e Date of Birth e The technical issue you e When the problem happened date and time e Patient s address e Patient s phone number e Item SKU number and description e g name of the device e Lot number and or serial number s of affected devices e g sensor Dexcom G5 Mobile System User Guide Need Help You re Not Alone 233 What Can They Help Me With The Dexcom Technical Support Team helps you with all CGM system related issues as well as software related issues Dexcom Technical Support does not offer medical advice 16 2 Patient Care Team The Patient Care Team PCT is a group of Certified Diabetes 28 OAE Educators CDE and Registered Nurses RNs offering you customer care and individualized education services around Dexcom CGM Your PCT provides education and support throughout your CGM experience such as e Initial CGM Product Training e Ongoing Dexcom product education e g how to use a specific feature e How to maximize Dexcom CGM use e Dexcom CGM reporting software and features e How to review and understand Dexcom CGM reports By Phone Available Monday Friday 5 30 am 8 00 pm PST subject to change Toll Free 1 877 339 2664 Toll Call 1 858 200 0200 By Email Email patientcare dexcom com If you prefer to email to help us help you best include the following information in your email e Name e DOB e Contact phone number e Reason for inquiry or education needed For addi
43. excludes and disclaims all other warranties including without limitation any warranty 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 G5 Mobile CGM System or any feature or service provided by Dexcom for use with the Dexcom G5 Mobile CGM System 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 Dexcom G5 Mobile System User Guide Warranty The Fine Print 219 This Limited Warranty is only provided to the original Purchaser and can t be transferred to anyone else and states Purchaser 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 will be enforced to the maximum extent permitted by law Dexcom G5 Mobile System User Guide Warranty The Fine Print Chapter 14 Everything Else G5 How to Take Care of Your Dexcom G5 Mobile CGM System
44. gray when Dexcom Share has not been activated The sharer should tap the light gray icon to get started using Dexcom Share When a device or connection is not working Dexcom Share will not work The Sharer will not be able to send their sensor glucose readings and data to their Follower Troubleshooting Status Issues Dexcom Share s status bar is a useful tool It can help identify if there is a problem and Dexcom Share is not working The following table provides troubleshooting tips for the Share status bar s 1000 AM 1s lt Dexcom Share On Off Switch Turns sharing on or off Sharing Status Bar Status of sharing your sensor glucose readings with your Follower List Add Followers Followers and lists status of Followers Figure 10 Dexcom Share Screen NOTE Whether or not Dexcom Share is working and the Followers are receiving glucose Alarm Alerts you must always refer to your Dexcom G5 Mobile display device for your sensor glucose readings and alerts All treatment decisions must be based on your BG value from your BG meter Dexcom G5 Mobile System User Guide Sharing Is Caring 324 What you see Sharing status v Oa What it means Green Check All connections are working What you do Sharing status xX Oa Sharing troubleshooting Dexcom G5 Mobile System User Guide Issue with e Sharer s CGM data e Your smart device Continued on
45. is the of time the device alarmed when the blood glucose level was at or below the alert setting within 15 or 30 minutes before or after the device alarmed The False Alert Rate is the of time the device alarmed when the blood glucose level was above the alert setting within 15 or 30 minutes before or after the device alarmed For example if you set the Low Glucose Alert to 70 mg dL and your alarm sounds how often can you expect your blood sugar to actually be low In the Software 505 Adult Study Table 5 A when your alarm sounds you can expect your blood sugar to be below 70 mg dL approximately 92 of the time and above 70 mg dL approximately 8 of the time within the 15 minute period before or after your alarm sounds Hypoglycemia Detection Rate The Detection Rate shows how often the device recognizes and alerts you to an episode of hypoglycemia or how often it misses such an event The Hypoglycemia Detection Rate is the of time the blood glucose level was at or below the alert setting and device alarmed within 15 or 30 minutes before or after the blood glucose was at or below the alert settings The Hypoglycemia Missed Detection Rate is the of time the blood glucose was at or below the alert setting but the device did not alarm within 15 or 30 minutes before or after the blood glucose was at or below the alert setting For example if you set the Low Glucose alert to 70 mg dL how often will your alarm alert you if your blood gluco
46. it Dexcom G5 Mobile System User Guide Calibration Chapter 8 Let s G5 The Basics Ending Your Sensor Session and Transmitter Session 8 1 Introduction Dexcom G5 Mobile Sensor Sessions last seven days This chapter reviews what you should expect when your session is about to expire removing the sensor and transmitter It also covers how to determine if you need to end your session early After this chapter you will be able to e Identify replace sensor prompts at the end of a seven day sensor session e Recognize when you have to end a sensor session early e Successfully end a sensor session early o Identify how you can prevent sensor session failures e Remove your sensor pod with transmitter attached e Separate transmitter from sensor pod e Determine if transmitter can be used for another sensor session To keep up with your glucose trends it s important to begin a new sensor session as quickly as possible After a sensor session ends the sensor stops taking your sensor glucose readings You won t get your trends nor will you get any Alarm or Alerts Before stopping a session and removing the sensor pod and transmitter review the following safety statements to make sure you don t harm yourself Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 109 8 2 Safety Statements WARNING Don t If a sensor breaks under the skin with no portion visible above the skin do
47. measurement for calibration o Determine if you need to calibrate outside of the normal calibration requirements e Initiate startup calibration e Perform update calibrations e Correctly enter your fingerstick measurement o Dexcom G5 Mobile App o Dexcom G5 Mobile Receiver e Identify calibration errors Dexcom G5 Mobile System User Guide Calibration 91 7 2 Calibration Overview What Is a Calibration As you learned earlier the sensor glucose readings come from measuring the glucose fluids found between your cells interstitial fluids Although blood and interstitial fluids are similar sensor glucose readings can be different between your fingerstick and your CGM Calibration provides a comparison or measurement between your meter s fingerstick measurement and the sensor s glucose readings allowing alignment between the sensor and meter Your BG meter teaches the sensor your glucose values through calibration Just like a clock can need adjusting calibrations allow your CGM to adjust to your body Why Is Calibrating Important Calibrations are a must to make sure the CGM system is performing at its best By calibrating when the system notifies you that a calibration is due the Dexcom G5 Mobile CGM System uses your meter s BG value to make sure the sensor glucose readings remain accurate throughout your session How Do Calibrate Take a fingerstick measurement from your meter and simply enter the meter s BG v
48. meets this standard in all modes may be used onboard the aircraft without any further testing by the operator This device can withstand exposure to common electrostatic ESD and electromagnetic interference EMI Still Have Questions Visit the TSA s website if you have any questions or concerns at tsa gov Dexcom G5 Mobile System User Guide On the Go With Dexcom G5 Mobile CGM System Getting Through Security 230 Email TSA ContactCenter dhs gov Phone Call 1 866 289 9673 Dexcom G5 Mobile System User Guide On the Go With Dexcom G5 Mobile CGM System Getting Through Security 231 Page intentionally left blank Dexcom G5 Mobile System User Guide On the Go With Dexcom G5 Mobile CGM System Getting Through Security 232 Chapter 16 Everything Else G5 Need Help You re Not Alone Dexcom has two support teams to help you each with their own specialty e Technical Support Team e Patient Care Team 16 1 Dexcom Technical Support Provides replacement units resolves technical issues or takes product complaints Call your Dexcom Technical Support Team 24 hours a day 7 days a week if something is wrong with your Dexcom G5 Mobile CGM System By Phone Dexcom Technical Support Phone Numbers Toll Free 1 877 339 2664 Toll Call 1 858 200 0200 By Email Email TechSupport dexcom com If you prefer to email to help us help you best include the following information in your email e Name of patient
49. receiver and or smart device Not included in packages 1 Alcohol wipes 2 Your blood glucose meter 3 Your test strips Before starting check your blood glucose meter make sure it s in good working order following manufacturer s directions and the meter s date and time match your display device s date and time Make sure test strips haven t expired and work with your meter Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 74 Before removing the sensor applicator out of its sterile pouch determine the best place to insert your sensor 6 4 Choosing Your Insertion Site Choose a place on your belly or if user is between the ages of 2 and 17 upper buttocks to insert the sensor the site should be either above or below your belt line The best areas are usually flat pinchable and free from where rubbing can occur along the waist band seat belt strap or where you lay when sleeping For more help on ideal sensor insertion sites contact your healthcare professional Insertion Sites Location Where it is Front of body belly area for ages 2 years and above If user is between the ages of 2 years and 17 Back of body Upper buttocks Do e Remove the sensor and applicator from its sterile package only at time of use e Place at least 3 inches from your insulin pump infusion set or injection site Dexcom G5 Mobile System Us
50. sensor may be inaccurate and as a result so will your display device s sensor glucose readings Alerts and prompts etc There are important times when you must calibrate 1 Initial or Start Up Calibration two hours after you insert your sensor 2 12 Hour Update every 12 hours after two hour startup calibration 3 When system prompts you With calibration prompts your sensor and display device helps you keep your calibration schedule on track If your BG values are not between 40 400 mg dL the system won t accept your calibration Wait until you are within the 40 400 mg dL range before entering your BG values Initial Calibration Sensor Start Up Completed 1 At prompts see next table enter two back to back fingerstick measurements into just one device 2 No need to do initial calibrations twice a Calibration data flows between the receiver and your app b Five minute reporting delay between devices 3 First update calibration is 12 hours after your initial calibration Update Calibration Update calibrations are typically 12 hours since your last calibration however it can be sooner As an example if you know your next calibration is due at 4 AM you can do the calibration before bedtime resetting the 12hour count down Dexcom G5 Mobile System User Guide Calibration 95 1 Enter one fingerstick measurement at least every 12 hours 2 Display devices provides calibration prompts 3 You may be prompted to ente
51. smart devices and operating systems go to dexcom com compatibility e The Dexcom G5 Mobile App is open or running in the background e Smart device has an active Internet connection Wi Fi 3G 4G LTE The Sharer can check to see if the Internet connection is working by trying to open a web page on the Sharer s smart device e f on a phone call using your smart device your CGM information may not upload into the Share Cloud while on your call e Airplane Mode turned off e Do Not Disturb is turned off e Smart device sound is on in order to hear prompts e Smart device is sufficiently charged or charging e Smart device is within 20 feet of the transmitter e Smart device has 35 MB of available memory e Refer to the smart device user manual for further instructions Tips e Read the Dexcom G5 Mobile CGM System User Guide before using the Dexcom Share feature e Always confirm information with a BG meter before you make treatment decisions Dexcom G5 Mobile System User Guide Sharing Is Caring 331 Dexcom G5 Mobile System User Guide Page intentionally left blank Sharing Is Caring Index A E Alarm 175 Error Messages 146 App Recommended Settings 183 Event Clearing 188 Prompts 178 Receiver Beeps and Vibrations 184 What is an 176 Alarm and Alerts Changing Receiver 204 Customizing 195 Alerts 175 Clearing 188 Default 176 Low Repeat High Repeat 185 Low High Glucose 179 180 Main Menu 207 Receiver
52. systems the app or receiver you can choose to monitor your glucose levels in the handiest method at that moment Smart device ran out of memory If you forgot your receiver at home use your smart device Battery died on your smart device Smart device memory full Your receiver has you covered With the exception of Dexcom Share the primary difference between the two monitoring systems is not the data itself but how it s presented The next section walks you through the initial set up for the app To set up the receiver go to Section 5 5 If you want to use both the mobile app and the receiver you need to set each up individually Once you have completed the initial set up you re one step closer to beginning your sensor session 5 4 Dexcom G5 Mobile App Before starting your first sensor session pick the smart device you want to use As mentioned in the previous chapter you can use the receiver with one smart device during a session however you can t use multiple smart devices during the same session While your smart device can have the app installed part of your initial set up is entering the transmitter s serial number SN If by accident you enter the SN into more than one smart device the system warns you and you won t be able to complete the set up process Suggested Smart Device Settings Bluetooth is designed wireless communication between devices unlike Wi Fi which wirelessly connects devices to the Intern
53. the area around the wire Dexcom G5 Mobile System User Guide y Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session WARNING Do Store sensor between 36 F 77 F during its shelf life Why Storing the sensor incorrectly might cause the sensor glucose readings to be inaccurate Never store sensors in the freezer Consequences If stored outside of 36 F 77 F your sensor glucose readings may not be accurate resulting in you missing a severe low or high glucose event WARNING Don t Never use the Dexcom G5 Mobile CGM System sensor glucose readings for treatment decisions Do Only use BG values from your BG meter for treatment decisions e g how much insulin to take Why Since they measure your glucose from different body fluids sensor glucose readings can be different from your meter s blood glucose values Consequences Using sensor glucose readings for treatment decisions could result in you missing a severe low or high event PRECAUTION Do Select sensor insertion site with care Avoid e Areas likely to be bumped pushed or squeezed e Areas of skin with scarring tattoos or irritation e Injecting insulin within 3 inches of sensor e Placing an insulin pump infusion set within 3 inches of sensor Why Inserting sensor in these areas may affect sensor glucose readings Consequences Inaccurate sensor glucose readings may result in you missing a sev
54. to Kevin Allow Trend Geagh View OFF Urgent Low Before Follower invitation is sent review the Summary screen Tap Send Invitation For More Than High on After sending invitation you cannot adjust the Notify Above moe Follower s settings For More Than Low Notify Below lt Dexcom Share Sharing d To emgnrarty nap cherie tuin marg of Sharing status v Ma To add more Followers Tap Followers tab on the Share Status screen Invite up to a total of five 5 Followers Followers 2 Laura Ba Ran 2 4 Dexcom G5 Mobile System User Guide Sharing Is Caring 20 6 Using Dexcom Share Dexcom Share Status You can look at the Dexcom Share icon on your home screen to see if Dexcom Share is working After turning Dexcom Share on check its status vha8 PM Kk amp Share icon Figure 9 Dexcom G5 Mobile App Home Screen Dexcom Share Status Icons Status Tab What it is The Share icon is in color when Dexcom Share is sending sensor glucose readings and information The Share icon is gray with a red circle when Dexcom Share is not working The sharer should tap on the grayed out Share icon when it is not working to get further information about the error Continued on next page Dexcom G5 Mobile System User Guide W N Ww Sharing Is Caring Continued from previous page Status Tab What it is The Share icon is light
55. to blood glucose values to assess its performance and how well the System readings compare to a laboratory test method that measures blood glucose values Additionally subjects performed self monitoring blood glucose meter tests at home to assess the System performance in real use environment Although the performance characteristics of the System are presented in the following there is no commonly accepted statistical approach for capturing performance of continuous glucose monitors CGMs such as the Dexcom G5 Mobile CGM System Clinical Study Overview The System performance was evaluated in four separate prospective clinical studies Two studies included adults and two studies included pediatrics In the following sections and tables the studies will be identified as follows Adult Studies 18 years and older Original Adult Study the Receiver included software version SW10050 Software 505 Adult Study the Receiver included software version SW10505 Pediatric Studies 2 to 17 years Original Pediatric Study the Receiver included software version SW10050 Software 505 Pediatric Study the Receiver included software version SW10505 The Dexcom G5 Mobile CGM System incorporates the algorithm from software version SW10505 and has a new software number Overview of Adult Studies The System performance for adults was evaluated in two separate prospective clinical studies Original Adult Study software SW10050 and the Software 505 Adult
56. younger than 6 years old and the Software 505 Pediatric Study enrolled 79 subjects with 20 of subjects younger than 6 years old All subjects had Type 1 or Type 2 diabetes mellitus and required insulin or oral medication to manage their diabetes In the Original Pediatric Study about 99 of subjects had Type 1 diabetes and 1 had Type 2 diabetes In the Software 505 Pediatric Study all subjects had Type 1 diabetes Sensors were inserted in either the abdomen or upper buttocks Subjects in all studies used the System for seven days In the Original Pediatric Study all subjects wore 2 sensors in the Software 505 Pediatric Study all subjects wore 1 sensor only Throughout Dexcom G5 Mobile System User Guide N W Technical Information the 7 day wear period the sensors were calibrated with an average of 2 fingersticks per day approximately once every 12 hours using self monitoring blood glucose SMBG meter values The Original Pediatric Study used the LifeScan OneTouch Verio IQ meter the Software 505 Pediatric Study used Bayer s CONTOUR NEXT USB meter All subjects were evaluated in a controlled clinic environment on Day 1 Day 4 or Day 7 of the 7 day wear period While using the System in the clinic subjects provided at least two fingerstick measurements per hour and subjects ages 6 17 also provided venous blood for comparison to a laboratory method the Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer This
57. your Dexcom G5 Mobile CGM System before using Incorrect use could lead you to misunderstand system information or might affect its performance and you might miss a severe low or high glucose event Treatment Decisions The Dexcom G5 Mobile CGM System does not replace your BG meter When making treatment decisions such as the amount of insulin you need only use your BG value Don t use the Dexcom G5 Mobile CGM System sensor glucose readings because readings can be different from your BG value If sensor glucose readings are used in determining treatments it could result in you missing a severe low or high glucose event Don t Ignore Low High Symptoms If your sensor glucose readings don t match your symptoms measure your BG with a fingerstick You may miss a severe low or high glucose event Who Shouldn t Use The Dexcom G5 Mobile CGM System was not evaluated for the following persons e Pregnant women e Persons on dialysis Do not use the Dexcom G5 Mobile System in critically ill patients It is not known how different conditions or medications common to the critically ill population may affect the performance of the system Sensor glucose readings may be inaccurate in critically ill patients The system s accuracy hasn t been tested in people falling into these groups and sensor glucose readings may be inaccurate resulting in missing a severe low or high event Dexcom G5 Mobile System User Guide Indications for Use
58. 16 App Tap OK to clear Receiver Press Select to clear Will not re alert once cleared Order new transmitter Troubleshooting 297 Dexcom G5 Mobile System User Guide Page intentionally left blank Troubleshooting Chapter 19 Everything Else G5 Symbols on Package Labels The following symbols may be found on the sensor transmitter and receiver package labels These symbols tell you about the proper and safe use of the Dexcom G5 Mobile System 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 Use By Date Batch Lot Number Caution Part Catalog Number Date of Manufacture Sterile by Radiation Do Not Reuse Temperature Limitation IP28 Protection Against Serial Number Insertion of Large Objects and Immersion in Water IP22 Protection Against Class II Equipment Insertion of Large Objects and Dripping Water Alternating Current Direct Current Continued on next page Dexcom G5 Mobile System User Guide Symbols on Package Labels 299 Type BF Applied Part Authorized Representative in the European Community Manufacturer Non lonizing Radiation Humidity Limitation Marking Certifies Device Meets European Council Directive 93 42 EEC European Union WEEE Directive 2012 19 EU Do Not Use if Package is Damaged Electrical Equipment Designed Prim
59. 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Sensor Stability Relative to YSI Sensors can be worn for up to 7 days Performance was estimated by calculating the percentage of System readings within 15 mg dL or 15 20 mg dL or 20 30 mg dL or 30 40 mg dL or 40 and greater than 40 mg dL or 40 of the YSI values at the beginning Day 1 middle Day 4 and end Day 7 of the System lifecycle The average and median of the absolute percent differences are included in Table 8 A and 8 B showing consistent accuracy and sensor stability over the 7 day life of the sensor Dexcom G5 Mobile System User Guide Technical Information 265 Relative to SMBG Pediatric Study Performance was also estimated by calculating the percentage of system readings within various percentages of the SMBG values at each day of the sensor wear period Table 8 C The average and median of the absolute percent differences are included in the table Precision of System Readings A subset of subjects wore two Systems at the same time This was to look at how similarly two Systems function on the same subject sensor precision Precision was evaluated by comparing the glucose readings from the two S
60. 61 200 201 250 251 300 301 350 351 400 gt 400 Dexcom G5 Mobile System User Guide Technical Information 247 Table 3 C Concurrence of CGM Readings and YSI Values Original Pediatric Study YSI mg dL Row Percentage of Matched Pairs in each CGM Glucose Range CGM mg dL ean 40 61 81 121 161 201 251 301 351 gt Number of Paired Je te 120 160 200 250 300 350 400 400 CGM YSI lt 40 0 0 54 31 15 0 0 0 0 0 40 60 21 58 16 5 0 0 0 0 0 0 61 80 81 120 121 160 161 200 201 250 251 300 301 350 351 400 gt 400 Dexcom G5 Mobile System User Guide Technical Information 248 Table 3 D Concurrence of CGM Readings and YSI Values Software 505 Pediatric Study YSI mg dL Row Percentage of Matched Pairs in each CGM Glucose Range CGM mg dL 40 61 81 121 161 201 251 301 351 number of Paired 60 80 120 160 200 250 300 350 400 CGM YSI 81 120 121 160 161 200 201 250 251 300 301 350 351 400 gt 400 Concurrence of System and Laboratory Reference Table 3 A Original Adult Study 3 B Software 505 Adult Study 3 C Original Pediatric Study and 3 D Software 505 Pediatric Study are categorized by ranges of CGM glucose readin
61. Contains small insertion needle and sensor wire Inserts sensor wire under the skin Disposable for single use only Removed after insertion Safety Lock Keeps all moving parts in place before insertion Prevents accidental sensor insertion Tool to remove transmitter after sensor session Put in transmitter box after removal to use later Collar Collar removes insertion needle Plunger Transmitter Latch Securely snaps transmitter into sensor pod Sensor Pod Sensor Pod Inserts sensor wire into your body Holds transmitter and sensor wire Water resistant when transmitter is properly installed Discarded after sensor session Adhesive Patch Keeps sensor pod attached to your skin Transmitter Cradle Holds transmitter in place during sensor session Sensor Wire Wire measures glucose levels in fluid in between your cells Attached to sensor pod Discarded with pod after session Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 43 Transmitter Overview Figure 2 Dexcom G5 Mobile Transmitter Front and Back Snapping into the sensor pod the gray plastic transmitter wirelessly sends your glucose information to your display devices receiver and or smart device If you have a new transmitter open the package when you are ready to use it The transmitter is 1 Reusable a Do not discard after sensor session b Only for you don t share trans
62. Day1 Day2 Day3 Day4 Day5 Day6 Day7 ae Original 98 98 98 98 97 99 95 97 Software 505 98 99 98 98 96 99 97 98 Original Software 505 Mean Median Standard Original Deviation Software 505 Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 A total of 108 sensors were included with the Original Study and 51 sensors were included with the Software 505 Study Dexcom G5 Mobile System User Guide Technical Information 269 Table 10 B System Readings Within Wear Days Pediatric All Days Original 98 97 99 97 Mean Software 505 Original Software 505 Statistic Study Day1 Day2 Day3 Day4 Day5 Day6 Day7 Median Standard Original Deviation Software 505 1Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 A total of 108 sensors were included with the Original Study and 77 sensors were included with the Software 505 Study Number of Readings Provided The System is capable of providing a reading up to every 5 minutes or up to 288 readings per day For a variety of reasons the System may not display a glucose reading and readings are skipped Table 9 A and 9 B estimate the number of readings you can expect to receive from the System over the entire 7 day period after calibration Table 10 A and 10 B show the numb
63. Dexcom GO CONTINUOUS GLUCOSE MONITORING SYSTEM User Guide Wf IMPORTANT CONTACTS AND NUMBERS Emergency Phone Number Your Healthcare Professional Your Receiver Serial Number Your Transmitter Serial Number Dexcom Technical Support Patient Care Team _ 1 877 339 2664 Dexcom Website _dexcom com Nearest Hospital Dexcom Table of Contents Part 1 Getting Started Glossary 5 Chapter 1 Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey 9 1 1 Introduction ceeeeeee eee 9 1 2 Self Paced Resources 4 10 1 3 Your Dexcom Account 4 12 Chapter 2 Indications for Use and Safety Statement 15 2 1 Introduction ceeeeeeee es 15 2 2 Important User Information 15 2 3 Safety Statements 006 16 2 4 Overview of Safety Statements 17 2 5 General CGM System Warnings 20 2 6 Calibration Warning and Precautions 20 2 7 System Hardware Software Warnings and PrecautionS ccccceseeeeeeeees 22 Chapter 3 Risks and Benefits 29 Bl RISKS eatet dci cided war oa 29 3 2 BenefitS ccccece cee eee eee tenes 30 Part 2 Let s G5 The Basics Chapter 4 What Is the Dexcom G5 Mobile mi System 35 System Description 45 35 i Safety Statement 606 35 4 3 The Dexcom G5 Mob
64. Did you catch your kid s sniffles How much insulin did you take for your dinner meal These are all Events that can raise or lower your blood sugars An Event is an action or situation affecting your glucose levels With the Dexcom G5 Mobile CGM System you have the ability to enter your daily Events helping you track their effect on your glucose trends Once entered into the smart device or receiver Events can be viewed in Dexcom reports The reports help you review how each Event influenced your glucose trends Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 153 You can use the reports with your healthcare professional to create a game plan in managing your diabetes Even though they differ on how to enter an Event and time the app and receiver have the same Event categories and subcategories Later in this chapter you ll learn how to enter Events in each device Event Categories There are four main Event categories 1 Carbs 2 Insulin 3 Exercise 4 Health The fourth category Health has more options e Illness e Stress e Feel High e Feel Low e Cycle e Alcohol The following table provides more detail on each type of Event Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 154 Events Menu What you see What it means What you do Smart Device In App How many grams did you just eat Enter Carb grams Receiver
65. Down o Scroll through trend screens o Highlight menu items o Change values e Left o Go back to last item or screen e Right o Go to next item or screen Initial Setup of the Dexcom G5 Mobile Receiver Press Select to turn receiver on The first screen you see is the startup screen with ascending green bars Once complete a set up wizard guides you through the initial set ups steps Don t be alarmed if your receiver buzzes or makes other sounds during this process After your initial setup is complete you won t see the setup wizard again Your settings can always be adjusted using menu options How you complete your initial set up differs between the receiver and your smart device however the data is the same Setup Wizard Prompts e Time Date e Transmitter Serial Number o Back of transmitter o Back of transmitter s box e Setting Low Alert e Setting High Alert Before starting a session you may want to check the receiver s battery level If it is less than half go to Chapter 4 for charging instructions Dexcom G5 Mobile System User Guide Set up Your Display Devices 64 Initial Receiver Set up Step What you see What you do Initial Screens Press Selectto turn receiver on Dexcom Time Date Press Up Down Arrow to change year Time Date Press Right Arrow to move forward Press Up Down Arrow to change month 04 10 Press Right Arrow Press Up Down Arrow to change day Press Right Arrow to m
66. Electrical Fast Transient Burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines Not applicable Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s Not applicable Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s Not applicable Mains power quality should be that of a typical commercial or hospital environment Voltage Dips Short Interruptions and Voltage Variations on Power Supply Input Lines IEC 61000 4 11 IEC 60601 1 11 0 U for 1 cycle 0 U for 0 5 cycle at 8 phase angles 70 U 30 dip in Ut for 25 cycles 0 U for 250 cycles 0 U for 1 cycle 0 U for 0 5 cycle at 8 phase angles 70 U 30 dip in Ut for 25 cycles 0 U for 250 cycles Mains power quality should be that of a typical commercial or hospital environment Power Frequency 50 60 Hz Magnetic Field IEC 61000 4 8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE U is the a c mains voltage prior to application of the test level Guidance and Manufacturer s Dec
