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Dexcom G4 PLATINUM Professional System User’s Guide | 1
USER’S GUIDE
DEXCOM G4
®
PLATINUM
PROFESSIONAL CONTINUOUS
GLUCOSE MONITORING SYSTEM
IMPORTANT CONTACTS AND NUMBERS
Dexcom
®
Website: www.dexcom.com
The Transmitter ID:
The Receiver ID:
Dexcom Technical Support: 1.877.339.2664
© 2014 Dexcom, Inc. All rights reserved.
Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom G4 PLATINUM
Professional, 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.
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Strany 1 - GLUCOSE MONITORING SYSTEM

Dexcom G4 PLATINUM Professional System User’s Guide | 1USER’S GUIDEDEXCOM G4® PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMIMPORTANT CON

Strany 2

10 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemGLOSSARY (continued from page before)Square Seal Square-shaped tape that is

Strany 3

100 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System8WARNINGDo not ignore symptoms of high and low glucose. If your sensor glu

Strany 4 - AND BLINDED MODE 125

Dexcom G4 PLATINUM Professional System User’s Guide | 101Status Symbols (continued from page before)Glucose Reading ErrorThis symbol means the receiv

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102 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

Strany 6 - CHAPTER 18: APPENDIX 235

Dexcom G4 PLATINUM Professional System User’s Guide | 1039chapter nineALERTS, ALARM & PROFILES

Strany 7 - GLOSSARY

104 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System9

Strany 8

Dexcom G4 PLATINUM Professional System User’s Guide | 105CHAPTER 9: ALERTS, ALARM & PROFILESThis chapter teaches you about the Dexcom G4 PLATINU

Strany 9

106 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System9Default Alert/Alarm Settings in Real-Time ModeWhat will I see on the rece

Strany 10

Dexcom G4 PLATINUM Professional System User’s Guide | 107Default Alert/Alarm Settings (continued from page before)What will I see on the receiver scr

Strany 11 - (CGM) SYSTEM DESCRIPTION

108 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System9This table describes the receiver alerts and alarm and explains how the r

Strany 12

Dexcom G4 PLATINUM Professional System User’s Guide | 109sensor glucose readings drop below the high glucose alert level. You can have the receiver r

Strany 13 - 1.1 SYSTEM CONTENTS:

Dexcom G4 PLATINUM Professional System User’s Guide | 111chapter oneDEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRI

Strany 14 - 1.2 INTRODUCTION

110 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System9•Thereceiverdisplaysthelowglucosealarmscreen.•Re-alarm:There

Strany 15 - 1.3 SENSOR OVERVIEW

Dexcom G4 PLATINUM Professional System User’s Guide | 1113. From the Main Menu, press the UP or DOWN button to scroll to “Alerts,” and press the SEL

Strany 16 - 1.4 TRANSMITTER OVERVIEW

112 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System9NOTE: Changing the high and low glucose alert is not necessary in blinded

Strany 17 - 1.5 RECEIVER OVERVIEW

Dexcom G4 PLATINUM Professional System User’s Guide | 1134. Press the DOWN button to highlight “Level.” The number that shows is the current high gl

Strany 18

114 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System94. From the Alerts menu, press the UP or DOWN button to select “Advanced

Strany 19

Dexcom G4 PLATINUM Professional System User’s Guide | 1159.2.2 RISE AND FALL GLUCOSE RATE ALERTS IN REAL-TIME MODERate alerts tell you when the glu

Strany 20 - 1.6 RECEIVER SHIELD OVERVIEW

116 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System92. Highlight “On/Off” and then press the SELECT button.3. Press the UP

Strany 21

Dexcom G4 PLATINUM Professional System User’s Guide | 1176. Press the LEFTbuttontoreturntothealertsmenuwhenyounish.9.2.3 SETTING THE OUT

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118 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System93. Press the UP or DOWN button to choose “Time,” and press the SELECT bu

Strany 23 - SAFETY STATEMENT

Dexcom G4 PLATINUM Professional System User’s Guide | 119Regardlessofwhichalertproleyouchoose,ifyouconrmtherstvibrate alert, you will

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12 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System1

Strany 25 - 2.1 INDICATIONS FOR USE

120 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System9The“TryIt”featureisfoundundertheProlesmenuandletsyouhearan

Strany 26 - 2.4 WARNINGS

Dexcom G4 PLATINUM Professional System User’s Guide | 121ALERT PROFILE DETAILS (continued from page before)PROFILE TYPEVIBRATE SOFT NORMAL ATTENTIVE

