Dexcom G4 Professional User's Guide

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Dexcom G4 PLATINUM User’s Guide | 1
USER’S GUIDE
DEXCOM G4
®
PLATINUM
CONTINUOUS GLUCOSE
MONITORING SYSTEM
IMPORTANT CONTACTS AND NUMBERS
Dexcom
®
Website: www.dexcom.com
Your Transmitter ID:
Your Receiver ID:
Your Healthcare Professional:
Nearest Hospital:
© 2013 Dexcom, Inc. All rights reserved.
Dexcom, Dexcom G4, Dexcom G4 PLATINUM, Dexcom Studio,
SEVEN, Stay Between the Lines and Dexcom Makes Sense 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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1 2 3 4 5 6 ... 209 210

Summary of Contents

Page 1 - MONITORING SYSTEM

Dexcom G4 PLATINUM User’s Guide | 1USER’S GUIDEDEXCOM G4® PLATINUMCONTINUOUS GLUCOSE MONITORING SYSTEMIMPORTANT CONTACTS AND NUMBERSDexcom® Website:

Page 2

10 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1

Page 3

100 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System94. Press the UP or DOWN button to choose the amount of time out of range after which

Page 4

Dexcom G4 PLATINUM User’s Guide | 101Normalprole:thedefaultprolewhenyoureceiveyoursystem.Thisprolesetsallalertsandalarmstohigher

Page 5

102 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9The“TryIt”featureisfoundundertheprolesmenuandletsyoutohearan example o

Page 6 - GLOSSARY

Dexcom G4 PLATINUM User’s Guide | 103 ALERT PROFILE DETAILS (continued from page before)PROFILE TYPEVIBRATE SOFT NORMAL ATTENTIVE HYPOREPEATOut of Ra

Page 7

104 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System92. Press the SELECT button to see the Main Menu.3. Press the UP or DOWN button to sc

Page 8

Dexcom G4 PLATINUM User’s Guide | 10510chapter tenEVENTS

Page 9

106 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System10

Page 10

Dexcom G4 PLATINUM User’s Guide | 107CHAPTER 10: EVENTSThe Events feature lets you record information that may help you and your healthcare professi

Page 11 - 1.1 SYSTEM CONTENTS:

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

Page 12 - 1.2 INTRODUCTION

Dexcom G4 PLATINUM User’s Guide | 1094. Press the SELECTbuttontoconrmtheentry.10.1.3 CARBOHYDRATESThe Carbs event lets you enter the amount o

Page 13 - 1.3 SENSOR OVERVIEW

Dexcom G4 PLATINUM User’s Guide | 11CHAPTER 1: DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION1.1 SYSTEM CONTENTS: •sens

Page 14 - 1.4 TRANSMITTER OVERVIEW

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

Page 15 - 1.5 RECEIVER OVERVIEW

Dexcom G4 PLATINUM User’s Guide | 1113. Check that the date and time for this entry are correct. Press the SELECT buttontoconrm.4. Press the LEF

Page 16

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

Page 17 - SAFETY STATEMENT

Dexcom G4 PLATINUM User’s Guide | 1132. Press the UP or DOWN button to choose your health event, and press the SELECT button. 3. Check that the dat

Page 18

114 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System10PAGE INTENTIONALLY LEFT BLANK

Page 19 - 2.1 INDICATIONS FOR USE

Dexcom G4 PLATINUM User’s Guide | 11511chapter elevenENDING A SENSOR SESSION

Page 20 - 2.4 WARNINGS

116 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System11

Page 21

Dexcom G4 PLATINUM User’s Guide | 117PRECAUTIONDo not discard your transmitter. It is reusable. The same transmitter is used for each session until y

Page 22 - 2.5 PRECAUTIONS

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

Page 23

Dexcom G4 PLATINUM User’s Guide | 119When you remove the sensor, make sure to pull out the sensor pod while the transmitter is still attached.Gently

Page 24 - 2.6 CAUTION

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

Page 25 - RISKS AND BENEFITS

120 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System11Method 2Useyourngerstospreadoutthetabsatthebackofthesensorpod(end clo

Page 26

Dexcom G4 PLATINUM User’s Guide | 12112chapter twelveTAKING CARE OF YOURDEXCOM G4 PLATINUM SYSTEM