67. G5 Mobile App from your smart device s store However if your smart device has been jailbroken do not install the app For information on how to install an app see your smart device s user guide Initial Dexcom G5 Mobile App Setup Setting up your app is easy You ll need your Dexcom account username and password along with your transmitter box Once inside simply follow the set up wizard instructions The set up wizard walks you through safety information recommended settings entering transmitter SN setting your high low glucose levels and receiving CGM notifications Your initial set up will require a Dexcom username and password You can create them by tapping Sign Up within the app or by going to dexcom com From Your Web Browser 1 Go to dexcom com 2 Click green Get Started tab or the three green bars then Get Started 3 Click green Get Started button on the page 4 Fill out User account screen 5 Click the green Create New Account button towards the bottom of the screen But what if you are unclear about a step The Dexcom App has prompts allowing you to get more information If you are unsure of something during your initial set up process look at the screen for additional information prompt Informational prompts include but aren t limited to don t understand Learn More or Question Mark Tap your informational prompt to get more information To close out of the information prompt tap the X in t
68. G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System 223 Step What you see Continued from previous page What it means Micro USB Cable What you do Plug into receiver to charge battery Don t plug into a computer port to charge Don t use an external USB hub it doesn t provide enough power to charge battery Battery can only be charged using the adapter wall charger Charge battery before each new sensor session Dexcom G5 Mobile System User Guide Wall Charger Continued on next page Plug USB cable into adapter wall charger Plug wall charger into an electrical outlet to charge receiver s battery Don t block access to the charger How to Take Care of Your Dexcom G5 Mobile CGM System Step What you see Continued from previous page What it means Battery Charging What you do Keep charging until icons are solid Battery Charged Unplug wall charger from outlet when fully charged Accessories USB Port Door Remove USB cable from receiver Close USB port door after removing USB cable to keep receiver clean and dry 1 Only use Dexcom supplied parts including cables and chargers a Use of non Dexcom supplied parts may affect safety and performance 2 Insert cables only as directed a Do not force cables in place 3 Look at cables for signs of wear and tear Do not u
69. G5 Mobile should not be used because it may be harmful to you The risk of use clearly outweighs any possible benefit Hyperglycemia High blood glucose Same as high or high blood sugar Hyperglycemia is a characterized by an excess of glucose in the bloodstream It s important to treat hyperglycemia If left untreated hyperglycemia can lead to serious complications The default high alert in the Dexcom G5 Mobile CGM System is set to 200 mg dL Consult your healthcare professional to determine the appropriate hyperglycemic setting for you Hypoglycemia Low blood glucose Same as low or low blood sugar Hypoglycemia is characterized by a low level of glucose in the bloodstream It s important to treat hypoglycemia If left untreated hypoglycemia can lead to serious complications The default low alert in the Dexcom G5 Mobile CGM System is set to 80 mg dL Consult your healthcare professional to determine the appropriate hypoglycemic setting for you Indications A condition making a particular treatment or procedure advisable How for what purposes and under what circumstances you should use the Dexcom G5 Mobile CGM System Indications let you know who should use the Dexcom G5 Mobile CGM System and when G5 Mobile System User Guide Glossary The International Electrotechnical Commission IEC is a nonprofit non governmental international organization created to produce safety standard
70. GM This tutorial covers what to expect in your first week and includes links to step by step videos on how to insert your sensor calibrations ending a sensor session etc Next Steps With Your Dexcom CGM Just finished First Steps or already familiar with how a CGM can benefit you This tutorial covers looking at trends and introduces some advanced features including our reporting tools Accessing Online Tutorials From dexcom com homepage click Support click Training Once you have viewed the online tutorials you should be pretty comfortable with what CGMs do and how the Dexcom G5 Mobile CGM System can help you Offline Tutorials You don t need to be tied to the Internet to view our instructional tutorials they re also available offline Accessing Offline Tutorials e USB Card o In the receiver package Dexcom G5 Mobile System User s Guide Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey 10 Written Mobile Resources Quick Start Guide QSG The Dexcom G5 Mobile Quick Start Guide compliments the tutorials by proving the same step by step instructions in a booklet form or within the app One of the great things about the QSG is you can use it in conjunction with the videos taking notes as you go Accessing the QSG e Receiver package o Booklet Both the tutorial and the QSG give you brief look at the Dexcom G5 Mobile CGM System But what if you want more detailed information
71. GM System N Chapter 15 Everything Else G5 On the Go With Dexcom G5 Mobile CGM System Getting Through Security 15 1 Introduction Dexcom G5 Mobile can be a great travel companion you can go through metal detectors be handwanded and even keep your receiver on during your flight This chapter only covers the Dexcom G5 Mobile CGM System It doesn t cover steps you need to take when traveling with your smart device See your smart device s instruction for use to learn how to travel with it After this chapter you will be able to 1 Explain proper procedure if you prefer a full body pat down 2 Describe steps needed for a TSA officer to inspect Dexcom G5 Mobile CGM System components 3 Identify when your display device s can be on during a flight 4 Contact TSA directly with your security questions 15 2 Going Through Security Walk Through Metal Detectors Transmitter and Sensor No worries about wearing your transmitter and sensor when going through security Go through walk in metal detectors or if you prefer be handwanded without worrying about damaging your transmitter or sensor If you re concerned or uncomfortable about walking through the metal detector the Transportation Security Administration TSA requests you tell the Security Officer you re wearing a continuous glucose monitor and want a full body pat down with a visual inspection of your sensor and transmitter Let the Security Officer kn
72. GM System uses the same sensor as the previous CGM system the Dexcom G4 PLATINUM The Dexcom G4 PLATINUM System Clinical studies and compliant data showed slight redness and swelling occurring only in a few patients During Dexcom s G4 PLATINUM System s clinical study no sensor wires broke however there is a remote chance sensor fragments could remain under your skin if the sensor breaks during normal wear Sterile broken sensor wires don t pose a significant medical risk If a sensor wire breaks off or detaches and remains under your skin contact your healthcare professional and call Dexcom s Technical Support toll free 24 7 at 1 877 339 2664 or toll at 1 858 200 0200 within 24 hours Those are the risks let s now review the benefits 3 2 Benefits Daily habits impact your BG levels With the Dexcom G5 Mobile CGM System you can track how your exercise carbs stress levels medication or illness influences your glucose levels Knowing Your Trends Wearing the Dexcom G5 Mobile CGM System on a consistent and ongoing basis helps you manage your diabetes Providing sensor glucose readings every five minutes for up to seven days the Dexcom G5 Mobile CGM System helps you detect trends and patterns Trend information reveals where your glucose is now where your glucose is heading and how fast it s changing Understanding your trends allows you to take proactive action helping you avoid dangerously low or high glucose val
73. Guide Technical Information 240 Table 1 B System Agreement to YSI within CGM Glucose Ranges Pediatric Percent Greater than 40 40 YSI CGM Number Percent Percent Percent Glucose Within Within Within Range Study ey 15 15 20 20 30 30 mg dL YSI YSI YSI Original Software 505 Overall Original Software 505 40 60 Original Software 505 61 80 Original Software 505 81 180 Original Software 505 Original Software 505 181 300 301 350 Original Software 505 351 400 CGM readings are within 40 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Agreement Relative to YSI Agreement between the System and blood glucose values is characterized using paired System and YSI values The System and YSI results were compared by pairing the YSI blood glucose value to a System glucose reading that occurred immediately after the YSI was collected The agreement of the System to blood glucose value was assessed by calculating the percentage of System readings that were within 15 20 30 and greater than 40 of the YSI values For readings less than or equal to 80 mg dL the absolute difference in mg dL between the two glucose results was calculated For values greater than 80 mg dL the absolute percent difference from the YSI values was calculated The
74. Hypoglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After Adult Hypoglycemic Alert Level Study Hypoglycemia Hypoglycemia Missed Detection Rate mg dL Detection Rate Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 253 Table 5 B Hypoglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After Pediatric Ages 6 17 Years Hypoglycemic Alert Level Study Hypoglycemia Hypoglycemia Missed Detection Rate mg dL Detection Rate Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 1Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 254 Table 5 C Hypoglycemic Alert and Detection Rate Evaluation in Reference to SMBG 30 Minutes Before and After Pediatric Ages 2 5 Years Hypoglycemic Alert Level Study Hypoglycemia Hypoglycemia Missed Detection Rate mg dL Detection Rate Original Softwar
75. MT21255 Class Il Input AC Input 100 240 Vac 50 60Hz 0 2A 0 2A rms at 100 Vac DC Output 5V DC 1A 5 0 Watts Dexcom G5 Mobile System User Guide Technical Information 282 17 3 FCC Requirements The transmitter and receiver covered by this user guide have been certified under FCC ID e G5 Mobile Transmitter PH29715 e G5 Mobile Receiver PH29496 Although the transmitter and receiver have been approved by the Federal Communications Commission there is no guarantee that they will not receive interference or that any particular transmission from either device will be free from interference Compliance Statement Part 15 19 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 This device must accept any interference received including interference that may cause undesired operation Warning Part 15 21 Changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equipment No modification of the equipment is allowed as it could create an unsafe condition FCC Interference Statement Part 15 105 b This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a
76. Rate of Change Arrows and Errors 141 Status Bar Glucose Information SZeszses Figure 7 Home Screen on Receiver Status Bar Receiver What it does Provides at a glance information about the receiver Status Bar system or you Icons will change based on current data What you do Review and take appropriate action Shows battery Battery level When low plug micro USB cable into receiver Plug USB into the adapter and then into electrical outlet Shows Bluetooth Bluetooth connection is working Continued on next page Dexcom G5 Mobile System User Guide Do nothing Receiver s Bluetooth is always on Home Screen Rate of Change Arrows and Errors 142 Receiver Continued from p Sensor Glucose Reading evious page What it does Shows most recent sensor glucose reading Color of status bar changes e Yellow At or above target e Gray Normal range e Red At or below target What you do Take appropriate action m DAN e w PEE La a thaw i450 100 yards Pa Trend Arrow Shows direction and speed your glucose is changing Review and take appropriate action based on fingerstick BG value Dexcom G5 Mobile System User Guide Status Area Far right Error icons and calibration prompts Take appropriate action Home Screen R
77. Study software SW10505 Dexcom G5 Mobile System User Guide Technical Information 237 Differences between the studies include the number of subjects enrolled the number of Systems worn by each participant the SMBG meter used and the number of clinic days each subject participated in during the study An overview of each study is provided here The Original Adult Study enrolled 72 subjects and the Software 505 Adult Study enrolled 51 subjects All subjects had Type 1 or Type 2 diabetes mellitus and required insulin or oral medication to manage their diabetes In the Original Adult Study 83 of subjects had Type 1 diabetes and 17 of subjects had Type 2 diabetes In the Software 505 Adult Study 86 of subjects had Type 1 diabetes and 14 of subjects had Type 2 diabetes Both studies included subjects greater than 18 years of age Subjects in both studies used the System for seven days In the Original Adult Study thirty six subjects each wore 2 sensors in the Software 505 Adult Study all subjects wore 1 sensor only Throughout the 7 day wear period the sensor was calibrated with an average of 2 fingersticks per day approximately once every 12 hours In the Original Adult Study subjects used the LifeScan OneTouch Ultra 2 meter and in the Software 505 Adult Study subjects used Bayer s CONTOUR NEXT USB meter In the Original Adult Study all subjects were evaluated in a controlled clinic environment on all three Clinic d
78. System didn t accept Section 7 6 and 7 7 calibration Immediately prepare e BG values are for next calibration Receiver very different from sensor glucose readings Tap message to clear prompt on your smart device and to clear a prompt on your receiver press Select Sound Vibration Prompts In case you can t look at your screen both the smart device and receiver provide with the exception of your regular 12 hour update calibration beep vibration prompts to let you know it s time to calibrate or if there was a system calibration error For more information on setting your sound vibration prompts and how to clear them please see Chapter 9 Smart Device Calibration prompts will alert you with a triple beep if your smart device is not on Silent or Do Not Disturb Dexcom G5 Mobile System User Guide Calibration 99 Receiver The receiver alerts you with an initial vibration for calibration prompts If not cleared you receive a vibrate beep every five minutes until confirmed 7 6 Preparing for Calibration Your sensor depends on you to help make its sensor glucose readings accurate If you don t prepare properly for the calibration your sensor may not provide you with the most accurate sensor glucose readings Eight Steps to Successful Calibration Do 1 Wash and dry your hands before staking a fingerstick measurement 2 Always use the same meter you routinely use to measure your bl
79. Tap Done Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 164 Continued from previous page Enter Carb Event s ths correct Carbs 85 grams Aprii28 1225PMm Tap Save or Cancel Tap Running Man x O a Carts O A insur O Exercise O 4 Hesith Tap Health Event Tine Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 165 Continued from previous page Enter Stress Event t lt Health Event iness Feel High Feel Low Cycle Tap Stress Tap Done Tap Event Time Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 166 Continued from previous page Enter Stress Event Scroll and select date and time Tap Done s hs Correct Health Stress Apri 50 LSO PM Tap Save or Cancel Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 167 Continued from previous page Enter Stress Event Turn to landscape The receiver and app don t talk to one another If you enter an Event only into the receiver while the information will appear on Dexcom reports you won t get an Even
80. Transmitter a Beyond specifications listed in Dexcom G5 Mobile CGM System s User Guide b User Guide is included in the Dexcom G5 Mobile System s Receiver package c Located on dexcom com Dexcom G5 Mobile System User Guide Warranty The Fine Print 218 13 4 Dexcom s Obligations Under the Limited Warranty During the Warranty Period Dexcom will replace without charge to purchaser any defective Dexcom G5 Mobile Transmitter To return you must send the Transmitter to an authorized Dexcom Technical Support Department Make sure you package the Transmitter adequately for shipping The return package needs to include 1 Transmitter 2 Sales receipt or comparable substitute proof of sale showing the date of purchase 3 Transmitter s Serial Number 4 Seller s name and address Call Dexcom Technical Support Department for delivery information or help e Toll free 1 877 339 2664 e Charges may apply 1 858 200 0200 Upon receipt Dexcom will promptly replace the defective Transmitter If Dexcom determines the Transmitter isn t covered by this Limited Warranty Purchaser must pay all shipping charges for the Transmitter s return by Dexcom Limits on Dexcom s Warranty and Liability Obligations The Limited Warranty described above is the exclusive warranty for the Transmitter and in lieu of all other warranties expressed or implied either in fact or by operations of law statutory or otherwise Dexcom expressly
81. a severe low or high glucose event Fingerstick Only Only use fingerstick measurements from your BG meter for calibration Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 21 Alternative site BG values from your arms palm of your hand etc may be different and less accurate than your fingerstick BG values Using alternative for calibration might affect sensor performance resulting in you missing a severe low or high glucose event Prior to Initial Calibration Data Alarm Alert After starting a new sensor session until completing your initial calibrations you won t receive any sensor information such as readings Alarm or Alerts Without these you may miss a severe low or high glucose event Continue to take fingerstick measurements during a new sensor warmup period Now that we have reviewed common CGM Safety Statements let s focus the Dexcom G5 Mobile CGM System components 2 7 System Hardware Software Warnings and Precautions In this section you will learn how to safely use the Dexcom G5 Mobile CGM System s hardware and software Some sections have either Precautions or Warnings others will have both Sensor Sensor Pod Warnings and Precautions Warnings Sensor Breaking Off On rare occasions the sensor wire may break or detach from the sensor pod Within 24 hours of experiencing a broken sensor wire please call our 24 7 Technical Support department toll free at 1 877 339 2664 or to
82. alue into your display device This chapter lets you know what precautions you need to take before taking your BG meter value then entering your data Up to now you needed to enter information such as Alerts transmitter SN etc separately for the receiver and smart device Calibration is different Don t enter your BG values in both devices enter into either your app or the receiver If you enter your meter s BG value into your receiver it takes about five minutes for your sensor glucose readings to begin In approximately ten minutes you can view the readings in the other display device How Often Do Calibrate There are three primary must do calibration events each with its own prompts 1 Two initial calibrations once your warmup session is complete 2 Update calibrations done twice daily once every 12 hours 3 When you re prompted Dexcom G5 Mobile System User Guide Calibration 92 If you receive a calibration prompt outside of your scheduled calibration schedule the system doesn t accept your most recent calibration or your meter s BG value is very different from the sensor s glucose reading Don t worry about keeping track of the time between calibrations the system will prompt you when you are ready for another Now you have an overview of calibration let s review some contraindications warnings and precautions you need to know and follow before you calibrate 7 3 Safety Statements
83. alue is Enter BG 127 mg dl 2 42 PM Dexcom G5 Mobile System User Guide Ww Ok Bere correct If incorrect Press Right Arrow to Cancel Press Select Reenter BG value Continued on next page Cancel and re enter BG value Fingerstick measurement must be within five minute window Calibration 105 Continued from previous page Step What you see What you do Additional Info Thinking screen BG value is accepted First calibration accepted Time for second calibration Immediately take another meter reading Enter meter s BG Value Wait for next calibration Default Trend screen prompt in 12 hours Calibration s accepted 7 8 Calibration Errors Before or during your calibration process your display device may show error prompts If the prompts don t go away after 15 minutes refer to Chapter 18 Troubleshooting Dexcom G5 Mobile System User Guide Calibration 106 DIA Smart Device In App What you see Receiver Enter BG in 15min What it means Sensor can t calibrate now What you do Wait 10 15 minutes Retake fingerstick measurement at prompt Enter BG value Smart Device In App Receiver System didn t accept recent Calibration Additional Calibration needed immediately Calibrate No sensor glucose readings
84. amp cloth or alcohol wipes Let dry before use or storage 4 When not in use a Protect transmitter by returning to its packaging or another safe place b Store between 32 F 113 F Receiver 1 Check receiver casing if it s cracked or damaged don t use a May get an electric shock 2 Keep receiver dry it is only splash resistant a Don t submerge in liquid b Don t spill fluids on receiver 3 Keep battery charged a Only use Dexcom USB charging download cable 4 Keep the micro USB port cover closed if not using USB cable a Prevents fluid from getting inside receiver Charging Receiver s Battery The receiver s status bar lets you see its battery level and prompts you when the battery is getting low While the receiver is being charged you will continue to get your sensor glucose readings if the transmitter and receiver are within 20 feet of each other Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System 222 Each charge lasts approximately three days If your receiver s battery was drained after charging you may need to reset its time and date If this is required the system tells you to reset and takes you to the time date setting screens Step What you see What it means What you do Low Battery Charge your battery Open USB port door Micro USB Port Plug USB cable into port for recharging Continued on next page Dexcom
85. and Safety Statement 20 2 6 Calibration Warning and Precautions Calibration is the process of making sure your sensor continues to be accurate Your sensor doesn t automatically know what your glucose levels are you have to teach your system what a given BG value is by entering ina KNOWN glucose value from your BG meter Warning Calibrate on Schedule Calibrate at least once every 12 hours Calibrating less often than every 12 hours might cause sensor glucose readings to be inaccurate resulting in you missing a severe low or high glucose event Precautions Be Accurate Be Quick Enter the exact BG value displayed on your BG meter within five minutes of a fingerstick Entering the wrong BG values or waiting more than five minutes before entry might affect sensor performance resulting in you missing a severe low or high event Significant Glucose Rate Changes Don t calibrate when your BG is changing at a significant rate more than 2 mg dL per minute Look for rate of change arrows on your display device screen and don t calibrate when you see e Asingle arrow pointing up o Rising 2 3 mg dL each minute e Two arrows pointing up o Rising more than 3 mg dL each minute e Single arrow pointing down o Falling 2 3 mg dL each minute e Two arrows pointing down o Falling more than 3 mg dL each minute Calibrating during a significant rise fall of your BG may affect accuracy of sensor glucose readings resulting in you missing
86. and might miss helping the patient in the event of low or high blood glucose values Check the Dexcom Follow App s trend graph if the Follower s smart device has been off or if there is no data connection e g Internet Wi Fi or mobile data service 3G 4G LTE is lost connection is turned off in Airplane Mode or smart device touch is placed in Do Not Disturb mode When the smart device is turned back on the Follower will only receive the most recent notification and might miss helping the patient in the event of prior low or high blood glucose values Sharers and Followers should check whether their cellular service carriers support voice and data at the same time simultaneous voice and data If their carriers do not support simultaneous voice and data the Dexcom G5 Mobile App may not be able to share glucose readings and the Dexcom Follow App may not be able to receive notifications or glucose readings during phone calls Dexcom Share will resume sharing after the phone call has ended and the Follower will receive any waiting notifications after the phone call has ended 20 5 Setting up Dexcom Share Dexcom Share Description What Dexcom Share does e Connects your smart device with your Follower s smart device via either a Wi Fi or mobile data connection connect to Wi Fi through a secured network to maintain data security e Invites and sends Followers your setting recommendations e Displays the status of your smart device and t
87. and the Follower might miss helping the patient in the event of low or high blood glucose values If the patient s smart device is powered off or restarted make sure the Dexcom G5 Mobile App is reopened after the smart device is turned back on in order to resume sharing If the G5 Mobile App is not reopened the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values Do not turn off sounds in the Follower s smart device at any time that he or she wants Follow notifications to be heard The smart device settings override the Dexcom Follow App and all notifications will be silent even if the Follower has selected a Dexcom Follow App notification sound If the smart device has a vibrate feature and vibrate is On the Dexcom Follow App notifications will only vibrate Dexcom G5 Mobile System User Guide Sharing Is Caring 312 Check the delay settings on the patient s smart device to make sure they are not too long The Follower will not receive notifications until after the time period in the delay has passed and the Follower might miss helping the patient in the event of low or high blood glucose values if the delay is too long The patient should not choose to Not Share with the Follower at any time when he or she wants the Follower to get notifications During the time the patient chooses to Not Share the Follower will not receive notifications
88. ansmitter holding it in place Push transmitter latch up and forward over the transmitter s wide end with your other hand You should hear 2 clicks Is transmitter secure Before removing transmitter latch verify transmitter is securely in place Make sure none of the transmitters sides popped out of the sensor pod If not completely snapped in you may have a bad connection and it won t be water tight Hold sensor pod sides with one hand Twist atch away from your body with other hand Remove aich Don t remove transmitter while sensor pod is attached to skin You re almost done starting your sensor session Inserting the sensor attaching the transmitter and the two hour sensor warmup are the same regardless whether you use the receiver or app The remaining steps vary from app to receiver 1 Letting your device know you need to start the sensor warmup 2 Following your warmup countdown 6 7 Loose Sensor Pod The sensor pod should stay on your skin using its own adhesive Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 81 If the patch peels up use medical tape such as Blenderm Tegaderm Smith amp Nephew 1V3000 3M tape for extra support e Tape over white adhesive patch on all sides for even support e Don t tape over the transmitter or any plastic parts of the sensor pod e Don t tape under s
89. ant rate typically more than 2 mg dL per minute Never calibrate when you see e A single arrow pointing up o Rising 2 3 mg dL each minute e Two Arrows pointing up o Rising more than 3 mg dL each minute e Single arrow pointing down o Falling 2 3 mg dL each minute e Two arrows pointing down o Falling more than 3 mg dL each minute Why Calibrating during significant rise fall of blood glucose may affect accuracy of sensor glucose readings Consequences You may miss a severe low or high glucose event PRECAUTION Do Enter the exact BG value displayed on your BG meter within five minutes of a carefully performed fingerstick measurement Why Entering the wrong blood glucose values or waiting more than five minutes before entry might affect sensor accuracy Consequences You may miss a severe low or high glucose events Dexcom G5 Mobile System User Guide Calibration 94 PRECAUTION Do Only use fingerstick measurements from your BG meter for calibration Don t Never use alternative site blood glucose values such as blood from palms forearms etc Why Alternative site BG values are different from a fingerstick blood glucose value and may not reflect most recent blood glucose value Consequences You may miss a severe low or high glucose event 7 4 When to Calibrate Calibrating on a regular schedule aligns your sensor glucose readings with your meter s BG values Without calibrations your
90. apter 18 Troubleshooting 285 18 1 Introduction ceeeeeee 285 18 2 Safety Statements 64 285 18 3 Troubleshooting 008 287 Chapter 19 Symbols on Package Labels 299 Part 5 Sharing Is Caring Chapter 20 Dexcom Share 303 20 1 Learning About Dexcom Share 303 20 2 Dexcom Share Overview 307 20 3 Risks and Benefits 4 309 20 4 Safety Statement 008 310 20 5 Setting up Dexcom Share 313 20 6 Using Dexcom Share 4 323 20 7 Dexcom Follow App 000000 328 20 8 Troubleshooting 0 000 330 Index 333 Table of Contents GETTING STARTED Glossary Getting Started Indications for Use and Safety Statement Risks and Benefits Page intentionally left blank Glossary Blood test used to diagnose type 1 or 2 diabetes and to gauge how well you re managing your diabetes The AIC test result reflects your average blood sugar level for the past two to three months Alternative Site Testing Using a blood sample from non fingertip alternate sites such as the palm forearm or upper arm for meter readings Do not use alternative site testing to calibrate the Dexcom G5 Mobile CGM System only use fingerstick measurement App A self contained program or piece of software designed to fulfill a particular purpose an application especial
91. arily for Indoor Use Ship By Date Input Prescription Required Keep Dry MR Unsafe Refer to Instruction Manual Booklet Bluetooth Symbols on Package Labels SHARING IS CARING Dexcom Share Page intentionally left blank Chapter 20 Sharing Is Caring Dexcom Share 20 1 Learning About Dexcom Share Glossary Airplane Mode A setting on a smart device where wireless features are disabled in order to comply with airline regulations Application or App A software program such as the Dexcom G5 Mobile App and the Dexcom Follow App designed to run on a smart device App Store Internet store for downloading applications to a smart device Blood Glucose Meter A device used to measure how much glucose is in the blood BG Value The measurement of glucose in the blood Bluetooth Bluetooth wireless technology allows devices to wirelessly communicate with each other Default A manufacturer s preset option for a device setting Delay Amount of set time that passes before a notification is sent to a Follower Dexcom Share Cloud A secure online storage server where Dexcom Share feature information is stored and then shared with Followers Dexcom Follow App Gets the Sharer s glucose information and prompt data from the Dexcom Share Cloud Dexcom G5 Mobile G4 PLATINUM Sensor The Dexcom G5 Mobile System part that include
