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USER'S GUIDE - Animas Canada

1. This icon means you need to enter a calibration This prompt will appear when it is time for your 12 hour calibration update any other time an additional calibration is needed see Chapter 4 Section 4 2 How to Calibrate Calibration Needed oo This icon means you need to enter one more blood glucose value in order Additional to calibrate the system and start receiving sensor glucose readings Calibration Needed 62 Dexcom G4 PLATINUM Continuous Glucose Monitoring System This icon means the receiver does not understand the sensor signal temporarily This icon is related to the sensor only You should wait for more prompts and do not enter any blood glucose values when you see Glucose Reading this symbol Error This icon means the receiver and sensor transmitter are not 62 communicating Make sure the receiver and sensor transmitter within 6 meters of each other see Chapter 1 Section 1 2 Transmitter Out of Range Overview 15 Minute Calibration Error This icon means the sensor cannot calibrate right now If you see this screen enter at least one more calibration blood glucose value after about 10 15 minutes If the sensor still cannot calibrate after that the sensor needs to be removed and a new sensor needs to be inserted 1 Hour Calibration Error This icon means the sensor is not calibrating correctly If you see this screen wait a minimum of one ho
2. Remove the adhesive backing Adhere the sensor on the skin 4 Press your finger firmly around the adhesive patch to make sure it is smooth 5 Hold on to the applicator Then pull the safety lock straight out away from the applicator in the direction the arrows show in the following picture Remove the safety lock HELPFUL HINT safety lock can be used later for transmitter removal Keep this piece to help you remove the transmitter at the end of a continuous glucose monitoring session When your glucose monitoring session is over follow the steps in Chapter 8 Section 8 3 Transmitter Removal NOTE Contact your health care provider for specific questions regarding the use of medical tape barrier wipes and or other adhesives as it relates to your use of Dexcom CGM 3 5 SENSOR INSERTION Once you have placed the applicator on your skin and removed the safety lock you are ready to insert the sensor To insert your sensor follow these steps Dexcom G4 PLATINUM User s Guide 39 1 Using one hand you may want to pinch up on the skin at the edge of the white adhesive Do not pinch up in the middle section of the plastic base With your other hand place two fingers above the collar on the applicator barrel so they are resting above the collar 2 Place your thumb on the white plunger Push the plunger down completely making sure it is flush against the applicator barrel You should hear 2 clicks This
3. 5 e Y Ep ra Alternating Current Direct Current 154 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Type BF Applied Part Follow Operating Instructions Manufacturer REP Authorized Representative in the European Community Two Sided Humidity Limitation Non ionizing Radiation European Union WEEE Directive 2006 66 EC 0086 Marking Certifies that the device meets the European Council Directive 93 42 EEC Electrical Equipment Designed Primarily for Indoor Use Do Not Use if Package is Damaged Input S B Ship By Date Marking Certifies that the device meets the Keep Dry Nemko CSA C22 2 No IEC 60601 1 ed 3 and IEC 60601 1 11 ed 1 Standard Dexcom G4 PLATINUM User s Guide 155 THIS PAGE LEFT INTENTIONALLY BLANK 156 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Dexcom Dexcom Inc EC MediTech Strategic Consutants B V 6340 Sequence Drive Maastrichterlaan 127 129 San Diego CA 92121 USA NL 6291 EN Vaals 1 858 200 0200 Tel 31 43 306 3320 www dexcom com Fax 31 43 306 3338 0086 Outside US Contact your local distributor LBL 012080 Rev 04 MT22346 PLANS
4. The sensor and transmitter once snapped in place remain on your skin for the entire sensor session up to 7 days Plunger Safety lock Applicator barrel contains small introducer needle and sensor Transmitter Latch Bc m Collar Sensor pod Release Tab 1 2 TRANSMITTER OVERVIEW The transmitter wirelessly sends your glucose information to the receiver The transmitter and sensor are water resistant when properly connected Do not throw away your transmitter It is reusable The transmission range from the transmitter to the receiver is up to 6 meters without obstruction Wireless communication does not work well through water so the range is much less if you are in a pool bathtub water bed etc The transmitter battery will last at least 6 months GC Once you see the transmitter low battery screen shown on the right replace the transmitter as soon Low Baltery as possible Your transmitter battery may drain as Paw quickly as one week after this alert appears Dexcom G4 PLATINUM User s Guide 15 1 3 RECEIVER OVERVIEW The receiver is a small hand held device that shows your sensor glucose readings direction and rate of change arrow and trend graph The international standard unit of measurement used for glucose testing systems i e blood glucose meters is mmol L millimoles per liter The transmission range from the transmitter to the receiver is up to 6 meters
5. All subjects were evaluated in a controlled clinic environment on Day 1 Day Dexcom G4 PLATINUM User s Guide 129 4 and Day 7 of the 7 day wear period While using the System in the clinic participants 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 the System performance was also paired with the comparative LifeScan OneTouch Ultra2 meter results and that is referred to as the SMBG Agreement 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 2096 3096 and 40 of the YSI values For readings less than or equal to 80 mg dL 4 4 mmol L the absolute difference in mg dL mmol L between the two glucose results was calculated For values greater than 80 mg dL 4 4 mmol L the absolute percent difference
6. Dexcom G4 PLATINUM User s Guide 121 Receiver Reading Frequency Dimensions Weight Receiver Input Power Supply Communication Range Memory Storage Re Chargeable Battery Use Charging Time Storage Operating Conditions Operating Altitude Moisture Protection Limited Warranty Control Classification 122 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Every 5 minutes Length 10 1 cm Width 4 6 cm Thickness 1 3 cm 69g 5 DC 1A MT21255 6m 30 days of glucose data 7 days of tech support data 3 days 3 hours wall outlet 5 hours powered USB Temperature 0 C 45 C Humidity 10 95 RH 152 to 3657 meters IP22 vertically falling drops 1 year Class equipment Guidance and Manufacturer s Declaration Electromagnetic Immunity The receiver is intended for use in the electromagnetic environment specified below The customer or the user of the receiver should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Receiver Compliance Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 6 kV Contact 8 kV Air Level 6 kV Contact 8kVAir Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical Fast 2 kV for power 2 kV for
7. If you see this screen wait at least 1 hour and then enter 1 more calibration blood glucose value Wait 15 minutes If this error screen still appears enter 1 more blood glucose value Wait another 15 minutes If this error screen still appears the sensor needs to be replaced 9 4 SYSTEM GLUCOSE ERROR Sometimes the system may tell you that it cannot provide a valid sensor glucose reading When this occurs you will see either the glucose reading error icon or the wait kl icon in the status area These symbols mean the receiver does not understand the sensor signal temporarily These symbols are related to the sensor only You should wait for more prompts and do not enter any blood glucose values when you see these symbols The system will not use a blood glucose value as a calibration if it is entered when these symbols are displayed see Chapter 5 Section 5 3 Glucose Status Area Symbols Troubleshooting tips before inserting your sensor Make sure your sensor is not expired Make sure your transmitter is fully snapped in place No glucose data Make sure your sensor pod is not dislodged peeling up Make sure nothing is rubbing the sensor pod i e clothing seat belts etc Make sure you have selected a good insertion site see Chapter 3 Section 3 3 Choosing an Insertion Site Make sure your insertion site is clean and dry before sensor insertion Clean the bottom of the transmitter
8. Receiver Rise and Fall Rate of Change Alerts RF Safety Lock Sensor Sensor Pod Snoozing Startup Period System Reading Transmitter Transmitter ID The distance between the receiver and transmitter Keep the two devices within 6 meters from each other to get glucose information on your receiver A re alert occurs when the initial alert has not been confirmed The small device which collects your glucose information from the sensor transmitter Your results are displayed on the receiver screen as a sensor glucose reading mmol L and as a trend Alerts based on how fast your glucose levels rise fall and by how much Radio frequency transmission used to send glucose information from the transmitter to the receiver The safety lock keeps the needle inside the applicator before you are ready to insert the sensor It also helps you snap the transmitter out of the sensor pod after your sensor session has ended The part of the sensor that is inserted under your skin with the applicator lt measures the glucose levels in your surrounding tissue fluid The small plastic base of the Sensor attached to your belly that holds the transmitter in place A snooze time every 15 minutes up to 5 hours can be set in between high and low glucose re alerts The 2 hour startup period after you tell the receiver you have inserted a new sensor sensor glucose readings are not provided
9. J Clean the bottom of the transmitter with a slightly damp cloth or isopropyl alcohol wipe Place the transmitter on a clean dry cloth and air dry for 2 3 minutes Make sure your blood glucose meter and receiver date and time match Sensors should be stored at temperatures between 2 C 25 C You may store your sensors in the refrigerator if it is within this temperature range Sensors should not be stored in a freezer REVIEW THE SENSOR APPLICATOR Review the sensor applicator picture below before using a new sensor Plunger Safety lock Applicator barrel contains small introducer needle and sensor Transmitter latch B Collar Sensor pod Release tab 3 2 REMOVING THE SENSOR FROM ITS PACKAGING not use any sensor if its sterile package has been previously damaged or opened The sensor is sterile its unopened undamaged package Do 36 Dexcom G4 PLATINUM Continuous Glucose Monitoring System e Wash your hands thoroughly and dry them Carefully remove the sensor from its packaging Look closely at the sensor to make sure it is not damaged The applicator is a single use disposable unit The safety lock prevents you from accidentally releasing the needle before you are ready The applicator and senso design prevents reuse 3 9 CHOOSING AN INSERTION SITE Change the site where you place your sensor with each insertion to allow your skin to heal Avoid areas that are lik
10. The customer or the user of the Dexcom G4 PLATINUM System should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Conducted RF IEC 61000 4 6 Receiver only Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 10 V m Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the receiver including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance d 1 2 150 kHz to 80 MHz d 1 2 VP 80 MHz to 800 MHz 2 3 VP 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 distance in meters m Field strengths from fixed RF 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 4 Note 1 At 80 MHz and 800 MHz 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 124 Dexcom G4 PLATINUM Continu
11. Your receiver is rated IP22 which means that it offers some protection from rain drops Do not spill fluids on the receiver or drop the receiver into fluids Keep the micro USB port cover closed to help prevent fluid and dust from getting inside the receiver Wireless communication does not work well through water so the range is much less if you are in a pool bathtub water bed etc Most recent 5 minute sensor glucose reading u Area Antenna J mmol L Bi Trend Arrow High Glucose Alert Setting Glucose Target Range pd Low Glucose Alert Setting 20 00 i Current Time Glucose Values Plot of most recent sensor glucose reading Trend Graph Hours EXAMPLE 3 Hour Trend Graph Screen 16 Dexcom G4 PLATINUM Continuous Glucose Monitoring System There are five receiver buttons to move you through the display screens that control setup and operation and allow you to change your receiver settings The screens display sensor glucose readings trend graphs and trend arrows Your receiver and transmitter are wirelessly paired together to communicate securely and only with each other You will need a commercially available blood glucose meter to use with your system UP button RIGHT button SELECT button LEFT button DOWN button Dexcom G4 PLATINUM User s Guide 17 1 4 CHARGING YOUR RECEIVER BATTERY The receiver battery is rechargeable The rechargeable battery will typic
12. and health status Alerts To change the settings for notifications of high and low Chapter 6 High Low alerts from your receiver Settings To change the time date and transmitter ID to look up Chapter 2 your Dexcom G4 PLATINUM System hardware and software version numbers to view transmitter battery status last calibration value sensor insertion time Shutdown To temporarily turn off all communications between Chapter 3 your sensor transmitter and receiver during an active sensor session You will not receive sensor glucose readings and it will not extend the life of your sensor Stop To end a sensor session early Chapter 9 Sensor This option only appears when you are in the middle of a sensor session You will not receive sensor glucose readings It will not extend the life of your sensor See Appendix Receiver Alerts Alarm and Prompts for a list of screens that may appear on the receiver during use 22 Dexcom G4 PLATINUM Continuous Glucose Monitoring System chapter two DEXCOM G4 PLATINUM SYSTEM SETUP This chapter will help you when you first set up your Dexcom G4 PLATINUM Continuous Glucose Monitoring System Read this chapter before you start 2 1 THE SETUP WIZARD 1 Before setting up the receiver remove the transmitter from its packaging It takes 10 minutes for the transmitter to turn on after it is removed from its packaging 2 Make sure your receiver is fully charged see Chapter 1
13. from the YSI values was calculated The percentages of total readings within 20 mg dL 1 1 mmol L or 20 30 mg dL 1 7 mmol L or 30 or 40 mg dL 2 2 mmol L or 40 were then calculated in Table 1 The total number of data pairs considered in this analysis was 9152 Of these eighty two percent 82 of the System readings fall within 20 mg dL 1 1 mmol L of the YSI blood glucose values lt 80 mg dL or 4 4 mmol L within 20 of YSI blood glucose values gt 80 mg dL or 4 4 mmol L Table 1 System Agreement to YSI within YSI Glucose Ranges YSI Glucose Ranae Number Percent Percent Percent m nu of paired within 20 20 within 30 30 within 40 40 9 CGM YSI YSI YSI YSI mmol L Overall 9152 82 92 97 40 80 2 2 2 4 4 1351 83 94 98 NOTE CGM readings are within 40 to 400 mg dL 2 2 22 2 mmol L inclusive 130 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Table 1 is categorized within YSI reference value ranges When you know your blood glucose level measured by YSI in the study this table shows how likely your CGM reading matches with your blood glucose level For example when your blood glucose level is less than 80 mg dL 4 4 mmol L you can expect your CGM reading to be within 20 mg dL 1 1 mmmol L of YSI values i e 60 to 100 mg dL 3 4 5 6 mmol L 83 of the time Accuracy Accuracy between matched pairs was also estimated by calculating the percent differenc
14. press the SELECT button to Stop Sensor confirm that you want to stop the sensor session Stop Sensor 3 The stop sensor processing screen will appear to Stop Sensor let you know the sensor session is stopping 4 Once the session has stopped a red stoplight symbol 8 will appear the upper right corner of the trend graph Dexcom G4 PLATINUM User s Guide 107 9 7 BATTERY AND CHARGER TROUBLESHOOTING Only use the Dexcom cable and battery charger to charge your receiver 1 Remember to charge your receiver battery as needed The charge will last approximately 3 days depending on how often you turn on your receiver use the alerts and enter events 2 If your receiver does not show the charging icon when plugged into the charger make sure that both ends of the USB cable are fully inserted into the receiver port and wall charger 3 If your battery drains and is not charged for a few weeks it may not turn on If your receiver does not turn on first try to charge it see Chapter 1 Section 1 4 Charging Your Receiver Battery If your receiver still does not turn on you may need to reset the receiver connect the receiver to the charger before resetting a Insert the end of a paperclip into the small circular hole on the back of the receiver and push down The receiver will vibrate and show the processing screen b You will now need to charge your receiver and the time and date may need to be reset see Cha
15. treatment and it is unknown if there are safety or performance issues The transmission range from the transmitter to the receiver is up to 6 meters without obstruction Wireless communication does not work well through water so the range is much less if you are in a pool bathtub water bed etc HELPFUL HINT The transmitter and receiver may lose communication at the following times When they are near metallic objects When you are using an electric blanket Once you are in a sensor session you can check that the receiver and transmitter are communicating View the trend graph screen by pressing the SELECT LEFT or RIGHT button to see the trend graph This antenna symbol shows that the transmitter ec and receiver are communicating Oe me ee ee a ni par Ge a r This out of range symbol shows the transmitter and receiver not communicating 32 Dexcom G4 PLATINUM Continuous Glucose Monitoring System chapter three INSERTING A SENSOR AND STARTING A SENSOR SESSION To use your Dexcom G4 PLATINUM Continuous Glucose Monitoring System you will need a sensor a transmitter and a receiver You will also need a blood glucose meter and test strips for calibration Once inserted and calibrated the sensor will continuously measure and display your sensor glucose readings for up to 7 days The following sections will show you how to insert the sensor and start a new continuous glucose monitoring se
16. 4 mmol L times then have turned Your most recent vibrates beeps on the low sensor glucose three times every alert snooze reading is at or 5 minutes until feature below the low alert confirmed or your setting glucose value goes above the alert level Fixed Low Alarm On Vibrates four Yes every Your most recent times then 30 minutes sensor glucose vibrates beeps after each reading is at or four times every confirmation below 3 1 mmol L five minutes until until your confirmed or your blood glucose glucose value value comes goes above 3 1 back into mmol L range Dexcom G4 PLATINUM User s Guide 67 What will see What does this What How will the Will the on the receiver mean is the receiver notify receiver screen default me re notify setting me Out of Range Off Alert The Sensor Transmitter No Gut of Range ey ON and Receiver are not communicating to each other Rise Fall Alert Off Off No Single Arrow Your glucose is rising falling RISING at or above a rate of 0 11 mmol L min at FALLIN G least 1 7 mmol L in 15 minutes Rise Fall Alert Off Off No Double Arrow Your glucose is rising falling RISING at or above a rate of 0 17 mmol L min at FALLIN e least 2 5 mmol L in 4 4 15 minutes HELPFUL HINT Your receiver may alert you at other times you need to take action such as low battery failed sensor etc See Chapter 12 Appendix for a deta