Page 27 - 3.1 RISKS

122 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System12

Page 28 - 3.2 BENEFITS

Dexcom G4 PLATINUM User’s Guide | 123Chapter 12: TAKING CARE OF YOUR DEXCOM G4 PLATINUM SYSTEM12.1 MAINTENANCETransmitter •Wipetheoutsideoft

Page 29 - 1, 2 , 3

124 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System •Storeattemperaturesbetween36°F-77°F.Storingoutsidethistemperature may

Page 30

Dexcom G4 PLATINUM User’s Guide | 12513chapter thirteenTROUBLESHOOTING

Page 31 - AND THE RECEIVER MAIN MENU

126 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13

Page 32

Dexcom G4 PLATINUM User’s Guide | 127Chapter 13: TROUBLESHOOTINGThischapterprovideshelpfultipsandinstructionstoxissuesyoumayhave while

Page 33

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

Page 34 - FROM AN AC POWER OUTLET

Dexcom G4 PLATINUM User’s Guide | 129 •SeeChapter7,CalibratingYourDexcomG4PLATINUMSystem,for further information.13.2.1 TYPES OF CALIBRA

Page 35

Dexcom G4 PLATINUM User’s Guide | 131.3 SENSOR OVERVIEWThe sensor is the piece that comes in a sterile, sealed sensor pouch. The sensor is made up o

Page 36 - 4.2 RECEIVER MENU OPTIONS

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

Page 37

Dexcom G4 PLATINUM User’s Guide | 131If you see this screen, wait at least 1 hour and then enter 1 more calibration blood glucose value. Wait 15 minu

Page 38

132 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13•Makesurenothingisrubbingthesensorpod(i.e.clothing,seatbelts, etc.).•M

Page 39

Dexcom G4 PLATINUM User’s Guide | 133If the difference between your sensor glucose reading and blood glucosevalueisgreaterthan20%ofthebloodg

Page 40

134 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13 •Makesureyouhavenottakenanymedicationscontainingacetaminophen (such as T

Page 41 - WITH YOUR TRANSMITTER

Dexcom G4 PLATINUM User’s Guide | 13513.6.2 MANUAL SENSOR SHUT-OFF – “STOP SENSOR”There may be times that you will want to stop your sensor session

Page 42

136 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System133. The stop sensor thinking screen will show to let you know the sensor session is s

Page 43 - 5.2 THE SETTINGS MENU

Dexcom G4 PLATINUM User’s Guide | 1371. Connect the receiver to the charger before resetting.2. Insert the end of a paperclip into the small circula

Page 44

138 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1313.8.3 TRANSMITTER LOW BATTERYThis screen shows when the transmitter nears the end o

Page 45

Dexcom G4 PLATINUM User’s Guide | 139This screen means your receiver and transmitter are not communicating and you are not getting sensor glucose rea

Page 46 - CONTRAINDICATION

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

Page 47

140 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System133.Remember,therstalertisvibrateonly.SeeChapter18,AppendixI, Receiver Al

Page 48

Dexcom G4 PLATINUM User’s Guide | 14114chapter fourteenTECHNICAL INFORMATION

Page 49 - STARTING A SENSOR SESSION

142 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14

Page 50

Dexcom G4 PLATINUM User’s Guide | 14316CHAPTER 14: TECHNICAL INFORMATION14.1 DEVICE PERFORMANCE CHARACTERISTICSNOTE: We recommend that you review t

Page 51

144 | Dexcom G4 PLATINUM Continuous Glucose Monitoring Systemaverageof2ngersticksperday(approximatelyonceevery12hours).All subjects were

Page 52 - 6.1 BEFORE YOU START

Dexcom G4 PLATINUM User’s Guide | 14516Table 1-A. System Agreement to YSI within CGM Glucose Ranges CGM Glucose Range mg/dL (mmol/L)Number of paired

Page 53 - PACKAGING

146 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 1-B. System Agreement to YSI within YSI Glucose Ranges YSI Glucose Range mg/dL

Page 54

Dexcom G4 PLATINUM User’s Guide | 1471620%ofYSIvalues,i.e.80to120mg/dL(4.5-6.7mmol/L),76%ofthetime.During the clinical study, the refe

Page 55 - 6.4 PLACING THE SENSOR

148 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Concurrence of System and Laboratory ReferenceThe percentage of concurring CGM readin

