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Strany 1 - USER’S GUIDE

Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.comLBL012528 Rev 03 MT22690CONTINUOUS GLUCOSE

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8 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemGLOSSARY (continued from page before)Proles Sound pattern and volume level settings for

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98 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1. Press the SELECT button to turn on the receiver. The 3-hour trend graph shows.2. Pr

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Dexcom G4 PLATINUM User’s Guide | 991. From the alerts menu, press the UP or DOWN button to select “High Alert” or “Low Alert” and press the SELECT

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100 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System95. To change this number, press the SELECT button, and then press the UP or DOWN butt

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Dexcom G4 PLATINUM User’s Guide | 1019.2.1 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTS The snooze feature lets you delay your high an

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102 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemIf you set your fall rate to 2 mg/dL per minute and your sensor glucose readings fall a

Strany 8 - GLOSSARY

Dexcom G4 PLATINUM User’s Guide | 1033. Press the UP or DOWN button to choose “On” or “Off.” Then, press the SELECT button to select “On” or “Off.”4

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104 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9glucose readings. The out of range symbol in the upper right corner of the trend gra

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Dexcom G4 PLATINUM User’s Guide | 1054. Press the UP or DOWN button to choose the amount of time out of range after which the receiver will alert. P

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106 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9Thesoft,normal,attentiveandHypoRepeatproleshavethefollowingalert sequence:

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Dexcom G4 PLATINUM User’s Guide | 107ALERT PROFILE OPTIONS (continued from page before)“HypoRepeat”prole:verysimilartothenormalprole,butit

Strany 13 - SYSTEM DESCRIPTION

Dexcom G4 PLATINUM User’s Guide | 9GLOSSARY (continued from page before)System ReadingA sensor glucose reading shown on your receiver. This reading i

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108 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9ALERT PROFILE DETAILS (continued from page before)PROFILE TYPEVIBRATE SOFT NORMAL ATTE

Strany 15 - 1.1 SYSTEM CONTENTS:

Dexcom G4 PLATINUM User’s Guide | 1091. Press the SELECT button to turn on the receiver. The 3-hour trend graph will show.2. Press the SELECT butto

Strany 16 - 1.2 INTRODUCTION

110 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

Strany 17 - 1.3 SENSOR OVERVIEW

Dexcom G4 PLATINUM User’s Guide | 11110chapter tenEVENTS

Strany 18 - 1.4 TRANSMITTER OVERVIEW

112 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System10

Strany 19 - 1.5 RECEIVER OVERVIEW

Dexcom G4 PLATINUM User’s Guide | 113CHAPTER 10: EVENTSThe Events feature lets you record information that may help you and your healthcare professi

Strany 20 - 1.6 SHARE OVERVIEW

114 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System4. Press the UP or DOWN button to choose the event you want: “Carbs,” “Insulin,” “Exer

Strany 21 - SAFETY STATEMENT

Dexcom G4 PLATINUM User’s Guide | 1154. Press the SELECTbuttontoconrmthe entry.10.1.3 CARBOHYDRATESThe Carbs event lets you enter the amount o

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116 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System4. Press the LEFT or RIGHT button to choose either“OK”toconrmor“Cancel”todisca

Strany 23 - 2.1 INDICATIONS FOR USE

Dexcom G4 PLATINUM User’s Guide | 1174. Press the LEFT or RIGHT button to choose either“OK”toconrmthisentryor“Cancel”to discard this entry,

Strany 24 - 2.4 WARNINGS

10 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

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118 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System3. Press the UP or DOWN button to enter your exercise duration (0-360 minutes), and pr

Strany 26 - 2.5 PRECAUTIONS

Dexcom G4 PLATINUM User’s Guide | 1192. Press the UP or DOWN button to choose your health event, and press the SELECT button.3. Check that the da

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120 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

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Dexcom G4 PLATINUM User’s Guide | 12111chapter elevenENDING A SENSOR SESSION