17. Rate On Of Level Fall Rate 0 11 0 17 mmel L min HELPFUL HINT You confirm alerts by pressing the SELECT button on the receiver 6 2 3 SETTING THE OUT OF RANGE ALERT The out of range alert lets you know when the sensor transmitter and receiver are not communicating with each other Typically you should keep the sensor transmitter and receiver within 6 meters of each other When the sensor transmitter and receiver are too far apart and are not communicating you will not receive sensor glucose readings from the sensor When this happens the out of range symbol will appear in the upper right corner of the trend graph and the screen to the right will appear The amount of time the devices are out of range will appear on the Out of Range out of range alert screen For are 1 Press the UP or DOWN button to choose Out of Kaya Range and press the SELECT button i ered PR Rise Rate ru Fall Rate ki Out of Range 2 On the out of range menu press the UP or DOWN button to choose On Off Then press the SELECT button to select On If you do not want to receive out of range alerts press the SELECT button to choose Off Time Out of Range 3 Next on the out of range menu press the UP or DOWN button to choose Time and press the SELECT button On Off Out of Range lime Dexcom G4 PLATINUM User s Guide 77 4 Press the UP or DOW N button to choose t
18. Section 1 4 Charging Your Receiver Battery 3 Turn your receiver on by pressing the SELECT button on the receiver When you turn the receiver on for the first time the Setup Wizard will help you get started by prompting you to enter the following setup information a Select your language language Press the UP or DOWN button to choose your desired language Press the SELECT button to set the highlighted Nederlands language Cesky b Set the time format Time formats available are either 24 Hour or AM PM 12 hour settings Press the UP and DOWN button to choose your desired time format Press the SELECT button to confirm changes to time format Dexcom G4 PLATINUM User s Guide 25 c Set the time and date The date format is YYYY MM DD Time Date Press the UP or DOWN button to enter the Beate current date and time 2010 IT E Press the RIGHT button to move to the next 19 39 section Press the SELECT button to confirm changes to time and date d Enter your transmitter ID Transmitter ID Y Press the UP or DOWN button to enter your transmitter ID Press the SELECT button to confirm entry of 20 0 0 transmitter ID Your transmitter ID is unique and contains a code with 5 numbers and or letters and can be found in the following locations the outside of the transmitter box label On the bottom of the transmitter HELPFUL HINTS Write your t
19. You ii sr will decide what to do based on the symbol shown in the status area a If the startup calibration symbol 2 is displayed Take 2 more blood glucose values and enter them into your receiver is Prompt in status area b If the additional startup calibration symbol displayed Take 1 more blood glucose value and enter it into your receiver c If the calibration needed symbol is displayed Take 1 more blood glucose value and enter it into your receiver 9 3 CALIBRATION ERROR TROUBLESHOOTING This screen means you recently entered a calibration blood glucose value and the sensor is having trouble calibrating If you clear this screen by pressing the SELECT button this symbol will be displayed in the status area If you see this screen wait 15 minutes and then enter 1 more calibration blood glucose value Wait 15 more minutes If this error screen still appears enter 1 more blood glucose value Wait another 15 minutes If this error screen still appears the sensor needs to be replaced This screen means you recently entered a calibration WI blood glucose value and the sensor is having trouble 4 calibrating If you clear this screen by pressing the SELECT button this symbol will be displayed in the status area Wait 15 minute calibration error screen 41 SL Enter BG in 1hr Wait 1 hour calibration error screen 102 Dexcom G4 PLATINUM Continuous Glucose Monitoring System
20. and alarms to higher volume beeps The attentive profile can be used when you need your alert to be the most noticeable This profile sets all the alerts and alarms to loud and highly distinctive melodies HypoRepeat profile is very similar to the normal profile The difference with this profile is it will continuously repeat the fixed low alarm every 5 seconds until your sensor glucose value rises above 3 1 mmol L or if it is confirmed This profile can be helpful if you want an additional level of awareness when you have severe low sensor glucose readings HELPFUL HINT The Try It feature is available under the profiles menu and allows you to hear an example of the alert sequence and sound for each individual alert and alarm Once you hear the sounds it is easier to understand the alert profile options 80 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 6 3 2 ALERT PROFILE DETAILS PROFILE TYPE VIBRATE NORMAL ATTENTIVE So HYPOREPEAT High Alert 2long 2 long 2 long 2 long 2 long vibrates vibrates vibrates 2 vibrates vibrates 2 medium beeps E low beeps 2 medium ascending beeps melody Low Alert 3short 3 short 3 short 3 short 3 short vibrates vibrates vibrates vibrates vibrates 3 medium beeps P low beeps 3 medium descending ze beeps melody Rise Alert 2 long 2 long 2 long 2 long 2 long vibrates vibrates vibr
21. battery is low vibrate beep day alert Replace the every 5 minutes transmitter as 2 times Low Battery soon as possible Uhde ew Irammets Transmitter The transmitter 1 vibrate then No Ld Transmitter Failed failed alert has failed Replace the transmitter immediately vibrate beep every 5 minutes 2 times 150 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Important alerts and alarms that can be verified by the user Out of Range Alert You can test this alert by moving the receiver more than 6 meters away for 30 minutes or more e 30 minute sensor expiration alert You will see this alert in the normal course of using a sensor for seven days 0 hour sensor expiration alert You will see this alert the normal course of using a sensor for seven days Other alerts and alarms cannot be safely verified by the user Dexcom G4 PLATINUM User s Guide 151 GLOSSARY IN ey e This is when you obtain a blood glucose value on your meter Testing using a blood sample from an area on your body other than your fingertip Do not use alternative site testing for entering blood glucose values into the receiver Applicator A disposable component piece that comes attached to the sensor pod and inserts the sensor under the skin There is a needle inside the applicator barrel that you remove once you have inserted the sensor BG Meter Blood g
22. confirm the High Symptoms entry 4 You will advance to the event confirmation screen Press the LEFT or RIGHT button to choose either OK to confirm this entry or Cancel to discard High 5 to this entry and then press the SELECT button You p will return to the events menu 23 47 7 2 DEXCOM STUDIO SOFTWARE The Dexcom Studio software is an optional component of your system This software allows you to view trends track patterns and create customizable charts to display your glucose trends You can change the date ranges to view long or short term patterns and trends You can use data from current and previous system downloads and save or print files that you and your healthcare professionals can review For system requirements refer to the Dexcom website www dexcom com The Dexcom Studio Software User s Guide gives you more information on how to use this software 90 Dexcom G4 PLATINUM Continuous Glucose Monitoring System COMPLETING A SENSOR SESSION Your sensor will continue to give you sensor glucose readings for up to seven days The performance of a sensor has not been tested beyond seven days HELPFUL HINTS Do not remove the transmitter from the sensor pod while the pod is attached to your skin Do not dispose of your transmitter It is reusable The same transmitter is used for each session until you have reached the end of the transmitter battery life Consult your loc
23. during this time A sensor glucose reading shown on your receiver This reading is given in mmol L units and is updated every 5 minutes The Dexcom G4 PLATINUM System component that snaps into the sensor pod and wirelessly sends glucose information to your receiver Transmitter ID that is entered into your receiver to enable it to communicate with the transmitter Dexcom G4 PLATINUM User s Guide 153 GLOSSARY continued Transmitter Latch The small disposable component that snaps the transmitter into the sensor pod It is removed after the transmitter is snapped in place Trend Rate of Arrows on trend graphs that indicate if and how fast your Change Arrows glucose levels are changing There are 7 different arrows that show when your glucose speed and direction change SYMBOLS USED IN LABELING 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 G4 PLATINUM CGM 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 Lot Number SETS REF Part Number Catalog Number Date of Manufacture STERILE R Sterile by Radiation Two sided Do NOEREUSE Temperature Limits Serial Number Temporary submersion 8 B Class Equipment Vertically falling drops
24. each minute If it continued falling at this rate your glucose could decrease up to 2 5 mmol L in 15 minutes Rapidly falling Your glucose is falling more than 0 17 mmol L each minute If it continued falling at this rate your glucose could decrease more than 2 5 mmol L in 15 minutes No arrow No rate of change information The receiver cannot calculate how fast your glucose is rising or falling at this time Dexcom G4 PLATINUM User s Guide 61 HELPFUL HINTS Trend arrows do not appear when there glucose data gaps see Chapter 9 Section 9 4 System Glucose Error If the glucose reading error symbol FFA the wait symbol the out of range symbol or the blood drop symbol f appear at the top of the trend graph the trend arrows will not appear e f the trend arrow is missing but you are concerned that your blood glucose level may be rising or falling take a blood glucose measurement test on your blood glucose meter Symptoms related to low or high blood glucose levels should not be ignored If you have symptoms of low or high glucose obtain a blood glucose measurement from your meter 5 3 GLUCOSE STATUS AREA SYMBOLS During your sensor session the status area at the top of the trend graph may display any of the status symbols below You will not receive sensor glucose readings during the time the status symbol is displayed except during the regular 12 hour calibration prompt
25. glucose readings 288 140 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Adverse Events There were two adverse events identified as skin irritations erythema reported from one subject at the sensor patch adhesive area No device related serious adverse events occurred during the study No noticeable infection bruising or bleeding occurred at the sensor needle insertion area and the patch adhesive area 11 3 FCC REQUIREMENTS The transmitter covered by this user s guide has been certified under FCC ID PH29433 Although the transmitter has been approved by the Federal Communications Commission there is no guarantee that it will not receive interference or that any particular transmission from the transmitter 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 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 desig
26. press the SELECT button 4 From the alerts menu press the UP or DOWN button to select Advanced and press the SELECT button Alerts E High Alert m Low Alert h wS Advanced Dexcom G4 PLATINUM User s Guide 73 6 2 1 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTS You have the option to set a snooze time every 15 minutes for up to 5 hours in between your high and low glucose re alerts 1 Press the UP or DOW N button to choose High Ad ed mm Snooze or Low Snooze and press the SELECT TOM EA button mem High Snooze Low Snooze Rise Rate 2 Press the UP or DOWN button to select the amount of time in 15 minute increments in between the first alert and re alerts Press the SELECT button If you set the amount of time to ry zero there will be no re alerts 1 5 3 When finished press the LEFT button to return to minutes the alerts menu High Alert 74 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 6 2 2 RISE AND FALL GLUCOSE RATE ALERTS Rate alerts notify you when your glucose levels are rising rise alert or falling fall alert and by how much You can choose whether your receiver alerts you when your sensor glucose value is either rising or falling 0 11 mmol L or more per minute or 0 17 mmol L or more per minute If you set your fall rate to 0 11 mmol L per minute and your sensor glucose readings fall at this rate or faster FALLIN G t
27. properly coded if required Carefully apply the blood sample to the test strip following the instructions provided with your meter or test strips Make sure you are using your blood glucose meter per manufacturing instructions to ensure you are getting accurate blood glucose values for calibration Make sure you have not taken any medications containing acetaminophen paracetamol such as Tylenol ingredients to ensure you are getting accurate blood glucose values for calibration Clean the bottom of the transmitter with a slightly damp cloth or isopropyl alcohol wipe Place the transmitter on a clean dry cloth and air dry for 2 3 minutes 9 6 SENSOR SHUT OFF TROUBLESHOOTING In some cases your sensor session may stop or need to be stopped before the end of a full 7 day period Once the sensor session is stopped you will need to remove your sensor To help improve future sensor performance Make sure your sensor is not expired Make sure your transmitter is fully snapped in place Make sure your sensor pod is not dislodged or peeling up Make sure nothing is rubbing the sensor pod i e clothing seat belts etc Make sure you have selected a good insertion site see Chapter 3 Section 3 3 Choosing an Insertion Site Make sure your insertion site is clean and dry prior to sensor insertion Dexcom G4 PLATINUM User s Guide 105 9 6 1 EARLY SENSOR SHUT OFF SENSOR FAILURE During a sensor session th
28. the UP or DOW N button Your system only reports glucose information between 2 2 22 2 mmol L Your trend graph will show a flat line or dots at 22 2 or 2 2 mmol L when your glucose is outside this range The sensor glucose reading is in millimoles per liter mmol L unit Scroll up from the 3 hour graph to reach the 1 hour graph 1 Hour Trend Graph The 1 hour trend graph shows your current glucose reading and the last 1 hour of sensor glucose readings 3 Hour Trend Graph The 3 hour trend graph shows your current glucose reading and the last 3 hours of sensor glucose readings Scroll down from the 3 hour graph to reach the 6 hour graph 6 Hour Trend Graph The 6 hour trend graph shows your current glucose reading and the last 6 hours of sensor glucose readings Scroll down from the 6 hour graph to reach the 12 hour graph 12 Hour Trend Graph The 12 hour trend graph shows your current glucose reading and the last 12 hours of sensor glucose readings Dexcom G4 PLATINUM User s Guide 59 Scroll down from the 12 hour graph to reach the 24 hour graph 24 Hour Trend Graph The 24 hour trend graph shows your current glucose reading and the last 24 hours of sensor glucose readings The receiver displays LOW when the most recent glucose reading is less than 2 2 mmol L and HIGH when the most recent glucose reading is greater than 22 2 mmol L 5 2 R
29. where you insert the sensor 3 10 TEMPORARY RECEIVER SHUTDOWN There may be times when you want to temporarily shut down your receiver Shutdown will stop all communication between the transmitter and receiver and will turn the receiver off You will not receive sensor glucose readings or any alerts or alarms while the receiver is shut down but your current sensor session will continue Follow these steps to shut down your receiver 1 From the main menu scroll to and highlight a Shutdown Press the SELECT button wwe 45 Alerts Settings 9 Shutdown 44 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 2 Confirm that you want to shutdown your receiver Shutdown W a If you want to shutdown press the LEFT button to highlight OK and then press the SELECT Shutdown button b If you want to cancel the shutdown press the SELECT button with Cancel highlighted to return to the main menu 3 To turn the receiver back on and resume communication with the transmitter press the SELECT button It may take up to 20 seconds for the display to turn back on HELPFUL HINTS e Remember that your alerts and low glucose alarm will not work when the receiver is shut down Shutting down the receiver does not extend the sensor life beyond 7 days Your sensor session will stop 7 days after you started the sensor session 3 11 THE DEXCOM G4 PLATINUM SYSTEM AND WATER You
30. with a slightly damp cloth or isopropyl alcohol wipe Place the transmitter on a clean dry cloth and air dry for 2 3 minutes Often the system can correct this problem and continue providing sensor glucose readings However if it has been at least 3 hours since your last glucose reading appeared contact your local distributor Dexcom G4 PLATINUM User s Guide 103 9 5 SENSOR INACCURACIES Inaccuracies are usually related to your sensor only and not your receiver or transmitter Your sensor glucose readings are meant to be used for trending purposes only Your blood glucose meter and sensor measure your glucose from two different types of body fluids blood and interstitial fluid Therefore your readings from your blood glucose meter readings and sensor may not match Your sensor glucose readings may be inaccurate if you calibrate less than every 12 hours To calibrate the system you must enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose value Entering incorrect blood glucose values or blood glucose values from more than 5 minutes ago could result in inaccurate sensor glucose readings If you see a difference between your sensor glucose reading and blood glucose value outside the 20 1 1 mmol L industry standard wash your hands and take an additional blood glucose measurement If the blood glucose value remains outside the industry standard e
