Dexcom G4 Betriebsanweisung

USER’S GUIDEDexcom G4CONTINUOUS GLUCOSE MONITORING SYSTEM

10 | Dexcom G4 Continuous Glucose Monitoring SystemDEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEM: SYSTEM KIT CONTENTS 5INTRODUCTION 6INDICATIONS

100 | Dexcom G4 Continuous Glucose Monitoring SystemSensor pod is not sticking long enough• Make sure your skin is clear of any cream or lotion bef

Dexcom G4 User’s Guide | 1019. 2.1 TYPES OF CALIBRATION PROMPTSThis section describes the three blood drop symbols you will see. The next section de

102 | Dexcom G4 Continuous Glucose Monitoring System9.2.2 STATUS AREA SYMBOLS DURING CALIBRATION PROMPTS1. Clear the prompt from the screen by pre

Dexcom G4 User’s Guide | 1039.4 SYSTEM GLUCOSE ERRORSometimes the system may tell you that it can not provide a valid sensor glucose reading. When t

104 | Dexcom G4 Continuous Glucose Monitoring System9If you see a difference between your sensor glucose reading and blood glucose value outside the

Dexcom G4 User’s Guide | 105• You should always use the same meter you routinely use to measure your blood glucose to calibrate. Do not switch your

106 | Dexcom G4 Continuous Glucose Monitoring System99.6.2 MANUAL SENSOR SHUT-OFF - “STOP SENSOR”There may be times that you will want to manually

Dexcom G4 User’s Guide | 1073. The stop sensor processing screen will appear to let you know the sensor session is stopping. 4. Once the session ha

108 | Dexcom G4 Continuous Glucose Monitoring System99.8 RECEIVER AND TRANSMITTER COMMUNICATION TROUBLESHOOTING9.8.1 SYSTEM RECOVERY CHECKThis scr

Dexcom G4 User’s Guide | 1099.8.3 LOW TRANSMITTER BATTERYThis screen will appear once the transmitter nears the end of its battery life (see Chapter

Dexcom G4 User’s Guide | 11CHAPTER 4: CALIBRATING YOUR DEXCOM G4 SYSTEM 474.1 Calibration Overview 494.2 How to Calibrate 504.3 Startup Calibrati

110 | Dexcom G4 Continuous Glucose Monitoring System99.10 ALERTS ARE NOT WORKING1. Make sure you have not disabled the sound and/or vibrations for

Dexcom G4 User’s Guide | 111chapter tenTAKING CARE OF YOURDEXCOM G4 SYSTEM

112 | Dexcom G4 Continuous Glucose Monitoring System

Dexcom G4 User’s Guide | 11310.1 MAINTENANCETransmitter• Wipe the outside of the transmitter with a wrung-out, slightly water-dampened cloth or iso

114 | Dexcom G4 Continuous Glucose Monitoring System10.2 STORAGESensor• Keep the sensor in its sterile packaging until you are ready to use it.•

Dexcom G4 User’s Guide | 1156. Do not use wipes that contain adhesives (e.g. Smith + Nephew IV Prep).7. Place the device on a clean, dry cloth and ai

116 | Dexcom G4 Continuous Glucose Monitoring System108. Place the receiver screen side facing down on a clean, dry cloth and air dry for 60 minute

Dexcom G4 User’s Guide | 117chapter elevenTECHNICAL INFORMATION

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Dexcom G4 User’s Guide | 11911.1 PRODUCT SPECIFICATIONSSensorGlucose Range 2.2 – 22.2 mmol/LSensor Life Up to 7 daysCalibration Commercially availab

12 | Dexcom G4 Continuous Glucose Monitoring SystemCHAPTER 8: COMPLETING A SENSOR SESSION 918.1 Automatic Sensor Shut-off 948.2 Removing a Sensor

120 | Dexcom G4 Continuous Glucose Monitoring SystemTransmitterPARAMETER PERFORMANCE CHARACTERISTICSTX/RX Frequencies2.424 999 877 GHz2.449 993 677

Dexcom G4 User’s Guide | 121Guidance and Manufacturer’s Declaration – Electromagnetic ImmunityThe transmitter is intended for use in the electromagne

122 | Dexcom G4 Continuous Glucose Monitoring SystemReceiverReading Frequency Every 5 minutesDimensions Length: 10.1 cmWidth: 4.6 cmThickness: 1.3