Strany 29 - 2.6 CAUTION

122 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System11

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Dexcom G4 PLATINUM User’s Guide | 123CHAPTER 11: ENDING A SENSOR SESSIONYour sensor gives you sensor glucose readings for up to seven days. The perf

Strany 31 - RISKS AND BENEFITS

124 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System11Youcansetthesealertswiththeprolessetting(seeChapter9,Section9.3.2,Aler

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Dexcom G4 PLATINUM User’s Guide | 125When you remove the sensor, make sure to pull out the sensor pod while the transmitter is still attached.1. Gen

Strany 33 - 3.1 RISKS

126 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1111.3 TRANSMITTER REMOVALDo not remove the transmitter while the sensor pod is still

Strany 34 - 3.2 BENEFITS

Dexcom G4 PLATINUM User’s Guide | 12712chapter twelveTAKING CARE OF YOURDEXCOM G4 PLATINUM SYSTEM

Strany 35 - 1, 2 , 3

Dexcom G4 PLATINUM User’s Guide | 111chapter oneDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION

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128 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System12

Strany 37 - AND THE RECEIVER MAIN MENU

Dexcom G4 PLATINUM User’s Guide | 129CHAPTER 12: TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM12.1 MAINTENANCETransmitter • Wipe the outside of t

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130 | Dexcom G4 PLATINUM Continuous Glucose Monitoring Systemformat is YYYY-MM-DD. Insert sensors on or before the end of the calendar day printed o

Strany 39 - THE RECEIVER MAIN MENU

Dexcom G4 PLATINUM User’s Guide | 13113chapter thirteenTROUBLESHOOTING

Strany 40 - FROM AN AC POWER OUTLET

132 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13

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Dexcom G4 PLATINUM User’s Guide | 133CHAPTER 13: TROUBLESHOOTINGThischapterprovideshelpfultipsandinstructionstoxissuesyoumayhave while

Strany 42 - 4.2 RECEIVER MENU OPTIONS

134 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13 • I am not able to remove the transmitter latch: - Hold the sensor pod with one

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Dexcom G4 PLATINUM User’s Guide | 135 • See Chapter 7, Calibrating Your Dexcom G4 PLATINUM System, for further information.13.2.1 TYPES OF CALIBRA

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136 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1313.2.2 WHAT TO DO FOR CALIBRATION PROMPTS1. When you see a calibration prompt, pres

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Dexcom G4 PLATINUM User’s Guide | 137SELECT button to clear the screen, this symbol shows in the status area.If you see this screen, wait at least

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12 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1

Strany 47 - WITH YOUR TRANSMITTER

138 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13 • Make sure your sensor pod is not dislodged or peeling up. • Make sure your tran

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Dexcom G4 PLATINUM User’s Guide | 139If the difference between your sensor glucose reading and blood glucose value is greater than 20% of the blood g

Strany 49 - AND DATE

140 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13glucose to calibrate. Do not switch your meter in the middle of a sensor session. Blo

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Dexcom G4 PLATINUM User’s Guide | 141 • Make sure your transmitter is snapped in. • Make sure your sensor pod is not dislodged or peeling up. •

Strany 51 - RECEIVER

142 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System132. Press the SELECT button with “OK” highlightedtoconrm.3. The Stop Sensor “thin

Strany 52 - COMMUNICATION

Dexcom G4 PLATINUM User’s Guide | 143This screen means you recently turned Share “On,” and your receiver is having trouble connecting with your iPhon

Strany 53 - CONTRAINDICATION

144 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System133. Charge your receiver.4. You may need to reset the time and date (see Chapter 4, S

Strany 54

Dexcom G4 PLATINUM User’s Guide | 14513.9.3 TRANSMITTER LOW BATTERYThis screen shows when the transmitter nears the end of its battery life (see Cha

Strany 55 - STARTING A SENSOR SESSION

146 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13This screen means your receiver and transmitter are not communicating and you are not

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Dexcom G4 PLATINUM User’s Guide | 14713.11 ALERTS ARE NOT WORKING1. Make sure you have not turned off the sound and/or vibrations for the alerts. C