31. you are in the middle of a sensor session a When the receiver does not have a recent sensor glucose reading the default is 6 7 Enter BG ry mmol L there has been a sensor glucose reading in n the past 15 minutes the Enter BG screen will 7 c display your current sensor glucose reading i as your starting point Do not use the current sensor glucose reading for calibration Use only blood glucose values from your meter c Before you take a blood glucose measurement to be used for calibration wash your hands make sure your glucose test strips are not expired and have been stored properly and that your meter is properly coded if required oO mmol L Carefully apply the blood sample to the test strip following the instructions provided with your meter or test strips 5 To enter the blood glucose value use the UP or DOWN button to scroll until you see the correct value and then press the SELECT button 6 Confirm that the blood glucose value you entered is correct Entering incorrect values may affect the sensor accuracy a If the blood glucose value displayed is correct Enter BG ry press the SELECT button b If the blood glucose value displayed is incorrect 6 7 mmol L press the RIGHT button to highlight Cancel 19 39 then press the SELECT button to return to the Enter BG screen Repeat the steps for re entering the correct blood glucose value C If you do not press the SELECT button the Enter
32. you are not in a sensor session During a sensor session Transmitter ID will not appear as an option on the settings menu To enter the transmitter ID follow the steps below Settings 1 From the Settings menu press the UP or DOWN button to scroll to Transmitter ID and press the ss SELECT button 2 Starting with the first number or letter do not enter SN a Press the UP or DOWN button to display to the correct number or letter b Then press the RIGHT button to move to the next value and repeat step a Continue repeating steps a and b until you have the transmitter ID displayed c After entering the fifth number or letter press the SELECT button You will return to the settings menu Y Transmitter ID e Time Format Transmitter ID Y 00007 Dexcom G4 PLATINUM User s Guide 29 2 2 4 SETTING YOUR RECEIVER TIME FORMAT To set your receiver time format 24 hour or AM PM follow the steps below 1 From the Settings menu press the UP or DOWN button to scroll to Time Format and press the settings SELECT button 2 Press the UP or DOWN button to scroll and highlight your desired time format En 4 24H i 3 Press the SELECT button to set the highlighted Sis time format You will return to the settings menu AM PM 2 2 5 SELECTING YOUR RECEIVER LANGUAGE To select your receiver language follow the steps below 1 From the Settings menu press the UP or DOW
33. ATE OF CHANGE ARROWS Your rate of change arrows add detail about the direction and speed your glucose is changing The trend arrows appear to the right of your current glucose reading HELPFUL HINT Do not overreact to the rate of change arrows Consider recent insulin dosing activity food intake your overall trend graph and your blood glucose value before taking action 60 Dexcom G4 PLATINUM Continuous Glucose Monitoring System This table shows the different trend arrows your receiver will display E Constant Your glucose is steady not increasing decreasing more than 0 06 mmol L each minute Your glucose could increase or decrease by up to 0 8 mmol L in 15 minutes A Slowly rising Your glucose is rising 0 06 0 11 mmol L each minute If it continued rising at this rate your glucose could increase up to 1 7 mmol L in 15 minutes t Rising Your glucose is rising 0 11 0 17 mmol L each minute If it continued rising at this rate your glucose could increase up to 2 5 mmol L in 15 minutes Rapidly rising Your glucose is rising more than 0 17 mmol L each minute If it continued rising at this rate your glucose could increase more than 2 5 mmol L in 15 minutes Slowly falling Your glucose is falling 0 06 0 11 mmol L each minute If it continued falling at this rate your glucose could decrease up to 1 7 mmol L in 15 minutes Falling Your glucose is falling 0 11 0 17 mmol L
34. Absolute phon dur within within within Percent Percent 20 20 30 30 4040 Pairs n Differences Differences Day 1 311 18 1 13 0 69 82 88 Day 2 300 16 2 12 8 74 88 95 Day 3 302 14 2 11 7 79 92 99 Day 4 273 14 9 10 9 75 90 94 Day 5 275 13 5 10 8 82 93 97 Day 6 201 13 0 10 3 84 96 98 Day 7 220 12 9 10 5 82 94 96 Precision of System Readings In the same study all subjects wore two Systems This was to look at how well sensors agree with each other when use by the same person Precision was evaluated by comparing the glucose readings from the two Systems worn on the same subject at the same time Results showed that System readings from the two sensors generally agreed with each other within 8 absolute percent difference and had a 6 coefficient of variation Sensor Life Sensors may be worn for up to 7 days 168 hours To estimate how long a sensor will work over 7 days 59 sensors were evaluated to determine how many days hours of readings each sensor provided Eighty one percent 81 of the sensors lasted until Day 7 145 168 hours 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 Adjusted within each system wear day the System provided an average of 92 of all expected
35. BG n receiver will time out and no blood glucose value will be recorded for calibration Cancel 7 The Enter BG processing screen will appear to let you know the blood glucose value is being processed for calibration Dexcom G4 PLATINUM User s Guide 51 8 For startup calibration repeat these steps for the second blood glucose value 9 Asensor glucose reading will appear on the receiver right away and sensor glucose readings will be updated every 5 minutes 10 If readings do not appear immediately see Chapter 9 Section 9 2 Calibration Troubleshooting HELPFUL HINTS Before calibration make sure a sensor glucose reading or a blood drop symbol is displayed at the top of the trend graph Due to the potential for confusion from low glucose you may want to treat low blood glucose prior to calibrating e Always make sure the antenna symbol 1 displayed in the upper left corner of the trend graph before you enter blood glucose values for calibration You should always use the same meter you routinely use to measure your blood glucose to calibrate Do not switch your meter in the middle of a sensor session Blood glucose meter and strip accuracy may vary between blood glucose meter brands The accuracy of the blood glucose meter measurement used for calibration may affect the accuracy of sensor glucose readings Do not calibrate your Dexcom G4 PLATINUM System when you have acetaminophe
36. Dexcom G4 PLATINUM User s Guide 145 What will see Prompt What does this How will the Will the on the receiver alert or mean receiver notify receiver screen alarm me re notify vibrate and or me beep Out of The transmitter and 1 vibrate then No unless range alert receiver are not vibrate beep every you have Ed communicating and 5 minutes until turned on the you will not receive the receiver and out of range Qut of Range sensor glucose transmitter are alert lor 0020 24 readings back in range Unknown The sensor is sending Symbol in status N A sensor sensor glucose area only prompt readings that the receiver does not understand You will not receive sensor glucose readings Wait The receiver has Symbol in status N A prompt detected a potential area only problem with the sensor signal You should wait about 30 minutes for more prompts Do not enter any blood glucose values during this time You will not receive sensor glucose readings 15 minute The sensor cannot 1 vibrate then No calibration calibrate Wait 15 vibrate beep every Fi error alert minutes then enter 1 5 minutes until more blood glucose confirmed value Wait 15 more Enter BG in 15min minutes If error screen still appears enter 1 more blood glucose value Wait 15 minutes If no sensor glucose readings appear on the receiver the sensor needs to be replaced 146 Dexcom G4 PLATINUM Con
37. ID when you are not in a sensor session During a sensor session Transmitter ID will not appear as an option on the Settings menu If you are still having trouble receiving system readings contact your local distributor 9 10 ALERTS ARE NOT WORKING 1 Make sure you have not disabled the sound and or vibrations for the alerts Chapter 6 Section 6 1 Setting Your Alerts explains how to change these alert options 2 Check to be sure you have turned on and set the level for your advanced alerts if you wish to receive these alerts see Chapter 6 Section 6 2 Advanced Alerts 3 Remember the first alert will vibrate only Please see Chapter 12 Appendix Receiver Alerts Alarm and Prompts sequence tables for reference on how the alerts alarm and prompts work HELPFUL HINT f your receiver gets wet or is dropped you need to make sure the speakers and vibrate mode are still working You can do this by using the Try It option in the profiles menu see Chapter 6 Section 6 3 1 Alert Profile Options 110 Dexcom G4 PLATINUM Continuous Glucose Monitoring System TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM 10 1 MAINTENANCE Transmitter e Wipe the outside of the transmitter with a slightly damp cloth or isopropyl alcohol wipe between uses Keep the transmitter clean and protected when not in use Receiver Do not spill fluid on the receiver or submerge the receiver in liquid Keep the rec
38. N settinas button to scroll to Language and press the SELECT button Y Transmitter 10 2 Press the UP or DOWN button to scroll and highlight your desired language angue Cesky 3 Press the SELECT button to set the highlighted BET language You will return to the settings menu Nederlands English 30 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 2 3 CHECKING INFORMATION ABOUT YOUR DEXCOM G4 PLATINUM SYSTEM You can check your receiver for information about your CGM at any time 1 From the Settings menu press the UP or DOWN button to scroll to Device Info and press the SELECT button Tina Fermat Language SeHings 2 Information about your sensor session and system will appear Scroll down to see all of the Device Info Device Into nsarton Time Last Calibration rong L Lu Insertion Time Transmitter Barllery Last Calibration Transmitter 10 Transmitter Battery Transmitter ID Serial Number Part Number Part Revision Software Number e Software Revision 3 Press the LEFT button to return to the Settings menu Dexcom G4 PLATINUM User s Guide 31 2 4 TRANSMITTER AND RECEIVER COMMUNICATION The Dexcom G4 PLATINUM Sensor Transmitter and Receiver must be removed prior to Magnetic Resonance Imaging MRI CT scan or diathermy treatment The Dexcom G4 PLATINUM System has not been tested during MRI CT scans or with diathermy
39. What does this mean How will the receiver notify me vibrate and or beep Will the receiver re notify me p Enter BG The receiver is Prompt screen N A processing processing the only screen blood glucose value prompt you entered Rise alert Your glucose levels 2 vibrates then 2 No are rising at 0 11 vibrates 2 beeps 4 mmol L per minute every 5 minutes or more 2 times or until RIS NG confirmed Rapid rise Your glucose levels 2 vibrates then 2 No alert are rising fast at vibrates 2 beeps 4 4 0 17 mmol L per every 5 minutes minute or more 2 times or until ah NG confirmed Fall alert Your glucose levels 3 vibrates then 3 No FALLING are falling at 0 11 vibrates 3 beeps mmol L per minute every 5 minutes or more 2 times or until confirmed Rapid fall Your glucose levels 3 vibrates then 3 No FALLING alert are falling fast at vibrates 3 beeps yy 0 17 mmol L per minute or more every 5 minutes 2 times or until confirmed 148 Dexcom G4 PLATINUM Continuous Glucose Monitoring System What will see on the receiver screen Prompt alert or alarm What does this mean How will the receiver notify me vibrate and or beep Will the receiver re notify me 6 hour Your sensor session Prompt screen N A will end in 6 hours only Replace expiration Sensor soon 05 54 30 2 hour Your
40. You can clear the prompt by pushing the SELECT button The blood drop symbol will remain at the top of the trend graph until you calibrate The system will re alert you every 15 minutes until you enter the blood glucose values You will not receive sensor glucose readings until the receiver accepts the blood glucose values If you do not clear the prompt the system will re alert you every 5 minutes 4 4 12 HOUR CALIBRATION UPDATE Calibrate your system every 12 hours after your initial calibration performed at 2 hours after sensor insertion to make sure your sensor glucose readings remain accurate and are close to your blood glucose meter values You can enter any blood glucose values you take during a sensor session If you have not entered any blood glucose values in the past 12 hours the receiver will ask you to enter a blood glucose value to update its calibration The following steps show you how to enter this calibration Your sensor glucose readings be inaccurate if you calibrate less than every 12 hours Dexcom G4 PLATINUM User s Guide 53 1 When you see this calibration prompt it means it is time to calibrate with a single blood glucose value You can clear the prompt by pushing the SELECT button The system will re alert you every 15 minutes until the receiver accepts the blood glucose value 2 Take 1 blood glucose measurement with your meter and enter the blood glucose value into the receiver Calibr
41. ace with one hand Using your other hand remove the transmitter latch by holding the end of the latch and quickly twisting off el the latch away from your body is Remove transmitter latch HELPFUL HINTS Make sure you hear 2 clicks when you snap the transmitter in place see Step 3 Failing to seat the transmitter completely may lead to a poor sensor connection and allow fluids to get under the transmitter This can lead to inaccurate sensor glucose readings Do not remove the transmitter from the sensor pod while the pod is attached to your skin 3 7 STARTING A SENSOR SESSION Follow the steps below to tell the receiver that you have inserted a new sensor 1 2 Press the Up or DOWN button to scroll until you Press the SELECT button to confirm the start of a Your receiver will then return to the 3 hour trend Press the SELECT button to turn the receiver on Main Menu From any trend graph press the SELECT button to display the main menu Trend Graph cae Start Sensor highlight Start Sensor Enter BG Start Sensor new sensor session The start sensor processing screen will appear to let you Know your sensor session has been activated and your 2 hour startup has begun graph 42 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 6 Check your receiver in approximately 10 minutes after starting your sensor session to make sure your receiver and transmitter are co
42. action inserts the needle and sensor under your skin When you are pushing down on the plunger do not pull back on the collar Push down the plunger Insert the needle and sensor 3 To remove the sensor introducer needle keep pinching up on your skin with one hand With your other hand place two fingers under the collar Keep your thumb lightly on top of the white plunger and pull the collar back towards your thumb until you hear 2 clicks or cannot pull back any more This step leaves the sensor under your skin and removes the sensor introducer needle from your body Pull back the collar Retract the Needle 4 To remove the applicator barrel squeeze the ribbed release tabs on the sides of the sensor pod when you squeeze the front part of the release tabs the back part of the tabs will widen allowing you to pull off the applicator barrel After this step only the sensor pod will be left on your body Make sure the transmitter latch is down against your body to remove the applicator barrel Release the applicator barrel 40 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Be sure to squeeze in the center of the ribbed part of the release tabs While squeezing the release tabs rock the applicator barrel forward and out away from the body If you have any problems with insertion save the sensor and applicator and contact your local distributor 3 6 TRANSMITTER ATTACHMENT Once
43. al waste management authorities for appropriate procedures for disposal of blood contacting components sensor and applicator In some cases your sensor session may end before you have completed a full 7 day period If this happens see Chapter 9 Section 9 6 Sensor Shut Off Troubleshooting Dexcom G4 PLATINUM User s Guide 93 8 1 AUTOMATIC SENSOR SHUT OFF The receiver will tell you how much time you have remaining until your sensor session is complete The sensor expiration screen will appear at 6 hours 2 hours and 30 minutes before your 7 day sensor session ends Replace BE Replace Sensor Sensor Soon Soon e 01 56 29 6 hour sensor expiration 2 hour sensor expiration notification screen notification screen ES Replace Sensor Sensor Soon Now 00 26 29 00 00 00 30 minute sensor expiration Sensor expiration notification notification screen end of session screen You can set the receiver to alert you with these displays using the profiles setting see Chapter 6 Section 6 3 Alert Profile Details All Other Alerts After the 6 hour 2 hour and 30 minute reminders you will continue to receive sensor glucose readings You can clear these screens by pressing SELECT on the receiver You must remove your sensor after the final sensor expiration screen 00 00 00 appears Once your sensor session has ended sensor glucose readings will no longer be shown on the receiver The trend gr
44. ally last about 3 days before you need to charge it with the charging cable provided Your battery life depends on how often you interact with your receiver The receiver will alert you when the battery charge is low The receiver battery may be charged using one of the following options Low battery prompt AC power outlet a personal computer with Windows operating system to charge your receiver from your PC Dexcom Studio must be installed For system requirements and more information see the Dexcom website www dexcom com or the Dexcom Studio Software User s Guide It takes about 3 hours to fully charge an empty battery with the wall charger and about 5 hours when the receiver is connected to a computer You can charge your receiver at any time and the battery does not need to be drained in order to fully charge the battery HELPFUL HINT When the receiver is used in a healthcare facility charging must take place away from the patient 1 4 1 CHARGING YOUR RECEIVER BATTERY FROM AN AC POWER OUTLET The AC power adapter comes with interchangeable plugs Install the appropriate plug for your wall outlet style by sliding the plug down onto the adapter until it snaps into place 18 Dexcom G4 PLATINUM Continuous Glucose Monitoring System To remove the plug from the AC power adapter place both thumbs on the bottom of the plug and push up until the plug pops out of the adapter To recharge your batt
45. ansmitter kit box away from young children it contains a magnet that should not be swallowed 8 Dexcom G4 PLATINUM Continuous Glucose Monitoring System PRECAUTIONS Before opening the sensor package wash your hands with soap and water and dry them to avoid contamination Before inserting the sensor always clean the skin at the sensor insertion location with a topical antimicrobial solution such as isopropyl alcohol This may help prevent infection Do not apply the sensor until the cleaned area is dry so that it will stick better e Change the site where you place your sensor with each insertion to allow your skin to heal Avoid areas that are likely to be bumped pushed or compressed or areas of skin with scarring tattoos or irritation as these are not ideal sites to measure glucose Avoid injecting insulin or placing an insulin pump infusion set within 7 62 cm of the sensor in case the insulin affects the sensor glucose readings The sensor is sterile in its unopened undamaged package Do not use any sensor if its sterile package has been previously damaged or opened To calibrate the system you must enter the exact blood glucose value that your blood glucose meter displays within 5 minutes of a carefully performed blood glucose measurement Entering incorrect blood glucose values or blood glucose values from more than 5 minutes ago could result in inaccurate sensor glucose readings The transmission range