Page 56 - 6.5 SENSOR INSERTION

Dexcom G4 PLATINUM User’s Guide | 14916Table 3. Concurrence of CGM Readings and YSI ValuesCGM mg/dL (mmol/L)YSI mg/dL (mmol/L)Percent of matched pai

Page 57 - “2 CLICKS”

Dexcom G4 PLATINUM User’s Guide | 151.5 RECEIVER OVERVIEWThe receiver is the small hand-held device that looks like a cell phone. It is about 4 inc

Page 58 - 6.6 TRANSMITTER ATTACHMENT

150 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14AccuracyAccuracy between matched pairs was also estimated by calculating the percent

Page 59

Dexcom G4 PLATINUM User’s Guide | 151Table 4-A. System Difference to YSI within CGM Glucose RangesCGMGlucose Ranges mg/dL (mmol/L)Number of Paired C

Page 60 - 6.8 SENSOR STARTUP PERIOD

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

Page 61 - Ready for

Dexcom G4 PLATINUM User’s Guide | 15316Table 5. Hypoglycemic Alert EvaluationHypoglycemicAlert Levelmg/dL (mmol/L)True Alert RateFalse Alert RateHyp

Page 62

154 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Hypoglycemia Alert RateThe Alert Rate shows how often the alert is right or wrong. Th

Page 63

Dexcom G4 PLATINUM User’s Guide | 15516The High Glucose AlertEstimates of how well the adjustable High Glucose Alert performs are presented in Table

Page 64

156 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Hyperglycemia Detection RateThe Detection Rate shows how often the device recognizes

Page 65 - CALIBRATING YOUR DEXCOM

Dexcom G4 PLATINUM User’s Guide | 157Time from CalibrationNumber of paired CGM-YSIPercent within 15/15% YSIPercent within 20/20% YSIPercent within 3

Page 66

158 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14Table 8. Sensor Stability (Accuracy over Time)Day of WearNumber of paired CGM-YSIMea

Page 67 - 7.1 CALIBRATION OVERVIEW

Dexcom G4 PLATINUM User’s Guide | 159provided between 1,811 and 1,992 valid glucose readings (or more than 76%oftheexpectednumberofreadings).A

Page 68

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

Page 69 - 7.2 HOW TO CALIBRATE

160 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14 Table 11. System Agreement to SMBG Within CGM Glucose RangesCGM Glucose Rangesmg/dL

Page 70

Dexcom G4 PLATINUM User’s Guide | 161example, if the CGM reads 100 mg/dL, it is between 81-180 mg/dL (4.5-10.0mmol/L)range,youcanexpecttheCGM

Page 71

162 | Dexcom G4 PLATINUM Continuous Glucose Monitoring Systemor less than the SMBG values and the Median Absolute Percent Differenceshowsthathalf

Page 72 - 7.3 STARTUP CALIBRATION

Dexcom G4 PLATINUM User’s Guide | 16314Transmitter Product Specications (continued from page before)Power Supply Silver oxide batteries (not replace

Page 73 - CALIBRATE

164 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemTransmitter Electromagnetic Immunity Specications Immunity Test IEC 60601 Test LevelTr

Page 74

Dexcom G4 PLATINUM User’s Guide | 165(continued on next page)Transmitter Electromagnetic Immunity Specications (continued from page before)Immunity

Page 75 - AND TRENDS

166 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14(continued on next page)Receiver Product SpecicationsPart Number MT20649Reading Freq

Page 76

Dexcom G4 PLATINUM User’s Guide | 167Receiver Product Specications (continued from page before)Communication Range20 feetMemory Storage30 days of gl

Page 77

168 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14(continued on next page)Receiver Electromagnetic Immunity Specications Immunity Test

Page 78 - 8.1 SENSOR GLUCOSE READINGS

Dexcom G4 PLATINUM User’s Guide | 169Receiver Electromagnetic Immunity Specications(continued from page before)Immunity Test IEC 60601 Test LevelRec

Page 79

Dexcom G4 PLATINUM User’s Guide | 172chapter twoINDICATIONS FOR USE AND SAFETY STATEMENT

Page 80 - Which Trend Graph Do You See?