Strany 57

Dexcom G4 PLATINUM User’s Guide | 13CHAPTER 1: DEXCOM G4® PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION1.1 SYSTEM CONTENTS: • sen

Strany 58 - 6.1 BEFORE YOU START

148 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

Strany 59 - PACKAGING

Dexcom G4 PLATINUM User’s Guide | 14914chapter fourteenTECHNICAL INFORMATION

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150 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14

Strany 61 - 6.4 PLACING THE SENSOR

Dexcom G4 PLATINUM User’s Guide | 15116CHAPTER 14: TECHNICAL INFORMATION14.1 DEVICE PERFORMANCE CHARACTERISTICSNOTE: We recommend that you review t

Strany 62 - 6.5 SENSOR INSERTION

152 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14and required insulin or oral medication to manage their diabetes. In the Original Stu

Strany 63 - “ 2 CLICKS”

Dexcom G4 PLATINUM User’s Guide | 15316SW10586 SW10505 SW10050Includes Software 505 Incudes Software 505Does not include Software 505; includes Origi

Strany 64 - 6.6 TRANSMITTER ATTACHMENT

154 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 1. System Agreement to YSI within CGM Glucose RangesCGM Glucose Range1 (mg/dL)

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Dexcom G4 PLATINUM User’s Guide | 15516Agreement Relative to YSIAgreement between the System and blood glucose values is characterized using paired S

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156 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14(SW10050) or Software 505 (SW10505).Agreement When CGM Reads “LOW” or “HIGH”The Syste

Strany 67 - 6.8 SENSOR STARTUP PERIOD

Dexcom G4 PLATINUM User’s Guide | 157System does not display glucose values below 40 mg/dL or above 400 mg/dL, the comparisons to the actual blood gl

Strany 68 - 6.9 TAPING THE SENSOR POD

14 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPRECAUTIONThe Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible wi

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158 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 3-A. Concurrence of CGM Readings and YSI Values (Original Study)CGM (mg/dL)YSI

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Dexcom G4 PLATINUM User’s Guide | 159Table 3-B. Concurrence of CGM Readings and YSI Values (Software 505 Study)CGM (mg/dL)YSI (mg/dL)Row percentage

Strany 71 - G4 PLATINUM SYSTEM

160 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Another estimate used to show the accuracy of the System is the absolute percent diff

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Dexcom G4 PLATINUM User’s Guide | 16116Table 4. System Difference to YSI within CGM Glucose RangesCGMGlucose Ranges1 (mg/dL)Study2 Number of Paired

Strany 73 - 7.1 CALIBRATION OVERVIEW

162 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Low and High Glucose AlertsThe ability of the System to detect high and low glucose l

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Dexcom G4 PLATINUM User’s Guide | 16316Table 5. Hypoglycemic Alert EvaluationHypoglycemicAlert Level(mg/dL)Study1True Alert RateFalse Alert RateHypo

Strany 75 - 7.2 HOW TO CALIBRATE

164 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 6. Hyperglycemic Alert EvaluationHyperglycemicAlert Level(mg/dL)Study1True Ale

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Dexcom G4 PLATINUM User’s Guide | 165Hyperglycemia Alert RateThe Alert Rate shows how often the alert is right or wrong. The True Alert Rate is the %

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166 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14your alarm to sound 98% of the time and not to sound approximately 2% of time within

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Dexcom G4 PLATINUM User’s Guide | 167Table 7. Percentage of System Readings within YSI Values with Data Stratied in 2-Hour Increments after Calibra

Strany 79 - 7.3 STARTUP CALIBRATION

Dexcom G4 PLATINUM User’s Guide | 151.3 SENSOR OVERVIEWThe sensor is the piece that comes in a sterile, sealed sensor pouch. The sensor is made up o

Strany 80 - CALIBRATE

168 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 8. Sensor Stability (Accuracy over Time)Day of Wear1Study2Number of paired CGM