46. aphs will indicate that the sensor session has ended by displaying a red stoplight symbol at the top as shown in the screen to the right You will need to remove your sensor and insert a new sensor 94 Dexcom G4 PLATINUM Continuous Glucose Monitoring System HELPFUL HINT Glucose level alerts and alarms will not function after the sensor session has ended 8 2 REMOVING A SENSOR portion of it is visible above the skin do not attempt to remove it f Sensors may fracture on rare occasions If a sensor breaks and no Seek professional medical help if you have symptoms of infection or inflammation redness swelling or pain at the insertion site If you experience a broken sensor please report this to your local distributor When you are ready to remove the sensor make sure to pull out the sensor pod while the transmitter is still attached 1 Gently peel up the sensor pod adhesive patch from your skin this will pull out your sensor 8 3 TRANSMITTER REMOVAL Once the sensor pod is off your body you will need to remove the transmitter do not dispose of the transmitter To remove the transmitter you can use either of the two methods below Method 1 The safety lock once removed from the applicator see Chapter 3 Section 3 4 Placing the Sensor can be used as a tool to remove the transmitter 1 Place the sensor pod on a table 2 Hold the rounded edge of the safety lock 3 Make sure the jagged edge o
47. ates 2 vibrates vibrates 2 medium beeps low beeps 2 medium 1 short beeps ascending melody Fall Alert 3 short 3 short 3 short 3 short 3 short vibrates vibrates 3 vibrates vibrates vibrates 3 low beep 3 medium 2 short medium beeps beeps descending melodies Out of 1 long vibrate 1 long 1 long 1 long vibrate 1 long vibrate 1 Range vibrate 1 vibrate 3 short medium beep Alert low beep 1 medium repeating beep melodies Fixed Low 4 short 4 short 4 short 4 short 4 short vibrates vibrates vibrates vibrate vibrates 4 low beeps 4 medium 4 medium 4 medium 2 long pause repeat tone beeps tone beeps tone beeps descending sequence melodies pause 4 low beeps All Other 1 long vibrate 1 long 1 long 1 long vibrate 1 long vibrate 1 Alerts vibrate 1 vibrate 1 short medium beep low beep 1 medium melody beep Dexcom G4 PLATINUM User s Guide 81 The following steps show you how to access and choose the profile you want to set 1 Press the SELECT button to turn on the receiver The 3 hour trend graph will appear 2 Press the SELECT button to display the main menu 3 From the main menu press the UP or DOWN button to scroll to Profiles and press the SELECT button The profiles menu will appear Main Menu Start Sensor ry Enter Bt Profiles mec 4 Press the UP or DOWN button to scroll to the profile you want to set and press the SELECT bu
48. ation Dexcom G4 PLATINUM User s Guide 43 Throughout the 2 hour startup period if you see the out of range Y symbol at the top of the screen review the following troubleshooting tips Make sure your receiver and transmitter are within 6 meters of each other Check in 10 minutes to see if the antenna symbol reappears in the upper left corner of the receiver screen If the receiver and transmitter are still not communicating check the device information screen to make sure the correct transmitter ID is entered into your receiver see Chapter 2 Section 2 3 Checking Information About Your Receiver If the correct transmitter ID has been entered into your receiver and the receiver and transmitter are still not communicating then contact your local distributor At the end of the 2 hour startup period the receiver will let you know that it is time to calibrate your sensor Chapter 4 Calibrating Your Dexcom G4 PLATINUM System tells you how to calibrate your sensor 3 9 TAPING THE SENSOR POD The sensor pod should stay securely attached to your skin using its own adhesive But if the patch is peeling up you can use medical tape such as Blenderm Tegaderm IV 3000 3M tape for extra support If you use tape only tape over the white adhesive patch on all sides for even support Do not tape over the transmitter or any of the plastic parts of the sensor pod Do not tape under the sensor pod or leave any substance on the skin
49. ation prompt If this screen reappears shortly after you have entered a new blood glucose value see Chapter 9 Section 9 2 Calibration Troubleshooting 4 5 OTHER REASONS YOU MAY NEED TO CALIBRATE When your system did not accept the last calibration e When your blood glucose value is very different from the sensor glucose reading 1 When you see this calibration prompt it means it is time to calibrate with a single blood glucose value 2 Take 1 blood glucose measurement with your meter and enter the blood glucose into the receiver If this screen reappears shortly after you have entered a new blood glucose value see Chapter 9 Section 9 2 1 Types of Calibration Prompts Calibration prompt HELPFUL HINT If you see these screens they are indicating calibration errors see Chapter 9 Section 9 3 Calibration Error Troubleshooting 15 minute calibration 1 hour calibration error screen error screen 54 Dexcom G4 PLATINUM Continuous Glucose Monitoring System chapter five SENSOR GLUCOSE READINGS AND TRENDS This chapter will teach you how to view your sensor glucose readings and trend information The trend graph will provide additional information that your blood glucose meter does not It shows your current glucose value the direction it is changing and how fast it is changing The trend graph can also show you where your glucose has been over time Taking acetaminophen paracetamol containing pro
50. below 70 mg dL 3 9 mmol L approximately 14 of the time within the 30 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 minutes before or after the blood glucose was at or below the alert settings Table 3 A or within 30 minutes before or after the blood glucose was at or below the alert settings Table 3 B 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 Dexcom G4 PLATINUM User s Guide 133 Methodology for the Hypoglycemia Detection Rate includes if the sensor glucose value is at or below the low alert level 15 or 30 minutes before and 15 or 30 minutes after the actual low glucose event This does not include any predictive alert contribution For example if you set the Low Glucose alert to 70 mg dL 3 9 mmol L how often will your alarm alert you if your blood glucose goes below 70 mg dL 3 9 mmol L If your blood sugar goes below 70 mg dL 3 9 mmol L you can expect your alarm to sound 87 of the time and not to sound approximately 13 of the time w
51. dings do not fit with your symptoms you should measure your blood glucose with a blood glucose meter In a pediatric clinical study larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study Use your blood glucose meter for treatment decisions In a pediatric clinical study a significant number of low glucose events were not detected by CGM Do not rely solely on CGM alerts to detect low glucose Your sensor glucose readings may be inaccurate if you calibrate less than every 12 hours e Sensors may fracture on rare occasions If a sensor breaks and no portion of it is visible above the skin do not attempt to remove it Seek professional medical help if you have symptoms of infection or inflammation redness swelling or pain at the insertion site If you experience a broken sensor please report this to your local distributor The Dexcom G4 PLATINUM System is not approved for use in pregnant women or persons on dialysis e Sensor placement is not approved for sites other than under the skin of the belly abdomen or in the case of patients between the ages of 2 and 17 the belly or upper buttocks If your transmitter or receiver case is damaged cracked do not use them as this could create an electrical safety hazard or malfunction The sensor and transmitter include small parts that may pose a choking hazard Keep the tr
52. dium or heavy and duration up to 360 minutes for any particular date and time 1 From the events menu press the UP or DOWN button to choose Exercise and press the SELECT button Events 2 Press the UP or DOW N button to choose your exercise intensity level and press the SELECT button Exercise Type 3 Press the UP or DOWN button to enter your exercise duration 0 360 minutes and press the SELECT button The number that first appears on this screen is the default amount of 30 minutes Exercise 30 minutes 4 Check that the date and time for this entry are correct Press the SELECT button to confirm the entry 5 You will advance to the event confirmation screen Exercise Press the LEFT or RIGHT button to choose either OK to confirm this entry or Cancel to discard Light 30 min this entry and then press the SELECT button You 2010 01 15 will return to the events menu 23 47 Dexcom G4 PLATINUM User s Guide 89 7 7 1 6 HEALTH The health event lets you enter episodes of illness stress high symptoms low symptoms cycle menstrual or alcohol consumption for any particular date and time 1 From the events menu press the UP or DOWN button to choose Health and press the SELECT button Events 2 Press the UP or DOW N button to choose your health event and press the SELECT button 3 Check that the date and time for this entry are correct Press the SELECT button to
53. ducts such as Tylenol while wearing the sensor may falsely raise your sensor glucose readings The level of inaccuracy depends on the amount of acetaminophen paracetamol active in your body Your blood glucose meter and sensor measure your glucose from two different types of body fluids blood and interstitial fluid Therefore your readings from your blood glucose meter and sensor may not match HELPFUL HINTS The greatest benefit you receive from using your Dexcom G4 PLATINUM System will come from the trending information It is important that you focus on the trends and rate of change on your receiver rather than the exact glucose reading f you have difficulty reading your receiver in bright sunlight you may need to seek a shady location used for treatment decisions such as how much insulin you should take The Dexcom G4 PLATINUM System does not replace a blood glucose meter Blood glucose values may differ from sensor glucose readings The direction rate of glucose change and trend graph on your Dexcom G4 PLATINUM System provide additional information to help with your diabetes management decisions The blood glucose value from your blood glucose meter should be Dexcom G4 PLATINUM User s Guide 57 5 1 Sensor Glucose Readings Press the SELECT button to wake up the receiver screen You will see the home screen which is the 3 hour trend graph The 3 hour trend graph will show the following Most rec
54. e SELECT button to clear the alert or until your sensor glucose readings drop below your high glucose alert level You can choose to have the receiver re alert you after clearing the alert by changing your snooze settings see Chapter 6 Section 6 2 Advanced Alerts High glucose alert setting Dexcom G4 PLATINUM User s Guide 69 6 1 4 LOW GLUCOSE ALERT When your sensor glucose readings are at or below your low alert level this screen will appear with your low glucose alert value displayed Your receiver will vibrate and or beep depending on your profile setting When you set the low glucose alert this level is indicated by a red line on the trend graph Low glucose alert set at 4 4 mmol L The receiver will continue to alert you until you press the SELECT button to clear the alert or until your sensor glucose readings rise above your low glucose alert level You can choose to have the receiver re alert you after clearing the alert by changing your snooze settings see Chapter 6 Section 6 2 Advanced Alerts m 1 18 00 Low glucose alert setting HELPFUL HINTS When you have both your high and low alerts turned on there will be a gray zone on your trend graphs indicating your target range f your high or low alert is turned off this gray zone will not appear 70 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 6 1 5 LOW GLUCOSE ALARM The Dexcom G4 PLATINUM System also has a fi
55. e between the System reading and the YSI value For example if the YSI value is 100 mg dL 5 6 mmol L and the System reading is 90 mg dL 5 0 mmol L 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 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 devices it tells you if the System reads higher or lower on average than the YSI at 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 These accuracy measures in differences are based on 9152 paired glucose results and summarized in the following Table 2 Overall the System reads on average 13 396 absolute different Mean Absolute Difference than the reference values The Median Absolute Percent Difference shows that half of the time the System reads about 9 8 or le
56. e receiver may detect a series of issues with your sensor signal where it can no longer determine your glucose reading At this time the sensor session will end and show the screen to the right If you see this screen it means your Sensor Failed continuous glucose monitoring session has ended Replace Senso Press the SELECT button to clear this screen L You will need to remove your sensor and insert a new sensor 9 6 2 MANUAL SENSOR SHUT OFF STOP SENSOR There may be times that you will want to manually stop your sensor session before the end of the seven days Some of these times may include removing the sensor early due to e Calibration issues that cannot be resolved e icon that does not resolve e Sensor adhesion issues e Lifestyle needs HELPFUL HINTS e Based on whether you are in an active sensor session the main menu options will change When you are in an active sensor session you will not see the Start Sensor option on the main menu When you are not in an active sensor session you will not see the Stop Sensor option on the main menu e Remember to stop your sensor session if you remove your sensor before the end of the full 7 day period 106 Dexcom G4 PLATINUM Continuous Glucose Monitoring System manually end your sensor session select Stop v w Sensor from the main menu Man Menu gt Settings shutdown Stop Sensor 2 With OK highlighted
57. eiver in its carrying case or otherwise protected Charge the receiver when the battery gets low Keep the micro USB port cover closed to help prevent fluid from getting inside the receiver Accessories Insert cables only as directed Do not force cables in place Observe cables for signs of wear and tear Only use Dexcom supplied parts including cables and chargers Use of non Dexcom supplied parts may affect safety and performance There is no repair service available for your Dexcom G4 PLATINUM CGM System If you experience problems with your system contact your local distributor Dexcom G4 PLATINUM User s Guide 113 10 2 STORAGE Sensor Keep the sensor in its sterile packaging until you are ready to use it Do not insert sensors past the Use By Date The Use By Date format is YYYY MM DD Sensors must be inserted on or before the end of the calendar day printed on the sensor package label Storage temperature should be 2 C 25 C You may store your sensors in the refrigerator if it is within this temperature range Sensors should not be stored in a freezer e Store at humidity levels between 0 95 relative humidity Transmitter Keep the transmitter clean and protected when not in use Storage temperature should be 0 C 45 C e Store at humidity levels between 10 95 relative humidity Receiver Keep the receiver clean and protected when not in use Fully charge battery bef
58. ely to be bumped pushed or compressed or areas of skin with scarring tattoos or irritation as these are not ideal sites to measure glucose Awoid injecting insulin or placing an insulin pump infusion set within 7 62 cm of the sensor in case the insulin affects the sensor glucose readings Reviewing the tutorial disc would be helpful to learn how to insert your sensor Choose a site to place the sensor Adults age 18 or older insert in the belly front of body option A Children and adolescents between 2 and 17 years old insert in the belly front of body option A or the upper buttocks back of body option B No other sensor insertion sites have been tested Front of body sensor site option A Back of body ages 2 and older sensor site option B ages 2 17 only Dexcom G4 PLATINUM User s Guide 37 The ideal sensor insertion site for you may be based on your body type activity sensitivities and other personal traits You can choose a site above or below your belt line The best areas to insert your sensor are usually flat and pinchable Avoid sensor insertion where something may rub or press against the sensor For example avoid sensor insertion along the waist band and seat belt strap in or near the belly button on the upper buttocks near the waist belt or too low on the buttocks where you sit Choose an area that is at least 7 62 cm from where you plan to inject insulin or from where your pump i
59. ensor pod but do not place the tape over the transmitter or the plastic parts of the sensor pod or where the needle inserts the sensor 9 2 CALIBRATION TROUBLESHOOTING Calibration prompts may appear during your sensor session Review the following troubleshooting tips to have a successful calibration HELPFUL HINTS Make sure the receiver and transmitter are communicating when you calibrate The 7 icon should not appear in the status area Make sure the icon does not appear in the status area when you calibrate Make sure your blood glucose values are between 2 2 and 22 2 mmol L before you calibrate Prior to obtaining a blood glucose value to be used for calibration wash your hands make sure your glucose test strips are not expired and have been stored properly and that your meter is properly coded if required Carefully apply the blood sample to the test strip following the instructions provided with your meter or test strips Make sure you have not taken any medications containing acetaminophen paracetamol such as Tylenol Make sure your transmitter is fully snapped in to your sensor pod See Chapter 4 Calibration for further information 100 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 9 2 1 TYPES OF CALIBRATION PROMPTS This section describes the three blood drop symbols you will see The next section describes what to do when you see one of these symbols Startup calibration pr
60. ent 5 minute Battery status M glucose reading Trend arrow Status area Antenna TE High glucose alert setting Glucose Glucose ii target range md Low glucose alert setting 19 00 20 00 Current time Each dot on the trend graph is a sensor glucose reading reported every 5 minutes The trend graph shows the current time The display light is activated with a press of any button The status area shows needed calibration updates calibration errors and sensor glucose reading issues Your high alert setting will be displayed as a yellow line across the trend graph Your low alert will be displayed as a red line across the trend graph The gray zone highlights your target glucose range based on your individualized settings for high and low glucose alerts Your current glucose reading will be red if it is low and yellow if it is high based on your high and low glucose alert settings The dots on your trend graph will also change colors based on your high and low alert settings f your low glucose alert is not set and your glucose is 3 1 mmol L or lower your glucose value will be red If your sensor glucose readings are in between your high and low glucose alert settings the glucose value will be white 58 Dexcom G4 PLATINUM Continuous Glucose Monitoring System You can view your past glucose information through the 1 3 6 12 and 24 hour trend graphs by pressing