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122 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System9ALERT PROFILE DETAILS (continued from page before)PROFILE TYPEVIBRATE SOF

Strany 28

Dexcom G4 PLATINUM Professional System User’s Guide | 123Trend graph in real-time modeTrend graph in blinded mode2. Press the SELECT button to see t

Strany 29 - 2.5 PRECAUTIONS

124 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

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Dexcom G4 PLATINUM Professional System User’s Guide | 12510chapter tenEVENTS, DEXCOM STUDIO SOFTWARE AND BLINDED MODE

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126 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System10

Strany 32

Dexcom G4 PLATINUM Professional System User’s Guide | 127CHAPTER 10: EVENTS, DEXCOM STUDIO SOFTWARE AND BLINDED MODEThe Events feature lets you reco

Strany 33 - 2.6 CAUTION

128 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System3. Press the UP or DOWN button to scroll to “Events,” and press the SELEC

Strany 34

Dexcom G4 PLATINUM Professional System User’s Guide | 1291. Press the RIGHT button to highlight each value in the date and time. 2. Press the UP or

Strany 35 - RISKS AND BENEFITS

Dexcom G4 PLATINUM Professional System User’s Guide | 13CHAPTER 1: DEXCOM G4® PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCR

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130 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System2. Press the UP or DOWN button to enter the carb amount (0-250 grams), an

Strany 37 - 3.1 RISKS

Dexcom G4 PLATINUM Professional System User’s Guide | 1312. Press the UP or DOWN button to enter the insulin amount (0-250 units), and press the SEL

Strany 38 - 3.2 BENEFITS

132 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System2. Press the UP or DOWN button to choose the exercise intensity level, an

Strany 39

Dexcom G4 PLATINUM Professional System User’s Guide | 1331. From the Events menu press the UP or DOWN button to choose “Health,” and press the SELEC

Strany 40

134 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System10Youcanusedatafromdownloadsandsaveorprintlesforusersandhea

Strany 41 - THE RECEIVER MAIN MENU

Dexcom G4 PLATINUM Professional System User’s Guide | 135see the Dexcom website (www.dexcom.com) or the Dexcom STUDIO Software User’s Guide.Once the

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136 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System10The Tools drop down menu now includes an option to Blind/Unblind Attache

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Dexcom G4 PLATINUM Professional System User’s Guide | 137NOTE: The choice of blinding/unblinding the receiver does not impact the data that is downlo

Strany 44 - FROM AN AC POWER OUTLET

138 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System10STUDIO software must be open to reset the receiver.Customize what happen

Strany 45

Dexcom G4 PLATINUM Professional System User’s Guide | 13911chapter elevenENDING A SENSOR SESSION

Strany 46

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

Strany 47 - 4.2 RECEIVER MENU OPTIONS

140 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System11

Strany 48 - Receiver Main Menu Options

Dexcom G4 PLATINUM Professional System User’s Guide | 141CHAPTER 11: ENDING A SENSOR SESSIONThe sensor gives you sensor glucose readings for up to s

Strany 49 - SYSTEM INITIAL SETUP

142 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System11Youcansetthesealertswiththeprolessetting(seeChapter9,Sectio

Strany 50

Dexcom G4 PLATINUM Professional System User’s Guide | 14311.2 REMOVING A SENSORWhen you remove the sensor, make sure to pull out the sensor pod whil

Strany 51 - WITH THE TRANSMITTER

144 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System1111.3 TRANSMITTER REMOVALDo not remove the transmitter while the sensor

Strany 52

Dexcom G4 PLATINUM Professional System User’s Guide | 145Safety lockTransmitter with safety lock snapped inMethod 2Usethengerstospreado

Strany 53 - 5.2 THE SETTINGS MENU

146 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

Strany 54

Dexcom G4 PLATINUM Professional System User’s Guide | 14712chapter twelveTAKING CARE OF THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM

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148 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System12

Strany 56

Dexcom G4 PLATINUM Professional System User’s Guide | 149CHAPTER 12: TAKING CARE OF THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM12.1 RECEIVING THE TR

Strany 57 - CONTRAINDICATION

Dexcom G4 PLATINUM Professional System User’s Guide | 15spread of contamination between multiple patient use.Please read this user’s guide closely. I

Strany 58

150 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System4. Remove and discard the triangle seal that is over the t-shaped slot in

Strany 59 - PATIENT USE

Dexcom G4 PLATINUM Professional System User’s Guide | 1519. Squeeze the receiver out of the shield (like squeezing toothpaste from a tube) until the

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152 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System12.3 CLEANING AND DISINFECTION OF THE TRANSMITTERDexcom validated 52 clea

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Dexcom G4 PLATINUM Professional System User’s Guide | 153Cleaning the Transmitter1. Wear clean gloves and goggles.2. Prepare a soaking container by

Strany 62

154 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System125. Flip the transmitter over to expose the contacts (metal circles).6.