92. arnings precautions and contraindications Glossary Sensor Session The seven day monitoring period after inserting a new sensor During this time frame your glucose is being monitored and reported every five minutes with data being sent to your display device s Smart Mobile Device A smart mobile device is an electronic device that is cordless unless charging mobile easily transportable connected via Wi Fi 3G 4G etc that can operate to some extent autonomously Examples of smart mobile devices are smartphones tablets or phablets Warning G5 Mobile System User Guid A safety statement letting you know the following feature has important hazard information Describes serious and life threatening circumstances of using the Dexcom G5 Mobile CGM System their consequences and how to avoid the hazard Glossary Chapter 1 Getting Started Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey 1 1 Introduction Welcome to the Dexcom G5 Mobile family We are excited you chose us to partner with you in your journey to manage your diabetes As a continuous glucose monitoring CGM device the Dexcom G5 Mobile CGM System allows you to break free from constant fingersticks But how do you use the Dexcom G5 Mobile CGM System What are its features Do you need to avoid anything Where do you even begin This chapter is the first step to answering these and ma
93. art device in order to send data to their Follower or it will not work Dexcom G5 Mobile System User Guide Sharing Is Caring 307 Dexcom Share Parts Sharer s smart device Follower s smart device Dexcom G5 Mobile App Dexcom Follow App Dexcom G5 Mobile Transmitter Dexcom G5 Mobile G4 PLATINUM Sensor Internet Wi Fi or mobile data service 3G 4G LTE Bluetooth Must be purchased separately 1A list of compatible devices can be found at dexcom com compatibility Dexcom G5 Mobile System User Guide Sharing Is Caring 308 Conditions Affecting Use Once sharing is active make sure the Share s and Follower s smart device settings are not altered Make sure the Sharer s and Follower s smart devices have e Enough battery power to maintain sharing e Sharer s smart device has Internet connection e Notifications turned on If turned off Follower won t receive any notifications e Follower s smart device has an Internet connection Dexcom recommends charging the smart device when sharing 20 3 Risks and Benefits Risks Dexcom Share is a feature of the Dexcom G5 Mobile Continuous Glucose Monitoring CGM System The main risks involved with using the feature Dexcom Share are based on misunderstanding its purpose Remember that the Dexcom Share in the Dexcom G5 Mobile CGM System is a secondary notification feature not a real time remote monitoring system With us
94. ate an Event o Dexcom G5 Mobile App o Dexcom G5 Mobile Receiver e Recognize Event Markers on the Dexcom G5 Mobile App o Describe how Event Markers are different in portrait and landscape view e Describe how to view Events entered via your receiver What s Next In the next chapter you will learn about your trend s Alarm and Alerts helping you monitor you glucose levels You ll also learn how you know when your system loses its signal and stops communicating Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 171 Page intentionally left blank Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 172 Chapter 11 Next Steps Sensor Glucose Alarm and Alerts 11 1 Introduction Monitoring your glucose trends is critical in managing your diabetes But what happens if you re driving in a meeting at the movies and can t or don t want to keep looking at your display device Dexcom s G5 Mobile CGM System understands there are times when you can t look at your receiver or smart device however you still need to know of actionable glucose trends or if you re not getting your sensor glucose readings This chapter reviews the sensor glucose Alarm and Alerts based on your sensor glucose readings allowing you to proactively manage your glucose trend levels and make sure your transmitter is communicating with your display device In the
95. ate of Change Arrows and Errors Glucose Information Receiver What it does Home screen Number Most recent sensor glucose reading Shown in milligrams per deciliter mg dL Color of status bar changes e Yellow At or above target e Gray Normal Within range e Red At or below target Historical Readings Default is most recent 3 hours Press Up Down Arrows to access 1 3 6 12 or 24 hour trend views Rate of Change Arrow Direction and speed of your glucose changes Sensor Glucose Reading Range Shows between 40 400 mg dL Continued on next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 144 Continued from previous page Receiver What it does Glucose target range Alert settings e Yellow Bar High Alert setting e Gray Fill Normal range e Red Bar Low Alert setting Now you re familiar with the basic layout of the trend graph screen can locate readings identify color coding and view time frames Let s take a closer look at the rate of change arrows 9 4 Rate of Change Arrows Not sure of how your sensor glucose readings are trending Rate of Change Arrows show the speed and direction of your glucose trends based on the last several sensor glucose readings Arrows and the trend graph help you know when to take action before you are too high or too low However before doing anything think about your most recent ins
96. ating Enter another BG meter value Receiver Calibration Error Smart Device Lock Screen Smart Device InA Pp Wait 15 minutes Enter a BG meter value Receiver Enter BG in 15min Continued on next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 150 Continued from previous page Display Devices and Transmitter not Communicating Smart Device Lock Screen Wait 10 minutes Move display device and transmitter within Smart Device 20 feet of each other without obstruction In App walls or water Wait up to 30 minutes In app if not resolved 1 Tap Settings PY 2 Tap Bluetooth Receiver 3 Turn Bluetooth Off and On Signal Loss for 01 22 10 If error messages don t go away after you followed necessary steps and you aren t getting sensor glucose readings contact Technical Support see Section 16 1 Now You Can e Recognize home screen icons e Locate sensor glucose reading e Explain glucose target range e Recognize the importance of gray yellow and red colors e Identify low high alert glucose setting lines e Describe when you receive a High or Low sensor glucose reading e Change Trend Graph Hours view e Cite differences between rate of change arrows e Recognize error messages What s Next By now you have a pretty good understanding how your trends look on the differe
97. ays Day 1 Day 4 and Day 7 of the 7 day wear period In the Software 505 Adult Study subjects were evaluated in one of the three clinic days so there are fewer data samples than in the Original Adult Study While using the System in the clinic subjects had their blood glucose measured every 15 minutes with a reliable laboratory method the Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer This instrument is referred to as the YSI Readings from the System were reported every 5 minutes and paired with YSI values in order to characterize how well the System readings agreed with laboratory standard blood glucose results The remainder of the study took place at home and the System performance was also paired with the comparative meter results referred to as the SMBG Overview of Pediatric Studies The System performance for children and adolescents was evaluated in two separate prospective Clinical studies the Original Pediatric Study SW10050 and the Software 505 Pediatric Study SW10505 Differences between the studies include the number of subjects enrolled the number of Systems worn by each participant the SMBG meter used the length of time subjects were evaluated in a controlled clinic environment and whether or not subjects ages 13 17 had their glucose levels intentionally manipulated during the study An overview of each study is provided here The Original Pediatric Study enrolled 176 subjects with 16 of subjects
98. bile CGM System CGM The Dexcom G5 Mobile Continuous Glucose Monitoring CGM System is a medical device you use on yourself It allows you to continually see your sensor glucose readings updated every five minutes for up to 7 days without the bother of taking constant fingerstick measurement Your sensor glucose readings are measured by a single use sensor inserted under your skin A reusable transmitter sends your data to your display device The Dexcom G5 Mobile CGM System provides personalized trend alerts prompting you to proactively react when your glucose levels are getting too low or too high Dexcom provides web based reports reflecting your glucose trends and patterns Share the reports with your healthcare professional when developing your diabetes management treatment plans Options to View Your Trends The Dexcom G5 Mobile CGM System transmitter works with a number of display devices giving you flexibility to use what s best for you your situation or your lifestyle 1 Dexcom G5 Mobile Receiver 2 Dexcom G5 Mobile App on your smart device While the system works with different smart devices they re not interchangeable during a sensor session Before starting one select which smart device you want to use and stick with it throughout your session You can t use multiple smart devices at the same time but you can combine the receiver with a smart device during a session The Dexcom G5 Mobile CGM System is the first CGM s
99. bile System User Guide Ending Your Sensor Session and Transmitter Session 110 or on rare occasions the receiver or app detects sensor issues and prompts you to end the session Let s review ending a normal session first later in this chapter we ll review the prompts for ending the session early Ending Your Seven Day Sensor Session Just like other prompts your sensor session ending prompts need clearing e App o Tap screen e Receiver o Press Select Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 111 End of Seven Day Sensor Session Prompts Ending Sensor Session Prompts Device What you see What it means At Six Hours Smart Device Lock Screen You will not receive alerts Prompts begin when sensor session has Of alarms after s time niist Vou teniseis vi only six hours left Smart Device Clock will countdown until session has In App ended Continue to get sensor glucose readings Replace Receiver Sensor Soon 46 00 00 Continued on next page Dexcom G5 Mobile System User Guide N Ending Your Sensor Session and Transmitter Session 11 Continued from previous page Device What you see What it means At Two Hours Smart Device Lock Screen Your sensor session wil end in two hours You will not receive alerts of alarms after thes time unless you replace your wines Two hours remain on your current sensor S
100. ble electrical shocks Precaution Keep Receiver Dry Keep the USB port cover on the receiver closed whenever the USB cable is not attached and do not submerge in water If water gets into the USB port the receiver could become damaged and stop displaying readings or providing alerts you might miss a severe low or high glucose event Caution U S law restricts the sale of the Dexcom G5 Mobile CGM System to sale by or on order of a physician Summary Now You Can e Define a Safety Statement o Explain the difference between an indication and a contraindication o Describe the importance of warnings o Describe what a precaution is e Correctly read a chapter s Safety Statement e Provide an overview of Safety Statements by category What s Next In our next chapter you will learn about the risks and benefits of using Dexcom s G5 Mobile CGM System Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 27 Page intentionally left blank Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 28 Chapter 3 Getting Started Risks and Benefits When using any medical device there are risks and benefits In this chapter you ll learn what they are helping you decide if Dexcom s G5 Mobile CGM System is right for you First let s review some possible risks 3 1 Risks There are some risks with using real time CGM Not Receiving Alarm Alerts If you aren
101. can check your app or receiver for information about your CGM system at any time Receiver Settings 0 Device Info E Time Date ete Y Transmitter we MY i Device Info SW Rev wins 403939 1 From the Settings menu press Up or Down arrows to scroll to Device Info 2 Press Select Information about your sensor session and system will show App COIN es ioes en Settings lt Device Info insertion Time Last Calibration Software Number Software Heveson Joi 1 From Main Menu tap Settings 2 Tap Device Info Available Information e Insertion Time e Last Calibration e Transmitter Battery e Transmitter SN e Serial Number e Part Number e Part Revision e Software Number Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System 227 14 5 System Disposal Different municipalities have different requirements when throwing away electronics receiver and transmitter and parts that have come in contact with blood or other bodily fluids Sensor Consult your area s local waste management authorities for proper disposal instructions Taking care of your Dexcom G5 Mobile CGM System is pretty easy In the next chapter traveling with your Dexcom G5 Mobile CGM System you ll learn how simple it is to see the world with your Dexcom G5 Mobile CGM System Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile C
102. cating causing you not to get your sensor glucose readings or rate of change arrows Each device notifies you when there is an issue however the notifications look different Before the system can move forward you need to address the error Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 146 App 1 If screen is locked a Swipe message to go to app 2 Within app a Read message i Tap Question Marks for more information and follow steps as appropriate Receiver 1 Press Select to clear message You will not get any sensor glucose readings or rate of change arrows on either display device until the error is resolved Check with your BG meter to monitor your glucose during these error periods Error Messages What you see What you do Bluetooth is Out of Range Smart Device Lock Screen Make sure there are no obstructions such Smart Device as a wall or water between your transmitter In App and your display device Move within 20 feet of display device Wait up to 30 minutes while transmitter restores communication Receiver Signal Loss tor 01 22 10 Continued Oo next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 147 Continued from previous page Bluetooth Off Smart Device Lock Screen Smart Device In App N A Bluetooth is always Receiver Oh Not Getting Sensor Gluc
103. ceipt Dexcom will promptly replace the defective Receiver Dexcom G5 Mobile System User Guide Warranty The Fine Print 216 If Dexcom determines the Receiver isn t covered by this Limited Warranty Purchaser must pay all shipping charges for the Receiver s return by Dexcom Limits on Dexcom s Warranty and Liability Obligations The Limited Warranty described above is the exclusive 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 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 G5 Mobile CGM System or any feature or service provided by Dexcom for use with the Dexcom G5 Mobile CGM System 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 Purchaser and can t be transferred to anyone else
104. chapter the receiver uses a series of beeps vibrations for an Alarm or Alert The receiver doesn t have the same variety of tones as the app however you can adjust their volume While the receiver doesn t have a silent mode selecting Vibrate will replace audible beeps with quiet vibrations The only exception is the Alarm the urgent low Alarm can t be turned off Changes made in Profiles are applied to all of the receiver s Alarm Alerts If you choose Soft see next table all Alerts are in Soft mode In Chapter 10 you learned how many beeps each Alarm Alert has Normal is the default setting for your receiver sound Profiles Attentive uses a rising or falling melody instead of beeps The receiver first vibrates when sending you an Alarm or Alert If you clear the alert at the first vibration by pressing the Select button on your navigation wheel you won t get any Alarm Alert tones If you would like to continue to get your Alarm or Alert after clearing later in this chapter you ll learn about setting up Repeat Alerts HypoRepeat is very similar to the Normal Profile but keeps repeating the fixed low alarm every 5 seconds until your sensor glucose value rises above 55 mg dL or you confirm by pressing the Select button The next table lists the different sound Profiles starting with the quietest working its way up to the loudest Dexcom G5 Mobile System User Guide 7 On the Go With G5 Customizing Your Alarm and Alerts 204
105. con Ends sensor session During session e Stop Sensor option appears Tap Stop Sensor Not in active session e Start Sensor option appears Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 120 Continued from previous page Step What you see What it means What you do Stop Sensor Are you sure you want to stop your sensor You will not receive alerts or alarms after you tog your Sensor uniess you replace your sensor Blue icons provide Ser w at see s eau additional information Tap Stop Sensor senso ireertion Remove sensor Confirms sensor session has ended Insert new sensor Ready for new session TaP green circle when ready for new session Receiver Ending a Sensor Session Early Step What you see What it means What you do Go to Main Menu Press Select Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 121 Continued from previous page Step What you see Main Menu 1 Settings 4 Shutdown Stop Sensor What it means Ends sensor session During session Stop Sensor option appears What you do Press Down Arrow to Stop Sensor Press Select Stop Sensor 2 Thinking screen Stop Sensor 36 Stop Sensor GEE Cancel Conf
106. data connection Dexcom Share Cloud or not being in the communication range could cause data to not be shared with the Follower In addition if the Delay setting is too long the Follower might not be aware of glucose level changes in a reasonable time Therefore the Dexcom Share feature should be used only to give a secondary level of awareness and should not be expected to always communicate and transfer sensor glucose readings and information Benefits Patients usually respond when their continuous glucose monitoring CGM systems alert them However experts advise that an additional CGM alert to another person may be helpful in increasing the detection of low glucose or high glucose values especially at night The Dexcom Share feature enables this additional awareness even when the Sharer and Follower are not in the same place The Dexcom Share feature may provide improved quality of life and greater peace of mind to patients their caregivers and their support team by allowing the Dexcom G5 Mobile Continuous Glucose Monitoring System Alerts Alarms and trend graphs to be checked remotely 20 4 Safety Statement Intended Use The purpose of Dexcom Share Direct Secondary Displays is to notify another person the Follower of the patient s Dexcom Continuous Glucose Monitoring CGM System sensor glucose information The Secondary Displays is intended for providing secondary notification of a continuous glucose monitoring system a
107. dications contraindications warnings precautions and other important user information Please review the instructions for each part of the system in this user guide before using any of the Dexcom G5 Mobile CGM System This chapter is important to read It helps you use the Dexcom G5 Mobile CGM System safely and covers e What is a Safety Statement o Telling the difference between an indication and a contraindication o Explaining why warnings are so important o Defining precautions e How to read a chapter s Safety Statement e Overview of Safety Statements Let s start with definitions look at a Safety Statement example used throughout the User Guide and then review the Safety Statements broken down into the system s components Safety Statement A Safety Statement is a brief statement of the Dexcom G5 Mobile CGM System s indications relevant warnings precautions or its contraindications when to avoid using it The Safety Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 15 Statements are meant to keep you and the system safe while using the Dexcom G5 Mobile CGM System 1 Indications How for what purposes and under what circumstances you should use the Dexcom G5 Mobile CGM System Indications let you know who should use the Dexcom G5 Mobile CGM System and when Indications are the who what and why of the Dexcom G5 Mobile CGM System 2 Contraindications Contraindications let you k
108. ding e Change trend graph views e Cite differences between rate of change arrows e Recognize error messages 9 2 Safety Statements Take a moment and read the safety statements If not followed your sensor glucose readings and trends may be less accurate plus and you may miss important high or low glucose alerts Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 1353 CONTRAINDICATION Don t Never take any medications containing acetaminophen during your sensor session Why Taking medications with acetaminophen such as Tylenol or Excedrin Extra Strength while wearing sensor may falsely raise sensor glucose readings Level of inaccuracy depends on 1 Amount of acetaminophen active in your body 2 May be different for each person Consequences Without correct readings you might miss a severe low event WARNING Don t Never use the Dexcom G5 Mobile CGM System sensor glucose readings for treatment decisions Do Only use BG values from your BG meter for treatment decisions e g how much insulin to take Why Since they measure your glucose from different body fluids sensor glucose readings can be different from your meter s blood glucose values Consequences Using sensor glucose readings for treatment decisions could result in you missing a severe low or high event WARNING Don t Never ignore symptoms of high and low glucose Do Measure your blood glucose w
109. e Main Menu ud Profiles x Events M Alerts Alerts option from the Main Menu Press Down Arrow Stop at Alerts Main Menu uf Profiles Events Ce Enter Alerts menu option Press Select Alerts ry Low Alert 8 Advanced 4 High Alert Alerts option menu Lists different Alerts High Low Advanced Repeat Rise Fall Signal Loss Alerts Press Up Down Arrow Stop at High Alert Press Select High Alert On Off Alert s current settings Change your current High Alert level Press Down Arrow Stop at Level Press Select High Alert 200 mg dl Dexcom G5 Mobile System User Guide Current setting Use Up Down arrows to change your High Alert level mg dL Continued on next page Press Down Arrow Stop at 190 mg dL On the Go With G5 Customizing Your Alarm and Alerts 209 Change High Alert Level High Alert 190 mg dl Turn Repeart On Low Alert gR Advanced Continued from previous page Saves new High Alert level Return to Alerts Menu Alerts Menu Choose Advanced to get to Repeat Alert Press Select To exit Press Left Arrow Press Down Arrow Stop at Advanced Alerts High Alert Low Repeat FF Rise Rate Enter Advanced Alert options Main Advanced screen Set Repeat Alerts Turn On Rise Fall Rate Alerts Press Select
110. e What you see Receiver Smart Device In App Signal Loss for 11 53 48 Receiver Dexcom G5 Mobile System User Guide Problem System display device and transmitter not communicating No sensor glucose readings What you do See Chapter 9 Don t calibrate Wait 10 minutes Move display device and transmitter within 20 feet of each other without obstruction Wait another 10 minutes App if not resolved 1 Go to Settings 2 Tap Bluetooth 3 Turn Bluetooth Off and On See Chapter 7 Wait up to 2 hours System is counting down to when you do your initial calibration Troubleshooting Applicator Picture Problem Safety lock stuck What you do See Chapter 6 Pull safety lock straight out e Away from your body e Follow direction of safety lock Up Arrow Collar won t pull up See Chapter 6 Use force when pulling the collar up Check white plunger is completely down flush to the applicator barrel Can t remove transmitter latch See Chapter 6 Don t pull it straight off Hold sensor pod with one hand Twist transmitter latch with other hand to break transmitter latch off Dexcom G5 Mobile System User Guide Sensor pod won t stick See Chapter 6 Put medical tape over sensor pod s white adhesive patch e g Blenderm Don t place tape over the transmitter Troubleshooting 291
111. e orff Fall Rate orr Access High Alert Signal Loss 2 ON gt settings mg dL Reset alert settings Tap High mg dL High Glucose Alert s High Alert Notify Me Above 200 mgt gt Repeat every 30 minutes gt Shows High Alert Hah gt options and current settings Continued on next page Dexcom G5 Mobile System User Guide Check High Alerts is On e On Orange e Off Gray On the Go With G5 Customizing Your Alarm and Alerts 197 Continued from previous page Changing an Alert 4 High Glucose Alert Notity Me Above 200 mgl gt Repeat every 30 minutes gt lf Off On Hgh gt Won t get Alerts if Off Slide to On e On Orange e Off Gray High Glucose Alert High Alert Notify Me Above 200 mgt gt Repeat every 30 minutes gt Change High Alert mg dL Tap Notify Me Above High gt Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts Continued from previous page Changing an Alert Notify Me Above Change glucose level from current level mg dL Scroll selection wheel Stop at 190 Notify Me Above Saves new High Alert glucose level mg dL Returns to High Glucose Alert screen options Notify Me Above set at 190 mg dL Continued on next page Dexcom G5 Mobile System User G
112. e if you set your High Glucose alert to 200 mg dL how often will your alarm alert you if your blood glucose goes at or above 200 mg dL In the Software 505 Adult Study Table 6 A when your blood sugar goes above 200 mg dL you can expect your alarm to sound 98 of the time and not to sound approximately 2 of time within the 15 minute period before or after your blood sugar goes above 200 mg dL Dexcom G5 Mobile System User Guide Technical Information 260 Table 7 A Percentage of System Readings within YSI Values With Data Stratified in 2 Hour Increments After Calibration Adult Percent Greater than 40 40 YSI Percent Percent Percent Within Within Within 15 15 20 20 30 30 YSI YSI YSI Number Study of Paired CGM YSI Time from Calibration Original Software 505 0 2 hours Original Software 505 2 4 hours Original Software 505 4 6 hours Original Software 505 6 8 hours Original Software 505 Original Software 505 8 10 hours 10 12 hours Original 12 14 hours Software 505 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 261 Table 7 B Percentage of System Readings within YSI Values With Data Stratified in 2 Hour Increments After Calibration Pediat
113. e smart device s settings Maximum distance two devices can communicate wirelessly without obstruction Sharing Is Caring Real Time CGM Data the Sharer receives on the Dexcom G5 Mobile App Although your Dexcom Follow App might be similar to what you see on your app it cannot be considered real time because there are layers of communication between the Dexcom G5 Mobile App and the Dexcom Follow App Repeat Amount of time the Follower chooses before they wish to receive a repeated notification Sensor Glucose Reading A glucose measurement taken by the Dexcom G5 Mobile System Sharer The person who uses the Dexcom G5 Mobile System Sharing The act of electronically transmitting glucose information from the Sharer s smart device to the Follower s smart device Simultaneous Voice and Data The ability to make a phone call and access the Internet on the same cellular connection at the same time Smart Device A smart device is a cordless electronic device unless charging mobile easily transportable connected via Wi Fi 3G 4G etc that can operate the Dexcom G5 Mobile App or the Dexcom Follow App Examples of smart devices are smartphones or tablets For a list of compatible smart devices see dexcom com compatibility Standard Home Glucose Monitoring Self monitoring of BG using blood taken from the finger and a BG meter Trend Arrow The arrow n
114. e 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Low and High Glucose Alerts The ability of the System to detect high and low glucose levels is assessed by comparing System results to YSI results at low and high blood glucose levels and determining if the alert may have sounded The System and YSI values were compared by pairing the System reading that occurred immediately after the YSI value was collected We suggest that you ask your doctor what alert settings would be best for you The Low Glucose Alert Estimates of how well the adjustable Low Glucose Alert performs are presented in Table 5 A 5 B and 5 C Table 5 A represents the hypoglycemic alert evaluation within 15 minutes of the YSI value in the adult studies Table 5 B represents the alert evaluation within 15 minutes of the YSI value for a subset of the pediatric population subjects age 6 to 17 years who had YSI measurements every 15 minutes Dexcom G5 Mobile System User Guide Technical Information 255 Table 5 C represents the alert evaluation within 30 minutes of an SMBG reading for 2 to 5 year old subjects in the pediatric studies Hypoglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong The True Alert Rate
115. e area 17 2 Product Specifications User is the single use operator in the home environment Use of accessories transducers and cables 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 Do not touch the metal connectors on the bottom of the transmitter and other open connectors on the receiver charging cable and charger Sensor Product Specifications Glucose Range 40 400 mg dL Sensor Life Up to 7 days Calibration Commercially available blood glucose meter Calibration Range 40 400 mg dL Temperature 36 F 77 F Humidity 15 85 RH Storage Condition Sterilization Sterile by radiation Dexcom G5 Mobile System User Guide Technical Information 275 Transmitter Product Specifications Part Number 9438 06 Length 1 5 inches Width 0 9 inches Thickness 0 5 inches Dimensions Including Sensor Pod Weight Including Sensor Gea puncee Pod Power Supply Silver oxide batteries not replaceable Ambient temperature is 10 C 42 C 50 F 107 6 F Operational Conditions Equilibrium temperature of less than 0 5 C 0 9 F above ambient Humidity 10 95 RH Temperature 32 F 113 F Humidity 10 95 RH Operating Altitude 1300 feet to 13800 feet Storage Conditions Limited Warranty 3 months IP28 Pro
116. e solutions here are meant to be brief and not all inclusive some have audible prompts and others don t When more detailed answers or preventative measures are in a chapter you ll get a brief explanation here and then get directed to the applicable chapter and section After looking at the troubleshooting chapter are you still not sure what to do Or maybe your problem is hardware e g receiver or transmitter failure If your problem is not found here follow the steps listed on your app screen or call Technical Support Please call the Dexcom Technical Support Team 24 7 toll free at 1 877 339 2664 or toll at 1 858 200 0200 if any of these errors continue and the instructions don t resolve the issue 18 2 Safety Statements Following are the Safety Statements for the Troubleshooting chapter WARNING Do Calibrate at least once every 12 hours Why Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings Consequences Missing severe low hypoglycemia or high hyperglycemia Alarm or Alerts Dexcom G5 Mobile System User Guide Troubleshooting 285 PRECAUTION Do Enter the exact BG value displayed on your BG meter within five minutes of a carefully performed fingerstick measurement Why Entering the wrong blood glucose values or waiting more than five minutes before entry might affect sensor accuracy Consequences You may miss a severe low or high glucose events