61. ercent difference from the SMBG values was calculated The percentages of total readings within 20 mg dL 1 1 mmol L or 20 30 mg dL 1 7 mmol L or 30 or 40 mg dL 2 2 mmol L or 40 were then calculated Table 7 System Difference to SMBG within CGM Glucose Ranges CGM Glucose Number of Mean Absolute Median Absolute Ranges dice paired Difference Difference mmol L CGM SMBG 40 400 2 2 2 22 2 7508 14 0 11 0 40 80 1699 11 2 mg dL 8 0 mg dL 2 2 4 4 0 62 mmol L 0 44 mmol L Overall the System reads on average 14 0 absolute different Mean Absolute Percent Difference than the SMBG values The Median Absolute Percent Difference shows that half of the time the System reads about 11 0 or less different than SMBG values Table 7 Adverse Events No serious adverse events or device related serious adverse events occurred during the study Mild skin irritation such as erythema or edema occurred in low frequency around adhesive area No infection bruising or bleeding occurred at the sensor needle insertion area or the adhesive area 11 2 2 SYSTEM PERFORMANCE IN PEDIATRICS Clinical Study Overview The System performance was evaluated in a prospective clinical study 30 participants were enrolled All participants had Type 1 or Type 2 diabetes mellitus and required insulin to manage their diabetes About 97 of participants had Type 1 diabetes and about 3 had Type 2 diabetes The average a
62. ery follow the instructions below 1 Plug the included USB cable into the AC power adapter 2 Plug the AC power adapter into an AC power outlet 3 Slide open the USB port cover on the side of the receiver to access the port 4 Plug the micro USB end of the cable into the receiver USB port Keep the USB port cover on the receiver closed whenever the USB cable is not attached 5 The battery charging screen will appear on the receiver 6 After a few seconds the trend graph will reappear with the battery charging symbol 8 shown in the upper left corner Dexcom G4 PLATINUM User s Guide 19 1 4 2 CHARGING YOUR RECEIVER BATTERY FROM WINDOWS COMPATIBLE COMPUTER The Dexcom Studio software must be installed to charge your receiver from a computer 1 Plug the included USB cable into your computer 2 Plug other end of the USB cable into the receiver 3 The battery charging screen will appear on the receiver 4 After a few seconds the trend graph will reappear with the battery charging symbol shown in the upper left corner HELPFUL HINT Charge only from a USB port on your computer or the AC power adapter Do not use an external USB hub An external USB hub may not provide enough power to charge the receiver 20 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 1 4 3 KNOWING YOUR RECEIVER IS CHARGED As the battery charges the battery symbol will begin to fill in The battery i
63. es greater than 80 mg dL 4 4 mmol L the absolute percent difference from the SMBG values was calculated The percentages of total readings within 20 mg dL 1 1 mmol L or 20 30 mg dL 1 7 mmol L or 30 or within 40 mg dL 2 2 mmol L or 40 within glucose measurable ranges were then calculated Table 1 The total number of data pairs considered in this analysis was 1882 Of these seventy seven percent 77 of the sensor readings fall within 20 mg dL 1 1 mmol L of the SMBG glucose values lt 80 mg dL i e 4 4 mmol L and within 20 of SMBG glucose values gt 80 mg dL i e 4 4 mmol L Table 1 Percentage of CGM Readings Within SMBG Values Glucose Number of Ranges Matchec Percent Percent Percent mg dL j within 20 20 within 30 30 within 40 40 Pairs mmol L 40 400 A 2 2 22 2 1882 77 90 95 138 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Accuracy Accuracy between matched pairs was also estimated by calculating the percent difference between the sensor reading and the SMBG value For example if the reference value is 100 mg dL 5 6 mmol L and the sensor reading is 90 mg dL 5 0 mmol L a 10 difference between the sensor and the SMBG value is reported In the example above the sensor reading is less than the SMBG value so the percent difference reading is negative The absolute percent difference tells you the relative difference in percentage or relative distance between the
64. f the safety lock is facing down the direction away from the removal arrow as shown below Dexcom G4 PLATINUM User s Guide 95 Safety lock Removal l arrow h from applicator Sensor pod with safety lock Sensor pod snapped in tab wings Sensor pod tabs 4 Insert the jagged edges so that they hug the wide end of the transmitter in the sensor pod Press the safety lock down until you cannot press down anymore and the transmitter will pop out of the sensor pod 5 Remove the transmitter clean it see Chapter 10 Section 10 1 Maintenance and store it in a cool dry place until your next glucose monitoring session Method 2 If you did not save the safety lock you can simply use your fingers to spread out the tabs at the back of the sensor pod end closest to the sensor pod tab wings The transmitter will pop out of the sensor pod 96 Dexcom G4 PLATINUM Continuous Glucose Monitoring System ne TROUBLESHOOTIN This chapter provides helpful tips and instructions to resolve issues you may experience while using your Dexcom G4 PLATINUM CGM System HELPFUL HINT e If the troubleshooting steps in this chapter do not fix your issue contact your local distributor 9 1 SENSOR INSERTION TROUBLESHOOTING Sensor insertion difficulties am having trouble taking out the safety lock Make sure to pull the safety lock straight out away from your body Use the arro
65. from the transmitter to the receiver is up to 6 meters without obstruction Wireless communication does not work well through water so the range is much less if you are in a pool bathtub water bed etc e Sensors should be stored at temperatures between 2 C 25 C for the length of the shelf life You may store your sensors in the refrigerator if it is within this temperature range Sensors should not be stored in a freezer Keep the USB port cover on the receiver closed whenever the USB cable is not attached The receiver may malfunction if water gets into the USB port Dexcom G4 PLATINUM User s Guide 9 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM SYSTEM KIT CONTENTS 5 INTRODUCTION 6 INDICATIONS FOR US Bossa rio eens eae ee 7 IMPORTANT USER 7 CHAPTER 1 THE DEXCOM G4 PLATINUM SYSTEM BASICS 13 14 Sensor Overview 15 1 2 Transmitter en ee 15 1 3 Receiver OveEVieW area een 16 1 4 Charging Your Receiver sun 18 1 4 1 Charging Your Receiver Battery from an AC Power Outlet 18 1 4 2 Charging Your Receiver Battery from a Windows Compatible COME Tee ee ee ers 20 1 4 3 Knowing Your Receiver is 21 CHAPTER 2 DEXCOM G4 PLATINUM SYSTEM SETUP 23 21 The Setup WIZSEC een 25 2 2 The Setinds essen 28 2 2 1 Get
66. ge of study subjects was 12 years old the youngest subject was 2 years of age and the oldest subject was 17 years of age Dexcom G4 PLATINUM User s Guide 137 Participants used the System for seven days each participant wore 2 sensors Sensors were calibrated approximately once every 12 hours using the SMBG values obtained from the Lifescan OneTouch Verio IQ meter Throughout the 7 day wear period the Sensor was calibrated with an average of 2 fingersticks per day The study took place at home the System performance was also paired with the comparative meter results and that is referred to as the reference SMBG Agreement Agreement between the System and blood glucose values is characterized using paired sensor and SMBG values The sensor and SMBG results were compared by pairing the SMBG to a sensor glucose reading that occurred immediately after the SMBG was collected within 5 minutes These results present the performance patients 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 The agreement of the sensor to reference glucose value was assessed by calculating the percentage of sensor readings that were within 20 30 and greater than 40 of the SMBG values For readings less than or equal to 80 mg dL 4 4 mmol L the absolute difference in mg dL mmol L between the two glucose results was calculated For valu
67. he FALLING single arrow screen will appear and the receiver will vibrate or beep according to your profile settings Fall alert If you set your rise rate to 0 17 mmol L per minute and your sensor glucose readings rise at this rate or faster the RISING double arrow screen will appear and the receiver will vibrate or beep according to your profile settings RISI NG Rapid rise alert Dexcom G4 PLATINUM User s Guide 75 The following steps show you how to change your rise or fall rate alert settings 1 76 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Press the UP or DOWN button to choose Rise Rate or Fall Rate and press the SELECT button Press the UP or DOWN button to highlight On Off then press the SELECT button Press the UP or DOWN button to choose On or Off Then press the SELECT button to select On or Off Press the LEF I button to go back to the previous screen Press the UP or DOWN button to select Level then press the SELECT button Choose whether the alerts should be delivered when your glucose levels are rising falling either 0 11 mmol L min 0 11 mmol L or more per minute or 0 17 mmol L min 0 17 mmol L or more per minute Press the SELECT button When finished press the LEFT button to return to the alerts menu Advanced E Low Snooze E Rise Rate Fal Rate LY On OF On 0 11 mmol L min Fal
68. he elapsed time after which the receiver will alert you and continue to re alert you until you are back in range Press the SELECT button 30 5 When finished press the LEFT button to return to the alerts menu minutes Out of Range a 6 3 ALERT PROFILES The Dexcom G4 PLATINUM System allows you to set profiles to choose the way you want your alerts to 4 behave This customizable feature is found under the Start Sensor Profiles option on the Main Menu shown to the right ry Enter BG ll Profiles You can set your profile to the sound pattern and the volume level that best fits your lifestyle needs Depending on your daily activities you can quickly and easily change the way your system alerts you by changing your profile settings Your profile options are 1 Vibrate 2 Soft 3 Normal 4 Attentive 5 HypoRepeat For each profile option you will first be alerted by a vibration When you choose your profile setting it is important to know this setting will apply to all alerts alarms and prompts Within each profile setting each specific alert will have its own unique sound pattern tone and volume level This allows you to easily identify each alert and alarm and its meaning 78 Dexcom G4 PLATINUM Continuous Glucose Monitoring System HELPFUL HINTS On the first alert notification the receiver will vibrate only no beep Regardless of the specific alert profile you chose if you co
69. iled list of these other alerts 68 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 6 1 2 GLUCOSE ALERTS The Dexcom G4 PLATINUM System lets you create your own personal settings for how you want the receiver to tell you what is going on The low and high glucose alerts will tell you when your sensor glucose readings are outside your target glucose range Rise and fall rate of change alerts let you know when your glucose levels are changing fast see Chapter 6 Section 6 2 Advanced Alerts The Dexcom G4 PLATINUM System also features a low glucose alarm that cannot be adjusted or turned off and is set at 3 1 mmol L This is a safety feature telling you your glucose level may be dangerously low In addition to the alert screens that appear on your receiver display you can also set high and low glucose alerts to notify you with vibrations and beeps This feature can be helpful during times such as sleeping driving exercising or during meetings 6 1 3 HIGH GLUCOSE ALERT When your sensor glucose readings are at or above your high alert level this screen will appear with your high glucose alert value displayed Your receiver will vibrate and or beep depending on your profile setting see Chapter 6 Section 6 3 Alert Profiles When you set the high glucose alert this level is indicated by a yellow line on the trend graph High glucose alert set at 11 1 mmol L The receiver will continue to alert you until you press th
70. ing 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 Adjusted within each system wear day the System provided an average of 97 of all expected glucose readings 288 Agreement and Accuracy Relative to SMBG During the study agreement between the System and blood glucose values is also characterized using paired System and SMBG results 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 patients 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 Table 6 System Agreement to SMBG within CGM Glucose Ranges Percent Percent Percent within within within CGM Glucose Number of Ranges mg dL paired 0 0 20 20 30 30 40 40 SMBG SMBG SMBG 40 400 22222 7508 81 94 98 40 80 A 2244 1699 85 94 97 136 G4 PLATINUM Continuous Glucose Monitoring System Table 6 is categorized within CGM glucose ranges For readings less than or equal to 80 mg dL 4 4 mmol L the absolute difference in mg dL mmol L between the two glucose results was calculated For values greater than 80 mg dL 4 4 mmol L the absolute p
71. inutes The System was evaluated in a clinical study in which System readings were compared 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 patients 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 G4 PLATINUM System 11 2 1 SYSTEM PERFORMANCE IN ADULTS Clinical Study Overview The System performance was evaluated in a prospective clinical study 72 participants were enrolled All participants had Type 1 or Type 2 diabetes mellitus and required insulin or oral medication to manage their diabetes About 83 of participants had Type 1 diabetes and about 17 of participants had Type 2 diabetes The study included subjects greater than 18 years of age Participants used the System for seven days Thirty six participants each wore 2 sensors Sensors were calibrated approximately once every 12 hours using the self monitoring blood glucose SMBG meter values obtained from the LifeScan OneTouch Ultra2 meter Throughout the 7 day wear period the sensor was Calibrated with an average of 2 fingersticks per day approximately once every 12 hours
72. ion mg dL mmol L Rate Rate 55 3 1 50 50 71 29 60 3 3 64 36 75 25 70 3 9 79 21 83 17 80 4 4 87 13 86 14 90 5 0 90 10 89 11 100 5 6 93 7 90 10 132 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Table 3 B Hypoglycemic Alert Evaluation 30 Minutes Before and After Hypoglycemia Hypoglycemia Hypoglycemic True Alert False Alert Alert Level Rate Rate Detection Missed Detection mg dL mmol L Rate Rate 55 3 1 62 38 75 25 60 3 3 74 26 79 21 70 3 9 86 14 87 13 80 4 4 93 7 90 10 90 5 0 94 6 92 8 100 5 6 96 4 93 7 Hypoglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong The True Alert Rate is the of time the device alarmed when the blood glucose level was at or below the alert setting within 15 minutes before or after the device alarmed Table 3 A or within 30 minutes before or after the device alarmed Table 3 B 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 3 9 mmol L and your alarm sounds how often can you expect your blood sugar to actually be low If your alarm sounds you can expect your blood sugar to be below 70 mg dL 3 9 mmol L approximately 86 of the time and not be
73. ithin the 30 minute period before or after your blood sugar goes below 70 mg dL 3 9 mmol L The High Glucose Alert Estimates of how well the adjustable High Glucose Alert performs are presented in Table 4 Table 4 Hyperglycemic Alert Evaluation Hyperglycemic Alert Level Hyperglycemia Missed Detection True Alert False Alert Hyperglycemia mg dL mmol L Rate Rate Detection Rate Rate 120 6 7 95 5 98 2 140 7 8 94 6 97 3 180 10 0 92 8 97 3 200 11 1 92 8 97 3 220 12 2 91 9 95 5 240 13 3 91 9 94 6 300 16 7 82 18 86 14 Hyperglycemia Alert Rate The Alert Rate shows how often the alert is right or wrong The True Alert Rate is the of time the device alarmed when the blood glucose level was at or above the alert setting within 15 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 minutes before or after the device alarmed For example if you set the High Glucose alert to 200 mg dL 11 1 mmol L and your alarm sounds how often can you expect your blood sugar to actually be high If your alarm soulds you can expect your blood sugar to be at or above 200 mg dL 11 1 mmol L approximately 8 of the time within the 15 minute period before or after your alarm sounds 134 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Hyperglyce
74. larm Low 3 1 Notifies with vibrate and beep Cannot be changed What will see on the receiver screen Prompt alert or alarm What does this mean How will the receiver notify me vibrate and or Will the receiver re notify me Low Your most recent Vibrates 4 Yes every glucose sensor glucose times then 30 minutes alarm reading is at or vibrates beeps after each below 3 1 mmol L 4 times every confirmation five minutes until until your confirmed or your blood glucose glucose value value comes goes above 3 1 back into mmol L range High Your most recent Vibrates twice No unless glucose sensor glucose then vibrates you have alert reading is at or beeps twice every turned on the above the high alert 5 minutes until high snooze setting confirmed or your feature See glucose value Chapter 6 2 drops below the Advanced alert level Alerts Low Your most recent Vibrates three No unless you glucose sensor glucose times then have turned on alert reading is at or vibrates beeps the low snooze below the low alert three times every feature See setting 5 minutes until chapter See confirmed or your Chapter 6 2 glucose value Advanced goes above the Alerts alert level Low The receiver battery Vibrates once Yes at 1096 battery is low Charge your at 20 battery battery alert receiver as soon as capacity left capacity left possible when you see this alert
75. lect High Alert or Low Alert and c press the SELECT button ds High Alert 55 Advanced 2 Press the UP or DOWN button to highlight On Off then press the SELECT button to set this option Malls Miu check mark will appear next to the current setting On Off m Level 11 1 mmol l 3 Press the LEFT button to return to the previous screen 4 Press the DOVVN button to highlight Level The number displayed is your current high glucose alert value setting To change this number press the SELECT button and then press the UP or DOWN button until your desired high glucose alert value is IL mmoljl displayed then press the SELECT button Your high glucose alert value can be set between 6 7 and 22 2 mmol L in 0 1 mmol L increments On Off High Alert Zu Your low glucose alert value can be set between 3 3 and 5 5 mmol L in 0 1 mmol L increments 11 mmol L 72 Dexcom G4 PLATINUM Continuous Glucose Monitoring System HELPFUL HINT Alerts must be acknowledged by pressing the SELECT button on the receiver 6 2 ADVANCED ALERTS In addition to your high and low alerts and alarm the high and low snooze rise and fall rate and out of range alerts may be set For any of these advanced alerts follow the steps below 1 Turn the receiver on by pressing the SELECT button 2 Press the SELECT button to enter the main menu 3 Press the UP or DOWN button to highlight Alerts and