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Dexcom G4 PLATINUM User’s Guide | 169Precision of System ReadingsIn the Original Study, 36 subjects wore two Systems. This was to look at how similar

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170 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemTable 9. Number of Readings Provided by Each Sensor Over 7-Days% of Total Possible Rea

Strany 83 - AND TRENDS

Dexcom G4 PLATINUM User’s Guide | 17114Table 10. System Readings Within Wear DaysStatistic Study1Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7All Days2M

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172 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 11. System Agreement to SMBG Within CGM Glucose RangesCGM Glucose Ranges1(mg/d

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Dexcom G4 PLATINUM User’s Guide | 173Agreement and Accuracy Relative to SMBGDuring the study, agreement between the System and blood glucose values i

Strany 86 - 8.1 SENSOR GLUCOSE READINGS

174 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 12. CGM System Difference to SMBG within CGM Glucose RangesCGM Glucose Ranges1

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Dexcom G4 PLATINUM User’s Guide | 175Table 12 is categorized within CGM glucose ranges. Overall, the System in the Original Study reads, on average,

Strany 88 - Which Trend Graph Do You See?

176 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1414.2 PRODUCT SPECIFICATIONSSensor Product SpecicationsGlucose Range 40 - 400 mg/dLS

Strany 89 - 8.2 RATE OF CHANGE ARROWS

Dexcom G4 PLATINUM User’s Guide | 177Moisture ProtectionIP28: temporary submersionProtection Against Electrical ShockType BF applied partTransmitter

Strany 90 - No arrow

16 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1.4 TRANSMITTER OVERVIEWThe transmitter is the gray, plastic “chip” that snaps into you

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178 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14device can withstand exposure to common electrostatic (ESD) and electromagnetic inter

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Dexcom G4 PLATINUM User’s Guide | 179Transmitter Electromagnetic Immunity Specications (continued from page before)Immunity Test IEC 60601 Test Leve

Strany 93 - ALERTS, ALARM & PROFILES

180 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Receiver Product SpecicationsPart Number MT22495Reading Frequency Every 5 minutesDim

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Dexcom G4 PLATINUM User’s Guide | 181Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe receiver (P/N MT22495) is intended for use

Strany 95 - 9.1 SETTING YOUR ALERTS

182 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Receiver Electromagnetic Immunity Specications(continued from page before)Immunity T

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Dexcom G4 PLATINUM User’s Guide | 183System Electromagnetic Immunity SpecicationsImmunity Test IEC 60601 Test LevelReceiver Compliance LevelElectrom

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184 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14System Electromagnetic Immunity Specications (continued from page before)Immunity Te

Strany 98 - 9.1.2.2 LOW GLUCOSE ALERT

Dexcom G4 PLATINUM User’s Guide | 185a.Fieldstrengthsfromxedtransmitters,suchasbasestationsforradio (cellular/cordless) telephones and l

Strany 99 - 9.1.2.3 LOW GLUCOSE ALARM

186 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Electromagnetic Emissions Specications (continued from page before)Emissions Test Co

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Dexcom G4 PLATINUM User’s Guide | 187Minimum Recommended Distance Between Transmitter and ReceiverRated MaximumOutput Power of Transmitter (W)Separa

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Dexcom G4 PLATINUM User’s Guide | 171.5 RECEIVER OVERVIEWThe receiver is the small hand-held device that looks like a cell phone. It is about 4 inc

Strany 102 - 9.2 ADVANCED ALERTS

188 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Power Supply/Charger SpecicationsDexcom P/N MT21255Class IIInput: AC Input 100-240

Strany 103 - HIGH AND LOW GLUCOSE ALERTS

Dexcom G4 PLATINUM User’s Guide | 18914interference in a residential installation. This equipment generates uses and can radiate radio frequency ener

Strany 104

190 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14PAGE INTENTIONALLY LEFT BLANK

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Dexcom G4 PLATINUM User’s Guide | 19115chapter fteenUSER ASSISTANCE