117. e the same transmitter over a number of sensor sessions You ll receive prompts as you near the end of its battery life Before reusing the transmitter in your new sensor session separate it from the old sensor pod You can detach transmitter two ways 1 Use safety lock see With Safety Lock table You removed this from the applicator barrel at the beginning of the session 2 Manually spread out tabs holding transmitter in sensor pod see Without Safety Lock table Dexcom G5 Mobile System User Guide a N Ending Your Sensor Session and Transmitter Session With Safety Lock Step Picture What you do Grasp end of adhesive patch Peel adhesive patch up and away from your body to remove sensor pod and transmitter Put sensor pod on flat surface Place safety latch s jagged edge e Over transmitters wide edge e In between open slots on sensor pods sides Lift up safety latch If you no longer have the safety lock don t worry You can use your fingers to remove the transmitter from the old sensor pod After removing your sensor and taking the transmitter out of the sensor pod you re ready to begin a new sensor session The transmitter s battery is good up to three months If you haven t received your final seven day transmitter battery life warning you can reuse the transmitter for your next session Remember 1 Never use same spot repeatedly for sensor insertio
118. e the user guide e Explain why you need a Dexcom account What s Next Now you are familiar with how to use this user guide and where to go for help Throughout the user guide you ll see color coded boxes containing Safety Statements The next chapter Indications for Use and Safety Statement lists all Safety Statements along with how to read and interpret them Next you ll learn about when and how to use the Dexcom G5 Mobile CGM System safely Dexcom G5 Mobile System User Guide Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey i Page intentionally left blank Dexcom G5 Mobile System User s Guide Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey 14 Chapter 2 Getting Started Indications for Use and Safety Statement 2 1 Introduction We want the Dexcom G5 Mobile CGM System to be a valuable tool in your diabetes management Like any system there are steps to take to get the most out of it As excited as you are about getting started did you know if you just took Tylenol maybe you should wait Did you know taking Tylenol is contraindicated In this chapter you ll learn about some key areas that might prevent you from having the best CGM experience or if you re not careful might even harm you or the system You ll even learn what a contraindication is 2 2 Important User Information Each part of your system has instructions including in
119. e turned on in the Setting s menu Verify app hasn t been shut down Turn Bluetooth on Turn off Do Not Disturb if available on your smart device Restart app after device is restarted Set Volume at a level you can hear Do not close app always run app in the background Make sure accessory devices do not override your smart device settings If your settings are incorrect you might miss a severe low or high glucose event Dexcom G5 Mobile CGM System Alarm Alert vibrations aren t any different from other vibrating apps on your smart device Medical device apps like the Dexcom G5 Mobile App don t have any special priorities over your smart device s features Dexcom G5 Mobile App notifications or alerts may sound or feel the same as notifications from another app The only way to know is look at the screen Can t Hear Your Alarm or Alert An Alarm or Alert can t be heard through your smart device s speakers if headphones are plugged in Make sure you unplug your headphones when you are done using them otherwise you might not hear an Alarm or Alert causing you to miss a severe low or high glucose event CONOR WN Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 26 Receiver Warning and Precaution Warning Don t Use Damaged Goods If your receiver is damaged or cracked don t use it This could create an electrical safety hazard or malfunction causing possi
120. ell you your transmitters battery is low or the transmitter failed Remember if your smart device is turned on to Silent or Do Not Disturb you won t get any sound prompts For more information on setting your sound vibration prompts and how to clear them please see Chapter 9 Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 129 Smart Device Your smart device prompts you with a triple beep If not cleared you receive the triple beep twice five minutes apart Receiver The receiver alerts you with an initial vibration prompts If not cleared you receive a vibrate beep twice five minutes apart Summary Now You Can e Identify replace sensor prompts at the end of a seven day sensor session e Recognize when you have to end a sensor session early e Successfully end a sensor session early o Identify how you can prevent sensor session failures e Remove your sensor pod with transmitter attached e Separate transmitter from sensor pod e Determine if transmitter can be used for another sensor session What s Next Congratulations you have the basics down You can set up your app and receiver start a sensor session calibrate along with ending your sensor session and when to replace your transmitter But the Dexcom G5 Mobile CGM System can do much more In the next part Part 3 Next Steps you will learn how to get the most out of your Dexcom G5 Mobile CGM System Dexcom G5 Mobile Syste
121. ensor pod e Don t leave any substance on the skin where you insert the sensor Figure 4 The Right Way to Use Tape for Extra Support 6 8 Starting Your Sensor Session If you choose to use both the receiver and the app each system requires individual setups see Chapter 5 After pairing the transmitter to your device s inserting your sensor and attaching the transmitter to the sensor pod your next step is telling your device s you want to start a sensor session Transmitters are reusable pairing is required only when using a new transmitter During the warmup period neither device will provide any sensor glucose readings Your sensor glucose readings begin after the two hour sensor warmup has passed and you entered the initial two calibration BG values into either the smart device or the receiver We ll first review starting the sensor session for the app Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 82 Dexcom App Starting a Session Step What you see What you do Wait for Successful Pairing notification Tap green checkmark in black square Tap Sensor Warmup circle to start your two hour sensor warmup NOTE You will NOT get any sensor glucose readings Alarm Alerts during your two hour sensor warmup period Wait Screen provides countdown to sensor warmup The orange dashes darken as the countdown moves forward Keep sma
122. ent Percent 15 15 20 20 30 30 Differences Differences YSI YSI NSI Study Original Percent Greater than 40 40 YSI Software 505 Original Software 505 Original Software 505 1CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 263 Table 8 B Sensor Stability Relative to YSI Accuracy Over Time Pediatric Ages 6 17 Years Median Percent Percent Percent Percent Absolute Absolute Within Within Within Percent Percent 15 15 20 20 30 30 Differences Differences YSI YSI NSI Study 40 40 YSI Original Software 505 Original Software 505 Original Software 505 1CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 264 Table 8 C Sensor Stability Relative to SMBG Accuracy Over Time Pediatric Ages 2 17 Years aaa Mean Median Percent Percent Percent Percent Study Paired Absolute Absolute Within Within Within y CGM Percent Percent 15 15 20 20 30 30 Differences Differences SMBG SMBG SMBG SMBG Original Software 505 Original Software 505 Original Software
123. er Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 75 e f needed shave the area so adhesive patch sticks securely e Make sure area is clean and free of lotions perfumes medications Don t e Never use same site repeatedly for sensor insertion e Never use same site for 2 sensor sessions in a row If you have concerns about the sensor pod not sticking before inserting your sensor you can make the sensor site stickier to help ensure the sensor pod does not peel Optional Site Preparation Use optional skin adhesives Mastisol SkinTac as part of your insertion site preparation to help keep your sensor pod attached Apply the skin adhesive after you selected and cleaned your insertion site Use circular motions and create an O outline making sure you don t get any skin adhesive inside the outline Let the O dry based on skin adhesive manufacturer s instructions Once dry your skin may feel slightly sticky See Step 3 in the next table for directions NOTE Contact your healthcare professional for specific questions regarding the use of medical tape barrier wipes and or other adhesives as it relates to your use of Dexcom CGM 6 5 Inserting Your Sensor You ve collected all of the needed items to begin a sensor session viewed the tutorials reviewed the sensor applicator and prepped the sensor pod site You re now ready to insert your sensor Step Picture What
124. er of readings you can expect to receive from the System within each system wear day For the Software 505 Adult Study SW10505 96 of Systems provided between 1 497 and 1 992 valid glucose readings or more than 75 of the expected number of readings as seen in Table 9 A Adjusted within each system wear day the System in the Software 505 Adult Study provided an average of 98 of all expected glucose readings 288 as seen in Table 10 A Dexcom G5 Mobile System User Guide Technical Information 270 Table 11 A System Agreement to SMBG Within CGM Glucose Ranges Adult CGM Percent Percent Percent percent Number Greater Glucose 3 Within Within Within Study of Paired than 9 9 o Range CGM SMBG 15 15 20 20 30 30 40 40 SMBG mg dL SMBG SMBG SMBG Original Software 505 Overall Original Software 505 40 60 Original Software 505 61 80 Original Software 505 81 180 Original Software 505 Original Software 505 181 300 301 350 Original Software 505 351 400 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 271 Table 11 B System Agreement to SMBG Within CGM Glucose Ranges Pediatric CGM Percent Percent Percent Berceni Number Greater Glucose Study o
125. er using Gluetooth Pairing request At prompt Tap Pair to pair app with smart device Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 62 Continued from previous page Connecting Pairing Transmitter with App Tap the Sensor warmup circle to start your two hour sensor warmup When you see the sensor warmup timer your initial set up is complete Congratulations at 2 hout warmup and two BG you meter values are compiere If you have any issues setting up the Dexcom G5 Mobile App call Technical Support toll free at 1 877 339 2664 or toll at 1 858 200 0200 We are here 24 7 to assist you If you are having problems with your smart device contact your smart device s support line After completing your initial app setup set up the receiver or go to Chapter 6 to start your initial sensor session 5 5 Dexcom G5 Mobile Receiver In the previous chapter you learned about the receiver s components The following is a refresher to help in your initial set up Display Screen e Trend screen e Menu selection screen Navigation Wheel e Select o Button in the middle of the navigation wheel Dexcom G5 Mobile System User Guide Set up Your Display Devices 63 Center button does not say Select o Press to Turn on receiver Select options features Accept changes Move forward through menus features e Up
126. ere low or high event Dexcom G5 Mobile System User Guide N e Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session PRECAUTION Do Check sensor package before opening Why Make sure the sterilized package has not been damaged or previously opened If opened or damaged sensor may be unsterile Consequences Using an unsterile sensor may cause an infection 6 3 Prepping for Sensor Insertion Before inserting a sensor make sure you have everything you need Some items are included in the Dexcom G5 Mobile CGM System s packages others are not Items Included in Your Dexcom G5 Mobile Packages For sensor insertion you need the sensor and transmitter Sensor Applicator Inside Sensor Box What you see What it is Sterilized sensor pouch with important label information Check expiration date Single use sensor applicator Knowing what each applicator piece does helps you successfully insert your sensor Chapter 4 Section 4 6 gave you overview of the sensor applicator Dexcom G5 Mobile System User Guide N N Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 4 Plunger 3 Safety Lock 5 Applicator Barrel contains small introducer needle and sensor 6 Collar 8 Transmitter Latch 9 Release Tab 7 Sensor Pod 2 Adhesive Patch Figure 3 Dexcom G5 Mobile Sensor Applicator and Pod The following table review
127. es it tells you if the System reads higher or lower on average than the YSI within each glucose range Another estimate used to show the accuracy of the System is the absolute percent difference The absolute percent difference tells you the percent difference or distance between the System and YSI values but does not tell you whether the System is reading on average higher or lower than the YSI laboratory standard The mean absolute percent difference is the average distance regardless if positive or negative between System readings and YSI values Accuracy measures in differences for both the Original Adult and Software 505 Adult Studies are summarized in Table 4 A Accuracy measures in differences for both the Original Pediatric and Software 505 Pediatric Studies are summarized in Table 4 B Table 4 A and 4 B are categorized within CGM glucose ranges For example in the Software 505 Adult Study Table 4 A overall on average the System reads 2 5 different Mean Percent Difference than the reference and 9 0 absolute different Mean Absolute Difference than the reference values The Median Percent Difference shows that half of the time the System reads 2 4 or less than the YSI blood glucose values and the Median Absolute Percent Difference shows that half of the time the System reads about 7 0 or less than the YSI blood glucose values Dexcom G5 Mobile System User Guide N N U Technical Information Table 5 A
128. et Your transmitter communicates to your app via Bluetooth Smart Before beginning make sure your smart device s Bluetooth is available and turned on Refer to your smart device s user guide if you have questions on how to change your smart device settings e While checking your Bluetooth settings check to see Silent and Do Not Disturb are off Your app does not override these settings if you have them on you will miss Alarm Alerts e After verifying all your settings are correct there is one more thing to check Make sure your smart device s Volume is loud enough for you to hear any Alarm Alerts Dexcom G5 Mobile System User Guide Set up Your Display Devices 50 e Make sure your smart device settings allow your Dexcom Alarm Alerts to always show on your lock screen e For information on how to set the above settings see your smart device s user guide Once you have verified your smart device s settings are right the next step is installing the Dexcom G5 Mobile App e The app needs to be open and running in the background This may drain your smart device s battery make sure you check its battery is charged e Don t change your smart device s time because it can make the time on the trend screen wrong and the app may stop displaying data If your smart device is broken or lost use receiver until it s fixed or replaced Dexcom G5 Mobile App Installation Installing the app is easy Simply download the Dexcom
129. ext to the Sharer s glucose value located on the Sharer s profile on the Dexcom Follow App This is the same trend arrow that is found on the Dexcom G5 Mobile Receiver Trend Graph Displays the pattern of the Sharer s glucose information G5 Mobile System User Guide Sharing Is Caring Continued from previous page Wi Fi or Wireless A wireless technology that allows electronic devices access to the Internet Internet These networks can include your home Internet or one found at a public location 20 2 Dexcom Share Overview Dexcom Share is a feature within the Dexcom G5 Mobile App It allows for remote monitoring from one person the Sharer of Dexcom G5 Mobile CGM data to another person the Follower Dexcom Share includes e Dexcom G5 Mobile CGM System e Sharer s smart device e Dexcom G5 Mobile App e internet connection e Follower s smart device e Dexcom Follow App You cannot use the Share feature with Dexcom G5 Mobile Receiver Once the Sharer activates the Share feature in their Dexcom G5 Mobile App the smart device transfers sensor glucose readings to the Dexcom Share Cloud using either Wi Fi or a cellular data plan Then the sensor glucose readings are sent from the Dexcom Share Cloud to the Follower s smart device using Wi Fi or the Follower s cellular data plan Internet Sharer s Followers Smart Device Smart Device Figure 8 Sharing The Sharer must be within 20 feet of their sm
130. f Paired Within Within Within than 1 o 9 o Range CGM SMBG 15 15 20 20 30 30 40 40 SMBG mg dL SMBG SMBG SMBG Original Software 505 Overall Original Software 505 Original Software 505 Original Software 505 Original Software 505 40 60 61 80 81 180 181 300 Original Software 505 301 350 Original Software 505 351 400 1CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 272 Table 12 A System Difference to SMBG Within CGM Glucose Ranges Adult CGM i Mean Median Glucose Numba Mean Median Absolute Absolute Range onnared percent Percent Percent Percent mg dL CGM SMBG Difference Difference Difference Difference Original Software 505 Overall Original Software 505 40 60 Original Software 505 61 80 Original Software 505 81 180 Original Software 505 Original Software 505 181 300 301 350 Original Software 505 351 400 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 For CGM lt 80 mg dL the differences in mg dL are included instead of percent differences Dexc
131. force quit a sensor session early e g you re getting an MRI and need to remove sensor pod Or occasionally the app or receiver may detect something is wrong with your sensor and let you know it s stopping the current session This may be caused by a number of reasons 1 Unresolved calibration issues 2 Error symbol does not go away 3 Wait symbol does not go away 4 Sensor is coming out of the body for example the adhesive is peeling off You ll receive error prompts leading to a new sensor session If you see error prompts always contact Technical Support before stopping a sensor session early Technical Support 24 7 at Toll free 1 877 339 2664 Toll call 1 858 200 0200 When your display device has system errors you may not receive any sensor glucose readings and you should not calibrate Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 117 Prompts to End Sensor Session Early System Prompts Smart Device Lock Screen What you see Smart Device In App aed Regiace rms af s time Receiver Sensor Failed Replace Sensor What it means Sensor issues detected Session ends automatically No e Sensor Glucose Readings e Alarm Alerts Replace sensor Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 118 DIA Smart Device Lock Screen
132. ge Label and Product Symbols At the end of your Dexcom G5 Mobile System User Guide Part 5 is the user guide of a new Dexcom G5 Mobile System feature Dexcom Share Part 5 Sharing is Caring 1 Dexcom Share What Is Dexcom Share Setting Up Dexcom Share How to Use Dexcom Share Your Followers Troubleshooting NOOR WD aog Part 6 1 Index for Dexcom G5 Mobile System and Dexcom Share How to Use Your User Guide All chapters in the Dexcom G5 Mobile User Guide are laid out the same way The beginning of each chapter lists what you ll be able to do after you have finished after that any applicable safety statements you need to know followed by the chapter s content At the end there s a recap of what was covered and what s in the next chapter 1 3 Your Dexcom Account You ll need a username and password to set up the Dexcom G5 Mobile App and for reordering Dexcom G5 Mobile System User s Guide Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey 12 If you haven t already done so go to dexcom com and set up your own account Or if you prefer the Dexcom G5 Mobile App walks you through creating your log in credentials as part of your initial app set up Summary Now You Can e Describe different training resources e Locate tutorials about using a real time CGM in your diabetes management e Find Dexcom G5 Mobile System s step by step instructions e Recall how to us
133. ge has been damaged or opened Using a non sterile sensor might cause infection Clean and Dry Before Using Before opening the sensor package wash your hands with soap and water then dry If your hands are dirty while inserting the sensor you may contaminate the insertion site and get an infection Before sensor insertion clean the skin with alcohol wipes to prevent infections Don t insert the sensor until the cleaned insertion site is dry and free from any lotions or perfumes If your insertion site is not clean and completely dry you run the risk of infection or the sensor pod not sticking and falling off Sensor Placement Change the site where you place the sensor with each new insertion Using the same site too often might not allow the skin to heal causing scarring or skin irritation Sensor placement is important Make sure the area you place your sensor won t e Be bumped pushed or squeezed e Have scars tattoos or irritation Insertion in these areas might affect sensor performance resulting in you missing a severe low or high glucose event Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement Avoid injecting insulin or placing an insulin pump infusion set within three inches of the sensor The insulin might affect sensor performance resulting in you missing a severe low or high glucose event Transmitter Warnings and Precautions Warnings Inspect Transmitter If your transmitte
134. gs These tables describe for each range of CGM glucose readings what percentage of paired YSI values were in the same glucose range shaded or in glucose ranges above and below the paired CGM readings For example based on the Software 505 Adult Study when CGM readings are within 81 to 120 mg dL you can expect your blood glucose levels are within 81 to 120 mg dL 72 of time Dexcom G5 Mobile System User Guide Technical Information 249 Table 4 A System Difference to YSI within CGM Glucose Ranges Adult CGM Glucose Range Mean Median Absolute Absolute Percent Percent Number Mean Median Study of Paired Percent Percent CGM YSI Difference Difference mg dL Difference Difference Original Software 505 Overall Original Software 505 40 60 Original Software 505 61 80 Original Software 505 Original Software 505 81 180 181 300 Original Software 505 301 350 Original Software 505 351 400 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 For CGM lt 80 mg dL the difference and absolute difference in mg dL are included instead of percent differences Dexcom G5 Mobile System User Guide Technical Information 250 Table 4 B System Difference to YSI within CGM Glucose Ranges Pediatric corey Glucose Range
135. hat mean Indications are the who what and why of the Dexcom G5 Mobile CGM System Who The Dexcom G5 Mobile CGM System is a single patient use device meaning you can t share the components with others for people 2 years or older with diabetes What The Dexcom G5 Mobile CGM System is a prescription only glucose monitoring device Dexcom G5 Mobile CGM System tracks your glucose patterns and detects trends Working with your home blood glucose BG meter the system is meant to complement not replace your BG meter Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 18 Why The CGM system s trend and pattern information its glucose Alarm Alerts combined with your meter s actual BG value can help you manage your diabetes By identifying low and high glucose level periods the Dexcom G5 Mobile CGM System allows you to take action when needed and create long term management strategies with your healthcare professional Using trend information to see your highs and lows helps you stay inside your target range The Dexcom G5 Mobile CGM System s trend and pattern information is based on a series of sensor glucose readings taken over a period of time Work with your healthcare professional and create a game plan on how to best use your trend and pattern information in managing your diabetes Contraindications Contraindications let you know when not to use the Dexcom G5 Mobile CGM System you may hu
136. he Dexcom Share Cloud o Confirms your sensor glucose readings are being shared with your Follower s What Dexcom Share does not do e Let you know when the Follower is not receiving your sensor glucose readings and information Dexcom G5 Mobile System User Guide Sharing Is Caring 313 Tips e Read the rest of the Dexcom G5 Mobile CGM System User Guide before using Dexcom Share e Always confirm information with a BG meter before making treatment decisions e Check the status screen after turning Dexcom Share On on the smart device to make sure it is working Installing the Dexcom G5 Mobile App Step What you see What you do Download the Dexcom G5 Mobile App from your app store See your smart device s user manual for instructions Download the Dexcom G5 Mobile App to use Dexcom Share Launch the Dexcom G5 Mobile App Setup your smart device see the Dexcom G5 Mobile User Guide before sharing Once your App has set up activate Dexcom Share A series of screens walk you through Dexcom Share s features highlighting important information Dexcom G5 Mobile System User Guide Sharing Is Caring 314 Activating Your Share Feature Step What you see What it means Activates Dexcom Share If Dexcom Share icon is gray your Share feature has not been turned on What you do Tap Dexcom Share icon in the upper right corner of your smart device s home screen SHRI
137. he absolute difference in mg dL between the two glucose results was calculated For values greater than 80 mg dL the absolute percent difference from the SMBG values was calculated The percentages of total readings within Dexcom G5 Mobile System User Guide Technical Information 274 15 mg dL or 15 20 mg dL or 20 30 mg dL or 30 40 mg dL or 40 or greater than 40 mg dL or 40 were then calculated For example if the System reads 100 mg dL it is between 81 180 mg dL range and you can expect the System readings to be within 20 of the SMBG values 85 of the time for the Software 505 Adult Study as seen in Table 11 A Overall the System in the Software 505 Adult Study reads on average 2 6 lower Mean Percent Difference than SMBG values and 11 3 absolute different Mean Absolute Percent Difference than the SMBG values The Median Percent Difference shows that half of the time the System reads lower in 2 7 or less than the SMBG values and the Median Absolute Percent Difference shows that half of the time the System reads about 8 6 or less different than SMBG values as seen in Table 12 A Adverse Events No serious adverse events or device related serious adverse events occurred during the studies Mild to moderate skin irritation such as erythema or edema occurred at the sensor needle insertion area or around the adhesive area No infection bruising or bleeding occurred at the sensor needle insertion area or the adhesiv
138. he upper right hand corner Dexcom G5 Mobile System User Guide Set up Your Display Devices Initial App Setup Step What you see What you do Introductory Screens Tap Dexcom G5 Mobile App icon to open app Dexcom Swipe through introductory screens or tap Log In Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 52 Continued from previous page Introductory Screens Dexcom Enter existing username and password OR Need a Dexcom username and password Tap Sign Up Complete Username Password fields Tap Login once Dexcom Welcome Use your Quick Start Guide and tutorial along with tus app to help you get started with Dexcom G5 Mobile For complete information sec your User Guide Tap Let s Get Started Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 53 Continued from previous page Introductory Screens The next screens are the Terms of Use safety warnings contraindications and the recommended Double check with your meter settings Once each screen is read tap the appropriate answer to move forward Tap Full Safety Statement or when applicable don t understand to get more information Full Safety Staternant Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 54 Continued fr
139. hnical Information 244 For example in the Software 505 Adult Study Table 2 A when the System displayed LOW 18 occasions 100 18 out of 18 of the YSI values were less than 80 mg dL and 94 17 out of 18 of the YSI values were less than 70 mg dL When the System displayed HIGH 45 occasions 100 45 out of 45 of the YSI values were greater than 240 mg dL and 100 45 out of 45 of the YSI values were greater than 280 mg dL Dexcom G5 Mobile System User Guide N Technical Information a Table 3 A Concurrence of CGM Readings and YSI Values Original Adult Study YSI mg dL Row Percentage of Matched Pairs in each CGM Glucose Range CGM mg dL cap 40 61 81 121 161 201 251 301 351 gt Number of Paired J te 120 160 200 250 300 350 400 400 CGM YSI lt 40 48 37 7 1 0 0 0 0 0 0 155 40 60 49 36 11 1 0 0 0 0 0 0 512 61 80 81 120 121 160 161 200 201 250 251 300 301 350 351 400 gt 400 Dexcom G5 Mobile System User Guide Technical Information 246 Table 3 B Concurrence of CGM Readings and YSI Values Software 505 Adult Study YSI mg dL Row Percentage of Matched Pairs in each CGM Glucose Range CGM mg dL a0 61 a1 121 161 201 251 301 351 number of Paired 60 80 120 160 200 250 300 350 400 CGM YSI 81 120 121 160 1
140. ile CGM System 36 4 4 What s New to the Dexcom G5 Mobile CGM System 0 cceeeeeee eee 38 4 5 System Information 38 4 6 System Components 45 39 4 7 Smart Device Overview 47 Chapter 5 Set up Your Display Devices 49 5 1 Introduction ccceceeeeeeeaes 49 5 2 Safety Statement 0006 49 Dexcom G5 Mobile System User Guide Chapter 6 Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 69 6 1 Overview ccccceeeee eee eeeeaeeaes 69 6 2 Safety Statements 0008 70 6 3 Prepping for Sensor Insertion 72 6 4 Choosing Your Insertion Site 75 6 5 Inserting Your Sensor 005 76 6 6 Attaching Your Transmitter 80 6 7 Loose Sensor POd ss0ceeeeeee 81 6 8 Starting Your Sensor Session 82 6 9 Receiver Bluetooth Tips 86 6 10 Sensor Session Warmup 90 Chapter 7 Calibration 91 71 Introduction ccceceee eee eaee 91 7 2 Calibration Overview 05 92 7 3 Safety Statements 000008 93 7 4 When to Calibrate 0000 95 7 5 Calibration Prompts 45 96 7 6 Preparing for Calibration 100 7 7 Ready Set Calibrate 100 7 8 Calibration Errors 0 c000s 106 Chapter 8 Ending Your Se
141. in a box broken down into four sections 1 Type of statement a Bold and color coded WARNING Red PRECAUTION Blue INDICATION Green CONTRAINDICATION Purple 2 Do s Don ts a An action you should or should not take b Italicized 3 Why a A statement of the potential harm 4 Consequences a What could happen if you don t follow the instructions The following is an example of a chapter s Safety Statement and how to read it WARNING Do Calibrate at least once every 12 hours Why Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings Consequences Missing severe low hypoglycemia or high hyperglycemia Alarm or Alerts Since this is a WARNING you know it covers important safety information Italics are the Do Don t steps to follow Calibrate at least once every 12 hours Below the italics is a statement explaining Why you need to follow the steps Calibrating less often than every 12 hours might cause inaccurate sensor glucose readings And finally what happens or the Consequences if you don t missing a severe low hypoglycemia or high hyperglycemia glucose event 2 4 Overview of Safety Statements This section provides a review of Safety Statements containing the same elements described above type of Safety Statement an action a statement of potential harm and consequences listed in a narrative not boxed format Here you ll learn what indications Dexco