Dexcom G4 User’s Guide | 123Immunity Test IEC 60601 Test LevelReceiver Compliance LevelElectromagnetic Environment GuidanceElectromagnetic Environmen

124 | Dexcom G4 Continuous Glucose Monitoring SystemReceiverImmunity Test IEC 60601 Test LevelReceiver Compliance LevelElectromagnetic Environment G

Dexcom G4 User’s Guide | 125a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobil

126 | Dexcom G4 Continuous Glucose Monitoring SystemEmissions Test Compliance Electromagnetic Environment GuidanceRF Radiated emissionsCISPR 11Group

Dexcom G4 User’s Guide | 127For transmitters rated at a maximum output power not listed above, the recommended separation distance in meters (m) can

128 | Dexcom G4 Continuous Glucose Monitoring SystemCharging Cable*Dexcom P/N MT20655Input/Output 5V DC, 1AType USB A to USB micro BLength 0.9 mPowe

Dexcom G4 User’s Guide | 12911.2 DEVICE PERFORMANCE CHARACTERISTICSThe Dexcom G4 System (The System) uses a glucose sensor to continuously measure a

Dexcom G4 User’s Guide | 13chapter oneTHE DEXCOM G4 SYSTEM BASICS

130 | Dexcom G4 Continuous Glucose Monitoring System11System readings agreed with laboratory standard blood glucose results. The remainder of the st

Dexcom G4 User’s Guide | 131Table 2. System and YSI Glucose AccuracyYSI Glucose Ranges mg/dL (mmol/L)Number of Paired System-YSIMean Percent Differe

132 | Dexcom G4 Continuous Glucose Monitoring System11Overall, the System reads, on average, 8.2% different (Mean Percent Difference) than the YSI a

Dexcom G4 User’s Guide | 133Figure 1. Clarke Error Grid, System Results Compared to YSI ResultsTable 4. Clarke Error Grid AnalysisGlucose Range mg/

134 | Dexcom G4 Continuous Glucose Monitoring System11Calibrations StabilityThe System must be calibrated every 12 hours. To demonstrate performance

Dexcom G4 User’s Guide | 135Sensor StabilitySensors can be worn for up to 7 days. To verify sensors performance over time, 42 sensors were evaluated

136 | Dexcom G4 Continuous Glucose Monitoring System11Number of Readings ProvidedThe System is capable of providing a reading up to every 5 minutes,

Dexcom G4 User’s Guide | 137Table 9. Percentage of CGM System Reading within Paired SMBG ResultsSMBG Glucose Ranges mg/dL (mmol/L)Number of Paired S

138 | Dexcom G4 Continuous Glucose Monitoring System11Adverse EventsThere were no adverse events nor any device-related adverse event occurred durin

Dexcom G4 User’s Guide | 13911.3 FCC REQUIREMENTSThe transmitter covered by this user’s guide has been certied under FCC ID: PH29433.Although the t

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Dexcom G4 User’s Guide | 141chapter twelveAPPENDIX

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Dexcom G4 User’s Guide | 143APPENDIX I, RECEIVER ALERTS, ALARM AND PROMPTSThe following tables describe the alarm, alerts and prompts and how the rec

144 | Dexcom G4 Continuous Glucose Monitoring System12What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the

Dexcom G4 User’s Guide | 145What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the receiver notify me?(vibrat

146 | Dexcom G4 Continuous Glucose Monitoring System12What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the

Dexcom G4 User’s Guide | 147What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the receiver notify me?(vibrat

148 | Dexcom G4 Continuous Glucose Monitoring System12What will I see on the receiver screen?Prompt, alert or alarm?What does this mean?How will the

Dexcom G4 User’s Guide | 149Important alerts and alarms that can be veried by the user:• Out of Range Alert - You can test this alert by moving the

Dexcom G4 User’s Guide | 15PlungerApplicator barrel (contains small introducer needle and sensor)Transmitter LatchSafety lockCollarSensor podRelease

150 | Dexcom G4 Continuous Glucose Monitoring SystemGLOSSARYAlternative Site BG TestingThis is when you obtain a blood glucose value on your meter u

Dexcom G4 User’s Guide | 151Re-alert A re-alert occurs when the initial alert has not been conrmed.Receiver The small device which collects your glu

152 | Dexcom G4 Continuous Glucose Monitoring System12“ Use By” Date Lot NumberCautionREFPart Number, Catalog NumberDate of ManufactureSTERILE RSt