Strany 63 - STARTING A SENSOR SESSION

Dexcom G4 PLATINUM Professional System User’s Guide | 155DisinfectionDisinfection removes and destroys microorganisms and pathogens from the transmit

Strany 64

156 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System122. Prepare a soaking container by adding enough Clorox Healthcare Bleac

Strany 65

Dexcom G4 PLATINUM Professional System User’s Guide | 15711. Place the transmitter on a clean non-porous surface and allow the disinfectant to conta

Strany 66 - 6.1 BEFORE YOU START

158 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System12(EPA registration number 56392-8) may be purchased from medical ofcesu

Strany 67 - PACKAGING

Dexcom G4 PLATINUM Professional System User’s Guide | 15912.4 USING THE RECEIVER SHIELDHealthcare professionals must apply a shield and its componen

Strany 68

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

Strany 69 - 6.4 PLACING THE SENSOR

160 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System123. Peel triangle seal from paper backing and secure seal over opening o

Strany 70 - 6.5 SENSOR INSERTION

Dexcom G4 PLATINUM Professional System User’s Guide | 161 •Insertcablesonlyasdirected.Donotforcecablesinplace. •Lookatcablesforsig

Strany 71 - “ 2 CLICKS”

162 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System •Storeathumiditylevelsbetween10%-95%relativehumidity.12.7 PR

Strany 72 - 6.6 TRANSMITTER ATTACHMENT

Dexcom G4 PLATINUM Professional System User’s Guide | 16313chapter thirteenTROUBLESHOOTING

Strany 73

164 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System13

Strany 74

Dexcom G4 PLATINUM Professional System User’s Guide | 165CHAPTER 13: TROUBLESHOOTINGThischapterprovideshelpfultipsandinstructionstoxissues

Strany 75 - 6.8 SENSOR STARTUP PERIOD

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

Strany 76 - Ready for

Dexcom G4 PLATINUM Professional System User’s Guide | 167 •SeeChapter7,CalibratingtheDexcomG4PLATINUMProfessionalSystem, for further info

Strany 77

168 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System1313.2.2 WHAT TO DO FOR CALIBRATION PROMPTS1. When you see a calibration

Strany 78 - PROFESSIONAL SYSTEM AND WATER

Dexcom G4 PLATINUM Professional System User’s Guide | 169SELECT button to clear the screen, this symbol shows in the status area.If you see this sc

Strany 79 - CALIBRATING THE DEXCOM G4

Dexcom G4 PLATINUM Professional System User’s Guide | 171.5 RECEIVER OVERVIEWThe receiver is the small hand-held device that looks like a cell phone

Strany 80

170 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System13Often, the system can correct the problem and continue providing or reco

Strany 81 - 7.1 CALIBRATION OVERVIEW

Dexcom G4 PLATINUM Professional System User’s Guide | 171uid.Therefore,thereadingsfromthebloodglucosemeterreadingsandsensor may not match

Strany 82

172 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System13 •Makesurethesensorisnotexpired. •Makesureyoudonotcalibra

Strany 83 - 7.2 HOW TO CALIBRATE

Dexcom G4 PLATINUM Professional System User’s Guide | 17313.6.1 EARLY SENSOR SHUT-OFF – SENSOR FAILUREThe receiver may detect issues with the sensor

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174 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System13 •LifestyleneedsWhen you are in an active sensor session, you will se

Strany 85

Dexcom G4 PLATINUM Professional System User’s Guide | 17513.7 BATTERY AND CHARGER TROUBLESHOOTINGOnly use the Dexcom cable and battery charger to ch

Strany 86

176 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System13Press the SELECT button to clear this display, and continue the sensor s

Strany 87 - 7.3 STARTUP CALIBRATION

Dexcom G4 PLATINUM Professional System User’s Guide | 17713.8.4 TRANSMITTER FAILED ERROR CODEThis screen means that the transmitter is not working.