142. ing the Dexcom Share feature there are 3 distinct parts of glucose monitoring 1 Blood glucose meter use this to make any treatment decisions 2 Dexcom G5 Mobile CGM System use the Dexcom G5 Mobile CGM System to complement but not replace information obtained from the blood glucose meter It detects glucose trends and tracks glucose patterns 3 Dexcom Share this is an optional add on to the Dexcom G5 Mobile CGM System that can share glucose information and notifications with up to five 5 other people Shared sensor glucose readings and information can add another level of awareness Using the wrong glucose information for treatment decisions could lead to low or high glucose Blood glucose values from a blood glucose meter may differ from the information displayed on Dexcom Follow App All treatment decisions should be made using a blood glucose value from your meter not the glucose information displayed on the Dexcom Follow App Followers who are concerned by notifications on the Dexcom Follow App should contact the patients and remind them to check their blood glucose with a blood glucose meter Dexcom G5 Mobile System User Guide Sharing Is Caring before driving a car or making any treatment decisions such as taking insulin or eating fast acting carbohydrates Sharers should not rely on Followers to notify them about low or high glucose Any problems with smart device s Bluetooth wireless Internet connection mobile
143. irms you want to stop sensor Return to Main Menu Press Select Main Menu ca Trend Graph Start Sensor Ready to start a new session Not in active session Start Sensor option Remove sensor Insert new sensor Press Start Sensor when ready for new W Enter BG appears session Temporary Shutdown Receiver To save on its battery you can temporarily shut down the receiver When shut down your receiver and transmitter no longer communicate and you will not get any Alarm or Alerts although your sensor session remains active Shutting down the receiver does not extend your sensor session past the seven days it only stops the receiver from communicating with the transmitter Your sensor session will stop seven days after you started the session Dexcom G5 Mobile System User Guide a N N Ending Your Sensor Session and Transmitter Session Step What you see What it means What it means Go to Main Menu Press Select AE DAM iA om Main Menu f Ends sensor session Press Down Arrow to 0 Settings During session Stop Stop Sensor i G Snuidown Sensor option appears Press Select Stop Sensor Shutdown Confirms you want to ee shut down Press Select Shuts down receiver GRE Conce Press Select to turn the receiver back on It may take up to 20 seconds for the receiver to turn on Preventing Sensor Failures
144. ith fingerstick measurement if sensor glucose readings don t match your symptoms Why Your sensor glucose readings may not be accurately reading your glucose Consequences Using sensor glucose readings for treatment decisions could result having severe low hypoglycemia or high hyperglycemia events 9 3 Overview of Home Screen Regardless of your display device the home screen shows your current sensor glucose value glucose trend rate of change arrow and CGM system status While the screen does look different between the receiver and smart devices their information and color coding are the same Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 134 No matter how you hold it the receiver s view does not change the Dexcom G5 Mobile App has two ways to view data based on how you hold your smart device 1 Vertically in portrait 3 hour trend information with task bar 2 Horizontally in landscape 1 3 6 12 or 24 hour trend information without task bar This section first familiarizes you with the app s home screen then with the receiver s home screen In other chapters you ll see how to use the icons or use the navigation wheel to enter data or make system changes App Home Screen The app s home screen has two main sections 1 Status Task Bar a Status Bar reflects status of smart devices system i Battery Bluetooth etc b Task Bar allows you to change settings
145. ks and benefits now let s take a look at Dexcom s G5 Mobile CGM System References Battelino T Phillip M Bratina N Nimri R Oskarsson P amp Bolinder J 2011 Effect of Continuous Glucose Monitoring on Hypoglycemia in Type 1 Diabetes Diabetes Care 34 4 795 800 The Diabetes Control and Complications Trial Research Group The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long Term Complications in Insulin Dependent Diabetes Mellitus The New England Journal of Medicine Vol 329 No 14 September 1993 pp 977 986 Garg S Zisser H Schwartz S Bailey T Kaplan R Ellis S amp Jovanovic L 2005 Improvement in Glycemic Excursions With a Transcutaneous Real Time Continuous Glucose Sensor A randomized controlled trial Diabetes Care 29 1 44 50 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group 2009 The Effect of Continuous Glucose Monitoring in Well Controlled Type 1 Diabetes Diabetes Care 32 8 1378 1383 Dexcom G5 Mobile System User Guide Risks and Benefits Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group 2009 Sustained Benefit of Continuous Glucose Monitoring on A1C Glucose Profiles and Hypoglycemia in Adults With Type 1 Diabetes Diabetes Care 32 11 2047 2049 Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group 2010 Quality of Life Measures i
146. laration Electromagnetic Immunity The Dexcom G5 Mobile System is intended for use in the electromagnetic environment specified in the next table The customer or the user of the Dexcom G5 Mobile System should ensure that it is used in such an environment Dexcom G5 Mobile System User Guide Technical Information 279 System Electromagnetic Immunity Specifications Transmitter Compliance Level IEC 60601 Test Level Electromagnetic Environment Guidance Immunity Test Conducted RF i Floors should be wood concrete or rms tei IEC 61000 4 6 ceramic tile If floors are covered i 150 kHz to 80 MHz with synthetic material the relative Receiver only humidity should be at least 30 Recommended Separation Distance d 1 2 P_150 kHz to 80 MHz d 1 2 P_80 MHz to 800 MHz d 2 3 JP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation Radiated RF 10 V m at 80 MHz distance in meters m IEC 61000 4 h eld strengths from fixed C6100043 Modulation transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with following symbol C NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Elect
147. le System User Guide What Is the Dexcom G5 Mobile CGM System Continued from previous page What you see What it s called What it does Press to scroll up or down to select menu items or set values Up Down Arrows Press to scroll back and forth beyond from the 3 hour trend graph to the 1 6 12 24 views 4 7 Smart Device Overview The Dexcom G5 Mobile App was created to work with your smart device giving you even more options in monitoring your glucose trends and patterns The app is similar to all other apps This User Guide is not meant to show you how to use your smart device Please contact your smart device support or read your smart device s user guide for assistance Summary Now You Can e Explain the Dexcom G5 Mobile CGM System e Describe options to view trends e Locate your historical readings e Recognize system components e Explain each part s function Next Steps Your next step in getting started with the Dexcom G5 Mobile CGM System is selecting how to continuously receive your sensor glucose readings Dexcom G5 Mobile App the Dexcom G5 Mobile Receiver or a combination Our next chapter helps you set up both Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 47 Page intentionally left blank Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 48 Chapter 5 Let s G5 The Basics Set up Your Display Devices 5 1 Introduction
148. level is dangerously low pay attention now What Are Alerts An Alert is a message telling you your glucose trend levels need attention Low High glucose Alerts tell you when your sensor glucose readings are outside your target glucose ranges Think of them as an FYI You need to know what s happening Rising Falling Alerts tell you your glucose levels are changing quickly Their default settings are Off see Chapter 12 on how to turn them on Alerts message you with vibrations vibrations not available on all smart devices visual prompts sounds or a combination of all three Unlike the Alarm you can customize your different Alert s target range Chapter 12 During your initial set up you establish your low and high alert levels As mentioned before this chapter is a review of the Alarm and Alerts recommended smart device settings and the receiver s default Alert settings Chapter 12 will show you how to change their settings customize glucose levels prompts how you are notified and in some cases how often you get notified The following are the defaults Default Alerts Low High Alerts Your Low High Alerts have the same color coding as your Trend Graph screen 1 Red Glucose levels are below your low threshold a Default setting of 80 mg dL 2 Gray Glucose levels are within your high low Alert levels a No Alerts 3 Yellow Glucose levels are above your high threshold a Default setting of 200 mg dL De
149. line at dexcom com a Top of page click Support Tab b Click Education After inserting the sensor start the sensor warmup on your smart device and receiver The sensor warmup takes approximately two hours during this time your body is getting used to the new sensor allowing for more accurate sensor glucose readings Once the two hour sensor warmup has passed you enter two back to back fingerstick measurements to calibrate the sensor s glucose readings with your fingerstick measurements Calibration is covered in the next chapter Make sure you give yourself enough time to finish the startup session Remember your smart device s Bluetooth needs to pair with the transmitter adding up to 30 minutes to your wait time Good news is you don t need to sit around waiting as long as you have your display device near you can go about your day running errands gardening personalizing the Dexcom G5 Mobile settings whatever you choose during that time frame Keep your display device s handy during the warmup period it shows how much time has passed notifying you with beeps and an icon when your sensor session is ready for its initial calibrations After this chapter you will be able to Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 69 e Identify sensor applicator features e Properly prepare for sensor insertion e Choose the best location to insert you
150. ll at 1 858 200 0200 If a sensor wire breaks under the skin with no portion of it visible don t remove it Contact your healthcare professional if you have redness swelling or pain at the insertion site Placement Do not insert the sensor component of the Dexcom G5 Mobile System in a site other than the belly abdomen ages 2 years and older or the upper buttocks ages 2 to 17 years The placement and insertion of the sensor component of the Dexcom G5 Mobile System is not approved for other sites If placed in other areas the Dexcom G5 Mobile System may not function properly Dexcom G5 Mobile System User Guide N Indications for Use and Safety Statement Storage During a sensor s shelf life store it between 36 F 77 F While you don t need to keep your sensor in a refrigerator you can as long as the refrigerator is between 36 F 77 F Never store sensors and or sensor packages in a freezer Storing the sensor incorrectly might cause the sensor glucose readings to be incorrect resulting in you missing a severe low or high glucose event Precautions Expiration Date Don t use expired sensors Before inserting always check the package label for the expiration date using the YYYY MM DD format If past the expiration date don t use because the sensor glucose readings might not be accurate resulting in you missing a severe low or high glucose event Sensor Package Don t use sensor if its sterile packa
151. llower is set to get prompts from their Sharer Follower is able to view their Sharer s trend graph Follower did not accept their Sharer s Follow Invitation email within 7 days The Sharer can invite their Follower again by pressing on the icon in the top right corner of the screen Follower has been sent a Follow Invitation email but has not accepted it yet Sharer stopped sharing with Follower Follower will not get any of the Sharer s glucose information Alarm Alerts or trend graph updates removes Editing Removing Followers Tap on a Follower to edit the Follower s profile nickname or ability to view trend graph or remove a follower Remove a follower by tapping Remove Follower Once removed they won t get glucose information or Alarm Alerts NOTE The Sharer cannot change any Follower settings after the Follow Invitation email is sent Stop Sharing The Sharer can swipe the On Off switch to temporarily stop glucose information and Alarm Alerts from being sent to Followers Sharing stops until the Sharer turns the On Off Switch back on Dexcom G5 Mobile System User Guide Sharing Is Caring 327 For reasons of safety and intended use the Follower will get a message telling them their Sharer s data was set to Not Sharing The Follower s dashboard will show the Sharer has stopped sharing glucose information 20 7 Dexcom Follow App Dexcom Follow A
152. lt Health Event tines Stress Feel High Feel Low Cycie Ak ohol Receiver You can have multiple Events in a single day or even during the same time frame and enter Health Wness Stress High Symptoms Health af Low Symptoms Cycle What it means Illness Have a cold flu or any other temporary illness affecting your well being Stress Are you under stress Feeling anxious High Symptoms Feel high BG symptoms Low Symptoms Feel low BG symptoms Cycle Have you started your menstrual cycle Alcohol Had a glass of wine beer or cocktail them all in at the same time As an example you re running late because of traffic Stress and quickly swing by a drive thru to get lunch Carbs of 85 grams Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns For your convenience and safety no need to stop everything and enter your Events as they are happening When you have a moment you can enter your Events retroactively in your app or receiver Events are meant to be entered as individual occurrences don t enter daily totals enter each Event separately In the next section you will learn how to enter Events first in your smart device then into the receiver 10 3 Entering Events You probably will enter Events in your in the display device you use most often however you should know how to enter Events into each First let
153. ly as downloaded by a user to a smart or mobile device The Dexcom G5 Mobile App was developed as a display for continuous glucose monitoring Blood Glucose BG Value Blood Glucose Meter Meter BG Meter BG is an abbreviation of blood glucose Blood glucose value is the amount of glucose in the blood measured by a BG meter A blood glucose meter is a medical device used to measure how much glucose is in the blood Calibration Calibration is a comparison or measurement between your meter s fingerstick BG values and the sensor s interstitial fluid glucose readings Although blood and interstitial fluids are similar glucose concentration is higher in your blood Calibration allows alignment between your sensor and meter readings When you calibrate you take a fingerstick measurement from your meter then enter the value into your receiver or smart device The system uses that value to verify the sensor glucose reading is on track Continued on next page Dexcom G5 Mobile System User Guide Glossary Continuous Glucose Monitoring CGM Continuous glucose monitoring CGM systems use a sensor inserted under the skin to check glucose levels in interstitial fluid A transmitter sends sensor glucose readings to a display device Users must confirm glucose levels with a BG meter before making a change in treatment Contraindication A safety statement outlining specific situations where the Dexcom
154. m G5 Mobile System User Guide Indications for Use and Safety Statement 17 and contraindications are and what to do to keep you safe and the system in proper working order Safety Statements are broken down into two major categories First general CGM system Warnings reviews warnings and precautions you take with most CGM systems and second Hardware Software Warnings and Precautions list warnings and precautions specific to the Dexcom G5 Mobile CGM System components Indications and Contraindications Indications What are the Dexcom G5 Mobile CGM System indications Well in technical terms the indications are The Dexcom G5 Mobile Continuous Glucose Monitoring CGM System is a glucose monitoring system indicated for detecting trends and tracking patterns in persons age 2 years and older with diabetes The system is intended for single patient use and requires a prescription The Dexcom G5 Mobile CGM System is indicated for use as an adjunctive device to complement not replace information obtained from standard home glucose monitoring devices The Dexcom G5 Mobile CGM System aids in the detection of episodes of hyperglycemia and hypoglycemia facilitating both acute and long term therapy adjustments which may minimize these excursions Interpretation of the Dexcom G5 Mobile CGM System results should be based on the trends and patterns seen with several sequential readings over time In Layman s Terms But what does t
155. m User Guide Ending Your Sensor Session and Transmitter Session 130 NEXT STEPS GETTING THE MOST OUT OF YOUR DEXCOM CGM Reading Trend Graph Screens and Recognizing Trends Events Alarm and Alerts Sounds for Alarm Alerts and System Messages Page intentionally left blank Chapter 9 Next Steps Home Screen Rate of Change Arrows and Errors 9 1 Introduction to Home Screens In the previous chapter you learned about calibrations why they are important and how to do complete them Within five minutes of your final calibration your sensor glucose readings begin In this chapter you ll learn three things First reading the home screen second identifying your sensor glucose readings and trends What do they mean What s the best way to use trend information And third what you do if you aren t getting your sensor glucose readings The purpose of this chapter isn t to tell you how to react to your trends but to help you recognize where your glucose was and where it s going Your healthcare professional can help you with your questions on what actions to take based on your glucose trends After this chapter you ll be able to e Recognize home screen icons e Locate sensor glucose reading e Explain sensor glucose target range e Recognize the importance of gray yellow and red colors e Identify low high glucose alert levels on your trend graph e Describe when you receive a High or Low sensor glucose rea
156. m of Alerts or an Alarm help you avoid getting too low or high Alarm and Alert notifications help keep you aware of your glucose trends and are made up of a combination of sounds vibrations and screens There are a number of Alerts but only one Alarm when your glucose level dips below 55 mg dL Some customization options are available and are part of the set up process for the receiver and smart device In Chapter 11 you can learn more about the Alarm and Alerts feature Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 37 Viewing Your Glucose Values The Dexcom G5 Mobile CGM System allows you to see your last 1 3 6 12 24 hours of your sensor glucose readings On the receiver from the home screen press Up Down Arrows to view On a smart device hold upright in portrait mode and see the most recent three hours turn sideways to andscape to view your glucose levels over the last 1 3 6 12 24 hours Go to Chapter 9 to learn more about viewing your glucose trends 4 4 What s New to the Dexcom G5 Mobile CGM System Dexcom s G5 Mobile CGM System has features not found in our previous generations They include e Dexcom G5 Mobile App for your smart device e Updates to the Dexcom G5 Mobile Receiver screens e Software updates o Dexcom Share in the Dexcom G5 Mobile App Share Your Data Through secure wireless connections Dexcom Share allows remote viewing of your sensor glucose readings trends a
157. mart Device session In App Continue to get sensor glucose readings m m f Replace Receiver Sensor Soon 92 00 00 Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 113 Continued from previous page Device What you see What it means At Thirty Minutes Smart Device Lock Screen Your session session will end in 30 minutes You will not receive alerts of alarms after thes time unless you replace your B sensor Thirty minutes remain Smart Device In App Continue to get sensor glucose readings m i Replace Receiver Sensor Soon 49 30 00 Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 114 DIA Session Ended Smart Device Lock Screen Smart Device In App Continued from previous page What you see Replace sensor now You will not receive alerts of alarrns after this time untess you replace your sensor Q Sensor removal O Sensor insertion Receiver Replace Sensor Now 90 00 00 What it means Session has ended App Tap screen s for steps to e Remove sensor e Insert new sensor Receiver Press Select to clear Continued on next page Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 115
158. mitter 2 Water resistant 3 Can transmit data to your display devices for up to 20 feet a Range is less if you are in or under water 4 Battery lasts approximately three months a Receiver or smart devices prompts you when battery is running low 5 Transmitter s serial number is on the back More transmitter features and insertion information is in Chapter 6 Now you are familiar with sensor and transmitter let s review the Dexcom G5 Mobile Receiver Dexcom G5 Mobile Receiver The receiver is a small hand held device Your receiver along with your smart device shows your sensor glucose readings trend graphs trend arrows and alerts you when your glucose is too high or too low or if there is something you should be aware of or need to do The receiver is neither water resistant nor waterproof and can get damaged if moisture gets inside so keep it away from any liquids and very high humidity Keeping the micro USB port closed helps prevent damaging fluids and dust from getting inside the receiver If your receiver does get wet test it to make sure the speaker and vibrations still work see Chapter 12 If your receiver isn t charged see Chapter 14 for charging your receiver s battery Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 44 If you want to use the receiver along with a smart device you need to set them up separately Remember you can t use a combination of smart devices duri
159. n 2 Never use same site for 2 sensor sessions in a row Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 125 Without Safety Lock Step Picture What you do Grasp end of adhesive patch Peel adhesive patch up and away from your body to remove sensor pod and transmitter Put sensor pod on flat surface Grasp sensor pod s wide end with two hands and place fingers in side s open slots Pull tabs away from transmitter 8 5 End of Transmitter Battery How do you know if your transmitter s battery will last through your next session System messages help you determine if your transmitter s battery will last through your next seven day session Starting at three weeks to the end of its battery life the messages countdown the transmitter s battery until it has only seven days If the transmitter battery has seven days or less remaining you won t be able to start a new session Dexcom G5 Mobile System User Guide Ending Your Sensor Session and Transmitter Session 126 Transmitter Battery Messages What you see What it means Smart Device Lock Screen You Warisrmnitior battery is low The transmitter wi stop working in about your ernail inbox re deta Smart Device In App Battery will expire in three weeks Check your email for more details Receiver Peeve Low Battery Order New Transmitter Days Lef 22
160. n t remove it Don t ignore sensor fractures Do Seek professional medical help if you have symptoms of infection or inflammation e g redness swelling or pain at the insertion site Always report a broken sensor to our Technical Support 24 7 team as soon as possible Toll free 1 877 339 2664 Toll call 1 858 200 0200 Why Sensors may fracture on rare occasions Testing done in a controlled environment in vitro didn t find any safety hazards during an MRI with a broken off sensor under the skin The wire didn t heat up nor have any significant movement during the MRI images were affected only in the area around the sensor s wire MRI with broken wire If you have experienced a broken sensor and are planning to take an MRI please discuss the following with your doctor or technician Laboratory in vitro MRI tests did not detect any safety hazards for a broken sensor that remains in the body There was no significant movement or heating of the wire Imaging artifacts were limited to the area around the wire PRECAUTION Do Keep Transmitter until it s battery life has ended Why Transmitter is reusable e Use for multiple sessions 8 3 Ending Your Sensor Session There are different ways your session might end The most common is your sensor s typical seven day timeframe ended The second is ending the sensor session early You may end a session early based on a personal decision Dexcom G5 Mo
161. n 7 6 and 7 7 Immediately prepare for next calibration Calibration 97 Continued from previous page Device What you see What it means What you do Second Calibration Smart Device Lock Screen Smart Device in App Sensor accepted Follow steps in first calibration Section 7 6 and 7 7 Wry two meter varies Ready for second Next calibration in Steps BG meter value 12 hours t Wash and dry your hands 2 Take a fingerstick with your meter 3 Tap the green circle above and romnpty enter he asart value mm b Your sensor glucose readings begin in approximately five minutes once the device s accepts your Calibrations Update Calibration Prompts Once your start up calibration is done your update calibration schedule begins Dexcom G5 Mobile System User Guide Calibration 98 The steps to enter your update calibrations are the same as your initial calibration including only entering values in one display device The only difference is with update calibrations enter your BG meter value just once Like the reminders you received with your initial calibration if you don t enter your BG meter values right away the system prompts you every 15 minutes Update Calibration Prompts Device What you see What it means What you do Smart Device Enter update Lock Screen calibration If prompt doesn t go Smart Device away In App Follow steps in e
162. n Children and Adults with Type 1 Diabetes Diabetes Care 33 10 2175 2177 Ohkubo Y Kishikawa H Araki E Miyata T Isami S Motoyoshi S amp Shichiri M 1995 Intensive Insulin Therapy Prevents the Progression of Diabetic Microvascular Complications in Japanese Patients with Non insulin dependent Diabetes Mellitus A Randomized Prospective 6 year Study Diabetes Research and Clinical Practice 28 2 103 117 Tamborlane W V Beck R W Bode B W Buckingham B Chase H P Clemons R amp Xing D 2008 Continuous Glucose Monitoring and Intensive Treatment Of Type 1 Diabetes The New England Journal of Medicine 359 14 1464 1476 Dexcom G5 Mobile System User Guide Risks and Benefits 32 LET S G5 THE BASICS Introduction to the Dexcom G5 Mobile CGM System Initial Set Up Starting a Sensor Session Inserting the Sensor amp Transmitter Calibration Ending a Sensor Session Page intentionally left blank Chapter 4 Let s G5 The Basics What Is the Dexcom G5 Mobile CGM System 4 1 System Description Now it s time to get an overview of the Dexcom s G5 Mobile CGM System After this chapter you ll be able to e Explain the Dexcom G5 Mobile CGM System e Describe options to view trends e Locate your historical readings e Recognize system components e Explain each part s function 4 2 Safety Statement If you ve used the Dexcom G4 PLATINUM CGM System yo
163. n or Off switch to turn on desired Alerts 3 Tap Notify me a Change the Alert glucose level mg dL i Scroll selection wheel find your desired Alert level ii Tap to highlight iii Tap Save 4 Tap Repeat a Change the amount of time you want between your High Low Alerts if your sensor glucose readings continue to be low or high i Scroll selection wheel find your desired Alert level ii Tap to highlight iii Tap Save 5 Tap Sound a Assign a different sound to each Alarm or Alert i Scroll selection wheel find your desired sound ii Tap to highlight iii Tap back arrow In this following example we ll change the High Alert level from 200 mg dL to 190 mg dL repeating every hour if you continue to stay high with a Door Bell sound Customizing Alerts App Step What you see What it means What you do Access Alerts Main Menu Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 195 Access Alerts Main Menu Menu Settings Heip Stop Sensor Dexcom G5 Mobile System User Guide 5 gt Continued from previous page Access Alerts Main Menu Continued on next page Tap Alerts On the Go With G5 Customizing Your Alarm and Alerts 196 Continued from previous page Changing an Alert x Alerts Urgent Low mgt Q 55 gt LOW mana gt High mgit Q 180 gt Rise Rat
164. nd data by your loved ones from a smart device Activate Dexcom Share by tapping on the app s Share icon follow a few simple steps then invite up to five people to connect with you After downloading the Dexcom Follow App they become your Follower As a Follower they can watch your sensor glucose readings trends and receive Alarm Alerts when your glucose is low or high You determine what your Follower can see Based on what you allow your Followers can receive your Alarm or Alerts and view your trends Followers can pick and choose or turn off the data they receive including the Alarm Alerts trends and messages The Share feature in the Dexcom G5 Mobile App is different than the Dexcom Share App used with other systems More information about Dexcom Share and instructions for use go to Part 5 NOTE Review all Dexcom Share System indications contraindications warnings precautions and detailed procedures in Part 5 Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 38 4 5 System Information The receiver and app also keep you informed on the system s status Technical notifications provide information about your sensor session and about the system s hardware Each chapter provides a table of the prompts system and error messages applicable to its subject As an example the calibration chapter will review all calibration messages you may see Now you know what the Dexcom G5
165. nd does not replace real time continuous glucose monitoring Dexcom G5 Mobile System or standard home blood glucose monitoring The Dexcom Share Direct Secondary Displays is not intended to modify or analyze data received from the continuous glucose monitor system Nor is it intended to instruct or to transmit information to the continuous glucose monitor system Dexcom G5 Mobile System User Guide Sharing Is Caring 310 The Dexcom Share Direct Secondary Displays is not intended to serve as a replacement for a primary display device for a continuous glucose monitoring system The Dexcom Share Direct Secondary Displays is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system Important User Information Please review the indications contraindications warnings precautions cautions and other important information in the Dexcom G5 Mobile System User Guide Dexcom Share is a feature of the Dexcom G5 Mobile System If you do not have the Dexcom G5 Mobile System User Guide you can view it on dexcom com or Call 1 877 339 2664 to request a copy Availability hours Monday Friday 6am 6pm PST Please contact your healthcare professional during hours the line is unavailable Contraindications Do not bring the smart device e g mobile phone tablet computer into a room containing medical equipment such as Magnetic Resonance Imaging MRI Computed Tomography CT or diathermy