Dexcom G4 User’s Guide | 153Two-Sided Humidity LimitationNon-ionizing RadiationEuropean Union WEEE Directive 2006-66-EC0086Marking Certies that the

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Dexcom G4 User’s Guide | 155

LBL-011277 Rev 05 MT21647 Stay Between the Lines Dexcom, Inc. 6340 Sequence Drive San Diego, CA 92121 USA +1.858.200.0200 www.dexcom.com Outs

16 | Dexcom G4 Continuous Glucose Monitoring System11.3 RECEIVER OVERVIEW The receiver is a small hand-held device that shows your sensor glucose r

Dexcom G4 User’s Guide | 17There are ve receiver buttons to move you through the display screens that control setup and operation and allow you to c

18 | Dexcom G4 Continuous Glucose Monitoring System11.4 CHARGING YOUR RECEIVER BATTERYThe receiver battery is rechargeable. The rechargeable batter

Dexcom G4 User’s Guide | 19To recharge your battery, follow the instructions below:1. Plug the included USB cable into the AC power adapter.2. Plug

20 | Dexcom G4 Continuous Glucose Monitoring System11.4.2 CHARGING YOUR RECEIVER BATTERY FROM A WINDOWS COMPATIBLE COMPUTERThe Dexcom Studio softwa

Dexcom G4 User’s Guide | 21HELPFUL HINTS:• Charge your receiver battery before each sensor insertion. Periodically check your battery level to make

22 | Dexcom G4 Continuous Glucose Monitoring System1 More information on main menu options can be found in the sections listed below:See Appendix I,

Dexcom G4 User’s Guide | 23chapter twoDEXCOM G4 SYSTEM SETUP

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Dexcom G4 User’s Guide | 25This chapter will help you when you rst set up your Dexcom G4 Continuous Glucose Monitoring System. Read this chapter bef

26 | Dexcom G4 Continuous Glucose Monitoring System2 c. Set the time and date. The date format is YYYY/MM/DD. • Press the UP or DOWN button to

Dexcom G4 User’s Guide | 27 e. Set your low and high glucose alert values. Your low and high glucose alerts are pre-set to 4.4 mmol/L and 11.1 mmol

28 | Dexcom G4 Continuous Glucose Monitoring System22.2.2 SETTING YOUR RECEIVER TIME AND DATETo set the time and date follow the steps below.1. Fr

Dexcom G4 User’s Guide | 292.2.3 ENTERING YOUR TRANSMITTER IDAny time you switch to a new transmitter and/or receiver (as a replacement to the trans

Dexcom G4CONTINUOUS GLUCOSE MONITORING SYSTEM

30 | Dexcom G4 Continuous Glucose Monitoring System2.2.5 SELECTING YOUR RECEIVER LANGUAGETo select your receiver language follow the steps below.1.

Dexcom G4 User’s Guide | 312.3 CHECKING INFORMATION ABOUT YOUR DEXCOM G4 SYSTEMYou can check your receiver for information about your CGM at any tim

32 | Dexcom G4 Continuous Glucose Monitoring SystemOnce you are in a sensor session, you can check that the receiver and transmitter are communicati

Dexcom G4 User’s Guide | 33chapter threeINSERTING A SENSOR AND STARTING A SENSOR SESSION

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Dexcom G4 User’s Guide | 35To use your Dexcom G4 Continuous Glucose Monitoring System you will need a sensor, a transmitter, and a receiver. You will

36 | Dexcom G4 Continuous Glucose Monitoring System3REVIEW THE SENSOR APPLICATORReview the sensor applicator picture below before using a new sensor

Dexcom G4 User’s Guide | 373.3 CHOOSING AN INSERTION SITEReviewing the tutorial CD would be helpful to learn how to insert your sensor. Choose a sit

38 | Dexcom G4 Continuous Glucose Monitoring System3.4 PLACING THE SENSOR1. Clean the area rst with an alcohol wipe. Make sure the area is clean

Dexcom G4 User’s Guide | 39“2 CLICKS”Push down the plunger – Insert the needle and sensor3. To remove the sensor introducer needle, keep pinching up

4 | Dexcom G4 Continuous Glucose Monitoring SystemIMPORTANT CONTACTS AND NUMBERSDexcom Website: www.dexcom.comYour Transmitter ID:Your Receiver ID:

40 | Dexcom G4 Continuous Glucose Monitoring System3 4. To remove the applicator barrel, squeeze the ribbed release tabs on the sides of the sensor