Strany 88

178 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System13This screen means the receiver and transmitter are not communicating and

Strany 89 - CALIBRATE

Dexcom G4 PLATINUM Professional System User’s Guide | 17913.10 ALERTS ARE NOT WORKING1. Make sure you have not turned off the sound and/or vibratio

Strany 90 - Wait 1 hour

18 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemReal-Time Receiver Mode:1EXAMPLE: 3-Hour Trend Graph ScreenStatus areaHigh

Strany 91 - AND TRENDS IN REAL-TIME MODE

180 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System to work properly when the shield is in place. If the spacer moves and th

Strany 92

Dexcom G4 PLATINUM Professional System User’s Guide | 18114chapter fourteenTECHNICAL INFORMATION

Strany 93

182 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14

Strany 94

Dexcom G4 PLATINUM Professional System User’s Guide | 183CHAPTER 14: TECHNICAL INFORMATION14.1 DEVICE PERFORMANCE CHARACTERISTICSNOTE: We recommend

Strany 95

184 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemParticipants used the System for seven days. Thirty-six participants each

Strany 96 - Which Trend Graph Do You See?

Dexcom G4 PLATINUM Professional System User’s Guide | 185The total number of data pairs considered in this analysis was 9152. Of these,eighty-twope

Strany 97

186 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14in the range of 81-180 mg/dL (4.5-10.0 mmol/L). You may expect your CGM

Strany 98 - Trend Arrows

Dexcom G4 PLATINUM Professional System User’s Guide | 187level. For example if you feel normal and your blood glucose level is at 100 mg/dL (5.6 mmol

Strany 99 - No arrow

188 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14mmol/L),and96%(238outof248)oftheYSIvaluesweregreaterthan28

Strany 100

Dexcom G4 PLATINUM Professional System User’s Guide | 189glucose ranges above and below the paired CGM readings. Table 3. Concurrence of CGM Reading

Strany 101

Dexcom G4 PLATINUM Professional System User’s Guide | 19Blinded Receiver Mode:Therearevereceiverbuttonstomoveyouthroughthescreens.When in

Strany 102 - PAGE INTENTIONALLY LEFT BLANK

190 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14readingis90mg/dL(5.0mmol/L),a10%differencebetweentheSysteman

Strany 103 - ALERTS, ALARM & PROFILES

Dexcom G4 PLATINUM Professional System User’s Guide | 191Table 4-A. System Difference to YSI within CGM Glucose RangesCGMGlucose Ranges mg/dL (mmol/

Strany 104

192 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14the reference at CGM reading within 351-400 mg/dL (Mean Absolute Percent

Strany 105

Dexcom G4 PLATINUM Professional System User’s Guide | 193on average, CGM reads 7.3 mg/dL (0.4 mmol/L) higher than the reference at YSI glucose levels

Strany 106

194 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14Hypoglycemia Alert RateThe Alert Rate shows how often the alert is right

Strany 107

Dexcom G4 PLATINUM Professional System User’s Guide | 195Table 6. Hyperglycemic Alert EvaluationHyperglycemic Alert Level mg/dL (mmol/L)True Alert R

Strany 108 - REAL-TIME MODE

196 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14event.TheHyperglycemiaDetectionRateisthe%oftimethebloodgluco

Strany 109

Dexcom G4 PLATINUM Professional System User’s Guide | 197Table 7. Percentage of System Readings within YSI Values with Data Stratied in 2-Hour Incr

Strany 110

198 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14Table 8. Sensor Stability (Accuracy over Time)Day of WearNumber of pair

Strany 111 - GLUCOSE ALERTS

Dexcom G4 PLATINUM Professional System User’s Guide | 199the System over the entire 7-day period after calibration. For example, 93.5%ofSystemspro

Strany 112

2 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemDEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMtable of

Strany 113 - 9.2 ADVANCED ALERTS

20 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System1Receiver buttons:•PresstheUP and DOWN buttons to scroll through trend

Strany 114

200 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14their daily diabetes management when comparing the system readings to th

Strany 115 - IN REAL-TIME MODE

Dexcom G4 PLATINUM Professional System User’s Guide | 201orgreaterthan40mg/dL(2.2mmol/L)or40%werethencalculated.For example, if the CGM r

Strany 116

202 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemPercentDifferenceshowsthathalfofthetimetheSystemreads-1.4%or l

Strany 117

Dexcom G4 PLATINUM Professional System User’s Guide | 203Transmitter Product Specications (continued from page before)Power Supply Silver oxide batt

Strany 118 - 9.3 ALERT PROFILES

204 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14The Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System

Strany 119 - 9.3.1 ALERT PROFILE OPTIONS

Dexcom G4 PLATINUM Professional System User’s Guide | 205Transmitter Electromagnetic Immunity Specications (continued from page before)Immunity Test