170 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14System Electromagnetic Immunity Specications Immunity Test IEC 60601 Test LevelRecei

Page 81 - 8.2 RATE OF CHANGE ARROWS

Dexcom G4 PLATINUM User’s Guide | 171(footnotes continued on next page)System Electromagnetic Immunity Specications (continued from page before) Imm

Page 82 - Trend Arrows

172 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14(footnotes continued page from page before)Electromagnetic Emissions Specications Em

Page 83

Dexcom G4 PLATINUM User’s Guide | 173Electromagnetic Emissions Specications (continued from page before) Emissions Test Compliance Electromagnetic E

Page 84 - Status Symbols

174 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14USB Charging/Download Cable* SpecicationsDexcom P/N MT20655Input/Output 5V DC, 1ATyp

Page 85

Dexcom G4 PLATINUM User’s Guide | 175Power Supply/Charger SpecicationsDexcom P/N MT21255Class IIInput: AC Input 100-240 Vac, 50/60Hz, 0.2A, 0.2A r

Page 86

176 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System14and can radiate radio frequency energy and, if not installed and used in accordance w

Page 87 - ALERTS, ALARM & PROFILES

Dexcom G4 PLATINUM User’s Guide | 17715chapter fteenUSER ASSISTANCE

Page 88

178 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System15

Page 89 - 9.1 SETTING YOUR ALERTS

Dexcom G4 PLATINUM User’s Guide | 17917CHAPTER 15: USER ASSISTANCE Dexcom Website: www.dexcom.com Dexcom Address: 6340 Sequence Drive San Diego,

Page 90

18 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System2

Page 91 - 9.1.2 GLUCOSE ALERTS

180 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK15

Page 92 - 9.1.2.2 LOW GLUCOSE ALERT

Dexcom G4 PLATINUM User’s Guide | 18116chapter sixteenWARRANTY

Page 93 - 9.1.2.3 LOW GLUCOSE ALARM

182 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System16

Page 94

Dexcom G4 PLATINUM User’s Guide | 183CHAPTER 16: WARRANTYDexcom G4 PLATINUM System Limited Warranty1. What is Covered and for How Long?Dexcom, Inc.

Page 95 - 9.2 ADVANCED ALERTS

184 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System16installation, maintenance, and service of products; or (g) equipment that has been di

Page 96 - HIGH AND LOW GLUCOSE ALERTS

Dexcom G4 PLATINUM User’s Guide | 185INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGE

Page 97

186 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemTransmitter is free from defects in material and workmanship under normal use (“Limited

Page 98

Dexcom G4 PLATINUM User’s Guide | 187of which was included with your Dexcom G4 PLATINUM CGM System and may be found at www.dexcom.com.3. What Are Dex

Page 99

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

Page 100 - 9.3 ALERT PROFILES

Dexcom G4 PLATINUM User’s Guide | 18917chapter seventeenTRAVEL INFORMATION

Page 101 - 9.3.1 ALERT PROFILE OPTIONS

Dexcom G4 PLATINUM User’s Guide | 19CHAPTER 2: INDICATIONS FOR USE AND SAFETY STATEMENT2.1 INDICATIONS FOR USEThe Dexcom G4 PLATINUM Continuous Glu

Page 102 - 9.3.2 ALERT PROFILE DETAILS

190 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System17

Page 103

Dexcom G4 PLATINUM User’s Guide | 191CHAPTER 17: TRAVEL INFORMATIONIt is safe for you to go through the metal detector or be “handwanded” while wear

Page 104

192 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK17

Page 105

Dexcom G4 PLATINUM User’s Guide | 19318chapter eighteenAPPENDIX

Page 106

194 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System18

Page 107 - CHAPTER 10: EVENTS

Dexcom G4 PLATINUM User’s Guide | 195CHAPTER 18: APPENDIXAPPENDIX I, RECEIVER ALERTS, ALARM AND PROMPTSThe following tables describe the alarm, aler

Page 108

196 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemWhat will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How w

Page 109 - 10.1.3 CARBOHYDRATES

Dexcom G4 PLATINUM User’s Guide | 197What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the receiver notify m

Page 110 - 10.1.4 INSULIN

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

Page 111 - 10.1.5 EXERCISE

Dexcom G4 PLATINUM User’s Guide | 199What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the receiver notify m

Page 112 - 10.1.6 HEALTH

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

Page 113 - 10.2 DEXCOM STUDIO SOFTWARE

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

Page 114 - PAGE INTENTIONALLY LEFT BLANK

200 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemWhat will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How w

Page 115 - ENDING A SENSOR SESSION

Dexcom G4 PLATINUM User’s Guide | 201What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the receiver notify m

Page 116

202 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemWhat will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How w

Page 117 - PRECAUTION

Dexcom G4 PLATINUM User’s Guide | 203Important alerts and alarm that can be checked by the user: • Out of Range alert - You can test this alert by

Page 118 - 11.2 REMOVING A SENSOR

204 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemAPPENDIX II, INDEXAAlarm, Low Glucose ...93Alerts ...