76. lectronic equipment RF emissions Class B The Dexcom G4 PLATINUM System is suitable for use in all establishments Sn other than domestic establishments and Harmonic emissions Not applicable those directly connected to the public IEC 61000 3 2 low voltage power supply network that supplies buildings used for domestic Voltage fluctuations Not applicable purposes flicker emissions IEC 61000 3 3 126 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 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 below according to the maximum output power of the communications equipment Rated Separation Distance maximum According to Frequency of Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2 vP d 1 2 vP d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 23 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equatio
77. lucose meter You can use any commercially available meter for obtaining blood glucose values to enter into your receiver BG Value Blood glucose value A blood glucose value taken with your commercially available blood glucose meter Calibration This is when you enter blood glucose values from a blood glucose meter into the receiver Calibrations are needed for your receiver to display continuous sensor glucose readings and trend information Do not use alternative site testing for calibration CGM Continuous Glucose Monitoring Default A setting that is selected automatically unless another option is chosen 4 The sensor transmitter and receiver PLATINUM System ej 8 15 tr This can happen when the receiver does not display a glucose reading that is sent from the transmitter A symbol will appear instead of a glucose reading to let you know that the receiver cannot display a reading Glucose Trends Trends let you see the pattern of your glucose levels you can see where your glucose levels have been and where your glucose levels are The graph shows glucose trends over the amount of time shown on the screen mmol L Millimoles per liter The international standard unit of measuring blood glucose levels Profiles Sound pattern and volume level settings for your alerts 152 Dexcom G4 PLATINUM Continuous Glucose Monitoring System GLOSSARY continued Re alert
78. magnetic Immunity The transmitter is intended for use in the electromagnetic environment specified below The customer or the user of the transmitter should ensure that it is used in such an environment Immunity Test IEC 60601 Test Level Transmitter Compliance Level Electromagnetic Environment Guidance Electrostatic 6 kV Contact 6 kV Contact Floors should be wood Discharge concrete or ceramic tile ESD Saal If floors are covered with re synthetic material the IEC 61000 4 2 relative humidity should be at least 30 Electrical Fast 2 kV for power Not applicable Transient supply lines burst 1 kV for input output Battery IEC 61000 4 4 lines operated Surge 1 kV line s to line s Not applicable IEC 61000 4 5 2 kV line s to earth Battery operated Voltage lt 5 Not applicable FRE Dips Short gt 95 dip in U_ for Battery Interruptions 0 5 cycle operated and Voltage Variati 40 U 60 dip in J for 5 Power Supply T A cycles Input Lines 70 U IEC 61000 4 11 309 dip in U for 25 cycles lt 5 U gt 95 dip U for 5 sec Power 3 A m 3 A m Power frequency Frequency magnetic fields should 50 60 Hz be at levels characteristic ue of a typical location in Magnetic Field E a typical commercial or IEC 61000 4 8 hospital environment Note U is the a c mains voltage prior to application of the test level
79. ment This device complies with Industry Canada license exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Hinia Model 9438 01 9438 05 Dimensions including Length 3 8 cm Length 3 8 cm sensor pod Width 2 3 cm Width 2 3 cm Thickness 1 3 cm Thickness 1 0 cm Weight including 11 3g 8 5 sensor pod Power Supply Silver oxide batteries not replaceable Temperature 10 42 Humidity 10 95 RH Dexcom G4 PLATINUM User s Guide 119 Transmitter Storage Conditions Operating Altitude Limited Warranty Moisture Protection Protection Against Electrical Shock Temperature 0 C 45 C Humidity 10 95 RH 152 to 3657 meters 6 months IP28 temporary submersion Type BF applied part 2 424 999 877 GHz TAX regnis 2 477 236 919 GHz Bandwidth 334 7 kHz Maximum Output Power 1 25 mW EIRP Modulation Minimum Shift Key Data Rate 49 987 Kbits Sec Total Packet 224 bits 4 48 ms every 5 minutes at each of the Transmit Duty Cycle four TX frequencies Data Detection Range 6m 120 Dexcom G4 PLATINUM Continuous Glucose Monitoring System Guidance and Manufacturer s Declaration Electro
80. mia 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 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 minutes before or after the blood glucose was at or above the alert setting For example if you set the High Glucose alert to 200 mg dL 11 1 mmol L how often will your alarm alert you if your blood glucose goes at or above 200 mg dL 11 1 mmol L If your blood sugar goes above 200 mg dL 11 1 mmol L you can expect your alarm to sound 97 of the time and not to sound approximately 3 of the time within the 15 minute period before or after your blood sugar goes above 200 mg dL 11 1 mmol L Sensor Stability Sensors can be worn for up to 7 days To verify sensor performance over time 108 sensors were evaluated across the 7 day wear period Performance was estimated by calculating the percentage of System readings within 20 mg dL 1 1 mmol L or 20 30 mg dL 1 7 mmol L or 30 or 40 mg dL 2 2 mmol L of the YSI values at the beginning Day 1 middle Day 4 and end Day 7 of the System lifecycle The average and media
81. mmunicating The antenna symbol should appear in upper left corner of trend graph If the out of range symbol Y appears in the upper right corner of the trend graph see Chapter 9 Section 9 9 Out of Range No Antenna HELPFUL HINTS The start sensor menu option will disappear from the main menu The option will only appear again after an active sensor session ends If you do not see the start sensor option on your menu screen you can continue that session or stop the session refer to Chapter 9 Section 9 6 Sensor Shut off Troubleshooting After starting a new sensor session you will not receive sensor glucose readings or alerts until your 2 hour startup period has ended and you have completed your initial calibrations See Chapter 4 Section 4 3 Startup Calibration 3 8 SENSOR STARTUP PERIOD The sensor needs a 2 hour startup period to adjust to being under the skin When you press the SELECT button during the startup period to turn the receiver display on your trend graph will include a 2 hour countdown symbol the upper right hand corner Over time the countdown symbol will fill to indicate that you are getting closer to initial calibration time See the pictures below for an example of what this looks like During the countdown period you will not get sensor glucose readings alerts and alarms 0 0 0 0 n Start 0 24 24 48 48 72 72 96 Ready for minutes minutes minutes minutes calibr
82. n 86 ZI SC 87 T T TM 88 e een ee ane TEUER MM E eee 89 90 7 2 Dexcom Studio 222222 90 CHAPTER 8 COMPLETING A SENSOR SESSION 91 8 1 Automatic Sensor 2 94 Dexcom G4 PLATINUM User s Guide 11 9 2 Removing a Sensor ansehe 8 3 Transmitter CHAPTER 9 TROUBLESHOOTING 9 1 Sensor Insertion 9 2 Calibration 9 2 1 Types of Calibration 222 2 9 2 2 Status Area Symbols During Calibration Prompts 9 3 Calibration Error 94 System Glucose EI Rienda i 9 5 Sensor INACCUTACIO SS 9 6 Sensor Shut off 9 6 1 Early Sensor Shut off Sensor 9 6 2 Manual Sensor Shut off Stop 9 7 Battery and Charger 9 8 Recei
83. n paracetamol active in your body Taking acetaminophen paracetamol containing products such as Tylenol while wearing the sensor may falsely raise your sensor glucose readings The level of inaccuracy depends on the amount of acetaminophen paracetamol active in your body Your sensor glucose readings may be inaccurate if you calibrate less than every 12 hours You must enter the exact blood glucose value that your blood glucose meter displays Enter all blood glucose values for calibration within 5 minutes Entering incorrect blood glucose values or blood glucose values that occurred more than 5 minutes ago will affect device performance and may cause inaccurate sensor glucose readings 52 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 4 3 STARTUP CALIBRATION Two hours after you start the sensor session see Chapter 3 Section 3 7 Starting a Sensor Session the receiver will tell you that you need to calibrate by displaying the startup calibration prompt This prompt means you need to calibrate with 2 separate blood glucose values from your meter You will not see sensor glucose readings until the receiver accepts the blood glucose values Startup calibration prompt 1 When you see this screen press the SELECT button to clear the display 2 Take 2 separate blood glucose measurements with your meter and enter the blood glucose values into the receiver see Chapter 4 Section 4 2 How to Calibrate 3
84. n such as a healthcare provider is helping you operate the receiver or transmitter the device should be disinfected before the second person uses it You will need gloves clean dry absorbent wipes 70 isopropyl alcohol wipes and several disinfectant wipes containing a 1 10 bleach solution Such as Alcavis Bleach Wipe 1 10 DIN 02333899 or Clorox Professional Disinfecting Bleach Wipes DIN 02349272 or sodium hypochlorite household bleach wipes Preparation 1 Use precaution when handling products worn or handled by another person 2 Wash hands thoroughly 3 Wear personal protective equipment as appropriate gloves protective goggles gowns etc 4 Close the receiver s USB port slide cover 5 The receiver is not waterproof Do not use a soaking wet cloth Disinfecting the receiver or transmitter 1 Wear gloves 2 Thoroughly pre clean the surface of any visible contamination with one disinfectant wipe wipe the front back and all four sides of the device 3 Thoroughly wet the surface of the device with a second disinfectant wipe to wipe the front back and all four sides of the device 4 The surface should remain wet for at least 1 minute at room temperature 21 C to ensure proper disinfection Use additional disinfection wipes to make sure the surface stays wet for the full minute 5 Dry the unit with a clean dry absorbent wipe 6 Wipe the outside of the device with a 70 isopropyl alcohol wipe to rem
85. n 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 manufacturer 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 Dexcom G4 PLATINUM User s Guide 127 Charging Cable Dexcom P N MT20655 Input Output 5V DC 1A Type USB Ato USB micro B Length 0 9m There is a separate AC wall charger adapter that can be connected to the USB charging download cable for charging using an AC power outlet Power Supply Charger Dexcom P N MT21255 Class 11 Input AC Input 100 240 Vac 50 60Hz 0 2 0 2A rms at 100Vac DC Output 5V DC 1A 5 0 Watts 128 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 11 2 DEVICE PERFORMANCE CHARACTERISTICS NOTE We recommend that you review the information in this chapter with your healthcare provider to understand how well the Dexcom G4 PLATINUM System performs The Dexcom G4 PLATINUM 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 and once calibrated the System reports glucose readings up to every 5 m
86. n of the absolute percent differences are included in Table 5 showing consistent accuracy and sensor stability over the 7 day life of the sensor Table 5 Sensor Stability Accuracy over Time Number Mean Median Percent Percent Percent of Paired Absolute Absolute within within within CGM YSI Percent Percent 20 20 30 30 40 40 Differences Differences YSI YSI YSI Day 1 3023 16 7 13 2 71 86 94 Day 4 3108 11 4 8 2 87 95 98 Day 7 3021 11 9 8 9 87 95 98 Dexcom G4 PLATINUM User s Guide 135 Precision of System Readings In the study 36 participants wore two Systems This was to look at how similarly two Systems function on the same patient Sensor precision Precision was evaluated by comparing the glucose readings from the two Systems worn on the same subject at the same time 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 Sensor Life Sensors may be worn for up to 7 days 168 hours To estimate how long a sensor will work over 7 days 108 sensors were evaluated to determine how many days hours of readings each sensor provided Ninety four percent 94 of the sensors lasted until Day 7 145 168 hours There were 6 4 sensors that ended early four of which lasted more than 3 days Number of Readings Provided The System is capable of providing a read
87. ned to provide reasonable protection against harmful interference in a 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 Reorient or relocate the receiving antenna Dexcom G4 PLATINUM User s Guide 141 Increase the separation between the equipment and receiver Connect the equipment into an outlet on a circuit different from that to which the receiver is connected 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 142 Dexcom G4 PLATINUM Continuous Glucose Monitoring System chapter twelve APPENDIX APPENDIX I RECEIVER ALERTS ALARM AND PROMPTS The following tables describe the alarm alerts and prompts and how the receiver notifies you Prompt Shows on screen only Silent no vibrate or beep Alert Notifies with vibrate and beep depending on your profile settings A
88. nfirm the initial vibrate alert you will not receive an additional audible alert fixed low alarm at 3 1 mmol L cannot be turned off or adjusted For the soft normal attentive HypoRepeat profiles the following alert sequence will occur The first alert is vibrate only e f the alert is not confirmed in five minutes the system will vibrate and beep e f the alert is not confirmed in five more minutes the system will vibrate and beep louder and this will continue at the same volume level every five minutes until confirmed For the HypoRepeat profile only e f the alert is confirmed and your sensor glucose readings continue to be at or below 3 1 mmol L your system will repeat the alert sequence above in 30 minutes To confirm any alert press the SELECT button Dexcom G4 PLATINUM User s Guide 79 6 3 1 ALERT PROFILE OPTIONS The vibrate profile can be used when you want to silence the receiver and be alerted by vibration The only exception to this will be with the fixed low alarm at 3 1 mmol L which will alert you as a vibration first followed by audible beeps 5 minutes later if not confirmed The soft profile can be used when you need your alert to be discreet This profile sets all the alerts and alarms to lower volume beeps which is intended to be less noticeable by people around you This normal profile is the default profile when you receive your system This profile sets all the alerts
89. nfusion site is located Avoid using the same spot repeatedly for sensor insertion Never use the same site for 2 sensor sessions in a row You may need to shave the area where you plan to put the sensor so that the adhesive patch sticks securely Make sure there are no traces of lotions perfumes or medications on the skin where you place the sensor For more help on ideal sensor insertion sites for you contact your health care provider 3 4 PLACING THE SENSOR 1 Clean the area first with an alcohol wipe Make sure the area is clean and completely dry before you insert the sensor NOTE Skin preparation or adhesive products Mastisol SkinTac are optional If you use an optional skin preparation or adhesive product place it on the skin in a doughnut shape where you will place the sensor adhesive patch Insert the sensor through the clean skin at the center of the doughnut where it is free of skin preparation or adhesive products Let dry skin may feel tacky 2 Using the white tabs on the adhesive backing remove the adhesive backing from the sensor pod one half at a time Hold the sensor by the applicator barrel and try not to touch the sticky adhesive patch 3 Place the sensor flat on your selected area Make sure the sensor is placed in the same direction shown in the picture below You should not place the sensor pointing in the up or down direction 38 Dexcom G4 PLATINUM Continuous Glucose Monitoring System
90. nter this blood glucose value as a calibration into your receiver The sensor glucose reading will correct over the next 15 minutes If you see differences between your sensor glucose readings and blood glucose values outside of this acceptable range follow the troubleshooting tips below before inserting your next sensor Make sure your sensor is not expired Make sure you do not calibrate when the or are displayed Do not use alternative blood glucose site testing blood from your palm or forearm etc for calibration as alternative site readings may be different than those obtained from a blood glucose value Use a blood glucose value obtained only from a fingerstick for calibration Only blood glucose values between 2 2 22 2 mmol L can be used for calibration If one or more of your readings entered was outside of this range the receiver will not calibrate You will have to wait until your blood glucose is in this range to calibrate 104 Dexcom G4 PLATINUM Continuous Glucose Monitoring System You should always use the same meter you routinely use to measure your blood glucose to calibrate Do not switch your meter in the middle of a sensor session Blood glucose meter and strip accuracy may vary between blood glucose meter brands Prior to obtaining a blood glucose value to be used for calibration wash your hands make sure your glucose test strips are not expired and have been stored properly and that your meter is
91. om your blood glucose meter should be used for treatment decisions such as how much insulin you should take The Dexcom G4 PLATINUM System does not replace a blood glucose meter Dexcom G4 PLATINUM Sensor Transmitter and Receiver must be removed prior to Magnetic Resonance Imaging MRI CT scan or diathermy treatment The Dexcom G4 PLATINUM System has not been tested during MRI or CT scans or with diathermy treatment and it is unknown if there are safety or performance issues Taking acetaminophen paracetamol containing products such as Tylenol while wearing the sensor may falsely raise your sensor glucose readings The level of inaccuracy depends on the amount of acetaminophen paracetamol active in your body Dexcom G4 PLATINUM User s Guide 7 WARNINGS Do not use the Dexcom G4 PLATINUM CGM System until after you have been trained or viewed the training materials included with your CGM system blood glucose value from your blood glucose meter should be used for treatment decisions such as how much insulin you should take The Dexcom G4 PLATINUM System does not replace a blood glucose meter Blood glucose values may differ from sensor glucose readings The direction rate of glucose change and trend graph on your Dexcom G4 PLATINUM System provide additional information to help with your diabetes management decisions e Symptoms of high and low glucose should not be ignored If your sensor glucose rea