166. next chapter you ll learn how to customize the Alarm and Alerts After this chapter you will be able to e Define an Alarm e Define an Alert e Identify the different types of Alerts e Describe the difference between an Alarm and an Alert e Recognize different Alarm Alert prompts and sounds e Determine signal loss is preventing you from getting an Alarm or Alert e Describe recommended app settings e Successfully clear an Alert notification o Dexcom G5 Mobile App o Dexcom G5 Mobile Receiver Your trending information is one of the greatest benefits of the Dexcom G5 Mobile System It s important to focus on your trends and rate of change arrows rather than the exact number of your glucose reading Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 173 11 2 Safety Statements The Alarm and Alerts were designed to keep you safe helping you avoid severe lows and highs or from missing your readings The following safety statements help ensure you get your Alerts and Alarm WARNING Do Verify your smart device settings let you get Alarm and Alerts To receive Alarm Alerts you must Make sure Dexcom G5 Mobile App Notifications are turned on in Settings menu Verify app hasn t been shut down Adjust volume so you can hear sounds Turn Bluetooth on Turn off Do Not Disturb Keep Dexcom G5 Mobile App running in the background Restart app after device is restarted NOOR WDM Why Your ap
167. next page The Sharer should make sure e There is a glucose value on the smart device e Transmitter is in range of the smart device e Tap on blue to learn more about how to troubleshoot this issue e The Sharer should allow up to 10 minutes for their status to turn green and a green check mark to appear If the Sharer continues to see this the Sharer should turn off Share and then turn it back on Sharing Is Caring 325 Continued from previous page What you see What it means What you do The Sharer should make sure e Their Wi Fi or cellular connection is ON e They are in an area that Issue with has cellular reception e They are not on a voice e Sharer s Internet connection call e They can access the e y Snaing Victron Dexcom Share Cloud web via a browser e Check later or follow up with their Internet connectivity provider e Tap on blue to learn more about how to troubleshoot this issue Follower List The Followers list allows the Sharer to manage their Followers In the Follower list you can e Invite a new Follower e See the status of Followers you have invited e Glance at what options your current Followers have Icon Status What you see What it means Invite a new Follower Continued on next page Dexcom G5 Mobile System User Guide Sharing Is Caring 326 Continued from previous page What you see What it means Fo
168. nformation 237 Transmitter Attaching 80 Battery Messages 127 Connecting Pairing Transmitter with App 58 Connecting Pairing with Receiver 66 End of Transmitter Battery 127 Overview 44 Remove from Sensor Pod 124 Safety Statements 24 Troubleshooting 287 Ww Warranty 215 Dexcom G5 Mobile System User Guide Index Dexcom 2015 Dexcom Inc All rights reserved Covered by patents www dexcom com patents Dexcom Dexcom Follow Dexcom G4 Dexcom G4 PLATINUM Dexcom G5 Dexcom G5 Mobile Dexcom Share Follow Dashboard and G5 are either registered trademarks or trademarks of Dexcom Inc in the United States and or other countries All other product or company names that may be mentioned in this publication are tradenames trademarks or registered trademarks of their respective owners wul Dexcom Inc 6340 Sequence Drive San Diego CA 92121 USA Phone 1 858 200 0200 Tech Support 1 877 339 2664 Web dexcom com
169. ng a sensor session select just one Receiver Overview What you see What it s called What it does Provides data about your glucose Receiver trends via screen display sounds and vibration Plug USB cable into port for Micro USB Port recharging Close USB port door after removing USB Port Door USB cable to keep receiver clean and dry Plug into receiver to charge battery Don t plug into a computer port to Micro USB Cable charge Battery can only be charged using the adapter wall charger Continued on next page Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 45 Continued from previous page What you see What it s called What it does Wall Charger Plug USB cable into adapter wall charger Plug wall charger into an electrical outlet to charge receiver s battery Don t block access to the charger Display Screen Shows sensor glucose readings trend graphs and arrows Alarm Alerts sensor session status Change settings on Menu screen Speaker Allows you to hear your Alarm Alerts sounds Navigation Wheel Arrows and button to help you navigate through the receiver s menu options and choose features Select Button Press to select menu option Left Arrow Press to go back to last item screen or home screen Right Arrow Press to highlight next item Continued on next page Dexcom G5 Mobi
170. ng in you missing a severe low or high glucose event Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 24 You can use a Dexcom G4 PLATINUM Sensor with the Dexcom G5 Mobile CGM System Before using the sensor make sure the sensor label says Dexcom G5 Mobile G4 PLATINUM Sensor or Dexcom G4 PLATINUM Sensor System Accuracy System accuracy may be affected when your glucose is changing at a significant rate such as during exercise or after a meal Significant glucose rise fall rates e Rising 2 3 mg dL each minute e Rising more than 3 mg dL each minute e Falling 2 3 mg dL each minute e Falling more than 3 mg dL each minute Receiver and Smart Device Precautions The Dexcom G5 Mobile Receiver and your smart device share some warnings and precautions Precautions Communication Range Do not separate the transmitter from the receiver or smart device by more than 20 feet The transmission range from the transmitter to receiver or smart device is up to 20 feet without obstruction Types of obstruction differ and not all have been tested Obstructions can include water walls metal etc If your transmitter and display device s are more than 20 feet from each other or are separated by an obstruction they might not communicate resulting in you missing a severe low or high glucose event Water is often the biggest culprit in reducing the communication distance between the transmitter and dis
171. no risks to connecting any part of the system to an MSO Multiple Socket Outlet Temperature 32 F 104 F Humidity 15 95 RH Storage 10 95 RH 1300 feet to 13800 feet 50 dBa at 1 meter IP22 Vertically falling drops Protection against insertion of large objects and dripping water 1 year Class Il equipment No cleaning methods are recommended or tested for the receiver The warranty life of the receiver is 1 year The service life for the accessories is noted to be up to one year If you have difficulty reading your receiver in bright sunlight you may need to seek a shady location Do not connect the receiver to any equipment not specified in IFU Guidance and Manufacturer s Declaration Electromagnetic Immunity The receiver MT22719 is intended for use in the electromagnetic environment specified in the next table The customer or the user of the receiver should ensure that it is used in such an environment Dexcom G5 Mobile System User Guide Technical Information 278 Receiver Electromagnetic Immunity Specifications Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 IEC 60601 Test Level 8 kV Contact 15 kV Air Transmitter Compliance Level 8 kV Contact 15 kV Air Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30
172. not permitted to use the CGM system otherwise You understand that misusing the CGM system improperly accessing it or the information it processes and transmits jailbreaking your CGM system or cell phone and taking other unauthorized actions may put you at risk cause the CGM system to malfunction is not permitted and voids your Limited Warranty This Limited Warranty does not cover 1 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 2 Equipment with the ID number removed or made illegible 3 All surfaces and other externally exposed parts that are scratched or damaged due to normal use 4 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 5 Defects or damage from improper testing operation maintenance installation or adjustment 6 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 cell phone or smart device and your connection to the Internet 7 Equipment which has been taken apart physically or which has had any of its software accessed in any unauthorized manner 8 Water damage to
173. not rely solely on the Follower to alert the patient of low or high glucose events or other important information At times the Follower may not receive data and the patient will not be notified of this fact When using Dexcom Share make sure Share is turned On If not the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values If the patient s smart device does not have a connection or loses the connection the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values Do not use Dexcom Share unless both the patient s and Follower s smart devices have active Internet connections in order to share data If either the patient or the Follower does not have a connection loses their connection turns off the connection Airplane Mode or if the smart device is in Do Not Disturb mode the patient will be unable to share data and the Follower might miss helping the patient in the event of low or high blood glucose values To check this make sure that the Follower s smart device can receive text messages Follow notifications and text messages work by a similar process Make sure the patient s and Follower s smart devices have charged batteries or are connected to electrical outlets If the smart device shuts down due to low battery the patient will be unable to share data
174. now when not to use the Dexcom G5 Mobile CGM System If used during these situations you may hurt yourself or the system the risk of use clearly outweighs the benefit 3 Warning Important hazard information Describes serious or life threatening circumstances to stay away from while using the Dexcom G5 Mobile CGM System their consequences and how to avoid danger 4 Precaution Special steps you need to take while using the Dexcom G5 Mobile CGM System preventing minor or moderate injury to either you or the system 2 3 Safety Statements This user guide presents Safety Statement two ways 1 In this chapter s Overview of Safety Statements o Lists all Safety Statements o Includes a section reviewing how the statements are formatted 2 Within a chapter o Lists only those statements applicable to the chapter Chapter s Safety Statements Each chapter will list all applicable indications contraindications warnings and precautions Some chapters will have multiple Safety Statements others have none Safety Statements are located towards the front so you can keep them in mind as you learn about that chapter s topic The same statement may be repeated throughout the user guide It s important to recognize which factors could prevent the system from working correctly or even harming you Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 16 Within chapters each color coded Safety Statement is
175. nsor Session and Transmitter Session 109 8 1 Introduction ceceee eee es 109 8 2 Safety Statements 0005 110 8 3 Ending Your Sensor Session 110 8 4 Remove Sensor Pod and Transmitter 124 8 5 End of Transmitter Battery 126 Part 3 Next Steps Getting the Most out of Your Dexcom CGM Chapter 9 Home Screen Rate of Change Arrows and Errors 133 Table of Contents 9 1 Introduction to Home Screens 133 9 2 Safety Statements 133 9 3 Overview of Home Screen 134 9 4 Rate of Change Arrows 145 9 5 Error Messages s0s0eeees 146 Chapter 10 Daily Events Affect Your Glucose Trends and Patterns 153 10 1 Introduction cece 153 10 2 What Is an Event 008 153 10 3 Entering Events 008 162 10 4 Viewing Events 008 170 Chapter 11 Sensor Glucose Alarm and Alerts 173 11 1 Introduction eee 173 11 2 Safety Statements 4 174 11 3 Alarm and Alerts 008 175 11 4 Alarm and Alerts Screens 177 11 5 App Alarm Alert Recommended SettingS cceeeeeee eens ee ee es 183 11 6 Receiver Default Beeps and Vibrations eneee 184 11 7 Clearing Alarm Alerts 188 Chapter 12 On the Go With G5 Customizing Your Alarm and Alerts 191 12 1 Introduction
176. nsor pod 6 6 Attaching Your Transmitter Now that you have inserted your sensor you need to attach your transmitter Since the transmitter is reusable you don t need a new one every time you start a sensor session Keep your current session s transmitter box The bottom label has important information you may need after you ve inserted the transmitter Once the transmitter has been attached you can t remove it until your session is over Chapter 8 reviews when and how to remove your transmitter Before inserting your transmitter check you entered the correct transmitter SN into your display device Chapter 5 covers entering transmitter s SN number Step Picture What you do Remove transmitter from box Keep box Save safety latch from sensor applicator helps remove transmitter once sensor session is over Get alcohol wipe Wipe back of transmitter with alcohol wipe Let dry for 2 3 minutes Don t let the back of transmitter touch your skin Don t scratch transmitter s back this can harm the waterproof seal Flat side down Slide transmitter s small end under the sensor pod lip located in front of pod s ribbed tabs away from transmitter latch Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 80 Continued from previous page Step Picture What you do Keep finger on tr
177. nsulin e Exercise e Health See Chapter 10 Dexcom Share Dexcom Share is only available on the app Gray icon means Share is not active Tap icon to activate see Part 5 Dexcom Share Dexcom G5 Mobile System User Guide Once activated Dexcom Share icon is colored Do nothing Tap icon to access Dexcom Share Home Screen Rate of Change Arrows and Errors Glucose Information App Portrait App Landscape What it means Home Screen In Landscape mode tap on the trend view you want to see at the top of the screen 1 3 6 12 or 24 historical trend views Number Most recent sensor glucose reading Shown in milligrams per deciliter mg dL 1 Yellow At or above target 2 Gray Within range 3 Red At or below target Continued on next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 138 Continued from previous page App Portrait App Landscape What it means Historical Readings Turn smart device to Landscape mode Tap time shows timeframe s sensor glucose reading Slide finger across screen to view rest of day s sensor glucose readings Rate of Change Arrow Direction and number of arrows show sensor glucose change rate Continued on next page Dexcom G5 Mobile System User Guide
178. nt display devices but did you know what you do can affect your trends and patterns It s important to track actions or well being to better understand what you do or how you feel can change your trends In the next chapter you will learn how to enter Events in the Dexcom G5 Mobile System Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 151 Page intentionally left blank Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 152 Chapter 10 Next Steps Daily Events Affect Your Glucose Trends and Patterns 10 1 Introduction Your daily activities can impact your glucose trends and patterns In the previous chapter you learned how to read your glucose trend screens in this chapter you learn how to enter situations or Events By tracking Events you can determine how certain actions or circumstances affect your glucose levels After this chapter you ll be able to e Define Event e Describe each Event e Create Events o Dexcom G5 Mobile App o Dexcom G5 Mobile Receiver e Recognize Event markers on the Dexcom G5 Mobile App o Describe how Event markers are different in portrait and landscape view e Describe how to view Events entered via your receiver e View Event markers on your smart device 10 2 What Is an Event Did you take a walk after lunch today Did you go to happy hour with your co workers and have a beer Are you feeling stressed
179. nternal function Therefore its RF emissions are very CISPR 11 low and are not likely to cause any interference in nearby electronic equipment ae The Dexcom G5 Mobile System is suitable for use in all RF Emissions Class B establishments including domestic and those directly CISPR 11 connected to the public low voltage power supply network that supplies buildings used for domestic purposes Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Receiver The receiver is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the receiver can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the receiver as recommended in the next table according to the maximum output power of the communications equipment Portable and mobile RF equipment include baby monitors Bluetooth wireless headsets wireless routers microwave ovens laptops with internal Wi Fi adapters GSM cell phones RFID scanners and hand held security metal detector often used by security screeners Minimum Recommended Distance Between Other RF Transmitters and the Dexcom Transmitter Receiver Rated Maximum Separation Distance According to Frequency of Transmitter m Output Power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 P d
180. nued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 88 Continued from previous page If Wrong SN Entered Stop Sensor Wait for sensor session to end From Main Menu Press Down Arrow to Settings Press Select Press Down Arrow to Transmitter Press Select mit Highlight Transmitter SN Yi Transmitter info Press Select Enter correct SN using Up Down Arrow Transmitter SN Y Press Up Down Arrow to select and enter transmitter SN 400 ona Press Right Arrow to move to next digit Press Select to save and close Press Left Arrow twice to return to Main Menu Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 89 Continued from previous page If Wrong SN Entered Main Menu f Start Sensor Session Press Up Down Arrow to highlight Start Sensor Press Select on Start Sensor Ri Trend Graph H Enter BG 6 10 Sensor Session Warmup The sensor takes about two hours to adjust to your body While you are in the sensor warmup period you can customize your settings Chapter 12 steps you through how to personalize your Dexcom G5 Mobile CGM System s display devices Once the sensor warmup is complete you re ready to enter your initial calibrations The next cha
181. ny other questions After this chapter you will be able to e Describe different training resources e Locate tutorials about using the Dexcom G5 Mobile CGM System in your diabetes management e Find Dexcom G5 Mobile System s step by step instructions e Recall how to use the User Guide e Explain why you need a Dexcom account We have numerous resources available to help you to get the most out of your Dexcom G5 Mobile CGM System Between our self paced training resources and our friendly and knowledgeable Dexcom customer support teams help is always available First Things First Learning How to Learn Knowing about the Dexcom G5 Mobile CGM System is your first step in creating a successful CGM experience Before using it learn about it You have numerous self paced resources helping you get to know the Dexcom G5 Mobile CGM System Dexcom G5 Mobile System User Guide Beginning Your Dexcom G5 Mobile Continuous Glucose Monitoring CGM System Journey 9 1 Tutorials 2 Quick Start Guide 3 User Guide No matter which resource you select make sure you review them prior to using your new CGM system 1 2 Self Paced Resources Tutorials Along with step by step instructions our tutorials illustrate how real time CGM can assist in your daily diabetes management The following is a list of tutorials and how to access them Online Tutorials First Steps With Your Dexcom CGM Designed for those who have never used a Dexcom C
182. obile Receiver e Adjust Alarm sound notification e Use receiver s Advanced Alerts o Low High Repeat o Rise Fall Alerts o Signal Loss Each display device has customization options however the setup flow is different Before making any changes to your Alert levels talk with your healthcare professional First let s take a look at personalizing your app Alarm and Alerts and then we ll review the same process for the receiver Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 191 12 2 Safety Statement WARNING Do f using both receiver and app for to get an Alarm or Alert change settings in each display device Why Any changes to the G5 Mobile app will not carry over to the receiver Consequences Missing severe low or high Alarm or Alerts 12 3 Changing App Alarm and Alerts App Screen Overview The Alerts Main Menu lists all customizable Alerts and Alarm and their current settings Part of your initial set up included setting your Low High Alerts In this chapter you ll learn how to change them Before learning how to change your settings let s review the app s Alerts Main Menu screen Customizing Alerts App Alarm Alerts Screen Overview Step What you see What it means What you do Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 192 What you see Continued from previous
183. often don t show the same Continued on next page Dexcom G5 Mobile System User Guide What you do See Chapter 7 Differences are not uncommon Readings from different body fluids reflect different numbers Meter from blood Sensor from interstitial fluid 20 20 Rule If the meter shows 80 or less CGM should read within 20 points If the meter shows 80 or above the CGM should read 20 Example a 202 mg dL sensor reading and a 188 mg dL glucose meter value a 7 difference this is still considered accurate Outside of 20 20 rule Calibrate again Troubleshooting N Device Smart Device In App Continued from previous page What you see Receiver Problem Not getting sensor glucose readings What you do See Chapter 9 Don t calibrate Wait for more prompts System may correct problem itself and continue to provide sensor glucose readings 3 hours since last sensor reading call Technical Support see Section 16 1 Smart Device In App Receiver Continued o Dexcom G5 Mobile System User Guide Not getting sensor glucose readings next page See Chapter 9 Wait System will often resolve itself If this continues for an extended period of time call Technical Support to report error see Section 16 1 Troubleshooting DIA Smart Device In App Continued from previous pag
184. ogress bar confirms two hour sensor warmup ARSARRER Keep your receiver within 20 feet during the warmup period Receiver returns to the trend graph screen Make sure receiver and transmitter are communicating Check receiver 10 minutes after starting for Bluetooth icon e Solid Connected e Blinking Searching for connection e No Bluetooth Icon No connection Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 85 Continued from previous page Step What you see What you do Wait Screen provides countdown of the two hour sensor warmup Sensor warmup is complete You re ready to calibrate 6 9 Receiver Bluetooth Tips Your transmitter and receiver begin communicating once you start a sensor session After approximately 30 minutes if the Bluetooth symbol is solid and not blinking your transmitter and receiver are talking to each other e If blinking Bluetooth is looking for your transmitter o Make sure your transmitter and receiver are within 20 feet of each other If the Bluetooth icon isn t on the receiver and the Signal Loss icon appears in the receiver s upper right corner of the status bar they re not communicating Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 86 No C
185. om G5 Mobile System User Guide Technical Information 273 Table 12 B System Difference to SMBG Within CGM Glucose Ranges Pediatric CGM Mean Median Glucose Number Mean Median Absolute Absolute of Paired Percent Percent Range Percent Percent mg dL CGM SMBG Difference Difference Difference Difference Original Software 505 Overall Original Software 505 Original Software 505 40 60 61 80 Original Software 505 81 180 Original Software 505 Original Software 505 181 300 301 350 Original 351 400 Software 505 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 For CGM lt 80 mg dL the differences in mg dL are included instead of percent differences Agreement and Accuracy Relative to SMBG Agreement between the System and blood glucose values is also characterized using paired System and SMBG results Table 11 to 12 The System and SMBG values were compared by pairing the comparative SMBG value to a System glucose reading that occurred immediately after the SMBG was collected These results characterize the performance subjects expect during real time use of the System in their daily diabetes management when comparing the System readings to their home blood glucose meter results For readings less than or equal to 80 mg dL t
186. om previous page Setting up Your App Alarm Alerts and Basic Settings Low Glucose Alert You will be alerted wher your sensor glucose readings fall below Set your Low Glucose Alert Default is 80 mg dL Scroll to select another amount Tap Save to move forward Once set you ll receive an Alert notification if your glucose dips below your set amount Gort understand High Glucose Alert You will be alerted when your sensor glucose readings fise above Set your High Glucose Alert Default is 200 mg dL Scroll to select another amount Tap Save to move forward Once set you ll receive an Alert notification if your glucose rises above your set amount 170 mg dl dort understand Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 55 Continued from previous page Setting up Your App Alarm Alerts and Basic Settings Receiving CGM Alerts in order to rece and High glucose alert yor must alow Dexcormn to send your iPhone notifications Tap OK when you receive the fotowing notification on the net Make sure you get your Alarm Alerts notifications Tap the appropriate response to move forward and set your notifications Send You Notifications soem sed con badana Tecan Tap OK to receive Alarm Alerts notifications Don t Allow OK Continued on next page Dexcom G5 Mobile System User
187. ommunication Between Transmitter and Receiver Step What you see What you do Check correct transmitter SN is in receiver e SN is on the label on bottom of transmitter box Press Select to go to Main Menu Press Down Arrow to Settings Press Select Settings 6 Time Date Press Down Arrow to Transmitter Tensmitier Press Select i Device Info Transmitter Y T Transmitter Into Press Select Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 87 Continued from previous page Step What you see What you do Check correct transmitter SN is in receiver e SN is on the label on bottom of transmitter box Compare SN in receiver to SN on transmitter box If correct call our 24 7 Technical Support department toll free at 1 877 339 2664 or toll at 1 858 200 0200 for help Press Select to exit screen Press Left Arrow twice to go to Main Menu If Wrong SN Entered Main Menu Alerts Press Left Arrow twice to go to Main Menu Shutdown MainMenu If sensor session has started to correct transmitter 1 Settings SN you must stop the sensor session Press Down Arrow to Stop Sensor C Shutdown Stop Sensor Press Select Stop Sensor 2 Stop Sensor Press Selectto stop session GK Conce Conti
188. on Advanced Arrow to High Repeat Press Select High Alert OF minutes Initial screen shows current repeat minutes Change time frame in 5 minute increments Press Up Down Arrow Stop at 60 minutes Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 210 Continued from previous page Turn Repeat On High Alert Changed Repeat time for sokl High Alert Press Select minutes Advanced R L High Repeat Changed completed To exit i Low Repeat Return to Alerts Menu Press Left Arrow FF Rise Rate It doesn t matter which device you first use to customize your Alarm Alert settings key is making sure you make the same changes in both or you may miss an Alarm or Alert Summary Now You Can e Customize your glucose trend Low High level notifications o Dexcom G5 Mobile App o Dexcom G5 Mobile Receiver e Adjust Alarm tones e Set up receiver s Advanced Alerts o Low High Repeat o Rise Fall Rate o Signal Loss What s Next Believe it or not you are becoming a pro at using your Dexcom G5 Mobile CGM System You ve set up the app and receiver started a session calibrated followed your glucose trends paid attention to your Alarm Alerts prompts and ended a session The next chapters begin our fourth part of the user guide information you need to know but unlike the previous cha
189. ood glucose a Blood glucose meter and strip accuracy vary between meter brands b Switching within a session might cause sensor glucose readings to be less accurate Follow meter s instructions exactly when taking your fingerstick measurement Verify test strips are current and if required coded correctly with meter Check Is Bluetooth is active Use fingerstick BG values only a Other sites are not as accurate b Must enter within five minutes of taking BG meter value c Enter exact BG value from your meter for each calibration oom amp ow Don t 7 Don t take acetaminophen containing medication during your session e g Tylenol a See your healthcare professional to better understand how long acetaminophen is active in your body 8 Don t calibrate if your BG values are under 40 mg dL or over 400 mg dL a If BG value is outside of this range receiver doesn t understand these values and won t calibrate i You must wait until your blood glucose is in the range to calibrate Be safe if blood glucose is low first treat low blood sugar and then calibrate 7 7 Ready Set Calibrate You ve followed the eight steps above have a valid BG value from your meter and your display device keeps alerting you Calibrate Calibrate Calibrate Dexcom G5 Mobile System User Guide Calibration 100 Remember You don t have to take a fingerstick measurement for each display device when calibrating once yo
190. ose Reading Smart Device Lock Screen Smart Device In App Receiver Smart device 1 Exit app 2 Tap Settings 3 Tap Bluetooth 4 Turn Bluetooth on Check Are you e Within 20 feet of your display device e In your two hour warmup period e Outside of your calibration schedule e In a sensor session Continued on next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 148 Continued from previous page System Found Temporary Sensor Issue Smart Device Lock Screen Smart Device In App Receiver Transmitter a Smart Device Lock Screen Don t calibrate System may correct problem on its own and display sensor glucose readings again If prompt stays for three hours Contact Technical Support see Section 16 1 nd Sensor not Communicating Wait three hours while the transmitter tries Smart Device In App to fix the error Do not enter calibrations during this time Make sure your transmitter is properly inserted into the sensor pod If not corrected Receiver e Contact Technical Support Section 16 1 e Remove sensor e Insert new sensor Continued on next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 149 Continued from previous page Calibration Required Smart Device Lock Screen Smart Device In App Error in calibr
191. ou will not receive Alarm Alerts Check BG meter to check your glucose and make any treatment decisions Receiver 11 5 App Alarm Alert Recommended Settings The receiver is a stand alone medical device and used solely to monitor your glucose trends The app cannot override the smart devices general settings The app can t override your smart device settings e When your smart device is on Silent you ll still receive Alarms and Alerts visual prompts and messages but not vibrations if you haven t adjusted your smart device settings e Some smart devices don t have a Vibration feature so you won t get any vibration notifications e When your ringer s volume is low you may not hear an Alarm or Alert e When your smart device is in Do Not Disturb mode you won t receive any Alarm Alerts The Dexcom G5 Mobile App can t override the Do Not Disturb setting e f you don t enable your Dexcom G5 Mobile push Notifications settings during set up you won t get any Alarm Alerts e Check in Settings under Notifications on how your Alarm Alerts are prioritized For information on smart device settings see your smart device s instructions Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 183 If you are concerned about missing an Alarm or Alert e g due to smart device settings app shutting off due to lack of storage low smart device battery etc bring your receiver with you 11