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192 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System15

Strany 107 - 9.3 ALERT PROFILES

Dexcom G4 PLATINUM User’s Guide | 19317CHAPTER 15: USER ASSISTANCE Dexcom Website: www.dexcom.com Dexcom Address: 6340 Sequence Drive San Diego,

Strany 108 - 9.3.1 ALERT PROFILE OPTIONS

194 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

Strany 109 - 9.3.2 ALERT PROFILE DETAILS

Dexcom G4 PLATINUM User’s Guide | 19516chapter sixteenWARRANTY

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196 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System16

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Dexcom G4 PLATINUM User’s Guide | 197CHAPTER 16: WARRANTYDexcom G4 PLATINUM System Limited Warranty1. What is Covered and for How Long?Dexcom, Inc.

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18 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemYour receiver and transmitter wirelessly pair together to communicate securely and only

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198 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System16operation, maintenance, installation or adjustment; (f) installation, maintenance, an

Strany 115 - 10.1 EVENTS

Dexcom G4 PLATINUM User’s Guide | 199AND DISCLAIMS ALL SUCH OTHER WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS

Strany 116 - AN EVENT

200 | Dexcom G4 PLATINUM Continuous Glucose Monitoring Systemthe original purchaser that the Dexcom G4 PLATINUM Transmitter is free from defects in

Strany 117 - 10.1.3 CARBOHYDRATES

Dexcom G4 PLATINUM User’s Guide | 201of which was included with your Dexcom G4 PLATINUM CGM System and may be found at www.dexcom.com.3. What Are Dex

Strany 118 - 10.1.4 INSULIN

202 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPURPOSE, OR NON-INFRINGEMENT. EXCEPT TO THE EXTENT PROHIBITED BY APPLICABLE LAW, DEXCOM

Strany 119 - 10.1.5 EXERCISE

Dexcom G4 PLATINUM User’s Guide | 20317chapter seventeenTRAVEL INFORMATION

Strany 120 - 10.1.6 HEALTH

204 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System17

Strany 121 - 10.2 DEXCOM STUDIO SOFTWARE

Dexcom G4 PLATINUM User’s Guide | 205CHAPTER 17: TRAVEL INFORMATIONIt is safe for you to go through the metal detector or be “handwanded” while wear

Strany 122

206 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

Strany 123 - ENDING A SENSOR SESSION

Dexcom G4 PLATINUM User’s Guide | 20718chapter eighteenAPPENDIX

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Dexcom G4 PLATINUM User’s Guide | 192chapter twoINDICATIONS FOR USE AND SAFETY STATEMENT

Strany 125 - PRECAUTION

208 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System18

Strany 126 - 11.2 REMOVING A SENSOR

Dexcom G4 PLATINUM User’s Guide | 209CHAPTER 18: APPENDIXAPPENDIX I, RECEIVER ALERTS, ALARM AND PROMPTSThe following tables describe the alarm, aler

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210 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the

Strany 128 - 11.3 TRANSMITTER REMOVAL

Dexcom G4 PLATINUM User’s Guide | 211Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiver screen?Prompt, al

Strany 129 - DEXCOM G4 PLATINUM SYSTEM

212 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the

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Dexcom G4 PLATINUM User’s Guide | 213Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiver screen?Prompt, al

Strany 131 - 12.2 STORAGE

214 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the

Strany 132 - 12.3 PRODUCT DISPOSAL

Dexcom G4 PLATINUM User’s Guide | 21520Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiver screen?Prompt,

Strany 133 - TROUBLESHOOTING

216 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the

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Dexcom G4 PLATINUM User’s Guide | 217Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiver screen?Prompt, al

Strany 135 - CHAPTER 13: TROUBLESHOOTING

20 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System2

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218 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemReceiver Alerts, Alarm and Prompts (continued from page before)What will I see on the r

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Dexcom G4 PLATINUM User’s Guide | 219Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiver screen?Prompt, al

Strany 138 - 13.3 CALIBRATION ERROR

220 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the

Strany 139 - 13.4 SYSTEM GLUCOSE ERROR

Dexcom G4 PLATINUM User’s Guide | 221Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiver screen?Prompt, al

Strany 140 - 13.5 SENSOR INACCURACIES

222 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemAPPENDIX II, INDEXAAlarm, Low Glucose ...97Alerts ...