Dexcom G4 User’s Guide | 413. With one hand, you may want to pinch up on your skin at the front edge of the white adhesive. a. Place one nger on

42 | Dexcom G4 Continuous Glucose Monitoring System3.7 STARTING A SENSOR SESSIONFollow the steps below to tell the receiver that you have inserted

Dexcom G4 User’s Guide | 433.8 SENSOR STARTUP PERIODThe sensor needs a 2-hour startup period to adjust to being under the skin.When you press the SE

44 | Dexcom G4 Continuous Glucose Monitoring System33. To turn the receiver back on and resume communication with the transmitter, press the SELECT

Dexcom G4 User’s Guide | 45HELPFUL H INT:• If your receiver gets wet you need to make sure the speakers and vibrate mode are still working. You can

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Dexcom G4 User’s Guide | 47chapter fourCALIBRATING YOUR DEXCOM G4 SYSTEM

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Dexcom G4 User’s Guide | 49The Dexcom G4 System requires you to calibrate the sensor glucose readings to your blood glucose meter. 4.1 CALIBRATION O

Dexcom G4 User’s Guide | 5SYSTEM CONTENTS: Reorder only the Dexcom G4 System components listed below:DEXCOM G4 CONTINUOUS GLUCOSE MONITORING SYSTEMDe

50 | Dexcom G4 Continuous Glucose Monitoring System4.2 HOW TO CALIBRATEFor calibration, you must enter the exact blood glucose value from your mete

Dexcom G4 User’s Guide | 51 a. When the receiver does not have a recent sensor glucose reading the default is 6.7 mmol/L. b. If there has been a

52 | Dexcom G4 Continuous Glucose Monitoring System4HELPFUL HINTS:• Before calibration make sure a sensor glucose reading or a blood drop symbol

Dexcom G4 User’s Guide | 534.3 STARTUP CALIBRATIONTwo hours after you start the sensor session (see Chapter 3, Section 3.7, Starting a Sensor Sessio

54 | Dexcom G4 Continuous Glucose Monitoring System1. When you see this calibration prompt it means it is time to calibrate with a single blood glu

Dexcom G4 User’s Guide | 55chapter veSENSOR GLUCOSE READINGS AND TRENDS

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Dexcom G4 User’s Guide | 57This chapter will teach you how to view your sensor glucose readings and trend information. The trend graph will provide a

58 | Dexcom G4 Continuous Glucose Monitoring System55.1 Sensor Glucose ReadingsPress the select button to wake up the receiver screen. You will see

Dexcom G4 User’s Guide | 59You can view your past glucose information through the 1, 3, 6, 12, and 24 hour trend graphs by pressing the UP or DOWN bu

6 | Dexcom G4 Continuous Glucose Monitoring SystemWhen you use the system, you will see continuous sensor glucose readings updated every 5 minutes f

60 | Dexcom G4 Continuous Glucose Monitoring SystemThe receiver displays “LOW” when the most recent glucose reading is less than 2.2 mmol/L and “HIG

Dexcom G4 User’s Guide | 61This table shows the different trend arrows your receiver will display:Constant: Your glucose is steady (not increasing/d

62 | Dexcom G4 Continuous Glucose Monitoring System55.3 GLUCOSE STATUS AREA SYMBOLSDuring your sensor session the “status area” at the top of the t

Dexcom G4 User’s Guide | 63Glucose Reading ErrorThis icon means the receiver does not understand the sensor signal temporarily. This icon is related

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Dexcom G4 User’s Guide | 65chapter sixALERTS, ALARMS AND ALERT PROFILES

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Dexcom G4 User’s Guide | 676.1 SETTING YOUR ALERTS6.1.1 DEFAULT ALERT/ALARM SETTINGSWhen you receive your Dexcom G4 CGM System the following alert

68 | Dexcom G4 Continuous Glucose Monitoring SystemWhat will I see on the receiver screen?What does this mean?What is the default setting?How will t

Dexcom G4 User’s Guide | 696.1. 2 GLUCOSE ALERTSThe Dexcom G4 System lets you create your own personal settings for how you want the receiver to te

Dexcom G4 User’s Guide | 7INDICATIONS FOR USEThe Dexcom G4 Continuous Glucose Monitoring System is a glucose-monitoring device indicated for detectin

70 | Dexcom G4 Continuous Glucose Monitoring System6.1.4 LOW GLUCOSE ALERTWhen your sensor glucose readings are at or below your low alert level, t