Strany 120 - 9.3.2 ALERT PROFILE DETAILS

206 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14Transmitter Electromagnetic Immunity Specications (continued from page

Strany 121 - (continued from page

Dexcom G4 PLATINUM Professional System User’s Guide | 207Receiver Product Specications (continued from page before)Charging Time3 hours wall outlet,

Strany 122

208 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14Receiver Electromagnetic Immunity Specications (continued from page bef

Strany 123

Dexcom G4 PLATINUM Professional System User’s Guide | 209Receiver Electromagnetic Immunity Specications (continued from page before)Immunity Test IE

Strany 124

Dexcom G4 PLATINUM Professional System User’s Guide | 21The receiver shield and components are disposable and must be replaced with each individual p

Strany 125 - AND BLINDED MODE

210 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14System Electromagnetic Immunity SpecicationsImmunity Test IEC 60601 Tes

Strany 126

Dexcom G4 PLATINUM Professional System User’s Guide | 211System Electromagnetic Immunity Specications (continued from page before)Immunity Test IEC

Strany 127 - 10.1.1 SELECTING AN EVENT

212 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14a.Fieldstrengthsfromxedtransmitters,suchasbasestationsfor ra

Strany 128

Dexcom G4 PLATINUM Professional System User’s Guide | 213Electromagnetic Emissions Specications (continued from page before)Emissions Test Complianc

Strany 129 - 10.1.3 CARBOHYDRATES

214 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14Minimum Recommended Distance Between Transmitter and ReceiverRated maxi

Strany 130 - 10.1.4 INSULIN

Dexcom G4 PLATINUM Professional System User’s Guide | 215Power Supply/Charger SpecicationsDexcom P/N MT21255Class IIInput: AC Input 100-240 Vac, 5

Strany 131 - 10.1.5 EXERCISE

216 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System14in accordance with the instructions, may cause harmful interference to r

Strany 132 - 10.1.6 HEALTH

Dexcom G4 PLATINUM Professional System User’s Guide | 21715chapter fteenUSER ASSISTANCE

Strany 133 - BLINDED MODE

218 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System15

Strany 134 - MODE/CLINICAL FEATURE

Dexcom G4 PLATINUM Professional System User’s Guide | 219CHAPTER 15: USER ASSISTANCE Dexcom Website: www.dexcom.com Dexcom Address: 6340 Sequence

Strany 135

22 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK

Strany 136 - 10.2.2 BLINDING THE RECEIVER

220 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System15SALES SUPPORTForhelpwithrst-timeorders,re-orders,trackingshipmen

Strany 137 - MULTIPLE PATIENT USE

Dexcom G4 PLATINUM Professional System User’s Guide | 22116chapter sixteenWARRANTY

Strany 138

222 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System16

Strany 139 - ENDING A SENSOR SESSION

Dexcom G4 PLATINUM Professional System User’s Guide | 223CHAPTER 16: WARRANTYDexcom G4 PLATINUM Professional System Limited Warranty1. What is Cover

Strany 140

224 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System16operation, maintenance, installation or adjustment; (f) installation, ma

Strany 141 - REAL-TIME AND BLINDED MODES

Dexcom G4 PLATINUM Professional System User’s Guide | 225AND DISCLAIMS ALL SUCH OTHER WARRANTIES, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCH

Strany 142

226 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring Systemthe original purchaser that the Dexcom G4 PLATINUM Transmitter is free fro

Strany 143 - 11.2 REMOVING A SENSOR

Dexcom G4 PLATINUM Professional System User’s Guide | 227Dexcom G4 PLATINUM Professional CGM System User’s Guide, a copy of which was included with t

Strany 144 - 11.3 TRANSMITTER REMOVAL

228 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemINCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR

Strany 145

Dexcom G4 PLATINUM Professional System User’s Guide | 229PLATINUM RECEIVER DUE TO MISUSE, AND IMPROPER INSTALLATION, CARE OR MAINTENANCE OF THE SHIEL

Strany 146

Dexcom G4 PLATINUM Professional System User’s Guide | 232chapter twoINDICATIONS FOR USE AND SAFETY STATEMENT

Strany 147 - PLATINUM PROFESSIONAL SYSTEM

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Dexcom G4 PLATINUM Professional System User’s Guide | 23117chapter seventeenTRAVEL INFORMATION

Strany 149 - RECEIVER FROM EACH USER

232 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System17

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Dexcom G4 PLATINUM Professional System User’s Guide | 233CHAPTER 17: TRAVEL INFORMATIONIt is safe for you to go through the metal detector or be “ha