92. ommercially distributed blood glucose BG meter required for use Make sure to use the correct version of Dexcom Studio with your system The sensor works with the Dexcom G4 PLATINUM family of products The Dexcom G4 PLATINUM Sensor Transmitter and Receiver are not compatible with the SEVEN SEVEN PLUS Transmitter and Receiver Dexcom G4 PLATINUM User s Guide 5 INTRODUCTION When you use the system you will see continuous sensor glucose readings updated every 5 minutes for up to 7 days These readings will help you detect trends and patterns in your glucose levels The system includes the sensor the transmitter and the receiver The sensor is a disposable unit that you insert under your skin to continuously monitor your glucose levels for up to 7 days The transmitter is a reusable device that wirelessly sends your sensor measured glucose information to your receiver The receiver is a hand held device that receives and displays your glucose information This user s guide describes how to use your system Please review this user s guide HELPFUL HINT Dexcom has developed an interactive self guided training tutorial for the Dexcom G4 PLATINUM CGM System based on well established adult learning principles Some people have found this to be an effective method of product training Please review the tutorial on the disc and discuss with your healthcare professional if the Dexcom G4 PLATINUM training tutorial is an appropriate
93. ompt This prompt means the receiver s 2 hour startup period is complete You need to enter two blood glucose values to calibrate the system and start receiving sensor glucose readings The receiver will continue to display the startup calibration prompt screen every 15 minutes until the receiver accepts the blood glucose values Startup calibration To clear this prompt press the SELECT button prompt Additional startup calibration prompt This prompt means you need to enter one more blood glucose value to calibrate the system and start receiving sensor glucose readings The receiver will continue to display the additional startup calibration prompt screen every 15 minutes until the receiver accepts the blood glucose values To clear this prompt press the SELECT button Additional startup blood drop prompt Calibration prompt This prompt means you need to enter one blood glucose value This prompt will appear when it is time for your 12 hour calibration update or any other time you may need to calibrate The receiver will continue to display this prompt screen every 15 minutes until the receiver accepts the blood glucose values Calibration prompt To clear this prompt press the SELECT button Dexcom G4 PLATINUM User s Guide 101 9 2 2 STATUS AREA SYMBOLS DURING CALIBRATION PROMPTS 1 Clear the prompt from the screen by pressing the SELECT button 2 Check the status area at the top of the screen
94. on to confirm the entry You will advance to the event confirmation screen Carbs Press the LEFT or RIGHT button to choose either OK to confirm or Cancel to discard this entry 50 grams and then press the SELECT button You will return 201 0 01 15 to the Events menu 23 46 Dexcom G4 PLATINUM User s Guide 87 7 7 1 4 INSULIN The insulin event lets you enter the amount of insulin you have taken up to 250 units You can only enter an insulin amount not the type of insulin taken 1 From the events menu press the UP or DOWN button to choose Insulin and press the SELECT MEM button Carbs P d Insulin Exercise Events 2 Press the UP or DOWN button to enter your insulin i F amount 0 250 units and press the SELECT button The number that first appears on this screen will be the last number you entered or the In default amount of 10 units mere Units 3 Check that the date and time for this entry are correct Press the SELECT button to confirm the entry 4 You will advance to the event confirmation screen Press the LEFT or RIGHT button to choose either Insulin OK to confirm this entry or Cancel to discard 10 00 Units this entry and then press the SELECT button You 201 0 01 15 will return to the Events menu 23 46 88 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 7 1 5 EXERCISE The exercise event lets you enter the intensity light me
95. ore storing for over 3 months Storage temperature should be 0 C 45 C Store at humidity levels between 10 95 relative humidity 10 3 CLEANING AND DISINFECTION Cleaning DO NOT clean the power supply charger Cleaning removes dirt from the surface of the device It does not kill bacteria or viruses The receiver and transmitter should be cleaned whenever they are visibly dirty and between each use You will need a soft water dampened cloth or an isopropyl alcohol wipe Cleaning the receiver or transmitter 1 Close the receiver s USB port slide cover 2 Wipe the outside of the device with a slightly damp cloth or isopropyl alcohol wipe 3 The receiver is not waterproof Do not use a soaking wet cloth 4 The transmitter is water resistant when snapped into the sensor pod but do not soak the transmitter by itself in liquid 5 Do not use soap nail polish remover or paint thinner Only use isopropyl alcohol and water 114 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 6 For cleaning do not use wipes that contain adhesives e g Smith Nephew IV Prep 7 Place the device on a clean dry cloth and air dry for 2 3 minutes Disinfection Disinfection removes and destroys microorganisms and pathogens from the surface of the device Disinfect the receiver and transmitter periodically or whenever you suspect that blood or body fluid has come in contact with the surface of the device If a second perso
96. ours after the initial startup calibration 3 More information needed or other reasons When calibrating you need to manually enter your blood glucose values into the receiver You can use any commercially available blood glucose meter On the first day of your sensor session you will need to enter 2 blood glucose values into your receiver as your 2 hour startup calibration After your 2 hour startup calibration has been entered you will need to enter 1 blood glucose value as your calibration at 12 hours after your startup calibration From that point on you will need to enter 1 blood glucose value every 12 hours The receiver will remind you when these calibrations are needed You may also be prompted to enter additional blood glucose values as needed An example of your minimum calibration schedule during a seven day sensor session is shown below Example Minimum Calibration Schedule During Seven Day Sensor Session Monday Day One of Sensor Session 8 00 10 00 22 00 Sensor 2 hr startup 12 hr update Insertion calibration calibration Tuesday Sunday Days 2 7 Sensor Session 10 00 22 00 12 hr update 12 hr update calibration calibration Dexcom G4 PLATINUM User s Guide 49 HELPFUL HINTS Do not use alternative blood glucose site testing blood from your palm or forearm etc for calibration as alternative site blood glucose values may be different than those obtained from a fingerstick blood glucose value U
97. ous Glucose Monitoring System a oO 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 television 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 G4 PLATINUM System is used exceeds the applicable RF compliance level above the Dexcom G4 PLATINUM 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 G4 PLATINUM System Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Dexcom G4 PLATINUM User s Guide 125 Guidance and Manufacturer s Declaration Electromagnetic Emissions The Dexcom G4 PLATINUM System is intended for use in the electromagnetic environment specified below The customer or the user of the Dexcom G4 PLATINUM System should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 1 The Dexcom G4 PLATINUM System CISPR 11 uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby e
98. ove any disinfectant residue 7 Dry the unit with a clean dry absorbent wipe Dexcom G4 PLATINUM User s Guide 115 8 Place the receiver screen side facing down on a clean dry cloth and air dry for 60 minutes 9 Place the transmitter on a clean dry cloth and air dry for 2 3 minutes 10 Remove gloves and dispose of gloves as biohazard waste 11 Wash hands thoroughly 10 4 PRODUCT DISPOSAL Consult your local waste management authorities for appropriate procedures for disposal of devices containing electronic waste transmitter and receiver or blood contacting components Sensor and applicator 116 Dexcom G4 PLATINUM Continuous Glucose Monitoring System TECHNICAL INFORMATION 11 1 PRODUCT SPECIFICATIONS Sensor Glucose Range 2 2 22 2 mmol L Sensor Life Up to 7 days Calibration Commercially available blood glucose meter Calibration Range 2 2 22 2 mmol L Temperature 2 C 25 C Condition Humidity 0 95 RH Sterilization Sterile by radiation Transmitter The Dexcom G4 PLATINUM Transmitter Model 9438 01 and Model 9438 05 has been certified by Nemko Canada to electrical safety requirements of CSA C22 2 No IEC 60601 1 ed 3 and IEC 60601 1 11 ed 1 under Certificate of Compliance NO67180 M1 Any changes or modifications not expressly approved by the party responsible for compliance could void the user s authority to operate the equip
99. pexcom G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USER S GUIDE 4 1 4 A 4 4 4 1 1 3 1 4 y y 4 gt Dexcom G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM Dexcom IMPORTANT CONTACTS AND NUMBERS Dexcom Website www dexcom com Your Transmitter ID Your Receiver ID Your Healthcare Professional Nearest Hospital Other Notes 2014 Dexcom Inc All rights reserved Dexcom Dexcom G4 Dexcom G4 PLATINUM Dexcom Studio and SEVEN 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 4 Dexcom G4 PLATINUM Continuous Glucose Monitoring System DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING CGM SYSTEM Dexcom G4 PLATINUM Receiver Dexcom G4 PLATINUM Transmitter Dexcom G4 PLATINUM Sensor SYSTEM CONTENTS Reorder only the Dexcom G4 PLATINUM System components listed below Sensor receiver case transmitter user s guide receiver quick start guide receiver USB charging download e tutorial disc cable Dexcom Studio software optional charger MT21255 and available in select countries adapter plugs MT21561 check with your local distributor HELPFUL HINT Sensors are sold separately C
100. power Mains power quality should be Transient burst supply lines supply lines that of a typical commercial or IEC 61000 4 4 1 kV for Not applicable hospital Toner input output lines Surge 1 kV line s to 1 kV line s to Mains power quality should be IEC 61000 4 5 line s line s ded E or 2 kV line s to Not applicable earth Voltage lt 5 lt 5 U Mains power quality should be Dips Short gt 95 dip in for gt 95 dip in that of a typical commercial or Interruptions and 0 5 cycle for 0 5 cycle hospital environment u 40 U rer SUPPIY 60 60 dip U for Input Lines T T for 5 cycles 5 cycles IEC 61000 4 11 70 U 70 U IEC 60601 1 11 30 dip in U_ 30 dip in U_ for for 25 cycles 25 cycles 85 U 85 15 dip in 15 dip in for 5 sec for 5 sec lt 5 lt 5 gt 95 dip in U for gt 95 dip in 5 sec for 5 sec Power Frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz Magnetic Field IEC 61000 4 8 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 Dexcom G4 PLATINUM User s Guide 123 Guidance and Manufacturer s Declaration Electromagnetic Immunity The Dexcom G4 PLATINUM System is intended for use in the electromagnetic environment specified below
101. pter 1 Section 1 4 Charging Your Receiver Battery and Chapter 2 Section 2 2 The Settings Menu 9 8 RECEIVER AND TRANSMITTER COMMUNICATION TROUBLESHOOTING 9 8 1 SYSTEM RECOVERY CHECK This screen means that the system discovered an error that it was able to fix itself Press the SELECT button to clear this display and continue your sensor session system Check 9 8 2 RECEIVER ERROR CODE This screen shows an error code and means the receiver not be working properly Write down the A error code and contact your local distributor Continue to check your blood glucose value using your meter Call Local Distributor There is no alert to warn you that you are no Emor ERRIT longer getting sensor glucose readings 108 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 9 8 3 LOW TRANSMITTER BATTERY This screen will appear once the transmitter nears the end of its battery life see Chapter 1 Section 1 2 Transmitter Overview When the transmitter battery GC is drained low enough the transmitter and receiver will stop communicating Contact your local distributor to Low Battery order a new transmitter Order New Transmitter Your transmitter battery may drain as quickly as one week after this alert appears 9 8 4 TRANSMITTER FAILED ERROR CODE This screen means that the transmitter is not working If you get this alert during a sensor session your sensor session will automatically stop Contact
102. r sensor is water resistant when showering bathing or swimming if the transmitter is fully snapped in The sensor has been tested to be water resistant when submerged for up to 2 44 meters for a maximum of 24 hours The receiver is rain resistant but you should try to keep it dry Do not spill fluids on it or drop it into fluids Keep the micro USB port cover closed to help prevent fluid from getting inside the receiver Wireless communication does not work well through water so the range is much less if you are in a pool bathtub water bed etc HELPFUL HINT f your receiver gets wet you need to make sure the speakers and vibrate mode are still working You can do this by using the Try It option in the profiles menu See Chapter 6 Section 6 3 Alert Profiles Dexcom G4 PLATINUM User s Guide 45 THIS PAGE LEFT INTENTIONALLY BLANK 46 Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM System requires you to calibrate the sensor glucose readings to your blood glucose meter as Tylenol while wearing the sensor may falsely raise your sensor glucose readings The level of inaccuracy depends on the amount of acetaminophen paracetamol active in your body Taking acetaminophen paracetamol containing products such 4 1 CALIBRATION OVERVIEW There are important times when you must calibrate 1 Initial startup 2 hours after you insert your sensor 2 12 hour update every 12 h
103. ransmitter ID number down in the Important Contacts and Numbers list on page 4 f you need to change the language time format time date or transmitter ID after you have completed the Setup Wizard see Section 2 2 The Settings Menu 26 Dexcom G4 PLATINUM Continuous Glucose Monitoring System e Set your low and high glucose alert values Your low and high glucose alerts are pre set to 4 4 mmol L and 11 1 mmol L but can be changed to meet your needs High Alert m mmol L mmol L Press the UP or DOWN button to select your desired alert value Changes can be made in increments of 0 1 mmol L Press the SELECT button to confirm your preferred alert value The Setup Wizard is now complete To begin using your Dexcom G4 PLATINUM CGM System you will need to insert a sensor see Chapter 3 Inserting a Sensor and Starting a Sensor Session HELPFUL HINTS You can also change your alert values in the alerts menu The unit of measure mmol L is not adjustable Dexcom G4 PLATINUM User s Guide 27 2 2 THE SETTINGS MENU The settings menu shows you how to change the time date or transmitter ID after you have already completed the Setup Wizard 2 2 1 GETTING TO THE SETTINGS MENU 1 Press the SELECT button to turn on the receiver The 3 hour trend graph will appear 2 Press the SELECT button to display the Main Menu 3 From the main menu press the UP or DOW N button to scroll to Settings and p
104. re correct The default date and time for events you enter is the current date and time stored in the receiver The date format is YY Y Y MM DD HELPFUL HINT If you change the date or time for any event it only applies to that event and will not change the current date and time in your receiver 1 To change the date and time for an event press r the RIGHT button to highlight each value inthe LU date and time Then press the UP or DOWN button to make any adjustments and then press 2010 01 15 the RIGHT button to move to the next value After 2377 adjusting the time press the SELECT button 2 You will advance to the event confirmation screen Bis Press the SELECT button to confirm the entry 50 grams 2010 01 15 23 46 Cancel 86 Dexcom G4 PLATINUM Continuous Glucose Monitoring System 7 1 3 CARBOHYDRATES The carbs event lets you enter the amount of carbohydrates you have consumed up to 250 grams 1 From the events menu press the UP or DOWN button to choose Carbs and press the SELECT Events button rl Carbs Insulin JA Exercise Press the UP or DOWN button to enter your carb amount 0 250 grams and press the SELECT button The number that first appears on this screen will be the last number you entered or the default amount of 50 grams 5 0 grams Check that the date and time for this entry are correct Press the SELECT butt
105. ress the SELECT button The settings menu will appear SeHings 2 2 2 SETTING YOUR RECEIVER TIME AND DATE To set the time and date follow the steps below 1 From the Settings menu press the UP or DOWN button to scroll to Time Date and press the SELECT button 2 Press the RIGHT button to highlight each value in the date and time Then press the UP or DOWN button to make any adjustments and then press the RIGHT button to move to the next value The 2010 ry date format is YYY Y MM DD After choosing the 19 39 time press the SELECT button You will return to the settings menu 28 Dexcom G4 PLATINUM Continuous Glucose Monitoring System HELPFUL HINT You might need to reset the receiver s time and date if the rechargeable battery is drained If this happens you will be alerted and automatically taken to the time date setting screen 2 2 3 ENTERING YOUR TRANSMITTER ID Any time you switch to a new transmitter and or receiver as a replacement to the transmitter and or receiver that came in your kit you must enter the transmitter ID into your receiver The transmitter ID is a series of 5 numbers and or letters that can be found in the following locations the outside of the transmitter box label the bottom of the transmitter If you have difficulty locating your transmitter ID please contact your local distributor HELPFUL HINT You can only set your transmitter ID when
106. s fully charged when battery symbol is completely shaded iim x Start Fully Charged 2 After the charge is complete remove the cable from the receiver and the wall outlet or computer USB port HELPFUL HINTS Charge your receiver battery before each sensor insertion Periodically check your battery level to make sure it has enough charge If your battery drains it will retain the time and date for 3 days without being charged After 3 days you will be prompted to reset your receiver time and date see Chapter 2 Section 2 2 The Settings Menu Only use the Dexcom battery charger provided in the receiver kit Do not use any other battery charger Dexcom G4 PLATINUM User s Guide 21 More information on main menu options can be found in the sections listed below Menu Purpose User s Guide Reference Trend To display the trend graphs Chapter 5 Graph 3 hour trend graph is the default screen displayed whenever you turn the receiver on Start To start a new sensor session Chapter 3 Sensor This option only appears if a transmitter ID has been entered and you are not in the middle of a sensor session Enter BG To enter your blood glucose values for calibration Chapter 4 Profiles Profiles allow you to customize the sound pattern and Chapter 6 volume level of alerts and alarms to meet your needs Events To enter personal information about meals insulin Chapter 7 exercise