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Dexcom G4 PLATINUM User’s Guide | 223C Calibration ...71 Calibration Update ...78 How

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224 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemM Maintenance, System...129Menu Options...

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Dexcom G4 PLATINUM User’s Guide | 225 Insertion Site ... 58 Overview ...15 Pod ...

Strany 144 - 13.7 SHARE PAIRING ERROR

226 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemLatch ... 9, 63 Overview ...

Strany 145 - 13.8 BATTERY AND CHARGER

Dexcom G4 PLATINUM User’s Guide | 227APPENDIX III, SYMBOLS USED IN LABELINGThe following symbols may be found on the sensor, transmitter, and receive

Strany 146 - 13.9.2 RECEIVER ERROR CODE

Dexcom G4 PLATINUM User’s Guide | 21CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT2.1 INDICATIONS FOR USEThe Dexcom G4 PLATINUM Continuous Glu

Strany 147 - 13.9.4 TRANSMITTER FAILED

228 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemSymbols (continued from page before)ManufacturerEC REPAuthorized Representative in the

Strany 149 - 13.11 ALERTS ARE NOT WORKING

Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA 1.858.200.0200 1.877.339.2664 www.dexcom.comLBL012528 Rev 03 MT22690CONTINUOUS GLUCOSE

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22 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System22.3 CONTRAINDICATIONS• Remove the Dexcom G4 PLATINUM Sensor, Transmitter, and Receive

Strany 151 - TECHNICAL INFORMATION

Dexcom G4 PLATINUM User’s Guide | 23values may differ from sensor glucose readings. Using the sensor glucose readings for treatment decisions could l

Strany 152

24 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System2• Sensor placement and insertion is not approved for sites other than the belly (abdom

Strany 153 - CHARACTERISTICS

Dexcom G4 PLATINUM User’s Guide | 25to measure glucose. Insertion in those areas might affect sensor performance, and you might miss a low or high bl

Strany 154

26 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System2ischangingatasignicantrate(e.g.,2-3mg/dL/minormore than 3 mg/dL each minute)

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Dexcom G4 PLATINUM User’s Guide | 27• The Dexcom G4 PLATINUM Sensor, Transmitter, and Receiver are not compatible with the SEVEN/SEVEN PLUS Transmit

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Dexcom G4 PLATINUM User’s Guide | 1USER’S GUIDEDEXCOM G4® PLATINUMCONTINUOUS GLUCOSE MONITORING SYSTEMRECEIVER WITH ShareTMIMPORTANT CONTACTS AND NU

Strany 157 - Agreement Relative to YSI

28 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

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Dexcom G4 PLATINUM User’s Guide | 293chapter threeRISKS AND BENEFITS

Strany 159

30 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13

Strany 160 - Values (Original Study)

Dexcom G4 PLATINUM User’s Guide | 31CHAPTER 3: RISKS AND BENEFITS3.1 RISKSThere are some known risks with using real-time CGM. You will not get sen

Strany 161 - Accuracy Relative to YSI

32 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System3events happen, you might feel discomfort in the area the sensor is inserted.There is a

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Dexcom G4 PLATINUM User’s Guide | 33A1c values, reducing glycemic variability and time spent in low and high blood glucose ranges)1, 2 , 3 which can

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Dexcom G4 PLATINUM User’s Guide | 354chapter fourCHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU

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36 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System4

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Dexcom G4 PLATINUM User’s Guide | 37CHAPTER 4: CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU4.1 CHARGING YOUR RECEIVER BATTERYThe receiver batt

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2 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEMtable of contentsGLOSSARY ...