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Strany 152 - TRANSMITTER

Dexcom G4 PLATINUM Professional System User’s Guide | 23518chapter eighteenAPPENDIX

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236 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18

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Dexcom G4 PLATINUM Professional System User’s Guide | 237CHAPTER 18: APPENDIXAPPENDIX I, RECEIVER ALERTS, ALARM AND PROMPTSThe following tables desc

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238 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will

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Dexcom G4 PLATINUM Professional System User’s Guide | 239Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiv

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24 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System2

Strany 158 - TECHNICAL SUPPORT

240 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will

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Dexcom G4 PLATINUM Professional System User’s Guide | 241Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiv

Strany 160 - 12.5 MAINTENANCE

242 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will

Strany 161 - 12.6 STORAGE

Dexcom G4 PLATINUM Professional System User’s Guide | 243Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiv

Strany 162 - 12.7 PRODUCT DISPOSAL

244 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will

Strany 163 - TROUBLESHOOTING

Dexcom G4 PLATINUM Professional System User’s Guide | 245Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiv

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246 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will

Strany 165 - CHAPTER 13: TROUBLESHOOTING

Dexcom G4 PLATINUM Professional System User’s Guide | 247Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiv

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248 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will

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Dexcom G4 PLATINUM Professional System User’s Guide | 249Receiver Alerts, Alarm and Prompts (continued from page before)What will I see on the receiv

Strany 168 - 13.3 CALIBRATION ERROR

Dexcom G4 PLATINUM Professional System User’s Guide | 25CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT2.1 INDICATIONS FOR USEThe Dexcom G4 PLA

Strany 169 - 13.4 SYSTEM GLUCOSE ERROR

250 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18Receiver Alerts, Alarm and Prompts (continued from page before)What will

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Dexcom G4 PLATINUM Professional System User’s Guide | 251APPENDIX II, INDEXAAlarm, Low Glucose ... 109Alerts ...

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252 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System Calibration Update ... 88 How to Calibrate...

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Dexcom G4 PLATINUM Professional System User’s Guide | 253Menu Options...47R Radio-Frequency (RF) ...

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254 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18 Pod ...9, 15 Removing from Packa

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Dexcom G4 PLATINUM Professional System User’s Guide | 255 Removal ...144 Safety Lock . . . . . . . . . . . . . .

Strany 175 - 13.8.1 SYSTEM RECOVERY CHECK

256 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System18APPENDIX III, SYMBOLS USED IN LABELINGThe following symbols may be found

Strany 176 - 13.8.2 RECEIVER ERROR CODE

Dexcom G4 PLATINUM Professional System User’s Guide | 257Symbols (continued from page before)ManufacturerEC REPAuthorized Representative in the Euro

Strany 177 - 13.9 OUT OF RANGE/NO ANTENNA

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26 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System2manage your diabetes. Your product instructions contain important informat

Strany 179 - PRECAUTIONS

Dexcom G4 PLATINUM Professional System User’s Guide | 27•DonotusetheDexcomG4PLATINUMProfessionalSystem for treatment decisions, such as how

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28 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System2manufacturer’s cleaning and disinfection procedures are followed.•Replac

Strany 181 - TECHNICAL INFORMATION

Dexcom G4 PLATINUM Professional System User’s Guide | 29blood glucose) events.•Ifyourtransmitterorreceivercaseisdamaged/cracked,donot use

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Dexcom G4 PLATINUM Professional System User’s Guide | 3CHAPTER 5: DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM INITIAL SETUP 495.1 Setting Up the Receive

Strany 183 - CHARACTERISTICS

30 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System2insertion, if the system is used multiple times. Using the same site too o

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Dexcom G4 PLATINUM Professional System User’s Guide | 31screen is showing the falling single arrow or double arrow, which indicates that your blood g

Strany 185 - Glucose Ranges

32 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System2•Donotdiscardyourtransmitter.Itisreusable.Thesametransmitter i

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Dexcom G4 PLATINUM Professional System User’s Guide | 33after giving to the patient, the patient should return the receiver to the healthcare profess

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Dexcom G4 PLATINUM Professional System User’s Guide | 353chapter threeRISKS AND BENEFITS

Strany 189 - Accuracy

36 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System13

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Dexcom G4 PLATINUM Professional System User’s Guide | 37CHAPTER 3: RISKS AND BENEFITS3.1 RISKSThere are some known risks with using real-time or bl

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38 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System3or low glucose alerts in blinded mode since these alerts are deactivated.