107. se a blood glucose value obtained only from a blood glucose meter for calibration In order to obtain accurate sensor glucose readings proper calibration is required using accurate blood glucose values 4 2 HOW TO CALIBRATE For calibration you must enter the exact blood glucose value from your meter Blood glucose values must be between 2 2 22 2 mmol L and must have been taken within the past 5 minutes that occurred more than 5 minutes ago may cause inaccurate Entering incorrect blood glucose values blood glucose values sensor glucose readings HELPFUL HINT Only blood glucose values between 2 2 22 2 mmol L can be used for calibration If the blood glucose value s you entered was outside of this range the receiver will not calibrate You will have to wait until your blood glucose is in this range to calibrate The steps below show you how to enter your blood glucose values for calibration 1 Take a blood glucose measurement using your meter 2 From any trend graph press the SELECT button to display the main menu 3 Use the UP or DOWN button to scroll until you highlight Enter BG Main Menu Trend eso 4 Press the SELECT button to choose this option You will see a screen with a blood drop and a ry Enter BG number in mmol L units 6 Profiles 50 Dexcom G4 PLATINUM Continuous Glucose Monitoring System HELPFUL HINT Enter BG will be the second main menu option when
108. sensor and SMBG values The average and median of the differences are summarized and are based on 1882 paired glucose results at different glucose ranges Table 2 Table 2 System Difference to YSI within YSI Glucose Ranges Glucose Ranges mg dL mmol L Number of Matched Mean Absolute Median Absolute Pairs n Difference Difference 40 80 0244 1882 14 9 11 6 Overall the System reads on average 14 9 absolute different Mean Absolute Percent Difference than SMBG values at glucose levels of 40 400 mg dL 2 2 22 2 mmol L The Median Absolute Percent Difference shows that 50 of the time the System reads about 11 6 or less different than the reference glucose values Sensor Stability Sensors can be worn for up to 7 days To verify sensor performance over time 108 sensors were evaluated across the 7 day wear period Performance was estimated by calculating the percentage of System readings within 20 mg dL 1 1 mmol L or 20 30 mg dL 1 7 mmol L or 30 or 40 mg dL 2 2 mmol L 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 5 showing consistent accuracy and sensor stability over the 7 day life of the sensor Dexcom G4 PLATINUM User s Guide 139 Table 3 System Sensor Stability Accuracy over Time Number Mean Median Percent Percent Percent of Absolute
109. sensor session Prompt screen N A sensor will end in 2 hours only Reploce H expiration Sensor prompt ACHOT E 01 54 27 30 minute Your sensor session 1 vibrate then No sensor will end in 30 vibrate beep Reploce expiration minutes every 5 minutes Sensor alert 2 times Soon 00 24 27 End of Your sensor session 1 vibrate then No session has ended vibrate beep Replace sensor every 5 minutes Sensor expiration 2 times How gt alert 00 00 00 Sensor The sensor is not 1 vibrate then Yes 2 failed alert working properly vibrate beep re alerts in PE every 5 minutes the next 10 2 times minutes for Sensor Falleg 30 minutes Scham Dexcom G4 PLATINUM User s Guide 149 What will see on the receiver screen Prompt alert or alarm What does this mean How will the receiver notify me vibrate and or beep Will the receiver re notify me Receiver error Your receiver 1 vibrate 4 No A alert is not working seconds 4 properly Record beeps VEL the error code Cam tocol and call your neve local distributor System check There was a 1 vibrate then No system Check alert system error vibrate beep every and the receiver 5 minutes until fixed it confirmed Passed Set time date Backup battery 1 vibrate No E Enter Time prompt has drained time date need to 201010 FEX be reset 15 34 Transmitter Transmitter 1 vibrate then Yes once a low battery
110. ss different than YSI blood glucose values The mean percent difference overall is 2 996 and the median percent difference overall is 1 796 This shows that the system is biased slightly higher than compared to the YSI Dexcom G4 PLATINUM User s Guide 131 Table 2 System Difference to YSI within YSI Glucose Ranges MD Number of Paired Mean Absolute Median Absolute Ranges mg dL System YSI Difference Difference mmol L Overall 9152 13 3 9 8 40 80 1351 11 8 mg dL 9 6 mg dL 2 2 4 4 0 66 mmol L 0 53 mmol L For YSI less than 80 mg dL 4 4 mmol L the differences in mg dL mmol L are included instead of percent differences Low and High Glucose Alerts The ability of the System to detect high and low glucose levels concentrations 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 readings were compared by pairing the System reading that occurred immediately after the YSI reading 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 Tables 3 A and 3 B Table 3 A Hypoglycemic Alert Evaluation 15 Minutes Before and After Hypoglycemia Hypoglycemia True Alert False Alert Alert Level Rate Rate Detection Missed Detect
111. ssion Please review the tutorial on the disc in your kit The tutorial is also available online at www dexcom com portion of it is visible above the skin do not attempt to remove it Seek professional medical help if you have symptoms of infection or inflammation redness swelling or pain at the insertion site If you experience a broken sensor please report this to your local distributor Sensors may fracture on rare occasions If a sensor breaks and For patients undergoing an MRI with a retained wire broken off from a Dexcom G4 PLATINUM Sensor in vitro MRI testing did not detect any safety hazards There was no significant movement or heating of the wire and imaging artifacts were limited to the area around the wire 3 1 BEFORE YOU START J Make sure you charge your receiver completely See Chapter 1 Section 1 4 Charging Your Receiver Battery FJ Check that the date and time are correct the receiver J Make sure the correct transmitter ID has been entered into your receiver see Chapter 2 Section 2 2 The Settings Menu J Check the Use by Date on the sensor The Use by Date format is YYYY MM DD Sensors must be inserted on or before the end of the calendar day printed on the sensor package label Make sure you are using your blood glucose meter per the manufacturer s instructions to ensure you are getting accurate blood glucose values for calibration Dexcom G4 PLATINUM User s Guide 35
112. tartup Callbralions ana 53 4 412 Hour calibration Update e etre 53 4 5 Other Reasons You May Need to 54 CHAPTER 5 SENSOR GLUCOSE READINGS AND TRENDS 55 51 Sensor Glucose 58 5 2 Rate of Change eese 60 5 3 Glucose Status Area Symbols 62 CHAPTER 6 ALERTS ALARMS AND ALERT PROFILES 65 6 1 Seting ee mee ee ee ene 67 6 1 1 Default Alert Alarm 67 Silo 69 alo A e 69 614A 70 6 1 5 Low Glucose 71 6 1 6 Getting to the Alerts Menu eot eno ner 71 6 1 7 High and Low Glucose 72 6 2 Advanced oencei est cotes 73 6 2 1 Setting a Snooze Time for Your High and Low Glucose Alerts 74 6 2 2 Rise and Fall Glucose Rate 15 6 2 3 Setting the Out of Range 77 63 Alert POMC 78 6 3 Alert Profile en eee 80 6 3 2 Alert Profile Details as dia 81 CHAPTER 7 EVENTS 83 VO ee 85 1 1 1 Seleeting an ee le se 85 7 1 2 Setting the Date and Time for a
113. ting to the Settings 28 2 2 2 Setting Your Receiver Time and 28 2 2 3 Entering Your Transmitter ID otto a 29 2 2 4 Setting Your Receiver Time 30 2 2 5 Selecting Your Receiver 30 2 3 Checking Information About Your Dexcom G4 PLATINUM System 31 2 4 Transmitter and Receiver 32 CHAPTER 3 INSERTING A SENSOR AND STARTING A SENSOR SESSION 33 3 1 Before You Sla esos patronal ias rico adan 35 3 2 Removing the Sensor from lts 36 3 2 CHOOSING 37 34 Placing he SeN Oat ee ea en 38 A ee 39 3 6 Transmitter Attachment socio cover anne 41 3 7 Starting a Sensor inneren 42 3 8 Sensor Startup Pel estarias rice 43 3 9 Taping the Sensor PO tie baeo Urea tane xU sonia 44 3 10 Temporary Receiver 44 3 11 The Dexcom G4 PLATINUM System and 45 10 Dexcom G4 PLATINUM Continuous Glucose Monitoring System CHAPTER 4 CALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEM 47 4 1 Calibration Wisconsin arica daa 49 4 2 HOW to catracho 50 S
114. tinuous Glucose Monitoring System What will see on the receiver screen Prompt alert or alarm What does this mean How will the receiver notify me vibrate and or beep Will the receiver re notify me 1 hour The sensor cannot 1 vibrate then No ware calibration calibrate Wait a vibrate beep every error alert minimum of 1 hour 5 minutes until then enter 1 more confirmed i ii blood glucose value Enter BG in Thi for calibration If no sensor glucose readings appear on the receiver the sensor needs to be replaced 12 hour The receiver needs Prompt screen Yes every calibration a blood glucose only 15 minutes prompt value entered to calibrate Additional The receiver needs 1 vibrate then Yes every calibration a blood glucose vibrate beep every 15 minutes prompt value entered to 5 minutes until calibrate Sensor confirmed glucose readings will not be displayed at this time Startup The receiver needs 1 vibrate then Yes every calibration 2 blood glucose vibrate beep every 15 minutes prompt values entered to 5 minutes until calibrate confirmed Additional The receiver needs 1 vibrate then Yes every startup 1 additional blood vibrate beep every 15 minutes calibration glucose value to 5 minutes until prompt complete startup confirmed calibration Dexcom G4 PLATINUM User s Guide 147 What will see on the receiver screen Prompt alert or alarm
115. training option for you 6 Dexcom G4 PLATINUM Continuous Glucose Monitoring System INDICATIONS FOR USE The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons age 2 and older with diabetes The system is intended for use by patients at home and in healthcare facilities The Dexcom G4 PLATINUM System is indicated for use as an adjunctive device to complement not replace information obtained from standard home glucose monitoring devices The Dexcom G4 PLATINUM 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 G4 PLATINUM System results should be based on the trends and patterns seen with several sequential readings over time IMPORTANT USER INFORMATION Please review your product instructions before using your continuous glucose monitoring system Contraindications warnings precautions cautions and other important user information can be found in your product instructions Discuss with your healthcare professional how you should use your sensor trend information to help manage your diabetes Your product instructions contain important information on troubleshooting your system and on the performance characteristics of the device CONTRAINDICATIONS blood glucose value fr
116. tton Vibrate p Profiles 5 When finished press the LEFT button to return to the main menu 82 Dexcom G4 PLATINUM Continuous Glucose Monitoring System chapter seven EVENTS The Events feature allows you to record information about your diabetes management that may help you and your healthcare professionals better understand your glucose patterns and trends You can enter details about carbohydrate intake insulin intake exercise and issues related to your health You can then view your trends and track your patterns using the Dexcom Studio software 7 1 EVENTS HELPFUL HINT Event markers can be downloaded and viewed the Dexcom Studio software but cannot be viewed on your receiver 7 1 1 SELECTING AN EVENT 1 Press the SELECT button to turn on the receiver The 3 hour trend graph will appear 2 Press the SELECT button to display the main menu 3 From the main menu press the UP or DOWN button to scroll to Events and press the SELECT button The events menu will appear Main Menu Dexcom G4 PLATINUM User s Guide 85 7 A Press the UP DOWN button to choose the event Events you want Carbs Insulin Exercise or Health and press the SELECT button carbs Insulin Law Exercise 71 2 SETTING THE DATE AND TIME FOR AN EVENT When you enter an event you will be prompted to check that the date and time for that event a
117. ur and then enter one more blood glucose value If no readings display on the receiver after this the sensor needs to be removed and a new sensor needs to be inserted Wait This icon means the receiver has detected a potential problem with the sensor signal You should wait about 30 minutes for more prompts Do not enter any blood glucose values when you see this symbol Dexcom G4 PLATINUM User s Guide 63 THIS PAGE LEFT INTENTIONALLY BLANK 64 Dexcom G4 PLATINUM Continuous Glucose Monitoring System ALERTS ALARMS AND ALERT PROFILES This chapter will teach you about your Dexcom G4 PLATINUM CGM System s many alerts and alarms and how to customize them 6 1 SETTING YOUR ALERTS 6 1 1 DEFAULT ALERT ALARM SETTINGS When you receive your Dexcom G4 PLATINUM CGM System the following alerts and alarms are preset on your receiver see table below What will see on the receiver screen What does this mean What is the default setting How will the receiver notify me Will the receiver re notify me High Glucose On at Vibrates twice No unless you Alert 11 1 mmol L then vibrates have turned Your most recent beeps twice every on the high sensor glucose 5 minutes until alert snooze reading is at or confirmed or your feature above the high glucose value alert setting drops below the alert level Low Glucose On at Vibrates three No unless you Alert 4
118. ver and Transmitter Communication Troubleshooting 9 8 1 System Recovery Check nun een 9 8 2 Receiver BIOL COGO sansa een 9 8 3 Low Transmitter 9 8 4 Transmitter Failed Error 9 9 Out of Ramis NO ANIC a ee Alens Not WOTKING 22 CHAPTER 10 TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM RN UNIS TET LETT 10 2 ORAS tare dereud ee ee M RM MEDI D nee 10 3 Cleaning and DISINTE CUO es oso rro Ee UR ERE E OR EDT n 10 4 PTOQUEEDISPO SA a ee CHAPTER 11 TECHNICAL INFORMATION 114 Product o pec olo redee oa 11 2 Device Performance 11 2 1 System Performance In 11 2 2 System Performance In 11 3 FCC Requirements ee ea CHAPTER 12 APPENDIX Appendix Receiver Alerts Alarm and Symbols Used in Labeling 2a een 12 Dexcom G4 PLATINUM Continuous Glucose Monitoring System ecc c pie 95 141 143 192 cnapter one THE DEXCOM G4 PLATINUM SYSTEM BASICS 1 1 SENSOR OVERVIEW The sensor is placed under the skin of your belly and continuously measures your glucose levels
119. ws on the safety lock as a guide Do not wiggle back and forth am not able to pull the collar up Make sure the plunger is completely pressed down before pulling the collar up When pulling the collar up you should hear 2 clicks Try using more force when pulling the collar up am not able to remove the applicator barrel from the sensor pod Make sure the collar is pulled all the way up You may need to use extra force to pull the collar as close to the top of the applicator as possible Make sure the transmitter latch is flat against the adhesive on your body before squeezing the release tabs Then squeeze the ribbed release tabs on the sides of the sensor pod and lift the Release the applicator barrel applicator away from your body in an arc motion am not able to remove the transmitter latch Hold the sensor pod with one hand and twist the transmitter latch with the other hand to remove it Do not try to snap it straight off Dexcom G4 PLATINUM User s Guide 99 Sensor pod is not sticking long enough Make sure your skin is clear of any cream or lotion before you attach the sensor pod Clean the area first with an alcohol wipe Make sure the area is clean and completely dry before you insert the sensor Do not leave any substance on the skin where the needle inserts You may use medical tape such as Blenderm Tegaderm IV 3000 3M tape over the white adhesive patch of the s
120. xed low alarm set at 3 1 mmol L This alarm is a feature in addition to your personal low and high glucose alerts You cannot change or turn off this alarm or its re alarm settings For the low glucose alarm the receiver will display the screen to the right Re alarm The receiver will automatically notify you again in 30 minutes after you press the SELECT button to clear it if your sensor glucose readings are still at or below 3 1 mmol L HELPFUL HINT Your receiver will not alert you if you have calibrated in the last 5 minutes and received a sensor glucose reading outside your target range The receiver will alert you if your sensor glucose reading remains outside your target range after five minutes 6 1 6 GETTING TO THE ALERTS MENU 1 Press the SELECT button to turn on the receiver The 3 hour trend graph will appear 2 Press the SELECT button to display the main menu 3 From the main menu press the UP or DOW N button to scroll to Alerts and press the SELECT button The alerts menu will appear Main Menu 4 Profiles High Alert m Low Alert 2485 Advanced Dexcom G4 PLATINUM User s Guide 71 6 1 7 HIGH AND LOW GLUCOSE ALERTS HELPFUL HINT steps for setting both the high alert and the low alert are the same The following steps show you how to change your high and low alert settings 1 From the alerts menu press the UP or DOWN Alai PT button to se
121. you have inserted your sensor you will need to snap the transmitter into the sensor pod Follow the steps below to attach your transmitter 1 Place the transmitter in the sensor pod with Clean and dry the bottom of the transmitter with a damp cloth or an alcohol wipe before every use Be careful not to touch the metal circles on the bottom of the transmitter with your skin For disinfection instructions refer to Chapter 10 Section 10 3 Cleaning and Disinfection Be careful not to scratch the bottom of the transmitter as scratches may compromise the waterproof seal the flat side facing down Install transmitter in sensor pod With one hand you may want to pinch up on your skin at the front edge of the white adhesive a Place one finger on the transmitter to keep it in place while securing the transmitter into the sensor pod h p transmitter to snap the transmitter into y place The transmitter should lie flat in the u 3 E sensor pod You should hear 2 clicks If MZ IL you do not hear 2 clicks the transmitter might not be fully snapped in place You can release your pinch on the adhesive edge at this time b Pull the transmitter latch over the Transmitter latc c Make sure the transmitter is secure by sliding your first and second fingers under the sensor pod wings and press down on the transmitter with your thumb Dexcom G4 PLATINUM User s Guide 41 4 Hold the transmitter in pl
122. your 2 local distributor Continue to check your blood glucose value using your blood glucose meter Transmitter Foiled Iraasmilte 9 9 OUT OF RANGE NO ANTENNA This screen means your receiver and transmitter are not communicating and you are not receiving sensor glucose readings x 7 Your receiver and transmitter will only communicate when you are in an active sensor session en a Rang or 00 20 21 Each time you start a new sensor session allow 10 minutes for your receiver and transmitter to start communicating You may occasionally experience loss of communication for 10 minutes at a time This is normal If you see the out of range symbol in the status area for more than 10 minutes move your receiver and transmitter within 6 meters of each other Wait 10 minutes and communication should be restored Dexcom G4 PLATINUM User s Guide 109 to 6 meters without obstruction Wireless communication does not work well under water so the range is much less if you are in a pool bathtub water bed etc transmission range from the transmitter to the receiver is up Your transmitter ID must be entered correctly into your receiver to receive sensor glucose readings see Chapter 2 Section 2 2 The Settings Menu Make sure you have removed your sensor and stopped your sensor session before checking or changing your transmitter ID HELPFUL HINT You can only set your Transmitter

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