192. our sensor data What you do Tap Let s Get Started to Move on and invite your Followers Sharing Is Caring 317 Inviting Followers Step What you see What you do Vou curenthyare nick shasing Tap Invite Followers to set up your Followers your glucose information with anyone since you have not added any Followers Continued on next page Dexcom G5 Mobile System User Guide Sharing Is Caring 318 Continued from previous page What you see What you do lt Add a Follower Enter your Followers information EP Invitation wil be sent to ths address ammam QWERTYUIOP ASDFGHJKL je ok 3 Enter the Follower s nickname and email address zxcvenm ey SE E Confirm Follower s email address The Follower will get a Follow Invitation email Make sure the Follower can access this email account from their smart device Enter your Follower s information Tap Next Invitation wil be sent to this address Eom oms oaene lt Add a Follower Continued on next page Dexcom G5 Mobile System User Guide Sharing Is Caring 319 Continued from previous page Step What you see What you do lt Trend Graph View Sat trend graph access for Kevin Aliow Trend Graph View K Tap Allow Trend Graph View s On Off switch if you When swite g n will e E chorus want Follower to see your trend graph Tap Next valve And Mot your t
193. ove to time Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 65 Continued from previous page Time Date Press Up Down Arrow to change hour Press Right Arrow Time Date A Press Up Down Arrow to change minutes Press Right Arrow tt Noh 10 j Press Up Down Arrow to select AM PM Press Selectto save and close NOTE After initial set up if battery is drained receiver will vibrate once and you will need to reset date and time Transmitter Turn transmitter box upside down to locate SN number If transmitter package isn t available e SN is on transmitter s back Transmitter SN Ys Press Up Down Arrows to select and enter transmitter SN 400 ona Press Right Arrow to move to next digit Press Select to save and close Continued on next page Dexcom G5 Mobile System User Guide Set up Your Display Devices 66 Setting Low Alert Low Alert 80 mg dl Continued from previous page System default is at 80 mg dL Press Selectto save at present levels and close Setting H Low Alert 75 mg dl igh Alert High Alert 200 mg dl To change value Press Up Down Arrows to change value at 5 mg dL increments Press Selectto save and close System default is at 200 mg dL Press Select to save at present levels and close High Alert 210 mg dl
194. ow the sensor can t be removed because it s inserted under the skin Dexcom G5 Mobile System User Guide On the Go With Dexcom G5 Mobile CGM System Getting Through Security N N tO X Ray Machines Receiver Extra Sensors Don t put your Dexcom G5 Mobile CGM System components through x ray machines Before your screening process begins ask the TSA Officer to perform a visual inspection of the receiver and your extra sensors Place all Dexcom G5 Mobile components in a separate bag before handing over to the Security Officer For other medical supplies such as medications meters and strips check manufacturer s instructions or the TSA website Body Scanners Use of AIT body scanners has not been studied and therefore we recommend hand wanding or full body pat down and visual inspection in those situations In the Plane You may keep the receiver on 1 Before take off 2 While in flight 3 After landing The Dexcom G5 Mobile CGM System is safe for use on U S commercial airlines If you choose to use your smart device the airlines request you put your smart devices in airplane mode You can do this but still keep your Bluetooth on and you will be able to receive sensor glucose information on your smart device Technical Information The Dexcom G5 Mobile Transmitter is an M PED with emission levels that meet RTCA DO160 Section 21 Category M Per FAA Advisory Circular 91 21 1B dated 8 25 06 Any M PED that
195. page What it means Menu Settings gt Help Stop Sensor Access Alerts Main Menu What you do Tap Alerts x Alerts LOW myat 6 High mgt Rise Rate Fall Rate Signal Loss Reset alert settings Urgent Low man 55 gt 5 All customizable Alarm and Alerts Current Alert settings All alerts have e On Off switch e Notify me options e Sound options Dexcom G5 Mobile System User Guide Continued on next page Tap Alarm Alert you want to change On the Go With G5 Customizing Your Alarm and Alerts Continued from previous page Step What you see What it means What you do High mgt explains Rise Rate e Each Alarm Alert Tap for Alarm Alert e Message options information Signal Loss gt e Recommended settings Fall Rate Reset alert settings Sound nyy Urgent Low Glucose Beep Alarm e Preset at 55 mg dL and cannot be changed Tap Sound to change e Repeat preset at 30 Sound minutes and can t be changed e Sound is the only change option Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 194 Steps to Customize App Alarm Alerts Although the results will vary depending on what Alarm or Alert you are customizing the steps to change your Alarm or Alert are the same From app s Main Menu 1 Tap Alerts 2 Tap the Alert you want a Tap O
196. percentages of total readings within 15 mg dL or 15 20 mg dL Dexcom G5 Mobile System User Guide Technical Information 241 or 20 30 mg dL or 30 or greater than 40 mg dL or 40 are provided in Table 1 A and 1 B The tables are categorized within CGM glucose ranges When you see a CGM reading on your receiver this table shows you how likely that reading matches your blood glucose level measured by YSI in the study For example in the SW10505 Adult Study Table 1 A the total number of data pairs considered in the analysis was 2263 Of these 93 of the System readings fall within 20 mg dL of the YSI blood glucose values lt 80 mg dL and within 20 of YSI blood glucose values gt 80 mg dL Dexcom G5 Mobile System User Guide Technical Information 242 Table 2 A Number and Percentage of YSI Values When CGM Readings are LOW or HIGH Adult CGM Readings LOW Study Original CGM YSI Pairs Cumulative Percent YSI mg dL lt 60 lt 70 lt 80 Software 505 Cumulative Percent CGM Readings HIGH Study Original CGM YSI Pairs YSI mg dL gt 320 gt 280 gt 240 Cumulative Percent Software 505 Cumulative Percent Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 243
197. play devices Take special care when swimming getting into a pool bathtub shower etc Setting Alarm Alert Notifications When using both a receiver and a smart device you must set your settings separately in each If you set up one device and then use another you might not get an Alarm or Alerts causing you to miss a severe low or high glucose event Using an accessory device like a smart watch might override your smart device sounds Alarms or Alerts might vibrate or be heard on the accessory instead of your smart device Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 25 After connecting any accessories make sure that the smart device settings allow you to continue receiving Alarms or Alerts on the smart device Is It On If the receiver or smart device is turned off Shut Down it will not display sensor data information Alarm or Alerts Make sure they are turned on otherwise you won t get sensor glucose readings or Alarm or Alerts causing you to miss a severe low or high glucose event Smart Device Warnings Next are warnings for just your smart device Warnings Smart Device Settings The Dexcom G5 Mobile App can t override your smart device s internal settings Also accessory devices like a smart watch or other wearable smart devices might override your smart device s Alerts and Alarm To receive Alarm or Alerts you must Make sure Dexcom G5 Mobile App Notifications ar
198. pp Description The Dexcom Follow App is a separate App from the Dexcom G5 Mobile App Your Followers only need to download and install the Dexcom Follow App What the Dexcom Follow App does e Allows Follower to view the Sharer s glucose information e Allows Follower to get Alerts and Alarms e Allows the Follower to view the Sharer s trend graph What the Follower app does not do e Provide treatment advice e Interact with the Dexcom G5 Mobile App Receiving Dexcom Follow Invitation Email After getting the Sharer s Follow invitation by email the Follower sets up their smart device Glucose Alarm and Alerts A glucose prompt is a visual message saying Glucose notification from Sharer s name that appears on the screen of the Follower s smart device The prompt may include sounds depending on their smart devices settings Types of prompts your Followers get e Low Sensor Glucose Reading e Urgent Low Sensor Glucose Reading lt 55 mg dL e High Sensor Glucose Reading Your Follower can change some of the initial settings to fit their needs The Follower cannot change your permission settings to see your Trend Graph Sharer Status Changes That Notify the Follower Some Sharer status changes will prompt your Followers Dexcom G5 Mobile System User Guide Sharing Is Caring 32 e Not Sharing Sharer decides to temporarily stop sharing e Removed by Sharer Sharer removes Follower e No More Data Prompt
199. pport see Section 16 1 to report error Receiver Dexcom G5 Mobile System User Guide Troubleshooting 295 Transmitter Error DIA What you see Receiver Transmitter Failed Replace Transmitter Problem Transmitter not working Sensor session automatically stopped No sensor glucose readings displayed What you do See Chapter 16 Contact Technical Support to report issue Section 16 1 Start checking BG value using BG meter App Tap OK to clear Alert Receiver Press Select to clear Will not re alert once cleared Order new transmitter Receiver Transmitter Not Found Conti Dexcom G5 Mobile System User Guide Pairing Failed ued on next page See Chapter 6 Check Transmitter SN in display device is correct If wrong Stop sensor session Re Enter correct transmitter SN App Menu gt Trans SN gt Enter correct SN Receiver Settings gt Trans SN gt Enter correct SN If correct Call Tech Support see Chapter 16 Troubleshooting 296 Continued from previous page Device What you see You Wartsrinitter battery is low The transmitter wil stop working in about three weeks Check your ernail inbox for more details Receiver Dexcom G5 Mobile System User Guide Problem Transmitter Low Battery What you do See Chapter
200. ps settings do not override phone settings Consequences Missing severe low or high Alarm or Alerts WARNING Don t Never assume the Dexcom G5 Mobile CGM System s Alarm Alert vibrations are different from other vibrating apps Do Look at your smart device and check if vibration is a Dexcom G5 Mobile CGM System Alarm or Alert Why Medical device apps don t have special priority over your smart device s features You can t determine if the vibration is coming from your Dexcom G5 Mobile App or another app Consequences Missing severe low or high Alarm or Alerts WARNING Do Unplug headphones from your smart device when not in use Why If headphones are plugged in while not being used you won t hear an Alarm or Alert Consequences Missing severe low or high Alarm or Alerts Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 174 PRECAUTION Don t Never prevent communication between transmitter and display devices Do Keep smart device and receiver within 20 feet of transmitter and away from obstructions Why If your transmitter display device s are more than 20 feet apart or are separated by an obstruction they might not communicate Types of obstruction differ and not all types have been tested Obstructions can include water walls metal etc Water e g swimming surfing bathing etc can severely limit communication range Consequences Missing severe low o
201. pter shows you how Summary Now You Can e Identify sensor applicator features e Properly prepare for sensor insertion e Choose the best location to insert your sensor e Correctly insert your sensor e Prepare transmitter for placement e Properly attach transmitter to sensor e Outline sensor warmup e Identify countdown icon What s Next The next chapter guides you through the calibration steps Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 90 Chapter 7 Let s G5 The Basics Calibration 7 1 Introduction In the previous chapter you learned how to insert your sensor transmitter and start a new sensor session You re now ready to begin your last step before getting your sensor glucose readings Calibration This chapter reviews not just your initial calibration but also update calibrations required throughout your sensor session After this chapter you will be able to e Calibration Overview o Define calibration o Explain the importance of calibration o Identify steps to ensure a successful calibration e Recognize steps in taking accurate blood glucose measurement o Identify the correct blood glucose site for calibrations o Prepare finger for fingerstick measurement e Determine if you should should not calibrate o Recognize when you can enter fingerstick measurement for calibration o Recognize when you shouldn t enter the fingerstick
202. pters typically not part of your day to day Dexcom G5 Mobile CGM System experience Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 211 The next part Part 4 Everything Else G5 reviews the technical specifications the warranty how to take care of the Dexcom G5 Mobile components going through security when traveling contacting the Help Desk Troubleshooting information and symbols on system components and packages Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 212 EVERYTHING ELSE G5 e Warranty e Maintenance Travel Tips Customer Service Contacts e Technical Information e Troubleshooting Package Symbols Page intentionally left blank Chapter 13 Everything Else G5 Warranty The Fine Print 13 1 Introduction Sometimes stuff happens Dexcom has you covered The following is our warranty information outlining what we do cover what we don t and for how long First the receiver s limited warranty information then the transmitter s limited warranty information 13 2 Receiver Warranty Information Dexcom G5 Mobile CGM System s Limited Warranty What s Covered and for How Long Dexcom Inc Dexcom provides a limited warranty to the original purchaser you or Purchaser that the Dexcom G5 Mobile Receiver the Receiver is free from defects in material and workmanship under normal use
203. r additional fingerstick measurements as needed Monday Day One of Sensor Session 8 am 10 am 10 pm Sensor 2 hr startup 12 hr update Insertion calibration calibration Tuesday Sunday Days 2 7 Sensor Session 10 am 10 pm 12 hr update 12 hr update calibration calibration Figure 5 Example Minimum Calibration Schedule During Seven Day Sensor Session 7 5 Calibration Prompts Sensor Session Start Up Calibration Prompts Once your two hour sensor start up is complete your display device tells you it s time to enter the first of your two back to back start up calibrations Once the system has accepted your BG values your glucose readings begin If you don t enter your BG values right away the system reminds you every 15 minutes Remember only use your BG meter for calibrations and never enter values from your CGM Dexcom G5 Mobile System User Guide Calibration 96 Start Up Calibration Prompts DIA First Calibration Smart Device Lock Screen Smart Device In App What you see Why two meter values Steps L Wash aned ory your hands 2 Take a fingerstick with your meter 3 Tap the green circle above and promptly ater ihe exact valu from your mete Receiver 66 What it means Sensor warmup is complete Ready for first of two initial Calibrations Continued on next page Dexcom G5 Mobile System User Guide What you do Follow steps in Sectio
204. r high Alarm or Alerts PRECAUTION Do Set smart device and receiver settings separately Why Settings are specific to each display device and don t carry over to other devices If you set up one device and then use another you won t get an Alarm or Alert Consequences Missing severe low or high Alarm or Alerts PRECAUTION Do Verify smart device and receiver are turned on Why Neither the receiver nor smart device will generate sensor glucose readings Alarm or Alerts if turned off Consequences Missing severe low or high Alarm or Alerts 11 3 Alarm and Alerts As part of managing your diabetes you learned how to read your Trend screen and how to enter Events In this chapter you ll learn how Alarm and Alerts can keep you safe from severe lows or highs Depending on your display device you can customize how you receive your Alarm or Alerts Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 175 What Is an Alarm While there are a variety of Alerts there is just one Alarm the Urgent Low Alarm Alarm is set at 55 mg dL The Alarm will repeat every 5 minutes until you clear the Alarm see Chapter 12 on how to customize the sounds If you clear the Alarm and your sensor glucose readings do not go over 55 mg dL in the next 30 minutes you get another Alarm Unlike Alerts the Urgent Low Alarm setting can t be changed or turned off Think of it as a safety net your glucose
205. r is damaged or cracked in any way don t use it Damaged components could create an electrical safety hazard or malfunction which might cause electrical shocks Choking The transmitter is small and may pose a choking hazard Don t put it in your mouth or allow children to play with it Precautions Reusable Don t Throw Away When ending a session don t throw away the transmitter The transmitter is reusable and can be used in multiple sensor sessions Keep using it until the system notifies you the transmitter battery is about to expire Don t Share Your Transmitter Never share your transmitter with another person The Dexcom G5 Mobile CGM System is a prescription only medical device and is meant or indicated for your use only Your transmitter is tied to your readings If used by someone else your reports Alarm and Alerts etc would be wrong resulting in you missing a severe low or high glucose event System Precautions Next are precautions for the receiver transmitter sensor and the system Precautions Use Correct Transmitter Receiver and Sensor Different generations transmitters and receivers aren t interchangeable with each other The Dexcom G5 Mobile CGM System s transmitter and receiver are not compatible with the Dexcom G4 PLATINUM CGM System s transmitter and receiver The Dexcom G5 Mobile CGM System won t work if you mix receiver and transmitter components from different generations resulti
206. r sensor e Correctly insert your sensor e Prepare transmitter for placement e Correctly attach transmitter to sensor e Outline what happens during the sensor warmup e Identify countdown icon 6 2 Safety Statements Following are some important Precautions and Warnings to review we want to make sure you and the system are safe before starting a sensor session WARNING Don t f a sensor breaks under the skin with no portion visible above the skin don t remove it Do Seek professional medical help if you have symptoms of infection or inflammation e g redness swelling or pain at the insertion site Always report a broken sensor to our Technical Support 24 7 team at as soon as possible Toll free 1 877 339 2664 Toll call 1 858 200 0200 Why Sensors may fracture on rare occasions Testing done in a controlled environment in vitro didn t find any safety hazards during an MRI with a broken off sensor under the skin The wire didn t heat up nor have any significant movement during the MRI images were affected only in the area around the sensor s wire MRI with broken wire If you have experienced a broken sensor and are planning to take an MRI please discuss the following with your doctor or technician Laboratory in vitro MRI tests did not detect any safety hazards for a broken sensor that remains in the body There was no significant movement or heating of the wire Imaging artifacts were limited to
207. rend groph Turned Off Follower sees only your sensor glucose reading and trend arrow Turned On Follower sees your sensor glucose reading trend arrow and trend graph Continued on next page Dexcom G5 Mobile System User Guide Sharing Is Caring 320 Continued from previous page Step What you see lt Follower s Settings Set notification settings for Kevin Kevin will be able to modily these settings later Urgent Low Q 4 Notify Below 55 moul gt Low Notity Betow 80 mgidt gt For More Then 30 min gt w C Notify Above 200 mgidt gt For More Than thr gt No More Data 8 For More Than the gt What you do Choose if your Follower gets your urgent low low and high sensor glucose Alarm Alerts Choose if you want your Follower to get prompts if they are not receiving your sensor glucose readings Select what Alarms Alerts your follower gets and how long you are low high or not sharing data for example if you want your Follower to know when your glucose is above 200 mg dL for more than 2 hours you can set up in the Follower Settings Menu Tap Save for each Follower Setting Save Tap Next when done Continued on next page Dexcom G5 Mobile System User Guide Sharing Is Caring 321 Continued from previous page What you see What you do lt Send Invitation Here is the summary of settings that will be sent
208. residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one of the following measures 1 Reorient or relocate the receiving antenna 2 Increase the separation between the equipment and receiver 3 Connect the equipment into an outlet on a circuit different from that to which the receiver is connected 4 Consult the dealer or an experienced radio TV technician for help This portable transmitter with its antenna complies with FCC IC RF exposure limits for general population uncontrolled exposure Dexcom G5 Mobile System User Guide Technical Information 283 Page intentionally left blank Dexcom G5 Mobile System User Guide Technical Information 284 Chapter 18 Everything Else G5 Troubleshooting 18 1 Introduction Sensor pod not sticking Prompt won t go away Not getting your sensor glucose readings Don t know when to replace your transmitter This chapter will help you figure it out Troubleshooting sections are categorized by function or system component Th
209. 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 5 Defects or damage from improper testing operation maintenance installation or adjustment 6 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 cell phone or smart device and your connection to the Internet 7 Equipment which has been taken apart physically or which has had any of its software accessed in any unauthorized manner 8 Water damage to the Receiver a Receiver is not water resistant b Do not get the receiver wet at any time Dexcom s Obligations Under the Limited Warranty During the Warranty Period Dexcom will replace without charge to purchaser any defective Dexcom G5 Mobile Receiver To return you must send the Receiver to an authorized Dexcom Technical Support Department Make sure you package the Receiver adequately for shipping The return package needs to include 1 Receiver 2 Sales receipt or comparable substitute proof of sale showing the date of purchase 3 Receiver s Serial Number 4 Seller s name and address Call Dexcom Technical Support Department for delivery information help e Toll free 1 877 339 2664 e Charges may apply 1 858 200 0200 Upon re
210. ric p Percent ercent Percent Percent Time from Amoer Within Within Within Greater Calibration 15 15 20 20 30 30 40 40 CGM YSI YSI YSI YSI YSI Original Software 505 0 2 hours Original Software 505 Original Software 505 2 4 hours 4 6 hours Original Software 505 6 8 hours Original Software 505 Original Software 505 8 10 hours 10 12 hours Original 12 14 hours Software 505 CGM readings are within 40 to 400 mg dL inclusive Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Calibration Stability The System must be calibrated every 12 hours To demonstrate performance of the System over a 12 hour calibration period Systems were evaluated to verify that performance remains consistent over the 12 hour calibration period Systems were evaluated in 2 hour increments after calibration Performance was estimated at each 2 hour interval and stratified by glucose values by calculating the percentage of System readings within 15 mg dL or 15 20 mg dL or 20 30 mg dL or 30 40 mg dL or 40 and greater than 40 mg dL or 40 of the YSI values in Table 7 A and 7 B Dexcom G5 Mobile System User Guide Technical Information 262 Table 8 A Sensor Stability Relative to YSI Accuracy Over Time Adult Median Percent Percent Percent Absolute Absolute Within Within Within Perc
211. rofessional to determine the appropriate hyperglycemic setting for you G5 Mobile System User Guide Sharing Is Caring Hypoglycemia Low BG Same as low The default low alert the Dexcom G5 Mobile CGM System is set to 80 mg dL Consult your healthcare professional to determine the appropriate hypoglycemic setting for you Invite Follow Invitation Email An email request for a person to download the Dexcom Follow App and get the Sharer s shared information Jailbroken The removal of limitations set by the manufacturer on a smart device Do not use jailoroken smart devices with Dexcom Share mg dL Milligrams per deciliter The standard unit of measure for sensor glucose information in the United States Mobile Data Connections Cellular networks such as 3G 4G and LTE used by a smart device to access the Internet No More Data prompt Prompts the Follower when the Sharer is unable to share glucose information Not Sharing When the Sharer chooses to temporarily not share glucose data with the Follower Obstruction An object that stops the wireless communication between devices such as wall thickness or radio waves Profile Located in Follow Dashboard and displays the Sharer s glucose information trend arrow and profile picture A visual message that appears on the screen of the Follower s smart device Prompt may also include a sound depending on th
212. romagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Dexcom G5 MOBILE System is used exceeds the applicable RF compliance level above the Dexcom G5 MOBILE System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Dexcom G5 MOBILE System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Dexcom G5 Mobile System User Guide Technical Information 280 Guidance and Manufacturer s Declaration Electromagnetic Emissions The Dexcom G5 Mobile System is intended for use in the electromagnetic environment specified in the next table The customer or the user of the Dexcom G5 Mobile System should ensure that it is used in such an environment Electromagnetic Emissions Specifications Emissions Test Compliance Electromagnetic Environment Guidance oe The Dexcom G5 Mobile System uses RF energy only for RF Emissions its i
213. rt Rate is the of time the device alarmed when the blood glucose level was at or above the alert setting within 15 or 30 Dexcom G5 Mobile System User Guide Technical Information 259 minutes before or after the device alarmed The False Alert Rate is the of time the device alarmed when the blood glucose level was below the alert setting within 15 or 30 minutes before or after the device alarmed For example if you set the High Glucose alert to 200 mg dL and your alarm sounds how often can you expect your blood sugar to actually be high In the Software 505 Adult Study Table 6 A when your alarm sounds you can expect your blood sugar to be at or above 200 mg dL approximately 96 of the time and not be above 200 mg dL approximately 4 of the time within the 15 minute period before or after your alarm sounds Hyperglycemia Detection Rate The Detection Rate shows how often the device recognizes and alerts you to an episode of hyperglycemia or how often it misses such an event The Hyperglycemia Detection Rate is the of time the blood glucose level was at or above the alert setting and the device alarmed within 15 or 30 minutes before or after the blood glucose was at or above the alert settings The Hyperglycemia Missed Detection Rate is the of time the blood glucose was at or above the alert setting but the device did not alarm within 15 or 30 minutes before or after the blood glucose was at or above the alert setting For exampl
214. rt device within 20 feet of transmitter during the sensor warmup period your 2 hout warmup and two BG meter valines ore Complete We wil notify you when your sersor warmup is complete Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 83 Continued from previous page Step What you see What you do Locked screen Initial calibration prompt tells you when warmup is complete Chapter 7 covers calibrating Initial calibration prompt tells you when warmup is complete Sensor warmup is complete You re ready to calibrate Why two meter values Steps L Wash arxi ory your herids 2 Take a fingerstick with your mester 3 Tap the green circle above and Receiver Starting a Session Step What you see What you do Press Selectto turn on receiver Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 84 Continued from previous page Step What you see What you do From Trend Graph Press Select to go to Main Menu Main Menu Press Down Arrow to highlight Start Sensor Trend Graph Press Select to start new sensor session te Start Sensor NOTE After sensor starts Start Sensor option U Enter BG disappears StartSensor gt Start Sensor pr
215. rt yourself or damage the system Remember if used during certain situations the risk of use may clearly outweigh any potential benefit Within the chapters contraindications are in purple boxes MRI CT Diathermy Remove the Dexcom G5 Mobile CGM System sensor transmitter and receiver before Magnetic Resonance Imaging MRI Computed Tomography CT scan or high frequency electrical heat diathermy treatment The system hasn t been tested during MRI CT scans or with diathermy treatment Magnetic fields and heat could damage the components stopping sensor glucose readings or Alarm Alert notifications Without sensor glucose readings or Alarm Alert notifications you might miss a severe low or high glucose event Medications Taking medications with acetaminophen such as Tylenol or Excedrin Extra Strength while wearing the sensor may falsely raise your sensor glucose readings The level of inaccuracy depends on the amount of acetaminophen active in your body and is different for each person Dexcom G5 Mobile System User Guide Indications for Use and Safety Statement 19 2 5 General CGM System Warnings Warnings Warnings outline important hazard information describing any serious and or life threatening situations their consequences how to avoid danger while using the system and how to protect the Dexcom G5 Mobile CGM System from harm Review Training Materials Thoroughly review the training materials included with
216. s an applicator and sensor wire Continued on next page Dexcom G5 Mobile System User Guide Sharing Is Caring Dexcom G5 Mobile System CGM system made of a sensor transmitter and smart device receiver Dexcom G5 Mobile Transmitter The Dexcom G5 Mobile System part that wirelessly sends glucose information to the Dexcom G5 Mobile App Dexcom G5 Mobile App Receives glucose information from the Dexcom G5 Mobile Transmitter Sends glucose information to the Dexcom Cloud using an Internet connection Dexcom Share Secondary notification using the following parts e Dexcom G5 Mobile System e Bluetooth wireless technology e Sharer s smart device e Dexcom G5 Mobile App e Internet e Follower s smart device e Dexcom Follow App Do Not Disturb A setting on a smart device where all incoming calls alerts and notifications are silenced Do Not Disturb can be set to specific times and can be set to allow exceptions people who can disturb you Follower A person that gets the Sharer s shared information in the Dexcom Follow App Follow Dashboard On the Dexcom Follow App the Follow Dashboard shows the glucose information of up to five 5 Sharers Follower s Smart Device Runs the Dexcom Follow App Hyperglycemia High BG Same as high The default high alert in the Dexcom G5 Mobile CGM System is set to 200 mg dL Consult your healthcare p