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38 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemCharge your receiver battery before each sensor insertion. Periodically check your batte

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Dexcom G4 PLATINUM User’s Guide | 395. The battery charging screen will show on the receiver.6. After a few seconds the trend graph will show with

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40 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System44. After a few seconds, the trend graph screen will show the battery charging symbol i

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Dexcom G4 PLATINUM User’s Guide | 412Receiver Main Menu Options (continued from page before)Menu PurposeUser’s Guide ReferenceStart SensorTo start a

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Dexcom G4 PLATINUM User’s Guide | 435chapter veDEXCOM G4 PLATINUM SYSTEM SETUP

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44 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System5

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Dexcom G4 PLATINUM User’s Guide | 45CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUPThischapterhelpsyouwhenyourstsetupyourContinuousGlucoseMo

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46 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System5 (3) Press the SELECT button after you enter the last number or lettertoconrm

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Dexcom G4 PLATINUM User’s Guide | 475.2 THE SETTINGS MENUThe Settings menu lets you change the time, date or transmitter ID. The SetupWizardonlyw

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Dexcom G4 PLATINUM User’s Guide | 3CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUP 435.1 Setting Up the Receiver and Pairing with Your Transmitter ...

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48 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System52. Press the RIGHT or SELECT button to highlight each value in the date and time.3.

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Dexcom G4 PLATINUM User’s Guide | 491. From the Settings menu, press the UP or DOWN button to scroll to “Transmitter ID” and press the SELECT button

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50 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System55.3 CHECKING INFORMATION ABOUT YOUR DEXCOM G4 PLATINUM SYSTEMYou can check your receiv

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Dexcom G4 PLATINUM User’s Guide | 51PRECAUTIONThe transmission range from the transmitter to the receiver is up to 20 feet without obstruction. Wirel

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52 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System5Press the SELECT, LEFT or RIGHT button to see the trend graph. This antenna symbol show

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Dexcom G4 PLATINUM User’s Guide | 536chapter sixINSERTING A SENSOR AND STARTING A SENSOR SESSION

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54 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6

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Dexcom G4 PLATINUM User’s Guide | 55CHAPTER 6: INSERTING A SENSOR AND STARTING A SENSOR SESSIONYou need a sensor, a transmitter, and a receiver to u

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56 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6.1 BEFORE YOU START• Make sure the correct transmitter ID has been entered into your

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Dexcom G4 PLATINUM User’s Guide | 576.2 REMOVING THE SENSOR FROM ITS PACKAGING• Wash your hands thoroughly, and dry them.• Carefully remove the sen

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4 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8.3 Glucose Status Area Symbols ...89CHAPTER 9: ALERTS, ALARM

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58 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System66.3 CHOOSING AN INSERTION SITEReview the tutorial disc for more help to learn how to i

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Dexcom G4 PLATINUM User’s Guide | 596.4 PLACING THE SENSOR1. Clean your skin at the sensor placement site with an alcohol wipe. Make sure the area

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60 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System63. Place the sensor horizontally, NOT vertically, on your skin. 4.Moveyourngersa

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Dexcom G4 PLATINUM User’s Guide | 612.Whilestillpinching,useyourotherhandtoplacetwongersabove the collar on the applicator barrel so th

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62 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6 • Make sure the transmitter latch is down (against your body) before squeezing the t

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Dexcom G4 PLATINUM User’s Guide | 63 c. With your other hand, pull the transmitter latch up and forward, over the transmitter, to snap it into plac

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64 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System63. Press the DOWN button to highlight “Start Sensor.” • The “Start Sensor” menu opti

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Dexcom G4 PLATINUM User’s Guide | 656.8 SENSOR STARTUP PERIODThe sensor needs a 2-hour startup period to adjust to being under the skin.Your trend g

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66 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6time to calibrate your sensor. Chapter 7, Calibrating Your Dexcom G4 PLATINUM System, t

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Dexcom G4 PLATINUM User’s Guide | 672.Conrmthatyouwanttoshutdownyour receiver. a. If you want to shut down, press the LEFT button to high

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Dexcom G4 PLATINUM User’s Guide | 512.2 Storage . ... 12912.3 Product Disposal . ...