Dexcom G4 User’s Guide | 716.1.6 GETTING TO THE ALERTS MENU1. Press the SELECT button to turn on the receiver. The 3-hour trend graph will appear.2

72 | Dexcom G4 Continuous Glucose Monitoring System6.1.7 HIGH AND LOW GLUCOSE ALERTS The following steps show you how to change your high and low a

Dexcom G4 User’s Guide | 736.2 ADVANCED ALERTSIn addition to your high and low alerts and alarm, the high and low snooze, rise and fall rate and out

74 | Dexcom G4 Continuous Glucose Monitoring System66.2.1 SETTING A SNOOZE TIME FOR YOUR HIGH AND LOW GLUCOSE ALERTSYou have the option to set a sn

Dexcom G4 User’s Guide | 756.2.2 RISE AND FALL GLUCOSE RATE ALERTSRate alerts notify you when your glucose levels are rising (rise alert) or falling

76 | Dexcom G4 Continuous Glucose Monitoring System6The following steps show you how to change your rise or fall rate alert settings.1. Press the U

Dexcom G4 User’s Guide | 776.2.3 SETTING THE OUT OF RANGE ALERTThe out of range alert lets you know when the sensor/transmitter and receiver are not

78 | Dexcom G4 Continuous Glucose Monitoring System64. Press the UP or DOWN button to choose the elapsed time, after which the receiver will alert

Dexcom G4 User’s Guide | 79HELPFUL HINTS:• On the rst alert notication the receiver will vibrate only (no beep). Regardless of the specic alert p

8 | Dexcom G4 Continuous Glucose Monitoring SystemWARNINGS• Do not use the Dexcom G4 CGM System until after you have been trained or viewed the tra

80 | Dexcom G4 Continuous Glucose Monitoring System6The vibrate prole can be used when you want to silence the receiver and be alerted by vibration

Dexcom G4 User’s Guide | 81PROFILE TYPEVIBRATE SOFT NORMALATTENTIVE HYPOREPEATHigh Alert2 long vibrates2 long vibrates + 2 low beeps2 long vibrates +

82 | Dexcom G4 Continuous Glucose Monitoring SystemThe following steps show you how to access and choose the prole you want to set. 1. Press the S

Dexcom G4 User’s Guide | 83chapter sevenEVENTS

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Dexcom G4 User’s Guide | 85The Events feature allows you to record information about your diabetes management that may help you and your healthcare p

86 | Dexcom G4 Continuous Glucose Monitoring System74. Press the UP or DOWN button to choose the event you want, “Carbs,” “Insulin,” “Exercise” or

Dexcom G4 User’s Guide | 877.1.3 CARBOHYDRATESThe carbs event lets you enter the amount of carbohydrates you have consumed, up to 250 grams. 1. Fro

88 | Dexcom G4 Continuous Glucose Monitoring System77.1.4 INSULINThe insulin event lets you enter the amount of insulin you have taken, up to 250 u

Dexcom G4 User’s Guide | 897.1.5 EXERCISEThe exercise event lets you enter the intensity (light, medium, or heavy) and duration (up to 360 minutes),

Dexcom G4 User’s Guide | 9• Avoid areas that are likely to be bumped, pushed or compressed or areas of skin with scarring, tattoos, or irritation as

90 | Dexcom G4 Continuous Glucose Monitoring System77.1.6 HEALTHThe health event lets you enter episodes of illness, stress, high symptoms, low sym

chapter eightCOMPLETING A SENSOR SESSION

Dexcom G4 User’s Guide | 93Your sensor will continue to give you sensor glucose readings for up to seven days. The performance of a sensor has not be

94 | Dexcom G4 Continuous Glucose Monitoring SystemYou can set the receiver to alert you with these displays using the proles setting (see Chapter

Dexcom G4 User’s Guide | 958.2 REMOVING A SENSORWhen you are ready to remove the sensor, make sure to pull out the sensor pod while the transmitter

96 | Dexcom G4 Continuous Glucose Monitoring System84. Insert the jagged edges so that they “hug” the wide end of the transmitter in the sensor pod

Dexcom G4 User’s Guide | 979chapter nineTROUBLESHOOTING

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Dexcom G4 User’s Guide | 999.1 SENSOR INSERTION TROUBLESHOOTINGSensor insertion difculties• I am having trouble taking out the safety lock: - M