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Dexcom G4 PLATINUM Professional System User’s Guide | 39professional to adjust your diabetes management therapy or techniques.Alerts and the low alar

Strany 193 - The Low Glucose Alert

4 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System8.2 Rate of Change Arrows in Real-Time Mode... 978.3 Glucos

Strany 194 - The High Glucose Alert

40 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System31 Garg S, Zisser H, Schwartz S, Bailey T, Kaplan R, Ellis S, Jovanovic L.

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Dexcom G4 PLATINUM Professional System User’s Guide | 414chapter fourCHARGING THE RECEIVER AND THE RECEIVER MAIN MENU

Strany 196 - Calibration Stability

42 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System4

Strany 197 - Sensor Stability

Dexcom G4 PLATINUM Professional System User’s Guide | 43CHAPTER 4: CHARGING THE RECEIVER AND THE RECEIVER MAIN MENU4.1 CHARGING THE RECEIVER BATTER

Strany 198 - Number of Readings Provided

44 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemCharge the receiver battery before each sensor insertion. Periodically chec

Strany 199 - Over 7- Days

Dexcom G4 PLATINUM Professional System User’s Guide | 455. Plug the micro USB end of the cable into the receiver USB port.Keep the USB port cover on

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46 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System42. Plug the included USB cable into the computer.3. Plug the other end o

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Dexcom G4 PLATINUM Professional System User’s Guide | 471. Disconnect the cable and power adapter. 2. Do not move the USB port cover; leave it open.3

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48 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemReceiver Main Menu OptionsMenu PurposeUser’s Guide ReferenceTrend GraphTo s

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Dexcom G4 PLATINUM Professional System User’s Guide | 495chapter veDEXCOM G4 PLATINUM PROFESSIONAL SYSTEM INITIAL SETUP

Strany 204 - Electromagnetic Immunity

Dexcom G4 PLATINUM Professional System User’s Guide | 5 10.2.4 Resetting the Receiver for Multiple Patient Use ... 137CHAPTER 11: ENDING A SEN

Strany 205 - (continued from page before)

50 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System5

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Dexcom G4 PLATINUM Professional System User’s Guide | 51CHAPTER 5: DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM INITIAL SETUPThischapterhelpsyouwheny

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52 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System5 (1) Press the UP or DOWN button to enter the transmitter ID. (2) Pres

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Dexcom G4 PLATINUM Professional System User’s Guide | 53 (1) Press the UP or DOWN button to select the alert level. The low alert can be changed i

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54 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System5graph shows.2. Press the SELECT button to see the Main Menu.3. From the

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Dexcom G4 PLATINUM Professional System User’s Guide | 55“AM” or “PM.” You will return to the Settings menu.You might need to reset the receiver’s tim

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56 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System5 a. Press the UP or DOWN button to show the correct number or letter. b

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Dexcom G4 PLATINUM Professional System User’s Guide | 57 •TransmitterID •SerialNumber •PartNumber •PartRevision •SoftwareNumber •So

Strany 213 - Receiver

58 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System5Press the SELECT, LEFT or RIGHT button to see the trend graph. This antenn

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Dexcom G4 PLATINUM Professional System User’s Guide | 595.5 USING THE RECEIVER SHIELD AND PREPARING THE RECEIVER FOR MULTIPLE PATIENT USEPRECAUTIONS

Strany 215 - 14.3 FCC REQUIREMENTS

6 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemCHAPTER 14: TECHNICAL INFORMATION 18114.1 Device Performance Characterist

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60 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System5The Dexcom G4 PLATINUM Receiver is protected by a receiver shield when use

Strany 217 - USER ASSISTANCE

Dexcom G4 PLATINUM Professional System User’s Guide | 61The receiver shield pack includes:  •Receivershield •1triangleseal(tapetocoverthe

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62 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System53. Peel triangle seal from paper backing and secure seal over opening on

Strany 219 - CHAPTER 15: USER ASSISTANCE

Dexcom G4 PLATINUM Professional System User’s Guide | 636chapter sixINSERTING A SENSOR AND STARTING A SENSOR SESSION

Strany 220 - SALES SUPPORT

64 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System6

Strany 221 - WARRANTY

Dexcom G4 PLATINUM Professional System User’s Guide | 65CHAPTER 6: INSERTING A SENSOR AND STARTING A SENSOR SESSIONYou need a sensor, a transmitter,

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66 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System6.1 BEFORE YOU START•MakesurethecorrecttransmitterIDhasbeenenter

Strany 223 - CHAPTER 16: WARRANTY

Dexcom G4 PLATINUM Professional System User’s Guide | 67Review the sensor applicator picture before using a new sensor.6.2 REMOVING THE SENSOR FROM

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68 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System66.3 CHOOSING AN INSERTION SITEChoose a site on the belly to place the sen

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Dexcom G4 PLATINUM Professional System User’s Guide | 696.4 PLACING THE SENSOR1. Clean the skin at the sensor placement site with an alcohol wipe.