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Dexcom G4 PLATINUM User’s Guide | 697chapter sevenCALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEM

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70 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System7

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Dexcom G4 PLATINUM User’s Guide | 71CHAPTER 7: CALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEMYou must calibrate Dexcom G4 PLATINUM System sensor glucose

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72 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System7Example Minimum Calibration Schedule During Seven-Day Sensor SessionPRECAUTIONDo not us

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Dexcom G4 PLATINUM User’s Guide | 737.2 HOW TO CALIBRATEYou must enter the exact blood glucose value from your meter for each calibration. Blood glu

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74 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System7Only use blood glucose values between 40-400 mg/dL for calibration. If the blood glucos

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Dexcom G4 PLATINUM User’s Guide | 751. Wash and dry your hands, make sure your glucose test strips are not expired and have been stored properly, an

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76 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System77. Conrm that the blood glucose value you entered is correct. Entering incorrect valu

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Dexcom G4 PLATINUM User’s Guide | 777.3 STARTUP CALIBRATIONTwo hours after you start the sensor session (see Chapter 6, Section 6.7, Starting a Sens

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6 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemGLOSSARYAlternative Site BG TestingThis is when you take a blood glucose value on your me

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78 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System7.4 12-HOUR CALIBRATION UPDATE Calibrateyoursystematleastevery12hoursafteryour

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Dexcom G4 PLATINUM User’s Guide | 79When you see this calibration prompt it means it is time to calibrate with a single blood glucose value.Take 1 bl

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Dexcom G4 PLATINUM User’s Guide | 818chapter eightSENSOR GLUCOSE READINGS AND TRENDS

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82 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1038

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Dexcom G4 PLATINUM User’s Guide | 83CHAPTER 8: SENSOR GLUCOSE READINGS AND TRENDS This chapter teaches you how to view your sensor glucose readings

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84 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8WARNINGDo not use the Dexcom G4 PLATINUM System for treatment decisions, such as how mu

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Dexcom G4 PLATINUM User’s Guide | 85 • Each “dot” on the trend graph is a sensor glucose reading reported every 5 minutes. • The trend graph shows

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86 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8Which Trend Graph Do You See?(Scroll up from the 3-hour graph to reach the 1-hour graph

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Dexcom G4 PLATINUM User’s Guide | 87The receiver displays “LOW” when the most recent sensor glucose reading is less than 40 mg/dL and “HIGH” when the

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Dexcom G4 PLATINUM User’s Guide | 7GLOSSARY (continued from page before)Dexcom Share™ SystemSecondary notication system to the Dexcom G4 PLATINUM Sy

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88 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8Trend Arrows (continued from page before)Slowly rising: Your glucose is rising 1-2 mg/d

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Dexcom G4 PLATINUM User’s Guide | 89top of the trend graph, the trend arrows will not show. If the trend arrow is missing, but you are concerned that

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90 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8Status Symbols (continued from page before)Glucose Reading ErrorThis symbol means the r

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Dexcom G4 PLATINUM User’s Guide | 919chapter nineALERTS, ALARM & PROFILES

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92 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9

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Dexcom G4 PLATINUM User’s Guide | 93CHAPTER 9: ALERTS, ALARM & PROFILESThis chapter teaches you about your Dexcom G4 PLATINUM CGM System’s many

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94 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9Default Alert/Alarm Settings (continued from page before)What will I see on the receive

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Dexcom G4 PLATINUM User’s Guide | 95Default Alert/Alarm Settings (continued from page before)What will I see on the receiver screen?What does this me

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96 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemWhen you have both your high and low alerts turned on, a gray zone on your trend graph s

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Dexcom G4 PLATINUM User’s Guide | 97the alert (to change your snooze settings see Chapter 9, Section 9.2, Advanced Alerts).9.1.2.3 LOW GLUCOSE ALARM

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