Page 119 - 11.3 TRANSMITTER REMOVAL

Dexcom G4 PLATINUM User’s Guide | 205C Calibration ... 67 Calibration Update ... 73 How

Page 120 - Method 2

206 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemM Maintenance, System...123Menu Options...

Page 121 - DEXCOM G4 PLATINUM SYSTEM

Dexcom G4 PLATINUM User’s Guide | 207 Failed ...134 Insertion . . . . . . . . . . . . . . . . . . . . . . . . . .

Page 122

208 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System ID Number ... 8 Setting ...

Page 123 - 12.2 STORAGE

Dexcom G4 PLATINUM User’s Guide | 209APPENDIX III, SYMBOLS USED IN LABELINGThe following symbols may be found on the sensor, transmitter, and receive

Page 124 - 12.3 PRODUCT DISPOSAL

Dexcom G4 PLATINUM User’s Guide | 21measure your blood glucose with a blood glucose meter even if your sensor is not reading in the high or low range

Page 125 - TROUBLESHOOTING

210 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemManufacturerEC REPAuthorized Representative in the European CommunityTwo-Sided Humidit

Page 126

22 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System2glucose readings to be inaccurate, and you might miss a low or high blood glucose value

Page 127 - Chapter 13: TROUBLESHOOTING

Dexcom G4 PLATINUM User’s Guide | 23carefully performed blood glucose measurement. Entering incorrect blood glucose values or blood glucose values fr

Page 128

24 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System2USB port, the receiver could become damaged and stop displaying readings or providing a

Page 129

Dexcom G4 PLATINUM User’s Guide | 253chapter threeRISKS AND BENEFITS

Page 130 - shows in

26 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System13

Page 131 - 13.4 SYSTEM GLUCOSE ERROR

Dexcom G4 PLATINUM User’s Guide | 27CHAPTER 3: RISKS AND BENEFITS3.1 RISKSThere are some known risks with using real-time CGM. You will not get sen

Page 132 - 13.5 SENSOR INACCURACIES

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

Page 133

Dexcom G4 PLATINUM User’s Guide | 29Real-time CGM can help improve diabetes control (lower A1c values, reducing glycemic variability and time spent i

Page 134

Dexcom G4 PLATINUM User’s Guide | 3CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUP395.1 Setting Up the Receiver and Pairing with Your Transmitter... 4

Page 135

30 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemPAGE INTENTIONALLY LEFT BLANK3

Page 136 - 13.7 BATTERY AND CHARGER

Dexcom G4 PLATINUM User’s Guide | 314chapter fourCHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU

Page 137 - 13.8.2 RECEIVER ERROR CODE

32 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System4

Page 138 - 13.9 OUT OF RANGE/NO ANTENNA

Dexcom G4 PLATINUM User’s Guide | 33CHAPTER 4: CHARGING YOUR RECEIVER AND THE RECEIVER MAIN MENU4.1 CHARGING YOUR RECEIVER BATTERYThe receiver batt

Page 139 - 13.10 ALERTS ARE NOT WORKING

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

Page 140

Dexcom G4 PLATINUM User’s Guide | 355. The battery charging screen will show on the receiver.6. After a few seconds the trend graph will show with

Page 141 - TECHNICAL INFORMATION

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

Page 142

Dexcom G4 PLATINUM User’s Guide | 372Receiver Main Menu Options (continued from page before)Menu PurposeUser’s Guide ReferenceStart SensorTo start a

Page 143 - Clinical Study Overview

38 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System4PAGE INTENTIONALLY LEFT BLANK

Page 144 - Agreement

Dexcom G4 PLATINUM User’s Guide | 395chapter veDEXCOM G4 PLATINUM SYSTEM SETUP

Page 145 - Glucose Ranges

4 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemCHAPTER 9: ALERTS, ALARM & PROFILES 879.1 Setting Your Alerts ...