217. s for electronics One of the safety standards it designed 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 comes across An IP22 rating lets you know your electronic device won t allow you to stick your fingers in it and won t get damaged or be unsafe during specific testing with water dripping down Jailbroken 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 use install or run the Dexcom G5 Mobile App on a jailoroken smart device The app may not work correctly on a jailbroken smart device Landscape If your smart device is oriented sideways mg dL Milligrams per deciliter The standard unit of measure for glucose readings in the United States Portrait If your smart device is oriented vertically Precaution A safety statement regarding any special care to be exercised by you or your healthcare professional for the safe and effective use of the Dexcom G5 Mobile CGM System RF Radio frequency transmission used to send glucose information from the transmitter to the receiver or smart device Safety Statement A statement of the intended uses of Dexcom G5 Mobile CGM System and relevant w
218. s is preventing you from getting an Alarm Alert e Describe recommended app settings e Successfully clear an Alert notification o Dexcom G5 Mobile App o Dexcom G5 Mobile Receiver What s Next Up to now you have learned about the Alarm or Alert default settings But what do you do if you want to decrease the High Alert glucose level threshold or you want to continue getting a Low Alert notification if your glucose levels don t improve even though you cleared the message How do you make your Alarm Alerts fit your needs Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 189 Page intentionally left blank Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 190 Chapter 12 Next Steps On the Go With G5 Customizing Your Alarm and Alerts 12 1 Introduction The receiver and app come with default glucose Alert level settings but perhaps they don t reflect the glucose level that works best for you Perhaps you re in a meeting and can only clear an Alert yet want to make sure your Alert repeats or continues until you re able to take corrective measures Maybe you d like to get a Rising Falling glucose Alert but their settings are off by default How do you turn them on In this chapter you ll learn how to personalize your Alarm and Alerts tones and glucose levels Afterwards you will be able to e Customize your Low High Alerts o Dexcom G5 Mobile App o Dexcom G5 M
219. s the sensor applicator components in order of use Order of Use Name What it does Sterilized for your protection Sensor Pouch Open to remove applicator and sensor Holds the sensor transmitter in place on your Adhesive Patch skin Prevents plunger from inserting sensor until Safety Lock you are ready Plunger Inserts sensor wire into your body Contains small insertion needle and sensor Applicator Barrel wire Disposable for single use only Collar removes insertion needle Collar Helps remove applicator barrel once sensor wire is inserted Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 73 Continued from previous page Order of Use What it does Holds sensor wire in place under skin Holds transmitter Sensor Pod Transmitter Latch Locks transmitter into sensor pod Allows you to remove applicator barrel from Release Tab sensor pod Transmitter Transmitter Box What you see What it is Bottom of box with important label information Keep box until transmitter battery dies Reusable transmitter In the previous chapter you entered your transmitter SN into your display devices and made sure your smart device and or receiver connected with the transmitter You won t be able to start a sensor session if your transmitter isn t paired with your
220. s were evaluated Ninety four percent 94 of the sensors lasted until Day 7 145 168 hours Dexcom G5 Mobile System User Guide Technical Information 266 Table 9 A Number of Readings Provided by Each Sensor Over 7 Days Adult LEIGE A Provided Min Max Original 167 491 Software 505 0 Original 719 914 Software 505 856 856 Original 1267 1267 Software 505 1253 1253 Original 1811 1992 Software 505 1497 1992 of Total Possible Readings Provided of Systems Providing That Number of Readings 0 25 26 50 51 75 76 100 1Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 267 Table 9 B Number of Readings Provided by Each Sensor Over 7 Days Pediatric LEIR CET eA Study Provided Min Max Original 103 427 Software 505 60 223 Original 569 954 Software 505 877 891 Original 1006 1484 Software 505 1131 1342 Original 1518 1992 Software 505 1623 1990 of Total Possible Readings Provided of Systems Providing That Number of Readings 0 25 26 50 51 75 76 100 Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 268 Table 10 A System Readings Within Wear Days Adult Statistic Study
221. se goes below 70 mg dL In the Software 505 Adult Study Table 5 A when your blood sugar goes below 70 mg dL you can expect your alarm to sound 91 of the time and not to sound approximately 9 of time within the 15 minute period before or after your blood sugar goes below 70 mg dL Dexcom G5 Mobile System User Guide Technical Information 256 Table 6 A Hyperglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After Adult Hyperglycemic False Alert Level Study Alert Hyperglycemia Hyperglycemia Missed Detection Rate mg dL Rate Detection Rate Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Both sets of study data are presented and are labeled as Original SW10050 or Software 505 SW10505 Dexcom G5 Mobile System User Guide Technical Information 257 Table 6 B Hyperglycemic Alert and Detection Rate Evaluation in Reference to YSI 15 Minutes Before and After Pediatric Ages 6 17 Years Hyperglycemic Alert Level Study Hyperglycemia Hyperglycemia Missed Detection Rate mg dL Detection Rate Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original Software 505 Original
222. se if worn or damaged There is no repair service available for any Dexcom G5 Mobile CGM System parts Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System If you experience problems call Dexcom Technical Support available 24 hours 7 days a week toll free at 1 877 339 2664 or toll at 1 858 200 0200 to report the issue 14 3 Storage Storing your Dexcom G5 Mobile CGM System correctly helps prevents system failures Sensor 1 Keep the sensor in its sterile packaging until you are ready to use it 2 Store at temperatures between 36 F 77 F a Stored outside of this range may cause inaccurate sensor glucose readings b May store in refrigerator if it s within this temperature range c Sensors should not be stored in freezer 3 Store at humidity levels between 15 85 relative humidity Transmitter 1 Keep transmitter protected when not in use 2 Store at temperatures between 32 F 113 F 3 Store at humidity levels between 10 95 relative humidity Receiver 1 Keep receiver protected when not in use 2 Fully charge the battery before storing for over 3 months 3 Store at temperatures between 32 F 104 F 4 Store at humidity levels between 10 95 relative humidity Dexcom G5 Mobile System User Guide How to Take Care of Your Dexcom G5 Mobile CGM System 226 14 4 Checking App and Receiver Information CHECKING YOUR APP amp RECEIVER SOFTWARE VERSION You
223. splay devices they reflect the same information After prompts we ll separately review the vibration and audible Alarm Alerts for app and receiver Alarm and Alerts look different based on your display device but reflect the same information Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 177 Urgent Low Glucose Alarm Device What you see What it means Smart Device Luanne Lock Screen Urgent Low Glucose Alarrr Sensor glucose reading at or below 55 Smart Device mg dL In App Shows last glucose value Arrows reflect rate of change Check BG meter to make treatment decisions URGENT LOW tila SST Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 178 Low High Glucose Alerts Device What you see What it means Smart Device Lock Screen Sensor glucose reading at or below your low Alert level Smart Device Shows most current sensor glucose Arrows reflect rate of change Can be set to repeat between 15 minutes to 4 hours Check your BG meter to make any treatment decisions Receiver Continued on next page Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 179 DIA Smart Device Lock Screen Continued from previous page What you see Smart Device In App High Glucose Alert Receiver HIGH Dexcom G5 Mobile System User Guide
224. srt valve horn your mete Meter icon has no To r calibration prompt Your calibration was successful Calibration accepted Continued on next page Dexcom G5 Mobile System User Guide Calibration 103 Step What you see Step What you see Dexcom G5 Mobile System User Guide Continued from previous page What you do Wait for next calibration prompt in 12 hours What you do Press Select to turn on receiver Press Select again for Main Menu Continued on next page Additional Info Default Home Trend screen Calibration accepted Additional Info You won t see calibration prompts when receiver screen is black Calibration 104 What you see Continued from previous page What you do Main Menu A Trend Graph D gt Start Sensor U Enterse Press Up Down Arrow Highlight Enter BG Press Select Additional Info Enter BG 120 mg dl p Press Up Down Arrow to change numbers Stop at meter s BG value Press Select Sensor default reading is 120 mg dL If sensor glucose reading is within the last 15 minutes screen will show sensor s actual reading Enter BG 120 mg dL 2 41 PM g OK Cancel Verify BG value is correct If correct Press Select If Select is not pressed e Receiver times out e BG level isn t recorded Verify BG v
225. t marker on your app s Trend screen The app has Event markers on its screen the receiver doesn t There may be times when you want or need to enter Events on the Dexcom G5 Mobile Receiver Enter Events Dexcom G5 Mobile Receiver While the Event data is the same between display devices the flow is not the same including how to enter the Event s date and time The following table reviews how to enter the same Carb Stress Event data from the previous scenario Carbs at 85 and a Stress Event Entering Events Receiver Step What you see What you do Enter Carbs Event Default screen Press Select to go to Main Menu Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 168 Continued from previous page Enter Carbs Event Main Menu g Enter BG Press Down Arrow until Events is highlighted sf Profiles Press Select X Events Highlight Carbs Press Select x Exercise Carbs Add up all carb grams from lunch Arrow up to 85 85 g Press Select grams Carbs amp Press Left Right Arrows to change time and date e Left Backwards 2014 12 31 e Right Forward 1ffem Y j Press Select Carbs amp 85 grams Confirmation screen 2014 12 31 1 00 PAA Press Select OKE Cancel Continued on next page Dexcom G5 Mobile System User Guide Daily Events Affect Your Gl
226. tection against insertion of large objects and immersion in water Mop rate Fic ecto for up to 8 feet for 24 hours Protection Against Electrical Shock Type BF applied part Transmitter Performance Characteristics Parameter Performance Characteristic TX RX Frequencies 2 402 2 480 GHz Bandwidth 1 02 MHz Maximum Output Power 1 0 mW EIRP Modulation Gaussian Frequency Shift Keying Data Rate 1 Mbps Data Communication Range 20 feet The Dexcom G5 Mobile CGM System is safe for use on U S commercial airlines The Dexcom G5 Mobile CGM System is an M PED with emission levels that meet RTCA D0160 Section 21 Category M Per FAA Advisory Circular 91 21 1B dated 8 25 06 any M PED that meets this standard in all Dexcom G5 Mobile System User Guide Technical Information 276 modes may be used onboard the aircraft without any further testing by the operator This device can withstand exposure to common electrostatic ESD and electromagnetic interference EMI Guidance and Manufacturer s Declaration Electromagnetic Immunity The transmitter P N 9438 06 is 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 Transmitter Electromagnetic Immunity Specifications Transmitter Compliance Level IEC 60601 Test Level Electromagnetic punt ule 6g Environment Guidance Elec
227. tional Dexcom CGM education check the Dexcom website dexcom com web based education Dexcom G5 Mobile System User Guide Need Help You re Not Alone 234 16 3 Sales Support Team Inside Sales Support Team For help with e First time orders e Re orders e Tracking shipments e Locating a local Dexcom representative By Phone Dexcom Inside Sales Support Phone Numbers Toll Free 1 877 339 2664 Toll Call 1 858 200 0200 By Email Dexcom Inside Sales Support Email CustomerService dexcom com By Fax 1 877 633 9266 16 4 Corporate Dexcom Website Dexcom com Dexcom Address 6340 Sequence Drive San Diego CA 92121 Dexcom G5 Mobile System User Guide Need Help You re Not Alone N N a Page intentionally left blank Dexcom G5 Mobile System User Guide Need Help You re Not Alone 236 Chapter 17 Everything Else G5 Technical Information 17 1 Device Performance Characteristics NOTE We recommend that you review the information in this chapter with your healthcare professional to understand how well the Dexcom G5 Mobile CGM System performs The Dexcom G5 Mobile CGM System the System uses a glucose sensor to continuously measure and monitor your glucose levels The sensor is calibrated using a commercially available blood glucose meter Once calibrated the System reports glucose readings up to every 5 minutes The System was evaluated clinical studies in which System readings were compared
228. trostatic Floors should be wood concrete or 8 kV Contact 8 kV Contact ceramic tile If floors are covered 15 kV Air 15 KV Air with synthetic material the relative Discharge ESD IEC 61000 4 2 humidity should be at least 30 Power Frequency Power frequency magnetic fields should be at levels Se mz Magnet characteristic of a typical location in a typical commercial or hospital IEC 61000 4 8 environment Receiver Product Specifications Part Number MT22719 Reading Frequency Every 5 minutes Length 4 0 inches Dimensions Width 1 8 inches Thickness 0 5 inches TX RX Frequencies 2 402 2 480 GHz Bandwidth 1 22 MHz Maximum Output Power 2 5 mW EIRP Modulation Gaussian Frequency Shift Keying Data Rate 1 Mbps Continued on next page Dexcom G5 Mobile System User Guide Technical Information 277 Weight Receiver Input Power Supply Communication Range Memory Storage Re Chargeable Battery Use Charging Time Storage Operating Conditions Operating Altitude Medium Priority Alarm Audible Output Moisture Protection Limited Warranty Control Classification Continued from previous page 2 4 ounces 5V DC 1A MT21255 20 feet 30 days of glucose data 7 days of tech support data 3 days 3 hours wall outlet The device behaves normally while being charged Do not hold the receiver while charging for over a minute There are
229. u enter the reading into one data is pushed to the other within five minutes Next are steps to enter your calibrations using the app followed by the steps for entering your Calibrations into the receiver Calibrate With Your Dexcom G5 Mobile App Step What you see What you do Additional info Initial calibration Enter two back to back meter BG value Update calibration Enter one meter BG value Tap circle Why two meter values Steps L Wash arxi ory your herids 2 Take a fingerstick with your meter 3 Tap the green circle above and Continued on next page Dexcom G5 Mobile System User Guide Calibration 101 Continued from previous page Step What you see What you do Additional Info Double check your Enter meter s BG value numbers using number pad Entering wrong values Tap Save can affect the sensor s accuracy i ths correct 125 modat Verify value is correct Tap Save If not correct Tap Cancel Reenter correct value Continued on next page Dexcom G5 Mobile System User Guide Calibration 102 Continued from previous page Step What you see What you do Additional Info Tap circle to enter your second BG value Follow steps 2 3 and Wit tiie iiaia enter second reading Steps 1 Wash and dry your hands 2 Take a fingerstick with your meter 3 Tap the green circle above and Promptly enter tha ar
230. u might still have its transmitter or receiver While you can use the sensors across the different generations look for G5 Mobile or G4 PLATINUM on the sensor s package you can t mix the transmitter or receiver between the two systems WARNING Don t The Dexcom G5 Mobile CGM System was not evaluated for the following persons e Pregnant women e Persons on dialysis Do not use the Dexcom G5 Mobile System in critically ill patients It is not known how different conditions or medications common to the critically ill population may affect the performance of the system Sensor glucose readings may be inaccurate in critically ill patients Consequences The system s accuracy hasn t been tested in people falling into these groups and sensor glucose readings may be inaccurate resulting in missing a severe low or high event Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 35 PRECAUTION Don t Never mix Dexcom G5 Mobile s Transmitter or Receiver with Dexcom G4 PLATINUM s Transmitter or Receiver Why The Dexcom G5 Mobile CGM System s Transmitter and Receiver are not compatible with the Dexcom G4 PLATINUM CGM System s Transmitter and Receiver The Dexcom G5 Mobile CGM System won t work if you mix Receiver and Transmitter components from different generations Consequences Missing a severe low hypoglycemia or high hyperglycemia event 4 3 The Dexcom G5 Mo
231. ucose Trends and Patterns 169 Continued from previous page Enter Health Event Events amp Insulin Exercise oh Health Health afe Press Down Arrow until Health Iliness Press Down Arrow to Stress Stress Press Select High Symptoms Health af Press Left Right Arrows to change time and date e Left Backwards 2014 12 31 p Right Forward i289em Y i Press Select Health afe Verify information is correct Stress Press Left Right Arrows to highlight field 2014 12 31 1 05 PM Press Up Down Arrows to change numbers GN cence Press Select to save 10 4 Viewing Events Events entered into your receiver can only be viewed on a Dexcom report there are no markers on your receiver s screen On your smart device turn to landscape to view your Event markers A single small square marks all Events Slide your finger across the screen or tap the square to get your Event s information Dexcom G5 Mobile System User Guide Daily Events Affect Your Glucose Trends and Patterns 170 Landscape What it does What you do Landscape Only Landscape Only Show Event details e Tap square e Slide finger across screen Once you have allowed your Share Follower s access to your Trend screen they too will be able to view your Events See Part 5 for more information Summary Now You Can e Define Event e Describe each Event e Cre
232. ues Using Dexcom Share see Part 5 allows friends and family your Followers to monitor your glucose activity adding another layer of support and peace of mind Dexcom G5 Mobile System User Guide y Risks and Benefits 30 Helps in Your Diabetes Management The Alarm Alerts features see Chapter 11 keep you aware of your glucose levels Alerts notify you when your glucose goes outside your target range or is rapidly falling or rising letting you to take action before you get too low or too high The Urgent Low Alarm lets you know when you are dangerously or urgently low going below 55 mg dL By taking corrective measures you lessen the time spent in your low high range while increasing time in your targeted range Garg S Z 2006 Battelino T 2011 Real time CGM can help improve your A1C as well as improve the quality of your glucose control If you are at or below 7 using a CGM such as Dexcom s G5 Mobile CGM System helps reduce hypoglycemia Tamborlane W V 2008 Lowering your A1C increasing your time in your target range while decreasing time in low high BG range is believed to reduce your risk of diabetes related complications Ohkubo Y 1995 In some cases patients perceived an increase in their quality of life and peace of mind when using real time CGM Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group 2010 What s Next You ve read the Safety Statements reviewed the ris
233. uide Tap Save On the Go With G5 Customizing Your Alarm and Alerts 199 Continued from previous page Changing an Alert High Glucose Alert High Alert Notify Me Above 200 mgt gt Changes how often your High Alert repeats after initial Alert and Sound tien gt Confirmation Tap Repeat Repeats only if you are above your high glucose level Changing the current repeat setting Can select in five minute steps range 15 minutes 4 hours Scroll selection wheel Stop at 1 hour Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 200 Continued from previous page Changing an Alert Saves your new repeat timing Returns to High Glucose Alert screen options Repeat shows how often you ll get notified Tap Save lt High Glucose Alert High Alert Notify Me Above 200 mgl gt Repeat every 30 minutes gt Hw gt Customize Alert sound Tap Sound Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 201 Continued from previous page Changing an Alert ry Sound Baby Cry Beep Blarno Tap Doorbl Fall Rate Changes current sound setting Tap Sound again to hear Hagh sound sample High Alert Low Low Alert Nerd Alert Short Beeps ror Sound Bab
234. ulin dosing food intake overall trend graph and your current BG value Don t overreact to the arrows Remember the arrows don t reflect your latest reading they reflect a combination of recent readings Rate of Change Arrows Receiver What your glucose is doing Glucose is steady Not increasing decreasing more than 1 mg dL per minute or up to 15 mg dL in 15 minutes Glucose slowly rising 1 2 mg dL each minute or up to 30 mg dL in 15 minutes Continued on next page Dexcom G5 Mobile System User Guide Home Screen Rate of Change Arrows and Errors 145 Continued from previous page Receiver What your glucose is doing Glucose rising 2 3 mg dL each minute or up to 45 mg dL in 15 minutes Glucose rapidly rising more than 3 mg dL each minute or more than 45 mg dL in 15 minutes Glucose is slowly falling 1 2 mg dL each minute or up to 30 mg dL in 15 minutes Glucose is falling 2 3 mg dL each minute or up to 45 mg dL in 15 minutes Glucose is rapidly falling more than 3 mg dL each minute or more than 45 mg dL in 15 minutes System can t calculate the speed and direction of No arrow Sarro your glucose change There are a number of reasons why you may not get rate of change arrows e You just started your sensor session e No sensor glucose readings over the last few minutes 9 5 Error Messages Sometimes the transmitter or sensor or display devices aren t communi
235. usable transmitter 3 Rechargeable receiver 4 Dexcom G5 Mobile App a Downloaded to your smart device Dexcom G5 Mobile CGM System optional Dexcom Share Sensor Overview For your safety the sensor is packaged in a sterile sealed pouch containing an applicator sensor pod and sensor wire When you first open the package your sensor looks like one item however it s actually three sensor applicator barrel sensor pod and sensor wire The applicator barrel helps you insert the sensor wire inside the sensor pod under your skin After inserting the sensor wire remove the applicator barrel The sensor wire stays in the sensor pod with the pod attached to your skin by adhesive The sensor wire is made of silver and platinum with polymer membranes Once inserted the thin and flexible wire measures your glucose levels in the fluid between your cells interstitial fluid for up to seven days This section is meant as a quick overview More information on using and inserting the applicator sensor and sensor wire can be found in Chapter 6 Plunger Safety Lock Applicator Barrel contains small introducer needle and sensor Collar Transmitter Latch Sensor Pod Adhesive Patch Figure 1 Dexcom G5 Mobile Sensor Applicator and Pod Release Tab Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 42 Applicator and Sensor Pod What it s called What it does Applicator Applicator Barrel
236. utes for a total of 6 times if not cleared After 6 times it will not alert again Dexcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 187 11 7 Clearing Alarm Alerts Alerts require you to acknowledge and clear them How this is done depends on your display device If using both display devices you ll need to clear each separately Due to their medical importance the Alarm is more persistent Even after acknowledging and clearing an Alarm if your sensor s glucose readings remain at or below 55 mg dL an Alarm will sound every 30 minutes until readings are above 55 mg dL Clearing Your Smart Device Device What you see What you do Smart Device Lock Screen G Slide Alarm or Alert to access app High Glucose Alert Smart Device In App Tap OK to accept Alarm or Alert Dexcom G5 Mobile System User Guide a Sensor Glucose Alarm and Alerts Clearing Your Receiver What you see What you do Press Select Once cleared you won t receive the same Alert unless you hit the Alert s target range again Your Alarm will repeat even after clearing if your glucose levels do not return to your target range Summary Now You Can e Define an Alarm e Define an Alert e Identify the different types of Alerts e Describe the difference between an Alarm and an Alert e Recognize different Alarm Alert prompts and sounds e Determine if signal los
237. xcom G5 Mobile System User Guide Sensor Glucose Alarm and Alerts 176 Rise Rate Fall Rate Repeat Signal Loss Alerts Rise Rate and Fall Rate Alerts warn you when your glucose levels are changing rapidly either down or up and look similar to the rate of change arrows Repeat Alerts let you know if your sensor glucose readings continue to be above or below your Alert levels Glucose Level Alerts 1 Rise Rate a Default setting is Off No Alert b Need to change settings to receive Rising Alert 2 Fall Rate a Default setting is Off No Alert b Need to change settings to receive Falling Alert 3 Repeat a Default setting is Off No Alert b Need to change settings to receive Repeat Alert Signal Loss Alert Signal Loss tells you when you and the transmitter are too far from your display device or something is blocking your transmitter signal causing you not to get sensor glucose readings The default setting for Signal Loss is On Now you have the basics for Dexcom s G5 Mobile s Alarm Alerts feature Next you will learn about each Alarm Alert in more detail 11 4 Alarm and Alerts Screens When you fall within an Alarm or Alert target range your display device tells you As mentioned in previous chapters you won t get any Alarm or Alerts within five minutes of calibration Let s first review how the information is presented visually across the devices While the Alarm Alerts prompts look different on the di
238. y Cry Beep Slamo Door Beil Saves your new Alert sound Fall Rate Tap Back Arrow Return to High Glucose Alert Menu High High Alert Low Low Alert Nerd Alert Short Beeps Continued on next page Dexcom G5 Mobile System User Guide On the Go With G5 Customizing Your Alarm and Alerts 202 Continued from previous page Changing an Alert Alerts Urgent Low meet Q LOW mya High meat Rise Rate pine Return to Main Menu Signal Loss Reset alert settings Ta p ay Menu Alerts Settings Heip Stop Sensor Return to trend screen Dexcom G5 Mobile System User Guide Tap Menu icon Or Swipe right On the Go With G5 Customizing Your Alarm and Alerts 203 Any changes to the app will not carry over to the receiver If using both make the same changes in the receiver you made in your smart device If you don t you may miss an Alarm or Alert 12 4 Changing Receiver Alarm and Alerts You ll notice a flow difference between the app and the receiver when personalizing your Alarm Alerts With the app all Alert adjustments are made from one screen whereas in the receiver you make changes in different screens Unlike the app you change your receiver s tones known as Profiles through a number of different screens in the Profiles menu Profiles Profiles determine the sound and volume of your Alarm and Alerts As mentioned in the previous
239. you do Preparation Wash and dry your hands Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 76 Continued from previous page Preparation Clean insertion site with alcohol wipe Let dry Optional Step Skin Adhesive Create an oval on the skin e Do not get any skin adhesive inside the circle e Let skin adhesive dry e Insert sensor on clean skin at the center of the circle Check pouch Is it damaged or already opened Remove sensor applicator from sterile pouch Closely inspect sensor check it hasn t been damaged Keep sensor packaging until sensor session is complete Pull adhesive backing tabs Don t touch sticky adhesive patch Continued on next page Dexcom G5 Mobile System User Guide Starting a Sensor Session Inserting Sensor Transmitter and Starting Your Session 77 Continued from previous page Inserting Sensor Wire Place sensor horizontally not vertically on skin Move fingers around adhesive patch s top several times to secure tape Hold applicator barrel Pull safety lock out Place fingers of one hand on edges of adhesive patch Pinch up your skin at the tips of the white adhesive Place two fingers directly above collar to steady applicator barrel Place thumb on the white plunger Push plunger completely down the
240. ystem where a smart device acts as a receiver For a list of current devices and operating systems go to dexcom com compatibility Dexcom G5 Mobile System User Guide What Is the Dexcom G5 Mobile CGM System 36 Chapter 5 covers how to set up your smart device with the Dexcom G5 Mobile App The primary difference between the receiver and app is not the information they give you but how that information is presented The following are some of the shared CGM data and system information features Tracking Real Time CGM Data The receiver and app give you the ability to track your glucose trends in a number of different ways Each device s home screen opens to your glucose trend screen View Glucose Levels The receiver and app share many of the same glucose monitoring features Your glucose values are color coded to highlight what zone you are in allowing you at a glance to see what your levels are Color coded glucose levels e Red Low e Grey Within your normal range e Yellow High Trend Arrows Glucose levels are not just about the numbers The Dexcom G5 Mobile CGM System includes trend arrows so you know the speed and direction of your glucose allowing you to proactively react before your glucose gets too high or too low Alarm Alerts Being warned when your glucose value is too high or too low falling or rising too quickly or if it s trending towards a severe low or high is very important Warnings in the for
241. ystems worn on the same subject at the same time In the Original Adult Study 36 subjects wore two Systems Results showed that System readings from the two sensors generally agreed with each other within 9 absolute percent difference with a 7 coefficient of variation In the Original Pediatric Study all subjects wore two Systems Results showed that System readings from the two sensors generally agreed with each other within 10 absolute percent difference with a 7 coefficient of variation Only one System was worn in the Software 505 Adult and Software 505 Pediatric Studies so precision data was not collected Sensor Life Sensors may be worn for up to 7 days 168 hours To estimate how long a sensor will work over 7 days all sensors worn were evaluated to determine how many days hours of readings each sensor provided In the Original Adult Study 108 sensors were evaluated Ninety four percent 94 of the sensors lasted until Day 7 145 168 hours There were 6 6 sensors that ended early four of which lasted more than 3 days In the Software 505 Adult Study 51 sensors were evaluated Ninety eight percent 98 of the sensors lasted until Day 7 145 168 hours There was 1 2 sensor that ended early which lasted until day 5 of the sensor wear In the Original Pediatric Study 351 sensors were evaluated Eighty five percent 85 of the sensors lasted until Day 7 145 168 hours In the Software 505 Pediatric Study 77 sensor

User Guide

Contents

Download Pdf Manuals

Related Search

Related Contents