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Dexcom G4 PLATINUM Professional System User’s Guide | 7GLOSSARYAcoustic SpacerSmall, L-shaped plastic piece to be placed above the receiver speaker t

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70 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System63. Place the sensor horizontally, NOT vertically, on the skin. 4.Movey

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Dexcom G4 PLATINUM Professional System User’s Guide | 712.Whilestillpinching,usetheotherhandtoplacetwongersabove the collar on the appl

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72 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System6 •Makesurethetransmitterlatchisdown(againstthebody)beforesqu

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Dexcom G4 PLATINUM Professional System User’s Guide | 73 c. With the other hand, pull the transmitter latch up and forward, over the transmitter, t

Strany 231 - TRAVEL INFORMATION

74 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System62. From any trend graph, press the SELECT button to see the Main Menu.3.

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Dexcom G4 PLATINUM Professional System User’s Guide | 757. If in real-time mode, you will not get sensor glucose readings or high/low glucose alerts

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76 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System61. Press SELECT during the startup period to turn the on receiver displ

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Dexcom G4 PLATINUM Professional System User’s Guide | 77for even support. Do not tape over the transmitter or any of the plastic parts of the sensor

Strany 235 - APPENDIX

78 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemTo turn the receiver back on and resume communication with the transmitter,

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Dexcom G4 PLATINUM Professional System User’s Guide | 797chapter sevenCALIBRATING THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEM

Strany 237 - CHAPTER 18: APPENDIX

8 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring SystemGLOSSARY (continued from page before)Dexcom G4 PLATINUM Professional SystemT

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80 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System7

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Dexcom G4 PLATINUM Professional System User’s Guide | 81CHAPTER 7: CALIBRATING THE DEXCOM G4 PLATINUM PROFESSIONAL SYSTEMIn both real-time and blind

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82 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System7prompted to enter additional blood glucose values as needed.PRECAUTIONDo n

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Dexcom G4 PLATINUM Professional System User’s Guide | 837.2 HOW TO CALIBRATEYou must enter the exact blood glucose value from the meter for each cal

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

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Dexcom G4 PLATINUM Professional System User’s Guide | 851. Wash and dry hands, make sure the glucose test strips are not expired and have been store

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86 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System77. Conrm that the blood glucose value you entered is correct. Entering i

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Dexcom G4 PLATINUM Professional System User’s Guide | 87PRECAUTIONTo calibrate the system, enter the exact blood glucose value that your blood glucos

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88 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System a. The startup calibration symbol will stay at the top of the trend grap

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Dexcom G4 PLATINUM Professional System User’s Guide | 89The following steps show you how to enter this calibration.1. When you see this screen, pres

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Dexcom G4 PLATINUM Professional System User’s Guide | 9GLOSSARY (continued from page before)Proles Sound pattern and volume level settings for the a

Strany 249

90 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System7Wait 15 minutescalibration error screenWait 1 hourcalibration error screen

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Dexcom G4 PLATINUM Professional System User’s Guide | 918chapter eight VIEWING SENSOR GLUCOSE READINGS AND TRENDS IN REAL-TIME MODE

Strany 251 - APPENDIX II, INDEX

92 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System108

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Dexcom G4 PLATINUM Professional System User’s Guide | 93CHAPTER 8: VIEWING SENSOR GLUCOSE READINGS AND TRENDS IN REAL-TIME MODEThis chapter teaches

Strany 253

94 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System8WARNINGDo not use the Dexcom G4 PLATINUM Professional System for treatment

Strany 254

Dexcom G4 PLATINUM Professional System User’s Guide | 95•Each“dot”onthetrendgraphisasensorglucosereadingreportedevery 5 minutes.•Thet

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96 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System8The sensor glucose reading is in milligrams per deciliter (mg/dL) unitWhic

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Dexcom G4 PLATINUM Professional System User’s Guide | 97Which Trend Graph Do You See? (continued from page before)(Scroll down from the 6-hour graph

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98 | Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System8The trend arrows show to the right of the current sensor glucose reading.D

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Dexcom G4 PLATINUM Professional System User’s Guide | 99Trend Arrows (continued from page before)Falling: The glucose is falling 2-3 mg/dL each minut

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