Page 146

40 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System5

Page 147

Dexcom G4 PLATINUM User’s Guide | 41CHAPTER 5: DEXCOM G4 PLATINUM SYSTEM SETUPThischapterhelpsyouwhenyourstsetupyourContinuousGlucoseMo

Page 148

42 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System5Your transmitter ID is a unique code with 5 numbers and/or letters found in the followi

Page 149

Dexcom G4 PLATINUM User’s Guide | 435.2 THE SETTINGS MENUThe Settings menu lets you change the time, date or transmitter ID. The SetupWizardonlyw

Page 150 - Accuracy

44 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System54. Press the RIGHT button to move to the next value. The date format is YYYY/MM/DD. 5.

Page 151

Dexcom G4 PLATINUM User’s Guide | 452.Startwiththerstnumberorletter(donotenter “SN”): a. Press the UP or DOWN button to show the correc

Page 152

46 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System53. Scroll down to see all of the Device Info: •InsertionTime •LastCalibration •

Page 153 - The Low Glucose Alert

Dexcom G4 PLATINUM User’s Guide | 47Press the SELECT, LEFT or RIGHT button to see the trend graph. This antenna symbol shows that the transmitter and

Page 154

48 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System5PAGE INTENTIONALLY LEFT BLANK

Page 155 - The High Glucose Alert

Dexcom G4 PLATINUM User’s Guide | 496chapter sixINSERTING A SENSOR AND STARTING A SENSOR SESSION

Page 156 - Calibration Stability

Dexcom G4 PLATINUM User’s Guide | 512.3 Product Disposal . ... 124CHAPTER 13: TROUBLESHOOTING 12513.1 Sensor Inser

Page 157 - Calibration

50 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6

Page 158 - Number of Readings Provided

Dexcom G4 PLATINUM User’s Guide | 51CHAPTER 6: INSERTING A SENSOR AND STARTING A SENSOR SESSIONYou need a sensor, a transmitter, and a receiver to u

Page 159 - Over 7-Days

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

Page 160

Dexcom G4 PLATINUM User’s Guide | 53PRECAUTIONDo not use the sensor if its sterile package has been damaged or opened. Using an unsterile sensor migh

Page 161

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

Page 162 - 14.2 Product Specications

Dexcom G4 PLATINUM User’s Guide | 556.4 PLACING THE SENSOR1. Clean your skin at the sensor placement site with an alcohol wipe. Make sure the area

Page 163

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

Page 164

Dexcom G4 PLATINUM User’s Guide | 573. Place your thumb on the white plunger. Push the plunger down completely,makingsureitisushagainstthea

Page 165 - (continued from page before)

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

Page 166

Dexcom G4 PLATINUM User’s Guide | 59place.Thetransmittershouldlieatinthesensorpod.  •Makesureyouhear2clickswhenyousnapthetra

Page 167 - Electromagnetic Immunity

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

Page 168

60 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6current session or stop the session (refer to Chapter 13, Section 13.6, Sensor Shut-off

Page 169

Dexcom G4 PLATINUM User’s Guide | 61Thecountdownsymbolllsinovertimetoshowthatyouaregettingclosertotherstcalibrationtime.

Page 170

62 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6Do not tape under the sensor pod or leave any substance on the skin where you insert th

Page 171

Dexcom G4 PLATINUM User’s Guide | 63To turn the receiver back on and resume communication with the transmitter, press the SELECT button. It may take

Page 172 - Electromagnetic Emissions

64 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System6PAGE INTENTIONALLY LEFT BLANK

Page 173 - Receiver

Dexcom G4 PLATINUM User’s Guide | 657chapter sevenCALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEM

Page 174

66 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System7

Page 175 - 14.3 FCC REQUIREMENTS

Dexcom G4 PLATINUM User’s Guide | 67CHAPTER 7: CALIBRATING YOUR DEXCOM G4 PLATINUM SYSTEMYou must calibrate Dexcom G4 PLATINUM System sensor glucose

Page 176

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

Page 177 - USER ASSISTANCE

Dexcom G4 PLATINUM User’s Guide | 697.2 HOW TO CALIBRATEYou must enter the exact blood glucose value from your meter for each calibration. Blood glu

Page 178

Dexcom G4 PLATINUM User’s Guide | 7GLOSSARY (continued from page before)Hypoglycemia Low blood glucose. Same as “low.” The default low alert in your

Page 179 - SALES SUPPORT

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

Page 180

Dexcom G4 PLATINUM User’s Guide | 71 a. When the receiver does not have a recent sensor glucose reading the default is 120 mg/dL. b. If there ha

Page 181 - WARRANTY

72 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System7.3 STARTUP CALIBRATIONTwo hours after you start the sensor session (see Chapter 6, Sec

Page 182

Dexcom G4 PLATINUM User’s Guide | 73WARNINGCalibrate at least once every 12 hours. Calibrating less often than every 12 hours might cause sensor gluc

Page 183 - CHAPTER 16: WARRANTY

74 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System7When you see this calibration prompt it means it is time to calibrate with a single blo

Page 184

Dexcom G4 PLATINUM User’s Guide | 758chapter eightSENSOR GLUCOSE READINGS AND TRENDS

Page 185

76 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System1038

Page 186

Dexcom G4 PLATINUM User’s Guide | 77CHAPTER 8: SENSOR GLUCOSE READINGS AND TRENDS This chapter teaches you how to view your sensor glucose readings

Page 187

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

Page 188

Dexcom G4 PLATINUM User’s Guide | 79•Each“dot”onthetrendgraphisasensorglucosereadingreportedevery 5 minutes.•Thetrendgraphshowsthe

Page 189 - TRAVEL INFORMATION

8 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemRF Radio-frequency transmission used to send glucose information from the transmitter to

Page 190

80 | 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

Page 191

Dexcom G4 PLATINUM User’s Guide | 81The receiver displays “LOW” when the most recent glucose reading is less than 40 mg/dL and “HIGH” when the most r

Page 192

82 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8This table shows the different trend arrows your receiver displays:Trend ArrowsConstant

Page 193 - APPENDIX

Dexcom G4 PLATINUM User’s Guide | 83Trend arrows do not show when there are glucose data gaps (see Chapter 13, Section 13.4, System Glucose Error). I

Page 194

84 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8Calibration NeededThis symbol means you need to enter a calibration. This prompt will s

Page 195 - CHAPTER 18: APPENDIX

Dexcom G4 PLATINUM User’s Guide | 85Wait 1 Hour Calibration ErrorThis symbol means the sensor is not calibrating correctly. If you see this screen, w

Page 196

86 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System8PAGE INTENTIONALLY LEFT BLANK

Page 197

Dexcom G4 PLATINUM User’s Guide | 879chapter nineALERTS, ALARM & PROFILES

Page 198

88 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9

Page 199

Dexcom G4 PLATINUM User’s Guide | 89CHAPTER 9: ALERTS, ALARM & PROFILESThis chapter teaches you about your Dexcom G4 PLATINUM CGM System’s many

Page 200

Dexcom G4 PLATINUM User’s Guide | 91chapter oneDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM DESCRIPTION

Page 201

90 | Dexcom G4 PLATINUM Continuous Glucose Monitoring SystemWhat will I see on the receiver screen?What does this mean?What is the default setting?H

Page 202

Dexcom G4 PLATINUM User’s Guide | 91What will I see on the receiver screen?What does this mean?What is the default setting?How will the receiver noti

Page 203

92 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9Low glucose alert set at 80 mg/dL9.1.2.1 HIGH GLUCOSE ALERTWhen your sensor glucose re

Page 204 - APPENDIX II, INDEX

Dexcom G4 PLATINUM User’s Guide | 939.1.2.3 LOW GLUCOSE ALARMTheDexcomG4PLATINUMSystemalsohasaxedlowalarmat55mg/dL. This is different

Page 205

94 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System9.1.4 HIGH AND LOW GLUCOSE ALERTS The steps for setting both the high alert and the low

Page 206

Dexcom G4 PLATINUM User’s Guide | 955. To change this number, press the SELECT button, and then press the UP or DOWN button to select your high gluc

Page 207

96 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System99.2.1 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTS The snooze feature le

Page 208

Dexcom G4 PLATINUM User’s Guide | 97Fall Rate menu, On/Off highlightedIf you set your fall rate to 2 mg/dL per minute and your sensor glucose reading

Page 209

98 | Dexcom G4 PLATINUM Continuous Glucose Monitoring System93. Press the UP or DOWN button to choose “On” or “Off.” Then, press the SELECT button

Page 210

Dexcom G4 PLATINUM User’s Guide | 99Out of Range menu, Time highlightedThe out of range symbol in the upper right corner of the trend graph an

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